We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to McDonnell Douglas Model DC-9-10, DC-9-20, DC-9-30, DC-9-40, and DC-9-50 series airplanes, equipped with certain tail cone evacuation slide containers. That NPRM was published in the Federal Register on August 6, 2007 (72 FR 43578). That NPRM proposed to require modifying the tail cone slide. That NPRM also proposed to require additional tail cone drops and slide deployments, and repair if necessary.

We gave the public the opportunity to participate in developing this AD. We considered the comments received from the one commenter.

Northwest Airlines (NWA) requests that we clarify whether the 150-flight-cycle compliance time specified in paragraph (g) of the NPRM starts after the first airplane is modified or after the last airplane is modified. Unless the FAA intends to have operators perform slide deployments while the fleet is still being modified, NWA recommends that the 150-flight-cycle clock start after the modification, or within 24 months after the effective date of the AD, whichever occurs first. NWA also states that it assumes the 150-day compliance clock in that same paragraph is intended for those operators who have already complied with the intent of the AD or who will comply very quickly after issuance of the AD. NWA states that it would be helpful if this was stated.

We agree with NWA's request for clarification. Our intent was for the operator to start and complete the tail cone modification and fly a minimum of 150 flight cycles before the additional tail cone deployment test, accomplished within 24 months after the effective date of the AD. When there are multiple airplanes, the 150 flight cycles apply to each individual airplane, and start after the modification is done to each airplane individually.

Scenario: An operator completes the modification on the first airplane, and then completes the minimum 150 flight cycles two months after the modification. After the operator successfully performs the tail cone slide deployment test on the first airplane, the second airplane is modified a week later. The second airplane will also be required to fly a minimum of 150 flight cycles before the deployment test of the tail cone slide. If the operator has 100 airplanes, then the operator must demonstrate a successful deployment test on 10 percent (ten) of the modified airplanes as terminating action for the AD.

We agree that the proposed 150-day compliance time specified in paragraph (g) of the NPRM needs not only to be clarified, but also revised. The 150-day requirement could impose a schedule hardship for some operators who might need more time to complete the modification. Our intent was to allow the operator time to modify the tail cone slide cover and to perform the deployment test after a minimum of 150 flight cycles after modification, and no later than 24 months after the effective date of this AD.

For all these reasons, we have revised paragraph (g) and added a new paragraph (h) to the AD to clarify the compliance time. The new paragraph (g) begins as follows: “* * * no earlier than 150 flight cycles after doing the modification required by paragraph (f) of this AD, and no later than 24 months after the effective date of this AD. * * *” The new paragraph (h) states that operators should contact the Manager, Los Angeles Aircraft Certification Office (ACO), FAA, if the repeat deployment cannot be performed as required by paragraph (g) of this AD.

NWA also requests exemption from the proposed requirements of paragraph (g) of the NPRM. NWA states that while performing testing to obtain Supplemental Type Certificate (STC) ST01967CH, it successfully performed 5 tail cone drops and slide deployments with the new design slide installation. NWA believes that the requirement to perform additional slide deployments is arbitrary, and that the 5 tail cone drops performed as part of the STC approval are sufficient to prove the design reliability of its airplanes.

We disagree with the request for exemption. The 5 tail cone drops and slide deployments that NWA did during the STC approval process did not represent the severity of the actual operating environment for the tail cone, including temperature and high takeoff and landing loads, nor did they represent repeated flight cycles with various types of contamination such as dirt and fuel. Tail cone slides must be overhauled, repacked and re-rigged every 3 years and have no other maintenance requirements in order to verify successful deployment. We have not changed the AD in this regard.

We have revised paragraph (f) of this AD, and have removed Note 1 of this AD, to remove reference to Northwest Airlines STC ST01967CH and Northwest Airlines Drawing 9B25-41477, Revision B, dated September 14, 2006; and Northwest Airlines Drawing 9B25-90399, Revision D, dated December 21, 2006. However, we have approved Northwest Airlines STC ST01967CH as a method for modifying the tail cone slide. Operators may contact the Manager, Los Angeles ACO, for information regarding Northwest Airlines STC ST01967CH for modifying the tail cone slide, as required by paragraph (f) of this AD.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

There are about 400 airplanes of the affected design in the worldwide fleet. This AD affects about 300 airplanes of U.S. registry. The tail cone drops/slide deployments take about 16 work hours per airplane, at an average labor rate of $80 per work hour. Required parts cost about $1,300 per airplane. Based on these figures, the estimated cost of the AD for U.S. operators is $774,000, or $2,580 per airplane.

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.

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.

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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), and

(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.

You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.

On April 11, 2008 (73 FR 19778), the Department of State published the proposed rule, “Amendments to the International Traffic in Arms Regulations: The United States Munitions List”. That proposed rule noted that there have been an increasing number of Commodity Jurisdiction (CJ) requests submitted to the Department of State for certain parts and components that have a long history of use on both civil and military aircraft. To provide guidance to the public regarding the proper export control jurisdiction for these parts and components, State proposed in that rule to amend the ITAR, Part 121, to add language clarifying how the criteria of Section 17(c) of the EAA are implemented in accordance with the Department of State's authority under the Arms Export Control Act (AECA). The State Department adopted the proposed rule, which was published, with minor edits, as a final rule on August 14, 2008 (73 FR 47523).

The State Department final rule added a new Note after Category VIII(h) to clarify that any part or component that (a) is standard equipment; (b) is covered by a civil aircraft type certificate (including amended type certificates and supplemental type certificates) issued by the Federal Aviation Administration for civil, non-military aircraft (which expressly excludes military aircraft certified as restricted and any type certification of Military Commercial Derivative Aircraft, defined by FAA Order 8110.101 effective date September 7, 2007 as “civil aircraft procured or acquired by the military”); and (c) is an integral part of such civil aircraft, is subject to the EAR.

Pursuant to the Note to Category VIII(h) of the ITAR, exporters may generally determine whether an item meets the 17(c) criteria. However, where a part or component would fall under a paragraph within ITAR Category VIII designated as Significant Military Equipment (SME) or any other USML category designated as Significant Military Equipment (SME), were such item to be found subject to the ITAR, the exporter is required to submit a CJ request to determine whether the 17(c) criteria are met, except where an SME part or component was integral to civil aircraft prior to August 14, 2008. The Department of Commerce, based on its licensing authority under the EAA, will participate in the review of CJ requests under established interagency procedures. In the course of its review of a CJ request, the Department of Commerce will apply the criteria of Section 17(c) in its review and recommendation, including an assessment of whether a part or component meets the definition of “standard equipment” included in the Note to Category VIII(h) of the ITAR. “Standard equipment” includes parts and components that are manufactured in compliance with an established and published industry specification or an established and published government specification (e.g., AN, MS, NAS, or SAE). Parts and components that are manufactured and tested to established but unpublished (e.g., proprietary) civil aviation industry specifications and standards are also “standard equipment,” e.g., pumps, actuators, and generators.

The purpose of this final rule amending the EAR is to clarify what parts and components meet the criteria of Section 17(c). Those that meet the Section 17(c) criteria are subject to the jurisdiction of the EAR.

Section 17(c) provides that notwithstanding any other provision of law, any product (1) which is standard equipment, certified by the Federal Aviation Administration (“FAA”), in civil aircraft and is an integral part of such aircraft, and (2) which is to be exported to a country other than a controlled country, shall be subject to export controls exclusively under the EAA. Since its passage, the Departments of State and Commerce have implemented Section 17(c) through various regulatory amendments and notices consistent with the aims of the EAA and the AECA.

In Section 770.2 (Item Interpretations), this rule revises paragraph (i) ( Interpretation 9: aircraft, parts, accessories and components ) to provide jurisdictional guidance for aircraft, parts, accessories and components, as follows:

This revised interpretation clarifies what (1) aircraft and related training equipment, (2) aircraft engines, and (3) components, parts, accessories, attachments, and associated equipment are subject to the jurisdiction of the Department of Commerce.

In Supplement No. 1 to Part 774 (Commerce Control List), this rule also makes a conforming change to paragraph (a) of the “Items” paragraph in the List of Items Controlled Section of ECCN 9A991 to conform this paragraph to Section 121.3 of the ITAR.

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as extended by the Notice of July 23, 2008, 73 FR 43603 (July 25, 2008), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act.

1. This final rule has been determined to be not significant for purposes of E.O. 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid Office of Management and Budget Control Number. This rule involves a collection of information subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq. ). This collection has been approved by the Office of Management and Budget under control number 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes for a manual or electronic submission.

3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable. Therefore, this regulation is issued in final form.

DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, for lawful exports, and for maintenance of reserve stocks, while deterring the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing, importing, and exporting controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity. The CSA as amended also requires DEA to regulate the manufacture, distribution, import, and export of chemicals that may be used to manufacture controlled substances illegally. Listed chemicals that are classified as List I chemicals are important to the manufacture of controlled substances. Those classified as List II chemicals may be used to manufacture controlled substances.

On March 9, 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). The Act amends the CSA by adding new provisions related to the importation, production, and sale of ephedrine, pseudoephedrine, and phenylpropanolamine, their salts, optical isomers, and salts of optical isomers, and products that contain any of the three chemicals.

The Combat Methamphetamine Epidemic Act of 2005 (CMEA) amends the CSA to tighten controls on the manufacture, distribution, import, export, and retail sale of three List I chemicals—ephedrine, pseudoephedrine, and phenylpropanolamine, and drug products containing them. CMEA imposes the following changes:

• Sales limits apply to retail sales of nonprescription (over-the-counter) (OTC) products, which the CMEA defined as “scheduled listed chemical products.” Regulated sellers are required to store the products behind the counter or in locked cabinets and maintain records on each sale, including verifying the name of the purchaser against an approved form of identification supplied by the purchaser. The exemption for blister packs has been removed. Thus, all products sold at retail are regulated under the CSA. (The law contained an exception from recordkeeping requirements for individual sales transactions consisting of a single package of pseudoephedrine where the package contains not more than 60 milligrams.)

• DEA must establish an assessment of the annual needs for the estimated medical, scientific, research, and industrial needs of the United States, for lawful exports, and for maintenance of reserve stocks, for the three chemicals. That assessment establishes an upper limit on the quantity of the chemicals and products containing the chemicals that can be produced in or imported into the United States.

• Bulk manufacturers must obtain a manufacturing quota to produce any of the three chemicals.

• Manufacturers who purchase the bulk chemicals to produce products must obtain a procurement quota.

• Importers must obtain a quota to import the chemicals in bulk or in drug products.

• Importers, exporters, brokers, and traders must provide additional information on the persons to whom they intend to sell the chemicals prior to the sale. They must also provide a return declaration, providing actual information regarding the import, export, or international transaction.

On July 10, 2007, DEA published an Interim Final Rule to establish the procedures for manufacturers to apply for manufacturing and procurement quotas and for importers to apply for import quotas, as required under CMEA (72 FR 37439). The Interim Final Rule created a new part 1315, which parallels the existing part 1303, which covers the same processes for controlled substances. The Interim Final Rule established the following requirements:

Bulk manufacturers of the three chemicals are required to obtain annual manufacturing quotas. A separate quota is required for each chemical. A bulk manufacturer must be registered as a manufacturer to handle the chemical for which a quota is applied. A bulk manufacturer must complete and file a DEA Form 189 on or before May 1 of each year for the following calendar year, as discussed further below. The applicant must provide the following information on the form:

• For the current and preceding two calendar years, the actual quantity manufactured, actual net disposals, and actual inventory as of December 31.

• For the next year, the desired quota, the name and registration number of each customer and the amount estimated to be sold to each, and any additional factors the applicant finds relevant to fixing the quota.

Each manufacturer that purchases the chemicals in bulk or in dosage forms is required to obtain a procurement quota to obtain the bulk chemicals or dosage forms. A separate procurement quota is required for each chemical. A manufacturer must be registered as a manufacturer to handle the chemical for which a quota is applied. A manufacturer must complete and file a DEA Form 250 on or before April 1 of each year for the following calendar year. The applicant must provide the following information:

• A statement about the purpose(s) of the requested chemical and the quantity which will be used for each purpose during the next calendar year. The applicant should provide information about the quantities used (acquired, distributed, and inventory) for the current and preceding two calendar years.

• If the purpose is to manufacture dosage forms, the applicant must state the official name, common or usual name, chemical name, or brand name of that dosage form, and must include the strength.

• The applicant must state the type of activity intended: Product development, repackaging, relabeling, manufacturing OTC finished product, or manufacturing prescription finished product.

• If the purpose is to manufacture a controlled substance listed in Schedule I or II or another List I chemical, the applicant must state the quantity of the other substance or chemical that the applicant has applied to manufacture under § 1303.22 and the quantity of the first chemical needed to manufacture a specified unit of the second chemical.

DEA recognizes that applicants may not have complete data on inventories and records for previous years because DEA has not required registrants to keep these records. Most manufacturers of OTC products should have the information in the records they maintain on regulated transactions. Applicants who manufacture prescription products may not have full records for the initial filings. DEA notes that the provision of incomplete information as part of an application for quota in the initial year of implementation of quotas for ephedrine, pseudoephedrine, and phenylpropanolamine may not, in and of itself, prevent an applicant from obtaining quota. DEA has significant experience regarding the processing of quota applications for which incomplete information is present at the initial establishment of quota (e.g., a new formulation of a controlled substance). DEA will work with quota applicants to obtain information that could be used in the processing of the applicant's initial application.

To track and control the quantity of each of the chemicals and drug products containing the chemicals, DEA must limit imports to a quantity consistent with the national needs. CMEA amended 21 U.S.C. 952(a) to state that “It shall be unlawful to import * * * ephedrine, pseudoephedrine, and phenylpropanolamine * * * except that such amounts of * * * ephedrine, pseudoephedrine, and phenylpropanolamine as the Attorney General [DEA by delegation] finds necessary to provide for the medical, scientific, or other legitimate purposes * * *.” Importers are required to obtain an import quota for each chemical covering both bulk chemicals and dosage forms. An importer must be registered as an importer of the chemical for which a quota is applied. An importer must complete and file a DEA Form 488 on or before April 1 of each year for the following calendar year. The applicant must provide the following information:

• The type of product (bulk chemical or finished forms to be transferred to a manufacturer or product to be sold for distribution).

• The quantity of each type of product.

• For the previous two calendar years, the name, address, and DEA registration number (if applicable) of each customer and the amount sold; inventory as of December 31 for each form of the product (i.e., bulk chemical, in-process material, or finished dosage form); and acquisitions (imports).

DEA recognizes that importers handling prescription products may not have historical records for their initial filings. If an importer is handling prescription drug products, it is possible that some of its customers may not be DEA registrants. DEA notes that the provision of incomplete information as part of an application for quota in the initial year of implementation of quotas for ephedrine, pseudoephedrine, and phenylpropanolamine may not, in and of itself, prevent an applicant from obtaining quota. As noted above, DEA has significant experience regarding the processing of quota applications for which incomplete information is present at the initial establishment of quota (e.g., a new formulation of a controlled substance). DEA will work with quota applicants to obtain information that could be used in the processing of the applicant's initial application.

Depending on the activities that a firm engages in, a firm may have to apply for multiple quotas. For example, a firm that imports ephedrine to bulk manufacture pseudoephedrine would need to obtain an import quota and a procurement quota for ephedrine and a manufacturing quota for pseudoephedrine. A manufacturer that imports bulk ephedrine and pseudoephedrine to produce dosage units of drugs containing the chemicals would need to obtain separate import and procurement quotas for each chemical.

DEA uses the information filed in support of the quota applications as one factor in the determination of an initial assessment of annual needs for each of the chemicals to ensure that the United States has sufficient quantities to meet medical, scientific, research, industrial, exportation, and reserve stock needs. The criteria to be considered in setting quotas are set forth in the CSA. Specifically, the CSA requires the Attorney General, DEA by delegation, to establish production quotas, referred to here as the assessment of annual national needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, in terms of quantities of the listed chemical and not in terms of individual dosage forms (21 U.S.C. 826(a); 21 CFR 1315.11). The actual setting of the annual assessment is done after considering the factors in 21 CFR 1315.11, publishing a proposed annual assessment, and giving the regulated community an opportunity to comment before finalizing the annual assessment (21 CFR 1315.13). DEA published the initial established assessment of annual needs for 2008 on December 27, 2007 (72 FR 73361), proposed revisions and accepted comments thereto (73 FR 35410, June 23, 2008), and published the final 2008 assessment of annual national needs (73 FR 63732, October 27, 2008). DEA must limit or reduce individual production quotas to the extent necessary to prevent the aggregate of all individual quotas from exceeding the assessment of annual national needs (21 U.S.C. 826(b)). In establishing individual manufacturing quotas based on the assessment of annual national needs, DEA considers the manufacturer's estimated disposal, inventory, and other requirements for the calendar year; DEA also considers the manufacturer's current rate of disposal, the trend of the national disposal rate during the preceding calendar year, the manufacturer's production cycle and inventory position, the economic availability of raw materials, yield and stability problems, emergencies such as strikes and fires, and other factors (21 U.S.C. 826(c); 21 CFR 1315.23). DEA notes that the rule being finalized today does not establish the assessment or individual quotas; today's rule simply finalizes the establishment of procedures for collecting information from manufacturers and importers.

The assessment of annual needs establishes a ceiling on domestic manufacturing and importation of these chemicals. DEA may, at its discretion, seek additional information from applicants if needed to determine an appropriate level for the annual assessment ceiling. For example, because repackagers and relabelers handle products that are covered by other procurement or import quotas, DEA may need more details on customers from those seeking procurement quotas to ensure that it is not double counting quantities. This issue may arise particularly in reference to OTC products, where a manufacturer may produce dosage units that are repackaged or relabeled to be sold under multiple store brand labels.

DEA adopted the same process for manufacturing and procurement quotas for the three chemicals as was already in place for manufacturing and procurement quotas for controlled substances. Manufacturers may apply for increases in their manufacturing quotas (21 CFR 1315.25); DEA may reduce individual manufacturing quotas to prevent the total amount produced from exceeding the assessment of annual needs (21 CFR 1315.26). Manufacturers may abandon their quota by notifying DEA (21 CFR 1315.27).

Manufacturers holding a procurement quota may apply for adjustment of the quota by applying to DEA with a statement indicating the need for an adjustment (21 CFR 1315.32(g)). Any manufacturer who holds a procurement quota must, before giving an order to another manufacturer or importer requiring the distribution of a covered chemical, certify in writing that the quantity being ordered does not exceed the unused portion of the person's procurement quota for the year (21 CFR 1315.32(h)).

As specified in the CMEA amendment to section 952 of the CSA, importers may apply for an increase in their quota and DEA may approve the application if DEA determines that the increase is needed to meet medical, scientific, or other legitimate purposes (21 CFR 1315.36). For changes in the import quota, DEA will approve or deny the application within 60 days of receiving the application; if DEA does not reach a decision within the 60 days, the application is considered to be approved until DEA notifies the applicant in writing that the approval is terminated (21 U.S.C. 952(d); 21 CFR 1315.36(c)).

DEA may hold hearings, at the Administrator's sole discretion, to obtain factual evidence regarding the determination or adjustment of any assessment of annual national needs (21 CFR 1315.52(a)). Applicants or quota holders may request hearings on the issuance, adjustment, suspension, or denial of a quota (21 CFR 1315.52(b)). In hearings on the assessment of annual national needs, each interested party has the burden of proving any propositions of fact or law that the party asserts (21 CFR 1315.58(a)). At hearings on the issuance, adjustment, suspension, or denial of an individual quota, DEA has the burden of proving that the requirements for issuance, adjustment, suspension, or denial of an individual quota are met (21 CFR 1315.58(b)).

DEA received five comments on the Interim Final Rule. Commenters included an association representing distributors of drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine; two manufacturers; one distributor; and an association representing manufacturers and distributors of OTC products.

One commenter supported the rule as written, three commenters requested clarification of certain aspects of the rule, and one commenter raised objections to the rule, although its comments actually addressed issues that were not the subject of the Interim Final Rule.

Three of the commenters raised issues about the actual assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine rather than the process manufacturers and importers will use to apply for a quota, which is the subject of this rulemaking. One distributor stated that DEA had failed to prove that convenience stores are a “gray market” for these products.

DEA Response: The issues raised about the assessment of annual needs are beyond the scope of this Final Rule, which deals only with the procedures for applying for and obtaining quotas in general. Any comments on the establishment or revision of the annual assessment and the methodology used to develop it should be submitted in response to notices DEA may publish regarding the assessment of annual needs. This rule includes only the general approach for establishing and issuing the proposed and final assessments of annual needs and individual quotas and contains only the statutory criteria. The issues related to the sale of products containing the three List I chemicals at nonconventional outlets are also beyond the scope of this rule, which does not regulate distributors or retailers. Therefore, these comments are not addressed in this Final Rule.

One pharmaceutical manufacturer asked DEA to revise the requirement that the certification that an order is within the manufacturer's procurement quota be signed by a person eligible to sign a registration. The commenter noted that for controlled substances, the certification may be signed by a person who is eligible to sign the DEA Form 222 “U.S. Official Order Form for Schedule I and II Controlled Substances”, which may be a person granted signing authority through a power of attorney.

DEA Response: DEA agrees with the commenter and is revising 21 CFR 1315.32(h) to permit the signature of a certification for procurement quota to be by an individual authorized to sign the registration, or a person granted power of attorney to sign the certification. DEA is also amending the regulations to add 21 CFR 1315.33, which establishes a process for granting and revoking power of attorney delegations. This process parallels the process in existence for controlled substance orders under part 1305.

One association representing manufacturers and distributors of OTC drug products supported the rule and DEA's tripartite distinction among manufacturers and importers: Those that handle prescription drugs, those that produce products sold mainly through conventional outlets, and those that sell certain high dosage unit products almost exclusively through nonconventional outlets. The commenter noted some inconsistencies in the references to these groups that the commenter stated could be confusing. A manufacturer also raised concerns about DEA's review of quota applications where the manufacturer's products are sold through conventional and nonconventional outlets.

DEA Response: DEA appreciates the support for this rulemaking expressed by the association. DEA emphasizes that each quota application will be reviewed on its own merits. DEA recognizes that many products are sold through both conventional and nonconventional outlets. As the 2002 Economic Census of the Retail Trade, Product Line, data indicate, nonconventional outlets handle only about three percent of sales of OTC medications. Products sold through both types of retail outlets, therefore, will be mainly sold through conventional outlets. As DEA stated in the Interim Final Rule, its concern with products sold through nonconventional outlets is with a limited number of high-dosage-unit products, sold almost exclusively through these outlets and the Internet. These high-dosage-unit products are generally not the bronchodilators used for asthma that commenters cited as a concern.

One manufacturer raised concerns about the consideration of data in the assessment of annual needs. The commenter stated that the trends in demand for ephedrine and pseudoephedrine appear to be changing as customers find the substitutes inadequate. The commenter asked that DEA consider both present and past trends.

DEA Response: DEA agrees with the commenter that changing trends in use need to be considered when establishing the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. DEA notes that manufacturers and importers had an opportunity to comment on the proposed 2008 assessment of annual needs (72 FR 53911, September 20, 2007), and to submit additional information on demand to assist DEA in ensuring that the initial established assessment (72 FR 73361, December 27, 2007) met the legitimate medical, scientific, research, and industrial needs of the United States, for lawful exports, and for maintenance of reserve stocks. As required, DEA will revise the assessment of annual needs and will again seek comment from importers and manufacturers (21 CFR 1315.13).

One manufacturer raised issues related to the inventory allowance for bulk manufacturers and asked that importers also be given inventory allowances. The commenter stated that unlike controlled substances, where imports are allowed only if domestic manufacturers cannot meet the need, with these chemicals most of the chemicals are imported. The commenter stated that providing inventory allowances only to bulk manufacturers would place other manufacturers that rely on imports for the chemical at a disadvantage. The commenter suggested that both manufacturers and importers be given a 20 percent inventory allowance.

DEA Response: DEA agrees with the commenter that the inventory allowance is an issue. Congress clearly intended that these chemicals should be closely regulated. In its Interim Final Rule establishing the procedures to implement individual procurement quotas, DEA established a 50 percent inventory allowance, the same allowance permitted for manufacturers of controlled substances. DEA believes that the 50 percent inventory allowance may be too great in some circumstances. Because this issue was not raised in the Interim Final Rule, however, DEA plans to address it in a separate rulemaking to give regulated entities an opportunity to comment.

Regarding the commenter's suggestion for an inventory allowance for importers and manufacturers obtaining procurement quotas, as noted previously, all importation of ephedrine, pseudoephedrine, and phenylpropanolamine is prohibited except such amounts as the Attorney General finds to be necessary to provide for the medical, scientific, and other legitimate needs of the United States (21 U.S.C. 952(a)). Further, CMEA specifically amended the CSA to require that importers specify, as part of the import declaration for all listed chemicals, the name of the transferee (“downstream customer”) of the chemicals and the quantity of the chemicals to be transferred (21 U.S.C. 971(d)). Thus, as importers must provide, prior to importation, the name of the transferee to whom the chemicals are to be transferred, there should be limited need for the importer to maintain an inventory of these chemicals.

One distributor stated that the Interim Final Rule will cause harm to the national economy through loss of jobs at convenience stores due to loss of sales of ephedrine-based products. The commenter also claimed that the Interim Final Rule would cause harm to rural communities which would not be able to obtain the products and that DEA had underestimated the cost of the rule. The commenter asked DEA to stay the Final Rule until DEA has ruled on its petition for repeal. The commenter also claimed that the Interim Final Rule quota was based on incomplete data and was, therefore, arbitrary and capricious and a violation of the Administrative Procedure Act. The commenter stated that DEA should have used notice and comment rulemaking for the Interim Final Rule. Finally, the commenter stated that the rule would not affect diversion and methamphetamine abuse.

DEA Response: The commenter appears to have misunderstood the nature of this rulemaking. The Interim Final Rule addressed only the procedures that importers and manufacturers must follow to apply for import, manufacturing, and procurement quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. The rule did not establish the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine or individual quotas, nor did it address the subsequent distribution of scheduled listed chemical products. The Interim Final Rule had no impact on the convenience store industry, nor on the availability of scheduled listed chemical products at retail—either in urban or rural communities.

Regarding the cost of the Interim Final Rule, as DEA discussed in that rule, the only cost associated with this rulemaking is the cost of applying for import, manufacturing, or procurement quota. DEA estimates that the cost of applying for a quota is about $96 for importers and $113 for manufacturers, which includes data collection and mailing.

Regarding the commenter's claim that the Interim Final Rule was arbitrary and capricious, and that DEA should have used notice and comment rulemaking to implement the provisions of CMEA, DEA believes that it had good cause under the Administrative Procedure Act to publish the rule as an Interim Final Rule. As DEA explained in the Interim Final Rule, it published this procedural rule as an Interim Final Rule to ensure that it would have a process in place for importers and manufacturers to apply for quotas. Without publication of the Interim Final Rule, DEA would not be able to issue quotas, but the rule does not set quotas. Given that Congress mandated that these chemicals and products containing these chemicals could only be imported and manufactured if the importer or manufacturer had obtained a quota from DEA, delaying the implementation of the procedural steps for seeking quotas would have cut off the supply of the chemicals and products containing those chemicals.

In regard to the commenter's discussion of the economic impact of the Interim Final Rule, the comments regarding the actual availability of those List I chemicals, the establishment of the assessment of annual national needs, and the issuance of individual import, manufacturing, and procurement quotas, are beyond the scope of the Interim Final Rule. The comments apply to the assessment of annual needs, not the application procedures; there are no provisions in this procedural rule that affect the supply or distribution of these chemicals or that impose significant costs on applicants. DEA notes that this commenter provided almost identical comments to this Interim Final Rule as it did to DEA's notice “Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008: Proposed” [Docket No. DEA-306] (72 FR 53911, September 20, 2007). 1 DEA provided an extensive response to the commenter's economic arguments to that notice in its notice “Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008” [Docket No. DEA-306] (72 FR 73361, December 27, 2007).

The commenter claimed that DEA had not assessed the impact on small entities. DEA, however, did precisely that even though it was not required to do so. The Regulatory Flexibility Act (RFA) applies only to rules that have been proposed; it does not apply to Interim Final Rules. Nonetheless, DEA did consider the issue. The Interim Final Rule simply sets out the process by which importers and manufacturers may apply for quotas. The costs of the application process are very low and do not impose a significant economic impact on small entities. DEA notes that distributors, such as the commenter, are not subject to this rule. DEA included the wholesale sector in its economic analysis in the Interim Final Rule because that is where importers are usually classified under the North American Industry Classification System.

Finally, the commenter stated that the rule would not affect diversion and methamphetamine abuse. Congress mandated these rules as part of a series of actions to prevent diversion of scheduled listed chemical products, and the chemicals used to manufacture them, to clandestine laboratories. Since the states and, in 2006, DEA, imposed sales limits on these products, the number of clandestine laboratory seizures in the United States has fallen dramatically, indicating that the Congressionally mandated actions have been effective in limiting diversion of products to clandestine laboratories in the United States. International sources of methamphetamine are addressed by other parts of CMEA.

While drafting this Final Rule, DEA noted that it had inadvertently required bulk manufacturers to complete and file DEA Form 189, Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine, on or before April 1 of each year for the following calendar year (21 CFR 1315.22). This differs from the requirement for controlled substances; DEA Form 189 to request manufacturing quota for any basic class of controlled substance in Schedules I and II must be completed and filed on or before May 1 of each year for the following calendar year (21 CFR 1303.22). To alleviate potential confusion and ensure that the systems for controlled substances and ephedrine, pseudoephedrine, and phenylpropanolamine are as similar as possible, DEA is revising 21 CFR 1315.22 to require applicants for manufacturing quota for ephedrine, pseudoephedrine, and phenylpropanolamine to complete and file DEA Form 189 on or before May 1 of the year preceding the calendar year for which the manufacturing quota is being applied. DEA notes that only one registrant has applied for manufacturing quota. Therefore, DEA believes that this change will not significantly impact any registrant and will benefit the one registrant that currently utilizes this form.

Further, DEA noted that it had inadvertently not revised 21 CFR 1316.41, the section discussing the scope of the subpart related to administrative hearings, to include in the listing of CFR sections in which specific procedures regarding administrative hearings can be found sections 1315.50-1315.62. Therefore, for clarity, DEA is adding these sections to the listing of sections in which specific procedures regarding administrative hearings are found in 21 CFR 1316.41.

The Interim Final Rule amending Parts 1300 and 1315 of Title 21, Code of Federal Regulations, which was published in the Federal Register on July 10, 2007 at 72 FR 37439, is hereby adopted as a Final Rule as published, with one change. DEA is revising the provision in 21 CFR 1315.32(h) regarding who may sign the required certification that an order is within the ordering company's quota. This revision provides a benefit to registrants, permitting the signature of a certification for procurement quota to be by an individual authorized to sign the registration, or a person granted power of attorney to sign the certification. To accomplish this, DEA is also adding a new 21 CFR 1315.33 to establish a process for granting and revoking power of attorney status; this section parallels the provisions of 21 CFR 1305.05.

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (5 U.S.C. 553), including making the rule effective upon the date of publication. DEA finds good cause to make this rule effective upon publication, as this Final Rule provides a benefit or relieves a restriction by permitting the signature of a certification for procurement quota to be by an individual authorized to sign the registration, or a person granted power of attorney to sign the certification. To accomplish this, DEA is adding a new 21 CFR 1315.33 to establish a process for granting and revoking power of attorney status. The rest of this Final Rule merely confirms existing regulatory requirements implemented as part of the Interim Final Rule published July 10, 2007 at 72 FR 37439.

The Acting Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612). Because this rule is codifying statutory provisions, DEA has determined that public notice and comment are not necessary. Consequently, the RFA does not apply.

DEA has nonetheless considered the impact of the rule on small entities. As discussed below, DEA estimates that about 310 firms in the manufacturing and wholesale sectors may be affected by this rule. About 250 of these may be small entities under the Small Business Administration definitions of small entities. For most of these firms the impact of the rule is very small; they are required to file an annual request for import or procurement quotas. DEA estimates that the cost of applying for a quota is about $96 for importers and $113 for manufacturers, which includes data collection and mailing. These costs do not represent a significant economic impact even on the smallest repackagers whose average revenues are above $54,000. The average revenues of the smallest firms in sectors subject to the rule for which the 2002 Economic Census has data are shown in Table 1.

The Acting Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). It has been determined that this is “a significant regulatory action.” Therefore, this action has been reviewed by the Office of Management and Budget.

Regulated Entities. The firms subject to this rule are manufacturers and importers. At present, only one firm in the United States manufactures any of these chemicals in bulk and, therefore, only that firm will have to apply for a manufacturing quota. DEA reviewed a list of pseudoephedrine OTC and prescription products and ephedrine prescription products and identified about 240 firms based on their labeler codes. Each of these firms, plus any firms that repackage or relabel, will need to obtain procurement quotas. Based on 2005 DEA data, DEA estimates that about 69 firms with 91 locations are currently registered to import the chemicals; these firms will need to obtain import quotas if they are actually importing the chemicals. Although 91 locations are registered to import these chemicals, import notices indicate that many of these locations do not handle the chemicals. If other firms import prescription drug products that contain the chemicals they will also have to obtain import quotas. Based on these data, DEA estimates that 332 locations may apply for quotas if the demand for the chemicals and drug products remains the same (1 bulk manufacturer, 240 manufacturers, and 91 importers). Table 2 presents the number of potential applicants by sector. Registrants must apply for quotas for each registered location rather than by firm. Consequently, the number of manufacturing locations applying may be higher than listed if the firms handle the product at multiple locations. The importers are, in some cases, also manufacturers, so that the total number of affected firms may be reduced. The total number of importer registrants includes firms with multiple registered locations.

Costs. As detailed in the Regulatory Flexibility Act section, there is some burden associated with applying for quotas. DEA estimates that the total cost of the quota application process is about $35,880 a year.

Benefits. Congress, in CMEA, imposed a set of requirements on the manufacture, import, and sale of the three chemicals. These requirements, taken together, are intended to limit production and sales of these chemicals to that needed for legitimate purposes. Reduction in the number of clandestine methamphetamine laboratories reduces costs to Federal, State, and local governments of raiding these clandestine operations and cleaning up pollution at clandestine methamphetamine laboratory sites. As DEA detailed in its Interim Final Rule implementing the retail sales provisions of CMEA (specifically 71 FR 56020, September 26, 2006), DEA, the States, and local governments spent more than $17 million in clean up costs in FY 2005. This cost covers only the removal of chemicals that could be reused from clandestine laboratory sites; the cost of cleaning up soil or property contamination is paid by the land owner, but if the owner cannot pay the cost, local governments bear the burden or the contamination remains. The costs also do not cover the time State and local governments spend investigating, arresting, and trying clandestine laboratory operators or the social costs related to children and others exposed to hazardous chemicals at these laboratories.

This Final Rule does not change existing requirements. Therefore, the approved information collections that were published with the Interim Final Rule are not being revised.

This regulation meets the applicable standards set forth in §§ 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.

This rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706.

This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) of the Navy, under authority delegated by the Secretary of the Navy, has certified that USS DALLAS (SSN 700) is a vessel of the Navy which, due to its special construction and purpose, cannot comply fully with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Rule 21(a) pertaining to the location of the masthead lights over the fore and aft centerline of the ship. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR Parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706.

The Secretary of the Navy previously certified that USS DWIGHT D. EISENHOWER (CVN 69) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with 72 COLREGS. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) of the Navy, under authority delegated by the Secretary of the Navy, has amended that certification to reflect that certain anchor lights on USS DWIGHT D. EISENHOWER (CVN 69), previously certified as not in compliance with 72 COLREGS, now comply with the applicable 72 COLREGS requirements, to wit: The two aft anchor lights located below the flight deck were removed and replaced by a single new aft anchor light above the hull and near ship's fore-aft centerline, as required by Rules 21(e), 30(a)(i) and 30(a)(ii). The side lights were also raised closer to compliance.

Moreover, it has been determined, in accordance with 32 CFR Parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

In a document published in the Federal Register (73 FR 19785) on April 11, 2008, we proposed to establish a new 38 CFR part 53 consisting of regulations captioned “PAYMENTS TO STATES FOR PROGRAMS TO PROMOTE THE HIRING AND RETENTION OF NURSES AT STATE VETERANS HOMES” (referred to below as the proposed regulations). This document adopts as a final rule, with changes discussed below, those proposed regulations. This final rule sets forth a mechanism and criteria for a State to obtain payments from VA to assist a State Veterans Home (SVH) in the hiring and retention of nurses for the purpose of reducing nursing shortages at that home. The final rule establishes regulations concerning provisions in section 201 of the Veterans Health Programs Improvement Act of 2004 (Pub. L. 108-422), which are codified at 38 U.S.C. 1744.

We provided a 60-day comment period that ended June 10, 2008. We received four submissions containing a number of comments that are all discussed below.

The proposed regulations at § 53.02 defined the term “nurse” to include only those who are bedside care givers at least a majority of the time. Consequently, the proposed regulations would allow payments only to promote the hiring and retention of those nurses licensed or certified, as described in the proposed definition, and who are bedside care givers at least a majority of the time. In support of this definition, the proposed rule noted that the applicable legislative history (H. Rep. No. 108-538 at 5 (2004)) indicates that the statutory provisions were intended to assist State homes “in hiring nurses to care for veterans.” Two commenters asserted that VA has misinterpreted 38 U.S.C. 1744 and its legislative history. With respect to the statute, the comments specifically discussed paragraphs (a) and (b), and the final sentence of paragraph (c), which states that when prescribing criteria for programs to be funded, the Secretary shall “take into consideration the need for flexibility and innovation.” They asserted that the proposed definition of nurse should be changed to remove its restriction to those who are bedside care givers at least a majority of the time, and should not generally exclude such individuals as those acting in the capacity of an advance practice nurse, an administrative nurse, or a director of nursing. We made no changes based on these comments.

Even if the statute and its legislative history are viewed as permitting VA to establish a more expansive definition of the term “nurse” than we proposed, we do not agree with the commenters’ argument that the proposed definition is not a permissible one under the statute. The provisions of 38 U.S.C. 1744(c) and (j) authorize VA to establish criteria for the award of payments and we believe that VA therefore has authority for the provisions in the proposed rule that, through the definition of “nurse,” limit the nurses for whom VA assistance may be provided. The greatest need for nurses is for those who are bedside care givers at least a majority of the time and we have determined that we can best use the available funding for recruiting and retaining such nurses. In establishing criteria for programs to be awarded payments, the need for flexibility and innovation is not the only permissible consideration. Our consideration of the need for flexibility and innovation has been reflected in the preambles and text of the proposed rule and of this final rule.

The provisions of proposed § 53.11(a)(3) would require, as a condition of receiving assistance, that the State applicant document by credible evidence that an individual SVH has a nursing shortage. One commenter raised a number of issues regarding the submission of such evidence.

The commenter questioned whether a State applicant would necessarily have to provide an application for each individual SVH within the State or whether general documentation could be used for groups of SVHs within the State. We made no changes based on this comment. The provisions of 38 U.S.C. 1744(e) require that documentation be provided for each SVH (“Any such application shall describe the nursing shortage at the State home. * * *”)

The commenter asserted that general criteria that set thresholds for defining a nursing shortage would be preferable to the proposed rule's provisions in § 53.11 for documentation of a nursing shortage, and that any SVH meeting the criteria should be able to submit an application. We made no changes based on this comment as each SVH could have a distinct factual scenario that would be subjected to specific criteria in § 53.11.

The commenter asked, what is the acceptable standard for “credible evidence;” and further questioned whether the States would need to hire an independent consultant to prepare their submission. We made no changes based on these comments. The proposed regulations at § 53.11(a)(3) provided a list of types of evidence that could be submitted to establish a nursing shortage, i.e., “including but not limited to SVH records showing nursing vacancies, SVH records showing nurse overtime use, and reports documenting that nurses are difficult to hire in the local area and difficult to retain as employees at the SVH.” A State could certainly choose to utilize consultants to gain information, but this is not a requirement.

The provisions of proposed § 53.11(a)(5) would require, as a condition of receiving assistance, that the SVH submit documentation establishing that it has an employee incentive program that (i) is likely to be effective in promoting the hiring and retention of nurses for the purpose of reducing nursing shortages at that home, and (ii) is in operation or ready for immediate implementation upon receipt of payments. One commenter asked what evidence would be necessary to show likely effectiveness of a new program for which there is no experience upon which to document success. We made no changes based on this comment. To determine whether this condition has been satisfied, we would review all relevant information provided, including information about the program's design and the applicant's description of how the program would eliminate the nursing shortage, as well as how long it would take to do so. We would also use similar experiences with other programs and apply our expertise to analyze such programs in determining whether they are likely to be effective.

One commenter interpreted the term “improvements to working conditions” in proposed § 53.11(b) to permit an employee incentive project to improve “working areas.” The commenter asked whether a project to improve working areas could qualify under a State home construction grant and also qualify for payment under the hiring and retention program. The commenter also asked whether such projects would be reviewed in a manner similar to that used for SVH construction grants. The statutory authority for the nurse hiring and retention program does not contemplate providing funds for construction projects. In addition, VA already has separate statutory authority that permits funding projects to remodel or alter working areas, under 38 U.S.C. 8131-8137. We interpret these statutory authorities to require that State applications for VA funding of all such construction projects be submitted under the State home construction grant program. Based on this comment, the final rule makes changes from the proposed regulation in § 53.11(a) by adding a new paragraph, § 53.11(a)(10), to provide that payments will not be made for projects that involve constructing, acquiring, expanding, remodeling, or altering State homes.

One commenter asserted that “the proposed program is looking at a three-year window for an incentive program to be successful with funding coming on an annual basis” and suggested that VA provide assurance that, if appropriations are made by Congress, VA would not for other reasons refrain from continuing to fund a program that would take 3 years to complete. We made no changes based on this comment. VA needs to be able consider other factors in addition to appropriations in determining whether to again fund a particular program.

Under the provisions of proposed § 53.11(a)(7), as a condition of receiving assistance the SVH program must “insofar as possible” be designed to eliminate any nursing shortage at the SVH within a 3-year period from the initiation of VA payments. One commenter asserted that “the requirement to put a plan in place that will eliminate all nursing shortages in 3 years is not feasible.” We made no changes based on this comment. We note that this was not an absolute since the text included the language “insofar as possible.” It certainly may not always be possible to eliminate a nursing shortage within this 3-year period, but we believe that such plans should, insofar as possible, be designed in accordance with this 3-year target.

The proposed regulations at § 53.11(b) stated that VA intends to allow flexibility and innovation in determining the types of employee incentive programs at SVHs eligible for payments. This paragraph further stated that programs could include such things as the provision of short-term scholarships for continuing nursing education, sign-on bonuses for nurses, and improvements to working conditions. One commenter asserted that the regulations should specifically state that the regulations allow student forgiveness programs. We agree that the student forgiveness programs could effectively help eliminate nursing shortages and in the final rule we are adding it to the list of examples.

Under the provisions of proposed § 53.20(a), applications must be submitted during the first quarter of the fiscal year in which VA payments are sought. One commenter asserted that the application window should be changed to the last quarter of the preceding Federal Fiscal Year (FFY) so that approved expenditures can begin with the start of the FFY in which funds are to be expended. We agree with the suggested change and the rationale for the change. In the final rule, we changed the provisions of § 53.20(a), and a related reference to that quarter in § 53.20(c), accordingly. We have also added “Federal” in this section and elsewhere to clarify references to “fiscal year”.

Under the provisions of proposed § 53.20(c), if an application does not contain sufficient information, VA would notify the State representative in writing that the State has 30 calendar days from the date of the notice to submit such additional information or no further action would be taken. These provisions also contain a mechanism for extending the 30-day period based on good cause. One commenter asserted that the time might be sufficient if the notice was provided electronically but it may not be sufficient if provided by mail. We are making a change in the final rule in § 53.20(c) to specify that such notice be given “in writing (electronically and by mail).” We agree with the commenter that it would be appropriate to provide electronic notice and that this would enable the SVH to have more time to reply. We agree for the reason stated by the commenter and have made appropriate changes to § 53.20(c). The commenter also asserted that there should be provision to allow an extension beyond the 30 days if the information required by VA will take longer than 30 days to obtain and submit. We made no changes based on this comment. The proposed regulations at § 53.20(c) already would provide for extensions based on good cause.

One commenter asked why we are “allowing the situation with the very high tuition for nursing school to go unchanged” and asserted that if nurses were trained on the job at hospitals the market could be flooded with nurses. The commenter also indicated her opposition to “importing nurses from other countries.” We made no changes based on this comment. The substance of the comment is outside the scope of our authority for this rulemaking proceeding. However, we note that the final rule does make a change to list student forgiveness programs as one of the types of incentives permitted.

The final rule also differs from the proposed rule by adding parentheticals displaying the information collection control number assigned by the Office of Management and Budget (OMB) following the sections that contain information collection provisions. In addition, the final rule differs from the proposed rule due by making nonsubstantive clarifying or technical changes.

Based on the rationale in the proposed rule and in this document, the provisions of the proposed rule are adopted as a final rule with changes discussed in this preamble.

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 Executive Order classifies a regulatory action as a “significant regulatory action,” requiring review by OMB unless OMB waives such review, if it is a regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this rule have been examined and it has been determined to be a significant regulatory action under Executive Order 12866.

The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule would have no such effect on State, local, or tribal governments, or on the private sector.

OMB assigns a control number for each collection of information it approves. Except for emergency approvals under 44 U.S.C. 3507(j), VA may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

In the proposed rule, we stated that proposed §§ 53.11, 53.20, 53.31, and 53.40 contain collection of information provisions under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521), and that we had requested public comment on those provisions in notices published in the Federal Register . Those notices were published on April 2, 2007 (72 FR 15763), and June 27, 2007 (72 FR 35303). We did not receive any comments on the proposed collections of information, which OMB has approved through February 28, 2011, under control number 2900-0709. Following each of those sections in this final rule, we set out an information collection approval parenthetical displaying OMB control number 2900-0709.

The Secretary hereby certifies that this rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The funding for this program would be made by the Federal government. The amount contributed by a SVH to fund an incentive program would be an insignificant amount of the costs for operating the SVH. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.005, Grants to States for Construction of State Home Facilities; 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016, Veterans State Hospital Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation—Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.026, Veterans State Adult Day Health Care.

Throughout this document “we,” “us,” and “our” refer to EPA.

On May 30, 2007, TCEQ submitted rule revisions to 30 TAC, Chapter 117, “Control of Air Pollution from Nitrogen Compounds,” as a revision to the Texas SIP for point sources of NO X (May 30, 2007 SIP revision). The State of Texas submitted the May 30, 2007 SIP revision to us, to, among other things, provide a portion of the NO X reductions needed for the D/FW area to attain the Federal 8-hour ozone NAAQS.

On July 11, 2008 (73 FR 39900) we proposed approval of the May 30, 2007 SIP revision. The public comment period for our proposal expired on August 11, 2008.

We received relevant comments from TCEQ on our July 11, 2008 (73 FR 39900) publication, correcting or clarifying some of the citations used in our proposed approval document. We appreciate the State's input, and have accordingly corrected those citations in today's final document. See our Technical Support Document (TSD) prepared in conjunction with today's final action for more information.

We received no other comments on our proposed approval of the May 30, 2007 SIP revision. Therefore, we are finalizing our July 11, 2008 proposal (73 FR 39900), except section 117.9810, rulemaking action, today. We will act on section 117.9810 in a separate rulemaking action in future  1 . We are taking four separate actions in today's final action.

First, we are approving revisions which involve repealing the current Chapter 117 rules from Texas SIP, and simultaneously approving into the Texas SIP, a new reformatted Chapter 117. We are approving the repeal of the current Chapter 117, and the recodification and reformatting of Chapter 117 because the reformatted revision will better accommodate future additions/revisions to the rules and will maintain consistency between the State rules and Federal SIP. We are approving all of the non-substantive reformatted, restructured, renumbered, reorganized, and administrative revisions to the wording of Chapter 117 into Texas SIP. In our proposal, we clarified that the specifically identified rules do not make any changes to the substance of the rules that we previously approved into the Texas SIP, Chapter 117. By approving the repeal of the current Chapter 117 from the Texas SIP, and approving the new Chapter 117's rules into the Texas SIP, we are making it clear that the new rules replace the previous rules in their entirety. We are approving these non-substantive reformatted, restructured, renumbered, reorganized, and administrative revisions to the wording of Chapter 117 under section 110 and part D of the Act. For a full list of affected sections see section C of this document.

Second, we are approving revisions to the D/FW NO X major point source rules. Sections 117.410(a), 117.410(b) and 117.310(b) contain substantive changes in the reformatted Chapter 117 rules that result in additional NO X reductions. These reductions were not previously a part of EPA-approved Texas SIP, Chapter 117.

Third, we are approving revisions to the D/FW minor source rules for the control of NO X . Section 117.2110(a) contains substantive changes in the reformatted Chapter 117 rules that result in additional NO X reductions which will help the D/FW area to attain the 1997 8-hour ozone standard. These reductions were not previously a part of EPA-approved Texas SIP, Chapter 117.

Fourth, we are proposing to approve revisions to the rules for the control of NO X emissions from combustion sources in East Texas. Section 117.3310(a) contains substantive changes in the reformatted Chapter 117 rules that result in significant NO X emissions reductions. These reductions were not previously a part of EPA-approved Texas SIP, Chapter 117.

Sections F through P of this document contain more information concerning each of these four actions.

The resulting emissions reductions of NO X , an ozone precursor, from this SIP revision will assist in bringing the D/FW area into attainment with the 1997 8-hour ozone NAAQS, and help with the maintenance of the 1997 ozone NAAQS in the East and Central parts of the State. The D/FW 8-hour ozone nonattainment area (Collin, Dallas, Denton, Tarrant, Ellis, Johnson, Kaufman, Parker, and Rockwall Counties) is designated nonattainment, and classified as a moderate 8-hour non-attainment area for ozone. See 69 FR 23857 published on April 30, 2004. We proposed approval of the D/FW 8-hour ozone attainment demonstration plan in a separate rulemaking action, and will consider relevant written comments received on the D/FW 8-hour ozone attainment demonstration plan in a separate Federal Register publication.

Table 1 below contains a summary list of the sections of 30 TAC, Chapter 117 that we proposed for approval, in our July 11, 2008 (73 FR 39900) rulemaking action, for point sources of NO X to become part of the Texas SIP. Table 1 below includes both the sections with substantive changes and the nonsubstantive changes.

Although we proposed approval of the new section 117.9810 concerning Use of Emission Reductions Generated from the Texas Emissions Reduction Plan (TERP) in our July 11, 2008 publication, we are taking no action upon 117.9810 today. We will take rulemaking action on 117.9810 in a separate publication in future.

Please keep in mind that the tables in this document are not intended to be exhaustive, but rather to provide a guide for readers to generally understand which affected sources are likely to be required to comply with the NO X control requirements in conjunction with today's rulemaking action. To determine whether or how your facility would be affected by this particular action, you should refer to the actual text of 30 TAC Chapter 117, and the June 8, 2007 issue of the Texas Register (32 TexReg 3206). You can find the entire TCEQ Chapter 117 rules at: http://www.tceq.state.tx.us/rules/indxpdf.html#117.

Our TSD prepared for the July 11, 2008 (73 FR 39900) proposal contained detailed discussion of each of the above changes, and why EPA believed they should be approved into Texas SIP. We are approving the above sections of Table 1 into Texas SIP.

Per TCEQ's request the following sections, listed in Table 2 below, of the May 30, 2007, SIP revision will not become a part of the EPA-approved Texas SIP. As stated in our proposal these rules mainly pertain to the control of ammonia or carbon monoxide emissions which are not ozone precursors and therefore, these rules are not necessary components of the Texas SIP. The rules listed in Table 2 are not already in the current Texas SIP and EPA continues to agree with Texas that these rules can remain outside the SIP.

Although the above sections of 30 TAC Chapter 117 will not become a part of the Texas SIP, they will continue to remain enforceable at the State level. As stated elsewhere in this document, we are taking no action upon 117.9810 today. We will take rulemaking action on 117.9810 in a separate publication in future.

Table 3 below contains a listing of sections of the May 30, 2007, SIP revision that we are not finalizing in today's action. We will review and act upon the cement kiln related sections of the May 30, 2007 SIP revision in a separate rulemaking action.

Table 4 below lists the Counties in the D/FW 8-hour Ozne nonattainment area that will be affected by today's action.

Table 5 below lists the Counties in the East and Central Texas that will be affected by today's action.

Nitrogen oxides belong to the group of criteria air pollutants. NO X are produced from burning fuels, including gasoline and coal. Nitrogen oxides react with volatile organic compounds (VOC) to form ozone or smog, and are also major components of acid rain. For more information on NO X see http://www.epa.gov/air/urbanair/nox/.

Ozone is a gas composed of three oxygen atoms. Ground level ozone is generally not emitted directly from a vehicle's exhaust or an industrial smokestack, but is created by a chemical reaction between NO X and VOCs in the presence of sunlight and high ambient temperatures. Thus, ozone is known primarily as a summertime air pollutant. NO X and VOCs are precursors of ozone. Motor vehicle exhaust and industrial emissions, gasoline vapors, chemical solvents and natural sources emit NO X and VOCs. Urban areas tend to have high concentrations of ground-level ozone, but areas without significant industrial activity and with relatively low vehicular traffic are also subject to increased ozone levels because wind carries ozone and its precursors hundreds of miles from their sources.

Repeated exposure to ozone pollution may cause lung damage. Even at very low concentrations, ground-level ozone triggers a variety of health problems including aggravated asthma, reduced lung capacity, and increased susceptibility to respiratory illnesses like pneumonia and bronchitis. It can also have detrimental effects on plants and ecosystems.

The SIP is a set of air pollution regulations, control strategies, other means or techniques and technical analyses developed by the state, to ensure that the state meets the NAAQS. The SIP is required by section 110 and other provisions of the Act. These SIPs can be extensive, containing state regulations or other enforceable documents and supporting information such as emissions inventories, monitoring networks, and modeling demonstrations. Each state must submit these regulations and control strategies to EPA for approval and incorporation into the Federally-enforceable SIP. Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin.

We approved NO X emissions specifications for stationary sources in 66 FR 15195 published March 16, 2001. In addition to requiring NO X emissions control requirements for those sources, we are approving the following NO X emissions requirements for the following affected sources with emissions greater than 50 Tons Per Year (TPY) in the D/FW 8-hour ozone nonattainment area. We have included the Chapter 117 citation for each source category in the Table 6 below for convenience purposes.

We are approving these NO X emissions specifications under Part D of the Act because their resulting emissions reductions will assist Texas in demonstrating attainment of the 1997 8-hour ozone standard in the D/FW 8-hour ozone nonattainment area. Therefore, we are approving these requirements into the Texas SIP.

This SIP revision requires reductions of NO X emissions from stationary diesel engines in the D/FW area. The following Table 7 contains a summary of the NO X emission specifications for stationary diesel engines in the D/FW area. We have included the Chapter 117 citation for each source category in the Table 7 below for convenience purposes.

Also see section 117.2110(a)(3) concerning stationary diesel engines at minor sources within the D/FW 8-Hour Ozone Nonattainment Area.

As stated in our July 11, 2008 (73 FR 39900) proposal, we are approving the above-listed NO X emission requirements for diesel engines because they are in agreement with those found in 40 CFR 89.112, and EPA's Document Number 420-R-98-016 dated August 1998, titled “Final Regulatory Impact Analysis: Control of Emissions from Nonroad Diesel Engines.” In addition, the above-listed NO X emission requirements for diesel engines are consistent with those we approved for similar units at Table VI of 66 FR 57230 published on November 14, 2001. We are therefore approving these NO X emission requirements into the Texas SIP under Part D of the Act because their resulting emissions reductions will assist Texas in demonstrating attainment of the 8-hour ozone standard within the D/FW 8-hour ozone nonattainment area.

These minor sources include stationary reciprocating internal combustion engines that are not a major source of NO X (emit, when uncontrolled, less than 50 Tons Per Year (TPY) of NO X ). See sections 117.2100 and 117.2103 for more information.

As an alternative, a minor source from the Table 8 above located within the D/FW area and having an annual capacity factor of 0.0383 or less may choose emissions specification of 0.060 lb/MMBtu, instead. See 117.2110(a)(4).

The NO X emissions requirements for the above-listed minor sources of NO X and their resulting emissions reductions will assist in demonstrating attainment of the 8-hour ozone NAAQS within the D/FW 8-hour ozone nonattainment area. Therefore, we are approving these requirements into the Texas SIP.

The gas-fired stationary reciprocating internal combustion engines located in Anderson, Brazos, Burleson, Camp, Cass, Cherokee, Franklin, Freestone, Gregg, Grimes, Harrison, Henderson, Hill, Hopkins, Hunt, Lee, Leon, Limestone, Madison, Marion, Morris, Nacogdoches, Navarro, Panola, Rains, Robertson, Rusk, Shelby, Smith, Upshur, Van Zandt, or Wood Texas Counties are subject to these requirements. See section 117.3300 for more information. The following Table 9 contains NO X emissions requirements and related information for these affected units.

On July 19, 2007 TCEQ announced implementation of Texas Senate Bill 2000, passed in 2007 by the 80th Texas Legislative Session. The Bill directs the TCEQ to develop an incentive grant program for the partial reimbursement of capital costs for installing nonselective catalytic reduction (NSCR) systems to reduce emissions of NO X from existing stationary gas-fired rich-burn compressor engines. For more information see http://www.tceq.state.tx.us/implementation/air/rules/sb2003.html (URL dating July 20, 2007).

The NO X emissions requirements for the stationary reciprocating internal combustion engines in East and Central Texas and their resulting emissions reductions will assist in demonstrating attainment of the 8-hour ozone NAAQS within the Houston-Galveston-Brazoria, D/FW, and Beaumont/Port Arthur areas. Furthermore, these reductions will contribute to the continued maintenance of the standard in the eastern half of the State of Texas, and they enhance the Texas SIP. Therefore, we are approving these requirements into the Texas SIP under part D, and sections 110 and 116 of the Act, respectively.

The water heaters, small boilers, and process heaters that use natural gas and have a rated capacity of 2 million Btu per hour or less are subject to these requirements. See 117.3200 and 117.3203 for more information. The following Tables 10 and 11 contain type and size categories, and NO X emissions requirements for these affected units.

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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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 FOR FURTHER INFORMATION CONTACT .

In addition to accessing electronically available documents at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . 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 site at http://www.gpoaccess.gov/ecfr .

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-2007-1106 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 February 2, 2009.

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 ADDRESSES . 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-2007-1106, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : 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.

In the Federal Register of January 23, 2008 (73 FR 3964) (FRL-8345-7), 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 7E7270) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.275 be amended by establishing tolerances for combined residues of the fungicide chlorothalonil, tetrachloroisophthalonitrile, and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on vegetables, fruiting, group 8 at 5.0 parts per million (ppm); okra at 5.0 ppm; persimmon at 1.9 ppm; horseradish at 4.0 ppm; rhubarb at 5.0 ppm; ginseng at 3.0 ppm; yam at 5.0 ppm; lupine at 0.1 ppm; lentil at 0.1 ppm; vegetable, cucurbit, group 9 at 5.0 ppm; and Brassica , head and stem, subgroup 5A at 5.0 ppm. That notice referenced a summary of the petition prepared by GB Biosciences Corporation, the registrant, on behalf of IR-4, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the tolerance levels for ginseng, okra, persimmon, rhubarb, and yam. EPA has also determined that a tolerance is not needed for lupine and that the proposed tolerance for vegetable, fruiting, group 8 should exclude tomato and be set slightly higher than proposed. The reasons for these changes are explained in Unit IV.C.

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....”

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 chlorothalonil and its 4-hydroxy metabolite on Brassica , head and stem, subgroup 5A at 5.0 ppm; ginseng at 4.0 ppm; horseradish at 4.0 ppm; lentil at 0.10 ppm; okra at 6.0 ppm; persimmon at 1.5 ppm; rhubarb at 4.0 ppm; vegetable, cucurbit, group 9 at 5.0 ppm; vegetable, fruiting, group 8, except tomato at 6.0 ppm; and yam, true at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

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.

Chlorothalonil has low-acute toxicity by the oral and dermal routes of exposure and is moderately toxic by the inhalation route. It is severely irritating to the eye and moderately irritating to the skin but is not a skin sensitizer.

Chlorothalonil causes gastric irritation upon ingestion. In a subchronic dog study, both males and females exhibited decreased body weights, body-weight gains and food consumption. In a chronic dog study, there was one death (female), decreased body-weight gain and food consumption, macroscopic and microscopic pathological findings in the stomach (including thickened appearance of the stomach and intra-epithelial nuclear pyknosis in the mucosal epithelium of the antrum of the stomach) and a very slight hypertrophy of the cells in the zona fasciculata of the adrenal glands. In a second chronic dog study, vacuolated epithelium of the kidney was observed. In a subchronic mouse study, chlorothalonil produced hyperplasia and hyperkeratosis of the squamous epithelium of the stomach. In a subchronic rat study, chlorothalonil increased relative kidney weights and produced dilated renal medullary tubules as well as hyperplasia and hyperkeratosis of the non-glandular area of the stomach. In rodent chronic toxicity studies, there was an increased incidence of epithelial hyperplasia of the limiting ridge and non-glandular region of the stomach in rats and mice.

There are two toxicology data sets, submitted by different basic registrants, available for chlorothalonil. There was no indication of a carcinogenic response in the rat chronic toxicity/carcinogenicity study from the newer data set; however, an increased incidence of renal adenomas and carcinomas and an increased incidence of papillomas and/or carcinomas of the forestomach were observed in both sexes of rats and mice with the older data set. The new carcinogenicity study in mice also demonstrates that chlorothalonil produces similar papillomas of the forestomach. Based on the increased incidence of renal adenomas and carcinomas observed in both sexes of rats and mice, the rarity of the tumor response in the kidney, and the increased incidence of papillomas and/or carcinomas of the forestomach in rats and mice, EPA classified chlorothalonil as a “likely” human carcinogen by all routes of exposure.

Several studies are available that address the mechanism of carcinogenicity of chlorothalonil. Based on the mechanistic data submitted for the kidney tumor response demonstrating a toxic response of the kidney and forestomach to repeated dietary administration of chlorothalonil, the mode of action for tumor induction of chlorothalonil is likely to be non-linear. With regard to the forestomach tumors, data submitted by the registrant showing cell proliferation and non-neoplastic pathology at doses near those producing a tumorigenic response also support a non-linear mode of action for chlorothalonil. Based on the weight of the evidence presented to the Agency, EPA has concluded that a non-linear risk assessment using a Margin of Exposure (MOE) approach is appropriate for chlorothalonil.

No developmental toxicity was observed in two rat developmental toxicity studies or in one of the two rabbit developmental toxicity studies available for chlorothalonil. In the other rabbit study, there was an increased incidence of thirteen ribs and reduced sternebrae in the absence of maternal toxicity. There was no evidence of reproductive toxicity in either rat reproduction study available for chlorothalonil.

There is no evidence that chlorothalonil causes neurotoxicity. There was no evidence of neuropathology, and there were no central nervous system (CNS) malformations, effects on brain weights, abnormal behavior or effects on offspring sexual maturation observed in the toxicity studies available for chlorothalonil, including a subchronic neurotoxicity study in rats.

In a 90-day oral toxicity study in rats, a slight decrease in thymus weight was observed at the highest dose tested, a possible indication of immunotoxicity. However, since there were no histopathological findings noted in the thymus and no effects on the thymus observed in other subchronic or chronic/carcinogenicity studies in rats, EPA has concluded that the slight effect on thymus weight seen in this study is a spurious effect and not indicative of immunotoxicity.

4-hydroxy-2,5,6-trichloroisophthalonitrile is a major metabolite of chlorothalonil in plants and the predominant residue in animals. Toxicology data available for this metabolite include acute oral and subchronic toxicity studies in rats, developmental toxicity studies in rats and rabbits, a reproduction toxicity study in rats, a chronic toxicity study in dogs and chronic/carcinogenicity studies in rats and mice. The results of these studies indicate that the toxicity of the 4-hydroxy metabolite is similar to that of parent chlorothalonil. Based on this determination, EPA has concluded that the chlorothalonil risk assessment adequately accounts for potential toxicity resulting from exposure to 4-hydroxy chlorothalonil, and a separate risk assessment is not needed.

Specific information on the studies received and the nature of the adverse effects caused by chlorothalonil and 4-hydroxy chlorothalonil, 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 http://www.regulations.gov in the document Chlorothalonil. Petition For Tolerances on Brassica Head and Stem Subgroup 5A, Cucurbit Vegetable Group 9, Fruiting Vegetable Group 8, Ginseng, Horseradish, Lentil, Lupin, Okra, Persimmon, Rhubarb, Yam, Lychee, and Starfruit. Human-Health Risk Assessment at page 15 in docket ID number EPA-HQ-OPP-2007-1106.

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 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).

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 http://www.epa.gov/pesticides/factsheets/riskassess.htm .

The endpoint used to establish the cPAD for chlorothalonil has changed since EPA conducted its previous risk assessment, described in the Federal Register of July 27, 2007 (72 FR 41224) (FRL-8127-9). Previously, the cPAD was based on forestomach lesions observed in the mouse carcinogenicity study. EPA has reconsidered this endpoint and concluded that it is not appropriate for use in human risk assessment because of differences in the physiological characteristics of the forestomach in rodents compared to other species, including humans. Therefore, EPA has selected another endpoint (kidney lesions observed in the rat chronic toxicity/carcinogenicity study) as the basis for the cPAD.

The dose used to assess risk from short-term and intermediate-term incidental oral exposure to chlorothalonil has also changed. Previously, EPA assessed incidental oral exposures based on forestomach and kidney effects observed in the 2-generation reproduction study (LOAEL = 30.8 milligrams/kilograms/day (mg/kg/day)). EPA is now assessing incidental oral exposures to chlorothalonil based on kidney effects observed in a different study, the 90-day rat feeding study (LOAEL = 10 mg/kg/day). This study provides the lowest NOAEL (3.0 mg/kg/day) and LOAEL in the database for short-term/intermediate-term exposures, and the study length is the most appropriate to assess exposures of these durations.

A summary of the toxicological endpoints for chlorothalonil used for human risk assessment can be found at http://www.regulations.gov in the document Chlorothalonil. Petition For Tolerances on Brassica Head and Stem Subgroup 5A, Cucurbit Vegetable Group 9, Fruiting Vegetable Group 8, Ginseng, Horseradish, Lentil, Lupin, Okra, Persimmon, Rhubarb, Yam, Lychee, and Starfruit. Human-Health Risk Assessment at page 36 in docket ID number EPA-HQ-OPP-2007-1106.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to chlorothalonil and its 4-hydroxy metabolite, EPA considered exposure under the petitioned-for tolerances as well as all existing chlorothalonil tolerances in 40 CFR 180.275. EPA assessed dietary exposures from chlorothalonil and its metabolite in food as follows:

i. Acute exposure . 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. No such effects were identified in the toxicological studies for chlorothalonil; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculutre (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed 100% crop treated (CT), tolerance-level residues and default processing factors for all foods except tomatoes (average field-trial residues and empirical processing factors used), peppers (average field-trial residues used), and snap beans (average field-trial residues used).

iii. Cancer . Because chlorothalonil's cancer effects are the result of chronic exposure, EPA is using the chronic exposure assessment to assess chlorothalonil's cancer risk.

iv. Anticipated residue information . 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 FFDCA section 408(f)(1) 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 FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

2. Dietary exposure from drinking water . The residues of concern in drinking water include parent chlorothalonil and its 4-hydroxy metabolite. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for chlorothalonil and 4-hydroxy chlorothalonil in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of chlorothalonil and 4-hydroxy chlorothalonil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

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 chlorothalonil and its 4-hydroxy metabolite for chronic exposures are estimated to be 68.2 parts per billion (ppb) for surface water and 3.2 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 68.2 ppb was used to assess the contribution from drinking water.

3. From non-dietary exposure . 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).

Chlorothalonil is currently registered for the following uses that could result in residential exposures: As a fungicide on golf courses and as a preservative in paints. EPA assessed residential exposure using the following assumptions: There is potential for short-term or intermediate-term dermal exposure of adults and children on golf courses that have been treated with chlorothalonil. There is also potential for short-term/intermediate-term dermal and inhalation exposure of handlers of paints containing chlorothalonil and potential for short-term/intermediate-term postapplication dermal exposure of adults, as well as short-term/intermediate-term postapplication dermal and episodic incidental oral exposures of children from the use of chlorothalonil-treated paints in residential buildings. Postapplication inhalation exposures to chlorothalonil on treated golf courses and in buildings from treated paint are expected to be negligible, and the Agency has not identified a hazard of concern for short-term or intermediate-term dermal exposures; therefore, EPA assessed only short-term and intermediate-term inhalation exposures of handlers using chlorothalonil-treated paints and episodic postapplication incidental oral exposures of children from the use of chlorothalonil-treated paints in residential buildings.

4. Cumulative effects from substances with a common mechanism of toxicity . 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.”

Chlorothalonil is a polychlorinated fungicide. Other members of this class include hexachlorobenzene (HCB), pentachlorophenol (PCP), and pentachloronitrobenzene (PCNB). This is a very loose classification of compounds related only in being polychlorinated and acting as fungicides. Available data do not support a finding for a common mechanism of toxicity for chlorothalonil and the other pesticides in the polychlorinated fungicide class. Chlorothalonil produces renal (kidney) tubular adenomas and carcinomas and papillomas of the stomach in rats. Chlorothalonil also produces gastric lesions and kidney toxicity due to perturbation of mitochondrial respiration. The other pesticides in the class do not have the same toxic effects and do not have the same mode of action. For the purposes of this tolerance action, therefore, EPA has assumed that chlorothalonil 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 http://www.epa.gov/pesticides/cumulative .

1. In general . 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.

2. Prenatal and postnatal sensitivity . The pre- and postnatal toxicity database for chlorothalonil includes rat and rabbit developmental toxicity studies (two of each) and two reproduction toxicity studies in rats, as well as a subchronic neurotoxicity study in rats. In addition, there are developmental toxicity studies in rats and rabbits and reproduction toxicity studies in rats available for the 4-hydroxy metabolite as well as the major soil degradate, SDS-46851.

There was no evidence of increased qualitative or quantitative susceptibility of fetuses or offspring in any of the submitted developmental or reproduction studies for chlorothalonil or its metabolites, except in one of the chlorothalonil developmental toxicity studies in rabbits. In the newer of the two rabbit studies, there was a slight increase in the incidence of two variations (13 th rib and reduced sternebrae) in fetuses in the high-dose group. No maternal effects occurred at any dose in this study. EPA's concern for this equivocal evidence of quantitative susceptibility is low, and there are no residual uncertainties with regard to prenatal and postnatal susceptability, for the following reasons: The variations were only observed in one of the two developmental toxicity studies conducted in the same strain of rabbit at the same dose levels; these variations are known to occur spontaneously within this strain (New Zealand White) of rabbit, as evidenced by the fact that the concurrent controls had high incidences of both variations; and there is a well-defined NOAEL for the study that is protective of these effects.

3. Conclusion . 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:

i. The toxicity database for chlorothalonil is complete, except for acute neurotoxicity and immunotoxicity studies, and EPA has determined that an additional uncertainty factor (UF) is not required to account for potential neurotoxicity or immunotoxicity. The reasons for this determination are explained below:

a. EPA began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007. Since this requirement went into effect after the tolerance petition was submitted, these studies are not yet available for chlorothalonil. In the absence of specific immunotoxicity studies, EPA has evaluated the available chlorothalonil toxicity data to determine whether an additional database UF is needed to account for potential immunotoxicity. In a 90-day oral toxicity study in rats, a slight decrease in thymus weight was observed at the highest dose tested, a possible indication of immunotoxicity. However, since there were no histopathological findings noted in the thymus and no effects on the thymus observed in other subchronic or chronic/carcinogenicity studies in rats, EPA has concluded that the slight effect on thymus weight seen in this study is a spurious effect and not indicative of immunotoxicity. Due to the lack of evidence of immunotoxicity for chlorothalonil, EPA does not believe that conducting immunotoxicity testing will result in a NOAEL less than the NOAEL of 2 mg/kg/day already established for chlorothalonil, and an additional factor (UFDB) for database uncertainties is not needed to account for potential immunotoxicity.

b. Acute neurotoxicity testing is also required as a result of changes made to the pesticide data requirements in December of 2007. Although an acute study has not yet been submitted, there is no evidence of neurotoxicity in any study in the toxicity database for chlorothalonil, including a subchronic neurotoxicity study. Therefore, EPA has concluded that an additional UF is not needed to account for the lack of these data.

ii. Although there was equivocal evidence of increased quantitative susceptibility of fetuses to chlorothalonil exposure in one of two rabbit developmental toxicity studies, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment.

iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments utilized tolerances or anticipated residues that are based on reliable field trial data. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to chlorothalonil in drinking water. EPA used similarly conservative assumptions to assess postapplication incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by chlorothalonil.

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 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.

1. Acute risk . 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 no acute dietary endpoint was selected. Therefore, chlorothalonil is not expected to pose an acute risk.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to chlorothalonil from food and water will utilize 94% of the cPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of chlorothalonil is not expected.

3. Short-term/intermediate-term risk . Short-term or intermediate-term aggregate exposure takes into account short-term or intermediate-term residential exposure plus chronic exposure from food and water (considered to be a background exposure level).

Chlorothalonil is currently registered for uses that could result in short-term and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term and intermediate-term residential exposures to chlorothalonil. Since the doses and endpoints selected for chlorothalonil to assess short-term and intermediate-term exposure are identical, the short-term and intermediate-term risk estimates for chlorothalonil are the same.

Using the exposure assumptions described in this unit for short-term/intermediate-term exposures, EPA has concluded the combined short-term/intermediate-term food, water, and residential exposures aggregated result in an aggregate MOE of 270 for adults. The MOE for adults includes food, drinking water, and short-term/intermediate-term inhalation exposure of individuals mixing, loading, and applying chlorothalonil-treated paint with an airless sprayer, the handler exposure scenario resulting in the highest estimated exposure to chlorothalonil.

As discussed in this unit, EPA also assessed incidental oral exposure of children from ingestion of paint chips containing chlorothalonil. The estimated incidental oral MOE for children is 1,200. Ingestion of paint chips is considered to be an episodic, rather than a routine behavior; therefore, EPA has determined that it is not appropriate to aggregate incidental oral exposures with chronic exposures from food and drinking water.

4. Aggregate cancer risk for U.S. population . As discussed in unit III.A., EPA classified chlorothalonil as a “likely” human carcinogen by all routes of exposure, based on the increased incidence of renal adenomas and carcinomas observed in both sexes of rats and mice, the rarity of the tumor response in the kidney, and the increased incidence of papillomas and/or carcinomas of the forestomach in rats and mice. EPA has determined that the mechanism of carcinogenicity of chlorothalonil is non-linear (i.e., not a non-threshold effect) and that the point of departure used in calculating the cPAD is protective of the cancer effects. Since there are no uses of chlorothalonil expected to result in chronic residential exposure, and since chronic dietary exposure for the overall U.S. population is less than the cPAD (43% of the cPAD), EPA concludes that aggregate cancer risk from exposure to chlorothalonil is below the LOC.

5. Determination of safety . 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 chlorothalonil residues.

Adequate enforcement methodology (gas chromatography (GC) method with electron-capture detection (ECD)) 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: residuemethods@epa.gov .

The Codex Alimentarius Commission has established maximum residue limits (MRLs) for chlorothalonil per se on several commodities associated with this petition: 7 ppm for sweet pepper; 5 ppm each for broccoli, brussels sprouts, cucumber, and squash (summer and winter); 2 ppm for melons (except watermelon); and 1 ppm each for cabbage, heads and cauliflower. Some of these MRLs are set at the same nominal value as the U.S. tolerances (broccoli and brussels sprouts from the Brassica group; cucumber and squash from the cucurbit group). However, since the U.S. tolerance definition includes the 4-hydroxy metabolite, harmonization with CODEX is not possible at this time.

Based upon review of the data supporting the petition, EPA has revised the tolerance levels for ginseng, okra, persimmon, rhubarb, and yam. EPA has also determined that a tolerance is not needed for lupine and that the proposed tolerance for fruiting vegetable group 8 should exclude tomato and be set slightly higher than proposed. EPA revised the tolerance levels for ginseng from 3.0 to 4.0 ppm, rhubarb from 5.0 to 4.0 ppm, persimmon from 1.9 to 1.5 ppm, and vegetable, fruiting, group 8 and okra from 5.0 to 6.0 ppm, based on analyses of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data . The Agency determined that a tolerance is not needed for lupine, since residues on lupine are covered by the existing tolerance on dry bean seed. Tomato was excluded from fruiting vegetable group 8 based on differences in the use pattern for tomatoes and the other members of this group. The tolerance for yam was reduced from 5.0 to 0.1 ppm, based on data translated from potato. The 5.0 ppm level proposed by the petitioner appears to have been a typographical error in the petition, since the 0.1 ppm level was discussed elsewhere in the text of the petition.

Therefore, tolerances are established for combined residues of chlorothalonil, tetrachloroisophthalonitrile, and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on Brassica , head and stem, subgroup 5A at 5.0 ppm; ginseng at 4.0 ppm; horseradish at 4.0 ppm; lentil at 0.10 ppm; okra at 6.0 ppm; persimmon at 1.5 ppm; rhubarb at 4.0 ppm; vegetable, cucurbit, group 9 at 5.0 ppm; vegetable, fruiting, group 8, except tomato at 6.0 ppm; and yam, true at 0.10 ppm.

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 Regulatory Planning and Review (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 Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (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 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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 et seq .) do not apply.

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 Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (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).

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).

The Congressional Review Act, 5 U.S.C. 801 et seq ., 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 Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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 FOR FURTHER INFORMATION CONTACT .

In addition to accessing electronically available documents at http:/ /www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . 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 pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

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-2007-0147 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 February 2, 2009.

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 ADDRESSES . 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-2007-0147, by one of the following methods:

Federal eRulemaking Portal : http://www.regulations.gov . Follow the o N -line instructions for submitting comments.

Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 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.

In the Federal Register of May 9, 2007 (72 FR 26372) (FRL-8121- 5), 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 6F7146) by E.I. DuPont de Nemours and Company, DuPont Crop Protection, Laurel Run Plaza, P.O. Box 80, Newark, DE 19714-0030. The petition requested that 40 CFR 180.364 be amended by establishing tolerances for combined residues of the herbicide glyphosate, N -(phosphonomethyl)glycine and its metabolite N -acetyl-glyphosate, N -acetyl- N -(phosphonomethyl)glycine resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate to Optimum TM GAT TM soybeans in or on the food commodities: Cattle, kidney; cattle, liver; egg, goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney; horse, liver; poultry, meat; poultry, meat byproducts; sheep, kidney; sheep, liver; soybean, forage; soybean, hay; soybean, hulls; and soybean, aspirated grain fractions at levels already established for glyphosate alone. That notice referenced a summary of the petition prepared by E.I. DuPont de Nemours and Company, the registrant, which is available to the public in the docket, http://www.regulations.gov . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

DuPont has requested a Section 3 registration under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) for the preplant application of the herbicides glyphosate and pyrithiobac sodium to glyphosate-tolerant soybean. The petitioner is also working to commercialize a genetically modified soybean designated as Optimum TM GAT TM soybeans. N -acetyl-glyphosate is produced when glyphosate is applied to Optimum TM GAT TM soybeans. As a result the petitioner is requesting that the glyphosate tolerance expression be modified from glyphosate per se to the combined residues of glyphosate and N -acetyl-glyphosate. This petition was filed in conjunction with Dupont's this requested change to its FIFRA registration.

Based upon review of the data submitted in support of the petition, EPA has determined that the residues of concern in these commodities are glyphosate and N -acetyl-glyphosate. The current tolerance expression specifies residues of glyphosate ( N (phosphonomethyl)glycine). To address that N -acetyl-glyphosate was the major residue in mature Optimum TM GAT TM soybean forage, hay, and seed, the Agency concluded that it is necessary to include this compound in the tolerance expression. EPA is splitting current § 180.364(a) into paragraphs (a)(1) and (a)(2). Paragraph (a)(1) will include all of the commodities currently in paragraph (a), except for the animal commodities and the commodities grain, aspirated fractions; soybean, forage; soybean, hay; soybean, hulls; and soybean, seed, which EPA is transferring to new paragraph (a)(2). The tolerances in paragraph (a)(2) will cover application of glyphosate to non-genetically modified soybeans, genetically-modified soybeans currently in use, and Optimum TM GAT TM soybeans. Note that based on the submitted residue data on application of glyphosate to Optimum TM GAT TM soybeans, the numerical value of the current soybean and livestock tolerances do not need to be changed (only the tolerance expression is changing). Combined residues of glyphosate and N -acetyl-glyphosate in soybean commodities derived from glyphosate-treated Optimum TM GAT TM soybeans and livestock commodities from animals which consume only glyphosate-treated Optimum TM GAT TM soybeans will not exceed the existing tolerance level. Additionally, the change in tolerance expression will not affect the application of the tolerance to soybean commodities derived from glyphosate-treated non-genetically modified soybean and livestock commodities from animals which consumed only glyphosate-treated non-genetically modified soybean because these commodities will have only glyphosate per se residues, and not N -acetyl-glyphosate residues.

In the Federal Register of May 2, 2007 (72 FR 24188)(FRL-8122-8), the Agency published a final rule revising the tolerance expression for glyphosate to include the dimethylamine salt of glyphosate. Because there is a potential for soybeans to be treated with product containing the dimethylamine salt of glyphosate the Agency has determined that the dimethylamine salt of glyphosate should be added to the tolerance expression for paragraph (a)(2).

Based upon review of the soybean processing studies submitted supporting the petition, EPA has determined that the currently established tolerances for the commodities grain, aspirated fractions and soybean, hulls need to be increased to 310 ppm and 120 ppm, respectively. Currently established tolerance levels for all other commodities in this rule are supported by available data.

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....''

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 the combined residues of glyphosate, N -(phosphonomethyl)glycine and its metabolite N -acetyl-glyphosate (expressed as glyphosate) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on the food commodities cattle, meat byproducts at 5.0 ppm; egg at 0.05 ppm; goat, meat byproducts at 5.0 ppm; grain, aspirated fractions at 310 ppm; hog, meat byproducts at 5.0 ppm; horse, meat byproducts at 5.0 ppm; poultry, meat, at 4.0 ppm; poultry, meat byproducts at 1.0 ppm; sheep, meat byproducts at 5.0 ppm; soybean, seed at 20.0 ppm; soybean, forage at 100.0 ppm; soybean, hay at 200.0 ppm, and soybean, hulls at 120 ppm and soybean, seed at 20.0 ppm. EPA's assessment of exposures and risk associated with establishing tolerances follows.

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. Specific information on the studies received and the nature of the adverse effects caused by glyphosate and its metabolite N -acetyl-glyphosate 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 http://www.regulations.gov in the document entitled Petition: 6F7146. Glyphosate-Isopropylammonium and Pyrithiobac Sodium. Human Health Risk Assessment for Application to Glyphosate Tolerant Soybean; pages 7-10 in docket ID number EPA- HQ-OPP-2007-0147 and identified as document EPA-HQ-OPP-2007- 0147-0007.

The toxicological profile of glyphosate is discussed in the risk assessment referenced earlier in this section and in the risk assessment referenced in the final rule published in the Federal Register of December 20, 2006 (71 FR 76180) (FRL-8105-9) which establishes tolerances for residues of glyphosate in or on noni at 0.20 ppm; pea, dry at 8.0 ppm; safflower at 85 ppm; sunflower at 85 ppm; and vegetable, legume group 6 except soybean and pea, dry at 5.0 ppm.

Toxicological endpoints and current risk assessments for glyphosate are discussed in the risk assessment referred to in the final rule published in the Federal Register of December 20, 2006 (71 FR 76180) (FRL-8105-9) which establishes tolerances for residues of glyphosate in or on noni at 0.20 ppm; pea, dry at 8.0 ppm; safflower at 85 ppm; sunflower at 85 ppm; and vegetable, legume group 6 except soybean and pea, dry at 5.0 ppm.

1. A summary of the data submitted in support of the metabolite N -acetyl-glyphosate is listed below. Refer to the risk assessment available in the public docket for this rule and identified above as document EPA-HQ-OPP-2007-0147-0007 for more information.

i. An acute oral toxicity study in rats with an Acute Oral LD 50 greater than 5,000 milligrams/kilogram (mg/kg).

ii. A 90-day subchronic oral (feeding) study, in which no systemic toxicity was observed in male and female rats at doses up to 18,000 ppm (equal to 1157/1461 mg/kg/day in males/females, respectively).

iii. N -acetyl-glyphosate was negative for mutagenicity in a bacterial reverse mutation assay (Ames test), an in vitro chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, an in vitro Mammalian Cell Gene Mutation Assay in CHO cells and an in vivo cytogenetics (bone marrow) in mice, and a metabolism and pharmacokinetics study.

2. N -acetyl aminomethylphosphonic acid ( N -acetyl-AMPA) was detected as one of the metabolites formed following oral administration of N -acetyl-glyphosate. It is not expected to be absorbed quickly from the gastrointestinal tract since it is a charged molecule at the physiological pH. N -acetyl-AMPA is expected to be less toxic than N -acetyl-glyphosate. Data submitted in support of this metabolite included the following:

i. An acute oral toxicity study with an LD 50 of greater than 8,300 mg/kg.

ii. A bacterial reverse mutation assay (Ames test), in which N -acetyl-AMPA was not mutagenic when tested up to 5,000 microgram (µg)/plate in presence and absence of activation in S. typhimurium strains of TA98, TA 100, TA1535, TA1537, and in Escheria coli strain WP2uvrA.

iii. An in vitro Mammalian Chromosome Aberration Test in Human Perpherral Blood Lymphocytes, in which N -acetyl-AMPA was negative for the induction of structural and numerical chromosome aberrations in both the non-activated and the S9-activated test systems when tested up to 15.30 milligrams/milliliter (mg/ml).

iv. An in vitro Mammalian Cell Gene Mutation Test (CHO/HPRT) Test, in which N -acetyl-AMPA was not mutagenic at the HGPRT locus in Chinese hamster ovary cells tested up to 1,531 µg/ml in the presence and absence of metabolic activation.

v. An in vivo Mouse Bone Marrow Micronucleus Test, in which N -acetyl-AMPA resulted in no detections of chromosomal aberrations were detected in male and female mice at doses up to 2,000 mg/kg.

3. For the purpose of assessing the aggregate risk from glyphosate tolerances, EPA has assumed that N -acetyl-glyphosate is equally toxic to glyphosate. This conservative assumption is based on the structural similarity of N -acetyl-glyphosate with glyphosate; a structure activity relationships (SAR) analysis of N -acetyl-glyphosate with a lack or structural alerts for carcinogenicity, mutagenicity and endocrine effects; and toxicity data for N -acetyl-glyphosate showing low acute toxicity, low subchronic toxicity and lack of mutagenicity, In all probability, N -acetyl-glyphosate is of lower toxicity than glyphosate. For example, subchronic toxicity testing with glyphosate showed no systemic toxicity in male and female rats at doses up to 400 mg/kg/day in males and females. Subchronic testing with N -acetyl-glyphosate showed no systemic toxicity in male and female rats at doses up to 1157/1446 mg/kg/day in males/females, respectively.

The toxicity of N -acetyl-AMPA is considered low and of limited concern based on the available data described above, and lack of any structural alerts.

Amendment of the glyphosate soybean and meat and milk tolerances to include N -acetyl-glyphosate in the tolerance expression does not result in changes in the exposure or risk estimates reported in the previous risk assessments for the reasons listed below and fully discussed in the risk assessment referenced earlier in this section.

i. The Agency has determined that N -acetyl-glyphosate has no greater toxicity than glyphosate and probably is of lower toxicity.

ii. The numerical value of all but two food tolerances will remain the same.

iii. The most recent dietary analysis assumed tolerance level residues and, 100% crop treated.

iv. The estimate of glyphosate levels in drinking water is based on a glyphosate use involving direct application to water at 3.75 pounds active ingredient per acre. Use of glyphosate on glyphosate-resistant soybeans will not result in higher levels in drinking water.

v. Previously calculated dietary burdens to poultry were based on alfalfa meal (400 ppm tolerance) and soybeans hulls (100 ppm tolerance) as significant contributors to the diet. Based on the latest guidance, although soybean seed, meal, and hulls are feed to poultry, soybean hulls are is no longer considered a significant contributor to poultry diets. The previously calculated dietary burdens to hog were based on alfalfa meal and barley grain (20 ppm tolerance) being significant contributors to the diet. Soybean seed and meal are fed to hogs; however, the current action does not require an increase in tolerance for soybean seed or meal. Based on these complications, the Agency concludes that the application of glyphosate to Optimum TM GAT TM soybean will not result in combined residues of glyphosate and N -acetyl-glyphosate (expressed as glyphosate) in poultry or hog commodities greater than the residues of glyphosate that result under the currently established glyphosate per se tolerances.

vi. Previously calculated dietary burdens to dairy or beef cattle were based on alfalfa hay (400 ppm tolerance) being the significant contributor to the diet. The Agency concludes that the consumption of glyphosate Optimum TM GAT TM soybean will not result in combined residues of glyphosate and N -acetyl-glyphosate (expressed as glyphosate) in or on beef/dairy cattle commodities greater than the currently established glyphosate per se tolerances for the reasons below.

a. The high tolerance value for alfalfa hay (400 ppm) and alfalfa hay occupies 40% of the total beef/dairy cattle diet.

b. The soybean hull tolerance is only increasing from 100 to 120 ppm and soybean hulls will occupy at most 20% of the beef/dairy cattle dietary burdens.

c. Aspirated grain fractions occupy at most 5% of the beef cattle dietary burden and are not feed to dairy cattle.

Accordingly, based on the risk assessments discussed in the notice referenced above, EPA concludes that no harm will result to the general population and to infants and children from aggregate exposure to the combined residues of glyphosate and its metabolite N -acetyl-glyphosate (expressed as glyphosate).

Adequate enforcement methodology (high performance liquid chromatography (HPLC) with tandem mass spectrometry (MS/MS)) 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: residuemethods@epa.gov .

There are Codex Maximum Residue Levels (MRL) established for glyphosate (sum of glyphosate and AMPA, expressed as glyphosate) on soybean, dry at 20 ppm; edible offal (mammalian) at 5 ppm; eggs at 0.05 ppm; poultry meat at 0.05 ppm and poultry, edible offal of at 0.5 ppm. Canadian MRLs are established for glyphosate including the metabolite aminomethylphosphonic acid (AMPA) on soybean seed at 20 ppm, kidney of cattle, goats, hogs, poultry and sheep at 2.0 ppm; and liver of cattle, goats, hogs, poultry, and sheep at 0.2 ppm. A Mexican MRL of 6 ppm is established for glyphosate. The glyphosate tolerances EPA is establishing in this action differ from the tolerance expression for the CODEX, Canadian or Mexican MRLs, due to the inclusion of N -acetyl-glyphosate in the expression. Additionally, the EPA tolerances differ from the CODEX and Canadian MRLs in that the EPA tolerances do not include AMPA in tolerance expression. At this time, harmonization between the U.S. tolerances and the CODEX, Canadian or Mexican MRLs can not be achieved because of the inclusion of N -acetyl-glyphosate in the EPA tolerances is necessary to support use patterns in the United States and EPA has concluded that AMPA should not be included in the tolerance expression because it is not toxicologically significant. The petitioner is seeking registration and amendment of the tolerance expressionin other countries. This may lead to harmonization between the U.S. tolerances and the CODEX, Canadian or Mexican MRLs.

Three commenters submitted comments in response to the notice of filing. A summary of the comments and EPA's response follows.

1. Comment . One commenter does not believe that DuPont has submitted sufficient toxicological data to demonstrate that N -acetyl-glyphosate is not of toxicological concern and that submitted data did not support the claim of equivalent toxicity between glyphosate and N -acetyl-glyphosate. The commenter argued that the single acute toxicity EPA relied on actually suggests that N -acetyl-glyphosate is more toxic than glyphosate. This commenter also believes that reproductive, developmental, and chronic and carcinogenicity data on N -acetyl-glyphosate should be generated and analyzed.

Another commenter expressed concern that sufficient data may not have been submitted on the metabolite N -acetyl-glyphosate to satisfy the requirements for EPA to establish tolerances or to support the establishment of MRLs by other countries. The first commenter expressed a similar concern that submitted data failed to meet requirements of international authorities such as Joint FAO/WHO Meeting in Pesticide Residues (JMPR), particularly when compared to the extensive data bases required for other metabolites such as AMPA and N -acetyl-glufosinate.

Response . EPA does not agree with the contention that N -acetyl-glyphosate is more toxic than glyphosate. The Agency concluded that N -acetyl-glyphosate is not likely to be more toxic than glyphosate based on the available toxicity studies and Structure Activity Relationship (SAR). The available acute toxicity study with N -acetyl-glyphosate and glyphosate indicate low toxicity (Acute Oral LD 50 was greater than 5,000 mg/kg bw). Both N -acetyl-glyphosate and glyphosate are placed in acute Tox Category IV. There was evidence of some mortality in an acute oral study with N -acetyl-glyphosate but not with glyphosate. However, the evidence from very high doses in this acute oral LD 50 test suggesting that N -acetyl-glyphosate might be more toxic than glyphosate is outweighed by the results of subchronic tests with the two compounds. There was no evidence of systemic toxicity in 90-day dietary toxicity studying rats with N -acetyl-glyphosate conducted at well above the limit dose (18,000 PPM equal to 1,157/1,461 mg/kg/day in males and females, respectively). In a 90-day dietary toxicity study in rats with glyphosate at 0, 1,000, 5,000 or 20,000 ppm (equivalent to 0, 63, 317, or 1,267 mg/kg/day in males and 0, 84, 404, or 1,623 mg/kg/day in females), glyphosate caused increased serum phosphorus and potassium at all doses treated in both sexes and occurrence of high dose pancreatic lesions in males (effect was not evaluated at lower doses). Based on these findings systemic toxicity NOAEL for glyphosate can be considered as less than 1,000 ppm (equivalent to <63 mg/kg/day). Thus the subchronic study with N -acetyl glyphosate clearly indicates that it is less toxic than glyphosate. The available adequate battery of mutagenicity studies with N -acetyl glyphosate and glyphosate indicate that they are not mutagenic. The metabolism of N -acetyl glyphosate and glyphosate is well studied in rats. These studies indicate that both compounds are rapidly absorbed and excreted from the body and are not biosequestered. In fact, nearly all of the orally administered N -acetyl-glyphosate was excreted unchanged in the urine and feces. There is extensive database available on glyphosate, which indicate that glyphosate is not mutagenic, not a carcinogen, and not a developmental or reproductive toxicant. Based on its structural similarities with glyphosate and available data, it is reasonable to conclude that the N -acetyl-glyphosate is not likely to be more toxic than the parent. The Agency evaluated available information and data and concluded that additional data on N -acetyl-glyphosate was not needed based on the weight of evidence described above. In addition, Agency has accepted bridging data where evidence is clear in order to reduce the animal usage.

EPA also disagrees with the claim that EPA has insufficient data on N -acetyl- glyphosate. EPA did review larger data sets on the metabolites AMPA and N -acetyl-glufosinate but these larger data sets were submitted voluntarily by pesticide registrants; EPA did not require these data to be submitted. EPA's decision to review all data that was submitted whether required or not (which is something the Agency does routinely) can not be converted into an EPA determination that such data would be required to make a safety finding for a similar pesticide metabolite. For the reasons expressed above, EPA concludes it has sufficient data on N -acetyl-glyphosate. For similar reasons, EPA also disagrees with the commenter's suggestion that because the Joint FAO/WHO Meeting in Pesticide Residues (JMPR) reviewed larger data sets on AMPA and N -acetyl-glufosinate, EPA's data set on N -acetyl-glyphosate must be deficient. The JMPR does not have any regulatory authority to require data and the commenters do not claim that JMPR defined the toxicological data needed to make the toxicity determinations with regard to AMPA and N -acetyl-glufosinate. The JMPR reviewed the data voluntarily submitted; it did not make a recommendation on the data necessary to make the needed toxicity evaluation.

2. Comment . One commenter argues that the higher residues of N -acetyl-glyphosate may be absorbed at a higher rate than glyphosate. Taking into consideration the increased absorption for N -acetyl-glyphosate compared to glyphosate are likely in meat, milk, poultry, and eggs due to the high values of N -acetyl-glyphosate that are likely in plants and the higher absorption in animals of N -acetyl-glyphosate (when compared to glyphosate). The commenter notes that Optimum TM GAT TM soybeans were specifically engineered to convert N -acetyl-glyphosate and thus is likely to result in significant amounts of N -acetyl-glyphosate in soybeans. As to the higher absorption in animals, the commenter references a rat metabolism study and argues that indicates that higher absorption would occur in poultry and livestock that ingest residues of N -acetyl-glyphosate in feed and that the higher absorption would likely result in higher residues in meat, milk, and eggs when compared with glyphosate.

Response . As the commenter stated, the rat metabolism studies indicate that N -acetyl-glyphosate may be absorbed at a higher rate than glyphosate. Taking into consideration the increased absorption for N -acetyl-glyphosate, the previously calculated livestock diets (driven by 400 ppm alfalfa hay/meal tolerances), and the previously revised guidance concerning the construction of livestock diets (changes to the percent each food feedstuff contributes to a livestock diet, livestock diets are now constructed taking in to consideration nutritional requirements), it was concluded that higher livestock tolerances are not necessary. Note that the dietary analysis assumed tolerance level residue for the livestock commodities (i.e. assumes all of the commodities feed to livestock have tolerance level residues and all livestock commodities consumed by humans have tolerance level residues).

3. Comment . One commenter expressed concern that the petitioner had stated its intent to increase glyphosate spray rates or change spray timing and that residue data had not be submitted to reflect levels of N -acetyl-glyphosate under actual use conditions.

Response . The petitioner submitted several Optimum TM GAT TM soybean magnitude-of-the-residue studies which monitored for residues of glyphosate and N -acetyl-glyphosate in forage and hay and soybean seed. (See document cited earlier in this unit for detailed discussion of these data). The Agency concluded that this data was acceptable and supported the proposed use pattern. The Agency also concluded that additional field trial data were not necessary and that the proposed tolerance levels discussed in Unit II of this document were acceptable. The Agency has not received an application requesting increased application rates or changes in application timing at this time. The Agency will reevaluate the need for additional magnitude-of-the-residue data if and when an application of this type is received.

4. Comment . A concern expressed by two of the three commenters was the possible amendment of FIFRA registration to allow higher application rates on soybeans of ALS inhibitor herbicides such as sulfonylureas already registered on soybeans or new uses of ALS inhibitor herbicides on soybeans. Such amended uses or new uses, the commenter urged, should be conditioned on the submission of additional residue data or consideration of possible effects to non-target plants and endangered species.

Response . The Agency has not received requests for increased use or new uses of ALS inhibitor pesticides on Optimum TM GAT TM soybean seed to additional herbicides at this time. The pre-plant use of pyrithiobac sodium in soybeans remained unchanged for this action. However, as discussed on page 3 of the risk assessment referenced in Section III of this document, since ALS tolerance is conferred via modification of the endogenous ALS gene such that the plant is no longer sensitive (i.e. the tolerance is not conveyed via metabolism of the herbicide), the Agency's current view is that the nature/magnitude of residues submitted in support of registration of ALS-inhibiting herbicides to nontransgenic soybean are applicable for application of these compounds to Optimum TM GAT TM soybean.

5. Comment . One commenter expressed a concern that the analytical method submitted may not enable simultaneous quantification of the combination of glyphosate, N -acetyl-glyphosate and aminomethylphosphonic acid (AMPA), all of which could be present in exported soybeans.

Response . Available information including Agency method trial confirms that proposed analytical method (high performance liquid chromatography (HPLC) with tandem mass spectrometry (MS/MS)) quantifies residues of glyphosate, N -acetyl-glyphosate, and AMPA in crops and animal commodities.

6. Comment . One commenter opposed the way the tolerance expression was written in the notice of filing and the fact that a new paragraph was being added to the tolerance expression allowing for duplicate listings of the same commodities dependent on genetic makeup.

Response . Based on the submitted comments and the available information the Agency has decided that 40 CFR 180.364(a) will be redesignated as paragraph (a)(1) and that the current listings from newly redesignated paragraph (a)(1) for soybean and animal commodities will be transferred to new paragraph (a)(2). The revised tolerance expression deletes any reference to genetic make up. See Unit II of this document for discussion.

7. Comment . One commenter expressed a concern that current EPA label policy allowing the use of general terminology such as “glyphosate tolerant soybeans” would permit use of any soybean seed that satisfies the general “glyphosate tolerant” criteria if crop seed such as Optimum TM GAT TM soybean seed were commercially available, even if appropriate data have not been reviewed and tolerances granted.

Response . The EPA label policy is intended to allow the use of glyphosate on any approved glyphosate tolerant seed. The Agency does not regulate or approve the glyphosate tolerant seed, only the use of glyphosate on the crops grown from the glyphosate tolerant seed. The approval of the seed itself is handled by the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). Information on approval of the Optimum TM GAT TM soybean seed is available in a notice published in the Federal Register of July 24, 2008 (73 FR 43203) which advised the public of their determination that a soybean line developed by Pioneer HI-Bred International, Inc., designated as transformation event 356043, which has been genetically engineered for tolerance to glyphosate and acetolactate synthase-inhibiting herbicides, is no longer considered a regulated article under their regulations governing the introduction of certain genetically engineered organisms, and the public docket established for that action by USDA/APHIS, which is available at http://www.regulations.gov and is identified as docket identification number APHIS-2007-019.

8. Comment . One commenter expressed a concern that Optimum TM GAT TM soybeans are plants that have high levels of a new abnormal enzyme that creates new untested metabolites. The commenter referenced an article (Science, 21 May 2004, vol. 34 pp 1151-1154) which shows that the new “shuffled enzyme” ( N -acetylate) can react with common amino acids L-aspartate, L-serine, phosphor-L-serine, L-threonine, L-glutamate, L-aspargine, and L-cysteine to form new N -acetylated versions of these common amino acids. The commenter stated that toxicology data may be necessary to address the safety of these N -acetylated metabolites.

Response . This issue concerns componets of the Optimum TM GAT TM soybean and not residues of the pesticide glyphosate and is not relevant to EPA's determination of safety under section 408 of the FFDCA. However, similar comments were received and addressed by APHIS during the course of their review of the Optimum TM GAT TM soybean seed which is fully discussed in the Federal Register notice of July 24, 2008 and the APHIS public docket referenced earlier in this unit. In summary APHIS reviewed available information toxicity data available for both the 356043 soybean seed and N -acetyl-L-aspartic acid (NAA) and determine that additional toxicological assessment was unwarranted. APHIS determined that quantification of other acetylated amino acids did not need to be measured based on the fact that the GAT4601 enzyme has different kinetic and specificity properties than the native enzymes from Bacillus licheniformis which have the ability to use additional amino acids as substrates under specific in vitro conditions. The study conducted with GAT4601 demonstrated the kinetic parameters could only be established for aspartate and glutamate. Additional information concerning this conclusion can be found in the APHIS public docket referenced earlier in this unit.

9. Comment . One commenter expressed concern that sufficient data may not have been submitted on the metabolite N -acetyl-glyphosate to satisfy the requirements for EPA to establish tolerances or to support the establishment of MRLs by other countries and Agencies. A second commenter expressed a similar concern that submitted data failed to meet requirements of international authorities such as Joint FAO/WHO Meeting in Pesticide Residues (JMPR), particularity when compared to the extensive databases required for other metabolites such as AMPA and N -acetyl-glufosinate.

Response . The Agency has determined that the submitted data discussed above and in the referenced risk assessments provided sufficient information for the Agency to make the required human safety determination required in the FFDCA and satisfy data requirements for establishment of tolerances and registration in the United States.

10. Comment . One commenter expressed concern that the proposed unilateral change to the glyphosate residue definition to include the new metabolite N -acetyl-glyphosate has significant potential to disrupt the international trade of soybeans for U.S. growers until the glyphosate residue definition is implemented globally. The commenter further noted that the data submitted to EPA may not be sufficient for other countries to modify their tolerance expressions.

Response . The petitioner submitted a summary of a metabolism study conducted with Optimum TM GAT TM soybean. This study indicated that both glyphosate and N -acetyl-glyphosate were significant residues in/on Optimum TM GAT TM soybean forage and straw. For mature Optimum TM GAT TM soybean seed, only N -acetyl-glyphosate was a significant residue (glyphosate represented a minor component of the total residue). Since N -acetyl-glyphosate was the major residue in mature Optimum TM GAT TM soybean forage, hay, and seed, EPA concluded that it is necessary to include this compound in the tolerance expression.

EPA believes that the new metabolite N -acetyl glyphosate is not likely to disrupt international trade of soybean for U.S. growers. DuPont is seeking registration in various countries. The Agency expects that the various countries will come to similar conclusion as the United States for Optimum TM GAT TM soybean and amend their tolerance expressions which will alleviate the potential trade issue. The current analytical method would detect glyphosate, AMPA and N -acetyl glyphosate allowing enforcement of the tolerances in other countries. Growers in the United States have the option of growing conventional soybeans or other varieties of glyphosate tolerant seed until any trade issues in other countries with Optimum TM GAT TM soybeans are resolved.

11. Comment . Several comments were received from a private citizen objecting to establishment of tolerances.

Response . The Agency has received similar comments from this commenter on numerous previous occasions. Refer to the Federal Register of March 14, 2007 (72 FR 11784; FRL-8117-2) for the Agency's response to these objections. In addition the commenter noted that bees and turkey vultures are dying. These comments are not relevant to human safety determination which is the sole focus of tolerance actions under section 408 of the FFDCA. For informational purposes, EPA would note that pesticide effects on wildlife are addressed in the FIFRA registration process. In a honey bee contact test with glyphosate, mortality was low in all treatment levels. The results indicate that glyphosate is classified as practically nontoxic to honeybees. Although the Agency does not require testing on turkey buzzards specifically, the potential for avian mortality to glyphosate has been assessed using bobwhite quail acute oral LD 50 study and bobwhite quail and mallard duck 8-day dietary LC 50 studies. These data indicate that glyphosate is practically nontoxic to avian species on an acute oral basis and no more than slightly toxic on a subacute dietary basis. The potential effects to avian growth and reproduction from glyphosate have been assessed using avian reproduction studies with mallard duck and bobwhite quail. These data indicate that glyphosate is not expected to cause reproductive impairment. The commenter did not submit any information to support a revision of Agency conclusions.

Therefore, tolerances are established for combined residues of glyphosate, N -(phosphonomethyl)glycine and its metabolite N -acetyl-glyphosate (expressed as glyphosate) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on the food commodities cattle, meat byproducts at 5.0 ppm; egg at 0.05 ppm; goat, meat byproducts at 5.0 ppm; grain, aspirated fractions at 310 ppm; hog, meat byproducts at 5.0 ppm; horse, meat byproducts at 5.0 ppm; poultry, meat, at 4.0 ppm; poultry, meat byproducts at 1.0 ppm; sheep, meat byproducts at 5.0 ppm; soybean, seed at 20.0 ppm; soybean, forage at 100.0 ppm; soybean, hay at 200.0 ppm, and soybean, hulls at 120 ppm as discussed in Unit II of this document.

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 Regulatory Planning and Review (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 Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (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 et seq. , nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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 et seq. ) do not apply.

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 Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (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).

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).

The Congressional Review Act, 5 U.S.C. 801 et seq. , 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 Federal Register . This final rule is not a ‘‘major rule as defined by 5 U.S.C. 804(2).

On June 15, 2006, President Bush established the Northwestern Hawaiian Islands Marine National Monument (Monument) by issuing Presidential Proclamation 8031 (Proclamation); (71 FR 36443, June 26, 2006) under the authority of the Antiquities Act (Act) (16 U.S.C. 431). The Proclamation reserves all lands and interests in lands owned or controlled by the Government of the United States in the Northwestern Hawaiian Islands (NWHI), including emergent and submerged lands and waters, out to a distance of approximately 50 nautical miles (nmi) from the islands. The outer boundary of the Monument is approximately 100 nmi wide and extends approximately 1200 nmi around coral islands, seamounts, banks, and shoals. The area includes the Northwestern Hawaiian Islands Coral Reef Ecosystem Reserve, the Midway Atoll National Wildlife Refuge/Battle of Midway National Memorial, and the Hawaiian Islands National Wildlife Refuge. The Monument was renamed the Papahanaumokuakea Marine National Monument by Proclamation 8112 (72 FR 10029, February 28, 2007).

The Proclamation provides that the Secretary of Commerce, through NOAA, has primary responsibility regarding the management of the marine areas of the Monument, in consultation with the Secretary of the Interior. The Secretary of the Interior, through the USFWS, has sole responsibility for management of the areas of the Monument that overlay the Midway Atoll National Wildlife Refuge, the Battle of Midway National Memorial, and the Hawaiian Islands National Wildlife Refuge, in consultation with the Secretary of Commerce. Further, the Proclamation provides that nothing in the Proclamation diminishes or enlarges the jurisdiction of the State of Hawaii. The Monument includes state waters, including the Northwestern Hawaiian Islands State Marine Refuge and State Seabird Sanctuary at Kure Atoll. The State currently holds the submerged and ceded lands of the NWHI in trust. This public trust is overseen by the Office of Hawaiian Affairs through an amendment to the Constitution of the State of Hawaii. The State of Hawaii has primary responsibility for managing the State waters of the Monument.

In 2006 NOAA and USFWS published joint regulations codifying the provisions of the Proclamation (71 FR 51134, August 29, 2006). With certain exceptions, the Proclamation and the joint regulations restrict access to the Monument to persons who have been issued Monument permits. Vessels that do not have permits cannot enter the Monument except for uninterrupted passage through the Monument and notice must be provided to NOAA by telephone, fax, or e-mail not less than 72 hours and not more than one month prior to passing through the Monument. Notice must also be provided not more than twelve hours after the vessel has exited the Monument. All of the terms of the Proclamation and the regulations are applied in accordance with international law.

The Proclamation directed the Secretary of State, in consultation with the Secretaries of Commerce and the Interior, to take appropriate action to enter into negotiations with other governments to make necessary arrangements for the protection of the Monument and to promote the purposes for which it was established. The proclamation further directed the Secretary of State to seek the cooperation of other governments and international organizations in furtherance of the purposes of the Proclamation and consistent with applicable regional and multilateral arrangements for the protection and management of special marine areas.

In April 2007 and in accordance with the Proclamation, the United States proposed to the International Maritime Organization (IMO), a specialized agency of the United Nations, that the Monument be designated as a Particularly Sensitive Sea Area (PSSA) to protect the attributes of the fragile and integrated coral reef ecosystem from potential hazards associated with international shipping activities. The U.S. noted in its proposal that the burden on international shipping by the proposed PSSA and its associated protective measures would be minimal while its objectives—increased maritime safety, protection of the fragile environment, preservation of cultural resources and areas of cultural importance significant to Native Hawaiians, as well as facilitation of the ability to respond to developing maritime emergencies—would be significantly furthered. PSSA designation had been granted previously to only ten marine areas globally, including the marine areas around the Florida Keys, the Great Barrier Reef, and the Galapagos.

On April 3, 2008, the IMO designated the Monument as a PSSA. As part of the PSSA designation process, the IMO adopted U.S. proposals for associated protective measures consisting of (1) expanding and consolidating the six existing recommendatory Areas To Be Avoided (ATBAs) in the Monument into four larger areas and enlarging the class of vessels to which they apply; and (2) establishing a ship reporting system for vessels transiting the Monument, which is mandatory for ships 300 gross tons or greater that are entering or departing a U.S. port or place and recommended for other ships. The system requires that ships notify the U.S. shore-based authority (i.e., the U.S. Coast Guard; NOAA will be receiving all messages associated with this program on behalf of the Coast Guard) at the time they begin transiting the reporting area and again when they exit. Notification is made by e-mail through the Inmarsat-C system or other satellite communication system. It is estimated that almost all commercial vessel traffic will be able to report via Inmarsat-C.

The PSSA and associated protective measures were adopted to provide additional protection to the exceptional natural, cultural and historic resources in the Monument. Requiring vessels to notify NOAA upon entering the reporting area will help make the operators of these vessels aware that they are traveling through a fragile area with potential navigational hazards such as the extensive coral reefs found in many shallow areas of the Monument. The PSSA is now in effect, and the IMO has provided for an effective date for the associated protective measures of May 1, 2008.

NOAA and USFWS are establishing the infrastructure that will be required to maintain an international ship reporting system and to ensure that information regarding PSSA designation will be incorporated into nautical charts and other information sources. This rule implements the mandatory ship reporting system as adopted by IMO, establishes the reporting area using the IMO boundary coordinates, and publishes the coordinates of the four ATBAs.

These regulations apply to vessels that do not have permits to enter the Monument and that pass through the Monument without interruption. These regulations do not change the exemptions at 50 CFR 404.8 (activities necessary to respond to emergencies or necessary for law enforcement purposes) and 404.9 (activities and exercises of the Armed Forces, including those of the United States Coast Guard) and, therefore, do not apply to vessels covered by those exemptions. As explained further, below, these regulations also do not apply to sovereign immune vessels.

The regulations accomplish the following actions:

(1) Modify the current notification requirements (at 50 CFR 404.4) for passing through the Monument without interruption and add several new associated terms and definitions (at Sec. 404.3);

(2) Establish a reporting area around the Monument, extending outward ten nautical miles from the Monument boundary but excluding the ATBAs within the Monument;

(3) Describe the categories of vessels that are subject to the reporting requirement;

(4) Specify the type of information regarding the vessel, its location, etc. that is required in the e-mail to NOAA and that is to be sent in a reporting format that is consistent with the reporting system adopted by IMO;

(5) Allow for vessels that do not have e-mail capability to continue to comply with the current prior notification requirements;

(6) Recommend voluntary participation in the reporting system for all other vessels that are not required to notify NOAA; and

(7) Publish the revised boundaries of the four voluntary ATBAs.

Each of these elements is described below.

Monument regulations at 50 CFR 404.4 prohibit entry into the Monument except in certain situations. One of the exceptions is for vessels passing through the Monument without interruption. Those vessels, however, are currently required to provide notice prior to entering and after leaving the Monument. Notification of entry must be provided at least 72 hours, but no longer than 1 month, prior to the entry date. Notification of departure from the Monument must be provided within 12 hours of leaving. Notification may be made by e-mail, telephone, or fax and must include the following information: Position when making the report; vessel name and IMO identification number; name, address, and telephone number of owner and operator; United States Coast Guard documentation, state license, or registration number; home port; intended and actual route through the Monument; general categories of any hazardous cargo on board; and length of vessel and propulsion type (e.g., motor or sail).

These changes to the regulations replace the current notification requirements for vessels that have e-mail capability. Vessels without e-mail capability will continue to provide notification in advance and upon exiting the Monument as described previously but the type of information to be provided is modified by these regulations as indicated below.

The following terms are being added to the definitions at 50 CFR 404.3 to facilitate implementation of the proposed ship reporting requirements: “Areas to be avoided”; “Categories of hazardous cargoes”; “IMO”; and “Reporting area.” The definitions to these terms are contained in the text of the regulations.

The regulations create a reporting area extending ten miles out and entirely around the Monument boundary. The coordinates of the area are set forth in Appendix D of the regulations and are the same as the coordinates that were adopted by IMO when it accepted the PSSA in principle and adopted the associated protective measures for the PSSA in 2007. Certain categories of vessels (described below) that intend to pass through the Monument without interruption are required to e-mail certain information at the time they cross the reporting area boundary and again when they exit the reporting area after having passed through the Monument.

The reporting area does not include the ATBAs within the Monument. As such, vessels that pass through an ATBA while passing through the Monument must notify NOAA at the time they exit the reporting area and enter the ATBA, and again when they exit the ATBA and re-enter the reporting area.

There are three large areas of the Monument (within the reporting area) that are not within the IMO-designated ATBAs. These breaks between the four ATBAs allow for primarily north-south passage through the Monument. From west to east, these areas are in the following locations and are shown in Figure 1: Between the ATBAs extending around Pearl and Hermes Atoll and Lisianski Island; between the ATBAs around Maro Reef and Gardner Pinnacles; and between the ATBAs around Mokumanamana (Necker Island) and Nihoa Island. It is anticipated that vessels will navigate through the Monument via these areas. Vessels passing through the Monument in these areas are only required to send e-mail notification upon entering the reporting area and again upon leaving it.