74 61 Wednesday, April 1, 2009 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 71 [Docket No. 00–094–2] RIN 0579–AB84 Interstate Movement of Sheep and Goats AGENCY:

Animal and Plant Health Inspection Service, USDA. ACTION:

Final rule. SUMMARY:

We are amending the regulations regarding the interstate movement of animals to add sheep and goats to the approved livestock facility agreement. Livestock facilities that handle sheep and goats in interstate commerce must meet the requirements for approval including complying with this agreement to utilize certain provisions in our scrapie regulations that reduce the movement requirements for sheep and goats moving to or from these establishments. Such facilities may include stockyards, livestock markets, buying stations, concentration points, or any other premises where sheep and goats in interstate commerce are assembled. Our approval will be contingent on the facility operator meeting certain minimum standards and other conditions related to the receipt, handling, and release of sheep and goats at the facility, as well as complying with certain animal identification and recordkeeping requirements. These standards and other conditions will serve, in part, to support our regulations relating to the interstate movement of sheep and goats in order to control the spread of scrapie, a serious disease of sheep and goats. DATES:

Effective Date: May 1, 2009. FOR FURTHER INFORMATION CONTACT:

Dr. Diane Sutton, Senior Staff Veterinarian, Ruminant Health Programs, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737–1236; (301) 734–6954. SUPPLEMENTARY INFORMATION: Background

On August 26, 2004, we published in the Federal Register (69 FR 52451–52461, Docket No. 00–094–1) a proposed rule to amend our regulations governing the interstate movement of sheep and goats to require livestock facilities that handle sheep and goats in interstate commerce to be approved by the Animal and Plant Health Inspection Service (APHIS) if they want to take advantage of provisions in our scrapie regulations in 9 CFR part 79 that reduce the movement requirements for sheep and goats moving to or from these establishments. Approval would be contingent on the facility operator meeting certain minimum standards and certain other conditions relating to receipt, handling, and release of sheep and goats at the facility, as well as complying with certain animal identification and recordkeeping requirements. The proposed standards and other conditions were based, in part, on our regulations relating to the interstate movement of sheep and goats in order to control the spread of scrapie, a serious disease of sheep and goats.

We solicited comments concerning our proposal for 60 days ending October 25, 2004. We received nine comments by that date. The comments came from private citizens, a livestock marketer and marketing association, wool growers associations, a sheep industry association, a farm bureau association, and a veterinary medical association. The comments generally supported the proposed rule. They did, however, raise several issues associated with the proposed rule. Those issues are discussed below.

Some commenters said that the definitions of exposed animal and high-risk animal in 9 CFR parts 54 and 79 did not properly describe animals that pose a true risk for the spread of scrapie based on current science. These commenters stated that genetically resistant sheep pose a minimal risk of transmitting scrapie and therefore should not be required to be quarantined at assembly points as proposed. In addition, the commenters stated that the definitions in the proposed rule excluded some animals that could pose a risk, such as genetically susceptible animals that have resided on infected premises.

We agree with the commenters and intend to modify the definitions in 9 CFR 54.1 and 79.1 in a future rulemaking. In our proposed rule, we proposed requiring exposed sheep that have not also been designated as high-risk animals be kept in quarantine pens away from other animals at livestock facilities. Because we agree with the commenters that genetically resistant exposed sheep pose a minimal risk of transmitting scrapie, we have removed the provision from this final rule.

Some commenters asked for clarification of the term “breeding sheep and goats,” which is not spelled out in the existing regulations. They said that a single, clear definition of breeding sheep and goats would help clarify both existing identification requirements and the additional requirements described in the proposed rule.

We agree with the commenters and have added the following definition of breeding sheep and goats to §&thnsp;71.1: “Any sexually intact sheep or goat that is not moving either directly to slaughter or through one or more restricted sales and/or terminal feedlots and then directly to slaughter.”

Several commenters requested clarification of the definition of a facility. The proposed rule suggests that a facility has permanent pens, etc., but some commenters stated that some business owners gather sheep for resale in interstate commerce using portable pens and loading ramps. The commenters believe that this portable equipment should be exempt from a definition of a facility.

Becoming an approved livestock facility for sheep and goats is only required if a facility wishes to utilize the provisions in part 79 that reduce the movement requirements for animals moving to or from these facilities, such as the ability to accept unidentified animals in interstate commerce that otherwise would have been required to be identified before entering the facility. As such it places no additional burden on facilities that are not currently approved, or on tent shows or other informal gatherings that use portable equipment.

A few commenters requested clarification of “interstate commerce,” which is defined in part as trade, traffic, or transportation of livestock interstate. The commenters noted that some sheep might cross State lines without ownership change and noted that there are also producers who buy and sell replacement females across State lines. The commenters asked if these types of movement are to be exempt from the proposed requirements which relate to the inspection of facilities, etc. If so, they stated, that exemption needs to be clearly spelled out; if not, then an exemption should be provided, as these activities by and of themselves are not likely to cause the dissemination of scrapie.

The movement of animals by private agreement or without transfer of ownership is governed by the requirements of part 79, and their premises of origin are not considered livestock facilities for the purposes of §&thnsp;71.20.

Some commenters questioned why the proposed rule did not include a requirement for high-risk or exposed sheep intended for slaughter to be kept in pens apart from the general population of sheep and goats, especially those that may return to a farm for breeding. They pointed out that if any of these high-risk animals have lambed or may lamb in the livestock facility, they could introduce scrapie contamination into the environment.

We agree with the commenters and will revise paragraph (a)(5) of §&thnsp;71.20 to read: “Any reactor, suspect, exposed, high-risk, or scrapie-positive livestock shall be held in quarantined pens apart from all other livestock at the facility. This requirement shall not apply to scrapie exposed sheep that are not also designated high-risk animals or to sheep or goats designated under 9 CFR part 79 as scrapie exposed or high-risk animals that either are not pregnant based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, or a certificate issued by an accredited veterinarian stating that the animals are open; or that the animals are under 12 months of age and are not visibly pregnant and are maintained in the same pen only with other animals that will be moved directly to slaughter or to a terminal feedlot in accordance with 9 CFR parts 71 and 79.” This is intended to prevent potential breeding animals from being exposed to scrapie during the time they are held in an approved livestock facility while allowing exposed and high-risk slaughter lambs and kids to move through markets.

We will also change 71.20(a)(11) to add “and the quarantined animal gave birth or aborted at the facility” after “if the disease of concern is scrapie.” This will significantly reduce the number of times the disinfection procedure specified in 9 CFR 54.7(e)(2) will be required in addition to the standard disinfection procedure.

One commenter noted that the proposed rule would require that facility operators separate breeding and slaughter animals at all times, but questioned how operators are to distinguish between animals for breeding and animals for slaughter. The commenter pointed out that sorting animals might entail a substantial amount of time being added to the check-in process, and that the increased time in unloading at the facility could be detrimental to the well-being of the animals.

In response to this comment, we are changing the wording of §&thnsp;71.20(a)(17)(iv) from “breeding and slaughter animals must be separated at all times so that no contact will occur” to “sexually intact animals that do not meet the requirements of part 79 to be sold as breeding animals must be maintained in separate enclosures at all times from animals that may be offered for sale as breeding animals unless all animals maintained in an enclosure arrived at the facility as part of the same consignment and are separated prior to sale.”

One commenter stated that the market approval requirement to provide quarantine pens for reactor, suspect, or exposed sheep or goats makes no sense since the approval requirements also prohibit “the sale of any reactor, suspect, or exposed livestock, and any livestock that show signs of being infected with any communicable disease.” The commenter asserted that market operators are unlikely to know the disease status of the animals entering their market, and even if the animals were known to be reactors, exposed, or suspect, the market operators would refuse to receive them for sale.

We agree it is unlikely that these animals would be found at a market. However, if they are found, it is important that they be segregated. These animals could be placed in a non-species specific quarantine pen that could be disinfected after the affected animals were removed. An APHIS or State animal health official must be notified immediately when such animals are quarantined. We also agree that facilities should not have to indicate that they will handle classes of animals that are prohibited from sale and are amending §&thnsp;71.20(a)(17) accordingly.

Some commenters said that it is not clear if businesses doing less than $750,000 in sales per year will be exempted from the requirements. The commenters further said that such small businesses pose little threat to the nation's economy because of the transport of sheep infected with scrapie and their transactions should be protected.

The $750,000 figure included in the regulatory flexibility analysis for the proposed rule represents the threshold established by the Small Business Administration for transition between small and large entities and has nothing to do with compliance requirements. Businesses doing less that $750,000 in sales per year will not be exempt from these regulations.

Some commenters expressed concern about a lack of resources for enforcement and that APHIS will expect the States and private enterprise to handle enforcement without offering sufficient funding.

APHIS establishes the necessary regulations on interstate commerce to conduct disease eradication, control, and surveillance programs. The States, through cooperative agreements and memorandums of understanding with APHIS, support these efforts by promulgating the necessary laws and regulations and undertaking associated compliance and enforcement activities within the State. The standards that States must meet to qualify as Consistent States are described in §&thnsp;79.6; as we are not amending that section in this rule, we do not agree that States are being assigned additional enforcement responsibilities. Some States currently work collaboratively with APHIS on market approvals and would likely continue to do so. Private enterprises are required to comply with the regulations, not enforce them.

One commenter noted that the issue of individual animal identification is hampered by the fact that there is no technology currently available that is workable at the speed of commerce and is affordable to the sheep and goat industry. The commenter stated that until a suitable technology is available, APHIS cannot assume that individual identification records can be kept on sheep and goats.

We agree with the commenter that in some circumstances reading and recording of pre-existing identification numbers may be impractical and are taking steps in conjunction with the sheep and goat industry ID working group to identify appropriate ID methods which meet the needs of commerce, the needs of disease eradication and surveillance programs, and the economics of sheep and goat production. As appropriate technologies are identified, they will be introduced through the scrapie eradication program and industry initiatives. Until this is achieved, we will continue to follow the established identification requirements in 9 CFR 79.2.

One commenter asserted that there are incorrect statements made in the rule, for example: “Most of the sheep and lambs shipped for immediate slaughter would not be affected by the proposed rule since they would not be handled by a livestock market or other assembly point en route to the slaughter facility.” The commenter asserted that most sheep and lambs are handled by livestock markets and other assembly points (dealers or feed yards) sometime during their lifetimes. As supporting evidence, the commenter asserted that of the approximately 170,595 head of sheep exported to Mexico in 2003, probably 95 percent came through a market or some other dealer in Texas. The commenter also asserted that many of the kid goats and lambs that are sold for immediate slaughter to slaughterhouses all over the United States go through markets first.

We acknowledge the major role of markets in the movement of lambs and cull sheep into and through slaughter channels; however, we believe it is accurate that more than 50 percent of slaughter animals do not move directly to slaughter through livestock facilities that would require approval under this rule.

Some commenters said that there was an inconsistency between the current recordkeeping requirements for livestock facilities and the proposed requirements, specifically with respect to how long the records must be kept. Given this, the commenters stated, clarification of the distinction between the recordkeeping schedule for sheep and goats and that for other species may be warranted in the final rule.

Approved markets that handle sheep and goats would have to agree to maintain records in a manner consistent with the requirements of the scrapie eradication program in 9 CFR part 79. Those recordkeeping requirements support the need for tracing activities for a disease with an incubation period of 4 to 5 years in most cases.

Some commenters stated that the current regulations are sufficient and that there is no need to add additional requirements. They stated that current efforts to eradicate scrapie through genetic selection in show animals would do more than any new regulations, and furthermore the proposed rule would add to the economic burden on producers and be detrimental to the health of the industry.

In order for the United States to eradicate scrapie, we must be able to trace all infected and exposed animals. To do this we need to increase compliance with the identification requirements in 9 CFR part 79. Accelerating the scrapie eradication program could help the United States sheep and goat industry to become more competitive in both the domestic and global market. Since both actual product quality and purchaser's perception of quality contribute to continued market acceptance, efforts to eradicate scrapie will serve the economic interests of the industry.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document. Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

This final regulatory flexibility analysis examines the rule's expected costs and benefits in accordance with requirements of the Office of Management and Budget for regulatory analysis and its expected impact on small entities, in accordance with the Regulatory Flexibility Act. This analysis for the final rule follows an earlier analysis that was prepared for the proposed rule, and takes into account public comment received in response to the proposed rule. There were no public comments in response to the initial regulatory flexibility analysis. Overview of U.S. Sheep and Goat Industry Operations, Inventory, and Trade

Production and trade: As of January 1, 2008, there were 6.055 million sheep and lambs in 67,160 operations, and values at $836 million.1 This number represented a 1.9 percent inventory decline from January 1, 2000. The above total consists of 4.505 million breeding sheep and lambs and 1.55 million market sheep. Of the breeding sheep, ewes, 1 year old or older, totaled 3.617 million, replacement lambs were 0.695 million, and rams totaled 0.193 million.

1&thnsp;USDA/NASS, Sheep and Goats, January 2008.

Sheep are produced in all parts of the United States, although stock levels vary from State to State. Ten States (Colorado, California, Idaho, Montana, Iowa, Oregon, South Dakota, Texas, Utah, and Wyoming) account for nearly 68 percent of the total inventory, with most in the Mountain, North Central, and South Central areas. These States also account for about 81 percent of incoming shipments, indicating most sheep and sheep meat production activities take place in these States.2 Northern and southeastern States have the smallest sheep populations, accounting only for 7.8 percent of the total.

2&thnsp;USDA/NASS, Meat Animal Production, Disposition, and Income: 2007 Summary, April 2008.

A total of about 4.8 million sheep and lambs were marketed in 2007. A little over 84 percent of these are lambs and the rest mature sheep. Marketing includes animals for slaughter market, younger animals shipped to other States for feeding and breeding purposes, and some exports. Most animals shipped for immediate slaughter will not be affected by this rule. A total of 2.69 million sheep and lambs were slaughtered in 2007, of which 95 percent were lambs.3

3&thnsp;USDA/NASS, Livestock Slaughter: 2007 Summary, March 2008. The national average sale price of a sheep between 2003 and 2007 was $132 (=(119 + 130 + 141 + 134 + 138)/5) per head (USDA/NASS, 2008 Agricultural Statistics). Note that these average sale prices reflect the sale of millions of slaughter sheep, selling near the average price, and a few thousand valuable registered breeding sheep selling for much more. The average price for registered breeding sheep is in the range of $300, with some selling for thousands of dollars (http://showcase.netins.net/web/sam/ccd.htm).

In 2002 (the latest year for which detailed data is available for goats), there were 91,462 goat operations in the United States, which raised about 2.53 million goats, valued at approximately $141 million, an increase of about 12 percent from the 1997 level. About 11.9 percent were Angora goats, about 11.5 percent were milk goats, and 76.6 percent were goats other than Angora or milk-type. The State of Texas accounted for about 47 percent of the goat inventory. Other important goat raising States are Alabama, California, Georgia, Kentucky, Missouri, North Carolina, Oklahoma, and Tennessee. These States together represented another 24 percent of the U.S. goat holdings. Goat holdings vary in size and degree of commercialization, with many producers relying on other sources of income. With an average holding of about 28 goats, most, if not all, goat operations are relatively small, and are classified as small entities with annual sales of $750,000 or less.4 Of the total number of operations, about 74 percent of goat producers were full owners, about 21 percent were part owners, and 5 percent were tenants.

4&thnsp;The average price for goats between 2003 and 2007 was $72 (=(63.3 + 67.2 + 75.9 + 78.5 + 74.8)/5) per head USDA/NASS, 2008 Agricultural Statistics). The annual prices are from various issues of Agricultural Statistics. The goat quantities are from the 2002 Census of Agriculture. As in the case of sheep there is variability in the market value of goats. Market values can vary depending on whether the animal is a slaughter goat, Angora goat, dairy goat, crossbred or purebred, etc. Boer goats are considered to be the most expensive goats with some commanding well over $50,000 for one Boer buck and over $10,000 for purebred does (www.jackmauldin.com/new.htm).

The United States produced about 183 million pounds of lamb and mutton in 2007, a decline of about 43 percent from a decade earlier. Imports of lamb and mutton increased from 42.1 million pounds in 1991 to 183.9 million pounds in 2007, an increase of about 337 percent.5

5&thnsp;USDA/NASS, Livestock Slaughter: 2004 Summary, March 2005; USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDP–M–172/October 17, 2008.

An increasing proportion of domestic demand for lamb and mutton is met by imports. The share of imports in domestic consumption of lamb and mutton increased from about 11 percent in 1991 to about 50 percent in 2007. Even with such increased imports both total consumption as well as per capita consumption of lamb declined. Total consumption declined from about 396 million pounds to 367 million pounds, a decline of about 8 percent. Trade

The United States has a limited foreign trade both in live sheep and goats and their products. Both the sources of imports and destination of exports are concentrated in a few countries. During calendar year 2007, the U.S. exported 116,618 sheep valued at $8.148 million (see table 1). Mexico (65,075 head) and Canada (50,808 head) accounted for over 95 percent of this total. Other importers were St. Vincent and the Grenadines (37), Ecuador (323), the Bahamas (22), and Guyana (20). The United States also exported 9,231 goats valued at $597,000 in 2007. Again, the primary importers were Mexico (7,211 head) and Canada (1,697). Other destinations included St. Vincent and the Grenadines, which imported 323 goats. Table 1—Sheep and Goats: Imports and Exports, 2007 Item Imports Exports Numbers Value in

  • millions Sheep 92 $0.058 116,618 $8.148 Goats 33 0.010 9,231 0.597 Total 125 0.068 125,849 8.745 Source: Global Trade Atlas, November 2008.

    The U.S. imported 92 sheep valued at $58,000 in 2007. The sheep imports in 2007 were from Canada (84 head), Australia (6) and New Zealand (2). Additionally, the U.S. imported 33 goats valued at $10,000 in 2007, all from Australia. The average value of an imported sheep ($630) is higher than the average value of an exported sheep ($70). Likewise, the average value of an imported goat ($300) is higher than the average value of an exported goat ($65).

    In 2007, the United States imported 207 million pounds of sheep and goat meat valued at $490.5 million and exported 9.2 million pounds of sheep and goat meat valued at $11.7 million. Most lamb and mutton imports came from Australia and New Zealand. The U.S. exports are distributed to a larger number of markets.6 Since imports of sheep and goats represent a very small fraction of domestic supply, most interstate movements would involve domestic sheep and goats.

    6&thnsp;Global Trade Atlas, November 2008. Expected Costs and Benefits

    There are currently 107 facilities that handle sheep and 62 facilities that handle goats moving in interstate commerce. These facilities would have to provide access to accredited veterinarians, State representatives, and APHIS representatives, as well as comply with certain notification requirements with respect to livestock known to be infected, exposed, or suspect, or that show signs of being infected with a communicable disease if they want to take advantage of provisions in our scrapie regulations in 9 CFR part 79 that reduce the movement requirements for sheep and goats moving to or from these establishments. Such facilities also would have to keep State animal health officials and APHIS informed of upcoming sale days at the facility. Some of the livestock facilities covered by this rule are already subject to these requirements as approved livestock facilities handling other classes of livestock.

    To be approved, such livestock facilities also would have to follow certain identification, recordkeeping, and handling practices with respect to sheep or goats under their control as provided in 9 CFR parts 71 and 79. Documents such as weight tickets, sales slips, and records of origin, identification, and destination relating to livestock at the facility would have to be maintained by the facility for a period of 5 years. Some of these requirements are already provided for elsewhere in the regulations, and thus would not represent a new burden. Still, any new paperwork and administrative burdens may result in additional cost to facility operators who find it necessary to adjust their operations to meet the new requirements. However, the additional activities are not expected to be significant for most facilities.

    The livestock facility and its equipment would have to be maintained in a state of good repair. Chutes, pens, alleys, and sales rings would have to be well constructed and well lighted for the inspection, identification, vaccination, testing, and branding of livestock. Electrical outlets would have to be provided at the chute area for branding purposes. The facility, including yards, docks, pens, alleys, sale rings, chutes, scales, means of conveyance, and their associated equipment would have to be maintained in a clean and sanitary condition. The operator of the facility would be responsible for maintaining an adequate supply of disinfectant and serviceable equipment for cleaning and disinfection. Meeting these standards could entail additional costs for some livestock facilities seeking to qualify as approved livestock facilities. Since most of these conditions represent good business practices and most facilities already follow them, it is not expected to be a significant issue. Most of these facilities are already complying with these conditions as approved livestock facilities handling other classes of livestock. Therefore, this rule should not result in a significant effect on facilities conducting their business.

    In addition, as a condition of approval, reactor, suspect, exposed, scrapie high-risk, or scrapie-positive livestock would have to be held in quarantine pens apart from all other livestock at the facility except exposed sheep that are not also high-risk animals or exposed and high-risk animals that are segregated from breeding animals and that do not pose a significant risk of lambing or kidding while in the facility. The quarantine pens in which such animals are held would have to be clearly marked and would have to be cleaned and disinfected before being used to hold other animals not affected with diseases. The quarantine pens would also have to have proper drainage and be constructed of materials that are substantially impervious to moisture and able to withstand continued cleaning and disinfection. The regulations in 9 CFR 71.20(a)(5) already require that approved livestock facilities hold any reactor, suspect, or exposed livestock in quarantine pens apart from all other livestock at the facility. Facilities handling sheep or goats that do not have quarantine pens would likely incur a one-time capital investment of about $3,000 to $5,000 to install such a pen. Otherwise, the number of reactor, suspect, exposed, scrapie high-risk, or scrapie-positive livestock handled by approved livestock facilities is expected to be very small, and thus quarantining of such animals should not have a significant effect on facility operations or economic activity.

    Furthermore, producers who are engaged in intrastate and interstate marketing may also pay higher consignment fees as approved facilities pass their increased costs of providing services to affected producers. Other costs to producers of this action could result for those animals requiring special handling at livestock facilities.

    This rule could result in a small increase in the time that APHIS and State representatives spend monitoring livestock facilities. In those cases where a facility is already operating as an approved livestock facility for other classifications of livestock, and APHIS and State representatives are already on site, the addition of sheep and goats to the classifications of livestock covered by the agreement is unlikely to substantially increase the workload for those representatives. APHIS and State representatives monitor compliance at such facilities with the identification requirements of the scrapie regulations in 9 CFR part 79. Thus, any additional monitoring responsibilities on the part of State or Federal representatives that may result from implementation of this rule could be handled by existing staff.

    This rule should not affect the interstate flow of sheep and goats. The interstate movement of sheep and goats is important as it reduces interstate price differences faced by consumers of livestock products and it allows movement of sheep and goats from areas of surplus to areas of deficit. A majority of sheep and goats moving across State lines are slaughter animals. Although we do not have specific data, based on our observation of livestock markets and the sheep and goat industry, we believe that most of these slaughter animals move directly to the slaughterhouse and bypass the types of livestock facilities that are the subject of this rule. In addition, the operators of livestock facilities that agree to handle animals affected by scrapie would be the entities most affected by this rule. However, the number of sheep and goats affected by scrapie and handled by these livestock facilities is likely to be very small. This rule should not post a significant burden on operators of livestock facilities or producers and is not expected to reduce interstate commerce or retard economic availability.

    In spite of the potential small burdens to livestock facility operators and producers, the long-term avoided costs of coping with losses associated with scrapie by the U.S. sheep and goat industries as a result of accelerating the scrapie eradication program far exceed the potential costs of this rule. This includes the avoidance of veterinary and associated costs for managing scrapie-affected flocks. An APHIS estimate showed that scrapie costs the U.S. sheep industry about $24 million per year in losses. This includes an estimated $10 million in lost breeding stock and embryo sales, $10.5 million in disposal costs for offal, and $2.8 million in lost meat and bone meal sales.

    Accelerating the eradication of scrapie in the United States also could facilitate movement of the U.S. sheep and goat industries toward increased competitiveness both in the domestic and global markets, particularly in the export of live sheep and goats. Currently, producers in countries such as Australia and New Zealand have a competitive advantage over U.S. producers, based in part on the absence of scrapie in those countries. The achievement of “scrapie-free” status in the United States could neutralize the competitive advantage of such countries.

    Since both actual product quality as well as purchasers' perception of quality contribute to continued market acceptance, efforts to eradicate scrapie and secure the health of U.S. sheep and goats will continue to serve the economic interests of the industry and the nation. Effects on Small Entities

    This rule will affect livestock facilities that handle sheep and goats in interstate commerce, including stockyards, livestock markets, buying stations, concentration points, or any other premises under State or Federal veterinary supervision where sheep or goats have been assembled and which choose to become an approved livestock facility. These facilities are considered small if they have 100 or fewer employees (North American Industry Classification System [NAICS] 424520).7 There are currently about 1,106 livestock facilities that handle cattle and calves, swine, or sheep and goats moving in interstate commerce. Of this total, about 107 handle sheep and 62 handle goats, and all are considered to be small entities.

    7&thnsp;The Small Business Administration defines small market facilities (NAICS 424520) as those having fewer than 100 employees.

    Producers of sheep or goats (NAICS 112410) also could be affected by the rule if livestock facilities pass on the increased costs of providing services attributable to the rule to affected producers. There were 44,189 sheep operations and 43,495 goat operations that sold animals in 2002. An operation engaged in sheep or goat production is considered small if it has annual sales of not more that $750,000.8 Small operations, as shown in table 2, accounted for over 99 percent of all operations that sold sheep and lambs. About 81 percent of the producers sold fewer than 100 animals each, but these accounted only for about 17 percent of total sales of sheep and lambs. On the other hand, large sheep operations that sold 5,000 sheep or more represented less than 1 percent of the farms but accounted for about 32 percent of the total number sold. The overall average size of a flock was 117 animals in 2002. The average size of a flock on large operations was 11,094 animals, while that on small operations was 80 animals. The vast majority of sheep and goat producers would be considered small entities based on such criteria. Of the total number of operations, about 68 percent of producers were full owners, about 26 percent were part owners and 6 percent were tenants. Approximately 81 percent of these sheep are marketed, involving crossing State lines in most cases.

    8&thnsp;Based on the size standard established by the Small Business Administration for livestock and animal specialties, sheep producers (NAICS 112410) and goat producers (NAICS 112420) with not more than $0.75 million in annual sales qualify as small entities. Table 2—Sheep and Lambs: Number Sold by Size of Flock: 2002 Number of sheep/lambs per farm Number of farms with sheep/lambs Percent farms

  • (based on total farms) Inventory of sheep and lambs Percent sheep and lambs
  • (based on total inventory) Average value per operation 1 to 99 35,647 80.7 899,589 17.4 $2,625 100 to 299 5,659 12.8 680,404 13.2 12,510 300 to 999 1,991 4.5 762,007 14.7 39,800 1,000 to 4,999 743 1.7 1,181,441 22.8 165,370 5,000 or more 149 0.3 1,653,010 31.9 1,153,780 Total 44,189 100 5,176,451 100 12,180 Source: USDA/NASS, 2002 Census of Agriculture.

    Livestock facilities that are considered small entities would have to meet the same standards as other larger firms if they choose to become an approved facility. This would include following certain identification, recordkeeping, and handling practices with respect to sheep or goats. Some of these requirements are already provided in part 79 of the regulations, and thus would not represent a new burden. In addition, a certain number of these facilities already comply with many of the conditions in this rule in operating as approved livestock facilities for other classes of livestock.

    We considered the feasibility of exempting small entities from some or all of the requirements in this rule or establishing differing compliance or reporting requirements that take into account the resources available to small entities. However, one of the aims of an effective national program to control and eradicate scrapie is to establish uniform standards that will be followed by all livestock facilities handling unidentified sheep or goats and animals with a certificate of veterinary inspection in interstate commerce. Programs relating to disease surveillance and control do not lend themselves to different compliance standards based on the size of the entity subject to regulation. Also, the requirements in part 79 pertaining to identification, recordkeeping, and handling of sheep and goats make no distinction as to the size of the producer or other livestock facility handling the animals.

    As discussed above, producers who are engaged in intrastate and interstate marketing may be indirectly affected by this rule if they have to pay higher consignment fees as livestock facilities pass their increased costs of providing services. Other costs to producers of this action could result for those animals requiring special handling at approved livestock facilities. However, because most of the facilities that handle sheep and goats are already in compliance with the regulations in part 79, the potential costs to sheep and goat producers considered small entities should not be significant.

    In sum, it is reasonable to expect that both small and large entities would benefit from this rule, which would strengthen scrapie control programs resulting in long-term avoided costs of coping with market losses associated with scrapie. Direct losses to the U.S. sheep industry alone are currently estimated to be as high as $24 million per year. We expect any costs to operators of livestock facilities or to producers to be more than offset by the added benefits to the industry at large in providing a more effective scrapie eradication program.

    The primary alternative to the rule would be to make no changes at all to the existing regulations. The regulations in part 79 already include certain requirements to be followed by approved livestock markets with respect to the identification, recordkeeping and handling of sheep and goats in interstate commerce. However, the regulations in part 71 do not specify the process by which these facilities are to be approved. Therefore, it is imperative that an approval process be added to our regulations.

    This rule contains various recordkeeping requirements, which were described in our proposed rule and which have been approved by the Office of Management and Budget (see “Paperwork Reduction Act” below). Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. National Environmental Policy Act

    An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the APHIS approval of livestock facilities that handle sheep and goats in interstate commerce under the conditions specified in this rule will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

    The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500–1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

    The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site.9 Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue, SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 690–2817 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

    9&thnsp;Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0069. The environmental assessment and finding of no significant impact will appear in the resulting list of documents. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579–0258. E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this final rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851–2908. List of Subjects in 9 CFR Part 71

    Animal diseases, Livestock, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements, Transportation. Accordingly, we are amending 9 CFR part 71 as follows: PART 71—GENERAL PROVISIONS 1. The authority citation for part 71 continues to read as follows: Authority:

    7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 2. Section 71.1 is amended by revising the definitions of Accredited veterinarian, Area veterinarian in charge, Interstate commerce, Livestock, State, State animal health official, and State representative and by adding, in alphabetical order, new definitions for Breeding sheep and goats, Consistent States and Inconsistent States to read as follows:

    §&thnsp;71.1 Definitions.

    Accredited veterinarian. A veterinarian who is approved by the Administrator, in accordance with part 161 of this chapter, to perform official animal health work of the Animal and Plant Health Inspection Service specified in subchapters A, B, C, and D of this chapter and to perform work required by cooperative State-Federal disease control and eradication programs.

    Area veterinarian in charge. The veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of the Animal and Plant Health Inspection Service in the State concerned.

    Breeding sheep and goats. Any sexually intact sheep or goat that is not moving either directly to slaughter or through one or more restricted sales and/or terminal feedlots and then directly to slaughter.

    Consistent States. Those States listed as consistent States in §&thnsp;79.1 of this subchapter because they meet certain standards, as provided in §&thnsp;79.6 of this subchapter, for conducting an active State scrapie program involving the identification of scrapie in sheep and goats for the purpose of controlling the spread of scrapie.

    Inconsistent States. Those States not included in the list of consistent States appearing in §&thnsp;79.1 of this subchapter.

    Interstate commerce. Trade, traffic, transportation, or other commerce between a place in a State and any place outside of that State, or between points within a State but through any place outside of that State.

    Livestock. Horses, cattle, bison, cervids, camelids, sheep, goats, swine, and other farm-raised animals.

    State. Any of the 50 States, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the District of Columbia, and any territories and possessions of the United States.

    State animal health official. The State official responsible for livestock and poultry disease control and eradication programs.

    State representative. An individual employed in animal health work by a State or a political subdivision thereof and authorized by such State or political subdivision to perform the function involved. 3. Section 71.3 is amended by reserving paragraph (c)(5) and by adding a new paragraph (c)(6) to read as follows:

    §&thnsp;71.3 Interstate movement of diseased animals and poultry generally prohibited.

    (c) * * *

    (6) Sheep or goats designated, with regard to scrapie, as exposed animals, high-risk animals, suspect animals, or scrapie-positive animals, as those terms are defined in part 79 of this subchapter, may be moved interstate only in accordance with part 79 of this subchapter.

    §&thnsp;71.6 [Amended] 4. In §&thnsp;71.6, paragraph (a), the first sentence is amended by adding the word “goats,” immediately after the word “sheep,”.
    §&thnsp;71.19 [Amended] 5. In §&thnsp;71.19, paragraph (d), the introductory text is amended by removing the words “Area Veterinarian in Charge” both times it appears and adding the words “area veterinarian in charge” in their place. 6. Section §&thnsp;71.20 is amended as follows: a. In paragraph (a)(3), by adding the number “79,” immediately after the number “78,”. b. In paragraph (a)(4), by adding the words “high-risk and scrapie-positive” immediately after the word “exposed,”. c. By revising paragraphs (a)(5), (a)(6), (a)(7), and (a)(11) to read as set forth below. d. In paragraph (a)(8), by adding the number “79,” immediately after the number “78,”. e. In paragraph (a)(12), by removing the words “or suspect, or exposed” and adding in their place the words “suspect, exposed, high-risk, or scrapie-positive”. f. By redesignating paragraphs (a)(17) through (a)(20) as paragraphs (a)(18) through (a)(21), respectively, and adding a new paragraph (a)(17) before the undesignated center heading “Approvals” to read as set forth below. g. By revising newly redesignated paragraph (a)(18) to read as set forth below. h. By adding a parenthetical containing an OMB citation at the end of the section to read as set forth below.
    §&thnsp;71.20 Approval of livestock facilities.

    * * *

    (5) Any reactor, suspect, exposed, high-risk, or scrapie positive livestock shall be held in quarantined pens apart from all other livestock at the facility. This requirement shall not apply to scrapie-exposed sheep that are not also designated high-risk animals or to sheep or goats designated under 9 CFR part 79 as scrapie-exposed or high-risk animals that either are not pregnant based on the animal being male, an owner certification that any female animals have not been exposed to a male in the preceding 6 months, or a certificate issued by an accredited veterinarian stating the animals are open; or that the animals are under 12 months of age and are not visibly pregnant and are maintained in the same pen only with other animals that will be moved directly to slaughter or to a terminal feedlot in accordance with 9 CFR parts 71 and 79.

    (6) No reactor, suspect, exposed, high-risk, or scrapie-positive livestock, nor any livestock that show signs of being infected with any infectious, contagious, or communicable disease, may be sold at or moved from the facility, except in accordance with 9 CFR parts 71, 75, 78, 79, and 85. Records

    (7) Documents such as weight tickets, sales slips, and records of origin, identification, and destination that relate to livestock that are in, or that have been in, the facility shall be maintained by the facility for a period of 2 years, or for a period of 5 years in the case of sheep or goats. APHIS representatives and State representatives shall be permitted to review and copy those documents during normal business hours.

    (11) Quarantined pens shall be clearly labeled with paint or placarded with the word “Quarantined” or the name of the disease of concern, and shall be cleaned and disinfected in accordance with 9 CFR part 71 as well as 9 CFR 54.7(e)(2) if the disease of concern is scrapie and the quarantined animal gave birth or aborted at the facility, before being used to pen livestock that are not reactor, suspect, exposed, high-risk, or scrapie-positive animals.

    (17) Sheep and goats: —This facility will handle breeding sheep or goats: [Initials of operator, date] —This facility will handle slaughter sheep or goats: [Initials of operator, date] —This facility will handle scrapie-exposed goats or high-risk sheep or goats: [Initials of operator, date] —This facility will not handle goats known to be scrapie-exposed or sheep or goats known to be high-risk animals, nor permit such animals to enter the facility: [Initials of operator, date]

    (i) All sheep and goats must be received, handled, and released by the facility only in accordance with 9 CFR parts 71 and 79.

    (ii) All sheep and goats at the facility must be officially identified and relevant records related to those identified animals must be maintained by the facility operator, as required under 9 CFR part 79.

    (iii) The identity of sheep and goats from consistent States and inconsistent States must be maintained by the facility operator.

    (iv) Sexually intact animals that do not meet the requirements of part 79 to be sold as breeding animals must be maintained in separated enclosures at all times from animals that may be offered for sale as breeding animals unless all animals maintained in an enclosure arrived at the facility as part of the same consignment and are separated prior to sale.

    (v) Any sheep or goats that are designated, with regard to scrapie, as high-risk, suspect or scrapie-positive animals, and goats designated with regard to scrapie as exposed animals, excluding slaughter sheep or goats that are designated as exposed or high-risk animals and are not pregnant, must be held in quarantined pens while at the facility. Approvals

    (18) Request for approval:

    I hereby request approval for this facility to operate as an approved livestock facility for the classes of livestock indicated in paragraphs (14) through (17) of this agreement. I acknowledge that I have received a copy of 9 CFR parts 71, 75, 78, 79, and 85, and acknowledge that I have been informed and understand that failure to abide by the provisions of this agreement and the applicable provisions of 9 CFR parts 71, 75, 78, 79, and 85 constitutes a basis for the withdrawal of this approval. [Printed name and signature of operator, date of signature] (Approved by the Office of Management and Budget under control number 0579–0258) Done in Washington, DC, this 26th day of March 2009. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service.</SIG> <FRDOC>[FR Doc. E9–7233 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 3410–34–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-037-*****-*****- -Name: bstamnas -Payroll No: -Folios: E884-886A -Date: 03/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='S'>DEPARTMENT OF AGRICULTURE <SUBAGY>Animal and Plant Health Inspection Service <CFR>9 CFR Parts 145, 146, and 147 <DEPDOC>[Docket No. APHIS–2007–0042] <RIN>RIN 0579–AC78 <SUBJECT>National Poultry Improvement Plan and Auxiliary Provisions <AGY><HED>AGENCY:<P>Animal and Plant Health Inspection Service, USDA. <ACT><HED>ACTION:<P>Final rule. </ACT> <SUM><HED>SUMMARY:<P>We are amending the National Poultry Improvement Plan (the Plan) and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The changes were voted on and approved by the voting delegates at the Plan's 2006 National Plan Conference. These changes will keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures. <DATES><HED>DATES:<P><E T='03'>Effective Date</E>: May 1, 2009. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>Mr. Andrew R. Rhorer, Senior Coordinator, Poultry Improvement Staff, National Poultry Improvement Plan, Veterinary Services, APHIS, USDA, 1498 Klondike Road, Suite 101, Conyers, GA 30094–5104; (770) 922–3496. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <HD1>Background <P>The National Poultry Improvement Plan (NPIP, also referred to below as “the Plan”) is a cooperative Federal-State-industry mechanism for controlling certain poultry diseases. The Plan consists of a variety of programs intended to prevent and control poultry diseases. Participation in all Plan programs is voluntary, but breeding flocks, hatcheries, and dealers must first qualify as “U.S. Pullorum-Typhoid Clean” as a condition for participating in the other Plan programs. <P>The Plan identifies States, flocks, hatcheries, dealers, and slaughter plants that meet certain disease control standards specified in the Plan's various programs. As a result, customers can buy poultry that has tested clean of <PRTPAGE P='14711'>certain diseases or that has been produced under disease-prevention conditions. <P>The regulations in 9 CFR parts 145, 146, and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS, also referred to as “the Service”) of the U.S. Department of Agriculture (USDA, also referred to as “the Department”) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan. <P>On May 28, 2008, we published in the <E T='04'>Federal Register</E> (73 FR 30528–20543, Docket No. APHIS–2007–0042) a proposal&thnsp;<SU>1</SU><FTREF> to amend the Plan and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The proposed changes were voted on and approved by the voting delegates at the Plan's 2006 National Plan Conference. These changes were intended to keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures. <FTNT><P><SU>1</SU>&thnsp;To view the proposed rule and the comments we received, go to <E T='03'>http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0042.</E></FTNT> <P>We solicited comments concerning our proposal for 60 days ending July 28, 2008. We received 11 comments by that date. They were from State agencies, a university, a diagnostic laboratory association, and private citizens. All 11 commenters raised specific issues regarding the proposed rule. Those issues are discussed below. <P>We proposed to amend §§&thnsp;145.14(d) and 146.13(b), which describe approved tests for avian influenza (AI) under the Plan, to approve the use of two agent detection tests for AI: The real time reverse transcriptase/polymerase chain reaction (RRT–PCR) assay and the USDA-licensed type A influenza antigen capture immunoassay (ACIA). In the proposed regulatory text, we stated that agent detection tests that detect influenza A matrix gene or protein would be allowed to be performed by an authorized laboratory, but tests that determine hemagglutinin (H) or neuraminidase (N) subtypes would not be allowed to be performed by an authorized laboratory. <P>Several commenters stated that laboratories that are not part of the National Animal Health Laboratory Network (NAHLN) should not be authorized to perform RRT–PCR assays for AI. As the commenters noted, many laboratories that are considered authorized laboratories under the Plan are operated by poultry industry groups or other parties and thus are not part of NALHN, which is composed of State and university laboratories and APHIS' National Veterinary Services Laboratories (NVSL). <P>NAHLN is a multifaceted network composed of sets of laboratories that focus on different diseases, using common testing methods and software platforms to process diagnostic requests and share information. The State and university laboratories in NAHLN perform routine diagnostic tests for endemic animal diseases as well as targeted surveillance and response testing for foreign animal diseases. The laboratories have the capability and capacity to conduct nationwide surveillance testing for the early detection of an animal disease outbreak, and they are able to test large numbers of samples rapidly during an outbreak and to demonstrate freedom from disease after eradication. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-038-*****-*****- -Name: bstamnas -Payroll No: -Folios: E887-889 -Date: 03/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>The commenters cited many concerns regarding allowing laboratories other than NAHLN laboratories to perform RRT–PCR assays for AI, including conflicts of interest in reporting positive results from industry-operated laboratories; loss of data or delays in reporting to State animal health officials in the event of positive results; lack of standardization of procedures between other laboratories and NALHN; NVSL's lack of resources for auditing industry laboratories; the potential for false positives or premature reporting from non-NAHLN laboratories; and biosafety and public health concerns. One of the commenters noted that only NALHN laboratories are currently authorized to perform RRT–PCR assays; this commenter stated that this system has worked well. <P>We agree with the commenters that RRT–PCR assays for AI should only be performed by NAHLN laboratories. We proposed that RRT–PCR assays would have to be conducted using the NVSL official protocol for RRT–PCR (AVPR01510) and be conducted by personnel who have passed an NVSL proficiency test. The protocol and the proficiency testing we proposed to require are only available to NALHN laboratories and personnel. <P>To resolve any confusion that may have arisen from our statement that tests that detect influenza A matrix gene or protein would be allowed to be performed by an authorized laboratory, we have modified that provision in this final rule. The regulatory text in this final rule states that agent detection tests may be used to detect influenza A matrix gene or protein but not to determine H or N subtypes. As described earlier, the specific requirements for performing RRT–PCR assays make it clear that only NAHLN laboratories can perform those assays. (As commenters noted, the ACIA may be performed by authorized laboratories as well as NAHLN laboratories.) <P>The proposed rule contained several other proposed changes related to AI. We proposed to add in a new §&thnsp;145.15 the requirements in §&thnsp;146.14 for AI diagnostic surveillance programs, which must include examination of all submitted cases of unexplained respiratory disease, egg production drops, and mortality for AI; this proposed change was intended to clearly indicate that these requirements apply to breeding poultry as well as commercial poultry. We proposed to increase the frequency at which multiplier egg-type chicken breeding flocks, multiplier meat-type chicken breeding flocks, and multiplier turkey breeding flocks that participate in the U.S. Avian Influenza Clean classifications in §§&thnsp;145.23(h)(2), 145.33(l)(2), and 145.43(g)(2), respectively, are tested, allowing 90 days rather than 180 days between tests. We proposed to establish a U.S. Avian Influenza Clean classification for ostrich, emu, rhea, and cassowary breeding flocks. We proposed to modify the sampling requirements for the U.S. H5/H7 Avian Influenza Monitored classification for meat-type turkey slaughter plants to allow testing at the flock level rather than at slaughter. Finally, we proposed to establish a U.S. H5/H7 Avian Influenza Monitored classification for commercial upland game bird slaughter plants, commercial waterfowl slaughter plants, raised-for-release upland game bird premises, and raised-for-release waterfowl premises. <P>One commenter stated a presumption that there is no AI being found in the U.S. chicken industry, based on the lack of such reports. Based on this information, the commenter stated, increasing sampling frequency does not appear to make sense. The commenter recommended instead that we require end-of-life testing of long-lived birds, such as breeder flocks, and symptomatic flocks, such as flocks with respiratory disease. The commenter stated that testing every meat bird flock in low-risk environments, such as conventional commercial poultry houses, appears to be an unnecessary step to placate international trading partners. <P>We agree with the commenter that testing of breeding flocks and symptomatic flocks is important. Our proposals to increase the frequency at which breeding flocks participating in <PRTPAGE P='14712'>the U.S. Avian Influenza Clean classification are tested and to add diagnostic AI surveillance program provisions to 9 CFR part 145 speak to our concern on those issues. However, contrary to the commenter's assertion, occurrences of AI in U.S. poultry are rare but regular. The testing requirements for participants in the U.S. H5/H7 Avian Influenza Monitored classifications for meat-type flocks and slaughter plants are necessary to provide assurance that such flocks and slaughter plants are monitored for AI. <P>We proposed to establish new requirements for authorized laboratories in a new §&thnsp;147.51. These included a requirement for an annual site visit and recordkeeping audit by the Official State Agency (OSA), which the regulations define as the State authority recognized by the Department to cooperate in the administration of the Plan. (In some States, the OSA is also the State animal health authority; in some States, the OSA includes representation from, but is not identical to, the State animal health authority.) <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-039-*****-*****- -Name: bstamnas -Payroll No: -Folios: E890-891 -Date: 03/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>One commenter recommended that we require that the OSA and the State animal health authority of the State in which the laboratory is located be in concurrence before a laboratory is approved. The commenter also recommended that the Plan be modified where applicable to say that a representative of the State animal health authority may accompany the OSA whenever a site visit is conducted. <P>The OSA is the entity designated in the NPIP to carry out the administration of the Plan within a State and, in that capacity, makes the final determination on whether to authorize a laboratory. Therefore, requiring in the regulations that the State animal health authority concur with the OSA to authorize a laboratory or that the State animal health authority participate in site visits with the OSA would be inappropriate. However, we note that, in those cases when the OSA is not the State animal health authority itself, the OSA always includes representation from the State animal health authority. <P>Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the change discussed in this document. <HD1>Executive Order 12866 and Regulatory Flexibility Act <P>This final rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. <P>In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. <P>We are amending the Plan and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The changes were voted on and approved by the voting delegates at the Plan's 2006 National Plan Conference. These changes will keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures. <P>The United States is the world's largest poultry producer, the second-largest egg producer, and the largest exporter of poultry meat. U.S. poultry meat production totals over 42 billion pounds annually; over four-fifths is broiler meat, most of the remainder is turkey meat, and a small fraction is other chicken meat. Cash receipts (<E T='03'>see</E> table 1) from sales of poultry and eggs (broilers, farm chickens, eggs, turkey, ducks, and other poultry) were about $28.9 billion in 2005 (with preliminary value for 2006 and forecasted value for 2007 being a little higher).<SU>2</SU><FTREF> Of this total, 72 percent was from broilers, 14 percent from eggs, 11 percent from turkeys, and 3 percent from other poultry. <FTNT><P><SU>2</SU>&thnsp;USDA/Economic Research Service (ERS), Farm Income/Cash receipts, 2002–2007.</FTNT> <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-040-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 892-94 -Date: 03/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <GPOTABLE COLS='7' OPTS='L2,i1' CDEF='s100,12,12,12,12,12,12'> <TTITLE>Table 1—Cash Receipts for Poultry and Eggs, United States, 2000–05; 2006, and 2007 <BOXHD> <CHED H="1">Commodity <CHED H="1">2002 <CHED H="1">2003 <CHED H="1">2004 <CHED H="1">2005 <CHED H="1">2006&thnsp;<SU>P</SU> <CHED H="1">2007&thnsp;<SU>F</SU> <ROW RUL="n,s&qdrt;"><ENT I="22">  <ENT A='05'>$1000s <ROW><ENT I="01">Poultry/eggs <ENT>21,138,999 <ENT>23,959,134 <ENT>29,540,692 <ENT>28,903,545 <ENT>27,700,000 <ENT>29,600,000 <ROW><ENT I="01">Broilers <ENT>13,437,700 <ENT>15,214,945 <ENT>20,446,096 <ENT>20,901,934 <ENT>19,000,000 <ENT>20,100,000 <ROW><ENT I="01">Farm chickens <ENT>49,850 <ENT>47,508 <ENT>57,260 <ENT>63,963 <ENT>+ <ENT>+ <ROW><ENT I="01">Chicken eggs <ENT>4,232,433 <ENT>5,273,099 <ENT>5,239,082 <ENT>4,000,142 <ENT>4,400,000 <ENT>5,100,000 <ROW><ENT I="01">Turkeys <ENT>2,643,273 <ENT>2,631,862 <ENT>2,995,802 <ENT>3,157,637 <ENT>3,500,000 <ENT>3,500,000 <ROW><ENT I="01">Ducks <ENT>15,300 <ENT>19,200 <ENT>20,900 <ENT>21,390 <ENT>+ <ENT>+ <ROW><ENT I="01">Other poultry <ENT>760,443 <ENT>772,521 <ENT>781,553 <ENT>758,479 <ENT>800,000 <ENT>900,000 <TNOTE>P = preliminary, F = Forecast, + = included in other poultry. <TNOTE>Source: USDA/ERS, Farm Income/Farm Cash Receipts, 1924–2005; 2006<SU>P</SU>, and 2007.<SU>F</SU> (<E T='03'>http://www.ers.usda.gov/data/FarmIncome/finfidmuxls.htm</E>). </GPOTABLE> <P>In terms of tonnage, poultry production and trade exceeds that of beef or pork. For instance, in 2006, the United States produced 41.4 billion pounds of poultry meat, compared with 26.2 billion pounds of beef and 21 billion pounds of pork. The United States also produced 6.5 billion dozen eggs in 2006. Per capita consumption of poultry meat (103.8 pounds in 2006) exceeds per capita consumption of both beef (65.7 pounds) and pork (49.3 pounds). Furthermore, the United States exports more poultry meat (5.8 billion pounds in 2006) than beef and veal (1.2 billion pounds) or pork (3 billion pounds).<SU>3</SU><FTREF> <FTNT><P><SU>3</SU>&thnsp;USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDP–M–158, August 20, 2007.</FTNT> <P>Broiler production is concentrated in a group of States stretching from Delaware south along the Atlantic coast to Georgia, then westward through Alabama, Mississippi, and Arkansas. The top broiler-producing State is Georgia, followed by Arkansas, Alabama, North Carolina, Mississippi, and Texas. Operations in these States account for over 65 percent of broiler cash receipts. <P>Most U.S. broiler production is conducted under contract with broiler processors. The grower normally supplies the grow-out house with all the necessary heating, cooling, feeding, and watering systems. The grower also supplies the labor needed in growing the birds. The broiler processor supplies the chicks, feed, and veterinary medicines. The processor schedules transportation of the birds from the farm <PRTPAGE P='14713'>to the slaughter plant. In many cases, the processor also supplies the crews who place broilers into cages for transportation to the slaughter plant. <P>The U.S. turkey industry produces over one-quarter of a billion birds annually, with the live weight of each bird averaging over 25 pounds. Production of turkeys is somewhat more scattered geographically than broiler production. The top five turkey-producing States are Minnesota, North Carolina, Missouri, Arkansas, and Virginia. The United States is by far the world's largest turkey producer, followed by the European Union. Even though exports are a major component of the U.S. turkey industry, the United States consumes more turkey per capita than any other country. <P>U.S. egg operations produce over 77 billion eggs annually. Over three-fourths of egg production is for human consumption (the table-egg market). The remainder of production is for the hatching market. These eggs are hatched to provide replacement birds for the egg-laying flocks and broiler chicks for grow-out operations. The top five egg-producing States are Iowa, Ohio, Pennsylvania, Indiana, and California.<SU>4</SU><FTREF> <FTNT><P><SU>4</SU>&thnsp;USDA/ERS, Livestock, Dairy, and Poultry Outlook/LDP–M–158, August 20, 2007.</FTNT> <P>The United States is the world's largest exporter of poultry meat. Annual poultry meat exports totaled about 5.8 billion pounds in 2006, which is about 14.5 percent of U.S. production. (All trade statistics in this and the following paragraph are for 2006.) Demand for U.S. poultry meat products has fluctuated over the last several years due to changing economic conditions and currency exchange rates in major importing countries. The largest importers of U.S. broiler products are Russia, Mexico, China, Canada, Hong Kong, Turkey, Taiwan, Angola, South Korea, and Ukraine. Together, these markets accounted for over 74 percent of U.S. poultry meat exports, on a quantity basis. The United States imports only small amounts of poultry meat, accounting for less than two-tenths of 1 percent of domestic production. Over 98 percent of imports come from Canada. <P>As in the case of poultry meat, U.S. exports of live poultry and exports of fresh shell eggs are widely distributed and significantly outweigh imports of these products. The United States exported 1,302 million eggs and imported 65.4 million eggs in 2006. The major importers of eggs are Canada, Mexico, Jamaica, United Kingdom, Hong Kong, Brazil, Trinidad and Tobago, Dominican Republic, Guyana, and Nicaragua. These countries altogether accounted for about 80 percent of U.S. egg exports. U.S. imports are mainly from Canada, China, France, and Taiwan. These countries together accounted for 91 percent of U.S. imports of eggs. The United States exported 51 million live poultry and imported 13.7 million live poultry in 2006. Major destinations include Canada, Mexico, China, Thailand, Peru, Colombia, Guatemala, Indonesia, Egypt, and El Salvador. These countries accounted for 70 percent of U.S. total live poultry exports. All U.S. imports of live poultry came from Canada, United Kingdom, and Italy. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-041-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 895-97 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>The decision to participate in the NPIP program is voluntary. Being a participating flock in NPIP has many benefits. These include: The flock being recognized as a participating member of NPIP; the flock having an approval number which may be used on shipping labels, certificates, invoices, and other documents for identification purposes; the flock being listed in the official <E T='03'>NPIP Directory of Participants</E>; free listing in various State fair brochures; and receiving emergency disease management updates. Furthermore, being a participant in the NPIP allows for greater ease in moving hatching eggs and live birds within a State, across State lines, and into international markets. In fact, most countries will not accept hatching eggs, live birds, table eggs, or broilers unless they can be shown to be from an NPIP participant. <P>Any increased cost to NPIP participants due to the proposed rule will be minor compared to the expected benefits of the changes in this final rule. Additional costs are likely to be minor because most of the participants already had been implementing these changes for several years. Even if additional tests are required, the additional number of birds tested will be very small compared to the size of flocks in the industry. Individual producers will continue to participate in the NPIP program only if the benefits they receive from participation outweigh the costs. Over 99 percent of poultry breeders and hatcheries, commercial table-egg layer flocks, and commercial meat-type chicken and turkey slaughter plants are Plan participants. <HD1>Impact on Small Entities <P>The Regulatory Flexibility Act requires that agencies consider the economic effects of their rules on small entities. According to the Small Business Administration's (SBA's) Office of Advocacy, regulations create economic disparities based on size when they have a significant economic impact on a substantial number of small entities. <P>Entities engaged in production of breeding stock and hatcheries will be affected by this final rule. Currently there are four major firms that produce primary breeding stock of egg-type chickens, three breeders of meat-type chickens, two breeders of turkeys, and one firm producing breeding stock of both egg-type and meat-type chickens.<SU>5</SU><FTREF> All of these are large facilities headquartered in the United States that operate in domestic and international markets, and would not be considered small entities. Few, if any, small producers will be directly affected by this final rule. <FTNT><P><SU>5</SU>&thnsp;Mary E. Delany, <E T="03">Genetic Diversity and Conservation of Poultry</E>, p. 261, in W.M. Muir and S.E. Aggrey, <E T="03">Poultry Genetics, Breeding and Biotechnology</E>, August 2003; Susanne Gura, <E T="03">Livestock Genetics Companies: Concentration and Proprietary Strategies of an Emerging Power in the Global Economy</E> (<E T='03'>http://pastoralpeoples.org/docs/Livestock_genetics.pdf</E>).</FTNT> <P>Broiler operations (North American Industry Classification System [NAICS] code 112320), turkey operations (NAICS 112330), hatcheries (NAICS 112340), and other poultry operations (112390) could also be affected by the changes in this final rule. All of these operations are considered to be small if they have annual sales of $750,000 or less (SBA Table of Small Business Size Standards, <E T='03'>http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf</E>). Commercial egg producers (NAICS 112310) are considered small if they have annual sales of not more than $11.5 million. <P>The broiler industry has evolved from small backyard flocks to fewer than 50 highly specialized, vertically integrated agribusiness firms. A measure of the changing structure is the number and size of chicken hatcheries. In 1973, there were 989 facilities that hatched all chickens in the United States. Those hatcheries had the capacity to incubate 436 million eggs at one time for an average capacity of 440,849 eggs per facility. In 2006, there were 313 chicken hatcheries, with an incubator capacity of 910 million eggs for an average capacity of 2.9 million eggs per facility. Similarly, there were 203 turkey hatching facilities with capacity to incubate 45 million eggs at one time, for an average capacity of 221,675 eggs per facility. In 2006, there were 55 turkey hatcheries, with an incubator capacity of 39 million eggs for an average capacity of 703,927 eggs per facility.<SU>6</SU><FTREF> <FTNT><P><SU>6</SU>&thnsp;USDA, ERS, Hatchery Production, March 1975; Hatchery Production 2006 Summary, April 2007.</FTNT> <P>We do not foresee any significant impact of this final rule on small <PRTPAGE P='14714'>entities. The NPIP is a voluntary program, so poultry producers can decide if it is beneficial for them to participate. <P>Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. <HD1>Executive Order 12372 <P>This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (<E T='03'>See</E> 7 CFR part 3015, subpart V.) <HD1>Executive Order 12988 <P>This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-042-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 898-900 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <HD1>Paperwork Reduction Act <P>This final rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 <E T='03'>et seq</E>.). <LSTSUB><HED>List of Subjects in 9 CFR Parts 145, 146, and 147 <P>Animal diseases, Poultry and poultry products, Reporting and recordkeeping requirements. </LSTSUB> <REGTEXT TITLE='9' PART='145'> <AMDPAR>Accordingly, we are amending 9 CFR parts 145, 146, and 147 as follows: <PART><HED>PART 145—NATIONAL POULTRY IMPROVEMENT PLAN FOR BREEDING POULTRY <AMDPAR>1. The authority citation for part 145 continues to read as follows: <AUTH><HED>Authority:<P> 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4.<Q P='04'></REGTEXT> <REGTEXT TITLE='9' PART='145'> <AMDPAR>2. Section 145.1 is amended as follows: <AMDPAR>a. By revising the definition of <E T='03'>authorized laboratory</E> to read as set forth below. <AMDPAR>b. By adding, in alphabetical order, new definitions of <E T='03'>NPIP Technical Committee</E> and <E T='03'>Senior Coordinator</E> to read as set forth below. <AMDPAR>c. In the definition of <E T='03'>equivalent or equivalent requirements</E>, by adding the words “or exceed” after the words “equal to” and the words “they are” after the words “with which.” <SECTION><SECTNO>§&thnsp;145.1 <SUBJECT>Definitions. <STARS> <P><E T='03'>Authorized laboratory</E>. An authorized laboratory is a laboratory that meets the requirements of §&thnsp;147.51 and is thus qualified to perform the assays described in part 147 of this subchapter. <STARS> <P><E T='03'>NPIP Technical Committee</E>. A committee made up of technical experts on poultry health, biosecurity, surveillance, and diagnostics. The committee consists of representatives from the poultry and egg industries, universities, and State and Federal governments and is appointed by the Senior Coordinator and approved by the General Conference Committee. <STARS> <P><E T='03'>Senior Coordinator</E>. An employee of the Service whose duties may include, but will not necessarily be limited to: <P>(1) Serving as executive secretary of the General Conference Committee; <P>(2) Serving as chairperson of the Plan Conference described in §&thnsp;147.47; <P>(3) Planning, organizing, and conducting the Plan Conference; <P>(4) Reviewing NPIP authorized laboratories as described in §&thnsp;147.51; <P>(5) Coordinating the State administration of the NPIP through periodic reviews of the administrative procedures of the Official State Agencies, according to the applicable provisions of the Plan and the Memorandum of Understanding; <P>(6) Coordinating rulemaking to incorporate the proposed changes of the provisions approved at the Plan conference into the regulations in parts 145, 146, and 147 of this subchapter; <P>(7) Directing the production of official NPIP publications; <P>(8) Proposing an annual budget for plan activities and the General Conference Committee; and <P>(9) Providing overall administration of the NPIP. <STARS></REGTEXT> <REGTEXT TITLE='9' PART='145'> <AMDPAR>3. In §&thnsp;145.2, paragraph (a) is amended by adding a new sentence at the end of the paragraph to read as follows: <SECTION><SECTNO>§&thnsp;145.2<SUBJECT> Administration. <P>(a) * * * In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency. <STARS></REGTEXT> <REGTEXT TITLE='9' PART='145'> <AMDPAR>4. Section 145.14 is amended as follows: <AMDPAR>a. By adding a new paragraph (b)(5) to read as set forth below. <AMDPAR>b. By revising paragraph (d) to read as set forth below. <SECTION><SECTNO>§&thnsp;145.14 <SUBJECT>Blood testing. <STARS> <P>(b) * * * <P>(5) The official molecular examination procedures for <E T='03'>Mycoplasma gallisepticum</E> and <E T='03'>M. synoviae</E> are the polymerase chain reaction (PCR) test described in §&thnsp;147.30 of this subchapter and the real-time PCR test described in §&thnsp;147.31 of this subchapter. <STARS> <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-043-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 901-03 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <P>(d) <E T='03'>For avian influenza</E>. The official tests for avian influenza are described in paragraphs (d)(1) and (d)(2) of this section. <P>(1) <E T='03'>Antibody detection tests</E>. (i) <E T='03'>Enzyme-linked immunosorbent assay (ELISA)</E>. ELISA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer. <P>(ii) <E T="03">The agar gel immunodiffusion (AGID) test.</E> <P>(A) The AGID test must be conducted on all ELISA-positive samples. <P>(B) The AGID test must be conducted using reagents approved by the Department and the Official State Agency. <P>(C) Standard test procedures for the AGID test for avian influenza are set forth in §&thnsp;147.9 of this subchapter. The test can be conducted on egg yolk or blood samples. <P>(D) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. <P>(2) <E T='03'>Agent detection tests</E>. Agent detection tests may be used to detect influenza A matrix gene or protein but not to determine hemagglutinin or neuraminidase subtypes. Samples for agent detection testing should be collected from naturally occurring flock mortality or clinically ill birds. <P>(i) <E T="03">The real time reverse transcriptase/polymerase chain reaction (RRT–PCR) assay.</E> <P>(A) The RRT–PCR tests must be conducted using reagents approved by the Department and the Official State Agency. The RRT–PCR must be conducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRT–PCR (AVPR01510) and must be conducted by personnel who have passed an NVSL proficiency test. <P>(B) Positive results from the RRT–PCR must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. <PRTPAGE P='14715'><P>(ii) <E T="03">USDA-licensed type A influenza antigen capture immunoassay (ACIA).</E> <P>(A) The USDA-licensed type A influenza ACIA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer. <P>(B) Positive results from the ACIA must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. <P>(3) The official determination of a flock as positive for the H5 or H7 subtypes of avian influenza may be made only by NVSL. <STARS></REGTEXT> <REGTEXT TITLE='9' PART='145'> <AMDPAR>5. Section 145.15 is revised to read as follows: <SECTION><SECTNO>§&thnsp;145.15 <SUBJECT>Diagnostic surveillance program for low pathogenic avian influenza. <P>(a) The Official State Agency must develop a diagnostic surveillance program for H5/H7 low pathogenic avian influenza for all poultry in the State. The exact provisions of the program are at the discretion of the States. The Service will use the standards in paragraph (b) of this section in assessing individual State plans for adequacy, including the specific provisions that the State developed. The standards should be used by States in developing those plans. <P>(b) Avian influenza must be a disease reportable to the responsible State authority (State veterinarian, etc.) by all licensed veterinarians. To accomplish this, all laboratories (private, State, and university laboratories) that perform diagnostic procedures on poultry must examine all submitted cases of unexplained respiratory disease, egg production drops, and mortality for avian influenza by both an approved serological test and an approved antigen detection test. Memoranda of understanding or other means must be used to establish testing and reporting criteria (including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service) and approved testing methods. In addition, States should conduct outreach to poultry producers, especially owners of smaller flocks, regarding the importance of prompt reporting of clinical symptoms consistent with avian influenza. </REGTEXT> <REGTEXT TITLE='9' PART='145'> <SECTION><SECTNO>§&thnsp;145.23 <SUBJECT>[Amended] <AMDPAR>6. In §&thnsp;145.23, paragraphs (h)(2)(i) and (h)(2)(ii) are amended by removing the number “180” and replacing it with the number “90” each time it occurs. </REGTEXT> <REGTEXT TITLE='9' PART='145'> <SECTION><SECTNO>§&thnsp;145.33 <SUBJECT>[Amended] <AMDPAR>7. In §&thnsp;145.33, paragraphs (l)(2)(i) and (l)(2)(ii) are amended by removing the number “30” and replacing it with the number “15” each time it occurs; and by removing the number “180” and replacing it with the number “90” each time it occurs. </REGTEXT> <REGTEXT TITLE='9' PART='145'> <SECTION><SECTNO>§&thnsp;145.43 <SUBJECT>[Amended] <AMDPAR>8. In §&thnsp;145.43, paragraphs (g)(2)(i) and (g)(2)(ii) are amended by removing the number “180” and replacing it with the number “90” each time it occurs.</REGTEXT> <REGTEXT TITLE='9' PART='145'> <AMDPAR>9. In §&thnsp;145.52, paragraph (c) is revised to read as follows: <SECTION><SECTNO>§&thnsp;145.52 <SUBJECT>Participation. <STARS> <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-044-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 904-06 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <P>(c) Subject to the approval of the Service and the Official State Agencies in the importing and exporting States, participating flocks may report poultry sales to importing States by using either VS Form 9–3, “Report of Sales of Hatching Eggs, Chicks, and Poults,” or by using a hatchery invoice form (9–3I) approved by the Official State Agency and the Service to identify poultry sales to clients. If the selling hatchery uses the 9–3I form, the following information must be included on the form: <P>(1) The form number “9–3I”, printed or stamped on the invoice; <P>(2) The hatchery name and address; <P>(3) The date of shipment; <P>(4) The hatchery invoice number; <P>(5) The purchaser name and address; <P>(6) The quantity of products sold; <P>(7) Identification of the products by bird variety or by NPIP stock code as listed in the NPIP APHIS 91–55–078 appendix; and <P>(8) The appropriate NPIP illustrative design in §&thnsp;145.10. One of the designs in §&thnsp;145.10(b) or (g) must be used. The following information must be provided in or near the NPIP design: <P>(i) The NPIP State number and NPIP hatchery approval number; and <P>(ii) The NPIP classification for which product is qualified (e.g., U.S. Pullorum-Typhoid Clean). <STARS></REGTEXT> <REGTEXT TITLE='9' PART='145'> <AMDPAR>10. In §&thnsp;145.63, a new paragraph (b) is added to read as follows: <SECTION><SECTNO>§&thnsp;145.63 <SUBJECT>Terminology and classification; flocks and products. <STARS> <P>(b) <E T='03'>U.S. Avian Influenza Clean</E>. This program is intended to be the basis from which the breeding-hatchery industry may conduct a program for the prevention and control of avian influenza. It is intended to determine the presence of avian influenza in all ostrich, emu, rhea, and cassowary breeding flocks through routine serological surveillance of each participating breeding flock. Acceptable tests include antigen and antibody detection tests, as approved by the Official State Agency. A flock, and the hatching eggs and chicks produced from it, will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: <P>(1) It is a primary breeding flock in which 10 percent of the flock, up to a maximum of 30 birds, has been tested negative for type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall be further tested by an authorized laboratory. To retain this classification: <P>(i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or <P>(ii) A sample of less than 10 percent of the birds, up to a maximum of 30 birds, may be tested and found to be negative at any one time if all pens are equally represented and a total of 30 birds are tested within each 180-day period. <P>(2) It is a multiplier breeding flock in which a minimum of 30 birds has been tested negative to type A influenza virus with all pens represented equally and when the tested birds are more than 4 months of age. Positive samples shall be further tested by an authorized laboratory. To retain this classification: <P>(i) A sample of at least 30 birds must be tested negative at intervals of 180 days, or <P>(ii) A sample of at least 10 percent of birds from each pen with all pens being represented must be tested negative at intervals of 180 days; or <P>(iii) A sample of less than 10 percent of the birds may be tested, and found to be negative, at any one time if all pens are equally represented and a total of 10 percent of the birds are tested within each 180-day period. </REGTEXT> <REGTEXT TITLE='9' PART='146'> <PART><HED>PART 146—NATIONAL POULTRY IMPROVEMENT PLAN FOR COMMERCIAL POULTRY <AMDPAR>11. The authority citation for part 146 continues to read as follows: <AUTH><HED>Authority:<P> 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4.<Q P='04'></REGTEXT> <REGTEXT TITLE='9' PART='146'> <AMDPAR>12. Section 146.1 is amended as follows: <AMDPAR>a. By revising the definition of <E T='03'>authorized laboratory</E> and the first sentence of the definition of <E T='03'>commercial meat-type flock</E> to read as set forth below. <PRTPAGE P='14716'><AMDPAR>b. In the definition of <E T='03'>equivalent</E>, by adding the words “or exceed” after the words “equal to” and the words “they are” after the words “with which.” <SECTION><SECTNO>§&thnsp;146.1 <SUBJECT>Definitions. <STARS> <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-045-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 907-10 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <P><E T='03'>Authorized laboratory</E>. An authorized laboratory is a laboratory that meets the requirements of §&thnsp;147.51 and is thus qualified to perform the assays described in part 147 of this subchapter. <STARS> <P><E T='03'>Commercial meat-type flock</E>. All of the meat-type chickens, meat-type turkeys, commercial upland game birds, or commercial waterfowl on one farm. * * * <STARS></REGTEXT> <REGTEXT TITLE='9' PART='146'> <AMDPAR>13. In §&thnsp;146.2, paragraph (a) is amended by adding a new sentence at the end of the paragraph to read as follows: <SECTION><SECTNO>§&thnsp;146.2 <SUBJECT>Administration. <P>(a) * * * In the Memorandum of Understanding, the Official State Agency must designate a contact representative to serve as a liaison between the Service and the Official State Agency. <STARS></REGTEXT> <REGTEXT TITLE='9' PART='146'> <AMDPAR>14. Section 146.3 is amended by revising paragraph (a) and the first sentence of paragraph (c) to read as follows: <SECTION><SECTNO>§&thnsp;146.3 <SUBJECT>Participation. <P>(a) Any table-egg producer, raised-for-release upland game bird premises, and raised-for-release waterfowl premises and any commercial upland game bird, commercial waterfowl, meat-type chicken or meat-type turkey slaughter plant, including its affiliated flocks, may participate in the Plan when the producer or plant has demonstrated, to the satisfaction of the Official State Agency, that its facilities, personnel, and practices are adequate for carrying out the relevant special provisions of this part and has signed an agreement with the Official State Agency to comply with the relevant special provisions of this part. <STARS> <P>(c) A participating slaughter plant shall participate with all of the commercial upland game bird, commercial waterfowl, meat-type chicken and/or meat-type turkey flocks that are processed at the facility, including affiliated flocks.* * * <STARS></REGTEXT> <REGTEXT TITLE='9' PART='146'> <AMDPAR>15. Section 146.6 is revised to read as follows: <SECTION><SECTNO>§&thnsp;146.6 <SUBJECT>Specific provisions for participating slaughter plants. <P>(a) Only commercial upland game bird, commercial waterfowl, meat-type chicken, and meat-type turkey slaughter plants that are under continuous inspection by the Food Safety and Inspection Service of the Department or under State inspection that the Food Safety and Inspection Service has recognized as equivalent to Federal inspection may participate in the Plan. <P>(b) To participate in the Plan, meat-type chicken, meat-type turkey, and commercial upland game bird and commercial waterfowl slaughter plants must follow the relevant special provisions in §§&thnsp;146.33(a), 146.43(a), and 146.53(a), respectively, for sample collection and flock monitoring, unless they are exempted from the special provisions under §§&thnsp;146.32(b), 146.42(b), or 146.52(b), respectively.</REGTEXT> <REGTEXT TITLE='9' PART='146'> <SECTION><SECTNO>§&thnsp;146.9 <SUBJECT>[Amended] <AMDPAR>16. In §&thnsp;146.9, paragraph (a) is amended by removing the word “and” and adding the words “, and 146.53(a) and (b)” at the end of the second sentence, before the period.</REGTEXT> <REGTEXT TITLE='9' PART='146'> <AMDPAR>17. Section 146.11 is amended as follows: <AMDPAR>a. By revising paragraph (a) to read as set forth below. <AMDPAR>b. By redesignating paragraphs (b) and (c) as (d) and (e), respectively. <AMDPAR>c. By adding new paragraphs (b) and (c) to read as set forth below. <SECTION><SECTNO>§&thnsp;146.11 <SUBJECT>Inspections. <P>(a) Each participating slaughter plant shall be audited at least once annually or a sufficient number of times each year to satisfy the Official State Agency that the participating slaughter plant is in compliance with the provisions of this part. The yearly audit will consist of an evaluation of 2 weeks' worth of records, selected at random, of the following data: <P>(1) The actual flock slaughter date for each flock. This information must come from a verifiable source. Verifiable sources include electronic record systems that have oversight from the Department's Grain Inspectors, Packers and Stockyards Administration or Food Safety and Inspection Service (FSIS) documents such as FSIS Form 9061–2. <P>(2) Laboratory test results for each flock slaughtered with the sample collection date and test result. The test must be NPIP-approved and performed in an authorized laboratory of the NPIP. <P>(b) A flock will be considered to be not conforming to protocol if there are no test results available, if the flock was not tested within 21 days before slaughter, or if the test results for the flocks were not returned before slaughter. <P>(c) Two or more flocks that are found to be not conforming to protocol in the yearly audit for a slaughter plant shall be cause for a deficiency rating for that plant. However, if the root cause for the deficiency was identified, corrected, and documented, the plant will be eligible for an immediate reevaluation of 2 additional weeks' worth of records, again selected at random. If no more than one missed flock is identified in this reevaluation, the plant will be considered in compliance and no further action will be required. Plants found to be deficient must provide a written corrective action plan to the auditor within 2 weeks of receipt of the deficiency rating. A followup audit on the information in paragraphs (a)(1) and (a)(2) of this section will occur within 90 days from the receipt of the corrective action plan. Slaughter plants will retain their classification and may continue to use the Plan emblem in §&thnsp;146.9(a) during this process. A failure on the followup audit may result in disbarment from participation according to the procedures in §&thnsp;146.12. <STARS></REGTEXT> <REGTEXT TITLE='9' PART='146'> <AMDPAR>18. In §&thnsp;146.13, paragraph (b) is revised to read as follows: <SECTION><SECTNO>§&thnsp;146.13 <SUBJECT>Testing. <STARS> <P>(b) <E T='03'>Avian influenza</E>. The official tests for avian influenza are described in paragraphs (b)(1) and (b)(2) of this section: <P>(1) <E T='03'>Antibody detection tests</E>. (i) <E T='03'>Enzyme-linked immunosorbent assay (ELISA)</E>. ELISA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer. <P>(ii) <E T="03">The agar gel immunodiffusion (AGID) test.</E> <P>(A) The AGID test must be conducted on all ELISA-positive samples. <P>(B) The AGID test must be conducted using reagents approved by the Department and the Official State Agency. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-046-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 911-13 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <P>(C) Standard test procedures for the AGID test for avian influenza are set forth in §&thnsp;147.9 of this subchapter. The test can be conducted on egg yolk or blood samples. <P>(D) Positive tests for the AGID must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. <P>(2) <E T='03'>Agent detection tests</E>. Agent detection tests may be used to detect <PRTPAGE P='14717'>influenza A matrix gene or protein but not to determine hemagglutinin or neuraminidase subtypes. Samples for this testing should be collected from naturally occurring flock mortality or clinically ill birds. <P>(i) <E T="03">The real time reverse transcriptase/polymerase chain reaction (RRT–PCR) assay.</E> <P>(A) The RRT–PCR tests must be conducted using reagents approved by the Department and the Official State Agency. The RRT–PCR must be conducted using the National Veterinary Services Laboratories (NVSL) official protocol for RRT–PCR (AVPR01510) and must be conducted by personnel who have passed an NVSL proficiency test. <P>(B) Positive results from the RRT–PCR must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. <P>(ii) <E T="03">USDA-licensed type A influenza antigen capture immunoassay (ACIA).</E> <P>(A) The USDA-licensed type A influenza ACIA must be conducted using test kits approved by the Department and the Official State Agency and must be conducted in accordance with the recommendations of the producer or manufacturer. <P>(B) Positive results from the ACIA must be further tested by Federal Reference Laboratories using appropriate tests for confirmation. Final judgment may be based upon further sampling and appropriate tests for confirmation. <P>(3) The official determination of a flock as positive for the H5 or H7 subtypes avian influenza may be made only by NVSL.</REGTEXT> <REGTEXT TITLE='9' PART='146'> <AMDPAR>19. In §&thnsp;146.43, in paragraph (a)(1), the first sentence is revised to read as follows: <SECTION><SECTNO>§&thnsp;146.43 <SUBJECT>Terminology and classification; meat-type turkey slaughter plants. <STARS> <P>(a) * * * <P>(1) It is a meat-type turkey slaughter plant that accepts only meat-type turkeys from flocks where a minimum of 6 birds per flock has tested negative for antibodies to type A avian influenza virus with an approved test no more than 21 days prior to slaughter. * * * <STARS> </REGTEXT><REGTEXT TITLE='9' PART='146'> <AMDPAR>20. A new subpart E, “Special Provisions for Commercial Upland Game Birds, Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-for-Release Waterfowl,” §§&thnsp;146.51 through 146.53, is added to read as follows: <CONTENTS> <SUBPART><HED>Subpart E—Special Provisions for Commercial Upland Game Birds, Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-for-Release Waterfowl <SECHD>Sec. <SECTNO>146.51 <SUBJECT>Definitions. <SECTNO>146.52 <SUBJECT>Participation. <SECTNO>146.53 <SUBJECT>Terminology and classification; slaughter plants and premises.</CONTENTS> <SUBPART><HED>Subpart E—Special Provisions for Commercial Upland Game Birds, Commercial Waterfowl, Raised-for-Release Upland Game Birds, and Raised-for-Release Waterfowl <SECTION><SECTNO>§&thnsp;146.51 <SUBJECT>Definitions. <P><E T='03'>Commercial upland game bird slaughter plant</E>. A commercial upland game bird slaughter plant that is federally inspected or under State inspection that the U.S. Department of Agriculture's Food Safety and Inspection Service has recognized as equivalent to Federal inspection. <P><E T='03'>Commercial upland game birds</E>. Upland game bird pheasants, quail, or partridges grown under confinement for the primary purpose of producing meat for human consumption. <P><E T='03'>Commercial waterfowl</E>. Domesticated ducks or geese grown under confinement for the primary purpose of producing meat for human consumption. <P><E T='03'>Commercial waterfowl slaughter plant</E>. A commercial waterfowl slaughter plant that is federally inspected or under State inspection that the U.S. Department of Agriculture's Food Safety and Inspection Service has recognized as equivalent to Federal inspection. <P><E T='03'>Raised-for-release upland game birds</E>. Pheasants, quail, and partridge that are raised under confinement for release in game preserves and are not breeding stock. <P><E T='03'>Raised-for-release waterfowl</E>. Waterfowl that are raised under confinement for release in game preserves and are not breeding stock. <P><E T='03'>Shift</E>. The working period of a group of employees who are on duty at the same time. <SECTION><SECTNO>§&thnsp;146.52 <SUBJECT>Participation. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-047-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 914-16 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <P>(a) Participating commercial upland game bird slaughter plants, commercial waterfowl slaughter plants, raised-for-release upland game bird premises, and raised-for-release waterfowl premises shall comply with the applicable general provisions of Subpart A of this part and the special provisions of this subpart E. <P>(b) Commercial waterfowl and commercial upland game bird slaughter plants that slaughter fewer than 50,000 birds annually are exempt from the special provisions of this subpart E. <P>(c) Raised-for-release upland game bird premises and raised-for-release waterfowl premises that raise fewer than 25,000 birds annually are exempt from the special provisions of this subpart E. <SECTION><SECTNO>§&thnsp;146.53 <SUBJECT>Terminology and classification; slaughter plants and premises. <P>Participating flocks which have met the respective requirements specified in this section may be designated by the following terms and the corresponding designs illustrated in §&thnsp;146.9 of this part: <P>(a) <E T='03'>U.S. H5/H7 Avian Influenza Monitored</E>. This program is intended to be the basis from which the commercial waterfowl and commercial upland game bird industry may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza in commercial waterfowl and commercial upland game birds through routine surveillance of each participating slaughter plant. A slaughter plant will qualify for this classification when the Official State Agency determines that it has met one of the following requirements: <P>(1) It is a commercial upland game bird slaughter plant or commercial waterfowl slaughter plant where a minimum of 11 birds per shift are tested negative for the H5/H7 subtypes of avian influenza at slaughter; <P>(2) It is a commercial upland game bird slaughter plant or commercial waterfowl slaughter plant that only accepts commercial upland game birds or commercial waterfowl from flocks where a minimum of 11 birds per flock have been tested negative for antibodies to the H5/H7 subtypes of avian influenza no more than 21 days prior to slaughter; or <P>(3) It is a commercial upland game bird slaughter plant or commercial waterfowl slaughter plant that has an ongoing active and passive surveillance program for H5/H7 subtypes of avian influenza that is approved by the Official State Agency and the Service. <P>(b) <E T='03'>U.S. H5/H7 Avian Influenza Monitored</E>. This program is intended to be the basis from which the raised-for-release upland game bird and raised-for-release waterfowl industries may conduct a program to monitor for the H5/H7 subtypes of avian influenza. It is intended to determine the presence of the H5/H7 subtypes of avian influenza through routine surveillance of each participating premises. A premises will qualify for the classification when the Official State Agency determines that a representative sample of 30 birds from <PRTPAGE P='14718'>the participating premises has been tested with negative results for the H5/H7 subtypes of avian influenza every 90 days. </REGTEXT> <REGTEXT TITLE='9' PART='147'> <PART><HED>PART 147—AUXILIARY PROVISIONS ON NATIONAL POULTRY IMPROVEMENT PLAN <AMDPAR>21. The authority citation continues to read as follows: <AUTH><HED>Authority:<P> 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4.<Q P='04'></REGTEXT> <REGTEXT TITLE='9' PART='147'> <AMDPAR>22. Section 147.9 is amended as follows: <AMDPAR>a. By revising paragraph (a)(4)(i)(F) to read as follows. <AMDPAR>b. By removing figure 1. <AMDPAR>c. By redesignating figures 2 and 3 as figures 1 and 2, respectively. <SECTION><SECTNO>§&thnsp;147.9 <SUBJECT>Standard test procedures for avian influenza. <P>(a) * * * <P>(4) * * * <P>(i) * * * <P>(F) To prepare the wells, place 50 μl of avian influenza AGID antigen in the center well using a micropipette with an attached pipette tip. Place 50 μl AI AGID positive control antiserum in each of three alternate peripheral wells, and add 50 μl per well of test sera in the three remaining wells. This arrangement provides a positive control line on each side of the test serum, thus providing for the development of lines of identity on both sides of each test serum (see figure 1). <NOTE><HED>Note:<P> A pattern can be included with positive, weak positive, and negative reference serum in the test sera wells to aid in the interpretation of results (<E T='03'>see</E> figure 2).</NOTE> <STARS></REGTEXT> <REGTEXT TITLE='9' PART='147'> <SECTION><SECTNO>§&thnsp;147.12, 147.14–16, 147.30 <SUBJECT>[Amended] <AMDPAR>23. Sections 147.12, 147.14, 147.15, 147.16, and 147.30 are amended by redesignating footnotes 12 through 24 as footnotes 8 through 20, respectively <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-048-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 917-19 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> </REGTEXT> <REGTEXT TITLE='9' PART='147'> <AMDPAR>24. A new §&thnsp;147.31 is added to read as follows: <SECTION><SECTNO>§&thnsp;147.31 <SUBJECT>Laboratory procedures recommended for the real-time polymerase chain reaction test for Mycoplasma gallisepticum (MGLP ReTi). <P>(a) <E T='03'>DNA extraction</E>. Use Qiagen Qiamp Mini Kit for DNA extraction or equivalent validated technique/procedure. This kit utilizes the following methods: 100 µl of swab suspension incubates with 10 µl of proteinase K and 400 µl of lysis buffer at 56 °C for 10 minutes. Following incubation, 100 µl of 100 percent ethanol is added to lysate. Wash and centrifuge following extraction kit recommendations. <P>(b) <E T='03'>Primer selection</E>. A forward primer mglpU26 (5′-CTA GAG GGT TGG ACA GTT ATG–3′) located at nucleotide positions 765,566 to 765,586 of the <E T='03'>M. gallisepticum</E> R strain genome sequence; a reverse primer mglp164 (5′-GCT GCA CTA AAT GAT ACG TCA AA–3′) located at nucleotide positions 765,448 to 765,470 of the <E T='03'>M. gallisepticum</E> R strain genome sequence; and a Taqman dual-labeled probe mglpprobe (5′-FAM–CAG TCA TTA ACA ACT TAC CAC CAG AAT CTG–BHQ1–3′) located at nucleotide positions 765,491 to 765,520 of the <E T='03'>M. gallisepticum</E> R strain genome should be used to amplify a 139-bp fragment of the lp gene. <P>(c) <E T='03'>MGLP ReTi</E>. Primers and probe should be utilized in a 25 μl reaction containing 12.5 μl of Quantitect Probe PCR 2X mix (Qiagen, Valencia, CA),<SU>21</SU><FTREF> primers to a final concentration of 0.5 µmolar, and probe to a final concentration of 0.1 μmolar, 1μl of HK–UNG Thermolabile Uracil N-glycosylase (Epicentre, Madison, WI), 2 μl of water, and 5 µl of template. The reaction can be performed in a SmartCycler (Cepheid, Sunnyvale, CA) or other equivalent validated platform procedure for real-time thermocycler at 50 °C for 2 minutes; 95 °C for 15 minutes with optics OFF; and 40 cycles of 94 °C for 15 seconds followed by 60 °C for 60 seconds with optics ON. <FTNT><P><SU>21</SU>&thnsp;Trade names are used in these procedures solely for the purpose of providing specific information. Mention of a trade name does not constitute a guarantee or warranty of the product by the U.S. Department of Agriculture or an endorsement over other products not mentioned.</FTNT> <P>(d) <E T='03'>Determination of positive</E>. For each MGLP ReTi assay reaction, the threshold cycle number (CT value) was determined to be the PCR cycle number at which the fluorescence of the reaction exceeded 30 units of fluorescence. For all samples tested, any MGLP reaction that has a recorded CT value was considered positive, while any MGLP reaction that had no recorded CT value was considered negative. <P>(e) <E T='03'>Controls</E>. Proper controls should be used when conducting the MGLP ReTi assay as an official test of the Plan. Positive, quantitative, extraction, and internal controls are commercially available from GTCAllison, LLC, Mocksville, NC.</REGTEXT> <REGTEXT TITLE='9' PART='147'> <AMDPAR>25. Section 147.43 is amended as follows: <AMDPAR>a. By revising paragraph (d)(4) to read as set forth below. <AMDPAR>b. In paragraph (d)(6), by removing the words “a forum” and adding the words “an official advisory committee” in their place. <SECTION><SECTNO>§&thnsp;147.43 <SUBJECT>General Conference Committee. <STARS> <P>(d) * * * <P>(4) Consider each proposal submitted as provided in §&thnsp;147.44 and make recommendations to subpart Committees and the Conference. Meet jointly with the NPIP Technical Committee and consider the technical aspects and accuracy of each proposal. Recommend whether new proposals (i.e., proposals that have not been submitted as provided in §&thnsp;147.44) should be considered by the delegates to the Plan Conference. <STARS></REGTEXT> <REGTEXT TITLE='9' PART='147'> <AMDPAR>26. In §&thnsp;147.45, the first sentence is revised to read as follows: <SECTION><SECTNO>§&thnsp;147.45 <SUBJECT>Official delegates. <P>Each cooperating State shall be entitled to one official delegate for each of the programs prescribed in subparts B, C, D, E, F, G, and H of part 145 of this chapter and for each of the programs prescribed in subparts B, C, D, and E of part 146 of this chapter in which it has one or more participants at the time of the Conference. * * *</REGTEXT> <REGTEXT TITLE='9' PART='147'> <AMDPAR>27. In §&thnsp;147.46, a new paragraph (a)(9) is added to read as follows: <SECTION><SECTNO>§&thnsp;147.46 <SUBJECT>Committee consideration of proposed changes. <P>(a) * * * <P>(9) Commercial upland game birds and waterfowl and raised-for-release upland game birds and waterfowl. <STARS></REGTEXT> <REGTEXT TITLE='9' PART='147'> <AMDPAR>28. A new Subpart F, “Authorized Laboratories and Approved Tests,” §§&thnsp;147.51 and 147.52, is added to read as follows: <CONTENTS> <SUBPART><HED>Subpart F—Authorized Laboratories and Approved Tests <SECHD>Sec. <SECTNO>147.51 <SUBJECT>Authorized laboratory minimum requirements. <SECTNO>147.52 <SUBJECT>Approved tests. </CONTENTS> <SUBPART><HED>Subpart F—Authorized Laboratories and Approved Tests <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-049-*****-*****- -Name: b7 -Payroll No: 96940 -Folios: 920-22 -Date: 3/30/09 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <SECTION><SECTNO>§&thnsp;147.51 <SUBJECT>Authorized laboratory minimum requirements. <P>These minimum requirements are intended to be the basis on which an authorized laboratory of the Plan can be evaluated to ensure that official Plan assays are performed and reported as described in this part A satisfactory evaluation will result in the laboratory being recognized by the NPIP office of the Service as an authorized laboratory qualified to perform the assays provided for in this part. <P>(a) <E T='03'>Check-test proficiency</E>. The laboratory must use a regularly <PRTPAGE P='14719'>scheduled check test for each assay that it performs. <P>(b) <E T='03'>Trained technicians</E>. The testing procedures at the laboratory must be run or overseen by a laboratory technician who has attended and satisfactorily completed Service-approved laboratory workshops for Plan-specific diseases within the past 3 years. <P>(c) <E T='03'>Laboratory protocol</E>. Official Plan assays must be performed and reported as described in this part. <P>(d) <E T='03'>State site visit</E>. The Official State Agency will conduct a site visit and recordkeeping audit annually. <P>(e) <E T='03'>Service review</E>. Authorized laboratories will be reviewed by the Service (NPIP staff) every 3 years. The Service's review may include, but will not necessarily be limited to, checking records, laboratory protocol, check-test proficiency, technician training, and peer review. <P>(f) <E T='03'>Reporting</E>. (1) A memorandum of understanding or other means shall be used to establish testing and reporting criteria to the Official State Agency, including criteria that provide for reporting H5 and H7 low pathogenic avian influenza directly to the Service. <P>(2) <E T='03'>Salmonella</E> <E T='03'>pullorum</E> and <E T='03'>Mycoplasma</E> Plan disease reactors must be reported to the Official State Agency within 48 hours. <P>(g) <E T='03'>Verification</E>. Random samples may also be required to be submitted for verification as specified by the Official State Agency. <SECTION><SECTNO>§&thnsp;147.52 <SUBJECT>Approved tests. <P>(a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In addition, all tests that use veterinary biologics (e.g., antiserum and other products of biological origin) that are licensed or produced by the Service and used as described in this part are approved for use in the NPIP. <P>(b) Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) may be approved through the following procedure: <P>(1) The sensitivity of the kit will be estimated in at least three authorized laboratories selected by the Service by testing known positive samples, as determined by the official NPIP procedures found in Subparts A, B, C, and D of this part. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated. <P>(2) The specificity of the kit will be estimated in at least three authorized laboratories selected by the Service by testing known negative samples, as determined by the official NPIP procedures found in this part. If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and significance of the effect(s) can be evaluated. <P>(3) The kit will be provided to the cooperating laboratories in its final form and include the instructions for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive clinical samples supplied by the manufacturer of the test kit. In addition, each laboratory will be asked to test 50 known negative clinical samples obtained from several sources, to provide a representative sampling of the general population. The identity of the samples must be coded so that the cooperating laboratories are blinded to identity and classification. Each sample must be provided in duplicate or triplicate, so that error and repeatability data may be generated. <P>(4) Cooperating laboratories will submit to the kit manufacturer all raw data regarding the assay response. Each sample tested will be reported as positive or negative, and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value. <P>(5) The findings of the cooperating laboratories will be evaluated by the NPIP technical committee, and the technical committee will make a recommendation regarding whether to approve the test kit to the General Conference Committee. If the technical committee recommends approval, the final approval will be granted in accordance with the procedures described in §§&thnsp;147.46 and 147.47. </REGTEXT> <SIG> <DATED>Done in Washington, DC, this 26th day of March 2009. <NAME>Kevin Shea, <TITLE>Acting Administrator, Animal and Plant Health Inspection Service. </SIG> <FRDOC>[FR Doc. E9–7240 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 3410–34–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-020-PDF**-*****- -Name: -Payroll No: 70070 -Folios: E671-E674 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='N'>DEPARTMENT OF TRANSPORTATION <SUBAGY>Federal Aviation Administration <CFR>14 CFR Part 39 <DEPDOC>[Docket No. FAA–2008–1206; Directorate Identifier 2008–NE–19–AD; Amendment 39–15869; AD 2009–07–10] <RIN>RIN 2120–AA64 <SUBJECT>Airworthiness Directives; General Electric Company CF6–80A Series Turbofan Engines <AGY><HED>AGENCY:<P>Federal Aviation Administration (FAA), DOT. <ACT><HED>ACTION:<P>Final rule.</ACT> <SUM><HED>SUMMARY:<P>The FAA is adopting a new airworthiness directive (AD) for General Electric Company (GE) CF6–80A series turbofan engines with a high-pressure turbine rotor (HPTR) stage 1 disk, part number (P/N) 9367M45G06, installed. This AD requires removing any HPTR stage 1 disk, P/N 9367M45G06, before exceeding 2,075 cycles-since-new (CSN). This AD results from an error by GE that incorrectly cited a cyclic life of 12,600 CSN for the HPTR stage 1 disk, P/N 9367M45G06. We are issuing this AD to prevent the HPTR stage 1 disk from exceeding its part life, which could cause fatigue cracks to start and grow. These cracks could result in a possible uncontained disk failure and damage to the airplane. <EFFDATE><HED>DATES:<P>This AD becomes effective May 6, 2009. <ADD><HED>ADDRESSES:<P>The Docket Operations office is located at the Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12–140, Washington, DC 20590–0001. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>Robert Green, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; <E T='03'>e-mail: robert.green@faa.gov</E>; telephone (781) 238–7754; fax (781) 238–7199. <SUPLINF><HED>SUPPLEMENTARY INFORMATION:<P>The FAA proposed to amend 14 CFR part 39 with a proposed AD. The proposed AD applies to GE CF6–80A series turbofan engines with a HPTR stage 1 disk, P/N 9367M45G06, installed. We published the proposed AD in the <E T='04'>Federal Register</E> on November 14, 2008 (73 FR 67433). That action proposed to require removing any HPTR stage 1 disk, P/N 9367M45G06, before exceeding 2,075 CSN. <PRTPAGE P='14720'><HD1>Examining the AD Docket <P>You may examine the AD docket on the Internet at <E T='03'>http://www.regulations.gov</E>; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647–5527) is provided in the <E T='02'>ADDRESSES</E> section. Comments will be available in the AD docket shortly after receipt. <HD1>Comments <P>We provided the public the opportunity to participate in the development of this AD. We have considered the comment received. The commenter supports the proposal. <HD1>Conclusion <P>We have carefully reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD as proposed. <HD1>Costs of Compliance <P>We estimate that this AD will affect 10 engines installed on airplanes of U.S. registry. We also estimate that it will take about 110 work-hours per engine to perform the actions, and that the average labor rate is $80 per work-hour. Required parts will cost about $437,000 per engine. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $4,458,000. <HD1>Authority for This Rulemaking <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. <P>We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. <HD1>Regulatory Findings <P>We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. <P><E T="03">For the reasons discussed above, I certify that this AD:</E> <P>(1) Is not a “significant regulatory action” under Executive Order 12866; <P>(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and <P>(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. <P>We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under <E T='02'>ADDRESSES</E>. <LSTSUB><HED>List of Subjects in 14 CFR Part 39 <P>Air transportation, Aircraft, Aviation safety, Safety.</LSTSUB> <REGTEXT TITLE='14' PART='39'> <HD1>Adoption of the Amendment <AMDPAR>Accordingly, under the authority delegated to me by the Administrator, the Federal Aviation Administration amends 14 CFR part 39 as follows: <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-021-PDF**-*****- -Name: Julia Jones (updt) -Payroll No: 48692 -Folios: E675-E677 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <PART><HED>PART 39—AIRWORTHINESS DIRECTIVES <AMDPAR>1. The authority citation for part 39 continues to read as follows: <AUTH><HED>Authority:<P> 49 U.S.C. 106(g), 40113, 44701. </REGTEXT><REGTEXT TITLE='14' PART='39'> <SECTION><SECTNO>§&thnsp;39.13<SUBJECT> [Amended] <AMDPAR>2. The FAA amends §&thnsp;39.13 by adding the following new airworthiness directive:<Q P="04"><EXTRACT> <FP-2><E T='04'>2009–07–10 General Electric Company:</E> Amendment 39–15869. Docket No. FAA–2008–1206; Directorate Identifier 2008–NE–19–AD. <HD1>Effective Date <P>(a) This airworthiness directive (AD) becomes effective May 6, 2009. <HD1>Affected ADs <P>(b) None. <HD1>Applicability <P>(c) This AD applies to General Electric Co. (GE) CF6–80A, CF6–80A1, CF6–80A2, and CF6–80A3 turbofan engines with a high-pressure turbine rotor (HPTR) stage 1 disk, part number (P/N) 9367M45G06, installed. These engines are installed on, but not limited to, Airbus A310 series and Boeing 767 series airplanes. <HD1>Unsafe Condition <P>(d) This AD results from an error by GE that incorrectly cited a cyclic life of 12,600 CSN in the Airworthiness Limitations Section (ALS) of the Instructions for Continued Airworthiness (ICA) for the HPTR stage 1 disk, P/N 9367M45G06. We are issuing this AD to prevent the HPTR stage 1 disk from exceeding its part life, which could cause fatigue cracks to start and grow. These cracks could result in a possible uncontained disk failure and damage to the airplane. <HD1>Compliance <P>(e) You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done. <HD1>New Reduced Life Limit for HPTR Stage 1 Disks, P/N 9367M45G06 <P>(f) After the effective date of this AD, remove HPTR stage 1 disks, P/N 9367M45G06, from service before exceeding the new, reduced life limit of 2,075 cycles-since-new. <HD1>Alternative Methods of Compliance <P>(g) The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. <HD1>Special Flight Permits <P>(h) Under 14 CFR part 39.23, we are prohibiting any special flight permits. <HD1>Related Information <P>(i) Contact Robert Green, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail: <E T='03'>robert.green@faa.gov;</E> telephone (781) 238–7754; fax (781) 238–7199, for more information about this AD. <HD1>Material Incorporated by Reference <P>(j) None. </EXTRACT> </REGTEXT> <SIG><DATED><P>Issued in Burlington, Massachusetts, on March 25, 2009. <NAME>Peter A. White, <TITLE>Assistant Manager, Engine and Propeller Directorate, Aircraft Certification Service.</SIG> <FRDOC> [FR Doc. E9–7280 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 4910–13–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-036-*****-*****- -Name: -Payroll No: -Folios: -Date: 06/15/2007 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration </SUBAGY> <CFR>21 CFR Part 5 <DEPDOC>[Docket No. FDA–2009–N–0144] <SUBJECT>Revision of Organization and Conforming Changes to Regulations <AGY><HED>AGENCY: <P>Food and Drug Administration, HHS. <ACT><HED>ACTION: <P>Final rule. </ACT> <SUM><PRTPAGE P='14721'><HED>SUMMARY: <P>The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational changes in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations. <DATES><HED>DATES: <P> This rule is effective April 1, 2009. <FURINF><HED>FOR FURTHER INFORMATION CONTACT: <P>Vanessa Starks, Office of Management Programs (HFA–410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4654; or Sharon Burgess, Office of Management Programs (HFA–410), 5600 Fishers Lane, Rockville, MD 20857, 301–827–2065. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <HD1>I. Background <P>FDA is issuing this final rule to amend the agency's regulations by updating the organizational information in part 5 (21 CFR part 5). The agency has updated the references to part 5, subpart M. <P>The portion of this final rule updating the organizational information in part 5, subpart M is a rule of agency organization, procedure, or practice. FDA is issuing these provisions as a final rule without publishing a general notice of proposed rulemaking because such notice is not required for rules of agency organization, procedure, or practice under 5 U.S.C. 553(b)(3)(A). For the conforming changes to the other regulations, the agency finds good cause under 5 U.S.C. 553(b)(3)(B) to dispense with prior notice and comment, and good cause under 5 U.S.C. 553(d)(3) to make these conforming changes effective less than 30 days after publication because such notice and comment and delayed effective date are unnecessary and contrary to the public interest. As discussed previously, these conforming changes merely update the footnotes in part 5, subpart M. These changes do not result in any substantive change in the regulations. <HD1>II. Analysis of Impacts <P>FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104–4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the principles identified in the Executive order. In addition, the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. <P>The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule simply updates the organizational information, it does not impose any additional costs on industry. Consequently, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required. <P>Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $130 million, using the most current (2007) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. <HD1>III. Paperwork Reduction Act of 1995 <P>This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. <HD1>IV. Environmental Impact <P>FDA has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. <HD1>V. Federalism <P>FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. <LSTSUB><HED>List of Subjects in 21 CFR Part 5 <P>Authority delegations (Government agencies), Imports, Organization and functions (Government agencies). </LSTSUB> <REGTEXT TITLE="21" PART="5"> <AMDPAR>Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority of the Commissioner of Food and Drugs, 21 CFR part 5 is amended as follows: <AMDPAR>1. Revise part 5 to read as follows: <PART><HED>PART 5—ORGANIZATION <SUBPART><HED>Subparts A–L—[Reserved] <SUBPART><HED>Subpart M—Organization <SECHD>Sec. <SECTNO>5.1100 <SUBJECT>Headquarters. <SECTNO>5.1105 <SUBJECT>Chief Counsel, Food and Drug Administration. <SECTNO>5.1110 <SUBJECT>FDA Public Information Offices. <AUTH><HED>Authority: <P>5 U.S.C. 552; 21 U.S.C. 301–397. <SUBPART><HED>Subparts A–L—[Reserved] <SUBPART><HED>Subpart M—Organization <SECTION><SECTNO>§&thnsp;5.1100 <SUBJECT>Headquarters. <P>The central organization of the Food and Drug Administration consists of the following:<Q P="04"> <FP>OFFICE OF THE COMMISSIONER.<SU>1</SU><FTREF> <Q P="02"> <FTNT> <P><SU>1</SU>&thnsp;Mailing address: 10903 New Hampshire Ave., Bldg. 1, Silver Spring, MD 20993–0002. </FTNT> <FP><E T="03">Office of the Chief Counsel.</E><SU>2</SU><FTREF> <FTNT> <P><SU>2</SU>&thnsp;The Office of the Chief Counsel (also known as the Food and Drug Division, Office of the General Counsel, Department of Health and Human Services), while administratively within the Office of the Commissioner, is part of the Office of the General Counsel of the Department of Health and Human Services. </FTNT> <FP><E T="03">Office of the Administrative Law Judge.</E> <FP><E T="03">Office of Chief of Staff.</E> <FP><E T="03">Office of Executive Secretariat.</E> <FP><E T="03">Office of Public Affairs.</E> <FP><E T="03">Office of Legislation.</E><SU>3</SU><FTREF> <FTNT> <P><SU>3</SU>&thnsp;Mailing address: 5600 Fishers Lane, Rockville, MD 20852. </FTNT> <FP><E T="03">Office of External Relations.</E> <FP><E T="03">Office of the Ombudsman.</E> <FP><E T="03">Office of Scientific and Medical Programs.</E> <FP><E T="03">Office of Critical Path.</E> <FP><E T="03">Office of Science and Health Coordination.</E> <PRTPAGE P='14722'><FP><E T="03">Office of Orphan Products Development.</E> <FP><E T="03">Office of Women's Health.</E> <FP><E T="03">National Center for Toxicology Research.</E><SU>4</SU><FTREF> <FTNT> <P><SU>4</SU>&thnsp;Mailing address: 3900 NCTR Rd., Jefferson, AR 72079. </FTNT> <FP><E T="03">Office of Management, NCTR.</E> <FP><E T="03">Office of Executive Programs and Services, NCTR.</E> <FP><E T="03">Office of Scientific Coordination, NCTR.</E> <FP><E T="03">Office of Research, NCTR.</E> <FP>Division of Biochemical Toxicology, NCTR. <FP>Division of Genetic and Reproductive Toxicology, NCTR. <FP>Division of Personalized Nutrition and Medicine, NCTR. <FP>Division of Microbiology, NCTR. <FP>Division of Neurotoxicology, NCTR. <FP>Division of Veterinary Services, NCTR. <FP><E T="03">Office of Regulatory Compliance and Risk Management, NCTR.</E> <FP><E T="03">Office of Management, NCTR.</E> <FP><E T="03">Office of Executive Programs and Services, NCTR.</E> <FP><E T="03">Office of Scientific Coordination, NCTR.</E> <FP><E T="03">Office of Research, NCTR.</E> <FP>Division of Biochemical Toxicology, NCTR. <FP>Division of Genetic and Reproductive Toxicology, NCTR. <FP>Division of Personalized Nutrition and Medicine, NCTR. <FP>Division of Microbiology, NCTR. <FP>Division of Neurotoxicology, NCTR. <FP>Division of Veterinary Services, NCTR. <FP><E T="03">Office of Regulatory Compliance and Risk Management, NCTR.</E> <FP><E T="03">Office of International Activities and Strategic Initiatives.</E><SU>3</SU> <FP><E T="03">Office of International Programs.</E><SU>3</SU> <FP><E T="03">Office of Pediatric Therapeutics.</E><SU>3</SU> <FP><E T="03">Office of Combination Products.</E><SU>5</SU><FTREF> <FTNT> <P><SU>5</SU>&thnsp;Mailing address: 15800 Crabbs Branch Way, Rockville, MD 20855. </FTNT> <FP><E T="03">Office of Operations.</E><SU>1</SU> <FP><E T="03">Office of Information Management.</E><SU>3</SU> <FP>Division of Business Partnership and Support. <FP>Division of Chief Information Officer Support. <FP>Division of Systems Management. <FP>Division of Infrastructure Operations. <FP>Division of Technology. <FP><E T="03">Office of Management.</E><SU>1</SU> <FP><E T="03">Office of Management Programs.</E><SU>3</SU> <FP>Division of Human Capital Management. <FP>Division of Freedom of Information. <FP>Division of Dockets Management.<SU>6</SU><FTREF> <FP><E T="03">Office of Shared Services.</E><SU>6</SU> <FP><E T="03">Office of Acquisitions and Grants Services.</E> <FP>Division of Contracts and Grants Management. <FP><E T="03">Office of Financial Services.</E> <FP>Division of Travel Services. <FP>Division of Payment Services. <FP><E T="03">Office of Equal Employment Opportunity and Diversity Management.</E><SU>3</SU> <FP><E T="03">Office of Real Property.</E><SU>6</SU> <FTNT> <P><SU>6</SU>&thnsp;Mailing address: Mailing address: 5630 Fishers Lane, Rockville, MD 20852. </FTNT> <FP>Division of Portfolio Development. <FP>Division of Engineering Services. <FP>Division of Facilities Operations. <FP>Division of Logistic Services. <FP><E T="03">Office of Field Financial and Acquisition Services.</E><SU>6</SU> <FP><E T="03">FDA Bioscience Library.</E><SU>6</SU> <FP><E T="03">Office of Financial Management.</E><SU>3</SU> <FP>Division of Financial Support Services. <FP>Division of Accounting. <FP>Division of Budget Execution and Control. <FP><E T="03">Office of Executive Operations.</E><SU>3</SU> <FP><E T="03">Office of Crisis Management.</E><SU>1</SU> <FP><E T="03">Office of Emergency Operations.</E><SU>3</SU> <FP><E T="03">Office of Security Operations.</E><SU>6</SU> <FP><E T="03">Office of Policy, Planning, and Preparedness.</E><SU>1</SU> <FP>Office of Counter-Terrorism and Emerging Threats.<SU>1</SU> <FP><E T="03">Office of Integrity and Accountability.</E><SU>1</SU> <FP><E T="03">Office of Policy and Planning.</E><SU>3</SU> <FP><E T="03">Office of Policy.</E><SU>3</SU> <FP><E T="03">Office of Planning.</E><SU>3</SU><Q P="04"> <FP>CENTER FOR BIOLOGICS EVALUATION AND RESEARCH.<SU>7</SU><FTREF> <FTNT><P><SU>7</SU>&thnsp;Mailing address: 5515 Security Ln., Rockville, MD 20852.</FTNT><Q P="02"> <FP><E T="03">Office of the Center Director.</E> <FP><E T="03">Office of Management.</E> <FP>Regulatory Information Management Staff. <FP>Division of Planning, Evaluation, and Budget. <FP>Division of Management Services. <FP><E T="03">Office of Compliance and Biologics Quality.</E> <FP>Division of Case Management. <FP>Division of Inspection and Surveillance. <FP>Division of Manufacturing and Product Quality. <FP><E T="03">Office of Biostatistics and Epidemiology.</E> <FP>Division of Biostatistics. <FP>Division of Epidemiology. <FP><E T="03">Office of Information Management.</E> <FP>Division of Vaccines and Related Products Applications. <FP><E T="03">Office of Communication, Training, and Manufacturers Assistance.</E> <FP>Division of Disclosure and Oversight Management. <FP>Division of Manufacturers Assistance and Training. <FP>Division of Communication and Consumer Affairs. <FP><E T="03">Office of Biostatistics and Epidemiology.</E> <FP>Division of Biostatistics. <FP>Division of Epidemiology. <FP><E T="03">Office of Information Management.</E> <FP>Division of Information Operations. <FP>Division of Information Development. <FP><E T="03">Office of Cellular, Tissue, and Gene Therapies.</E> <FP>Division of Cell and Gene Therapies. <FP>Division of Clinical Evaluation and Pharmacology/Toxicology Review. <FP>Division of Human Tissues. <FP>Information Technology Staff. <FP>Division of Information Operations. <FP>Division of Information Development. <FP><E T="03">Office of Blood Research and Review.</E> <FP>Division of Emerging and Transfusion Transmitted Diseases. <FP>Division of Hematology. <FP>Division of Blood Applications. <FP><E T="03">Office of Vaccines Research and Review.</E> <FP>Analytical Chemistry Staff. <FP>Standards and Testing Staff. <FP>Program Operation Staff. <FP>Division of Bacterial, Parasitic, and Allergenic Products. <FP>Division of Viral Products. <FP>Division of Vaccines and Related Product Applications. <FP><E T="03">Office of Cellular, Tissue, and Gene Therapies.</E> <FP>Regulatory Management Staff. <FP>Division of Cell and Gene Therapies. <FP>Division of Clinical Evaluation and Pharmacology/Toxicology Review. <FP>Division of Human Tissues. <FP><E T="03">Office of Communication, Training, and Manufacturers Assistance.</E> <FP>Division of Disclosure and Oversight Management. <FP>Division of Manufacturers Assistance and Training. <FP>Division of Communication and Consumer Affairs.<Q P="04"> <FP>CENTER FOR FOOD SAFETY AND APPLIED NUTRITION.<SU>8</SU><FTREF> <FTNT><P><SU>8</SU>&thnsp;Mailing address: 5100 Paint Branch Pkwy., College Park, MD 20740–3835.</FTNT> <Q P="02"><FP><E T="03">Office of the Center Director.</E> <PRTPAGE P='14723'><FP>Senior Science Advisor Staff. <FP>Executive Operations Staff. <FP>International Staff. <FP><E T="03">Office of Management Systems.</E> <FP>Division of Planning and Financial Resources Management. <FP>Division of Program Support Services. <FP><E T="03">Office of Food Defense, Communication and Emergency Response.</E> <FP>Division of Education and Communication. <FP>Division of Public Health and Biostatistics. <FP><E T="03">Office of Food Safety.</E> <FP>Retail Food and Cooperative Programs Support Staff <FP>Division of Seafood Science and Technology. <FP>Division of Food Processing Science and Technology. <FP>Division of Plant and Dairy Food Safety. <FP>Division of Seafood Safety. <FP><E T="03">Office of Cosmetics and Colors.</E> <FP>Cosmetic Staff. <FP>Division of Color Certification and Technology. <FP><E T="03">Office of Regulatory Science.</E> <FP>Division of Analytical Chemistry. <FP>Division of Microbiology. <FP>Division of Bioanalytical Chemistry. <FP><E T="03">Office of Food Additive Safety.</E> <FP>Senior Science and Policy Staff. <FP>Division of Food Contact Notifications. <FP>Division of Biotechnology and GRAS Notice Review. <FP><E T="03">Office of Compliance.</E> <FP>Division of Enforcement. <FP>Division of Field Programs and Guidance. <FP><E T="03">Office of Applied Research and Safety Assessment.</E> <FP>Muirkirk Technical Operations Staff. <FP>Division of Molecular Biology. <FP>Division of Virulence Assessment. <FP>Division of Toxicology. <FP><E T="03">Office of Regulations, Policy and Social Sciences.</E> <FP>Regulations and Special Government Employees Management Staff. <FP><E T="03">Office of Nutrition, Labeling and Dietary Supplements.</E> <FP>Food Labeling and Standards Staff. <FP>Nutrition Programs Staff. <FP>Infant Formula and Medical Foods Staff. <FP>Division of Dietary Supplement Programs.<Q P="04"> <FP>CENTER FOR DRUG EVALUATION AND RESEARCH.<SU>1</SU><Q P="02"> <FP><E T="03">Office of the Center Director.</E> <FP>Equal Employment Opportunity Staff. <FP>Controlled Substance Staff. <FP><E T="03">Office of Regulatory Policy.</E> <FP>Division of Regulatory Policy I. <FP>Division of Regulatory Policy II. <FP>Division of Information Disclosure Policy. <FP><E T="03">Office of Management.</E> <FP>Division of Management and Budget. <FP>Division of Management Services. <FP><E T="03">Office of Training and Communication.</E> <FP>Medwatch Staff. <FP>Division of Library and Information Services. <FP>Division of Training and Development. <FP>Division of Public Affairs. <FP>Division of Drug Information. <FP><E T="03">Office of Surveillance Research and Communication Support.</E> <FP>Division of Medical Errors and Technical Support. <FP>Division of Drug Risk Evaluation. <FP><E T="03">Office of Compliance.</E> <FP>Division of Compliance Risk Management and Surveillance. <FP>Division of New Drugs and Labeling Compliance. <FP>Division of Manufacturing and Product Quality. <FP>Division of Scientific Investigations. <FP><E T="03">Office of New Drugs.</E> <FP><E T="03">Office of Drug Evaluation I.</E> <FP>Division of Cardiorenal Drug Products. <FP>Division of Neuropharmacological Drug Products. <FP>Division of Metabolic and Endocrine Drug Products. <FP>Division of Pulmonary and Allergy Drug Products. <FP>Division of Anesthetic, Critical Care and Addiction Drug Products. <FP>Division of Oncology Drug Products. <FP><E T="03">Office of Drug Evaluation II.</E> <FP>Division of Metabolic and Endocrine Drug Products. <FP>Division of Pulmonary and Allergy Drug Products. <FP>Division of Anesthetic, Critical Care and Addiction Drug Products. <FP><E T="03">Office of Drug Evaluation III.</E> <FP>Division of Gastrointestinal and Coagulation Drug Products. <FP>Division of Medical Imaging and Radiopharmaceutical Drug Products. <FP>Division of Reproductive and Urologic Drug Products. <FP><E T="03">Office of Drug Evaluation IV.</E> <FP>Division of Anti-Infective Drug Products. <FP>Division of Anti-Viral Drug Products. <FP>Division of Special Pathogen and Immunologic Drug Products. <FP><E T="03">Office of Drug Evaluation V.</E> <FP>Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products. <FP>Division of Dermatologic and Dental Drug Products. <FP>Division of Over-The-Counter Drug Products. <FP><E T="03">Office of Drug Evaluation VI.</E> <FP>Division of Therapeutic Biological Oncology Products. <FP>Division of Therapeutic Biological Internal Medicine Products. <FP>Division of Review Management and Policy. <FP><E T="03">Office of Post-Marketing Drug Risk Assessment.</E> <FP>Division of Therapeutic Biological Oncology Products. <FP>Division of Therapeutic Biological Internal Medicine Products. <FP>Division of Review Management and Policy. <FP><E T="03">Office of Post-Marketing Drug Risk Assessment.</E> <FP>Extramural Programs Staff. <FP>Information Technology Staff. <FP>Division of Drug Risk Evaluation I. <FP>Division of Drug Risk Evaluation II. <FP><E T="03">Office of Pediatric Drug Development and Program Initiatives.</E> <FP>Pediatric Therapeutics Staff. <FP>Program Initiatives Staff. <FP><E T="03">Office of Pharmaceutical Science.</E> <FP>Quality Implementation Staff. <FP>Operations Staff. <FP>Informatics and Computational Safety Analysis Staff. <FP><E T="03">Office of Clinical Pharmacology and Biopharmaceutics.</E> <FP>Division of Pharmaceutical Evaluation I. <FP>Division of Pharmaceutical Evaluation II. <FP>Division of Pharmaceutical Evaluation III.<SU>1</SU> <FP><E T="03">Office of Generic Drugs.</E><SU>9</SU><FTREF> <FP>Division of Bioequivalence. <FP>Division of Chemistry I. <FP>Division of Chemistry II. <FP>Division of Labeling and Program Support. <FP>Division of Chemistry III. <FTNT> <P><SU>9</SU>&thnsp;Mailing address: 7519 Standish Pl., Rockville, MD 20855. </FTNT> <FP><E T="03">Office of New Drug Chemistry.</E> <FP>Division of New Drug Chemistry I. <FP>Division of New Drug Chemistry II. <FP>Division of New Drug Chemistry III. <FP><E T="03">Office of Testing and Research.</E> <FP>Laboratory of Clinical Pharmacology. <PRTPAGE P='14724'><FP>Division of Applied Pharmacology Research. <FP>Division of Pharmaceutical Analysis. <FP>Division of Product Quality Research. <FP><E T="03">Office of Biotechnology Products.</E> <FP>Division of Monoclonal Antibodies. <FP>Division of Therapeutic Protein. <FP><E T="03">Office of Information Technology.</E><SU>3</SU> <FP>Division of Applications Development and Services.<SU>3</SU> <FP>Division of Infrastructure Management and Service. <FP><E T="03">Office of Medical Policy.</E> <FP>Division of Drug Marketing, Advertising and Communication. <FP><E T="03">Office of Executive Programs.</E> <FP>Executive Operations Staff. <FP>Quality Assurance Staff. <FP>Advisors and Consultants Staff.<SU>3</SU> <FP><E T="03">Office of Translational Science.</E> <FP><E T="03">Office of Biostatistics.</E> <FP>Division of Biometrics I. <FP>Division of Biometrics II. <FP>Division of Biometrics III. <FP>Division of Biometrics IV. <FP>Division of Biometrics V. <FP>Division of Biometrics VI. <FP><E T="03">Office of Clinical Pharmacology.</E> <FP>Division of Clinical Pharmacology I. <FP>Division of Clinical Pharmacology II. <FP>Division of Clinical Pharmacology III. <FP>Division of Clinical Pharmacology IV. <FP>Division of Clinical Pharmacology V. <FP><E T="03">Office of Counter-Terrorism and Pediatric Drug Development.</E><Q P="04"> <FP>OFFICE OF REGULATORY AFFAIRS.<SU>3</SU> <Q P="02"> <FP>Equal Employment Opportunity Staff. <FP><E T="03">Office of Resource Management.</E><SU>3</SU> <FP>Division of Planning, Evaluation, and Management. <FP>Division of Human Resource Development. <FP>Division of Management Operations. <FP>Division of Personnel Operations. <FP><E T="03">Office of Information Technology.</E> <FP><E T="03">Office of Enforcement.</E><SU>5</SU> <FP>Division of Compliance Management and Operations. <FP>Division of Compliance Policy. <FP>Division of Compliance Information and Quality Assurance. <FP><E T="03">Office of Regional Operations</E>.<SU>3</SU> <FP>Division of Federal-State Relations. <FP>Division of Field Science. <FP>Division of Import Operations and Policy. <FP>Division of Field Investigations. <FP><E T="03">Office of Criminal Investigations.</E><SU>10</SU><FTREF> <FTNT> <P><SU>10</SU>&thnsp;Mailing address: 7500 Standish Pl., Rockville, MD 20855. </FTNT> <FP>Mid-Atlantic Area Office.<SU>11</SU><FTREF> <FTNT> <P><SU>11</SU>&thnsp;Mailing address: 11750 Beltsville Dr., Beltsville, MD 20705. </FTNT> <FP>Midwest Area Office.<SU>12</SU><FTREF> <FTNT> <P><SU>12</SU>&thnsp;Mailing address: 901 Warrenville Rd., Lisle, IL 60532. </FTNT> <FP>Northeast Area Office.<SU>13</SU><FTREF> <FTNT> <P><SU>13</SU>&thnsp;Mailing address: 10 Exchange Pl., Jersey City, NJ 07302. </FTNT> <FP>Pacific Area Office.<SU>14</SU><FTREF> <FTNT> <P><SU>14</SU>&thnsp;Mailing address: 201 Avenida Fabricante, San Clemente, CA 92672. </FTNT> <FP>Southeast Area Office.<SU>15</SU><FTREF> <FTNT> <P><SU>15</SU>&thnsp;Mailing address: 865 SW., 78th Ave., Plantation, FL 33324. </FTNT> <FP>Southwest Area Office.<SU>16</SU><FTREF> <FTNT> <P><SU>16</SU>&thnsp;Mailing address: 5799 Broadmoor St., Mission, KS 66202.</FTNT> <Q P="04"><FP>CENTER FOR VETERINARY MEDICINE.<SU>17</SU><FTREF> <FTNT> <P><SU>17</SU>&thnsp;Mailing address: 7500 Standish Pl. (MPN–2), Rockville, MD 20855. </FTNT> <Q P="02"><FP><E T="03">Office of the Center Director.</E> <FP><E T="03">Office of Management.</E> <FP>Management Services Staff. <FP>Information Resources Management Staff. <FP><E T="03">Office of New Animal Drug Evaluation.</E> <FP>Division of Therapeutic Drugs for Non-Food Animals. <FP>Division of Biometrics and Production Drugs. <FP>Division of Therapeutic Drugs for Food Animals. <FP>Division of Human Safety. <FP>Division of Manufacturing Technologies. <FP>Division of Scientific Support. <FP><E T="03">Office of Surveillance and Compliance.</E> <FP>Division of Surveillance. <FP>Division of Animal Feeds. <FP>Division of Compliance. <FP>Division of Epidemiology. <FP><E T="03">Office of Research.</E> <FP>Division of Residue Chemistry. <FP>Division of Animal Research. <FP>Division of Animal and Food Microbiology. <Q P="04"><FP>CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.<SU>18</SU><FTREF> <FTNT> <P><SU>18</SU>&thnsp;Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.</FTNT> <Q P="02"><FP><E T="03">Office of the Center Director.</E> <FP><E T="03">Office of Systems and Management.</E> <FP>Division of Ethics and Management Operations. <FP>Division of Planning, Analysis and Finance. <FP>Division of Information Dissemination. <FP>Division of Information Technology. <FP><E T="03">Office of Compliance.</E> <FP>Promotion and Advertising Policy Staff. <FP>Division of Bioresearch Monitoring. <FP>Division of Program Operations. <FP>Division of Enforcement A. <FP>Division of Enforcement B. <FP><E T="03">Office of Device Evaluation.</E> <FP>Program Management Staff. <FP>Program Operations Staff. <FP>Division of Cardiovascular Devices. <FP>Division of Reproductive, Abdominal, and Radiological Devices. <FP>Division of General, Restorative, and Neurological Devices. <FP>Division of Ophthalmic, and Ear, Nose and Throat Devices. <FP>Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices. <FP><E T="03">Office of Science and Engineering Laboratories.<SU>1</SU></E> <FP>Division of Biology. <FP>Management Support Staff. <FP>Standards Management Staff. <FP>Division of Chemistry and Materials Science. <FP>Division of Solid and Fluid Mechanics. <FP>Division of Physic. <FP>Division of Imaging and Applied Mathematics. <FP><E T="03">Office of Communication, Education and Radiation Programs.</E> <FP>Program Operations Staff. <FP>Regulations Staff. <FP>Staff College. <FP>Division of Device User Programs and Systems Analysis. <FP>Division of Small Manufacturers Assistance. <FP>Division of Mammography Quality and Radiation Programs. <FP>Division of Communication Media. <FP><E T="03">Office of Surveillance and Biometrics.</E> <FP>Issues Management Staff. <FP>Division of Biostatistics. <FP>Division of Postmarket Surveillance. <FP>Division of Surveillance Systems. <FP><E T="03">Office of In Vitro Diagnostic Device Evaluation and Safety.</E> <FP>Division of Chemistry and Toxicology Devices. <FP>Division of Immunology and Hematology Devices. <FP>Division of Microbiology. <SECTION><SECTNO>§&thnsp;5.1105 <SUBJECT>Chief Counsel, Food and Drug Administration. <P>The Office of the Chief Counsel's mailing address is 5600 Fishers Lane, rm. 6–05, Rockville, MD 20857.<SU>1</SU><FTREF> <FTNT> <P><SU>1</SU>&thnsp;The Office of the Chief Counsel (also known as the Food and Drug Division, Office of the General Counsel, Department of Health and Human <PRTPAGE>Services), while administratively within the Office of the Commissioner, is part of the Office of the General Counsel of the Department of Health and Human Services. </FTNT> <SECTION><PRTPAGE P='14725'><SECTNO>§&thnsp;5.1110 <SUBJECT>FDA public information offices. <P>(a) <E T="03">Division of Dockets Management (HFA–305)</E>. The Division of Dockets Management public room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852, Telephone: 301–827–6860. <P>(b) <E T="03">Division of Freedom of Information (HFI–35)</E>. The Freedom of Information public room is located in rm. 6–30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, Telephone: 301–827–6567. <P>(c) <E T="03">Press Relations Staff (HFI–40)</E>. Press offices are located at 10903 New Hampshire Ave., Bldg. 1, Silver Spring, MD 20993–0002, Telephone: 301–827–6242; and at 5100 Paint Branch Pkwy., College Park, MD 20740, Telephone: 301–436–2335. </REGTEXT> <SIG> <DATED>Dated: March 27, 2009. <NAME>Jeffrey Shuren, <TITLE>Associate Commissioner for Policy and Planning. </SIG> <FRDOC>[FR Doc. E9–7349 Filed 3–31–09; 8:45 am]</FRDOC><BILCOD>BILLING CODE 4160–01–S</BILCOD> <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-050-*****-*****- -Name: bstamnas -Payroll No: -Folios: E923-926 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='N'>DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT <CFR>24 CFR Part 30 <DEPDOC>[Docket No. FR–5081–C–04] <RIN>RIN 2501–AD23 <SUBJECT>Civil Money Penalties: Certain Prohibited Conduct; Technical Amendment <AGY><HED>AGENCY:<P>Office of the Secretary, HUD. <ACT><HED>ACTION:<P>Final rule, technical amendment. </ACT> <SUM><HED>SUMMARY:<P>On January 15, 2009, HUD published a final rule to revise HUD's regulations that govern the imposition of civil money penalties. The effect of the rulemaking was to remove one item from the list of actions for which the Mortgagee Review Board may initiate a civil money penalty action against a mortgagee or lender, reducing the list from 15 numbered items to 14, and redesignating the 15th item as item number 14. However, a related cross reference was not updated to reflect this change. In addition, a section revised in 2006 involving delinquent mortgages, also requires a cross-reference change. This document corrects these cross-references. <DATES><HED>DATES:<P><E T='03'>Effective Date</E>: April 1, 2009. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>Dane Narode, Associate General Counsel for Program Enforcement, Department of Housing and Urban Development, 1250 Maryland Avenue, SW., Suite 200, Washington, DC 20024–0500; telephone number 202–708–2350 (this is not a toll-free number), or e-mail address <E T='03'>Dane.M.Narode@hud.gov</E>. Individuals with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at 800–877–8339. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <P>On January 15, 2009 (74 FR 2750), HUD published a final rule that revised HUD's regulations that govern the imposition of civil money penalties, located at part 30 of Title 24 of the Code of Federal Regulations. The final rule followed a proposed rule published on October 17, 2008 (73 FR 61754), that provided a 60 day public comment period. HUD received no comments in response to the proposed rule, the proposed rule was adopted as final without change., The rule was adopted as final effective February 17, 2009, see 74 FR 2750, Jan. 15, 2009. <P>The civil money penalty regulations at 24 CFR 30.35 contain a list of actions, the commission of which allows the mortgagee review board to initiate a civil money penalty action. There were originally 14 such actions (see 61 FR 50216–50217). On April 26, 2005, HUD amended the rule to add a 15th action, failure to engage in loss mitigation. This action was codified at 24 CFR 30.35(a)(15). Along with this addition, 24 CFR 30.35(c)(2) was added pursuant to statutory requirement to provide for a triple civil money penalty for violations of this section. <P>On January 15, 2009, HUD adopted as final regulations that revised 24 CFR 30.35(a) to remove item 24 CFR 30.35(a)(14) from the list, and to redesignate the failure to engage in loss mitigation item from 24 CFR 30.35(a)(15) to 24 CFR 30.35(a)(14) (74 FR 2751, Jan. 15, 2009). However, the 2009 rule failed to incorporate the related cross reference. Therefore, this technical amendment revises 24 CFR 30.35(c)(2) to refer to §&thnsp;30.35(a)(14). <P>The civil money penalty regulations at §&thnsp;30.35(a)(9)(vi) contain a provision stating that the mortgagee review board may initiate a civil money penalty action for failure to report all delinquent mortgages to HUD. Section 30.35(a)(9)(vi) cross-references §&thnsp;203.332 on delinquent mortgages. In 2006, §&thnsp;203.332 was moved to §&thnsp;203.330 and revised (71 FR 16234, Mar.31, 2006). Therefore, this technical amendment revises the cross-reference. <LSTSUB><HED>List of Subjects in 24 CFR Part 30 <P>Administrative practice and procedure, Grant programs-housing and community development, Loan programs-housing and community development, Mortgages, Penalties.</LSTSUB> <REGTEXT TITLE='24' PART='30'> <AMDPAR>Accordingly, 24 CFR part 30 is amended as follows: <PART><HED>PART 30—[AMENDED] <AMDPAR>1. The authority citation for 24 CFR part 30 continues to read as follows: <AUTH><HED>Authority:<P> 12 U.S.C. 1701q–1, 1703, 1723i, 1735f–14, 1735f–15; 15 U.S.C. 1717a; 28 U.S.C. 2461 note; 42 U.S.C. 1437z–1 and 3535(d).<Q P="04"> <AMDPAR>2. Amend §&thnsp;30.35 by revising paragraphs (a)(9)(vi) and (c)(2) to read as follows. <SECTION><SECTNO>§&thnsp;30.35<SUBJECT>Mortgagees and lenders. <P>(a) * * * <P>(9) * * * <P>(vi) Report all delinquent mortgages to HUD, as required by §&thnsp;203.330 of this title; <STARS> <P>(c) * * * <P>(2) <E T="03">Maximum penalty for failing to engage in loss mitigation.</E> The penalty for a violation of paragraph (a)(14) of this section shall be three times the amount of the total mortgage insurance benefits claimed by the mortgagee with respect to any mortgage for which the mortgagee failed to engage in such loss mitigation actions. </REGTEXT> <SIG><DATED>Dated: March 25, 2009. <NAME>Aaron Santa Anna, <TITLE>Assistant General Counsel for Regulations.</SIG> <FRDOC> [FR Doc. E9–7078 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-014-PDF**-*****- -Name: -Payroll No: 70070 -Folios: E651-E653 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='N'>DEPARTMENT OF HOMELAND SECURITY <SUBAGY>Coast Guard <CFR>33 CFR Part 117 <DEPDOC>[USCG–2009–0150] <SUBJECT>Drawbridge Operation Regulations; Chelsea River, Chelsea and East Boston, MA <AGY><HED>AGENCY:<P>Coast Guard, DHS. <ACT><HED>ACTION:<P>Notice of temporary deviation from regulations.</ACT> <SUM><HED>SUMMARY:<P>The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the P.J. McArdle Bridge across the Chelsea River, mile 0.3, between Chelsea and East Boston, Massachusetts. This deviation is <PRTPAGE P='14726'>necessary to facilitate the Chelsea River Revel and 5K Road Race. This deviation allows the bridge to remain in the closed position during the running of the 5K Road Race and for the remainder of the Chelsea River Revel. Vessels that can pass under the draw without a bridge opening may do so at all times. <DATES><HED>DATES:<P>This deviation is effective from 8 a.m. through 5 p.m. on June 13, 2009. <ADD><HED>ADDRESSES:<P>Documents indicated in this preamble as being available in the docket are part of docket USCG–2009–0150 and are available online at &fnl;<E T='03'>http://www.regulations.gov</E>. They are also available for inspection or copying at two locations: The Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and the First Coast Guard District, Bridge Branch Office, 408 Atlantic Avenue, Boston, Massachusetts 02110, between 7 a.m. and 3 p.m., Monday through Friday, except Federal holidays. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>John McDonald, Project Officer, First Coast Guard District, at (617) 223–8364. <SUPLINF><HED>SUPPLEMENTARY INFORMATION:<P>The owner of the bridge, the City of Boston, requested this temporary deviation. The P.J. McArdle Bridge, across the Chelsea River at mile 0.3, between Chelsea and East Boston, Massachusetts, has a vertical clearance in the closed position of 21 feet at mean high water and 30 feet at mean low water. The bridge opens on signal as required by 33 CFR 117.593. <P>This deviation which allows the bridge to remain closed is effective from 8 a.m. through 5 p.m. on June 13, 2009. Vessels able to pass under the closed draw may do so at any time. Tankers, and tug and barge units transit Chelsea Creek under the McArdle Bridge. Waterway users were advised of the requested bridge closure period and offered no objection. <P>In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35. <SIG><DATED>Dated: March 17, 2009. <NAME>Gary Kassof, <TITLE>Bridge Program Manager, First Coast Guard District.</SIG> <FRDOC>[FR Doc. E9–7257 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 4910–15–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-015-PDF**-*****- -Name: -Payroll No: 70070 -Folios: E654-E656 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='S'>DEPARTMENT OF HOMELAND SECURITY <SUBAGY>Coast Guard <CFR>33 CFR Part 117 <DEPDOC>[Docket No. USCG–2009–0104] <SUBJECT>Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Jay Jay, FL <AGY><HED>AGENCY:<P>Coast Guard, DHS. <ACT><HED>ACTION:<P>Notice of temporary deviation from regulations.</ACT> <SUM><HED>SUMMARY:<P>The Commander, Seventh Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the NASA Railroad bridge across the Atlantic Intracoastal Waterway, mile 876.6, at Jay Jay, FL. The deviation is necessary to perform rehabilitation work on the bridge. This deviation allows the bridge to not open to vessel traffic from 7 a.m. until 11 a.m. and from 1 p.m. until 5 p.m., Monday through Friday except federal holidays until June 30, 2009; all other times the bridge will continue to operate in accordance with 33 CFR 117.261(j). <DATES><HED>DATES:<P>This deviation is effective from March 11, 2009, until June 30, 2009. <ADD><HED>ADDRESSES:<P>Documents indicated in this preamble as being available in the docket are part of docket USCG–2009–0104 and are available online at <E T='03'>www.regulations.gov</E>. They are also available for inspection or copying at two locations: The Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and the Commander (dpb), Seventh Coast Guard District, 909 SE. 1st Avenue, Room 432, Miami, Florida 33131–3028 between 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>If you have questions on this rule, call Mr. Barry Dragon, Bridge Branch, Seventh Coast Guard District, at 305–415–6743. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826. <SUPLINF><HED>SUPPLEMENTARY INFORMATION:<P>This deviation was requested by NASA, the bridge owner, in order to complete rehabilitation of the NASA Bridge, mile 876.6, of the Atlantic Intracoastal Waterway, Jay Jay, FL. The bridge has a vertical clearance of 7 feet in the closed position and a horizontal clearance of 90 feet. The work will require four hours of continuous closure followed by two hours for vessel passage followed by four hours of continuous closure, Monday through Friday except Federal holidays. The normal operating schedule for the bridge is in 33 CFR 117.261(j). The draw is normally in the fully open position and lowers upon command by operator of approaching train. This deviation is effective until June 30, 2009. <P>In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35. <SIG><DATED>Dated: March 11, 2009. <NAME>R.S. Branham, <TITLE>Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard District.</SIG> <FRDOC>[FR Doc. E9–7258 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 4910–15–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-016-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E657-E658 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='S'>DEPARTMENT OF HOMELAND SECURITY <SUBAGY>Coast Guard <CFR>33 CFR Part 165 <DEPDOC>[Docket No. USCG–2008–0411] <RIN>RIN 1625–AA00 <SUBJECT>Safety Zone; Captain of the Port Zone Jacksonville; Offshore Cape Canaveral, FL <AGY><HED>AGENCY:<P>Coast Guard, DHS. <ACT><HED>ACTION:<P>Final Rule. </ACT> <SUM><HED>SUMMARY:<P>The Coast Guard is establishing four safety zones to protect infrastructure and marine traffic from the hazards associated with recurring space vehicle launches from Cape Canaveral Air Force Station (CCAFS). The safety zones extend from the shoreline to points approximately 12 nautical miles offshore and will only be activated and enforced during pre-launch hours and terminate approximately 15 minutes after a successful launch. In addition to protecting marine traffic from the hazards associated with the launching of space vehicles, the regulation will expedite notification to the public of such launches and also reduce the administrative workload of the Coast Guard. <DATES><HED>DATES:<P>This rule is effective May 1, 2009. <ADD><HED>ADDRESSES:<P>Comments and material received from the public, as well as <PRTPAGE P='14727'>documents mentioned in this preamble as being available in the docket, are part of docket USCG–2008–0411 and are available online by going to <E T="03">http://www.regulations.gov</E>, selecting the Advanced Docket Search option on the right side of the screen, inserting USCG–2008–0411 in the Docket ID box, pressing Enter, and then clicking on the item in the Docket ID column. This material is also available for inspection or copying at two locations: The Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays and the Coast Guard Sector Jacksonville Prevention Department, 4200 Ocean Street, Atlantic Beach, Florida 32233, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>If you have questions on this rule, call LCDR Mark Gibbs at Coast Guard Sector Jacksonville Prevention Department (904) 564–7563. If you have questions on viewing docket, call Renee V. Wright, Program Manager, Docket Operations, telephone (202) 366–9826. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-017-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E659-E662 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <HD1>Regulatory Information <P>On August 18, 2008, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone; Captain of the Port Zone Jacksonville; Offshore Cape Canaveral, FL in the <E T='04'>Federal Register</E> (73 FR 160). We received 0 letters commenting on the rule. No public meeting was requested, and none was held. <HD1>Background and Purpose <P>Space vehicle launches from CCAFS occur throughout the year and have a decided impact on the waters offshore Cape Canaveral. These waters are located within the boundaries of Seventh Coast Guard District, Captain of the Port (COTP) Zone Jacksonville, as defined by CFR 3.35–20. Currently, CCAFS launches 12 to 15 vehicles per year. For each launch, the Coast Guard activates and enforces the security zone in 33 CFR 165.701. The offshore portion of that security zone extends three miles from the baseline. However, to ensure the safety of all maritime interests, CCAFS has requested an additional safety buffer be added to an extent reaching 12 nautical miles offshore, the maximum distance from baseline for which the COTP has jurisdictional authority to establish safety zones. Presently, for each space vehicle launch, CCAFS requests, and the Coast Guard creates, a Temporary Final Rule establishing a safety zone from the baseline out to 12 nautical miles. This temporary safety zone covers an area of the Atlantic Ocean that commences at the shoreline and extends 3 miles either side of the launch azimuth bearing out to 12 nautical miles. Administrative efficiency and can be achieved while improving public notice through the promulgation of a final rule and subsequent enforcement notice rather than through promulgation of individual temporary final rules for each launch. In 2007, the Coast Guard issued 12 temporary regulations. In addition to the administrative burden, the repeated temporary rules have caused confusion among maritime interests who must adjust plans and operations to each new and different temporary zone. This problem will worsen in the near future as CCAFS pursues more robust launch schedules. <P>Furthermore, the unpredictability of weather causes a significant proportion of launches to be delayed. Any delay precludes suitable notification to the public on the effective date and time safety zones are enacted and enforced. The Coast Guard must therefore create temporary final rules that sometimes are not completed until days or hours before the event. This Final Rule coupled with notice will serve the public interest by ensuring the safety of maritime interests at risk during a launch. <P>This rule will significantly relieve the administrative burden on the Coast Guard, and at the same time allow the Coast Guard to notify the public of launch area restrictions in a timely manner. The public notification of launch date and time along with a description of the regulated zone will be furnished via Broadcast Notice to Mariners, Public Notices, and on-scene Patrol Commanders. In addition, the closing of the area will be signified by the display of a yellow ball from a 90-foot pole near the shoreline at approximately 28°35′00″ N, 080°34′36″ W, and from a 90-foot pole near the shoreline at approximately 28°25′18″ N, 080°35′00″ W. <HD1>Discussion of Comments and Changes <P>On August 18, 2008 the Coast Guard published a notice of proposed rulemaking (NPRM) that proposed establishment of four safety zones to protect infrastructure and marine traffic from the hazards associated with recurring space vehicle launches from Cape Canaveral Air Force Station. No comments were received in response to the NPRM, however the COTP has incorporated the following changes to notify the public the safety zone has been activated. <P>The closing of the area will be signified by the display of a yellow ball from a 90-foot pole near the shoreline at approximately 28°35′00″ N, 080°34′36″ W, and from a 90-foot pole near the shoreline at approximately 28°25′18″ N, 080°35′00″ W. <HD1>Regulatory Analyses <P>We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analysis based on 13 of these statutes or executive orders. <HD1>Regulatory Planning and Review <P>This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. <P>We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. Safety zones will be enacted 45 minutes prior to launch time and only extend 15 minutes beyond a successful launch. During this time, no vessel will be permitted to transit through the safety zone(s). <HD1>Small Entities <P>Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-018-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E663-E666 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. Total time of safety zone activation and thus restriction to the public is expected to be one hour per launch. We do not anticipate any significant economic impact resulting from activation of the safety zone(s). <HD1>Assistance for Small Entities <P>Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), in the NPRM we offered to assist small entities in understanding the rule so <PRTPAGE P='14728'>that they could better evaluate its effects on them and participate in the rulemaking process. <HD1>Collection of Information <P>This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). <HD1>Federalism <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. <HD1>Unfunded Mandates Reform Act <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. <HD1>Taking of Private Property <P>This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. <HD1>Civil Justice Reform <P>This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. <HD1>Protection of Children <P>We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that may disproportionately affect children. <HD1>Indian Tribal Governments <P>This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. <HD1>Energy Effects <P>We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. <HD1>Technical Standards <P>The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (<E T='03'>e.g.</E>, specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. <P>This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. <HD1>Environment <P>We have analyzed this rule under Department of Homeland Security Management Directive 5100.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have concluded under the Instruction that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2–1, paragraph (34)(g), of the Instruction, from further environmental documentation. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-019-PDF**-*****- -Name: -Payroll No: 70070 -Folios: E667-E670 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under <E T='02'>ADDRESSES</E>. <LSTSUB><HED>List of Subjects in 33 CFR Part 165 <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</LSTSUB> <REGTEXT TITLE='33' PART='165'> <AMDPAR>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: <PART><HED>PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS <AMDPAR>1. The authority citation for part 165 continues to read as follows: <AUTH><HED>Authority:<P> 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. </REGTEXT><Q P="02"><REGTEXT TITLE="33" PART="165"> <AMDPAR>2. Add section 165.775 to read as follows: <SECTION><SECTNO>§&thnsp;165.775 <SUBJECT>Safety Zone; Captain of the Port Zone Jacksonville; Offshore Cape Canaveral, Florida. <P>(a) <E T='03'>Regulated Area</E>. (1) Zone (A) is defined by four latitude and longitude corner points. Zone A originates from the baseline at position 28°45.7′ N, 080°42.7′ W; then proceeds northeast to 28°50.1′ N, 080°29.9′ W; then proceeds southeast to 28°31.3′ N, 080°19.6′ W; then proceeds west back to the baseline at position 28°31.3′ N, 080°33.4′ W. <P>(2) Zone (B) is defined by four latitude and longitude corner points. Zone B originates from the baseline at position 28°40.1′ N, 080°38.4′ W; then proceeds northeast to 28°48.8′ N, 080°28.9′ W; then proceeds southeast to 28°29.7′ N, 080°18.9′ W; then proceeds west back to the baseline at position 28°29.7′ N, 080°31.6′ W. <P>(3) Zone (C) is defined by four latitude and longitude corner points. Zone C originates from the baseline at position 28°36.2′ N, 080°35.3′ W; then proceeds northeast to 28°45.6′ N, 080°25.2′ W; then proceeds south to 28°26′ N, 080°20.8′ W; then proceeds west back to the baseline at position 28°26′ N, 080°34.4′ W. <P>(4) Zone (D) is defined by four latitude and longitude corner points. Zone D originates from the baseline at position 28°31.6′ N, 080°34′ W; then proceeds east to 28°31.6′ N, 080°20.1′ W; then proceeds south to 28°16.7′ N, 080°23.3′ W; then proceeds northwest back to the baseline at position 28°21.6′ N, 080°36.1′ W. <P>(b) <E T='03'>Definitions</E>. The following definitions apply to this section: <P><E T='03'>Designated representative</E> means Coast Guard Patrol Commanders <PRTPAGE P='14729'>including Coast Guard coxswains, petty officers and other officers operating Coast Guard vessels, and federal, state, and local officers designated by or assisting the Captain of the Port (COTP) Jacksonville in the enforcement of regulated navigation areas, safety zones, and security zones. <P>(c) <E T='03'>Regulations</E>. In accordance with the general regulations in §&thnsp;165.23 of this part, anchoring, mooring or transiting in this zone is prohibited unless authorized by the Coast Guard Captain of the Port Jacksonville or his designated representative. <P>(d) <E T='03'>Notice of a Safety Zone</E>. The proposed safety zones are temporary in nature and will only be enacted and enforced prior to, and just after a successful launch. The COTP will inform the public of the existence or status of the safety zone(s) by Broadcast Notice to Mariners on VHF–FM channel 16, Public Notice, on-scene presence, and by the display of a yellow ball from a 90-foot pole near the shoreline at approximately 28°35′00″ N, 080°34′36″ W, and from a 90-foot pole near the shoreline at approximately 28°25′18″ N, 080°35′00″ W. Coast Guard assets or other Federal, State, or local law enforcement assets will be clearly identified by lights, markings, or with agency insignia. <P>(e) <E T='03'>Contact Information</E>. The COTP Jacksonville may be reached by telephone at (904) 564–7513. Any on-scene Coast Guard or designated representative assets may be reached on VHF–FM channel 16. </REGTEXT> <SIG><DATED>Dated: November 26, 2008. <NAME>Paul F. Thomas, <TITLE>Captain, U.S. Coast Guard, Captain of the Port Jacksonville.</SIG> <EDNOTE><HED>Editorial Note: <P>This document was received in the Office of the Federal Register on Friday, March 27, 2009.</EDNOTE> <Q P="03"> <FRDOC>[FR Doc. E9–7259 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 4910–15–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-028-PDF**-*****- -Name: M Mauck -Payroll No: 62280 -Folios: E809-812 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='S'>DEPARTMENT OF HOMELAND SECURITY <SUBAGY>Coast Guard <CFR>33 CFR Part 165 <DEPDOC>[Docket No. USCG–2008–1272] <RIN>RIN 1625–AA00 <SUBJECT>Safety Zone; Underwater Object, Massachusetts Bay, MA <AGY><HED>AGENCY:<P>Coast Guard, DHS. <ACT><HED>ACTION:<P>Temporary final rule. </ACT> <SUM><HED>SUMMARY:<P>The Coast Guard is extending the duration of a temporary safety zone surrounding the fishing vessel PATRIOT located approximately 17 miles northeast of Scituate, Massachusetts in Massachusetts Bay. This action is necessary to ensure that vessels are not endangered by conducting dredging, diving, salvage, anchoring, fishing or other activities in this area. This temporary rulemaking is needed to protect the environment, the commercial fishing industry, and the general public from potential hazards associated with the underwater object. <EFFDATE><HED>DATES:<P>This rule is effective from 11:59 p.m. March 14, 2009 through 11 p.m. April 28, 2009. <ADD><HED>ADDRESSES:<P>Documents indicated in this preamble as being available in the docket are part of docket USCG–2008–1272 and will be available online at <E T="03">www.regulations.gov</E>. They will also be available for inspection or copying in two locations: the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and United States Coast Guard Sector Boston, 427 Commercial St, Boston, MA 02109 between 7 a.m. and 3 p.m., Monday through Friday, except Federal holidays. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>If you have questions on this temporary rule, call Chief Eldridge McFadden, Waterways Management Division, at 617–223–3000. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <HD1>Regulatory Information <P>We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because initial immediate action was needed to protect the public from the hazards posed by an unknown underwater object located in Massachusetts Bay. This object was later identified as the F/V Patriot. The F/V PATRIOT is located in approximately 95 feet of water 17 miles northeast of Scituate, Massachusetts. This rule extends the duration of the existing safety zone, which would have expired on March 14, 2009, to ensure, to the extent practicable, the immeadiate, continued protections for the environment, the commercial fishing industry, and the general public from the hazards associated with the F/V PATRIOT, while investigative efforts continue, risk mitigation strategies are further explored and implemented, and salvage efforts are conducted. <P>For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the <E T='04'>Federal Register</E>. <HD1>Background and Purpose <P>On January 3, 2009, the F/V PATRIOT, a 54-foot steel-hull boat, sank with the loss of two crewmembers onboard. The vessel was reported to have an estimated 5000 gallons of fuel onboard. There were no survivors and the exact position of the vessel was not immediately known. On January 8, 2009, the Coast Guard established a temporary safety zone around a reported underwater object believed to be the &fnl;F/V PATRIOT, located in Massachusetts Bay approximately 17 miles northeast of Scituate, Massachusetts, in position 42°24&min;27.34&sec; N, 70°27&min;17.23&sec; W. <P>This underwater object created an immediate and significant danger to the environment, the commercial fishing industry, and the general maritime public, as mariners unaware of its presence could make contact with the object and cause damage to their vessel, equipment below the water or fishing gear. On January 14, 2009, the Coast Guard extended the temporary safety zone until March 14, 2009, while investigative efforts continued and risk mitigation strategies were further explored. On January 23, 2009, underwater exploratory operations with photographic equipment confirmed that the object was the F/V PATRIOT. The owners of the vessel intend to conduct dive and salvage operations on the vessel. The extension of this zone will help ensure the planned dive and salvage operations can be conducted safely. <HD1>Discussion of Rule <P>This regulation extends the duration of the temporary safety zone on the navigable waters of Massachusetts Bay, Massachusetts, 17 miles northeast of Scituate, Massachusetts. This extension is necessary to allow the owners of the F/V PATRIOT to conduct salvage operations. The first safety zone, on this matter, was effective from January 8, through January 14, 2009. On January 14, 2009, the duration of the zone was extended until March 14, 2009 (74 FR 7817). With this rule, we are extending the duration of the safety zone from March 14, 2009 through April 28, 2009. The zone extends for 500 yards, in all directions, from the F/V PATRIOT in approximate position 42°24&min;27.34&sec; N, <PRTPAGE P='14730'>70°27&min;17.23&sec; W. The position of the safety zone has been modified slightly from the prior safety zones so as to better identify its location. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-029-PDF**-*****- -Name: M Mauck -Payroll No: 62280 -Folios: E813-E815 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>This action is intended to prohibit vessels and persons from entering, transiting, anchoring, diving, dredging, dumping, fishing, trawling, laying cable, or conducting salvage operations in this zone except as authorized by the Coast Guard Captain of the Port Boston, Massachusetts. Public notifications about this safety zone have been and will continue to be made through broadcast and local notice to mariners. Marine traffic may transit safely in surrounding areas of Massachusetts Bay, but are restricted from entering the area delineated above. <P>The Captain of the Port anticipates minimal negative impact on vessel traffic due to the limited area and duration covered by this safety zone. <HD1>Regulatory Analyses <P>We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders. <HD1>Regulatory Planning and Review <P>This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. <P>We expect the economic impact of this rule will be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This regulation may have some impact on the public. This impact, however, is outweighed by the safety risks mitigated by the enactment of this zone. Further, the safety zone extends only 500 yards in all directions of the fishing vessel PATRIOT, and as such mariners will be able to transit around the zone without incurring additional costs. <HD1>Small Entities <P>Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. <P>The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit, anchor, or fish in a portion of the Massachusetts Bay covered by the safety zone. This rule will not have a significant impact on a substantial number of small entities for the following reasons: The area this rule is affecting is very small and there is plenty of water in the area for vessels to transit around. <HD1>Assistance for Small Entities <P>Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. <P>Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1–888–REG–FAIR (1–888–734–3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. <HD1>Collection of Information <P>This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-030-PDF**-*****- -Name: M Mauck -Payroll No: 62280 -Folios: E816-819 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <HD1>Federalism <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. <HD1>Unfunded Mandates Reform Act <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. <HD1>Taking of Private Property <P>This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. <HD1>Civil Justice Reform <P>This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. <HD1>Protection of Children <P>We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. <HD1>Indian Tribal Governments <P>This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. <HD1>Energy Effects <P>We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. <PRTPAGE P='14731'><HD1>Technical Standards <P>The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (<E T='03'>e.g.,</E> specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. <P>This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. <HD1>Environment <P>We have analyzed this rule under Department of Homeland Security Management Directive 0023.1 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2–1, paragraph (34)(g), of the Instruction, from further environmental documentation as the rule pertains to a temporary safety zone established and extended to address an emergency situation lasting more than one week. The written environmental analysis checklist and Categorical Exclusion Determination prepared for the initial effective period of this safety zone regulation is applicable to this extension. These documents are available in the docket where indicated under <E T='02'>ADDRESSES</E>. <LSTSUB><HED>List of Subjects in 33 CFR Part 165 <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</LSTSUB> <REGTEXT TITLE='33' PART='165'> <AMDPAR>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows: <PART><HED>PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS <AMDPAR>1. The authority citation for part 165 continues to read as follows: <AUTH><HED>Authority:<P> 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Public Law 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. </REGTEXT><Q P="04"><REGTEXT TITLE='33' PART='165'> <AMDPAR>2. Revise temporary §&thnsp;165.T01–1272, to read as follows: <SECTION><SECTNO>§&thnsp;165.T01–1272<SUBJECT>Safety Zone: Underwater Object, Massachusetts Bay, MA. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R33 PC\J\217001-A01AP0-031-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E820-E822 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED][REGTEXT][P]*[/P] ?><?USGPO Galley Info End?> <P>(a) <E T='03'>Location</E>. The following area is a safety zone: All navigable waters, from surface to bottom, of Massachusetts Bay within a 500 yard radius of underwater object, in approximate position 42°24′27.34″ N, 70°27′17.23″ W. <P>(b) <E T='03'>Definitions</E>. The following definition applies to this section: <E T='03'>Designated representative</E> means any commissioned, warrant, and petty officers of the Coast Guard on board Coast Guard, Coast Guard Auxiliary, and local, state, and federal law enforcement vessels who have been authorized to act on the behalf of the Captain of the Port Boston. <P>(c) <E T='03'>Regulations</E>. (1) The general regulations contained in 33 CFR §&thnsp;165.23 apply. <P>(2) In accordance with the general regulations in §&thnsp;165.23 of this part, all vessels and persons are prohibited from entering the safety zone without permission from the Captain of the Port Boston. In addition, all vessels and persons are prohibited from anchoring, diving, dredging, dumping, fishing, trawling, laying cable, or conducting salvage operations in this zone except as authorized by the Coast Guard Captain of the Port Boston. <P>(3) All persons and vessels shall comply with the Coast Guard Captain of the Port Boston or designated representative. <P>(4) Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed. <P>(5) Persons desiring to enter the safety zone may request permission from the Captain of the Port Boston via VHF Channel 16 or via telephone at (617) 223–3201. <P>(d) <E T='03'>Enforcement Period.</E> This rule will be enforced from 11 p.m. January 8, 2009, until 11 p.m. April 28, 2009. </REGTEXT> <SIG><DATED>Dated: March 6, 2009. <NAME>G.P. Kulisch, <TITLE>Captain, U.S. Coast Guard, Captain of the Port Boston.</SIG> <FRDOC>[FR Doc. E9–7260 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 4910–15–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-025-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E798-E801 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='N'>ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 52 <DEPDOC>[EPA–R06–OAR–2008–0509; FRL–8788–8] <SUBJECT>Approval and Promulgation of Implementation Plans; New Mexico; Albuquerque/Bernalillo County <AGY><HED>AGENCY:<P>Environmental Protection Agency (EPA). <ACT><HED>ACTION:<P>Direct final rule.</ACT> <SUM><HED>SUMMARY:<P>EPA is taking direct final action to approve a revision to the New Mexico Albuquerque/Bernalillo County State Implementation Plan (SIP). This revision replaces Regulation 8, Airborne Particulate Matter, with New Mexico Administrative Code (NMAC), 20.11.20, Fugitive Dust Control. This rulemaking action is being taken under section 110 of the Clean Air Act (CAA). <EFFDATE><HED>DATES:<P>This rule is effective on June 1, 2009 without further notice, unless EPA receives adverse comment by May 1, 2009. If EPA receives such comment, EPA will publish a timely withdrawal in the <E T='04'>Federal Register</E> informing the public that this rule will not take effect. <ADD><HED>ADDRESSES:<P>Submit your comments, identified by Docket No. EPA–R06–OAR–2008–0509, by one of the following methods: <P>&sbull; <E T='03'>http://www.regulations.gov:</E> Follow the on-line instructions for submitting comments. <P>&sbull; <E T='03'>E-mail:</E> Mr. Guy Donaldson at <E T='03'>donaldson.guy@epa.gov</E>. Please also send a copy by email to the person listed in the <E T='02'>FOR FURTHER INFORMATION CONTACT</E> section below. <P>&sbull; <E T='03'>Fax:</E> Mr. Guy Donaldson, Chief, Air Planning Section (6PD–L), at fax number 214–665–7263. <P>&sbull; <E T='03'>Mail:</E> Mr. Guy Donaldson, Chief, Air Planning Section (6PD–L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202–2733. <P>&sbull; <E T='03'>Hand Delivery:</E> Mr. Guy Donaldson, Chief, Air Planning Section (6PD–L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202–2733. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. <P><E T='03'>Instructions:</E> Direct your comments to Docket ID No. EPA–R06–OAR–2008–0509. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at <E T='03'>http://www.regulations.gov</E>, including any personal information provided, unless <PRTPAGE P='14732'>the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through <E T='03'>http://www.regulations.gov</E> or e-mail. The <E T='03'>http://www.regulations.gov</E> Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through <E T='03'>http://www.regulations.gov</E> your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. <P><E T='03'>Docket:</E> All documents in the docket are listed in the <E T='03'>http://www.regulations.gov</E> index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in <E T='03'>http://www.regulations.gov</E> or in hard copy at the Air Planning Section (6PD–L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202–2733. The file will be made available by appointment for public inspection in the Region 6 FOIA Review Room between the hours of 8:30 am and 4:30 pm weekdays except for legal holidays. Contact the person listed in the <E T='02'>FOR FURTHER INFORMATION CONTACT</E> paragraph below or Mr. Bill Deese at 214–665–7253 to make an appointment. If possible, please make the appointment at least two working days in advance of your visit. There will be a 15 cent per page fee for making photocopies of documents. On the day of the visit, please check in at the EPA Region 6 reception area at 1445 Ross Avenue, Suite 700, Dallas, Texas. <P>The State submittal is also available for public inspection at the State Air Agency listed below during official business hours by appointment: <P>The City of Albuquerque, Environmental Health Department, One Civic Plaza, Albuquerque, NM, 87102. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>Joe Kordzi, Air Planning Section (6PD–L), Environmental Protection Agency, Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202–2733, telephone (214) 665–7186; fax number 214–665–7263; e-mail address <E T='03'>kordzi.joe@epa.gov</E>. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <P>Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA. <EXTRACT><HD1>Outline <FP-2>I. Background <FP-2>II. Evaluation of the Albuquerque Fugitive Dust Control Rule <FP-2>III. Final Action <FP-2>IV. Statutory and Executive Order Reviews </EXTRACT> <HD1>I. Background <P>The Albuquerque/Bernalillo County Air Quality Control Board (AQCB) is the federally delegated air quality authority for Albuquerque and Bernalillo County. The AQCB is authorized to administer and enforce the CAA and the New Mexico Air Quality Control Act, and to require local air pollution sources to comply with air quality standards. <P>EPA approved the AQCB's Rule 8, Airborne Particulate Matter, on February 23, 1993 (58 FR 10970). The AQCB revised this regulation with NMAC 20.11.20, Airborne Particulate Matter, in 1996. The AQCB later substantially revised NMAC 20.11.20 on January 14, 2004, and renamed it “Fugitive Dust Control.” On September 7, 2004, the Governor of New Mexico submitted a SIP revision requesting that EPA revise the New Mexico Albuquerque/Bernalillo County SIP by replacing Regulation 8 with NMAC 20.11.20, Fugitive Dust Control. The AQCB later requested that this SIP submission be placed on hold, anticipating that NMAC 20.11.20 would again be revised. Subsequently, on April 3, 2008, the Governor of New Mexico submitted a SIP revision with the newly revised NMAC 20.11.20. <HD1>II. What did the state submit and how did we evaluate it? <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-026-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E802-E804 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>The AQCB's SIP revision package included (1) Regulation 8, Airborne Particulate Matter; (2) NMAC 20.11.20, Fugitive Dust Control; (3) documents associated with a public hearing and a public meeting conducted on February 13, 2008; (4) evidence that legal notices were published in the local newspaper and the New Mexico Register, and (5) evidence NMAC 20.11.20, Fugitive Dust Control was filed with the New Mexico State Records Center on February 15, 2008. <P>NMAC 20.11.20, Fugitive Dust Control has a number of changes over Regulation 8, Airborne Particulate Matter, that will enable the City of Albuquerque Air Quality Division to improve its ability to address particulate matter emissions. In general, NMAC 20.11.20, Fugitive Dust Control is designed to capture all sources of fugitive dust, in contrast to Regulation 8, which targeted industrial and commercial activities. Examples of the improvements incorporated into NMAC 20.11.20, Fugitive Dust Control include the following: <P>&sbull; The use of reasonably available control measures identified in the regulation, or other effective control measures to prevent or abate fugitive dust leaving a property where human actions may or will generate fugitive dust. <P>&sbull; The stabilization of new and existing unpaved roadways and unpaved lots in Bernalillo County to abate fugitive dust. <P>&sbull; A requirement that permits be obtained for surface disturbing activities involving <FR>3/4</FR> acre or more. <P>&sbull; Control of greenwaste (e.g., grass clippings or leaves) from being deposited on publicly owned properties, where it can become airborne. <P>&sbull; Provisions for programmatic permits for routine maintenance, routine surface disturbance activities, or routine ongoing active operations. <P>&sbull; Provisions for construction permits. <P>&sbull; Re-seeding specifications for native plants. <P>&sbull; Provisions for public outreach and training on fugitive dust for those involved in earthwork activities. <P>&sbull; Guidelines for responding to complaints, especially where damage to private property by fugitive dust is alleged. <P>&sbull; Appeal procedures for permits and enforcement actions. <P>See the Technical Support Document for a more detailed comparison of NMAC 20.11.20, Fugitive Dust Control with the earlier Regulation 8. <P>Under section 110(l), EPA cannot approve a SIP revision if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP), or any other applicable requirement of the CAA. As shown above, this revision makes the SIP more stringent and includes coverage of more sources. It will not result in increased emissions. Therefore, EPA's approval of this SIP revision will not interfere with any <PRTPAGE P='14733'>applicable requirement concerning attainment and RFP or any other CAA requirement in compliance with the requirements of section 110(l) of the Act. <HD1>III. What is our final action? <P>The EPA is approving the April 3, 2008 revision to the New Mexico Albuquerque/Bernalillo County SIP regarding Fugitive Dust Control. This revision replaces Regulation 8, Airborne Particulate Matter, with NMAC 20.11.20, Fugitive Dust Control because it is a substantial improvement over the approved SIP. Furthermore, as the April 3, 2008 SIP submission is a replacement of the September 7, 2004 SIP submission, we are taking no action on the September 7, 2004 submission. This rulemaking action is being taken under section 110 of the CAA. <HD1>IV. Why is this a “final action?” <P>EPA is publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this <E T='04'>Federal Register</E> publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are received. This rule will be effective on June 1, 2009 without further notice unless we receive adverse comment by May 1, 2009. If we receive adverse comments, we will publish a timely withdrawal in the <E T='04'>Federal Register</E> informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment. <HD1>V. Statutory and Executive Order Reviews <P>Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action: <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-027-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E805-E808 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>&sbull; Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); <P>&sbull; Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 <E T='03'>et seq.</E>); <P>&sbull; Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 <E T='03'>et seq.</E>); <P>&sbull; Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); <P>&sbull; Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); <P>&sbull; Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); <P>&sbull; Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); <P>&sbull; Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and <P>&sbull; Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). <P>In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. <P>The Congressional Review Act, 5 U.S.C. 801 <E T='03'>et seq.</E>, as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the <E T='04'>Federal Register</E>. A major rule cannot take effect until 60 days after it is published in the <E T='04'>Federal Register</E>. This action is not a “major rule” as defined by 5 U.S.C. 804(2). <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2009. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) <LSTSUB><HED>List of Subjects in 40 CFR Part 52 <P>Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.</LSTSUB> <SIG><DATED>Dated: March 16, 2009. <NAME>Lawrence E. Starfield, <TITLE>Acting Regional Administrator, Region 6.</SIG><Q P="03"> <REGTEXT TITLE='40' PART='52'> <AMDPAR>40 CFR part 52 is amended as follows: <PART><HED>PART 52—[AMENDED] <AMDPAR>1. The authority citation for part 52 continues to read as follows: <AUTH><HED>Authority:<P> 42 U.S.C. 7402 <E T='03'>et seq</E>. </REGTEXT><REGTEXT TITLE='40' PART='52'> <SUBPART><HED>Subpart GG—New Mexico <AMDPAR>2. In §&thnsp;52.1620(c), the second table entitled “EPA Approved Albuquerque/Bernalillo County, NN Regulations,” is amended as follows: <AMDPAR>a. Under the centered heading “Albuquerque/Bernalillo County, Air Quality Control Regulations,” by removing the entry for “Regulation No. 8, Airborne Particulate Matter;” and <AMDPAR>b. Under the centered heading “New Mexico Administrative Code (NMAC) Title 20—Environment Protection, Chapter 11- Albuquerque/Bernalillo County Air Quality Control Board,” immediately following the entry for “Part 8 (20.11.8 NMAC),” by adding a new entry for “Part 20 (20.11.20 NMAC), Fugitive Dust Control,” to read as follows: <SECTION><SECTNO>§&thnsp;52.1620 <SUBJECT>Identification of plan. <STARS> <P>(c) * * * <PRTPAGE P='14734'><GPOTABLE COLS="5" OPTS="L1,i1" CDEF="s50,r50,12,r50,xs50"> <TTITLE>EPA Approved Albuquerque/Bernalillo County, NN Regulations <BOXHD> <CHED H="1">State citation <CHED H="1">Title/subject <CHED H="1">State approval/<LI>effective date <CHED H="1">EPA approval<LI>date <CHED H="1">Explanation <ROW RUL="s&qdrt;"><ENT I="22"> <ROW><ENT I="28"> *          *          *          *          *          *          *          <ROW EXPSTB="04" RUL="s&qdrt;"><ENT I="21"><E T="02">New Mexico Administrative Code (NMAC) Title 20—Environment Protection, Chapter 11—Albuquerque/Bernalillo County Air Quality Control Board</E> <ROW EXPSTB="00"><ENT I="22"> <ROW><ENT I="28"> *          *          *          *          *          *          *          <ROW><ENT I="01">Part 20 (20.11.20 NMAC) <ENT>Fugitive Dust Control <ENT>3/17/2008 <ENT>April 1, 2009 [Insert FR page where document begins] <ROW><ENT I="22"> <ROW><ENT I="28"> *          *          *          *          *          *          *          </GPOTABLE> </REGTEXT> <FRDOC>[FR Doc. E9–7296 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 6560–50–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-022-PDF**-*****- -Name: Julia jones (updt) -Payroll No: 48692 -Folios: E678-E680 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='S'>ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 52 <DEPDOC>[Docket No. EPA–R02–OAR–2008–0020; FRL–8775–6] <SUBJECT>Approval and Promulgation of Implementation Plans; Variance Determination for Particulate Matter From a Specific Source in the State of New Jersey <AGY><HED>AGENCY:<P>Environmental Protection Agency (EPA). <ACT><HED>ACTION:<P>Final rule.</ACT> <SUM><HED>SUMMARY:<P>The Environmental Protection Agency (EPA) is approving a revision to the State Implementation Plan (SIP) submitted by the State of New Jersey. This SIP revision consists of a source-specific reasonably available control technology (RACT) determination for controlling particulate matter from the cooling tower operated by the PSEG Nuclear LLC Hope Creek and Salem Generating Stations. This action approves a source-specific variance determination and emission limitations that were made by New Jersey in accordance with the provisions of its rule to help meet the national ambient air quality standards (NAAQS) for particulate matter. The intended effect of this rule is to approve source-specific emissions limitations required by the Clean Air Act. <EFFDATE><HED>DATES:<P><E T='03'>Effective Date:</E> This rule will become effective on May 1, 2009. <ADD><HED>ADDRESSES:<P>EPA has established a docket for this action under Docket ID No. EPA–R02–OAR–2008–0020. All documents in the docket are listed on the <E T='03'>http://www.regulations.gov</E> Web site. Although listed in the index, some information is not publicly available, <E T='03'>e.g.,</E> CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through <E T='03'>http://www.regulations.gov</E> or in hard copy at the Environmental Protection Agency, Region II Office, Air Programs Branch, 290 Broadway, 25th Floor, New York, New York 10007–1866. This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is 212–637–4249. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>Paul Truchan, Air Programs Branch, Environmental Protection Agency, 290 Broadway, 25th Floor, New York, New York 10278, (212) 637–3711, <E T='03'>e-mail: Truchan.Paul@epa.gov.</E> <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <HD1>I. What Action Is EPA Taking Today? <P>EPA is approving New Jersey's revision to the particulate matter (PM) State Implementation Plan (SIP) submitted on November 2, 2007. This SIP revision relates to New Jersey's PM variance determination for the cooling tower at the PSEG Nuclear LLC Hope Creek and Salem Generating Stations located in Lower Alloways Creek Township, Salem County. As part of this variance evaluation, alternate emission limitations are specified for total suspended particulates (TSP) and PM–10 (particles with an aerodynamic diameter of 10 micrometers or less). No variance was requested, or is being granted for PM2.5. This evaluation and variance only involves the operation of the cooling tower. The reader is referred to the proposed rulemaking on this action (May 29, 2008, 73 FR 30873) for additional details. <HD1>II. What Comments Were Received and What Is EPA's Response? <P>EPA received one anonymous comment which did not support the variance request. The commenter indicated concern with the health effects of particulate matter and the need to clean up our air. The commenter also stated that the plant should be forced to upgrade and that the proposed SIP revision should have included a discussion of particulates smaller than 2.5 parts per million (ppm). <P>EPA is also concerned with the health effects of particulates and revised the national ambient air quality standard (NAAQS) for PM2.5 in September 2006, lowering the 24-hour PM2.5 NAAQS from 65 μg/m<E T="51">3</E> to 35 μg/m<SU>3</SU> and readopted the annual PM2.5 NAAQS at 15 μg/m<SU>3</SU>. States were required to make recommendations for designating their counties as either attainment or nonattainment by December 2007. On December 18, 2008, EPA's Administrator signed a final rulemaking containing the new PM2.5 air quality designations. <P>Based on current air quality monitoring data, Salem County is in attainment of the new 24-hour PM2.5 standard. Salem County is currently designated as attaining the previous 24-hour PM2.5 standard, and annual PM2.5 standard, and this is confirmed with air quality monitoring data. Therefore, the County where the cooling tower is located is currently attaining the 65 μg/m<SU>3</SU> NAAQS and is also attaining the new lower 35 μg/m<SU>3</SU> NAAQS. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-023-PDF**-*****- -Name: Julia Jones (updt) -Payroll No: 48692 -Folios: E681-E683 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <PRTPAGE P='14735'><P>As part of the requirements for obtaining a variance, an air quality modeling analysis may be required. Such an analysis was performed for the potential increase in emissions from the PSEG cooling tower which looked at annual and 24-hour TSP, PM10 and PM2.5 standards. The PM2.5 standard regulates fine particulates with an aerodynamic diameter of 2.5 micrometers or less (that is, all particulates 2.5 micrometers and smaller). The proposed approval (73 FR 30874, May 29, 2008) and the air quality modeling analysis included in the Docket for this action addressed the PM2.5 emissions from the cooling tower. Maximum modeled concentrations were compared to the respective significant impact levels. In general, concentrations of pollutants (in micrograms per cubic meter) above the significant impact levels may contribute to a violation of a NAAQS. However, in this case, the modeled impact of all three pollutants was less than their respective significance levels. In addition, the modeled impacts were added to the area-wide background concentrations, and all the results were less than the NAAQS. Therefore, the proposed SIP revision has demonstrated no interference with any NAAQS and satisfied section 110(l) of the Act, and EPA concludes the proposed SIP revision will not interfere with attainment or any other requirements of the Act. Further, as discussed in the proposal (73 FR 30873), the cooling tower will have its annual allowable particulate matter emissions limited to 65.9 tons per year (tpy) instead of the current allowable of 129 tpy. Under worst case assumptions, hourly emissions are allowed to increase to 42.0 pounds per hour (lbs/hr) from 29.4 lbs/hr. The worst-case particulate matter emissions were modeled and are not predicted to cause an exceedance of the NAAQS. <P>The variance request also included a review of the existing controls at PSEG's cooling tower, an evaluation of other methods of reducing emissions at this facility, including the cost of these controls, and a comparison of controls that could be required on newly constructed cooling towers. The control efficiency currently measured for this cooling tower is comparable to or better than similar cooling towers documented in EPA's RACT/BACT/LAER Clearinghouse. Therefore, no additional controls are feasible. <P>In determining whether to approve the variance request submitted by New Jersey, EPA was guided by the applicable rules contained in the State Implementation Plan (SIP), the results of air quality monitoring for the area, the results of air quality modeling of the proposed impact of the variance request, and the results of the technological and economic evaluations which were used to justify the variance. The New Jersey Administrative Code, Title 7, Chapter 27, Subchapter 6, Control and Prohibition of Particulates from Manufacturing Processes, Section 6.5 specifically permits variances to be issued and provides procedures and requirements which must be met in order for the variance to be granted. New Jersey has demonstrated to EPA's satisfaction that these requirements have been met and that the variance will not cause or contribute to an exceedance of the applicable NAAQS. <HD1>III. Conclusion <P>EPA is approving New Jersey's SIP revision request for a variance and an alternative emission limit determination for the PSEG Nuclear LLC Hope Creek and Salem Generating Stations cooling tower. This SIP revision contains source-specific particulate emission limitations contained in New Jersey's Air Pollution Control Operating Permit for this source of: TSP less than or equal to 65.9 tpy, PM–10 less than or equal to 65.9 tpy, TSP less than or equal to 42 lbs/hr, and PM–10 less than or equal to 42 lbs/hr. <HD1>IV. Statutory and Executive Order Reviews <P>Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action: <P>&sbull; Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); <P>&sbull; Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 <E T='03'>et seq.</E>); <P>&sbull; Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 <E T='03'>et seq.</E>); <P>&sbull; Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); <P>&sbull; Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-024-PDF**-*****- -Name: leonard horne -Payroll No: 08642 -Folios: E684-E687 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>&sbull; Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); <P>&sbull; Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); <P>&sbull; Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and <P>&sbull; Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). <P>In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. <P>The Congressional Review Act, 5 U.S.C. 801 <E T='03'>et</E> <E T='03'>seq.</E>, as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the <E T='04'>Federal Register</E>. A major rule cannot take effect until 60 days after it is published in the <E T='04'>Federal Register</E>. This action is not a “major rule” as defined by 5 U.S.C. 804(2). <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 1, 2009. Filing a petition for reconsideration of this rule with the Administrator does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness <PRTPAGE P='14736'>of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) <LSTSUB><HED>List of Subjects in 40 CFR Part 52 <P>Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.</LSTSUB> <SIG><DATED>Dated: February 12, 2009. <NAME>George Pavlou, <TITLE>Acting Regional Administrator, Region 2.</SIG> <REGTEXT TITLE='40' PART='52'> <AMDPAR>Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows: <PART><HED>PART 52—[AMENDED] <AMDPAR>1. The authority citation for part 52 continues to read as follows: <AUTH><HED>Authority: <P>42 U.S.C. 7401 <E T='03'>et seq.</E> <Q P="04"> <AMDPAR>2. Section 52.1570 is amended by adding new paragraph (c)(86) to read as follows: <SECTION><SECTNO>§&thnsp;52.1570 <SUBJECT>Identification of plan. <STARS> <P>(c) * * * <P>(86) Revisions to the New Jersey State Implementation Plan (SIP) for particulate matter granting a variance from Subchapter 6, Control and Prohibition of Particles from Manufacturing Processes for the cooling tower at the PSEG Nuclear LLC Hope Creek and Salem Generating Stations located in Lower Alloways Creek Township, Salem County dated November 2, 2007 submitted by the New Jersey State Department of Environmental Protection (NJDEP) which establishes hourly emission limits for TSP and PM–10 (total) of less than or equal to 42 pounds per hour and annual emission limits for TSP and PM–10 (total) of less than or equal to 65.9 tons per year. <P>(i) Incorporation by reference: <P>(A) A letter from Lisa P. Jackson, Commissioner, New Jersey Department of Environmental Protection, addressed to Alan J. Steinberg, Regional Administrator, EPA, dated November 2, 2007 submitting the variance for PSEG Nuclear LLC Hope Creek and Salem Generating Stations without the attachments. <P>(B) Section J, Facility Specific Requirements, Emission Unit U24 Cooling Tower, (Significant Modification Approval date August 7, 2007) contained in the Air Pollution Control Operating Permit, Significant Modification and Preconstruction Approval, PSEG Nuclear LLC Hope Creek and Salem Generating Stations, Permit Activity Number: BOP05003. <STARS> </REGTEXT> <Q P="03"> <FRDOC> [FR Doc. E9–7179 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 6560–50–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-032-*****-*****- -Name: M Mauck -Payroll No: 62280 -Folios: E833-835 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='S'>ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 112 <DEPDOC>[EPA–HQ–OPA–2007–0584; FRL–8788–5] <RIN>RIN 2050–AG16 <SUBJECT>Oil Pollution Prevention; Non-Transportation Related Onshore Facilities; Spill Prevention, Control, and Countermeasure Rule—Final Amendments <AGY><HED>AGENCY:<P>Environmental Protection Agency. <ACT><HED>ACTION:<P>Final rule; delay of effective date. </ACT> <SUM><HED>SUMMARY:<P>The Environmental Protection Agency (EPA) is delaying the effective date of the final rule that amends the Spill Prevention, Control, and Countermeasure (SPCC) regulations promulgated in the <E T='04'>Federal Register</E> on December 5, 2008. The amendments will become effective on January 14, 2010. EPA additionally is requesting public comment on whether a further extension of the effective date may be warranted. <DATES><HED>DATES:<P>This document is effective April 1, 2009. The effective date of the final rule (FR Doc. E8–28159), published in the <E T='04'>Federal Register</E> on December 5, 2008 (73 FR 74236), that was delayed until April 4, 2009 (74 FR 5900), is further delayed to January 14, 2010. <P>Comments must be received on or before May 1, 2009. <ADD><HED>ADDRESSES:<P>Submit your comments, identified by Docket ID No. EPA–HQ–OPA–2007–0584, by one of the following methods: <P>&sbull; <E T='03'>http://www.regulations.gov:</E> Follow the on-line instructions for submitting comments. <P>&sbull; <E T='03'>Mail:</E> EPA Docket, Environmental Protection Agency, Mail Code: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. <P>&sbull; <E T='03'>Hand Delivery:</E> EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. <P><E T='03'>Instructions:</E> Direct your comments to Docket ID No. EPA–HQ–OPA–2007–0584. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at <E T='03'>http://www.regulations.gov</E>, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through <E T='03'>http://www.regulations.gov</E> or e-mail. The <E T='03'>http://www.regulations.gov</E> Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through <E T='03'>http://www.regulations.gov</E>, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at <E T='03'>http://www.epa.gov/epahome/dockets.htm</E>. <P><E T="03">Docket:</E> All documents in the docket are listed in index at the <E T='03'>http://www.regulations.gov</E>. Although listed in the index, some information may not be publicly available, such as Confidential Business Information (CBI) or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at <E T='03'>http://www.regulations.gov</E> or in hard copy at the EPA Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Public Reading Room is 202–566–1744, and the telephone number to make an appointment to view the docket is 202–566–0276. <FURINF><HED>FOR FURTHER INFORMATION CONTACT:<P>For general information, contact the Superfund, TRI, EPCRA, RMP, and Oil <PRTPAGE P='14737'>Information Center at 800–424–9346 or TDD at 800–553–7672 (hearing impaired). In the Washington, DC metropolitan area, contact the Superfund, TRI, EPCRA, RMP, and Oil Information Center at 703–412–9810 or TDD 703–412–3323. For more detailed information on specific aspects of this final rule, contact either Vanessa E. Principe at 202–564–7913 (<E T='03'>principe.vanessa@epa.gov</E>), or Mark W. Howard at 202–564–1964 (<E T='03'>howard.markw@epa.gov</E>), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460–0002, Mail Code 5104A. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R2 PC\J\217001-A01AP0-033-*****-*****- -Name: M Mauck -Payroll No: 62280 -Folios: E836-E837 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT] ?><?USGPO Galley Info End?> <SUPLINF><HED>SUPPLEMENTARY INFORMATION:<P>On February 3, 2009 (74 FR 5900), EPA delayed, by sixty days, the effective date of the final rule that amends the Spill Prevention, Control, and Countermeasure (SPCC) regulations that was promulgated in the <E T='04'>Federal Register</E> on December 5, 2008 (73 FR 74236) under section 311 of the Clean Water Act. This was done in accordance with the January 20, 2009, White House memorandum entitled “Regulatory Review” (74 FR 4435, January 26, 2009) and the memorandum from the Office of Management and Budget entitled “Implementation of Memorandum Concerning Regulatory Review” (M–09–08, January 21, 2009) (OMB memorandum). The Agency took that action to ensure that the rule reflects proper consideration of all relevant facts. In the February 3, 2009 notice (74 FR 5900), EPA requested public comment on the extension of the effective date and its duration, and on the regulatory amendments contained in the final rule. The SPCC rule amendments clarify, tailor, and streamline certain existing requirements for those facility owners or operators who are required to prepare and implement an SPCC Plan (or “Plan”) to prevent the discharge of oil into or upon navigable waters of the United States or adjoining shorelines. <P>EPA received 57 comments in response to the February 3, 2009 notice. Several comments addressed the effective date for the December 2008 rule amendments. Specifically, three commenters suggested the rule become effective on April 4, 2009, particularly for provisions related to onshore, non-oil production facilities, while one commenter requested that EPA finalize the rule expeditiously to ensure time to conduct outreach efforts. On the other hand, one commenter suggested the rule not become effective on April 4, 2009 and requested that the rule be withdrawn permanently, or the effective date extended indefinitely until the 2008 proposed amendments can be carefully reconsidered. Other commenters provided recommendations related to specific amendments, such as the optional approaches for produced water containers, the criteria for qualified oil production facilities, and other amendments. Consistent with the January 21, 2009 OMB memorandum “Implementation of Memorandum Concerning Regulatory Review,” the EPA Administrator has chosen this rule for additional assessment of policy and legal issues; therefore, EPA must carefully consider the issues raised in these comments. Because EPA cannot adequately address the comments before an April 4, 2009 effective date, the Agency agrees with the comment in support of delaying the effective date. With this action, the Agency is extending the effective date of the December 5, 2008 SPCC amendments and is requesting public comment on whether a further extension of the effective date may be warranted. The Agency will provide a complete discussion of the comments received specific to the amendments, and its response to those comments, in a <E T='04'>Federal Register</E> notice describing any changes to the 2008 amendments. <P>The effective date of the final rule would have been April 4, 2009. With this extension, the amendments will become effective on January 14, 2010. <P>This rule is effective immediately. Section 553(d) of the Administrative Procedures Act requires 30 days notice before the effective date of a final rule. However, section 553(d)(1) allows an exception to the 30-day notice where a rule relieves a restriction. Because this final rule relieves a restriction, the Agency invokes section 553(d)(1) to allow an immediate effective date. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-034-*****-*****- -Name: -Payroll No: 70070 -Folios: E838-E840 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <P>Finally, the Agency is also reviewing the dates by which owners or operators of facilities must prepare or amend their SPCC Plans, and implement those Plans. EPA intends to address these dates in a separate notice. <HD1>Statutory and Executive Order Reviews <HD2>A. Executive Order 12866—Regulatory Planning and Review <P>This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order. <HD2>B. Paperwork Reduction Act <P>This action does not impose any new information collection burden. This action results in no changes to the information collection requirements of the SPCC rule and will have no impact on the information collection estimate of project cost and hour burden previously submitted to OMB. <HD2>C. Regulatory Flexibility Act <P>The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. <P>For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant <E T='03'>adverse</E> economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. <P>This action is delaying the effective date of the final rule that amends the SPCC regulations promulgated in the <E T='04'>Federal Register</E> on December 5, 2008. We have therefore concluded that today's final rule will relieve regulatory burden for all affected small entities. <HD2>D. Unfunded Mandates Reform Act <P>This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform <PRTPAGE P='14738'>Act of 1995 (UMRA), 2 U.S.C. 1531– 1538 for state, local, or tribal governments or the private sector. This action imposes no enforceable duty on any state, local, or tribal governments or the private sector. Therefore, this action is not subject to the requirements of sections 202 and 205 of the UMRA. This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action only delays the effective date of the December 5, 2008 rule and does not impose any additional enforceable duty. <HD2>E. Executive Order 13132: Federalism <P>Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the states, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” <P>This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action will not impose direct compliance costs on state or local governments, and will not preempt state law. Thus, Executive Order 13132 does not apply to this action. <HD2>F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments <P>This action does not have tribal implications, as specified in Executive Order 13175 (59 FR 22951, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action. <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R22 PC\J\217001-A01AP0-035-*****-*****- -Name: -Payroll No: 700770 -Folios: E841-E842 -Date: 03/30/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] [RULE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT][/PREAMB] [SUPLINF][HED]*[/HED] ?><?USGPO Galley Info End?> <HD2>G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks <P>EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5– 501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in Executive Order 12866, and because the Agency does not believe the environmental health or safety risks addressed by this action presents a disproportionate risk to children. <HD2>H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use <P>This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. <HD2>I. National Technology Transfer and Advancement Act <P>Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104–113; section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards (<E T='03'>e.g</E>., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when EPA decides not to use available and applicable VCS. This action does not involve technical standards. Therefore, EPA did not consider the use of any VCS. <HD2>J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations <P>Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. <P>EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. <HD2>K. Congressional Review Act <P>The Congressional Review Act, 5 U.S.C. 801, <E T='03'>et seq</E>., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary, or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefore. EPA will submit a report containing this rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the <E T='04'>Federal Register</E>. This action is not a “major rule” as defined by 5 U.S.C. 804(2). <SIG><DATED>Dated: March 26, 2009. <NAME>Lisa P. Jackson, <TITLE>Administrator.</SIG> <FRDOC>[FR Doc. E9–7301 Filed 3–31–09; 8:45 am] <BILCOD>BILLING CODE 6560–50–P <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-001-PDF**-*****- -Name: -Payroll No: -Folios: E196-E207 -Date: 03/27/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180 <DEPDOC>[EPA–HQ–OPP–2008–0362; FRL–8405–2] <SUBJECT>Quinoxyfen; Pesticide Tolerances <AGY><HED>AGENCY: <P>Environmental Protection Agency (EPA). <ACT><HED>ACTION: <P>Final rule. </ACT> <SUM><HED>SUMMARY: <P>This regulation establishes tolerances for residues of quinoxyfen in or on artichoke, globe; fruit, stone, group 12; squash, winter; pumpkin; and gourd, edible. This regulation also deletes the established cherry, sweet; <PRTPAGE P='14739'>and cherry, tart tolerances, as they will be superseded by inclusion in the stone fruit crop group. This regulation additionally deletes the time-limited tolerances for pumpkin; winter squash; and melon subgroup 9A, as the tolerances expired on December 31, 2007. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). <DATES><HED>DATES: <P>This regulation is effective April 1, 2009. Objections and requests for hearings must be received on or before June 1, 2009, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the <E T="02">SUPPLEMENTARY INFORMATION</E>). <ADD><HED>ADDRESSES: <P>EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2008–0362. All documents in the docket are listed in the docket index available at <E T="03">http://www.regulations.gov</E>. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at <E T="03">http://www.regulations.gov</E>, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. <FURINF><HED>FOR FURTHER INFORMATION CONTACT: <P>Laura Nollen, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–7390; e-mail address: <E T="03">nollen.laura@epa.gov</E>. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <HD1>I. General Information <HD2>A. Does this Action Apply to Me? <P>You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: <P>&sbull; Crop production (NAICS code 111). <P>&sbull; Animal production (NAICS code 112). <P>&sbull; Food manufacturing (NAICS code 311). <P>&sbull; Pesticide manufacturing (NAICS code 32532). <P>This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E>. <HD2>B. How Can I Access Electronic Copies of this Document? <P>In addition to accessing electronically available documents at <E T="03">http://www.regulations.gov</E>, you may access this <E T="04">Federal Register</E> document electronically through the EPA Internet under the “<E T="04">Federal Register</E>” listings at <E T="03">http://www.epa.gov/fedrgstr</E>. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at <E T="03">http://www.gpoaccess.gov/ecfr</E>. <HD2>C. Can I File an Objection or Hearing Request? <P>Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ–OPP–2008–0362 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 1, 2009. <P>In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in <E T="02">ADDRESSES</E>. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA–HQ–OPP–2008–0362, by one of the following methods: <P>&sbull; <E T="03">Federal eRulemaking Portal</E>: <E T="03">http://www.regulations.gov</E>. Follow the on-line instructions for submitting comments. <P>&sbull; <E T="03">Mail</E>: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. <P>&sbull; <E T="03">Delivery</E>: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. <HD1>II. Petition for Tolerance <P>In the <E T="04">Federal Register</E> of June 4, 2008 (73 FR 31862) (FRL–8365–3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8E7325) by Interregional Research Project Number 4 (IR–4), 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.588 be amended by establishing tolerances for residues of the fungicide quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or on artichoke, globe at 1.4 parts per million (ppm); fruit, stone, group 12 at 0.70 ppm; squash, winter at 0.20 ppm; pumpkin at 0.20 ppm; and gourd, edible at 0.20 ppm. IR–4 additionally proposed to remove the established tolerances for the residues of quinoxyfen in or on the food commodities cherry, sweet; and cherry, tart at 0.30 ppm. That notice referenced a summary of the petition prepared on behalf of IR–4 by Dow AgroSciences LLC, the registrant, which is available to the public in the docket, <E T="03">http://www.regulations.gov</E> There were no comments received in response to the notice of filing. <HD1>III. Aggregate Risk Assessment and Determination of Safety <P>Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes <PRTPAGE P='14740'>exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” <P>Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of quinoxyfen on artichoke, globe at 1.4 ppm; fruit, stone, group 12 at 0.70 ppm; squash, winter at 0.20 ppm; pumpkin at 0.20 ppm; and gourd, edible at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows. <HD2>A. Toxicological Profile <P>EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. <P>The existing quinoxyfen data indicate that it possesses low acute toxicity via the oral, dermal and inhalation routes. It is a mild eye irritant and dermal sensitizer, but it is not a dermal irritant. <P>The primary target organs affected by quinoxyfen are the liver and kidney. Subchronic effects in rats and mice included increased liver weights, hepatocellular hypertrophy and individual cell hepatocellular necrosis, and chronic effects in the dog included increased liver weights, increased alkaline phosphatase levels and increased incidences of slight microscopic hepatic lesions. Kidney effects were noted only in the rat combined chronic/carcinogenicity study, resulting in an increased severity of chronic progressive glomerulonephropathy in males. Rabbits were much more susceptible to the effects of quinoxyfen than any other species. Systemic effects observed in the rabbit developmental study included inanition, loss of body weight, perineal soiling, blood in the cage pan associated with urine, and abortions. <P>Long-term dietary administration of quinoxyfen did not result in an overall treatment-related increase in incidence of tumor formation in rats or mice. As a result, EPA classified quinoxyfen as “not likely to be carcinogenic to humans.” Quinoxyfen did not show evidence of mutagenicity in <E T="03">in vitro</E> or <E T="03">in vivo</E> studies. No evidence of neurotoxicity or neuropathology was seen in any of the submitted studies, including the acute and subchronic neurotoxicity studies. <P>The toxicology data for quinoxyfen provides no indication of increased susceptibility, as compared to adults, of rat and rabbit fetuses to <E T='03'>in utero</E> exposure in developmental studies. No maternal or developmental toxicity was observed in the rat developmental toxicity study. The rabbit developmental toxicity study included maternal toxic effects (inanition, decreased body weight and weight gain, decreased fecal output, perineal soiling, blood in the cage pan associated with urine, and abortions) at the same dose as developmental effects (increased abortions). In the 2–generation reproduction study conducted with rats, increased quantitative susceptibility of offspring (minimally reduced pup weights) was noted in the absence of maternal toxicity at the high dose. There was no evidence of immunotoxicity in the database. <P>Specific information on the studies received and the nature of the adverse effects caused by quinoxyfen as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at <E T="03">http://www.regulations.gov</E> in document “Quinoxyfen. Human Health Risk Assessment for the Proposed Food Use of Quinoxyfen on Stone Fruits Crop Group 12 (excluding Cherry), Artichoke, Winter Squash, (Pumpkin and Edible Gourds),” at pages 45–48 in docket ID number EPA–HQ–OPP–2008–0362. <HD2>B. Toxicological Endpoints <P>For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). <P>For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see <E T="03">http://www.epa.gov/pesticides/factsheets/riskassess.htm</E>. <P>A summary of the toxicological endpoints for quinoxyfen used for human risk assessment can be found at <E T="03">http://www.regulations.gov</E> in document “Quinoxyfen. Human Health Risk Assessment for the Proposed Food Use of Quinoxyfen on Stone Fruits Crop Group 12 (excluding Cherry), Artichoke, Winter Squash, (Pumpkin and Edible Gourds),” at pages 25–26 in docket ID number EPA–HQ–OPP–2008–0362. <HD2>C. Exposure Assessment <P>1. <E T="03">Dietary exposure from food and feed uses</E>. In evaluating dietary exposure to quinoxyfen, EPA considered exposure under the petitioned-for tolerances as well as all existing quinoxyfen tolerances in 40 CFR 180.588. EPA assessed dietary exposures from quinoxyfen in food as follows: <P>i. <E T="03">Acute exposure</E>. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1–day or single exposure. <P>No such effects were identified in the toxicological studies for quinoxyfen; therefore, a quantitative acute dietary exposure assessment is unnecessary. <P>ii. <E T="03">Chronic exposure</E>. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994–1996 and 1998 <PRTPAGE P='14741'>Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance-level residues, Dietary Exposure Evaluation Model (DEEM) default processing factors, and assumed 100 percent crop treated (PCT) for all proposed commodities. <P>iii. <E T="03">Cancer</E>. Based upon lack of evidence of carcinogenicity in rats and mice by all routes of exposure, EPA has classified quinoxyfen as “not likely to be carcinogenic to humans;” therefore, a quantitative exposure assessment to evaluate cancer risk is unnecessary. <P>iv. <E T="03">Anticipated residue and PCT information</E>. EPA did not use anticipated residue and/or PCT information in the dietary assessment for quinoxyfen. Tolerance level residues and/or 100 PCT were assumed for all food commodities. <P>2. <E T="03">Dietary exposure from drinking water</E>. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for quinoxyfen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of quinoxyfen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at <E T="03">http://www.epa.gov/oppefed1/models/water/index.htm</E>. <P>Based on the First Index Reservoir Screening Tool (FIRST) model for surface water, and the Screening Concentration in Ground Water (SCI-GROW) model for ground water, the estimated drinking water concentrations (EDWCs) of quinoxyfen for surface water are estimated to be 9.9 parts per billion (ppb) for acute exposures, and 0.66 ppb for chronic exposures. For ground water, the estimated drinking water concentration is 0.0034 ppb. <P>Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.66 ppb was used to assess the contribution to drinking water. <P>3. <E T="03">From non-dietary exposure</E>. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Quinoxyfen is not registered for any specific use patterns that would result in residential exposure. <P>4. <E T="03">Cumulative effects from substances with a common mechanism of toxicity</E>. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” <P>EPA has not found quinoxyfen to share a common mechanism of toxicity with any other substances, and quinoxyfen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that quinoxyfen does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at <E T="03">http://www.epa.gov/pesticides/cumulative</E>. <HD2>D. Safety Factor for Infants and Children <P>1. <E T="03">In general</E>. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. <P>2. <E T="03">Prenatal and postnatal sensitivity</E>. The toxicology data for quinoxyfen provides no indication of increased susceptibility, as compared to adults, of rat and rabbit fetuses to <E T='03'>in utero</E> exposure in developmental studies up to the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day). In the multi-generation rat reproduction study, offspring effects were noted at the high dose of 100 mg/kg/day tested (minimally reduced F<E T='52'>1a</E> pup weights) in the absence of maternal toxicity at the same level; thereby showing quantitative evidence of increased susceptibility in rat offspring. However, concern is low since: <P>i. The effects in pups are well-characterized with a clear NOAEL of 20 mg/kg/day. <P>ii. The pup effects are minimal at the LOAEL and only noted in the first generation offspring. <P>iii. The doses and endpoints selected for regulatory purposes would address the concerns of the pup effects noted in the rat reproduction study. <P>3. <E T="03">Conclusion</E>. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: <P>i. The toxicity database for quinoxyfen is complete except for immunotoxicity testing. Recent changes to 40 CFR part 158 make immunotoxicity testing (OPPTS Guideline 870.7800) required for pesticide registration; however, the existing data are sufficient for endpoint selection for exposure/risk assessment scenarios, and for evaluation of the requirements under the FQPA. The available data for quinoxyfen do not show potential for immunotoxic effects. Therefore, EPA does not believe that conducting the immunotoxicity study will result in a NOAEL lower than the NOAEL of 20 mg/kg/day already set for quinoxyfen. Consequently, an additional database uncertainty factor does not need to be applied. <P>ii. There is no indication that quinoxyfen is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. <P>iii. Although there is quantitative evidence of increased susceptibility of offspring (minimally reduced pup weights) in the absence of maternal effects in the rat multi-generation reproduction study, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment. Therefore, there are no residual concerns regarding developmental effects in the young. <P>iv. There are no residual uncertainties identified in the exposure databases. Dietary food exposure assessments were performed based on 100% crop treated and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to quinoxyfen in drinking water. These assessments will not underestimate the exposure and risks posed by quinoxyfen. <HD2>E. Aggregate Risks and Determination of Safety <P>EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by <PRTPAGE P='14742'>all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. <P>1. <E T="03">Acute risk</E>. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No acute dietary endpoint was identified for any segment of the United States (U.S.) population. Therefore, quinoxyfen is not expected to pose an acute risk. <P>2. <E T="03">Chronic risk</E>. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to quinoxyfen from food and water will utilize 2% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. There are no residential uses for quinoxyfen to consider. <P>3. <E T="03">Short-term and intermediate-term risk</E>. Short-term and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). <P>Quinoxyfen is not registered for any use patterns that would result in residential exposure. Therefore, the short-term and intermediate-term aggregate risk is the sum of the risk from exposure to quinoxyfen through food and water and will not be greater than the chronic aggregate risk. <P>4. <E T="03">Aggregate cancer risk for U.S. population</E>. Based on the lack of evidence of carcinogenicity in mice and rats at doses that were judged to be adequate to assess the carcinogenic potential, quinoxyfen was classified as “not likely to be carcinogenic to humans.” Therefore, quinoxyfen is not expected to pose a cancer risk to humans. <P>5. <E T="03">Determination of safety</E>. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to quinoxyfen residues. <HD1>IV. Other Considerations <HD2>A. Analytical Enforcement Methodology <P>Adequate enforcement methodology (gas chromatography with mass-selective detection (GC-MSD)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e-mail address: <E T="03">residuemethods@epa.gov</E>. <HD2>B. International Residue Limits <P>There are no Mexican maximum residue limits (MRLs) established for residues of quinoxyfen in crops associated with this review. Codex MRLs exist for quinoxyfen on cherry, sweet and tart at 0.4 ppm; and Canadian MRLs exist for cherry, sweet and tart at 0.3 ppm. However, the proposed tolerance for fruit, stone, group 12 (0.70 ppm), of which cherry is a part, cannot be harmonized with the Codex or Canadian MRLs on these commodities because field trial data supporting the stone fruit group tolerance shows residue levels that are higher than 0.4 ppm. <HD1>V. Conclusion <P>Therefore, tolerances are established for residues of quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or on artichoke, globe at 1.4 ppm; fruit, stone, group 12 at 0.70 ppm; squash, winter at 0.20 ppm; pumpkin at 0.20 ppm; and gourd, edible at 0.20 ppm. This regulation also deletes the established tolerances in or on cherry, sweet; and cherry, tart, as they are superseded by inclusion in fruit, stone, group 12. This regulation additionally deletes the time-limited tolerances for pumpkin; winter squash; and melon subgroup 9A, as the tolerances expired on December 31, 2007. <HD1>VI. Statutory and Executive Order Reviews <P>This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled <E T="03">Regulatory Planning and Review</E> (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled <E T="03">Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</E> (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled <E T="03">Protection of Children from Environmental Health Risks and Safety Risks</E> (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 <E T="03">et seq</E>., nor does it require any special considerations under Executive Order 12898, entitled <E T="03">Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations</E> (59 FR 7629, February 16, 1994). <P>Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 <E T="03">et seq</E>.) do not apply. <P>This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled <E T="03">Federalism</E> (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled <E T="03">Consultation and Coordination with Indian Tribal Governments</E> (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). <P>This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). <HD1>VII. Congressional Review Act <P>The Congressional Review Act, 5 U.S.C. 801 <E T="03">et seq</E>., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the <PRTPAGE P='14743'><E T="04">Federal Register</E>. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). <Q P="04"> <LSTSUB><HED>List of Subjects in 40 CFR Part 180 <P>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. </LSTSUB> <SIG> <DATED>Dated: March 19, 2009. <NAME>Lois Rossi, <TITLE>Director, Registration Division, Office of Pesticide Programs. </SIG> <REGTEXT TITLE="40" PART="180"> <AMDPAR>Therefore, 40 CFR chapter I is amended as follows: <PART><HED>PART 180—[AMENDED] <AMDPAR>1. The authority citation for part 180 continues to read as follows: <AUTH><HED>Authority: <P>21 U.S.C. 321(q), 346a and 371.<Q P="04"> <AMDPAR>2. Section 180.588 is amended in paragraph (a), by removing the commodities “Cherry, sweet” and “Cherry, tart”; and by alphabetically adding the following commodities to the table; and in paragraph (b), by removing all of the commodities and reserving the paragraph designation and heading to read as follows: <SECTION><SECTNO>§&thnsp;180.588 <SUBJECT>Quinoxyfen; tolerances for residues. <P>(a) * * * <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s25,15"> <BOXHD> <CHED H="1">Commodity <CHED H="1">Parts per million <ROW><ENT I="01">Artichoke, globe <ENT>1.4 <ROW><ENT I="01">Fruit, stone, group 12 <ENT>0.70 <ROW><ENT I='28'>   *   *   *    *   *    <ROW><ENT I="01">Gourd, edible <ENT>0.20 <ROW><ENT I='28'>   *   *   *    *   *    <ROW><ENT I="01">Pumpkin <ENT>0.20 <ROW><ENT I="01">Squash, winter <ENT>0.20 <ROW><ENT I='28'>   *   *   *    *   *    </GPOTABLE> <P>(b) <E T="03">Section 18 emergency exemptions</E>. [Reserved] <STARS> </REGTEXT> <Q P="03"> <FRDOC>[FR Doc. E9–7046 Filed 3–31–09; 8:45 am]</FRDOC> <BILCOD>BILLING CODE 6560–50–S</BILCOD> <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-003-PDF**-*****- -Name: -Payroll No: -Folios: E223-E226 -Date: 03/27/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE='S'>ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180 <DEPDOC>[EPA–HQ–OPP–2007–0097; FRL–8407–2] <SUBJECT>Captan, 2,4-D, Dodine, DCPA, Endothall, Fomesafen, Propyzamide, Ethofumesate, Permethrin, Dimethipin, and Fenarimol; Technical Amendment <AGY><HED>AGENCY: <P> Environmental Protection Agency (EPA). <ACT><HED>ACTION: <P> Final rule; technical amendment. </ACT> <SUM><HED>SUMMARY: <P> EPA issued a final rule in the <E T='04'>Federal Register</E> of September 12, 2007, revoking, revising, and establishing certain tolerances. This document is being issued to correct a terminology omission associated with DCPA and onions. <DATES><HED>DATES: <P> This final rule is effective April 1, 2009. <ADD><HED>ADDRESSES: <P> EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2007–0097. All documents in the docket are listed in the docket index available in <E T='03'>http://www.regulations.gov</E>. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at <E T='03'>http://www.regulations.gov</E>, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. <FURINF><HED>FOR FURTHER INFORMATION CONTACT: <P> Jane Smith, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–0048; e-mail address: <E T='03'>smith.jane-scott@epa.gov</E>. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <HD1>I. General Information <HD2>A. Does this Action Apply to Me? <P>The Agency included in the final rule a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under <E T='02'>FOR FURTHER INFORMATION CONTACT</E>. <HD2>B. How Can I Access Electronic Copies of this Document and Other Related Information? <P>In addition to accessing electronically available documents at <E T='03'>http://www.regulations.gov</E>, you may access this <E T='04'>Federal Register</E> document electronically through the EPA Internet under the “<E T='04'>Federal Register</E>” listings at <E T='03'>http://www.epa.gov/fedrgstr</E>. <HD1>II. What Does this Technical Amendment Do? <P>EPA issued a notice of proposed rulemaking in the <E T='04'>Federal Register</E> of June 6, 2007 (72 FR 31221) (FRL–8122–7), that proposed to revoke, revise, and establish certain tolerances for captan, 2,4-D, dodine, DCPA, endothall, fomesafen, propyzamide, ethofumesate, permethrin, dimethipin, and fenarimol. On page 31228, third column, first full paragraph, the Agency stated the following:<Q P="04"> <EXTRACT> <P>. . . EPA is proposing to revise commodity terminology and tolerances to conform to current Agency practice in 40 CFR 180.185(a) for the combined residues of the herbicide DCPA and its metabolites MTP and TCP (calculated as DCPA) in or on melon, honey dew to muskmelon; and onion to onion, bulb . . . . </EXTRACT> <Q P='04'> <FP>The June 6, 2007 <E T='04'>Federal Register</E> publication was intended only to update commodity terminology, and not to revoke or revise the scope of existing tolerances. The existing tolerance for “onion” covered both “onion, bulb” and “onion, green” as defined under current commodity terminology. The reference to “onion, green” was inadvertently omitted from both the June 6, 2007 proposed rule and the final rule published on September 12, 2007 (72 FR 52013) (FRL–8142–2). Use on both “onion, bulb” and “onion, green” continues to be permitted according to labels of currently registered DCPA products, and the required safety findings for the residues permitted under the tolerance were made taking into account both types of onions. Therefore, 40 CFR 180.185(a) is amended by establishing a tolerance for DCPA in/on onion, green at 1.0 ppm to effectuate EPA's original intention in the proposed and final rules changing terminology only. <HD1>III. Why is this Technical Amendment Issued as a Final Rule? <P>Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical amendment final without prior proposal and opportunity for comment, because this action merely corrects a drafting error in the rulemaking that was <PRTPAGE P='14744'>contrary to the intention of the changes as discussed in the proposed rule. Notice and comment are unnecessary to correct an erroneous deletion of a tolerance that was neither intended nor discussed in rulemaking. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B). <HD1>IV. Do Any of the Statutory and Executive Order Reviews Apply to this Action? <P>The discussion in Unit IV. of the September 12, 2007 final rule also applies to this action. <HD1>V. Congressional Review Act <P>The Congressional Review Act, 5 U.S.C. 801 <E T='03'>et seq</E>., generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the <E T='04'>Federal Register</E>. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). <LSTSUB><HED>List of Subjects in 40 CFR Part 180 <P>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. </LSTSUB> <SIG> <DATED>Dated: March 18, 2009. <NAME>Debra Edwards, <TITLE>Director, Office of Pesticide Programs. </SIG> <AMDPAR>Therefore, 40 CFR Chapter I is amended as follows: <PART><HED>PART 180—[AMENDED] <AMDPAR>1. The authority citation for part 180 continues to read as follows: <AUTH><HED>Authority: <P> 21 U.S.C. 321(q), 346(a) and 371. <Q P='04'> <AMDPAR>2. Section 180.185, is amended by alphabetically adding the following commodity to the table in paragraph (a) to read as follows: <SECTION><SECTNO>§&thnsp;180.185 <SUBJECT>DCPA; tolerances for residues. <P>(a) <E T='03'>General</E>.  * * * <GPOTABLE COLS='2' OPTS='L2,i1' CDEF='s50,15'> <BOXHD> <CHED H='1'>Commodity <CHED H='1'>Parts per million <ROW><ENT I='28'>*   *   *    *   * <ROW><ENT I='01' O='xl'>Onion, green <ENT>1.0 <ROW><ENT I='28'>*   *   *    *   * </GPOTABLE> <STARS> <Q P='03'> 4 <FRDOC>[FR Doc. E9–7040 Filed 3–31–09; 8:45 am]</FRDOC> <BILCOD>BILLING CODE 6560–50–S</BILCOD> <?USGPO Galley End: ?><?USGPO Galley Info Start:{movepis} ! RULES R1 PC\J\217001-A01AP0-002-PDF**-*****- -Name: -Payroll No: -Folios: E208-E222 -Date: 03/27/2009 [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/DATE][RULES] ?><?USGPO Galley Info End?> <RULE> <PREAMB> <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 180 <DEPDOC>[EPA–HQ–OPP–2008–0327; FRL– 8403–9] <SUBJECT>Prothioconazole; Pesticide Tolerance <AGY><HED>AGENCY: <P>Environmental Protection Agency (EPA). <ACT><HED>ACTION: <P>Final rule. </ACT> <SUM><HED>SUMMARY: <P>This regulation increases a tolerance for combined residues of prothioconzole and prothioconazole-desthio, calculated as parent in or on, wheat, forage. Bayer CropScience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). <DATES><HED>DATES: <P>This regulation is effective April 1, 2009. Objections and requests for hearings must be received on or before June 1, 2009 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the <E T="02">SUPPLEMENTARY INFORMATION)</E>. <ADD><HED>ADDRESSES: <P>EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2008–0327. All documents in the docket are listed in the docket index available at <E T="03">http://www.regulations.gov</E>. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at <E T="03">http://www.regulations.gov</E>, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. <FURINF><HED>FOR FURTHER INFORMATION CONTACT: <P>Bryant Crowe, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–0025; e-mail address: <E T="03">crowe.bryant@epa.gov</E>. <SUPLINF><HED>SUPPLEMENTARY INFORMATION: <HD1>I. General Information <HD2>A. Does this Action Apply to Me? <P>You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: <P>&sbull; Crop production (NAICS code 111). <P>&sbull; Animal production (NAICS code 112). <P>&sbull; Food manufacturing (NAICS code 311). <P>&sbull; Pesticide manufacturing (NAICS code 32532). <P>This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E>. <HD2>B. How Can I Access Electronic Copies of this Document? <P>In addition to accessing electronically available documents at <E T="03">http://www.regulations.gov</E>, you may access this <E T="04">Federal Register</E> document electronically through the EPA Internet under the “<E T="04">Federal Register</E>” listings at <E T="03">http://www.epa.gov/fedrgstr</E>. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at <E T="03">http://www.gpoaccess.gov/ecfr</E>. <HD2>C. Can I File an Objection or Hearing Request? <P>Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ–OPP–2008–0327 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 1, 2009. <P>In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please <PRTPAGE P='14745'>submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in <E T="02">ADDRESSES</E>. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA–HQ–OPP–2008–0327, by one of the following methods: <P>&sbull; <E T="03">Federal eRulemaking Portal</E>: <E T="03">http://www.regulations.gov</E>. Follow the on-line instructions for submitting comments. <P>&sbull; <E T="03">Mail</E>: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. <P>&sbull; <E T="03">Delivery</E>: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. <HD1>II. Petition for Tolerance <P>In the <E T="04">Federal Register</E> of June 4, 2008 (73 FR 31863) (FRL–8365–3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F7279) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.626 be amended by increasing a tolerance for combined residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and prothioconazole-desthio, in or on, wheat, forage from 6.0 to 8.0 parts per million (ppm). That notice referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available to the public in the docket, <E T="03">http://www.regulations.gov</E>. There were no comments received in response to the notice of filing. <HD1>III. Aggregate Risk Assessment and Determination of Safety <P>Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” <P>Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for combined residues of prothioconazole, and prothioconazole-desthio, calculated as parent, in or on wheat, forage at 8.0 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows. <HD2>A.Toxicological Profile <P>EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Prothioconazole has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin or eye irritant. Prothioconazole's metabolite, prothioconazole-desthio, also has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin irritant, but it is a slight eye irritant. The subchronic and chronic studies show that the target organs at the lowest-observed-adverse effect level (the LOAEL) include the liver, kidney, urinary bladder, thyroid and blood. In addition, the chronic studies showed body weight and food consumption changes, and toxicity to the lymphatic and GI systems. Prothioconazole and its metabolites may be primary developmental toxicants, producing effects including malformations in the conceptus at levels equal to or below maternally toxic levels in some studies; particularly those conducted using prothioconazole-desthio. Reproduction studies in the rat with prothioconazole and prothioconazole-desthio suggested that these chemicals may not be primary reproductive toxicants. Acute and subchronic neurotoxicity studies were conducted in the rat using prothioconazole. A developmental neurotoxicity study was conducted in the rat using prothioconazole-desthio. The available data show that the prothioconazole-desthio metabolite produces toxicity at the lowest dose levels in the areas of subchronic, developmental, reproductive, and neurotoxic toxicities compared with prothioconazole and the two additional metabolites that were tested. The available carcinogenicity and/or chronic studies in the mouse and rat, using both prothioconazole and prothioconazole-desthio, show no increase in tumor incidence. Therefore, EPA has concluded prothioconazole or its metabolites are not carcinogenic, and are classified “Not likely to be Carcinogenic to Humans” according to the 2005 Cancer Guidelines. Specific information on the studies received and the nature of the adverse effects caused by prothioconazole as well as the no-observed-adverse-effect-level (NOAEL) and LOAEL from the toxicity studies can be found at <E T="03">http://www.regulations.gov</E> in document <E T="03">Prothioconazole; Pesticide Tolerance</E> pages 14714–14719 in docket ID number EPA–HQ–OPP–2007–0178. <HD2>B. Toxicological Endpoints <P>For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The <PRTPAGE P='14746'>aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). <P>For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see: <E T="03">http://www.epa.gov/oppfead1/trac/science; http://www.epa.gov/pesticides/factsheets/riskassess.htm</E>; and <E T="03">http://www.epa.gov/pesticides/trac/science/aggregate.pdf</E>. <P>A summary of the toxicological endpoints for prothioconazole used for human risk assessment can be found at <E T="03">http://www.regulations.gov</E> in document <E T="03">Prothioconazole: Human Health Risk Assessment for Proposed Section 3 Seed treatment Use on Wheat, Barley, and Triticale, Plus Increase Tolerance on Forage of Wheat, Barley, and Triticale</E> pages 20–21 in docket ID number EPA–HQ–OPP–2008–0327. <HD2>C. Exposure Assessment <P>1. <E T="03">Dietary exposure from food and feed uses</E>. In evaluating dietary exposure to prothioconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing prothioconazole tolerances in (40 CFR 180.626). EPA assessed dietary exposures from prothioconazole residues in food as follows: <P>i. <E T="03">Acute exposure</E>. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. <P>In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). A moderately refined acute dietary exposure (food and drinking water) assessment was conducted for prothioconazole. Average field trial values, empirical processing factors, and livestock maximum residues were incorporated into the refined acute assessment. The assessment also assumed 100 percent of crops covered by the existing tolerances, as well as the changed tolerance on wheat forage, are treated with prothioconazole. <P>ii. <E T="03">Chronic exposure</E>. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994–1996 and 1998 CSFII. A moderately refined chronic dietary exposure (food and drinking water) assessment was conducted for prothioconazole. Average field trial values, empirical processing factors, and livestock maximum residues were incorporated into the refined acute assessment. The assessment also assumed 100 percent of crops covered by the existing tolerances, as well as the changed tolerance on wheat forage, are treated with prothioconazole. <P>iii. <E T="03">Cancer</E>. The available toxicology studies in the mouse and rat showed no increase in tumor incidence, and therefore the Agency has concluded that neither prothioconazole, nor its metabolites are carcinogenic. Thus classified, by the Agency, as “Not Likely to Carcinogenic to Humans” according to the 2005 Cancer Guidelines. Consequently, a quantitative dietary cancer assessment was not performed. <P>iv. <E T="03">Anticipated residue and percent crop treated (PCT) information</E>. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to section 408(f)(1) of FFDCA that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by section 408(b)(2)(E), and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Average residues and 100 PCT were assumed for all food commodities. <P>2. <E T="03">Dietary exposure from drinking water</E>. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prothioconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prothioconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at <E T="03">http://www.epa.gov/oppefed1/models/water/index.htm</E>. <P>Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of prothioconazole for acute exposures are estimated to be 29 parts per billion (ppb) for surface water and 0.67 ppb for ground water. The EDWCs for chronic exposures are estimated to be 13 ppb for surface water and 0.67 ppb for ground water. <P>Modeled estimates of drinking water concentrations were directly entered into the dietary exposure models. For acute dietary risk assessment, the water concentration value of 29 ppb was used to assess the contribution from drinking water. For the chronic dietary risk assessment, the water concentration value of 13 ppb was used to assess the contribution from drinking water. EPA used the EDWCs from surface water only in assessing the risk from prothioconazole because the EDWCs for ground water source are less than 1 ppb, and considered minimal in comparison to surface water. <P>3. <E T="03">From non-dietary exposure</E>. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). <P>Prothioconazole is not registered for use patterns that would result in residential exposure. <P>4. <E T="03">Cumulative effects from substances with a common mechanism of toxicity</E>. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” <P>Prothioconazole is a member of the triazole-containing class of pesticides, often referred to as the conazoles. EPA is not currently following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. The conazole pesticides, as a whole, tend to exhibit carcinogenic, developmental, reproductive, and/or neurological effects in mammals. Additionally, all the members of this class of compounds are capable of forming, via environmental and metabolic activities, 1,2,4-triazole, triazolylalanine and/or triazolylacetic acid. These metabolites have also been shown to cause developmental, reproductive, and/or neurological effects. Structural similarities and sharing a common effect does not constitute a common mechanism of toxicity. Evidence is needed to establish <PRTPAGE P='14747'>that the chemicals operate “by the same, or essentially the same sequence of major biochemical events. Hence, the underlying basis of toxicity is the same, or essentially the same for each chemical.” (EPA, 2002) A number of potential events could contribute to the toxicity of conazoles (<E T="03">e.g.</E>, altered cholesterol levels, stress responses, altered DNA methylation). At this time, there is not sufficient evidence to determine whether conazoles share common mechanisms of toxicity. Without such understanding, there is no basis to make a common mechanism of toxicity finding for the diverse range of effects found. Investigations into the conazoles are currently being undertaken by the EPA's Office of Research and Development. When the results of this research are available, the Agency will make a determination of whether there is a common mechanism of toxicity and, therefore, a basis for assessing cumulative risk. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at <E T="03">http://www.epa.gov/pesticides/cumulative</E>. <P> Triazole-derived pesticides can form the common metabolite 1,2,4-triazole and three triazole conjugates (triazole alanine, triazole acetic acid, and triazolylpyruvic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including prothioconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's September 1, 2005 risk assessment can be found in the propiconazole reregistration docket at <E T="03">http://www.regulations.gov</E> (Docket ID EPA–HQ–OPP–2005–0497). In October and December of 2008, EPA updated the dietary and aggregate risk assessments for exposure to 1,2,4-triazole, triazole alanine, triazole acetic acid, and triazolylpyruvic acid resulting from the use of all current and pending uses of any triazole-derived fungicide to support existing tolerances and to establish new tolerances for new uses of metconazole (canola, corn, cotton, and sugarcane; PP 7F7221, 7F7292, and 08FL03), propiconazole (beets, parsley, and pineapple; PP 7F7300), prothioconazole (wheat and barley; PP 7F7279), and tetraconazole (grapes; PP 7E7273). These updated dietary and aggregate assessments are below the Agency's level of concern. These updated triazole risk assessments can be found in the Rule's docket (EPA–HQ–OPP–2008–0327) and the following associated dockets at <E T="03">http://www.regulations.gov</E> (Docket IDs EPA–HQ–OPP–2007–514 and EPA–HQ–OPP–2008–0718). <HD2>D. Safety Factor for Infants and Children <P>1. <E T="03">In general</E>. Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. <P>2. <E T="03">Prenatal and postnatal sensitivity</E>. There is evidence of increased susceptibility following prematal/or postnatal exposure in: <P>i. Rat developmental toxicity studies with prothioconazole as well as its prothioconazole-desthio and sulfonic acid K salt metabolites. <P>ii. Rabbit developmental toxicity studies with prothioconazole-desthio. <P>iii. A rat developmental neurotoxicity study with prothioconazole-desthio; and <P>iv. Multi-generation reproduction studies in the rat with prothioconazole-desthio. Effects include skeletal structural abnormalities, such as cleft palate, deviated snout, malocclusion, extra ribs, and developmental delays. Available data also show that the skeletal effects such as extra ribs are not completely reversible after birth in the rat, but persist as development continues. Although increased susceptibility was seen in these studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole because: <P>&sbull; Developmental toxicity NOAELs and LOAELs from prenatal exposure are well characterized after oral and dermal exposure <P>&sbull; The off-spring toxicity NOAELs and LOAELs from postnatal exposures are well characterized; and <P>&sbull; The NOAEL for the fetal effect malformed vertebral body and ribs is used for assessing acute risk of females 13 years and older and, because it is lower than the NOAELs in other developmental studies, is protective of all potential developmental effects. <P>3. <E T="03">Conclusion</E>. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: <P> i. The toxicity database for prothioconazole is complete, except for immunotoxicity testing. EPA began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007. Although an immunotoxicity study in the mouse is part of the existing prothioconazole toxicity data base, this study as reported does not satisfy the current guideline requirements for an immunotoxicity study (OPPTS 870.7800). As such, EPA is requiring that an immunotoxicity study be submitted which meets guideline requirements. EPA has evaluated the available prothioconazole toxicity database (including the non-guideline study in the mouse) to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. In one chronic study in the rat (but not in the mouse or dog), blood leukocyte counts were significantly elevated at the high dose level (750 milligrams/kilogram/day (mg/kg/day)) along with increased thrombocyte counts and decrease hemoglobin. However, this finding is made in the presence of toxicity to a broad range of organ systems such as the liver, urinary bladder, kidney, thyroid, and decreased body weight gains. Furthermore, no signs of immunotoxicity, including evidence of toxicity to the lymphatic system, were observed at dose levels up to 400 mg/kg/day in the non-guideline immunotoxicity study in the mouse. There appears to be no basis for concern for immunotoxicity, particularly at the Points of Departure (POD) for prothioconazole and its metabolites which, at 2.0 and 1.1 mg/kg/day (Acute and Chronic Reference Dose (aRfD and cRfD), respectively) are two orders of <PRTPAGE P='14748'>magnitude lower than the 400 and 750 mg/kg/day dose levels mentioned in this Unit. This finding, along with the absence of immunotoxicity observed in the subchronic and chronic studies with prothioconazole and its metabolites supports the reduction of the FQPA factor to 1X in the interim, pending receipt of an acceptable guideline immunotoxicity study. <P>ii. Previously, because of incomplete data reporting, there were uncertainties regarding dose levels at which neurotoxicities (brain morphometrics and peripheral nerve degeneration) were occurring in the pups. Because of this database uncertainty, the FQPA safety factor was retained at 10X in previous hazard characterizations. Critical data on brain morphometry and peripheral nerve lesions in a rat developmental neurotoxicity study have now been submitted and reviewed. Upon evaluation of these new data, neither the apparent increases in axonal degeneration at the high dose or the brain morphometric changes at the low and mid doses were considered treatment-related. Therefore, these data support the reduction of the FQPA factor to 1X. <P>iii. Although increased susceptibility was seen in the developmental and reproduction studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole for the reasons explained in Unit III.D.2. <P>iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level or anticipated residues derived from reliable residue field trials. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to prothioconazole in drinking water. Residential exposures are not expected. These assessments will not underestimate the exposure and risks posed by prothioconazole. <HD2>E. Aggregate Risks and Determination of Safety <P>EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the Acute Percent Adjusted Dose and Chronic Percent Adjusted Dose (aPAD and cPAD). The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. <P>1. <E T="03">Acute risk</E>. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and therefore no acute dietary endpoint was selected for the general population. However, an acute dietary endpoint was selected for the population subgroup females 13 to 49 years of age. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and drinking water to prothioconazole will occupy 8% of the aPAD for (female 13 to 49 years old). <P>2. <E T="03">Chronic risk</E>. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prothioconazole from food and water will utilize 22% of the cPAD for (infants less than 1 year old) the population group receiving the greatest exposure. There are no residential uses for prothioconazole. <P>3. <E T="03">Short-term risk</E>. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). <P>Prothioconazole is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to prothioconazole through food and water and will not be greater than the chronic aggregate risk. <P>4. <E T="03">Intermediate-term risk</E>. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). <P>Prothioconazole is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to prothioconazole through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. <P>5. <E T="03">Aggregate cancer risk for U.S. population</E>. Aggregate cancer risk for U.S. population. The available studies in the mouse and rat show no increase in tumor incidence, therefore the Agency has concluded that neither prothioconazole nor its metabolites are carcinogenic, and are classified “Not likely to be Carcinogenic to Humans” according to the 2005 Cancer Guidelines. Therefore, prothioconazole is not expected to pose a cancer risk. <P>6. <E T="03">Determination of safety</E>. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to prothioconazole residues. <HD1>IV. Other Considerations <HD2>A. Analytical Enforcement Methodology <P>Adequate enforcement methodology are available to enforce the tolerance expression, consisting of liquid chromatography/tandem massspectrometry (LC/MS/MS) for both plant and livestock commodities, usingtandem mass spectrometry electrospray ionization in both the positive and negative modes. Both methods (LC/MS/MS Method RPA JA/03/01 for plants and LC/MS/MS Method Bayer Report No. 200537 for animals) have successfully passed tolerance method validation at ACB/BEAD. Methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e-mail address: <E T="03">residuemethods@epa.gov</E>. <HD2>B. International Residue Limits <P>There are no maximum residue limits (MRLs) (tolerances) established for prothioconazole in Codex or in Mexico. MRLs have been established in Canada on barley grain at 0.35 ppm and wheat grain at 0.07 ppm. <HD1>V. Conclusion <P>Therefore, a tolerance is being revised for combined residues of prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2- hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and prothioconazole-desthio, α-(1-chlorocyclopropyl)-α-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, calculated as parent, in or on wheat, forage, from 6.0 ppm to 8.0 ppm. <HD1>VI. Statutory and Executive Order Reviews <P>This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled <E T="03">Regulatory Planning and Review</E> (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under <PRTPAGE P='14749'>Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled <E T="03">Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</E> (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled <E T="03">Protection of Children from Environmental Health Risks and Safety Risks</E> (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 <E T="03">et seq</E>., nor does it require any special considerations under Executive Order 12898, entitled <E T="03">Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations</E> (59 FR 7629, February 16, 1994). <P>Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 <E T="03">et seq</E>.) do not apply. <P>This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled <E T="03">Federalism</E> (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled <E T="03">Consultation and Coordination with Indian Tribal Governments</E> (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). <P>This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). <HD1>VII. Congressional Review Act <P>The Congressional Review Act, 5 U.S.C. 801 <E T="03">et seq</E>., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the <E T="04">Federal Register</E>. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). <LSTSUB><HED>List of Subjects in 40 CFR Part 180 <P>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. </LSTSUB> <SIG> <DATED>Dated: March 19, 2009. <NAME>Lois Rossi, <TITLE>Director, Registration Division, Office of Pesticide Programs. </SIG> <REGTEXT TITLE="40" PART="180"> <AMDPAR>Therefore, 40 CFR chapter I is amended as follows: <PART><HED>PART 180—[AMENDED] <AMDPAR>1. The authority citation for part 180 continues to read as follows: <AUTH><HED>Authority: <P>21 U.S.C. 321(q), 346a and 371. </REGTEXT> <REGTEXT> <AMDPAR>2. Section 180.626 is amended by revising the entry for “wheat, forage” in the table in paragraph (a)(1) to read as follows: <SECTION><SECTNO>§&thnsp;180.626 <SUBJECT>Prothioconazole; tolerances for residues. <P>(a) *  *  *  (1) *  *  *  <GPOTABLE COLS="2" OPTS="L2,p7,7/8,i1" CDEF="s70,8"> <BOXHD> <CHED H="1">Commodity <CHED H="1">Parts per million <ROW><ENT I='28'>*    *    *     *    *     <ROW><ENT I="01">Wheat, forage <ENT>8 </GPOTABLE><STARS> </REGTEXT> <FRDOC>[FR Doc. E9–7175 Filed 3–31–09; 8:45 am]</FRDOC> <BILCOD>BILLING CODE 6560–50–S</BILCOD> <?USGPO Galley End:?>