The regulations in 9 CFR part 93 restrict the importation of certain animals and animal products into the United States to prevent the introduction of communicable animal diseases. Subpart C—Horses (§§ 93.300 through 93.326, referred to below as the regulations), regulates the importation of horses into the United States. Section 93.304 of the regulations contains, among other things, specific provisions for reservation fees for space at quarantine facilities maintained by the Animal and Plant Health Inspection Service (APHIS).

Under the current regulations in § 93.304(a)(3), the importer or importer's agent must pay or ensure payment of a reservation fee for each lot of horses to be quarantined in a facility maintained by APHIS. The reservation fee is 100 percent of the cost of providing care, feed, and handling during quarantine, as estimated by the quarantine facility's veterinarian in charge. Any reservation fee will be forfeited if the importer or the importer's agent fails to present for entry, within 24 hours following the designated time of arrival, the horse or horses for which the reservation was made. However, a reservation fee will not be forfeited if written notice of cancellation from the importer or the importer's agent is received by the office of the veterinarian in charge of the quarantine facility during regular business hours (8:00 a.m. to 4:30 p.m. (local time) Monday through Friday, excluding holidays) no later than 5 business days prior to the beginning of the time of importation as specified in the import permit or as arranged with the veterinarian in charge of the quarantine facility if no import permit is required. When a reservation is canceled, a $40 cancellation fee is charged.

Recently, stall space for imported horses at the United States Department of Agriculture (USDA) quarantine facilities has been in high demand. Importers or their agents can sometimes expect to wait up to 2 to 4 months to obtain stall space. Some importers or their agents have been making speculative reservations far in advance of the projected date of arrival of the imported horses, and then canceling those reservations with 5 business days notice if they have no horses to import. While 5 business days' notice is what is required under the regulations to avoid forfeiture of the total reservation fee, this period does not allow sufficient time to offer the canceled space to other prospective importers. Five business days also does not allow sufficient time for another importer who might be able to make use of the available stall space to make the necessary arrangements for importing horses. We believe the current cancellation fee does not provide sufficient deterrent against speculative reservations and does not recover the fixed cost associated with operating quarantine facilities when stall space goes unused.

Therefore, we are amending the regulations to establish a graduated fee schedule for cancellations. Under this schedule, the fee depends on when the reservations are canceled prior to the reservation date. Persons who cancel a reservation 30 business days or more prior to the reservation date will be charged 25 percent of the reservation fee. Persons who cancel a reservation 15 to 29 business days prior to the reservation will be charged 50 percent of the reservation fee. Persons who cancel a reservation less than 15 business days prior to the reservation date will forfeit 100 percent of the reservation fee.

We believe that a cancellation fee of 100 percent of the reservation fee is appropriate when a cancellation occurs less than 15 days prior to the expected date of arrival because it is rarely possible to find other horses to take the space in that short a time. It takes at least 15 days to prepare a horse for importation into the United States. Brokers are required to have certain diagnostic tests performed on their horses and these tests must be processed at National Veterinary Services Laboratories. The reduced cancellation fees for more notice reflects the increased likelihood of the space being filled.

We are taking this action to discourage importers from reserving space they may not use and cancelling when it is too late for others to use the space. We believe this action will improve the occupancy rate of stall space, and, therefore, the efficiency of the quarantine facilities. Furthermore, the increased cancellation fee will recover a larger portion of the fixed costs associated with operating quarantine facilities when stall space goes unused.

We considered an alternative in which APHIS would refund brokers their cancellation fee if we were able to fill the stall space with other horses. We also considered charging a set cancellation fee greater than $40 per reservation regardless of when notice is provided. We are not adopting these alternatives for the following reasons:

As noted, it is generally not feasible to fill spaces canceled within 15 days. In cases where cancellation occurs 15 or more days in advance, we may be able to fill the space. However, a refund procedure would be very complex due to the nature of scheduling shipments and arranging stall space. There are times when an entire shipment of 20 horses may be canceled and we may be able to fill only 10 of those slots. There may also be times when the space that becomes available may be inappropriate for a new shipment due to size or location of the newly available stalls. In addition, we do not have the staffing or infrastructure to track and control refunds, especially refunds that must be prorated because there would not be an even exchange. We also were concerned that providing refunds would mean that the fees would no longer be a deterrent to canceling stall space for brokers who can arrange for another importer to fill their canceled space. Such arrangements also could limit which brokers might have an opportunity to use the stall space.

Regarding the other alternative, which would set a flat fee of above $40, we decided instead to establish a graduated fee schedule for cancellations. Under this schedule, the fee would depend on when the reservations were canceled prior to the reservation date, therefore, there would be a greater deterrent to cancelling reservations close to the reservation date, while the lower cancellation fees for more notice reflects the increased likelihood, but no certainty, of the space being filled.

Immediate action is necessary to discourage importers from reserving space that they may not use and canceling when it is too late for others to use the space. APHIS put a freeze on taking reservations for stall space from importers until this issue is resolved. Because we wish to resume taking stall space reservations at these facilities by December 2002, it is important to make this action effective as quickly as possible. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this action effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule.

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

We are amending the regulations regarding the importation of horses into the United States by requiring persons who cancel reservations for stall space at import quarantine facilities to notify us earlier and by increasing the fee for canceling reservations. Under the new fee structure, persons who cancel a reservation at least 30 business days prior to the reservation date will be charged 25 percent of the reservation fee; persons who cancel a reservation 15 to 29 business days prior to the reservation date will be charged 50 percent of the reservation fee; and persons who cancel a reservation less than 15 business days prior to the reservation date will forfeit 100 percent of the reservation fee. We are taking this action to discourage importers from reserving space that they may not use and canceling when it is too late for others to use the space. We believe this action will improve the occupancy rate of stall space, and therefore the efficiency of import quarantine facilities.

In 1999, the U.S. horse industry directly produced goods and services of $25.3 billion and had a total economic impact of $112.1 billion on the U.S. gross domestic product. 1 Racing, showing, and recreation each contributed more than 25 percent to the total value of goods and services produced by the industry. Activities related to the horse industry generated approximately $1.9 billion in tax revenues, most of which were generated in States where parimutuel betting was allowed. 2

The horses quarantined at USDA's New York and Florida quarantine facilities include horses that are valued at up to $1 million. The average value of these horses in 2001 was $10,400 per horse. The number and total value of horses imported into the United States has been increasing over the last 8 years (table 1).

Due to this increase in imported horses and the limited space available at USDA horse quarantine facilities, it is important that reservation space be fully utilized.

Horses are quarantined at a USDA facility for either 3 or 7 days before being cleared. European horses are quarantined for 3 days; South American and Caribbean horses are quarantined for 7 days. The user fee for a 3-day quarantine is $792 per horse. The user fee for a 7-day quarantine is $1,556 per horse (Table 2).

Eighty to ninety percent of the quarantine reservations cancelled 5 business days before a reservation are not refilled. The 5-day period does not allow sufficient time to find a replacement. The USDA quarantine facilities in Florida and New York each lose approximately $300,000-$470,000 each year in forgone user fees. In addition, the horse industry as a whole incurs additional costs through delays in being able to import horses. The result is fewer imports than would otherwise occur.

The current practice of charging $40 for a cancellation allows horse brokers to reserve stall space even before securing clients for the space. Brokers with significant capital resources may make several reservations and simply forfeit the $40 reservation fees if a client is not found to fill them. This practice of reserving stall space before securing a client has led to stall reservations being bartered on the open market even though the program receives Federal funding. Some brokers have complained that a $40 reservation fee is not an effective deterrent to prevent brokers from reserving stall space before a client is found.

The graduated fee schedule for canceled reservations will provide greater deterrence against late cancellations. Under a graduated fee schedule, brokers and horse owners will lose 25 percent of the reservation fee if they cancel at least 30 days prior to the reservation. Thirty days notice will provide opportunity for APHIS to refill the stall space. Brokers and horse owners who cancel 15-29 days prior to the reservation will lose 50 percent of the reservation fee. Brokers and horse owners who cancel less than 15 days prior to the reservation will be charged 100 percent of the reservation fee due to the insufficient time to refill the stall space (Table 3). 3

Increasing the cancellation fee and the time-period required for cancellation has potential to affect both horse owners and brokers. Horse brokers who cancel space will incur additional cancellation fees. While the cost of cancellations will most likely be borne by the horse owners, the effects on those owners should be minimal compared to the high values of the horses being quarantined. 4

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

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

This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

This final rule is being adopted without prior notice and prior public comment. The Regulatory Policies and Procedures of the Department of Transportation (DOT) (44 FR 1134, February 26, 1979), however, provide that, to the maximum extent possible, operating administrations for the DOT should provide an opportunity for public comment on regulations issued without prior notice. Accordingly, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from this amendment. The most helpful comments reference a specific portion of the amendment, explain the reason for any recommended changes, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section.

The FAA will consider all comments received on or before the closing date for comments. Late filed comments will be considered to the extent practicable. This final rule may be amended in light of the comments received.

If you want the FAA to acknowledge receipt of your comments on this amendment, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it to you.

You can get an electronic copy of this final rule using the Internet by:

(1) Searching the Department of Transportation's electronic Docket Management System (DMS) Web page ( http://dms.dot.gov/search ).

(2) On the search page, typing in the last four digits of the Docket number shown at the beginning of this final rule, and clicking on “search.”

(3) On the next page, which contains the Docket summary information for the Docket you selected, clicking on the final rule.

You can also get an electronic copy using the Internet through the Office of Rulemaking's Web page at http:/www.faa.gov/avr/armhome.htm, or the Government Printing Office's Web page at http://www.access.gpo.gov/su_docs/aces/aces140.html.

You can also get a copy by submitting a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680. Make sure to identify the amendment number or docket number of this final rule.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. Any small entity that has a question regarding this document may contact their local FAA official, or the person listed under FOR FURTHER INFORMATION CONTACT . You can find out more about SBREFA on the Internet at, http://www.faa.gov/avr/arm/sbrefa.htm. For more information on SBREFA, e-mail us at 9-AWA-SBREFA@faa.gov.

Following the 1996 TWA 800 accident, which was caused by an explosion in the center wing fuel tank, the FAA issued regulations to establish several new transport airplane fuel tank safety requirements (66 FR 23086, May 7, 2001). The final rule, which was effective June 6, 2001, included:

1. Amendment 21-78 (SFAR 88) which requires type certificate (TC) and supplemental type certificate (STC) holders to:

• Conduct a revalidation of the fuel tank system designs on the existing fleet of transport category airplanes carrying 30 or more passengers or a payload of 7,500 lbs. or more;

• Develop all design changes required to demonstrate they meet the new ignition prevention requirements; and

• Develop fuel tank maintenance and inspection instructions,

2. Amendments 91-266, 121-282, 125-36, and 129-30, which require certain operators to incorporate FAA-approved fuel tank maintenance and inspection requirements into their maintenance or inspection programs, and

3. Amendment 25-102, which adopts new airworthiness standards for future designs to impose ignition prevention design and maintenance requirements (§ 25.981(a) & (b) and paragraph H25.4 of appendix H), and fuel tank flammability requirements (§ 25.981(c)).

On September 10, 2002, the FAA amended SFAR 88 by incorporating provisions into the rule that allow for findings of equivalent safety (Amendment 21-82, 67 FR 67490). This amendment added a paragraph that allows the FAA to approve a type certificate holder's required submission based on a finding that it provides an equivalent level of safety to full compliance with the SFAR. SFAR 88 is a part 21 rule which did not provide certificate holders the ability to make compliance findings based upon a finding of equivalent safety, as is available when making findings of compliance with part 25 for new or amended type certificates. Therefore, Amendment 21-82 provides a “level playing field” between pending applicants and current holders of TCs. It also allows applicants to propose other means to achieve the safety goals of the SFAR such as flammability reduction using polyurethane foam or nitrogen inerting.

SFAR 88 requires that holders of type certificates and supplemental type certificates review the designs of fuel tank systems of large transport category airplanes, and develop design changes and maintenance and inspection programs based on the findings of those reviews. The reviews are conducted using the ignition prevention requirements that were adopted for new or amended type designs in § 25.981. Reports documenting compliance must be submitted to the FAA by December 6, 2002.

When the SFAR was written, the FAA believed that, to the extent that STC holders would be dependent upon the TC holders for the information needed to show compliance with the SFAR, this information would be available either from the original certification data or through business agreements with the TC holders. For a variety of reasons, this information has generally not been made available to the STC holders.

Since issuance of SFAR 88, we have gained experience and now recognize that STC holders can show compliance without access to data from the TC holders. On August 27, 2002, about 3 months prior to the compliance date for the SFAR, we conducted a seminar in Chicago with STC holders where methods for showing compliance without TC data were presented. (Presentations from this seminar can be accessed at the following Web site: http://www.faa.gov/certification/aircraft/sfar88/index.htm). These methods allow STC holders to conduct the safety assessment of their STC up to the interface with the TC holder's design, and to define service information (both maintenance instructions and design changes) needed to correct any deficiencies identified in the assessment. For all safety issues associated with the interface between the STC and the TC holder's design, the STC holder can reference the design configuration control limitations defined by the TC holder, which will be sufficient to address these issues.

Until the August seminar, STC holders did not have access to this information regarding a means of compliance that is not dependent on access to TC holder data. Because of the widespread belief that access to these data was necessary, many STC holders had not made significant progress in assessing their designs. A six-month extension of the compliance time for STC holders will allow them to complete their compliance submittals using the method described above. This amendment therefore provides an extension of six months for STC holders to the compliance time of December 6, 2002, specified in SFAR 88.

It should be noted that the compliance deadline is not being extended for TC holders; and we expect them to comply by the original deadline. As noted previously, Amendment 21-82 allows TC holders to use factors providing an equivalent level of safety in complying with SFAR 88. Under this provision, some TC holders have expressed an intention to provide fuel tank inerting systems as an alternative to some design changes that would otherwise be necessary to eliminate ignition sources. Because these inerting systems involve new technology, the TC holders have indicated that they will not be able to complete the design changes by the deadline. Given the potential safety benefits of these systems, we have stated that a short delay in providing these design changes may be acceptable for a finding of equivalent safety, provided that the TC holders otherwise comply with SFAR 88's system safety assessment and maintenance program requirements by the December 6, 2002, deadline.

Operators are dependent upon STC holders for showing compliance with the operating rules (parts 91, 121, 125, and 129) that require development of an approved maintenance program by June 2004. Therefore this rulemaking would also provide a six-month extension of the compliance times for these rules. This extension will also enable operators to fully address any maintenance program changes associated with fuel tank inerting system changes that TC holders may develop, as discussed previously.

Since this rule simply extends the compliance time for STC holders and operators, it should not result in additional costs and therefore is not considered “significant” for purposes of Executive Order 12866, DOT Regulatory Policies and Procedures, or the Regulatory Flexibility Act, and it does not require preparation of a regulatory evaluation.

There are no new requirements for information collection associated with this amendment.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to comply with International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations.

Sections 553(b)(3)(B) and 553(d)(3) of the Administrative Procedures Act (APA) (5 U.S.C. Sections 553(b)(3)(B) and 553(d)(3)) authorize agencies to dispense with certain notice procedures for rules when they find “good cause” to do so. Under section 553(b)(3)(B), the requirements of notice and opportunity for comment do not apply when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Section 553(d)(3) allows an agency, upon finding good cause, to make a rule effective immediately, thereby avoiding the 30-day delayed effective date requirement in section 553.

In the context of the APA, “impracticable” means that, if notice and comment procedures are followed, they would defeat the purpose of the rule. As explained previously, the purpose of this final rule is to prevent a large number of STC holders from being in noncompliance with SFAR 88 as of the December 6, 2002, deadline by extending this deadline by six months. There is no way we could issue a notice, receive comments, and issue a final rule before then. Therefore, it is “impracticable” to provide notice and opportunity to comment.

This final rule also provides a six-month extension of the compliance time for the operating rules, which originally had a deadline of June 2004 (18 months after the deadline for SFAR 88). The need to extend this deadline results directly from the extension for STC holders. We acknowledged in the original fuel tank safety final rule that the operators are heavily dependent on TC and STC holders' compliance, and we gave the operators 18 months after the SFAR 88 compliance deadline with the understanding that they would need that entire time to develop the maintenance program changes required by the operating rules. Nothing has occurred to make us reconsider that decision, so the extension of the STC holder deadline necessitates extending the operating rule deadline, as well.

Providing notice and opportunity to comment on this extension would create uncertainty for the operators and could be highly disruptive. Since it is important for operators to be able to plan their compliance activities, and notice and comment procedures would make this impossible, we also find that providing notice and opportunity to comment are impracticable for the operating rule extension.

For the same reasons, we find good cause to make this rule effective immediately upon publication.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs each Federal agency to propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (19 U.S.C. section 2531-2533) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, use them as the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation.)

In conducting these analyses, the FAA has determined this rule (1) Is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866 and is not “significant” as defined in DOT's Regulatory Policies and Procedures; (2) will not have a significant impact on a substantial number of small entities; (3) will have little effect on international trade; and (4) does not impose an unfunded mandate on state, local, or tribal governments, or on the private sector.

For regulations with an expected minimal economic impact, the above-specified analyses are not required. The Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If it is determined that the expected impact is so minimal that the proposal does not warrant a full evaluation, a statement to that effect and the basis for it is included in the proposed regulation. The FAA has determined that there are minimal costs associated with this final rule and the safety benefits contemplated by the SFAR will still be achieved. Since current circumstances preclude industry from meeting the original compliance time, a 6-month extension will impose de minimus economic impact.

The Regulatory Flexibility Act of 1980 (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the RFA requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. If, however, an agency determines that a proposed or final rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

This action simply provides a six-month extension of the original compliance times. The FAA therefore expects this final rule to impose no cost on small entities. Consequently, the FAA certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

The Trade Agreement Act of 1979 prohibits Federal agencies from engaging in any standards or related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and has determined that it will not result in additional costs to supplemental type certificate holders or operators and will have a minimal effect on international trade

The Unfunded Mandates Reform Act of 1995 (the Act) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. Such a mandate is deemed to be a “significant regulatory action.”

This final rule does not contain such a mandate; therefore, the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do not apply.

The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. We determined that this action will not have a substantial direct effect on the States, or the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. We therefore determined that this final rule does not have federalism implications.

Executive Order 12866 (58 FR 51735, Oct. 4, 1993) requires each agency to write regulations that are simple and easy to understand. We invite your comments on how to make these regulations easier to understand, including answers to questions such as the following:

• Are the requirements in the regulation clearly stated?

• Does the regulation contain technical language or jargon that interferes with their clarity?

• Would the regulation be easier to understand if it was divided into more (but shorter) sections?

• Is the description in the preamble helpful in understanding the regulation?

Please send your comments to the address specified in the ADDRESSES section.

FAA Order 1050.1D defines FAA actions that may be categorically excluded from preparation of a National Environmental Policy Act (NEPA) environmental impact statement. In accordance with FAA Order 1050.1D, appendix 4, paragraph 4(j), this final rule qualifies for a categorical exclusion.

The energy impact of the final rule has been assessed in accordance with the Energy Policy and Conservation Act (EPCA), Pub. L. 94-163, as amended (42 U.S.C. 6362), and FAA Order 1053.1. It has been determined that the final rule is not a major regulatory action under the provisions of the EPCA.

Background on Viticultural Areas What Is ATF's Authority To Establish a Viticultural Area?

The Federal Alcohol Administration Act (FAA Act) at 27 U.S.C. 205(e) requires that alcohol beverage labels provide the consumer with adequate information regarding a product's identity while prohibiting the use of deceptive information on such labels. The FAA Act also authorizes the Bureau of Alcohol, Tobacco and Firearms (ATF) to issue regulations to carry out the Act's provisions.

Regulations in 27 CFR Part 4, Labeling and Advertising of Wine, allow the establishment of definitive viticultural areas. The regulations allow the name of an approved viticultural area to be used as an appellation of origin on wine labels and in wine advertisements. A list of approved viticultural areas is contained in 27 CFR Part 9, American Viticultural Areas.

Title 27 CFR 4.25a(e)(1) defines a viticultural area as a delimited grape-growing region distinguishable by geographical features. Viticultural features such as soil, climate, elevation, topography, etc., distinguish it from surrounding areas.

Any interested person may petition ATF to establish a grape-growing region as a viticultural area. The petition must include:

• Evidence that the name of the proposed viticultural area is locally and/or nationally known as referring to the area specified in the petition.

• Historical or current evidence that the boundaries of the viticultural area are as specified in the petition.

• Evidence relating to the geographical features (climate, soil, elevation, physical features, etc.) that distinguish the proposed area from surrounding areas.

• A description of the specific boundaries of the viticultural area, based on features that can be found on United States Geological Survey (USGS) maps of the largest applicable scale.

• A copy of the appropriate USGS map(s) with the boundaries prominently marked.

Ms. Patricia McRitchie petitioned ATF, on behalf of Shelton Vineyards, Inc., Dobson, North Carolina, to establish a viticultural area within the State of North Carolina, to be known as “Yadkin Valley.” The petitioned viticultural area encompassed all of Surry, Wilkes, and Yadkin counties and portions of Stokes, Forsyth, and Davie counties. It was located entirely within the Yadkin River watershed.

The area, as originally proposed, covered approximately 1,924 square miles or 1,231,000 acres. Within these boundaries, there are over 30 growers who devote approximately 350 acres to the cultivation of wine grapes. Currently, there are three bonded wineries in the petitioned area, with at least two other wineries under construction.

ATF published a Notice of Proposed Rulemaking, Notice No. 936, in the Federal Register on February 7, 2002 (67 FR 5756). The comment period for the proposed rule closed on April 8, 2002. During this 60-day time period, we requested comments concerning the proposed Yadkin Valley viticultural area from all interested persons. ATF received four written comments, all in favor of the Yadkin Valley viticultural area's establishment.

Alliston J. Stubbs, IV, Cedar Ridge Vineyards, Reeds, North Carolina, sought to expand the petitioned area's boundaries. ATF accepted Mr. Stubbs' expansion proposal based on the evidence he provided to support his proposed expansion.

Mr. David Bradley, president of the Greater Mount Airy Chamber of Commerce, submitted a comment fully supporting the establishment of the Yadkin Valley viticultural area, but he did not request that the area be expanded.

Ken Furr, Albemarle, North Carolina, supported a Yadkin Valley viticultural area with larger boundaries. Mr. Furr stated that, as petitioned, the area's boundaries were “much too exclusive.” He argued that the entire Yadkin River basin should be included in one viticultural area. His primary concern was that the few existing vineyards and “the many that will be created over the next 20 years will be disenfranchised and deprived of a marketing mechanism that they deserve.”

State Representative Pryor Gibson of the 33rd District also submitted comments in support of expanding the proposed Yadkin Valley area. Representative Gibson supported the inclusion of “the entirety of the Yadkin River Basin to include Stanly, Montgomery, and any other counties, which border these counties to the east and west which geographically and climatically would include areas conducive to the grape production.”

ATF will consider an expansion of a viticultural area when the appropriate supporting evidence is furnished. Mr. Furr and Representative Gibson did not provide the detailed evidence required by the regulations to support an expansion of the boundaries proposed in Notice No. 936 and, therefore, ATF is unable to expand the Yadkin Valley viticultural area based on these two requests. The requirements for expanding an approved area are the same as those for establishing a new area. A petitioner must include evidence that the additional land is also known by the viticultural area's name, in this case Yadkin Valley, and has growing conditions similar to the ones in the approved area. Any interested person may petition ATF to expand the boundaries of an existing American viticultural area. See the section titled What is Required to Establish a Viticultural Area? listed earlier in this final rule.

Comments from Mr. Allston J. Stubbs, IV, submitted on behalf of Cedar Ridge Vineyards, Reeds, North Carolina, proposed an expansion of the proposed area's southern boundary. His proposed expansion added a portion of Davidson County and an additional area in Davie County. Mr. Stubbs provided data and analyses, including climate, geographical, and name evidence, supporting his proposal. ATF agrees that this proposed expansion's characteristics are consistent with the original petition's area and, therefore, meet the regulatory criteria for an American viticultural area. The revised size of the Yadkin Valley viticultural area is approximately 1,416,600 acres. The final rule has been modified accordingly.

The viticultural area has been known as the Yadkin Valley since pre-colonial times. The first known written use of the name Yadkin (also spelled as Yattken or Yattkin) was in 1674 in the writing of an early trader, Abraham Wood, whose English scouts passed through the area in 1673. It was used in reference to the Native American tribe found living along the river known as the Yadkin. Subsequently, the name Yadkin was applied to many natural features and man-made structures in the area. In fact, the only references to Yadkin as a place name are to places located in North Carolina: the Yadkin Valley, the Yadkin River, Yadkin County, and the towns of Yadkin Falls, Yadkin College, and Yadkinville. It is also used to name businesses, schools, and organizations located in the State's northwestern piedmont region.

There is rich historical and anthropological evidence of settlement and cultivation in the Yadkin Valley. Native American settlements date back to approximately 500 B.C. The first non-Native settlers, the Moravians, arrived in the Yadkin Valley in the 1740s. They originally scouted land in the Blue Ridge Mountains near Boone, but did not find a satisfactory site for settlement. The Moravians followed the Yadkin River east, finally reaching the three forks of Muddy Creek, a tributary of the Yadkin River. It was here that the Moravians made the first settlements in what are now Forsyth and Stokes counties. The settlements were Bethabara, established in 1753, and Bethania, established in 1759. These early settlers were meticulous recordkeepers and references to the Yadkin Valley can be found in their colonial writings as well as in later sources. References to the Yadkin Valley can also be found in histories of the region during the American Revolution and the Civil War periods.

An influx of settlers who farmed the Valley's rich soil characterized the period immediately after the Civil War. In the latter part of the 19th century, cotton and tobacco were the Valley's main crops. By the early 20th century, the change to tobacco as the Valley's main cash crop was complete, but by the century's close, however, the predominance of tobacco growing in the northwest piedmont of North Carolina had waned. In its place is an increased interest in grape growing, which is rooted in pre-colonial North Carolina's history.

An article titled “N.C. Winery History” (North Carolina Grape Council website, 2/24/01, http://www.ncagr/com/markets/commodit/horticul/ grape/winehist.htm), states that the first cultivated wine grape in the United States was grown in North Carolina. The first known recorded account of the Scuppernong grape in North Carolina is found in the logbook of explorer Giovanni de Verranzano. He wrote in 1524, “Many vines growing naturally there [in North Carolina] that would no doubt yield excellent wines.”

The wine industry in North Carolina thrived through the 19th and 20th centuries until prohibition. At that time, the industry, which was centered in the eastern part of the State, was based on muscadine wine.

One of the first modern major plantings of vinifera grapes in North Carolina occurred in 1972, when Jack Kroustalis established Westbend Vineyards, located in the Yadkin Valley. According to “Carolina Wine Country,” “[t]he vines flourished in the rich soil of the Yadkin River Valley.” In 1988, Kroustalis built the first bonded winery in the Yadkin Valley. Other growers in Yadkin Valley took note of Westbend Vineyard's success with vinifera grapes and followed suit. By the end of 2000, over 350 acres of grapes were planted in the Yadkin Valley. The North Carolina Department of Agriculture has recognized this area as a “unique and valuable winegrowing region.”

In 1999, Shelton Vineyards began planting 200 acres of vinifera grapes on land considered perfectly suited to vinifera grape growing. The following year, Shelton opened a state-of-the-art 30,000 case winery. There are currently two additional wineries under construction in the viticultural area, and the Yadkin Valley Wine Grower's Cooperative was recently incorporated.

In 1999, Surry Community College began offering continuing education viticulture courses. Spurred on by the tremendous interest in grape growing, the College initiated a two-year viticulture program, which began in the fall of 2000. The program will educate future grape growers to take advantage of the favorable growing environment provided by the Yadkin Valley. In December of 2000, the Golden Leaf Foundation awarded the College over $130,000 to support the establishment of a demonstration vineyard and winery for use by students in the program.

The reference materials used to prepare this petition consistently included all of Wilkes, Surry, and Yadkin counties in the Yadkin Valley, as well as portions of Stokes and Forsyth counties. Davie and Iredell counties were also commonly included.

The Yadkin Valley viticultural area petition included a report by Roger J. Leab, a soil scientist with the Natural Resource Conservation Service, United States Department of Agriculture. Mr. Leab was the soil survey project leader for Surry and Stokes counties, and is currently the project leader for Alamance County. He compiled his report from the published soil surveys of Wilkes, Stokes, Yadkin, Davie, and Forsyth counties and the data collected for the soon-to-be-published soil survey of Surry County.

The soils of the Yadkin Valley viticultural area were formed mainly from residuum (saprolite) weathered from felsic metamorphic rocks (gneisses, schists, and phyllites) of the Blue Ridge Geologic Belt and the Smith River Allochothon and from metamorphosed granitic rocks of the inner Piedmont Belt. The extreme southeastern part of the area was formed from saprolite weathered from igneous intrusive rocks (granites, gabbros, and diorites) and some gneisses and schists, all of the Charlotte Belt.

Most of the viticultural area is in the mesic soil temperature regime, which, at a depth of 20 inches, has an average annual soil temperature of 47 to 59 degrees Fahrenheit. The extreme southeastern part of the area is in the thermic temperature regime, which is in the 59 to 72 degree Fahrenheit range.

The dominant soil series formed from residuum in the mesic area are Fairview, Clifford, Woolwine, Westfield, Rhodhiss, and Toast soils. The dominant soil series formed from residuum in the thermic area are Pacolet, Cecil, Madison, Appling, and Wedowee soils. There are also some large areas of soils, which formed in old fluvial sediments of high stream terraces. These are the Braddock series in the mesic area and the Masada, Hiwassee, and Wickham series in the thermic area. These soils all have clayey or fine-loamy subsoils with good internal structure and moderate permeability. They are mostly very deep and well drained. These soils are acidic and have low natural fertility, requiring a well-structured fertility plan.

The soil series that formed in residuum from the mafic intrusive rocks (gabbros and diorites), which occur scattered along the extreme southeastern part of the viticultural area, have slightly better natural fertility. However, they have subsoils with mixed mineralogy clays. The Gaston and Mecklenburg series have moderate or moderately slow permeability and are suitable to moderately suitable for viticulture. However, the Enon and Iredell series have high shrink-swell clayey subsoils, which perch water during wet periods and result in less than desirable internal drainage.

The less than desirable, high shrink-swell clayey soils are more abundant to the south and east of the viticultural area. The Blue Ridge Mountains are to the west and north of the area. The petitioner states that these limitations define the Yadkin Valley as a unique viticultural area.

The petition's data for precipitation, temperature and heat summation were provided by the State Climate Office of North Carolina.

Hardiness Zone. The Yadkin Valley viticultural area is in Zone 7a of the USDA Hardiness Zone Map. The surrounding regions are in Zones 6b and 7b. This zone is well suited for growing grapes while the adjacent zones are not as favorable for growing vinifera grapes. For example, the Columbia Valley viticultural area in Washington State is also located in Zone 7a.

The Yadkin Valley is located in the warm temperate latitude between 36°00′ and 36°30′ N. This latitude is well suited to growing vinifera grapes while latitudes below 35°00′ are not suited to vinifera grape growing, according to Gordon S. Howell and Timothy K. Mansfield's article, “Microclimate and the Grapevine: Site Selection for Vineyards (A Review),” in “Vinifera Wine Growers Journal,” Fall 1977, page 373.

Precipitation. The Yadkin Valley receives an average rainfall of 46.42 inches. The regions to the west and northwest receive, on average, more than 68 inches of rain per year. The regions to the south and east receive, on average, 43.37 inches of rain per year. In general, the Yadkin Valley receives less precipitation than the land to the west and northwest and slightly more than the regions to the south and the east.

Temperature. The Yadkin Valley has an average maximum annual temperature of 69.85 degrees Fahrenheit and an average minimum annual temperature of 44.90 degrees Fahrenheit. The regions to the west and northwest have an average maximum temperature of 58.6 degrees Fahrenheit and an average minimum annual temperature of 40.00 degrees Fahrenheit. The region to the east has an average maximum annual temperature of 68.4 degrees Fahrenheit and an average minimum annual temperature of 46.0 degrees Fahrenheit. The region to the south has an average maximum annual temperature of 71.5 degrees Fahrenheit and an average minimum annual temperature of 48.1 degrees Fahrenheit.

In summary, the Yadkin Valley is much warmer than the regions to the west and northwest and has slightly higher maximum and minimum temperatures than the region to the east. The Yadkin Valley has lower maximum and minimum temperatures than the land to the south. Temperature differences become more pronounced the further south one travels. In addition, as one proceeds east past the Greensboro area, the temperatures, both maximum and minimum, become warmer than in the viticultural area.

Heat Summation. Using Amerine and Winkler heat summation definitions, the Yadkin Valley viticultural area is in climatic region IV, with 3743 degree-days. The land to the east is in region IV. The land to the west-northwest is in region I, while lands to the south are in region V (Greensboro is close to region V).

Frost-Free Season/Growing Season . The petition also offered data regarding the Yadkin Valley's growing season from the North Carolina State University horticulture information leaflet “Average Growing Season for Selected North Carolina Locations” (12/96, revised 12/98) by Katharine Perry. The viticultural area enjoys a frost-free season lasting from April 22 to October 15. This is a growing season of 176 days and is two to four weeks longer than the region to the west. The frost-free/growing season in the viticultural area is similar to the lands immediately to the south. In contrast, the regions to the east and southeast have a frost-free and growing season four to six weeks longer than the viticultural area.

Climate Summary . The Yadkin Valley viticultural area has more moderate temperatures and precipitation than the surrounding areas. The growing season and frost-dates fall within the optimum range for cultivation of premium vinifera grapes. These data support the proposition that the Yadkin Valley possesses climatic conditions distinguishing it from the surrounding areas.

The petition also included a report on the Yadkin Valley's geology prepared by Matthew Mayberry, president of the River Ridge Land Company, Inc. The highly complex rocks of the present day Blue Ridge and Piedmont provinces represent a core area that has been present and re-crystallized and re-metamorphosed through several mountain building cycles to produce the complex schists, gneisses and igneous rocks of today's Yadkin Valley. Relics of a couple of the hot spots that re-crystallized rock are the granites of Mount Airy and Stone Mountain, North Carolina. Mr. Mayberry's report noted that the weathering of these Piedmont rocks has produced soils with chemical and physical properties that are very amenable to the viticulture industry. The petition stated that the soils and climate of the Yadkin Valley viticultural area cover a spectrum equal to most vineyards of Europe and California.

After the Yadkin River's origin and descent from mountain springs in the Blowing Rock, North Carolina region, it encounters a major structural feature known as the Brevard Shear Zone (fault system), which also defines the Blue Ridge Escarpment in the area, paralleled by the river. At the base of the Blue Ridge Escarpment, the Yadkin River turns and flows northeastward under the structural control of this shear zone for a distance of approximately 50 miles before bending to the east between the northeast end of the Brushy Mountains and Pilot Mountain. At the Surry, Yadkin, and Forsyth County corner, the Yadkin turns southward and later becomes the Pee Dee River at High Rock Lake, about six miles northwest of Salisbury, North Carolina.

Mr. Mayberry also provided the petition's boundary description. The area of the Yadkin Valley viticultural area proposed in Notice No. 936 covers approximately 1,924 square miles or 1,231,000 acres in Wilkes, Surry, Yadkin and parts of Stokes, Forsyth, and Davie counties. The subject area is identified on two 1:250,000 scale USGS maps:

(1) Winston-Salem, N.C.; VA., Tenn. 1953 Limited Revision 1962; and

(2) Charlotte, North Carolina; South Carolina 1953 Revised 1974.

As noted above, ATF has expanded the Yadkin Valley viticultural area at the request of Mr. Allston J. Stubbs. The expansion adds an additional portion of the Yadkin River basin southeast of Winston-Salem in Davidson and Davie counties. As approved, the area covers about 1,416,600 acres. The finalized, expanded Yadkin Valley viticultural area boundary is determined on a 1:250,000 scale, based on the USGS maps. Primarily, county lines define the viticultural area's boundaries. In cases where directions change, where county lines or rivers are too irregular to measure, a “trend direction bearing” with straight-line miles is reported. The beginning point is defined as a point 3.6 miles west of the northeast corner of Surry County on the Surry County and North Carolina/Virginia state line at the crest of Slate Mountain.

The revised Yadkin Valley viticultural area boundaries are discussed in detail in § 9.174(c) of the final rule shown below in this Treasury Decision. In addition to the boundaries expanded by Mr. Stubbs proposal, ATF expanded a small portion of the northeastern boundary. This expansion was necessary to meet the requirements of 27 CFR 9.3(b)(4), i.e. , so that the boundaries were based on features that could be found on the associated USGS maps.

As stated earlier in this Treasury Decision, a commenter, Mr. Allston J. Stubbs, IV, requested the expansion of the southeastern boundary of the proposed Yadkin Valley viticultural area. Mr. Stubbs provided evidence to ATF to amend the boundaries as they were originally proposed, in Notice of Proposed Rulemaking, Notice No. 936. “The addition” is used to refer to the area inside the expanded boundary and “the petitioned viticultural area” is used to refer to the area originally proposed in Notice No. 936. A summary of this evidence, and the associated references, is provided below.

The State Climate Office of North Carolina and the Southeast Regional Climate Center ( See, respectively, http://www.nc-climate.ncsu.edu and http://water.dnr.state.sc.us/ climate/sercc/ ) provided data for precipitation, temperature, and heat summation. The addition is defined by climate data from weather stations at its four geographic corners of Mocksville, Winston-Salem, Lexington/Lexington Agricultural Research Station, and the Rowan Agricultural Research Station.

Hardiness Zone . The petitioned Yadkin Valley viticultural area is in Zone 7a of the USDA Hardiness Zone Map. The addition is also in Zone 7a. Interstate 85 through Davidson County—the southern border of the addition—approximates the demarcation between Zone 7a and 7b.

Precipitation . The petitioned viticultural area has areas of average annual precipitation ranging from 44 inches per year in the east to 56 inches per year in the west and an average annual precipitation of 46.42 inches per year. The addition has an average annual precipitation of 45.05 inches per year. The amount of precipitation in the addition is similar to areas included in the petitioned viticultural area. The addition has more precipitation than areas to the southeast (outside the boundary) where the average annual precipitation ranges from 42 to 44 inches per year.

Temperature . The petitioned viticultural area has average maximum annual temperatures of 69.85 degrees Fahrenheit and average minimum annual temperatures of 44.90 degrees Fahrenheit. The addition has an average maximum annual temperature of 70.93 degrees Fahrenheit and an average minimum annual temperature of 46.80 degrees Fahrenheit. The temperatures of the addition are similar to those within the petitioned area and are cooler than areas outside of the petitioned area's southern and southeastern borders.

Heat Summation . The petitioned viticultural area is located in Amerine and Winkler Climatic Region IV, with 3743 degree-days. The addition is also located in Climatic Region IV, with 3904 degree-days.

Frost-Free Season/Growing Season. The petitioned viticultural area has a range of growing seasons: 176 days (April 22 to October 15) in Mt. Airy, N.C. (northern Surry County), 185 days (April 19 to October 21) in Yadkinville, N.C. (central Yadkin County), and 198 days (April 14 to October 24) in Mocksville, N.C. (central Davie County).

Using data from the North Carolina Climate Office (50 year average dates of last spring freeze and first fall freeze), the addition has an estimated growing season of 191 days (April 11 to October 20). This is similar to the growing seasons of the petitioned viticultural area.

All referenced growing seasons have a standard deviation of 11 to 13 days. This variability limits the distinctions among the growing seasons across the Yadkin Valley area. Hence, the addition has a similar growing season duration compared with the petitioned viticultural area. The growing season of the petitioned area and the addition is shorter than the areas along its southern and southeastern borders.

Climate Summary. The addition, like the petitioned viticultural area, has a climate defined by temperature and precipitation that is different from the surrounding areas. The growing season and frost-dates of the addition, like the originally petitioned region, fall within the optimum range for cultivation of premium vinifera grapes.

Location. The petitioned viticultural area lies between the north latitudes of 35 degrees 52 minutes and 36 degrees 35 minutes and between the east longitudes of 80 degrees 14 minutes and 81 degrees 32 minutes. The addition extends the southern boundary to a latitude of 35 degrees 41 minutes North. The southern boundary of the addition remains above the 35 degree parallel recommended for vinifera grape growing by Howell and Mansfield's article, “Microclimate and the Grapevine: Site Selection for Vineyards (A Review),” in the “Vinifera Wine Growers Journal,” Fall 1977, 373.

Elevation. The elevation for the petitioned viticultural area ranges from 694 feet (NW Davie County) to 3800 feet (NW Wilkes County). The addition's elevation ranges from 696 feet (NW Davie County) to 921 feet (SW Forsyth County). The addition does not increase the range of elevation found in the petitioned viticultural area.

Mr. Stubbs provided soil information that was compiled from soil survey data of Wilkes, Surry, Stokes, Yadkin, Davie, Forsyth, and Davidson counties. A general distribution of soil types across the petitioned viticultural area, and the addition can be viewed on the General Soil Map of NC, Overlay #2, May 1978, Soil Conservation Service, USGS, 1:250,000. Additional information is from the respective county soil surveys and the Soil Survey Division, Natural Resources Conservation Service, United States Department of Agriculture, Official Soil Series Descriptions ( http://www.statlab.iastate.edu/soils/osd/ ).

The soil types of the petitioned viticultural area comprise mesic and thermic residuum (saprolite). The mesic soils include the Fairview, Clifford, Woolwine, Westfield, Rhodhiss, and Toast series. The thermic soils include the Pacolet, Cecil, Madison, Appling, Louisburg, and Wedowee series.

The soil types of the addition (southwestern Forsyth, western Davidson, and eastern Davie counties) are thermic residuum, weathered primarily from felsic rock. Characteristic of the petitioned viticultural area, these thermic soils include the Pacolet, Cecil, Madison, Appling, Louisburg, and Wedowee series. These soils are distinguished by the properties of a low shrink-to-swell ratio, good drainage, and moderate permeability, which are good for grape growing.

The soil types of areas to the west, east, and south of the addition are composed of soil series weathered from mafic and felsic sources. These soils include Iredell, Mecklenburg, Enon, Wilkes, Sedgefield, Tatum, Goldston, and Badin series. As these soils are characterized by the properties of a low to high shrink-to-swell ratio, fair to good drainage, and slow to moderate permeability, they are less desirable for grape growing. These soils are neither characteristic of the petitioned area nor of the addition.

The geology of the petitioned viticultural area has been defined by multiple orogenies or mountain building cycles. The current geology reflects the convergence of several metamorphic and igneous formations including the Blue Ridge Belt, the Smith River Allochothon, the Sauratown Mountains Anticlinorium, the Milton Belt, the Charlotte Belt, and the Inner Piedmont Belt. The addition lies on the Charlotte Belt at the Churchland Pluton. The Churchland Pluton is composed primarily of Porphyritic granite with occasional Alluvium superstrata. The erosion of Porphyritic granite results in soils like Appling, Cecil, Pacolet, and Wedowee found throughout the Yadkin Valley region. These soil types have desirable characteristics for grape growing.

The area to the east of U.S. 52 and Interstate 85, along the eastern and southern borders of the addition, rests on the Carolina Slate Belt. The Carolina Slate Belt comprises dioritic rock types which when weathered result in soils like Enon, Iredell, Mecklenburg, Sedgefield, and Wilkes. These soil types have less desirable characteristics for grape growing and are generally outside the petitioned area and the requested addition.

The flow of the Yadkin River is measured at several points including Yadkin College, Davidson County (included in the addition). The Yadkin River proper ends at its crossing of Interstate 85, the southern border of the addition. South of Interstate 85 and outside of the addition, the river becomes a series of three lakes: High Rock, Badin, and Tillery. Beyond Lake Tillery, the river is referred to as the Pee Dee and continues from North Carolina into South Carolina and toward the Atlantic Ocean.

This regulation is not a significant regulatory action as defined in Executive Order 12866. Accordingly, this final rule is not subject to the analysis required by this Executive Order.

This regulation will not have significant economic impact on a substantial number of small entities. The establishment of a viticultural area is neither an endorsement nor approval by ATF of the quality of wine produced in the area. Rather, it is an identification of an area that is distinct from surrounding areas. We believe that the establishment of viticultural areas allows wineries to more accurately describe the origin of their wines to consumers, and helps consumers identify various wines. Any benefit derived from the use of a viticultural area name is the result of the proprietor's own efforts and consumer acceptance of wines from that area. No new requirements are proposed. Accordingly, a regulatory flexibility analysis is not required.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(j)) and its implementing regulations, 5 CFR part 1320, do not apply to this final rule because no requirement to collect information is imposed.

The principal author of this document is Tim DeVanney, Regulations Division, Bureau of Alcohol, Tobacco and Firearms.

The Coast Guard encourages interested persons to participate in this rulemaking by submitting written data, views, or arguments. Persons submitting comments should include their names and addresses, identify this rulemaking (CGD01-02-131) and the specific section of this document to which each comment applies, and give the reason for each comment.

Please submit two copies of all comments and attachments in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. Persons wanting acknowledgment of receipt of comments should enclose stamped, self-addressed postcards or envelopes. The Coast Guard will consider all comments received during the comment period. It may change this proposed rule in view of the comments.

The Coast Guard plans no public hearing. Persons may request a public hearing by writing to the Marine Safety Office at the address under ADDRESSES . The request should include the reasons why a hearing would be beneficial. If it determines that the opportunity for oral presentations will aid this rulemaking, the Coast Guard will hold a public hearing at a time and place announced by a later notice in the Federal Register .

Pursuant to 5 U.S.C. 553, a notice of proposed rulemaking (NPRM) was not published for this regulation. Good cause exists for not publishing a NPRM and for making this rule effective less than 30 days after Federal Register publication because specific information regarding the drilling and blasting was not provided to the Coast Guard by the Hubline Project until November 6, 2002, making the proposed rule too vague to solicit comments, thus impossible to draft or publish a NPRM or a final rule 30 days in advance of its effective date. The rule is effective immediately as any delay encountered in this regulation's effective date would be contrary to public interest since immediate action is needed to protect the public from the hazards of marine blasting and to protect the vessels Drillboat No. 8 and Lablift IV, which will be carrying explosives used in this operation, from possible acts of terrorism or other sabotage.

The zones affect a small area of water only while the drill barges are conducting drilling and blasting operations and while the vessels are transiting with explosives (on-board) and when they are moored to Conley Marine terminal in order to load and discharge explosives.

As part of the Hubline Pipeline Project that will be placing a 30-inch, 800-PSI natural gas pipeline beneath the sea floor between Salem Sound and Quincy Bay, MA, several locations along this planned route have areas of bedrock that need to be removed to ensure the placement of the pipeline at a specific depth. Algonquin Pipeline and Great Lakes Dredge and Dock Company approached the Coast Guard to establish a safety and security zone around the Drillboat No. 8 and Lablift IV to protect the public and the drill vessels themselves. After meeting with all parties involved, the Captain of the Port is placing these safety and security zones around the above listed vessels to protect them from potential acts of terrorism and to protect the marine public from the hazards associated with marine blasting. This rule establishes safety and security zones on the waters surrounding the Drillboat No. 8 and Lablift IV. The zones extend 600 yards around the vessels one hour prior to and after blasting operations and 400 yards while the barge is otherwise operating. Blasting operations will take place at various locations and at various times along the track line of the project. A local notice to mariners and safety marine information broadcast will identify the time and location of the blasting and whether the zones are in effect. These zones are in effect only while there are explosives on board the vessels.

The safety and security zone around each vessel is in effect from November 18, 2002 through February 28, 2003. Marine traffic may safely transit outside of the safety and security zone in Broad Sound during the effective period and while the vessel in transiting to and from Conley Marine Terminal. The Captain of the Port will allow access as necessary through the zones where the zones impinge on navigation channels within other blasting areas. Public notifications will be made via safety marine information broadcasts, local notice to mariners, notification of local pilots, and notification of parties in the areas that the project will affect as operations proceed.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT)(44 FR 11040, February 26, l979). The Coast Guard expects the economic impact of this rule to be minimal enough that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

Although this rule prevents traffic from transiting into a portion of the above mentioned waters, the effect of this rule will be minimal for several reasons: Number of private vessels transiting the area is significantly less in the winter months, vessels will only be restricted from the safety and security zones during blasting operations or when the Drillboat No. 8 and Lablift IV are moored at Conley Marine Terminal, South Boston, MA. The majority of the track line for the project is in open waters with large areas for vessels to transit safely around the project. Advance notifications will be made to the local maritime community by safety marine information broadcasts, local notice to mariners, contact with local pilots, and contact with affected parties.

For areas of restricted waterways such as inshore areas in Quincy Bay, vessels may transit through the zones as necessary with Captain of the Port approval, and vessels may safely transit outside of the safety and security zones without restriction.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard considered whether this rule would have a significant economic impact on a substantial number of small entities. The Coast Guard and Hubline project contractors have been in contact with local maritime concerns and are coordinating activities with entities such as commuter boats and fishing associations to minimize any impact the project may have on them. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the above mentioned waters while the zones are in effect. For reasons enumerated under the Regulatory Evaluation section above this safety zone will not have significant economic impact on small entities.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

The Coast Guard analyzed this rule under Executive Order 13132, Federalism, and has determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule does not impose an unfunded mandate.

This rule does not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

The Coast Guard analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not pose an environmental risk to health or risk to safety that may disproportionately affect children.

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. A rule with tribal implications has a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Coast Guard considered the environmental impact of this rule and concluded that, under figure 2-1, (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES .

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

On the following dates EPA found these rule submittals met the completeness criteria in 40 CFR part 51 Appendix V: July 3, 2001 for MBUAPCD rule 213; March 10, 1995 for MBUAPCD rule 421; and June 24, 1999 for VCAPCD rule 103. The completeness criteria must be met before formal EPA review.

We approved a version of MBUAPCD rule 213 into the SIP on July 1, 1999.

We approved a version of MBUAPCD rule 421 into the SIP on July 13, 1987.

We approved a version of VCAPCD rule 103 into the SIP on December 14, 1994. At that time, the rule was titled “Stack Monitoring”.

MBUAPCD rule 213 includes the following significant changes from the current SIP:

• The rule is applicable to any source required to install CEMS pursuant to a District Authority to Construct or Permit to Operate.

• A reference is provided to the California Health and Safety Code (section 40702—Adoption of Rules and Regulations and section 42706—Report of Violation of Emission Standard).

• The definition of “Authority to Construct” is added.

• Sources with CEMS are required to develop and comply with a Quality Assurance/Preventative Maintenance Procedures Manual.

MBUAPCD rule 421 includes the following significant changes from the current SIP:

• Definitions are added for “Administrator” and “District”.

• References are provided to pertinent sections of the CAA.

• Any credible evidence or federally-approved monitoring methods may be used to determine compliance.

VCAPCD rule 103 includes the following significant changes from the current SIP:

• The title was changed from “Stack Monitoring” to “Continuous Monitoring Systems”.

• CEMS sources subject to federal CEMS requirements must install and operate equipment in accordance federal regulations.

• The requirement for opacity monitoring for gas fired boilers was removed.

• The time to report violations was increased from 48 to 96 hours.

• The length of time that records must be kept was increased from 4 years to 5 years.

• The requirement to maintain permanent records was changed from “net and gross” megawatt-hours to “net” megawatt-hours produced by a boiler/turbine generator system.

• Permanent records are required for a period of at least 5 years for emisions limits based on calculations.

• The requirement for quarterly reports is deleted. Sources must report excess emissions and inoperable CEMS upon written request from the District.

• CEMS data reduction requirements are added for (1) electric power generating units subject to a new source performance standards (NSPS), (2) large boilers, steam generator and process heaters, and (3) equipment with emissions of any single air pollutant greater than or equal to either 5 pounds per hour or 40 pounds per day when requested by the District to install a CEMS.

• Standards of performance are described standards for electric power generating units and units subject to NSPS.

The TSDs have more information about these rules.

These rules describe administrative provisions and definitions that support emission controls found in other local agency requirements. In combination with the other requirements, these rules must be enforceable ( see section 110(a) of the Act) and must not relax existing requirements ( see sections 110(l) and 193). EPA policy that we used to help evaluate enforceability requirements consistently includes the Bluebook (“Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988) and the Little Bluebook (“Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001).

We believe these rules are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The TSDs have more information on our evaluation.

The TSDs describe additional rule revisions that do not affect EPA's current action but are recommended for the next time the local agency modifies the rules.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the proposed rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by January 8, 2003, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on February 7, 2003. This will incorporate these rules into the federally enforceable SIP.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Section 110(a) of the CAA requires states to submit regulations that control volatile organic compounds, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. These rules were developed as part of the local agency's program to control these pollutants. Table 2 lists some of the national milestones leading to the submittal of these rules.

Throughout this document wherever “we”, “us”, or “our” is used we mean EPA.

On October 17, 2002, Lori F. Kaplan, Commissioner of the Indiana Department of Environmental Management, submitted to EPA a requested amendment to the Indiana SIP. This amendment consisted of revisions to Title 326, Air Pollution of the Indiana Administrative Code (326 IAC). These changes to 326 IAC 11-4-5 were adopted final by the Indiana Air Pollution Control Board on May 1, 2002, filed with the Secretary of State on August 28, 2002 and became effective on September 27, 2002. They were published in the Indiana Register on October 1, 2002 (26 IR 10). The amendments update references to equipment to reflect current operations and delete references to equipment that no longer exists, along with their associated emissions limits, at the Knauf facility located in Shelbyville, Indiana.

The revised rule removes references to emission points which are no longer operational at Knauf and renames several other emission points. Specifically, Indiana deleted from the rule references to 203 oven, 304 oven, 1101 oven, 1102 oven, 1103 oven, 1104 oven, 1110 oven, 1111 oven 203 furnace, and 203 forming. Indiana renamed the 204 oven as the 605 oven, with no change in its maximum hourly PM emission rate of eight pounds per hour. Indiana renamed the 204 furnace as the 605 furnace, with no change in its maximum hourly PM emission rate of 10 pounds per hour. Indiana has renamed the 204 forming operation as 605 forming with no change in its maximum hourly PM emission rate of 15 pounds per hour.

Three emission points continue to be listed in the revised rule with the same emission limits they had in the previous rule: 601 forming plus oven, with a maximum hourly PM emission limit of 28.28 pounds per hour, 603 forming plus oven, with a maximum hourly PM emission limit of 16.49 pounds per hour, and 602 forming plus oven with a maximum hourly PM emission limit of 33.27 pounds per hour.

These revised rules reduce both allowable emissions and the allowable emissions rate. The revisions also reflect current operations at the Knauf facility. Consequently, EPA approval of these changes should not result in an adverse impact on air quality. In fact, EPA estimates a PM emission reduction of 155 tons per year.

EPA is approving the incorporation of 326 IAC 11-4-5 Shelby County, as revised, into the Indiana SIP. The rule revisions modify the emissions limits adopted by the State in the 1980s which are part of the current Indiana SIP. The revised rules delete references to equipment no longer in use by Knauf and update names of equipment which remains in use. Because the revised rules reduce both allowable emissions and the allowable emissions rate and reflect current operations at the Knauf facility, EPA approval of these revisions should not result in an adverse impact on air quality.

EPA is publishing this action without prior proposal because we view this as a noncontroversial revision and we anticipate no adverse comments. However, in a separate document in this Federal Register publication, EPA is proposing to approve the State's SIP revision request should adverse written comments be filed. This action will be effective without further notice unless EPA receives relevant adverse written comment by January 8, 2003. Should EPA receive such comments, we will publish a final rule informing the public that this action will not take effect. Any parties interested in commenting on this action should do so at this time. If no comments are received, the public is advised that this action will be effective on February 7, 2003.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding this action under section 801 because this is a rule of particular applicability.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 7, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

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:

•  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 provides 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 .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2002-0326. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of February 23, 2000 (65 FR 8970) (FRL-6390-1), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 9F6036) by Gustafson LLC, 1400 Preston Road, Suite 400, Plano, Texas 75093. That notice included a summary of the petition prepared by Gustafson, LLC, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.301 be amended by establishing a tolerance for combined residues of the fungicide carboxin, 5,6-dihydro-2-methyl-1,4-oxathiin-3-carboxanilide] and its sulfoxide metabolite 5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-oxide], each expressed as the parent compound], in or on canola, seed at 0.03 parts per million (ppm).

Section 408(b)(2)(A)(i) of the 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 the 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 the 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....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of the 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, consistent with section 408(b)(2) of the FFDCA, for a tolerance for combined residues of carboxin (5,6-dihydro-2-methyl-N-phenyl-1,4-oxathiin-3-carboxamide) and its metabolite 5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-oxide (calculated as carboxin) (from treatment of seed prior to planting) on canola, seed at 0.03 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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. The nature of the toxic effects caused by carboxin are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for carboxin used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.301) for the combined residues of carboxin and its sulfoxide metabolite, in or on a variety of raw agricultural commodities (RAC). Risk assessments were conducted by EPA to assess dietary exposures from carboxin and its sulfoxide metabolite in food as follows:

i. Acute exposure . Acute dietary 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 toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on carboxin. As a result, an acute endpoint was not identified and an acute dietary exposure assessment was not performed.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the Department of Agriculture (USDA) 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The chronic dietary exposure analysis was an unrefined assessment. Tolerance level residues and 100% crop treated assumptions were used.

iii. Cancer . Carboxin was classified as “not likely to be carcinogenic to humans.” Therefore, a cancer dietary exposure assessment was not performed.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for carboxin and its sulfoxide metabolite] in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of carboxin and its sulfoxide metabolite.

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop (PC) area factor as an adjustment to account for the maximum PC coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to carboxin and its sulfoxide metabolite they are further discussed in the aggregate risk sections in Unit E.

Based on the FIRST and SCI-GROW models the estimated environmental concentrations (EECs) of carboxin and its sulfoxide metabolite for acute exposures are estimated to be 29.6 parts per billion (ppb) for surface water and 0.09 ppb for ground water. The EECs for chronic exposures are estimated to be 0.63 ppb for surface water and 0.09 ppb for ground 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). Carboxin is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the 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.”

EPA does not have, at this time, available data to determine whether carboxin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, carboxin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that carboxin has 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 the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold 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 that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . The developmental toxicity and reproduction studies performed with carboxin did not indicate evidence for enhanced susceptibility to the fetuses/offspring of rats or rabbits. Neither quantitative nor qualitative increased susceptibility was observed in the developmental toxicity study in rats, the developmental toxicity study in rabbits, or the 2-generation reproduction toxicity study in rats. In none of the toxicity studies on carboxin was there any toxicologically significant evidence of treatment-related neurotoxicity. A developmental neurotoxicity study in rats is not required. There is, however, a concern for possible germinal cell toxicity.

In genotoxicity studies, carboxin demonstrated clear evidence of clastogenic potential. It was also noted that in the 2-generation reproduction study in rats, treatment-related decreased fertility indices for the F1b male and female parents (due to a decreased number of pregnancies for the F2b generation) were observed. Based on these considerations, the registrant will be required to submit a germinal cell assay, specifically a dominant lethal assay in rats, to the Agency in order to evaluate possible interaction between carboxin and germinal cell targets.

3. Conclusion . Based upon clear evidence of clastogenic activity and the requirement for a dominant lethal study, EPA concluded that a FQPA safety factor of 3X is appropriate for this risk assessment. The safety factor of 10X was reduced to 3X because: i. There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure; ii. A developmental neurotoxicity study is not required; iii. The dietary (food and drinking water) exposure assessments will not underestimate the potential for exposures to infants and children; and iv. There are no registered residential uses for carboxin.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model EECs of a pesticide. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . No toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on carboxin. As a result, carboxin 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 exposure to carboxin and its sulfoxide metabolite from food will utilize 41% of the cPAD for the U.S. population and 92% of the cPAD for children 1-6 years, the most highly exposed population. There are no residential uses for carboxin. In addition, there is potential for chronic dietary exposure to carboxin and its sulfoxide metabolite in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term and Intermediate-term risk . Both short-term aggregate exposure and intermediate-term aggregate exposure take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Since carboxin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern as described in Table 3.

4. Aggregate cancer risk for U.S. population . Carboxin was classified as “not likely to be carcinogenic to humans.” Therefore, carboxin is not expected to pose a cancer risk.

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, and to infants and children from aggregate exposure to residues of carboxin and its sulfoxide metabolite.

FQPA requires EPA to develop a screening program to determine whether certain substances (including all pesticides and inerts or inactive ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect...” EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. In the available toxicity studies for carboxin, there is no evidence of endocrine disruptor effects. When appropriate screening and/or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, carboxin may be subjected to further screening and/or testing to better characterize effects related to endocrine disruption.

The current available enforcement methods for tolerances of the combined residues of carboxin and its carboxin sulfoxide metabolite are described in the Pesticide Analytical Manual (PAM) Vol. II. Method I is a colorimetric method which is used for determination of residues in or on corn, peanuts, rice, rice straw, sorghum, soybeans, eggs, meat, and milk. Method II and its modification, Method A, are gas liquid chromatography (GLC) methods which are used for wheat, oats, barley, peanuts, peanut oil and meal, sorghum, cottonseed, and cottonseed oil and meal. Adequate recovery data were submitted to validate the methods used in the canola field trials. Residues in canola seeds were converted to aniline, which was derivatized with heptafluorobutyric anhydride prior to gas chromatography mass selective detector (GC/MSD) analysis. Recoveries were 100-103% for 0.025 ppm fortifications in canola seeds.

Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, U.S. Environmental Protection Agency, 701 Mapes Road, Fort George G. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: griffith.francis@epa.gov.

There are no CODEX, Canadian, or Mexican maximum residue levels (MRLs) for carboxin in/on onion seed. As a result, harmonization of tolerances is not an issue.

Therefore, the tolerance is established for combined residues of carboxin, (5,6 dihydro-2-methyl-N-phenyl-1,4-oxathiin-3-carboxamide) and its metabolite 5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-oxide (calculated as carboxin) (from treatment of seed prior to planting) insert regulated chemical, in or on canola, seed at 0.03 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object”” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0326 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 on or before February 7, 2003.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA;. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov , or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2002-0326, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under section 408(d) of the 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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. , or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this 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 manufacture (defined by statute to include import) any of the chemical substances that are listed in Table 1 of this unit. Persons who intend to import any chemical substance governed by a final SNUR are subject to TSCA section 13 (15 U.S.C. 2612) import certification requirements, and to the regulations codified at 19 CFR 12.118 through 12.127 and 12.728. Those persons must certify that they are in compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export any of the chemical substances listed in Table 1 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR 721.20 and 40 CFR part 707, subpart D.Potentially affected entities may include, but are not limited to:

• Chemical manufacturers or importers (NAICS 325), e.g., persons who manufacture (defined by statute to include import) one or more of the subject chemical substances.

• Chemical exporters (NAICS 325), e.g., persons who export, or intend to export, one or more of the subject chemical substances.

This listing is not intended to be exhaustive, but rather provides 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5 for SNUR-related obligations. Also, consult Unit II. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPPT-2002-0043. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ”listings at http://www.epa.gov/fedrgstr/.A frequently updated electronic version of 40 CFR part 721 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr721_00.html, a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

This action promulgates the supplemental proposed SNUR published in the Federal Register of March 11, 2002 (67 FR 11014) (FRL-6823-7), which modified the original proposed SNUR published in the Federal Register of October 18, 2000 (65 FR 62319) (FRL-6745-5).

This rule requires persons to notify EPA at least 90 days before commencing the manufacture or import of the chemical substances identified in Table 1, Unit I.A., for the significant new uses described in this document. The chemical substances identified in Table 1, Unit I.A., are 75 chemical substances, including PFOSH, PFOSS, POSF, certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to throughout this rule as PFAS. In the original proposed SNUR, these chemicals were referred to collectively as perfluorooctyl sulfonates, or PFOS, but commenters noted that this generic usage of the term PFOS was inconsistent with the use by the manufacturer of PFOS, 3M, to refer only to chemicals with an eight-carbon, or C8, chain length. Many of the chemicals in this SNUR include a range of carbon chain lengths, although most include C8 within the range. Accordingly, EPA uses the generic term PFAS to refer to any carbon chain length, including mixed ranges and higher and lower homologues as well as C8, and the term PFOS to represent only those chemical substances which are predominantly C8.

The significant new uses described in this document are:

1. Any manufacture or import for any use of any chemical listed in Table 1, Unit I.A., on or after January 1, 2003, except as noted in Unit II.A.2.

2. Manufacture or import of any chemical listed in Table 1, Unit I.A., solely for one or more of the following specific uses shall not be considered as a significant new use subject to reporting under this section:

i. Use as an anti-erosion additive in fire-resistant phosphate ester aviation hydraulic fluids.

ii. Use as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices.

iii. Use in coatings for surface tension, static discharge, and adhesion control for analog and digital imaging films, papers, and printing plates, or as a surfactant in mixtures used to process imaging films.

iv. Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in Unit II.A.2.i., ii., or iii.

The chemical substances subject to this SNUR are listed in Table 1, Unit I.A. Most of these PFAS chemical substances include the C8 chain length characteristic of PFOS and thus have the potential to degrade to PFOSH in the environment or to be converted to PFOSH via incomplete oxidation during the incineration of PFOS-containing materials. Once PFOSH has been released to the environment, it does not undergo further chemical (hydrolysis), microbial, or photolytic degradation. PFOS is highly persistent in the environment and has a strong tendency to bioaccumulate. Studies have found PFOS in very small quantities in the blood of the general human population as well as in wildlife, indicating that exposure to the chemicals is widespread, and recent tests have raised concerns about their potential developmental, reproductive, and systemic toxicity (Refs. 1, 2, and 3). These facts, taken together, raise concerns for long term potential adverse effects in people and wildlife over time if PFOS should continue to be produced, released, and built up in the environment.

3M, the principal manufacturer of PFAS worldwide, voluntarily committed to discontinue the production of the specific PFOS-based PFAS chemicals covered by this rule by December 31, 2002 (Ref. 4). Based on the information EPA possessed when the original proposed SNUR was published, EPA concluded that this action by 3M would reduce manufacture and importation of these chemicals to zero, with a corresponding reduction in the type, form, and duration of exposure to these chemicals. EPA therefore concluded that any subsequent new manufacture or importation of these chemicals would constitute a significant new use.

Commenters on the original SNUR proposal provided information confirming that, contrary to the information available to the EPA when the original proposed SNUR was published, 3M was not the sole manufacturer of certain of the chemical substances on Table 1, Unit I.A.These commenters were importing a few of these substances in small quantities below mandatory reporting thresholds for their specific uses from non-3M sources outside the United States prior to the publication of the proposed SNUR. The identities, amounts, and suppliers of those specific chemicals were claimed as CBI, and thus cannot be specifically identified in this rule. To the extent that specific PFAS chemical substances on the proposed SNUR lists were being obtained from sources other than 3M for specific uses prior to the publication of the proposed SNUR, and thus would not be affected by 3M's unilateral decision to discontinue production, the manufacture of those specific chemicals for particular uses is considered to be ongoing and would not be subject to a significant new use determination. These specific uses are as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. Accordingly, this SNUR identifies the manufacture or importation of chemicals listed in Table 1, Unit I.A., for these specific uses as not being a significant new use.

Commenters on the original SNUR proposal who had obtained listed chemicals only from 3M sources prior to the publication of the proposed SNUR also identified non-3M sources for specific PFAS chemicals that were essential to their specific uses in the semiconductor, aviation hydraulics, and imaging industries. Based on the information presented by these commenters about the limited volume of their uses, the extent of controls on exposure and releases, and the absence of viable alternatives for these specific chemicals, some of which are claimed as CBI and thus cannot be specifically identified in this rule, this SNUR identifies the manufacture of chemicals in Table 1, Unit I.A., for these specific uses as not being significant new uses. Manufacture or importation of these chemicals for these uses is thus not subject to this SNUR. Because certain of the SNUR chemicals are intermediates required in the manufacture of the specific listed chemicals associated with these excluded uses, the use of PFAS chemicals listed in Table 1, Unit I.A., as intermediates solely to produce other chemicals for one or more of the specific excluded uses is also excluded from the definition of a significant new use.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” The Agency makes this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). These factors include the volume of a chemical substance's production or importation; the extent to which a use changes the type, form, magnitude, or duration of exposure to the substance; and the reasonably anticipated manner of producing or otherwise managing the substance. Once EPA makes this determination and promulgates a SNUR, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that significant new use (15 U.S.C. 2604 (a)(1)(B)).

As noted in the proposed SNUR, EPA believes that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish SNUR notice requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing.

Accordingly, persons who may have begun commercial manufacture or import of the PFAS chemicals listed in Table 1, Unit I.A., for the significant new uses listed in this final SNUR after the initial proposal was published on October 18, 2000, must stop that activity before the effective date of this final rule. Persons who cease those activities will have to meet all SNUR notice requirements and wait until the end of the notice review period, including all extensions, before engaging in any activities designated as significant new uses. If, however, persons who may have begun commercial manufacture or import of these chemical substances between the proposal and the effective date of the SNUR meet the conditions of advance compliance as codified at 40 CFR 721.45(h), those persons will be considered to have met the final SNUR requirements for those activities.

Eight parties submitted timely comments on the supplemental proposed SNUR. All of the comments generally supported the SNUR, although several of them requested clarification of specific points. Two parties submitted late comments addressing broader issues of EPA's SNUR authority.

Three of the comments, from Solutia, Inc., ExxonMobil Biomedical Sciences, Inc., and Boeing Company, supported the approach and language of the proposed SNUR with respect to the aviation hydraulics use.

The Semiconductor Industry Association and Semiconductor Equipment and Materials, Inc. (SIA/SEMI), submitted joint comments generally approving the proposed SNUR, but requested clarification on two issues, including the scope of the proposed exclusion of the semiconductor photomicrolithography use from the rule and the application of the section 12(b) export notification requirements of TSCA to the export of chemicals and products intended for the excluded use. SIA/SEMI noted that the photomicrolithography processes used in the semiconductor industry are used to produce not only semiconductors, but also electronic components of disk drives, electronics packaging, micromachines, and optoelectronic devices and circuits. SIA/SEMI indicated that they read the proposed exclusion to apply to such production activities, which were included in the industry mass balance materials they supplied to the Agency, and asked EPA to confirm that understanding. EPA acknowledges that the language of the exclusion, which describes “... a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices,” is intended to apply to all of these activities for which the semiconductor industry, in its data submissions to the Agency, detailed the current need to use PFAS to achieve the technical requirement of fineness of lines requiring sharp definition in the submicron area. EPA agrees that the specific items listed by SIA/SEMI are “components of electronic or other miniaturized devices.” Broader photolithography uses are not intended to be covered by this exclusion, and manufacture or importation of listed PFAS chemicals for such uses is considered to be a significant new use subject to this rule.

With respect to TSCA section 12(b), SIA/SEMI stated that it assumes that a person who exports one of the chemicals covered by the SNUR for a use that is excluded from the SNUR would not need to meet export notification requirements for such exports. EPA does not concur with this interpretation. Section 12(b)(2) of TSCA provides that, “If any person exports or intends to export to a foreign country a chemical substance or mixture for which ... a rule has been proposed or promulgated under section 5 ..., such person shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of such rule ...” Regulations implementing TSCA section 12(b) are at 40 CFR part 707, subpart D.

The TSCA section 12(b) export notification requirement for a chemical is not contingent on whether the intended use of the chemical has been regulated under the SNUR, and EPA does not interpret TSCA section 12(b) to include an exemption for uses that are not regulated. In promulgating the original TSCA section 12(b) regulations, EPA explained its position, “that the export notification requirement for a chemical is not contingent on whether the intended use of the chemical has been regulated . . . Notice must be given to EPA even though the chemical is being exported for a use, or in a manner, that is not regulated domestically under the relevant TSCA section 5, 6, or 7 action, rule or order.” (45 FR 82844, 82846, December 16, 1980.) Under TSCA section 12(b), the Agency is responsible for informing the importing country about actions taken with respect to a chemical that is the subject of a proposed or final SNUR. This notice includes information about any exempt uses within the United States. It is up to the foreign government to determine what action, if any, should be taken with respect to the substance in that country. The Agency also notes that, in many cases, the exporter will not know the use of the substance or mixture being exported. Requiring the exporter to make a use determination would be unnecessarily burdensome, and could be impossible in some cases. Accordingly, EPA believes its current interpretation of TSCA section 12(b) best furthers the intent of the statute.

Air Products Electronic Chemicals (APEC) requested that the Agency clarify specifically whether the semiconductor photomicrolithography exclusion would apply to developer products with a PFAS component. This exclusion applies only to “components of photoresist substances” and “components of anti-reflective coatings.” Developers are not components of either “photoresist substances” or “anti-reflective coatings,” and thus are not included within the scope of the exclusion. The manufacture or importation of PFAS for use in developers and polyimides is considered a significant new use under this rule.

The Eastman Kodak Company filed comments and supporting materials on behalf of the International Imaging Industry Association (I3A), requesting minor changes to the language of the proposed exclusion for certain imaging uses and providing substantial information on the industry's reductions in PFAS use and on the details of PFAS use, exposures, and releases by the industry. I3A also met twice with the Agency to present information and answer questions, and materials and correspondence from those meetings were included in the rulemaking record. The language changes requested by I3A help to clarify the intended application of the exclusion, and have been incorporated into the regulatory text of the rule.

The specific imaging uses excluded from the significant new use definition are uses in coatings for surface tension, static discharge, and adhesion control for analog and digital imaging films, papers, and printing plates, or as a surfactant in mixtures used to process imaging films. Coatings for surface tension control allow the rapid spreading of multiple thin layers of light-sensitive materials at high speed to prevent drying of materials as they are laid down. This prevents irregularities in the coating which would make the films, papers, or printing plates unuseable. Coatings to control static discharge help to repel dirt, reduce friction, and thus prevent the discharge of static electricity otherwise built up during the transport of imaging materials through manufacturing and image processing equipment. This prevents light-sensitive imaging materials from being fogged and rendered useless by light from a static discharge. Because tape is the primary way in which imaging materials are attached to spools and to each other during processing, adhesion control coatings help to ensure that the bond between the tape and the coating will be strong enough to withstand transport during use and processing, but will separate before it would damage either the imaging material or the equipment.

The exclusion for use of PFAS as a surfactant in mixtures used to process imaging films involves incorporation of a PFAS material into a mixture that is used as a photoprocessing solution where its surfactant properties function to prevent discoloration of films while the films are being processed through the solution. This exclusion applies only to processing films. Use as a surfactant in mixtures to process papers and printing plates would be a significant new use under the rule.

The I3A comments and supporting documents characterized the specific uses, exposures, and releases of PFAS materials in the imaging industry in such a way as to greatly improve the Agency's understanding. The submission also reflected a significant reduction in the use of the chemicals subject to the SNUR. Comments on the original SNUR proposal indicated that the annual worldwide usage volume of these chemicals was approximately 36,000 kilograms (kg) (79,200 pounds), of which the U.S. consumption was approximately 18,000 kg/year (yr). The recent I3A comments reported that the United States demand for these chemicals is expected to be down to 3,000 kg/yr by the end of 2002. Of this amount, I3A estimates that less than 50 kg/yr are used for paper products and less than 300 kg/yr are used for printing plates, with the remainder being used for various film products in the United States. Of the remaining 2,650 kg/yr that are used for film, I3A estimates that 30 kg/yr are used as a surfactant in processing solutions and 2,620 kg/yr are used in film coatings. I3A reported that the industry has pursued alternative chemicals aggressively, indicating that the PFAS usage volumes are expected to continue to decline over time. EPA commends the members of I3A for the significant steps made in reducing the use of the PFAS chemicals listed in the SNUR, and for the effort expended in supplying the Agency with a substantial base of information on which to make its decision.

3M requested clarification of the SNUR scope and nomenclature to emphasize that the hazard assessment supporting the proposed rule addressed only PFOS, the C8 chain length, not the entire range of PFAS chemicals covering all carbon chain lengths. 3M also stated that all of the chemicals voluntarily discontinued by 3M and subject to the SNUR would be properly characterized as being predominantly C8, or PFOS, and expressed concern that using the PFAS term in connection with the regulation of these specific chemicals could be confusing because many PFAS chemicals exist that are not subject to this rule. In this final rule, EPA has continued to use the PFAS name for the entire category, but has attempted to make clear that most of the chemicals subject to this rule do include the C8 chain length specifically of concern, although individual chemicals on the list include a range of higher and lower homologues in addition to C8. EPA acknowledges that the hazard assessment supporting the original proposed rule addressed only C8, or PFOS, chemicals, and not the full range of homologues.

3M requested that EPA clarify its future regulatory intentions with respect to these related chemicals. As indicated in the supplemental proposed SNUR, EPA is evaluating and assessing other PFAS and PFAS-related chemicals not listed in this rule. It is true that other PFAS chemicals, including lower homologues, have distinct hazard profiles and may not present the same concerns expressed by EPA with respect to PFOS. However, EPA is reviewing data on those other homologues, and, if warranted, will take action as appropriate on other PFAS chemicals. Because of the unique properties of perfluorinated compounds, EPA is currently assessing a variety of these compounds to determine their hazard profiles, including not only PFAS chemicals but also perfluorooctanoic acid (PFOA) and its salts, as well as fluorinated telomers. That these chemicals are currently under assessment does not necessarily indicate that regulation will follow; it indicates only that EPA is seeking answers to questions that have been raised about these chemicals and their behavior.

3M also requested that EPA acknowledge the substantial amount of data on PFOS submitted by 3M since the drafting of the original hazard assessment, and acknowledge the effort underway by the Organization for Economic Cooperation and Development (OECD) to prepare an international hazard assessment on PFOS. EPA has been an active contributor to the OECD assessment effort, and toward that end, has been reviewing all of the data submitted by 3M and others with respect to PFOS. EPA commends 3M for the extensive research it has conducted and continues to pursue to improve the understanding of these unique chemicals. When the OECD assessment document is released, it will be included in both the docket for this rule, and in Administrative Record (AR) file AR-226. AR-226 is the non-regulatory public access file for information on all the related fluorinated chemicals being assessed by the EPA, including PFOS, PFAS, PFOA and its salts, and fluorinated telomer chemicals. Copies of the index to and all documents contained within AR-226 can be obtained through the docket facility identified in Unit I.B.1.

Waste Not questioned whether PFAS chemicals previously on the list of pesticide inerts would continue to be listed, whether one named chemical on the inerts list was included in the SNUR, and whether its understanding of the status of sulfluramid products was correct. Waste Not also asked whether EPA would identify crops on which these products were used. EPA confirms that none of the PFAS chemicals on the inerts list identified by Waste Not , including the named chemical without a CAS number provided, are currently formulated into pesticide products, and they will all be removed from the EPA List 3 Inerts list the next time that list is updated. EPA notes that, although these PFAS chemicals will remain on the List 3 Inerts list until that list is updated, the manufacture or import of chemicals listed in this rule for use as inert ingredients in pesticide products would be a significant new use subject to this rule. Although TSCA does not regulate chemicals manufactured for use solely as pesticide active ingredients, chemical intermediates and pesticide inert ingredients are subject to regulation under TSCA.

With respect to Waste Not 's comment concerning the current status of registered insecticide products containing sulfluramid, EPA concurs with the list of active and cancelled products provided by Waste Not . There are currently 16 products listed as active and 3 products cancelled. Three of the four products listed as transferred, EPA Registration Nos. 11540-21, 1812-330, and 1812-329, are the same as the three products listed as cancelled. The fourth product listed as transferred, EPA Registration No. 11540-20, is the same as the active product under EPA Registration No. 499-45. All pesticide products containing sulfluramid are under a specific timeline to be phased out by 2016. The pesticide products that are registered are for use in a variety of enclosed termite, ant, and roach bait stations. These products are pre-filled and sold only in child-resistant packaging. Products containing sulfluramid have not been registered for food or crop uses.

The American Chemistry Council (ACC) filed late comments supporting the effort by EPA and industry to address concerns pertaining to PFAS compounds on a cooperative basis, but also expressed the opinion that an increase in manufacture or importation for an existing use should not be considered a “new use” within the meaning of TSCA section 5(a)(2). ATOFINA Chemicals, Inc. filed late comments supporting the comments of ACC. As no volume cap or trigger on manufacturing or importation for an existing use has been incorporated into this rule, EPA will not address this issue in the context of this rule. In addition, EPA believes ACC's and ATOFINA's comments present a broader legal issue regarding EPA's authority under TSCA section 5, rather than specific issues related to PFAS. EPA does not believe it is necessary or appropriate to engage in a broader legal discussion in the context of this specific SNUR.

These references have been placed in the official record that was established under docket ID number OPPT-2002-0043 for this rulemaking as indicated in Unit I.B.1. Reference documents identified with an AR number are cross-indexed to non-regulatory, publicly accessible information files maintained in the OPPT Docket. Other documents which the Agency considers relevant to this final rule have previously been identified in the Federal Register in the proposed and supplemental proposed SNURs discussed in Unit II.A. Copies of these documents can be obtained as described in Unit I.B.1.

1. (AR226-0620) Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1, 2000.

2. (AR226-0547) The Science of Organic Fluorochemistry. 3M. St. Paul, MN. February 5, 1999.

3. (AR226-0548) Perfluorooctane Sulfonate: Current Summary of Human Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999.

4. (AR226-0550) Fluorochemical Use, Distribution, and Release Overview. 3M. St. Paul, MN. May 26, 1999.

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that SNURs are not a “significant regulatory action” subject to review by OMB, because SNURs do not meet the criteria in section 3(f) of the Executive order.

According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq ., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the Federal Register and in addition to its display on any related collection instrument, are listed in 40 CFR part 9.

The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188.06). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 98.96 and 118.92 hours per response at an estimated reporting cost of between $5,957 and $7,192 per SNUN. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review and submit the required SNUN, and maintain the required records. This burden estimate does not include 1 hour of technical time at $64.30 per hour estimated to be required for customer notification of SNUR requirements, or the $2,500 user fee for submission of a SNUN ($100 for businesses with less than $40 million in annual sales).

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information, Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new,” and based on all information currently available to EPA, it appears that no small or large entities currently engage in such activity. Since a SNUR requires merely that any person who intends to engage in such activity in the future must first notify EPA (by submitting a SNUN), no economic impact will even occur until someone decides to engage in those activities. As a voluntary action, it is reasonable to presume that this decision would be based on a determination by the person submitting the SNUN that the potential benefits would outweigh the costs. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. EPA's experience to date is that, in response to the promulgation of over 530 SNURs, the Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to be from small entities. In fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR. Therefore, EPA believes that the economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. This rationale has been provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with past SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

This rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 276755, May 19, 1998), do not apply to this rule. Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), which took effect on January 6, 2001, revokes Executive Order 13084 as of that date. EPA developed this rulemaking, however, during the period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084. For the same reasons stated for Executive Order 13084, the requirements of Executive Order 10175 do not apply to this rule either.

This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This 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), because this action is not expected to affect energy supply, distribution, or use.

In addition, since this action does not involve any technical standards, 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), does not apply to this action.

This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive order.

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

The Congressional Review Act, 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and 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 the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Section 648.72(c) of the regulations implementing the Fishery Management Plan (FMP) for the Atlantic Surf Clam and Ocean Quahog Fisheries allows the Administrator, Northeast Region, NMFS (Regional Administrator) to suspend annually, by publication of a notification in the Federal Register , the minimum size limit for Atlantic surf clams. This action may be taken unless discard, catch, and survey data indicate that 30 percent of the Atlantic surf clam resource is smaller than 4.75 inches (12.07 cm) and the overall reduced size is not attributable to harvest from beds where growth of the individual clams has been reduced because of density-dependent factors.

At its June 2002, meeting, the Mid-Atlantic Fishery Management Council (Council) voted to recommend that the Regional Administrator suspend the minimum size limit. Commercial surf clam shell length data for 2002 were analyzed to determine the percentage of surfclams landed that were smaller than the minimum size requirement. The analysis indicated that 14 percent of the samples taken overall were composed of surf clams that were less than 4.75 inches (12.07 cm). Based on these data, the Regional Administrator adopts the Council's recommendation and suspends the minimum size limit for Atlantic surf clams from January 1, 2003, through December 31, 2003.

This action is authorized by 50 CFR part 648 and is exempt from review under Executive Order 12866.