Under the Federal Election Campaign Act of 1971 (“FECA” or the “Act”), as amended, 2 U.S.C. 431 et seq. , a national committee, State committee, or a subordinate committee of a State committee of a political party may make expenditures in coordination with a Federal candidate for that candidate's general election campaign up to prescribed limits without these expenditures counting against the party committee's contribution limits. 2 U.S.C. 441a(d)(1)-(3). While the Act limits coordinated expenditures, political party committees may make unlimited “independent expenditures,” which are not coordinated with a candidate's campaign. See Colorado Republican Federal Campaign Committee v. FEC , 518 U.S. 604 (1996) (“Colorado I”). 1

Section 213 of the Bipartisan Campaign Reform Act of 2002 (Pub. L. 107-155 (Mar. 27, 2002)) (“BCRA”) amended 2 U.S.C. 441a(d), by prohibiting political party committees, under certain conditions, from making both coordinated party expenditures and independent expenditures with respect to the same candidate, and from making transfers and assignments to other political party committees. 2 U.S.C. 441a(d)(4).

In 2002, the Commission promulgated rules at 11 CFR 109.35 to implement section 213. Coordinated and Independent Expenditures; Final Rules, 68 FR 421, 422 (January 3, 2003).

Subsequently, in McConnell v. FEC , 540 U.S.__; 124 S.Ct. 619, 700-704 (2003), the Supreme Court found section 213 unconstitutional. The Court held that by requiring political parties to choose between coordinated and independent expenditures during the post-nomination, pre-election period, section 213 placed an unconstitutional burden on the parties' right to make unlimited independent expenditures. 124 S.Ct. at 700-704. Accordingly, the Commission now proposes to remove its regulations at 11 CFR 109.35 implementing BCRA section 213 and to delete from other regulations cross-references to the rules that would be removed.

The Commission proposes to revise section 102.6 by deleting the cross-reference to current section 109.35, which the Commission proposes to remove.

The Commission proposes to revise section 106.8 by deleting the cross-reference to current section 109.35, which the Commission proposes to remove.

The Commission proposes to revise section 109.30 by deleting the cross-references to current section 109.35, which the Commission proposes to remove.

The Commission proposes to revise section 109.33 by deleting the cross-reference to current section 109.35, which the Commission proposes to remove.

The Commission proposes to remove and reserve current section 109.35, because, as explained above, the statutory foundation for this section, 2 U.S.C. 441a(d)(4), has been invalidated by the Supreme Court.

The Commission proposes to revise section 109.36 by deleting the word “additional” in the heading of section 109.36, because, if section 109.35 is removed, the circumstances described in section 109.36 will be the only circumstances under which a political party committee is prohibited from making independent expenditures.

The attached proposed rules, if promulgated, would not have a significant economic impact on a substantial number of small entities. The basis of this certification is that the national, State, and local party committees of the two major political parties are not small entities under 5 U.S.C. 601 because they are not small businesses, small organizations, or small governmental jurisdictions.

To the extent that political party committees may fall within the definition of “small entities,” their number is not substantial. In addition, the proposed rules would remove, not add, restrictions applicable to political party committees.

For the reasons set out in the preamble, the Federal Election Commission proposes to amend Subchapter A of Chapter I of Title 11 of the Code of Federal Regulations as follows:

The insular possessions watch industry provision in Sec. 110 of Pub. L. No. 97-446 (96 Stat. 2331) (1983), as amended by Sec. 602 of Pub. L. No. 103-465 (108 Stat. 4991) (1994); additional U.S. Note 5 to chapter 91 of the Harmonized Tariff Schedule of the United States (“HTSUS”), as amended by Pub. L. 94-241 (90 Stat. 263) (1976) requires the Secretary of Commerce and the Secretary of the Interior (“the Secretaries”), acting jointly, to establish a limit on the quantity of watches and watch movements which may be entered free of duty during each calendar year. The law also requires the Secretaries to establish the shares of this limited quantity which may be entered from the Virgin Islands, Guam, American Samoa and the Commonwealth of the Northern Mariana Islands. After the Departments have verified the data submitted on the annual application (Form ITA-334P), the producers' duty-exemption allocations are calculated from the territorial share in accordance with 15 CFR 303.14 and each producer is issued a duty-exemption license. The law further requires the Secretaries to issue duty-refund certificates to each territorial watch and watch movement producer based on the company's duty-free shipments and creditable wages paid during the previous calendar year.

We propose amending Sec.303.14(b)(3) by raising the maximum total value of watch components per watch that are eligible for duty-free entry into the U.S. from $500 to $800. The insular watch program producers requested an increase primarily due to a substantial increase in the price of gold and the weakness of the dollar against the euro over the last several years. Also, there has not been an adjustment in the maximum value since 1998. Raising the value levels of watch components that may be used in the assembly of duty-free watches will help producers maintain the level of diversity in the kinds of watches they assemble, thereby affording them an opportunity to maintain or hopefully increase shipments and raise territorial employment.

Regulatory Flexibility Act. In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , the Chief Counsel for Regulation at the Department of Commerce has certified to the Chief Counsel for Advocacy, Small Business Administration, that the proposed rule, if promulgated as final, will not have a significant economic impact on a substantial number of small entities. There are currently four watch companies in the insular watch program, all of which are small entities. This rulemaking would update the total maximum value of watch components per watch that are eligible for duty-free entry into the U.S. Increases in the price of gold and a weakened dollar against the euro have driven up the price of gold watch components. Therefore, companies are faced with a difficult situation because if the value limit is exceeded, the watch becomes ineligible for the duty-free benefit under the program (due to the fact that the insular possessions are outside the Customs territory of the United States). Adoption of this rule would increase the maximum value of watch components per watch that would be eligible for duty-free treatment into the United States. This would allow producers to include higher-priced components in their watches. As a result, producers would realize an economic benefit in that they would regain greater flexibility in the types of watches they could produce, which, hopefully, will lead to increased sales and employment to help the insular economy. There would be no adverse economic impact from this proposed change.

This proposed rule also would not change reporting or recordkeeping requirements. The changes in the regulations will also not duplicate, overlap or conflict with other laws or regulations. Consequently, the changes are not expected to meet of the RFA criteria of having a “significant” economic effect on a “substantial number” of small entities, as stated in 5 U.S.C. 603 et seq. Therefore, a regulatory flexibility analysis was not prepared.

Paperwork Reduction Act. This proposed rulemaking does not contain revised collection of information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Collection activities are currently approved by the Office of Management and Budget under control numbers 0625-0040 and 0625-0134.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information unless it displays a currently valid OMB Control Number.

E.O. 12866. It has been determined that the proposed rulemaking is not significant for purposes of Executive Order 12866.

For reasons set forth above, the Departments propose to amend 15 CFR Part 303 as follows:

The Joint Board for the Enrollment of Actuaries (Joint Board) was established on October 31, 1974, pursuant to section 3041 of the Employee Retirement Income Security Act of 1974 (ERISA). Section 3042 of ERISA provides that the Joint Board shall, by regulations, establish reasonable standards and qualifications for persons performing actuarial services under ERISA and enroll qualified actuaries. It also provides that the Joint Board may, after notice and an opportunity for a hearing, suspend or terminate the enrollment of an actuary who fails to discharge his or her duties under ERISA or who does not satisfy the requirements for enrollment.

Consistent with section 3042 of ERISA, the Joint Board has promulgated regulations, addressing eligibility for enrollment, requirements for continuing education of enrolled actuaries, professional standards for performance of actuarial services under ERISA, bases for disciplinary actions and the procedures to be followed in taking those actions. Those regulations are found at 20 CFR part 901 and were last amended in 1988. 1

In recent years, the Joint Board has noted that changes in the actuarial profession, as well as modern innovations, such as the availability of alternative modes of training, are not adequately addressed in the regulations, thus necessitating revision of the regulations.

Prior to issuing proposed regulations, the Joint Board wishes to obtain comments from the public regarding matters for consideration, including but not limited to the following areas:

(1) Whether and to what extent the provisions in the current regulations on the procedures and conditions for enrollment and renewal of enrollment should be updated or revised, including provisions on qualifying experience, the structure and content of the basic and pension examinations, the completion of professional society examinations and qualifying formal education in lieu of the basic and pension examinations, and the definitions of terms used in the regulations.

(2) Whether and to what extent provisions in the current regulations on Continuing Professional Education (CPE) should be updated or revised, including those relevant to formal and informal programs, the means for measuring attendance and completion, and acceptability of new technologies (computer-based programs, webcasts, recorded telecasts, audiotapes, videotapes, etc.).

(3) Whether and to what extent provisions in the current regulations relevant to waivers of the CPE requirement should be updated or revised, including the circumstances, conditions, and limitations under which a waiver might be granted.

(4) Whether and to what extent provisions in the current regulations on the types of enrollment statuses (active, inactive, retired) should be updated or revised, including the incorporation of limitations on the number of consecutive enrollment cycles during which an individual may be placed in either inactive or retired status.

(5) Whether and to what extent provisions in the current regulations relevant to standards of conduct, performance and practice that relate to enrolled actuaries' duties under ERISA should be updated or revised, including those relevant to conflicts of interest, professional independence, disciplinary procedures, and sanctions.

The Joint Board is also interested in obtaining information regarding the potential costs and benefits of any changes to the current regulations, including the potential impact of such changes on small entities. Therefore, in submitting comments in response to this notice, commentators are encouraged to include information with regard to the potential costs, benefits, and impact of any suggested regulatory changes for small businesses.

All comments submitted will be made available for public inspection and copying, although comments will not be individually acknowledged. Therefore, commentators should refrain from including personal information or other information that they believe should not be publicly disclosed. Additionally, in submitting comments with regard to some or all of the listed areas, please refer to the item numbers specified above.

The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq. ), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (Public Law 101-629), the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115), and the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendments devices, are classified after the following requirements are met: (1) FDA has received a recommendation from a device classification panel (an FDA advisory committee); (2) FDA has published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) FDA has published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Under section 520(l) of the act (21 U.S.C. 360j(l)), devices formerly regulated as new drugs are automatically classified into class III, unless the Secretary of Health and Human Services, in response to a reclassification petition, has classified the device into class I or II.

In the Federal Register of August 12, 1987 (52 FR 30082), FDA issued a final rule codifying the classification of “tricalcium phosphate for dental bone repair” as a class III device under the 1976 amendments. At that time, FDA was not aware that bone grafting material, other than TCP, was a preamendments device and inadvertently omitted classifying it. Consistent with the act and regulations, FDA has since consulted with the Dental Products Advisory Panel (the panel), an FDA advisory committee, regarding classification of this device.

On November 12, 2002, Bicon, Inc., Boston, MA, submitted a petition to FDA to reclassify beta-tricalcium phosphate for dental indications from “Class III to Class Unclassified” (Ref. 1). On December 9, 2002, the petitioner amended its petition to make clear that it was requesting that FDA reclassify beta-tricalcium phosphate from class III to class II. Beta-tricalcium phosphate and all other forms of tricalcium phosphate for dental bone repair, including alpha and amorphous forms, are transitional devices and are currently regulated as class III devices under 21 CFR 872.3930, “Tricalcium phosphate granules for dental bone repair,” requiring premarket approval. Consistent with section 520(l)(2) the act and the regulations in 21 CFR 860.136, FDA consulted with the panel regarding reclassification of this device.

Other bone grafting materials in the form of synthetic hard tissue replacements have been used in dentistry since the 1970s (Ref. 2). Because they were inadvertently omitted from the August 12, 1987, final rule classifying most dental devices, these other bone grafting materials are unclassified preamendments devices. Although unclassified, they are nevertheless subject to general controls, such as premarket notification. TCP and other bone grafting materials share the same indications, risks, and recommended mitigation measures.

FDA believes that one classification identification that encompasses all bone grafting materials for dental indications would provide a more scientifically accurate and more administratively transparent regulation for these materials. Therefore, FDA is identifying bone grafting material as a naturally or synthetically derived material, such as hydroxyapatite, tricalcium phosphate, demineralized bone additives, collagen, or polylactic acids, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

At the meeting of the Dental Products Advisory Panel held on May 22, 2003, the panel voted five to zero (with no abstentions) to recommend that TCP for dental indications be reclassified from class III to class II (special controls). The panel considered all forms of TCP, including beta-tricalcium phosphate, and concluded that special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of these bone grafting materials devices (Ref. 3).

In addition, on August 8 and 9, 1995, in accordance with the procedures set forth in 21 CFR 860.84, the panel considered classification of the non-TCP materials. The panel recommended unanimously that non-TCP bone grafting materials be classified into class II, except when intended to be used alone in filling or repair of bony defects and/or augmentation of the alveolar ridge. For that indication, the panel recommended placing the device in class III, but with a low priority for establishing an effective date for the requirement for premarket approval (Ref. 4).

For TCP for dental indications and for bone grafting materials for certain dental indications, the panel believed that special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of these devices and that there is sufficient information to establish special controls to provide such assurance.

The panel recommended that TCP should remain in class III when used alone in filling or repair of bony defects and/or augmentation of the alveolar ridge because they believed that the materials present risks to health that cannot be addressed by special controls.

For TCP for dental indications, the panel based its recommendation on the information provided by the petitioner and FDA, the presentations made by stakeholders and FDA at the panel meeting, the open discussion during the panel meeting, and the panel members' personal knowledge of and clinical experience with the device (Ref. 5). The panel did not discuss bone grafting materials containing a drug or biologic component.

For non-TCP materials, the panel based its recommendation on the information provided by FDA, presentations made by stakeholders who marketed bone filling and augmentation devices, the open discussion during the panel meeting, and the panel members' personal knowledge of and clinical experience with the device.

The panel identified the following risks to health associated with bone grafting material: Ineffective bone formation, adverse tissue reaction, infection, and improper use.

The quality and physical properties of bone grafting material may be insufficient to support the required loads and lead to device failure. Device failure may result in ineffective treatment, revision, and permanent impairment for the patient.

Inadequate biocompatibility of any of the components contained in bone grafting material may result in adverse tissue reaction and presents the potential for surgical revision (i.e., reoperation).

Implantation of an improperly sterilized device may result in an infection. Infection may result in revision or explantation of the device, which presents the potential for permanent impairment.

Inadequate labeling may result in improper use. Improper use may result in ineffective treatment and may cause permanent impairment.

FDA believes that bone grafting material that does not contain a drug or biologic component should be classified into class II and that TCP should be reclassified into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls to provide such assurance.

FDA disagrees with the (1995) panel's recommendation that bone grafting materials should remain in class III when used alone in filling or repair of bony defects and/or augmentation of the alveolar ridge. FDA believes that when used for these indications, the risks to health can be addressed by special controls and that all of these bone grafting material devices share the same risks and recommended mitigation measures. Accordingly, FDA has developed the draft guidance document entitled “Class II Special Controls Guidance Document: Dental Bone Grafting Material” to serve as the special control for TCP and other bone grafting material devices for dental indications. As noted previously, bone grafting material that contains a drug or biologic component would remain in class III and the special control guidance document would not apply.

FDA believes that the special controls guidance document entitled “Class II Special Controls Guidance Document: Dental Bone Grafting Material,” in addition to general controls, can address the risks to health described in section III of this document. Elsewhere in this issue of the Federal Register , FDA is announcing the availability of the draft guidance document.

If adopted, following the effective date of a final rule reclassifying and classifying the device, any firm submitting a 510(k) premarket notification for the device would need to address the issues covered in the special control guidance. However, the firm would need to show only that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

The special controls guidance document contains recommendations with regard to the information and testing that should be included in a premarket notification. The guidance document addresses the following topics: Characterization, biocompatibility, sterilization, and labeling. Adequate characterization of the composition, physical properties, and in vivo performance can address the risk of ineffective bone formation. Adequate biocompatibility can address the risk of adverse tissue reaction. Sterilization can address the risk of infection, and labeling can address the risk of improper use.

The agency is not proposing to exempt this device from the premarket notification requirements of the act, as permitted by section 510(m) of the act (21 U.S.C. 360(m)). FDA believes that it needs to review information in a premarket notification submission that addresses the risks identified in the guidance document in order to assure that a new device is at least as safe and effective as legally marketed devices of this type.

FDA proposes that any final rule that may issue based on this proposal become effective 30 days after its date of publication in the Federal Register .

The agency has determined under 21 CFR 25.34(b) that this proposed classification is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, as categorically excluded, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule is not a significant regulatory action as defined by the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Manufacturers of the preamendments devices that FDA is reclassifying are being relieved of the burden of eventually submitting a premarket approval application. Manufacturers of these devices are already subject to the premarket notification requirements. FDA has designated a guidance document as the special control. FDA believes that manufacturers, including small manufacturers, are already substantially in compliance with the recommendations in the guidance document, and they will not need to submit substantially more information in their premarket notification submissions in order to meet the recommendations in the guidance document or otherwise provide reasonable assurances of safety and effectiveness. FDA believes that any regulation based on this proposed rule will impose no significant economic impact on any small entities. The agency, therefore, certifies that this proposed rule will not have a significant impact on a substantial number of small entities. In addition, it will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore, a summary statement or analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA tentatively concludes that this proposed rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Request for Comments

We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking CGD01-03-107, indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of comments received.

We do not plan to hold a public meeting, but you may submit a request for a meeting by writing to Commander (oan) CGD01-03-107, First Coast Guard District, 408 Atlantic Ave., Boston, Massachusetts 02110 or delivering your request to room 628 at the same address above between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. In your request please explain why a public meeting would be beneficial. If we determine that a public meeting would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

As part of a waterfront revitalization and redevelopment effort, the City of Yonkers is proactively encouraging waterfront use by the general public. This proposed rule is in response to a request made by the City of Yonkers to help ensure the safe navigation of increased vessel traffic expected to arrive along the city waterfront due to this revitalization effort.

The Coast Guard is designating the areas as special anchorage areas in accordance with 33 U.S.C. 471. In accordance with that statute, vessels will not be required to sound signals or exhibit anchor lights or shapes which are otherwise required by rule 30 and 35 of the Inland Navigation Rules, codified at 33 U.S.C. 2030 and 2035. The two proposed special anchorage areas will be located on the west side of the Hudson River in the vicinity of Main Street and the JFK Marina, well removed from the channel and located where general navigation will not endanger or be endangered by unlighted vessels. Providing anchorage well removed from the channel and general navigation would greatly increase navigational safety.

While developing the proposed rule, in accordance with Title 33 of the Code of Federal Regulations, Part 109.05(b) the U.S. Coast Guard has consulted with the U.S. Army Corps of Engineers, New York District, located at 26 Federal Plaza, New York, NY 10278. The U.S. Army Corps of Engineers has determined that the proposed Special Anchorage Areas would not have an adverse affect on any federally maintained navigation channels in the area, structures the U.S. Army Corps of Engineers has permitted, or any pending permit applications submitted to the U.S. Army Corps of Engineers in this area.

The proposed rule would create two new special anchorage areas. The first, located on the Hudson River at Main Street, Yonkers, New York, would be that portion of the Hudson River starting on shore at point 40°56′15.4″ N, 073°54′11.1″ W; thence northwest to point 40°56′18.0″ N, 073°54′21.0″ W; thence south to point 40°55′58.8″ N, 073°54′24.8″ W; thence southeast to shore at point 40°55′58.0″ N, 073°54′21.0″ W.

The second, located on the Hudson River at JFK Marina, Yonkers, New York, would be that portion of the Hudson River starting on shore at point 40°57′28.5″ N, 073°53′46.0″ W; thence west to point 40°57′30.5″ N, 073°53′56.8″ W; thence southwest to point 40°57′07.5″ N, 073°54′06.2″ W; thence east to shore at point 40°57′08.0″ N, 073°53′58.5″ W. All proposed coordinates are North American Datum 1983 (NAD 83).

The special anchorage areas would be limited to vessels no greater than 20 meters in length. Vessels not more than 20 meters in length are not required to sound signals as required by rule 35 of the Inland Navigation Rules (33 U.S.C. 2035) or exhibit anchor lights or shapes required by rule 30 of the Inland Navigation Rules (33 U.S.C 2030) when at anchor in a special anchorage area. Additionally, mariners utilizing the anchorage areas are encouraged to contact local and state authorities, such as the local harbormaster, to ensure compliance with additional applicable state and local laws. Such laws may involve, for example, compliance with direction from the local harbormaster when placing or using moorings within the anchorage.

This proposed 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 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 Homeland Security.

We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of Department of Homeland Security is unnecessary. This finding is based on the fact that this proposal conforms to the changing needs of the City of Yonkers and the changing needs of recreational vessels along the Hudson River. This proposed rule is in the interest of safe navigation and property protection.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which might be small entities: the owners or operators of recreational or commercial vessels intending to transit in a portion of the Hudson River encumbered by the special anchorage areas. These anchorage areas, however, would not have a significant economic impact on these entities for the following reasons. The proposed special anchorage areas extend past the 30-foot depth contour by approximately 200 feet on the east side of the Hudson River. This leaves approximately 2,200 feet of safe water before reaching the 30-foot depth contour on the west side. This is more than enough room for the types of vessels currently operating on the river, which include both small and large commercial vessels. Thus these special anchorage areas will not impede safe and efficient vessel transit on the Hudson River.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Mr. John J Mauro at the address listed in ADDRESSES above.

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

Arule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This proposed rule would not effect a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This proposed 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.

We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that may disproportionately affect children.

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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.

We have analyzed this proposed 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.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this proposed rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(f), of the Instruction, from further environment documentation. A draft “Environmental Analysis Check List” and a draft “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES. Comments on this section will be considered before we make the final decision on whether the rule should be categorically excluded from further environmental review.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR Part 110 as follows:

In the final rules section of the Federal Register , EPA is approving the state's SIP revision and redesignation request as a direct final rule without prior proposal because the Agency views this as a noncontroversial revision amendment and anticipates no relevant adverse comments to this action. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the rules section of this Federal Register .

Regulated Entities. The proposed amendments could possibly apply to a large number of industries that could be using the provisions of 40 CFR part 63, appendix C, to demonstrate compliance with an air standard. Therefore, we have not listed specific affected industries or their North American Industrial Classification System (NAICS) codes here. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Outline. The information presented in the preamble is organized as follows:

Appendix C to 40 CFR part 63 provides procedures for calculating F bio in a biological treatment system. The appendix currently contains five procedures for determining F bio : bench-top reactors, site-specific system performance data, inlet and outlet concentration data, batch tests, and multiple zone concentration measurements. Each of the procedures in appendix C are compound-specific ( i.e. , the individual compound fraction biodegraded (F bio ) is determined for each identified compound and then summed to obtain an overall F bio ). However, in developing the new source performance standards for wastewater sources in the synthetic organic chemical manufacturing industry, we realized that F bio determinations on an individual compound basis may be problematic for sources demonstrating compliance for large numbers of undefined VOC.

Wastewater streams from SOCMI processes can contain hundreds of organic wastewater compounds (OWWC). For these wastewater streams, identifying all (or the predominant constituents) of the OWWC would require costly analytical testing. To provide for a more cost-effective evaluation of wastewater streams with multiple OWWC, the proposed amendments to appendix C to 40 CFR part 63 add a procedure for determining an overall F bio that does not require identification of specific OWWC.

The proposed amendments to appendix C to 40 CFR part 63 add a non-speciated, aerated draft tube reactor test to the existing batch test procedures described in section III.D of appendix C. The proposed non-speciated test procedure uses the same approach as the aerated reactor test, but also includes procedures that are related to evaluating individual components in a wastewater stream without having to identify these components or make separate measurements of the characteristics of the components.

The proposed test procedure relies on establishing correlations between peak areas of unidentified compounds resulting from gas chromatography (GC) analysis with the measured concentrations of the unidentified compounds in the draft tube headspace. Automated gas sampling or solid phase microextraction (SPME) fibers are used to collect samples of the gas in the headspace of the draft tube over the time period of the test. Compounds in the gas samples are measured using a gas chromatography/flame ionization detector (GC/FID).

The change in each VOC concentration in the headspace of the draft tube is related to the decrease in aqueous phase concentration of each VOC over time. This correlation is used to calculate biodegradation rates for each VOC. Also, an overall F bio for the biological treatment system is calculated from the sum of the individual organic compound concentrations and individual F bio values. Appendix C to 40 CFR part 63 allows the use of manual or computer-assisted methods to analyze the GC concentration data.

Today's proposed non-speciated aerated draft tube reactor test method is an appropriate addition to appendix C to 40 CFR part 63 to provide a more cost-effective option for compliance demonstrations for activated sludge biological treatment units affected by wastewater rules regulating VOC. While we consider this to be a cost-effective option, the non-speciated method also provides an accurate procedure for demonstrating biodegradation as opposed to volatilization for an activated sludge biological unit. Although appropriate for rules such as the proposed SOCMI Wastewater NSPS that would regulate OWWC, the non-speciated aerated method may not be appropriate for other rules. In the case of the proposed SOCMI Wastewater NSPS, the regulated pollutants would be OWWC which comprise all of the organic compounds in the wastewater streams that may volatilize, i.e. , compounds with a Henry's law constant greater than 0.1 atmosphere per mole fraction. For rules requiring destruction of hazardous air pollutants (HAP), other appendix C procedures are preferred because they require identification and quantification of HAP, ensuring the overall F bio reflects the actual destruction of the HAP and not the average of all the organic compounds present in the wastewater. Therefore, today's proposed non-speciated aerated draft tube reactor test method may only be used to comply with rules that regulate VOC, such as the SOCMI Wastewater NSPS.

In addition to the non-speciated aerated draft tube reactor test, the proposed amendments also make minor revisions to clarify the existing batch test procedures in section III.D of appendix C to 40 CFR part 63. We are clarifying that the batch test procedures are headspace characterization methods. Also, we are clarifying that the equilibrium verification required by the aerated reactor test must be demonstrated for one or more of the most volatile compounds to be tested for biodegradation.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA must determine whether the regulatory action is “significant” and, therefore, subject to review by the OMB and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or

(4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

We have determined that the proposed amendments are not a “significant regulatory action” under the terms of Executive Order 12866 and do not impose any additional control requirements. The proposed amendments add an additional, potentially less-costly option for compliance demonstration for certain biological treatment units. Therefore, the proposed amendments are not subject to review by OMB.

The proposed amendments to appendix C to 40 CFR part 63 do not impose or change any information collection requirements. Therefore, the requirements of the Paperwork Reduction Act do not apply to the proposed amendments.

The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant impact on a substantial number of small entities. Small entities include small businesses, small government organizations, and small government jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business with up to 1,000 employees; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Today's proposed amendments do not increase the cost of compliance because: (1) The proposed amendments do not impose requirements independent of the proposed SOCMI Wastewater NSPS; (2) we proposed using appendix C to 40 CFR part 63 to demonstrate compliance with the proposed SOCMI Wastewater NSPS in the supplement to the proposed rule; (3) the cost of compliance demonstrations is accounted for in the proposed SOCMI Wastewater NSPS; and (4) the procedure we are proposing to add to appendix C provides another, less expensive, alternative to the procedures currently available in appendix C. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.

Title II of the Unfunded Mandates Reform Act of 1995 (URMA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, the EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed, under section 203 of the UMRA, a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA's regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

The EPA has determined that the proposed amendments do not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. Thus, the proposed amendments are not subject to the requirements of section 202 and 205 of the UMRA. In addition, EPA has determined that the proposed amendments do not contain regulatory requirements that might significantly or uniquely affect small governments because the proposed amendments do not impose any additional regulatory requirements. Therefore, the proposed amendments are not subject to the requirements of section 203 of the UMRA.

Executive Order 13132 (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

The proposed amendments do not have federalism implications. The proposed amendments will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The proposed amendments will not impose substantial direct compliance costs on State or local governments, and they will not preempt State law. Thus, Executive Order 13132 does not apply to the proposed amendments.

Executive Order 13175 (65 FR 67249, November 9, 2000) 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.”

The proposed amendments do not have tribal implications and 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. Thus, Executive Order 13175 does not apply to the proposed amendments.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that (1) is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the EPA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by EPA.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the rule. The proposed amendments are not subject to Executive Order 13045 because they are based on technology performance and not on health and safety risks. Also, the proposed amendments are not “economically significant.”

The proposed amendments are not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because they are not a significant regulatory action under Executive Order 12866 and because they will not have an adverse effect on the supply, distribution, or use of energy.

Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995, (Public Law 104-113; 15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in their regulatory and procurement activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , material specifications, test methods, sampling procedures, business practices) developed or adopted by one or more voluntary consensus bodies. The NTTAA directs EPA to provide Congress, through annual reports to OMB, with explanations when an agency does not use available and applicable voluntary consensus standards.

The proposed amendments include technical standards and requirements for taking measurements. Consistent with the NTTAA, we conducted searches for applicable voluntary consensus standards that could be used in addition to the method proposed in this action by searching the National Standards System Institute (NSSN) database. We searched for methods and tests required by the proposed amendments, all of which are methods or tests previously promulgated. No potentially equivalent methods for the methods and tests in the proposal were found in the NSSN database search. Therefore, we do not propose to use any voluntary consensus standards. The search and review results are documented in Dockets No. OAR-2003-0191 and A-94-32.

For reasons cited in the preamble, title 40, chapter I, part 63 of the Code of Federal Regulations is proposed to be amended as follows:

A plot of -ln(C/C o ) as a function of t will have a slope equal to GK eq /V. The equilibrium assumption can be verified by comparing the experimentally determined K eq for the system to literature values of the Henry's Law constant (including those listed in this appendix). If K eq does not match the Henry's law constant, K eq shall be determined from analysis of the headspace and liquid concentration in a batch system.

The concentration of a compound decreases in the bioreactor due to both biodegradation and stripping. Biodegradation processes are typically described with a Monod model. This model and a stripping expression are combined to give a mass balance for the aerated draft tube reactor:

Equation App. C-3 can be integrated to obtain the following equation:

This equation is used along with the substrate concentration versus time data to determine the best fit parameters (Q m and K s ) to describe the biodegradation process in the aerated reactor. If the Aerated Reactor test is used, the following procedure is used to analyze the data. Evaluate K eq for the compound of interest with Form XI. The concentration in the vented headspace or liquid is measured as a function of time and the data is entered on Form XI. A plot is made from the data and attached to the Form XI. K eq is calculated on Form XI and the results are contrasted with the expected value of Henry's law obtained from Form IX. If the comparison is satisfactory, the stripping constant is calculated from K eq , completing Form XI. The values of K eq may differ because the theoretical value of K eq may not be applicable to the system of interest. If the comparison of the calculated K eq from the form and the expected value of Henry's law is unsatisfactory, Form X can alternatively be used to validate K eq . If the aerated reactor is demonstrated to not be at equilibrium, either modify the reactor design and/or operation, or use another type of batch test. This equilibrium testing must only be demonstrated for one or more of the most volatile compounds to be tested for biodegradation. Once it is demonstrated that the aerated reactor achieves equilibrium, then Form IX is used to adjust published or measured Henry's law constants for the other volatile compounds to be tested.

The compound-specific biorate constants are then measured using Form XII. The stripping constant that was determined from Form XI and a headspace correction factor of 1 are entered on Form XII. The aerated reactor biotest may then be run, measuring concentrations of each compound of interest as a function of time. If headspace concentrations are measured instead of liquid concentrations, then the corresponding liquid concentrations are calculated from the headspace measurements using the K eq determined on Form XI and entered on Form XII.

The concentration data on Form XII may contain scatter that can adversely influence the data interpretation. It is acceptable to curve fit the concentration data and enter the concentrations on the fitted curve instead of the actual data. If curve fitting is used, the curve-fitting procedure must be based upon the Equation App. C-4. When curve fitting is used, it is necessary to attach a plot of the actual data and the fitted curve to Form XII.

If the stripping rate constant is relatively large when compared to the biorate at low concentrations, it may be difficult to obtain accurate evaluations of the first-order biorate constant. In these cases, either reducing the stripping rate constant by lowering the aeration rate, or increasing the biomass concentrations should be considered. The final result of the batch testing is the measurement of a biorate that can be used to estimate the fraction biodegraded, f bio . The number transferred to Form III is obtained from Form XII, line 9.

2. Sealed Reactor Test. This test uses a closed system to prevent losses of the test compound by volatilization. This test may be conducted using a serum bottle or a sealed draft tube reactor (for an example see Figure 3 of appendix C). Since no air is supplied, it is necessary to ensure that sufficient oxygen is present in the system. The DO concentration in the system must not fall below 2 mg/liter so that the biodegradation observed will not be DO-limited. As an alternative, oxygen may be supplied by electrolysis as needed to maintain the DO concentration above 2 mg/liter. The reactor contents must be uniformly mixed, by stirring or agitation using a shaker or similar apparatus. The test mixture (or compound) of interest is injected into the reactor and the concentration is monitored over time. A minimum of six samples shall be taken over the period of the test. However, it is necessary to monitor the concentration until it falls below the LOQ.

The equilibrium assumption must be verified for the batch reactor system that depends on headspace characterization. In this case, K eq may be determined by simultaneously measuring gas and liquid phase concentrations at different times within a given experiment. The equilibrium testing must only be demonstrated for one or more of the most volatile component(s) that will be tested. A constant ratio of gas/liquid concentrations indicates that equilibrium conditions are present and K eq is not a function of concentration. This ratio is then taken as the K eq for the specific component(s) in the test. It is not necessary to measure K eq for each experiment. If the ratio is not constant, the equilibrium assumption is not valid and it is necessary to (1) increase mixing energy for the system and retest for the equilibrium assumption, or (2) use a different type of test that does not depend on headspace characterization (for example, a collapsible volume reactor).

The concentration of a compound decreases in the bioreactor due to biodegradation according to Equation App. C-5:

Equation App. C-5 can be solved analytically to give:

This equation is used along with the substrate concentration versus time data to determine the best fit parameters (Q m and K s ) to describe the biodegradation process in the sealed reactor.

If the sealed reactor test is used, Form X is used to determine the headspace correction factor. The disappearance of a compound in the sealed reactor test is slowed because a fraction of the compound is not available for biodegradation because it is present in the headspace. If the compound is almost entirely in the liquid phase, the headspace correction factor is approximately one. If the headspace correction factor is substantially less than one, improved mass transfer or reduced headspace may improve the accuracy of the sealed reactor test. A preliminary sealed reactor test must be conducted to test the equilibrium assumption. As the compound of interest is degraded, simultaneous headspace and liquid samples should be collected and Form X should be used to evaluate K eq . The ratio of headspace to liquid concentrations must be constant in order to confirm that equilibrium conditions exist. If equilibrium conditions are not present, additional mixing or an alternate reactor configuration may be required.

The compound-specific biorate constants are then calculated using Form XII. For the sealed reactor test, a stripping rate constant of zero and the headspace correction factor that was determined from Form X are entered on Form XII. The sealed reactor test may then be run, measuring the concentrations of each compound of interest as a function of time. If headspace concentrations are measured instead of liquid concentrations, then the corresponding liquid concentrations are calculated from the headspace measurements using K eq from Form X and entered on Form XII.

The concentration data on Form XII may contain scatter that can adversely influence the data interpretation. It is acceptable to curve fit the concentration data and enter the concentrations on the fitted curve instead of the actual data. If curve fitting is used, the curve-fitting procedure must be based upon Equation App. C-6. When curve fitting is used, it is necessary to attach a plot of the actual data and the fitted curve to Form XII.

If a sealed collapsible reactor is used that has no headspace, the headspace correction factor will equal 1, but the stripping rate constant may not equal 0 due to diffusion losses through the reactor wall. The ratio of the rate of loss of compound to the concentration of the compound in the reactor (units of per hour) must be evaluated. This loss ratio has the same units as the stripping rate constant and may be entered as the stripping rate constant on line 1 of Form XII.

If the loss due to diffusion through the walls of the collapsible reactor is relatively large when compared to the biorate at low concentrations, it may be difficult to obtain accurate evaluations of the first-order biorate constant. In these cases, either replacing the materials used to construct the reactor with materials of low permeability or increasing the biomass concentration should be considered.

The final result of the batch testing is the measurement of a biorate that can be used to estimate the fraction biodegraded, f bio . The number transferred to Form III is obtained from Form XII, line 9.

The number on Form XII line 9 will equal the Monod first-order biorate constant if the full-scale system is operated in the first-order range. If the full-scale system is operated at concentrations above that of the Monod first-order range, the value of the number on line 9 will be somewhat lower than the Monod first-order biorate constant. With supporting biorate data, the Monod model used in Form XII may be used to estimate the effective biorate constant K1 for use in Form III.

If a reactor with headspace is used, analysis of the data using Equation App. C-6 is valid only if V l and V g do not change more than 10 percent ( i.e. , they can be approximated as constant for the duration of the test). Since biodegradation is occurring only in the liquid, as the liquid concentration decreases it is necessary for mass to transfer from the gas to the liquid phase. This may require vigorous mixing and/or reducing the volume in the headspace of the reactor.

If there is no headspace ( e.g. , a collapsible reactor), Equation App. C-6 is independent of V l and there are no restrictions on the liquid volume. If a membrane or bag is used as the collapsible-volume reactor, it may be important to monitor for diffusion losses in the system. To determine if there are losses, the bag should be used without biomass and spiked with the compound(s) of interest. The concentration of the compound(s) in the reactor should be monitored over time. The data are analyzed as described above for the sealed reactor test.

3. Non-speciated aerated draft tube reactor test. This method is appropriate for compliance demonstrations with rules that regulate VOC. The aerated draft tube reactor test is used for assessing the F bio for non-speciated VOC. The methods and procedures that are used with the Aerated reactor test (described in section 1 above) are also used with the non-speciated draft tube test, with the exception of special procedures that are related to the limited information available for identifying the waste components, the volatility of the components, and the amount of the components that are present in the waste. The non-speciated test method described here is based upon evaluating individual components in a waste without the need to identify the name of the component or make separate measurements of the characteristics of the components.

3.1  Purpose of the method. The following sections identify specific purposes for which the non-speciated method is used. For each purpose identified in sections 3.1.1 through 3.1.6, a correlation between the peak area of the compound in the GC analysis and the concentration in the draft tube headspace must be available as discussed in section 3.10.

3.1.1  Henry's law constant for each non-speciated organic compound. One run of the non-speciated method without biomass is used to obtain estimates of the Henry's law value for each individual organic compound identified in the waste. For each volatile organic component, correlations of the vapor phase concentration and the stripping times are developed. A Henry's law value is determined for each component. See section 3.6.

3.1.2  Non-speciated organic compound concentration. One run of the non-speciated method without biomass is used to evaluate the individual organic compound concentrations in the waste. The amount of each component initially present in the waste is determined from the Henry's law value and the correlation between the peak area and the gas correlation. See section 3.9.

3.1.3  Total concentration of non-speciated organic compounds. One run of the non-speciated method without biomass is used to obtain estimates of the individual organic compound concentrations in the waste. These individual concentrations are summed to obtain the total concentration of organic compounds. See section 3.11.

3.1.4  Biodegradation rate for each non-speciated organic compound. Two runs of the non-speciated method, one with biomass and one without biomass are used to obtain estimates of the biodegradation rate for each individual organic compound identified in the waste. The stripping rates from the run without biodegradation is compared to the air stripping run with biodegradation. The difference in the rates of removal in the two runs is used to calculate the biodegradation rate. See section 3.7.

3.1.5  Individual values of f e and f bio for each non-speciated organic compound. The use of Form III or an equivalent method is used to evaluate the fraction biodegraded (individual F bio ) using the Henry's law value for each component (3.6), the amount of each component (3.9), and the biodegradation rate for each component (3.7), together with the characteristics of the biotreatment unit. See section 3.12.

3.1.6  Overall F e and F bio for the total concentration of non-speciated organic compounds. The use of Form III or an equivalent method is used to evaluate the fraction biodegraded (individual f bio ) using the Henry's law value for each component (3.6), the amount of each component (3.9), and the biodegradation rate for each component (3.7), together with the characteristics of the biotreatment unit.

These individual F bio numbers for each of the components are used to obtain an overall F bio value for the overall non-speciated waste. Non-speciated compounds with low Henry's law constants of less than 0.1 mol fraction gas per mol fraction in liquid at one atmosphere can be excluded from this summation.

A weighted summation of these individual estimates of biological and air emission removal is used to obtain an overall F bio and an overall Fe. See section 3.13.

3.2  Reactor configuration. An aerated draft tube reactor is used for the biokinetics testing for the non-speciated reactor test (as an example see Figure 2 of appendix C). Other aerated reactor configurations may also be used if equivalent to the aerated draft tube reactor. Air is bubbled through a porous frit at a rate sufficient to aerate and keep the reactor uniformly mixed. A discussion of the setup and the operation of the aerated draft tube reactor is presented in Section D.1.

3.3  Reactor sampling. Concentrations of volatile compounds are only monitored in the headspace in the non-speciated aerated draft tube reactor test. The headspace may be monitored with solid phase microextraction (SPME) fibers or with automated gas sampling. A minimum of six headspace samples shall be taken over the period of the test for each individual run and analyzed by gas chromatography. Sufficient gas samples will be taken to provide at least 3 data samples for each relevant component for each air stripping run. It is necessary to collect enough samples to quantify the characteristics of the individual volatile compound peaks in the system; therefore, in some cases it is possible to reduce the total number of headspace samples by sampling more frequently at the beginning of the run.

3.4  Reactor equilibrium verification. It is necessary to verify the equilibrium assumption for the non-speciated aerated draft tube reactor test as discussed in section D.1, using Equation C-2.

A plot of −ln(C/C o ) as a function of t will have a slope equal to GK eq /V. Verification of equilibrium can be performed initially and periodically with a set of known volatile compounds with known Henry's law constants. The selection of compounds should represent the most volatile compounds in the waste stream (at least as great as the experimentally measured Henry's law constants for the top 5 percent of the non-speciated components, or alternatively with Henry's law constants of 300 y/x). Experimentally measured Henry's law values are available from the WATER7 (or any subsequent update to the model) data base for a number of compounds. In addition, the compounds that are selected for the verification of equilibrium should be included in the determination of the SPME fiber partition factor. Verification of equilibrium in the non-speciated aerated draft tube reactor test under each set of operating conditions is important because accurate measurement of the Henry's law constant is necessary to permit accurate characterization of non-speciated peaks. Non-speciated compound peaks that demonstrate Henry's law constants less than 0.1 (y/x) in the test are excluded from the analysis. If the aerated draft tube reactor cannot be demonstrated to be at equilibrium, modify the reactor design and/or operation.

3.5  Two reactor runs. The concentration of a compound in the bioreactor is measured in the headspace in two different runs, first with air stripping only and then second with both biodegradation and air stripping. A first order biodegradation rate model is used to model the biodegradation in the aerated draft tube reactor. Since the measurement of the first order biodegradation rate constant is a function of concentration, it is important to have concentrations of non-speciated compounds in this test that closely represent the conditions in the full-scale biodegradation unit that you are evaluating. Since the components and concentrations are generally unknown for this non-speciated method, samples of actual wastewater should be obtained from the applicable location in the full-scale facility, or as close to these conditions as practicable, such as a sample of wastewater from a pilot plant, a full-scale process from another site, etc. This model and a stripping expression are combined to give a mass balance for the aerated draft tube reactor:

Equation App. C-7 can be integrated to obtain the following equation:

If ln(Peakarea) is plotted on the y axis and t is plotted on the x axis, the data should form a straight line with a slope that equals the negative of the terms in parenthesis on the right of Equation App. C-8 and the intercept of this line on the y axis equals ln (Peakarea o ).

A discussion of Equation App. C-8 is provided in reference 9. This equation is used to analyze the two stripping runs, with and without biodegradation. Evaluate the slope for each non-speciated peak for both the run without biodegradation and the run with biodegradation.

3.6  Henry's law constants. To evaluate the Henry's law constant for each unspeciated VOC, you obtain the slope for the run without biodegradation and then equate this slope (with a negative value) to −GK eq . The value of K eq is then equal to the product of the negative of the slope and V, divided by G.

3.7  Biodegradation rate constant. To evaluate the first order biorate constant, use the slope for each non-speciated peak for the run without biodegradation and subtract the corresponding slope of the non-speciated peak with biodegradation. This difference equals K 1 X. The value of K 1 that is determined in this manner is used to characterize the biodegradation rate under the conditions in the full-scale biodegradation unit that you are evaluating.

3.8  Accuracy concerns. The non-speciated compound peak data may contain scatter that can adversely influence the data interpretation. In the case of significant data scatter for a specific compound that will limit the ability to determine the difference in slopes from the two runs, it is possible to use conventional statistics to estimate the accuracy of the difference in slopes. When it is not possible to demonstrate a significant difference in the slopes of the two runs for a non-speciated compound, the value of K 1 is set to zero. A negative value of K 1 is never used. If the specific compound of concern has a statistically significant negative value of K 1 , this can be an indication of the formation of the compound as a byproduct and is reported as an anomalous result. It is necessary to provide documentation of data and calculations.

If the stripping rate constant is relatively large when compared to the biorate, it may be difficult to obtain an accurate evaluation of the first-order biorate constant. In these cases, either reducing the stripping rate constant by lowering the aeration rate, or increasing the biomass concentrations should be considered. If the aeration rate is changed, the equilibrium assumption will have to be verified again. Equilibrium conditions are typically more difficult to obtain at greater aeration rates, but lower aeration rates could result in difficulty in achieving equilibrium conditions due to poorer mixing.

3.9  The concentration of each compound. The amount of each individual non-speciated organic compound is calculated by measuring the initial area of the chromatographic peak of the individual compound, Peakarea o , the ratio of the peak area to the gas phase concentration, F, the SPME fiber partition factor, K fiber , and the partition coefficient, K eq . The Peakarea o is the intercept of the line with the y axis (plot of ln Peakarea vs. time). If automatic gas sampling is used for the analysis, a representative calibration of the gas chromatographic peak area and the gas phase concentration is required, and a correlation for the fiber partition factor is not used because the SPME method is not used. For complex chemicals with relatively poor biodegradation rates, it may be necessary to modify the procedure using multiple columns or detectors.

The equation used for the SPME method is as follows:

The equation used for the automatic headspace sampling alternative is as follows:

3.10  SPME fiber partition correlation. If automatic gas sampling is used, it is not necessary to account for SPME fiber partition effects, but it is necessary to use gas chromatographic calibration factors for the compounds of interest. Reference 9 presents additional details on the use of gas chromatographic calibration factors and SPME fiber partition factors.

The SPME fiber partition factor is obtained by preparing an aqueous solution or solutions with known compounds of varying volatility and chemical characteristics that are representative of the waste stream of concern. The detector peak areas and retention times are then obtained with the SPME method for these known compounds. The mass of compound is calculated from the area counts of the GC compound peak, and the concentration in the headspace is calculated from the Henry's law factor and the known liquid concentration. The fiber partition factor K fiber is the ratio of the mass of compound to the concentration in the headspace at equilibrium with the aqueous solution. A correlation is then obtained between the value of K fiber and the retention time of the detector response.

The SPME fiber partition factor correlation for a series of petrochemical compounds that is provided in Figure 4 of reference 9 can be used with verification of the correlation with a few compounds if the chemicals in that correlation are representative of the waste stream of concern. The fiber recovery of the compound is correlated with the volatility (aqueous Henry's law constant) as a result of the experimental measurements of the headspace concentrations by the fiber extraction method.

If some characterization is available for the waste stream of concern, such as a compound identification of more than 25 percent of the major compounds present in the waste, it is recommended that selected members of these identified compounds are included in the measurements for the determination of the site-specific SPME fiber partition factor correlation.

In some cases, after concluding the non-speciated method runs for the waste with and without biomass, the SPME partition factor correlation may appear to be inappropriate for the waste stream. Some of the reasons for this could include incorrect compound concentration for a known compound, incorrect concentration ratios of known compounds, or test data outside the applicable range of the correlation. When there are problems with the SPME partition factor correlation, the correlation may be improved without the need to rerun the non-speciated method runs for the waste with and without biomass.

If, unlike the petroleum compound set evaluated in reference 9, you are unable to obtain a single correlation for use in interpreting the data that you obtain from this method, you should consider the use of two or more correlations with multiple correlations and multiple detectors/fiber types. A discussion of the methods used in this multiple correlation technique alternative is outside the scope of this discussion. This alternative of more than one correlation should not be used without supporting experimental investigations to verify the technical approach that you are using. The EPA Method 25D describes the use of two different types of gas chromatograph detectors to more completely characterize the compounds in the waste. You may wish to consider the use of automatic direct headspace sampling in the case of difficulty with identifying adequate SPME correlations.

3.11  Calculation of the total non-speciated compound concentration . The measured individual organic compound concentrations are summed to obtain the total non-speciated compound concentration. Certain compounds may be excluded from this total. Examples of components that may be excluded from the total summation procedures are the following:

• Components that are present in the vapor phase in concentrations too low to measure.

• Components that are identified and have specific regulatory exclusion.

• Components that have gas chromatographic retention times that are substantially greater than can be considered characteristic of volatile components.

3.12  Calculation of f e and f bio for each compound. The site specific biodegradation unit characteristics are used with the measured values of the compound Henry's law value and the biodegradation first order rate constant to estimate f e and f bio for each compound.

3.13  Calculation of the overall f e and f bio for the total volatile waste components. The individual organic compound concentrations are used with individual values of f e and f bio to obtain the total biological removal and the total air emission removal from the treatment unit. In the case of an ideal stirred tank reactor, the amount of each component entering the reactor is calculated by multiplying the flow rate of the waste (m 3 /s) by the concentration (g/m 3 ) to obtain the individual loading rate (g/s). For each compound that is not excluded, the individual loading is summed to obtain the total loading. The overall biological removal is the sum of the products of the individual loading rate (g/s) and the individual value of f bio . The overall air removal is the sum of the products of the individual loading rates (g/s) and the individual values of f e . The overall f bio value is the ratio of the overall biological removal to the total loading. The overall f e value is the ratio of the overall air emissions loss to the total loading.

Reference 9 presents examples of the use of the above procedures to evaluate the fraction biodegraded for two types of biotreatment units.

3.14 Computer assisted calculations. It is possible to use computer assisted data acquisition and data analysis in order to reduce the extensive labor requirements to perform the above procedures manually. You may use either manual methods, electronic spreadsheets, or compiled programs that can directly import the gas chromatographic computer files. Present the results for each non-speciated component, the summary of the weighted average f bio using each relevant component, and supporting quality assurance information. The slope and intercept of the correlation curve, the correlation coefficient, and the number of data points used for the correlation are examples of supporting quality assurance information.

4.  Quality Control/Quality Assurance (QA/QC) . A QA/QC plan outlining the procedures used to determine the biodegradation rate constants shall be prepared and a copy maintained at the source. The plan should include, but may not be limited to:

1. A description of the apparatus used ( e.g. , size, volume, method of supplying air or oxygen, mixing, and sampling procedures) including a simplified schematic drawing.

2. A description of how biomass was sampled from the activated sludge unit.

3. A description of how biomass was held prior to testing (age, etc.).

4. A description of what conditions (DO, gas-liquid equilibrium, temperature, etc.) are important, what the target values are, how the factors were controlled, and how well they were controlled.

5. A description of how the experiment was conducted, including preparation of solutions, dilution procedures, sampling procedures, monitoring of conditions, etc.

6. A description of the analytical instrumentation used, how the instruments were calibrated, and a summary of the precision for that equipment.

7. A description of the analytical procedures used. If appropriate, reference to an ASTM, EPA or other procedure may be used. Otherwise, describe how the procedure is done, what is done to measure precision, accuracy, recovery, etc., as appropriate.

8. A description of how data are captured, recorded, and stored.

9. A description of the equations used and their solutions, including a reference to any software used for calculations and/or curve-fitting.

3. Appendix C is amended by revising section III.E to read as follows:

Procedure 5 is the concentration measurement method that can be used to determine the f bio for units that are not thoroughly mixed and thus have multiple zones of mixing. As with the other procedures, proper determination of f bio must be made on a system as it would exist under the rule. For purposes of this calculation, the biological unit must be divided  1 into zones with uniform characteristics within each zone. The number of zones that is used depends on the complexity of the unit. Reference 8, “A Technical Support Document for the Evaluation of Aerobic Biological Treatment Units with Multiple Mixing Zones,” is a source for further information concerning how to determine the number of zones that should be used for evaluating your unit. The following information on the biological unit must be available to use this procedure: (1) Basic unit variables such as inlet and recycle wastewater flow rates, type of agitation, and operating conditions; (2) measured representative organic compound concentrations in each zone and the inlet and outlet; and (3) estimated mass transfer coefficients for each zone.

The estimated mass transfer coefficient for each compound in each zone is obtained from Form II using the characteristics of each zone. A computer model may be used. If the Water7 model or the most recent update to this model is used, then use Form II-A to calculate KL. The TOXCHEM or BASTE model may also be used to calculate KL for the biological treatment unit, with the stipulations listed in procedure 304B. Compound concentration measurements for each zone are used in Form XIII to calculate the f bio . A copy of Form XIII is completed for each of the compounds of concern treated in the biological unit.

4. Appendix C is amended by revising equation C-7 in section IV to read as follows:

IV. Calculation of f bio

The Agency included in the proposed rule and the supplemental notice a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT .

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials, including the paper-only docket for the proposed rule and the partial reopening of the comment period, through the docket facility (OPP-190001). A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

This document reopens the public comment period for the rulemaking titled “Standards for Pesticide Containers and Containment,” which was proposed on February 11, 1994 (59 FR 6712). In that document, EPA sought comment on proposed regulations for pesticide container design and residue removal and for containment structures at pesticide storage and container refilling operations. Because significant time has passed since the proposed rule in 1994 and a supplemental notice in 1999 (64 FR 56918, Oct. 21, 1999), EPA is hereby reopening the comment period for an additional 45 days. While EPA has attempted to stay current on developments in pesticide container and containment structure policies, regulations, technology and practices, the Agency believes that it is appropriate to solicit input from the regulated community, state regulators and others to ensure that we are fully aware of the current state of the pesticide container and containment universe before finalizing the pesticide container and containment regulations.

The Agency has reviewed and carefully considered all of the public comments submitted in response to the proposed rule and the supplemental notice. Accordingly, the Agency is not soliciting comments which are essentially repetitions of those comments or which could have been raised at the time of either of the previous notices. In addition, EPA will not consider submissions that are related solely to policies, regulations and pesticide market conditions and practices that existed in 1994 and 1999. Similarly, EPA is not interested in receiving restated comments about which pesticide products should be exempted from the pesticide container regulations.

EPA is soliciting public input on any policies, market practices, technology or other issues relating to this rule's requirements which would not have been available or could not have been addressed at the time of either the proposed rule in 1994 or the supplemental notice in 1999. Three examples of the types of issues which could be addressed in comments to this notice are described below.

Since the Agency proposed the bulk containment standards in 1994, 19 states have been implementing state containment regulations. Some states had their own containment regulations before 1994, and have modified and improved them over the years. These states (with the longest standing regulations) had the majority of the bulk storage facilities within their borders, and recognized the need for regulation to prevent pollution from bulk storage and refilling operations. The Agency has carefully considered all comments regarding containment that were submitted on the 1994 proposed requirements. The 1999 supplemental notice did not discuss changes to the proposed containment standards. However, the additional 10 years of experience in implementing containment regulations may have led to new suggestions, observations, problems, market practices or other data submissions by state regulators, registrants, dealers, commercial applicators, engineers, other businesses, or the public. For example, the additional experience in designing and building containment structures and inspecting, operating, and maintaining bulk storage and refilling facilities could have changed commenters' opinions about specific proposed containment requirements. As another example, EPA has received anecdotal reports that bulk storage on farms, which was very rare if not nonexistent when the regulations were proposed, is becoming more common and may present a risk to the environment. Comments and data on the proposed containment standards that could not have been anticipated in 1994 because the comments are based on the additional years of experience with state containment regulations are an example of comments that would be appropriate to submit.

EPA also believes that the experiences and results of pesticide container collection and recycling programs over the past decade could lead to new observations, data, and comments on the proposed container standards. The Ag Container Recycling Council (ACRC) is a non-profit organization that promotes and supports the collection and recycling of plastic pesticide containers in the United States. The collection and recycling programs conducted by the ACRC grew significantly during the past decade from the developmental stage when the proposed regulations were being developed in the early 1990's to collecting over 6.6 million pounds of plastic containers in each of the past few years. The ACRC, pesticide registrants, pesticide container recyclers, State extension agents and State and local regulators have had multiple years to observe end users' rinsing practices, the cleanliness of containers, the rate of rejecting containers and other container-related issues that could lead to comments on the proposed container requirements that are different from when the regulations were proposed.

The regulations for plant-incorporated protectants in 40 CFR parts 152 and 174 were finalized in the Federal Register on July 19, 2001 (66 FR 37771). A plant-incorporated protectant is a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. As explained in the preamble to the final rule for plant-incorporated protectants (66 FR 37774), “[p]lant-incorporated protectants are primarily distinguished from other types of pesticides because they are intended to be produced and used in a living plant. This difference in use pattern dictates in some instances differences in approach.” Plant-incorporated protectants are not sold and distributed in containers as distinct substances (e.g., liquids, solids or gels) like other pesticides; they are distributed as part of the seeds or plants. Therefore plant-incorporated protectants do not have containers like most pesticides.

EPA did not specifically mention plant-incorporated protectants in either the proposed rule or the supplemental notice because there were either no registrations for these products or they were uncommon at that time; these types of products are relatively new to the marketplace. In addition, the plant-incorporated protectant regulations in 40 CFR part 174 were finalized in 2001 after the container/containment proposed rule and supplemental notice were published. Comments relating to regulating the containers, container-related labeling or containment of plant-incorporated protectants, and other types of pesticides that may be in similar situations, are the kind of input that would be appropriate to submit in response to this notice.

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) sections 19(e) and (f) grant EPA broad authority to establish standards and procedures to assure the safe use, reuse, storage, and disposal of pesticide containers. FIFRA section 19(e) requires EPA to promulgate regulations for “the design of pesticide containers that will promote the safe storage and disposal of pesticides.” The regulations must ensure, to the fullest extent practicable, that the containers:

1. Accommodate procedures used for removal of pesticides from the containers and rinsing of the containers.

2. Facilitate safe use of the containers, including elimination of splash and leakage.

3. Facilitate safe disposal of the containers.

4. Facilitate safe refill and reuse of the containers.

FIFRA section 19(f) requires EPA to promulgate regulations “prescribing procedures and standards for the removal of pesticides from containers prior to disposal.” The regulations may:

1. Specify, for each major type of pesticide container, procedures and standards for, at a minimum, triple rinsing or the equivalent degree of pesticide removal.

2. Specify procedures that can be implemented promptly and easily in various circumstances and conditions.

3. Provide for reusing, whenever practicable, or disposing of rinse water and residue.

4. Coordinate with requirements imposed under the Resource Conservation and Recovery Act (RCRA) for rinsing containers.

Section 19(f) provides that EPA, in its discretion, may exempt products intended solely for household use.

Section 19(h), titled “Relationship to Solid Waste Disposal Act,” specifies that nothing in section 19 shall diminish the authorities or requirements of RCRA. It also exempts certain antimicrobial pesticides from the container regulations:

This notice neither proposes nor takes final action regarding any substantive requirements and is procedural in nature. This notice merely opens up the docket for further comments on a rule that has already been proposed. Therefore, it is not subject to the statutory and executive order reviews generally applicable to proposed and final rules.

This action is directed to the public in general. It simply announces the submission of a draft final rule to the United States Department of Agriculture (USDA) and does not otherwise affect any specific entities. This action may, however, be of particular interest to agricultural employers, including employers in farms as well as nursery, forestry, or greenhouse establishments, who are subject to the Worker Protection Standards. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . Please note that the draft final rule is not currently publicly available. It will only become publicly available when the final rule is signed, at which time it will publish in the Federal Register . A frequently updated electronic version of 40 CFR part 170 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

Section 25(a)(2) of FIFRA requires the Administrator to provide the Secretary of Agriculture with a copy of any final regulation at least 30 days before signing it for publication in the Federal Register . The draft final rule is not available to the public until after it has been signed by EPA. If the Secretary comments in writing regarding the draft final rule within 15 days after receiving it, the Administrator shall include the comments of the Secretary, if requested by the Secretary, and the Administrator's response to those comments in the final rule when published in the Federal Register . If the Secretary does not comment in writing within 15 days after receiving the draft final rule, the Administrator may sign the final rule for publication in the Federal Register anytime after the 15-day period.

Section 4 (b)(3)(A) of the Endangered Species Act (Act) of 1973, as amended (16 U.S.C. 1531 et seq. ), requires that we make a finding on whether a petition to list, delist, or reclassify a species, or to revise a critical habitat designation, presents substantial scientific or commercial information to demonstrate that the petitioned action may be warranted. We are to base this finding on all information available to us at the time the finding is made. To the maximum extent practicable, we are to make this finding within 90 days of the receipt of the petition, and to publish a notice of the finding promptly in the Federal Register . Our regulations at 50 CFR 424.14(b) state that for the purposes of petition findings, “'substantial information” is that amount of information that would lead a reasonable person to believe that the measure proposed in the petition may be warranted * * *.” If we find that substantial information was presented, we are required to promptly commence a review of the status of the involved species, if one has not already been initiated under our internal candidate assessment process. After completing the status review, we will issue an additional finding (the 12-month finding) determining whether listing is, in fact, warranted.

Based on our regulations at 50 CFR 424.14(b)(2), in making a 90-day finding as to whether a petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted, we are to consider whether such petition—

(1) Clearly indicates the administrative measure recommended and gives the scientific and any common names of the species involved;

(2) Contains detailed narrative justification for the recommended measure, describing, based on available information, past and present numbers and distribution of the species involved and any threats faced by the species;

(3) Provides information regarding the status of the species over all or a significant portion of its range; and

(4) Is accompanied by appropriate supporting documentation in the form of bibliographic references, reprints of pertinent publications, copies of reports or letters from authorities, and maps.

On August 30, 2000, we received a petition dated August 29, 2000, requesting that we list the New England cottontail ( Sylvilagus transitionalis ) as a threatened or endangered species, and that critical habitat be designated “within a reasonable period of time following the listing.” The petition, submitted by the Biodiversity Legal Foundation, Conservation Action Project, Endangered Small Animals Conservation Fund, and Defenders of Wildlife, was clearly identified as a petition for a rule, and contained the names, signatures, and addresses of the requesting parties. Included in the petition was supporting information regarding the species' taxonomy and ecology, historic and current distribution, present status, and potential causes of decline. We acknowledged receipt of the petition in a letter to Mr. D. C. Jasper Carlton, dated September 14, 2000. In this letter, we also advised the petitioners that due to funding constraints in fiscal year (FY) 2000, we would not be able to begin processing the petition in a timely manner. Those constraints persisted into FY 2001.

On December 19, 2000, Defenders of Wildlife sent a Notice of Intent to sue the Service for violating the Act by failing to make a timely 90-day finding on the petition to list the New England cottontail. On May 14, 2002, we advised the Defenders of Wildlife that we would begin action on the petition in FY 2002. This notice announces and summarizes our 90-day finding for the petition to list the New England cottontail.

Sometimes called the gray rabbit, brush rabbit, wood hare, or coony, the New England cottontail is a medium-sized cottontail rabbit that may reach 1,000 grams (g) (2.2 pounds (lbs)) in weight. Dorsal portions of its body are buff to ocher in color, and the back is overlain with distinct black hair (Chapman and Ceballos 1990). The ears are short and rounded, and have a distinct black edge. There is a distinct black spot between the ears.

A New England cottontail in the hand usually can be distinguished from two sympatric lagomorphs (lagomorphs are a suborder of mammals that includes rabbits, hares, and pikas), the eastern cottontail ( Sylvilagus floridanus ) and the snowshoe hare ( Lepus americanus ), by several features, including fur color, ear length, body mass, presence of the black spot between the ears, absence of a white spot on the forehead, and the black line on the anterior edge of the ears (Litvaitis et al. 1991). Pelage characteristics, however, are not 100 percent reliable in distinguishing between the visually similar New England and eastern cottontails (Chapman and Ceballos 1990), and the two species are difficult to tell apart in the field. Cranial differences, however, are a highly reliable means of distinguishing the two cottontail species (Chapman and Morgan 1973).

The New England cottontail was formally described in 1894 (Bangs 1894 in Litvaitis and Johnson 2002). Until the early 1990s, the species was considered to occur in a mosaic pattern from southeastern New England, south along the Appalachian Mountains to Alabama (Hall 1981). However, Ruedas et al. (1989) and others questioned the taxonomic status of S. transitionalis because they found evidence of two distinct chromosomal races within its geographic range. Chapman et al. (1992) conducted a review of the systematics and biogeography of the species and reported finding clear evidence for two morphometrically distinct taxa within what had conventionally been regarded as a single species. Accordingly, Chapman et al. (1992) defined a new species, the Appalachian cottontail ( S. obscurus ), with a range from west of the Hudson River, New York south along the Appalachian Mountains through Pennsylvania, Maryland, West Virginia, Virginia, Tennessee, North Carolina, South Carolina, Georgia, and Alabama. Chapman et al. (1992) defined the New England cottontail ( S. transitionalis ) as that species east of the Hudson River, New York, north through Vermont, Connecticut, Rhode Island, Massachusetts, New Hampshire, and southern Maine.

In addition to the morphometric and genetic differences reported by researchers, the two species also occupy somewhat different habitats. The Appalachian cottontail is generally an inhabitant of ericaceous vegetation zones (areas dominated by plants in the heath family) associated with higher elevations and mountain balds, while the New England cottontail occurs at lower elevations nearer the coastline, in forested or disturbed habitats with a dense understory.

Not all biologists concur with the taxonomic separation proposed by Chapman et al. (1992); see, for example, Litvaitis et al. (1997). However, the change in taxonomy and nomenclature proposed by Chapman is included in the Smithsonian Institution's book on North American mammals (Chapman in Wilson and Ruff, eds., 1999). Jones et al. (1997), in the revised checklist of North American mammals, also recognizes both species as valid. The Service currently accepts the taxonomic separation of S. transitionalis and S. obscurus.

Pursuant to the definitions in section 3 of the Act, “the term species includes any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.” In order for a species to be considered as a listable entity under the Act, it must meet the above definition. The Service agrees with the petitioners that the New England cottontail qualifies as a listable entity under the Act based on the definition of species. We base this conclusion on two arguments. First, we believe there is general acceptance of the S. transitionalis / S. obscurus taxonomy put forth by Chapman et al. (1992) as noted above. Second, we believe that the New England cottontail within its range in the Northeast (east of the Hudson River, New York) would warrant listing consideration as a distinct vertebrate population segment in the event that the taxonomy of these species is further revised. Accordingly, and consistent with the species as described in the petition, in this finding we are considering only the New England cottontail ( S. transitionalis ), as defined and with the range as described by Chapman et al. (1992). Consistent with Chapman et al. (1992) and other references (Chapman and Ceballos 1990, Hall 1981), no subspecies of the New England cottontail are recognized.

The New England cottontail is the only endemic cottontail in New England (Probert and Litvaitis 1996). Because the New England cottontail was not formally described until 1894 (Bangs 1894), there are few comprehensive reports on the historic range of the species (Litvaitis and Johnson 2002). However, it is believed that during early European settlement, New England cottontails occurred in a more or less continuous distribution from eastern New York (including Long Island) through Connecticut, statewide in Massachusetts (Cardoza in litt. 1999), Rhode Island, southern Vermont at least to Rutland, New Hampshire south of the White Mountains (Jackson 1922 in Jackson 1973), and four counties in southern Maine (Couse and Allen 1877 in Litvaitis and Johnson 2002).

Presently, the range of the New England cottontail appears to be limited to relatively small patches of suitable habitat from eastern New York, to several counties in Connecticut, western and possibly northern Rhode Island, only a few locations in eastern Massachusetts and in the Berkshire Mountains, several southern counties in New Hampshire, and two southern coastal counties in Maine (Litvaitis and Johnson 2002). The species has not been reported from Vermont since 1990 and may be extirpated there (Litvaitis 1993a; Litvaitis et al. 2002). Litvaitis and Johnson (2002) report that, since 1960, the region occupied by the New England cottontail has declined by approximately 75 percent.

The eastern cottontail has been introduced into much of the range of the New England cottontail. The historical range of the eastern cottontail extended northeast only as far as the lower Hudson Valley, and possibly extreme western Connecticut (Goodwin 1935 in Chapman and Stauffer 1981). Large-scale introductions of eastern cottontails to Connecticut (Dalke 1942, in Chapman and Stauffer 1981), Rhode Island (Johnston 1972), Massachusetts (Nelson 1909, in Johnston 1972) and possibly Vermont (C. M. Kilpatrick, in litt. 2002) have firmly established the eastern cottontail in all of New England, except Maine. Introductions usually have been conducted by States and private hunting clubs. The eastern cottontail is both larger (1,300 g (2.9 lb)) and more fecund than the New England cottontail.

Fay and Chandler (1955) documented the extension of the range of introduced eastern cottontails in Massachusetts, and recorded that S. floridanus had replaced the native New England cottontail in many places. Linkkila (1971) reported the disappearance of S. transitionalis throughout much of the northeastern United States. Johnston (1972) described the replacement over a 40 to 50 year period of S. transitionalis by S. floridanus as the predominant cottontail in much of southern New England.

Despite the widespread introductions of eastern cottontails into the range of the New England cottontail, the two species are not hybridizing. Wilson (1981) conducted a genetic study of the two species in five of the New England States and found that the New England cottontail has maintained its genetic identity in the face of eastern cottontail range expansion.

The New England cottontail is considered an early successional forest species, where disturbance occurring as a result of timber harvest, hurricanes and other wind storms, or beaver activity maintains areas of suitable habitat. Historically, fires set by Native Americans, a practice continued by early European colonists, also set back forest succession and maintained areas of suitable habitat (Bromley 1935; Cronon 1983). Suitable habitat for the species can be found in both forest and shrub lands, provided there is dense understory growth where both food and cover are found in close proximity. New England cottontail habitats include native shrublands, beaver flowages, old fields, and early successional forests (Barbour and Litvaitis 1993). In southern New England, however, this cottontail may also occur in more stable forests where laurel (Kalmia sp.) provides a dense understory. Like other cottontails, the New England cottontail is an herbivore and feeds on a wide variety of woody and herbaceous plants.

There is considerable overlap between habitats used by eastern and New England cottontails. In general, however, eastern cottontails are associated with plants indicative of open land such as old fields and meadows, whereas New England cottontails are associated with forest plant species (Eabry 1968).

The status of the New England cottontail has been of concern to biologists and natural resource agencies for nearly five decades. Reductions in the range of the New England cottontail were first reported by Fay and Chandler (1955) and subsequently by Linkkila (1971) and Johnston (1972). In 1979, Chapman and Stauffer suggested to the International Union for the Conservation of Nature (IUCN) Lagomorph Specialist Group that the species be listed in the category “Special Concern” (Chapman and Stauffer 1981). In 1989, we placed the New England cottontail in category 2 of the Animal Notice of Review (54 FR 553). We no longer maintain a list of category 2 candidate species, but at the time, category 2 was defined as including species for which we had some information indicating that the taxa may be under threat, but not enough information was available to determine if they warranted Federal listing and the preparation of a proposed rule.

On the basis of the research and other information noted above, concern for the status of the New England cottontail was well documented even prior to the revision of the taxon by Chapman et al. (1992). The separation of the taxon into two species with reduced and allopatric (separate) ranges resulted in increased concern for the New England cottontail, which was recognized as being restricted to east of the Hudson River, New York, and New England. In 1999, a committee composed of 13 State endangered species and wildlife diversity program coordinators included the New England cottontail among 26 declining species most in need of conservation attention in the northeast region (Therres 1999). This committee described the New England cottontail as warranting “federal endangered or threatened species listing consideration, including prelisting status reviews.”

Under section 4(a) of the Act, we may list a species on the basis of any of five factors, as follows: “(A) the present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; (E) other natural or manmade factors affecting its continued existence.” The petitioners contend that four of the five factors (A, B, D, and E) are applicable to the New England cottontail (see below). A brief discussion of how each of the five listing factors applies to the New England cottontail follows.

In regard to factor A, the petitioners cite loss of habitat to urban and suburban development as a major threat to the New England cottontail. Further, the petitioners note that this species requires thicket habitat frequently associated with early seral stages of forest regeneration after a disturbance such as timber harvest, fire, or beaver activity. They note that an increasingly urbanized landscape, with many small, partially-forested residential parcels is not conducive to timber harvesting, fire, or other disturbance regimes that would maintain and/or regenerate habitat for the species.

Information currently available indicates that loss of habitat to these and other causes appears to be a significant threat to the status of this species. Litvaitis (1993b) considered habitat succession to be the most important cause of habitat loss for this species. As agricultural land in the Northeast was abandoned after the Civil War, forest succession led to a period where habitat conditions were highly favorable for early successional or thicket-dependent species such as the New England cottontail. However, as forests matured and forest canopy closed, the habitats entered a mid-successional stage and were no longer suitable for these early successional species (Brooks and Birch 1988). Further, Litvaitis et al. (1999) reported that remaining shrub-dominated and early successional habitats in the Northeast continue to decline in both coverage and suitability. U.S. Forest Service inventories reveal that in New Hampshire and New York, the extent of forest in the seedling/sapling stage (thickets favorable to the New England cottontail) has declined by about 50 percent in the past three decades (Askins 1998; Litvaitis et al. 1999). In Maine, young forest stands in the two southern counties that still support populations of the New England cottontail declined even more sharply, from about 38 percent in 1971 to 11 percent in 1995 (Litvaitis et al. 2002).

In addition to habitat succession, development has also contributed to direct and more permanent loss and fragmentation of habitat for the species. The three southern New England states, Connecticut (>700 inhabitants per square mile), Rhode Island (>1,000 inhabitants per square mile), and Massachusetts (>800 inhabitants per square mile), which comprise the center of the New England cottontail's range, are among the most densely populated areas in the United States (U.S. Census Bureau 2000). Early successional habitats that once supported New England cottontails have been converted to a variety of uses which make them unsuitable for the species. Among shrub-dominated plant communities, which sometimes support New England cottontail populations, scrub oak and pitch pine barrens have been heavily degraded by development (Patterson 2002). These areas are rapidly being lost to uses such as airport development, roadways, sand and gravel mining, industrial parks, residential development, and retail development. Litvaitis et al. (1999) conclude that shrub-dominated and early successional habitats may be the most altered and among the most rapidly declining communities in the Northeast.

The fragmentation of remaining suitable habitats into smaller patches separated by roads, residential, and other development can have profound effects on the occupancy and persistence of New England cottontail populations in relatively small patches. Barbour and Litvaitis (1993) found that New England cottontails occupying small patches of habitat (less than or equal to 2.5 hectares (ha) or about 6 acres) were predominantly males, had lower body mass, consumed lower quality forage, and had to feed farther from protective cover than rabbits in larger patches (greater than or equal to 5 ha or slightly more than 12 acres). This study also demonstrated that New England cottontails in the smaller patches had only half the survival rate of those in the larger patches due to increased mortality from predation. Barbour and Litvaitis (1993) concluded that local populations of New England cottontails may be vulnerable to extinction if large patches of habitat are not maintained.

Although there are no reliable estimates for historic or current population numbers of New England cottontails, the reduction in the amount of suitable habitat and the range of the species, as well as the effects of competition and predation, are believed to have resulted in a concomitant reduction in numbers.

In regard to factor B, the petitioners contend that while anecdotal evidence implies that hunting pressure on the New England cottontail (and rabbits in general) is not severe, “any hunting, in a population reduced to remnants as the NE cottontail is, is too much.”

Our review of information for this 90-day finding indicates there is presently little hunting pressure on New England cottontails. All of the State wildlife agencies within the range of the New England cottontail regard it as a small game animal and allow hunting with specific season and bag restrictions. Most States report fewer rabbit and other small game hunters today than in earlier decades (U.S. DOI and U.S. DOC 1985, 1991, 1996, 2001), and the New England cottontail is not the rabbit species preferred by most small game hunters because of its smaller size and behavior. New England cottontails forage within or close to dense cover (Smith and Litvaitis 2000), and typically hold in safe areas when disturbed. They are therefore not as easily run by hounds and taken by hunters as eastern cottontails or snowshoe hares. Research shows that New England cottontails are more vulnerable to mortality from predation in smaller patches of habitat than in larger ones (Barbour and Litvaitis 1993). This may hold true for hunting mortality as well, because rabbits on small patches must venture farther from shelter to feed and have less escape cover in which to hide, but this has not been demonstrated.

The petitioners also assert that rabbits may still be regarded as pests and killed indiscriminately by farmers, but provided no objective information to support that assertion. In our review of available information, we did not find evidence either to support or refute this claim. However, because of differences in habitat preference of the two cottontail species, most farmers and homeowners are more likely to encounter eastern cottontails, which occur in the more open habitats of farms and residential lawns, than New England cottontails. Whether either species is killed indiscriminately by farmers, however, is an assertion that lacks supporting information in the petition. Thus, on the basis of available information, current human hunting pressure does not appear to be a significant mortality factor for the New England cottontail.

The petitioners speculate that hunting pressure on the New England cottontail earlier in the century ( e.g. , 1930s) led to declining numbers of rabbits, and in response to reduced hunting opportunity, States and hunting clubs then introduced large numbers of eastern cottontails, with “disastrous” results. The Service agrees that the introduction and establishment of eastern cottontail populations in the Northeast for the purpose of providing small game hunting opportunities has been deleterious to the New England cottontail. However, available evidence suggests that habitat loss, through forest maturation and other causes (Jackson 1973; Brooks and Birch 1988; Litvaitis et al. 1999), rather than hunting pressure, was the primary reason for the decline of New England cottontail populations in the mid-20th century.

With regard to disease (factor C), the petitioners cited one reference that suggested disease could be a factor in the decline of the New England cottontail, but stated that no specifics were provided. In our review of available information, we found little evidence to suggest that disease is a limiting factor for this species. Cottontail rabbits are known to contract a number of different diseases, such as tularemia, and are afflicted with both ecto-parasites such as ticks, mites and fleas, and endo-parasites such as tapeworms, and nematodes (Eabry 1968). Chapman and Ceballos (1990) do not identify disease as an important factor in the dynamics of cottontail populations. Rather, they state that habitat is key to cottontail abundance and that populations are regulated through other causes of mortality and dispersal. Further, they note that escape cover is an essential habitat requirement, suggesting that mortality from predation is an important population regulation mechanism.

With regard to predation, the petitioners discussed its importance as a mortality factor in the section, “life history and ecology of the New England cottontail,” but did not refer to predation as a threat to the species in their review of the five listing factors (Carlton et al. 2000). Available information indicates that predation is likely a significant cause of mortality for New England cottontails and that both mammalian and avian predators are important. Because female New England cottontails are capable of producing 24 young annually (Chapman and Ceballos 1990), the species has the potential to be abundant were it not for mortality and other factors affecting population growth. Litvaitis et al. (1984) noted that New England cottontails were a major prey of bobcats ( Felis rufus ) in New Hampshire during the 1950s. Presently, coyotes ( Canis latrans ) and red foxes ( Vulpes vulpes ) are believed to be the major predators of the New England cottontail in New Hampshire (Barbour and Litvaitis 1993; Brown and Litvaitis 1995). Among avian predators known or suspected to take cottontails are several species of owls (Smith 1997, in Smith and Litvaitis 1999) and red-tailed hawks ( Buteo jamaicensus ) (Bent 1961). Lastly, anecdotal evidence and at least one study (Walter et al. 2001) indicate that cottontails are also killed by domestic dogs and cats.

Available evidence suggests that habitat fragmentation has exacerbated predation rates and reduced New England cottontail survival in several ways. Populations of generalist carnivores have increased with forest fragmentation (Oehler and Litvaitis 1996), and supplemental food resources associated with human dwellings ( e.g. , trash, bird feeders, fruiting shrubs) may lead to “spillover” predation on cottontails (Oksanen et al. 1992, in Brown and Litvaitis 1995).

Studies have shown that, as landscapes become fragmented, New England cottontails become increasingly vulnerable to predation, because habitat quantity and quality are reduced (less forage and escape cover) (Smith and Litvaitis 2000). A study by Villafuerte et al. (1997) demonstrated that the abundance of food and the risk of predation are very influential in determining the persistence of small- and medium-sized vertebrates such as the New England cottontail. As food in the most secure areas is depleted, rabbits are forced to utilize lower quality forage or feed farther from cover where the risk of predation is greater. This study found that rabbits on small patches were “on the lowest nutritional plane” and as a result, were killed at twice the rate (and were killed sooner) than rabbits on larger habitat patches. Villafuerte et al. (1997) concluded that forage limitations imposed by habitat fragmentation affect the viability of local populations of New England cottontails by influencing their vulnerability to predation. Rabbits on larger patches were less vulnerable; therefore, they concluded that large patches of habitat are essential for sustaining populations of this species in a human-altered landscape. Smith and Litvaitis (2000) report that because eastern cottontails appear to have the ability to forage farther from cover and detect predators sooner than New England cottontails, eastern cottontails will likely persist while populations of New England cottontails will continue to decline.

In regard to factor D, the petitioners cite the inability of State wildlife agencies to adequately monitor the status of the New England cottontail within their respective jurisdictions as a threat to the species. We note that the lack of monitoring is not a threat to a species per se but agree that adequate monitoring is important in order to promptly detect and respond to a decline in a species' status.

Conducting research on the status of this species is relatively difficult and expensive because New England cottontails are labor intensive to capture, and identifying them in the field is seldom possible due to their general similarity to the eastern cottontail. Also, because the habitat conditions that support New England cottontail populations change over time with plant succession ( e.g. , forest maturation), status surveys (even presence/absence surveys) need to be repeated periodically. Many States, such as Massachusetts, Rhode Island, and Connecticut, have attempted to monitor the status of the New England cottontail through voluntary hunter and public submittal of specimens. While these data fall short of providing a comprehensive review of the status of the species in a particular state, they are nonetheless useful in demonstrating abundance relative to eastern cottontails, locations of occupied habitats, and trends in frequency of occurrence over time.

All seven State wildlife agencies within the northeastern area have the authority to control the hunting of New England cottontails through the setting of hunting and trapping seasons and bag limits. However, most northeastern States cannot presently restrict hunting of New England cottontails without also reducing hunting opportunities for eastern cottontails and, to a lesser extent, snowshoe hares. This is because these species are visually similar in the field and they co-occur on the landscape, sometimes within the same or adjacent habitat patches. In Maine, where the only cottontail is the New England cottontail, the state has limited hunters to one cottontail per day and two in possession (Maine Hunting and Trapping Laws and Rules 2003).

While States have legal authority to address the mortality of New England cottontails from hunting and trapping, there are only limited regulatory mechanisms available to address the loss of habitat. New England cottontails occur on sites with dense understory vegetation, including native shrublands, beaver flowages, old fields, and early successional forests (Barbour and Litvaitis 1993). In Connecticut, Walter et al. (2001) reported that most current New England cottontail collection records are associated with sites that contain or are adjacent to riparian vegetation, such as borders of lakes, swamps, and rivers. However, the New England cottontail is primarily an upland, terrestrial species that occurs along the margins of these wetland types. This suggests that Federal and State laws that provide protection to shorelands and wetlands may offer some protection to a small portion of New England cottontail habitat (see also the discussion of factor A regarding habitat loss).

Several areas that have persistent populations of New England cottontails are on lands protected by Federal or State ownership and some are being managed for early successional species. However, in our review of information available for this 90-day finding, we were unable to determine the number and location of large patches of occupied New England cottontail habitat which occur on State and Federal conservation lands. Quantifying this information will be an important component of the status review.

In regard to factor E, the petitioners address the adverse effects of eastern cottontail introductions. On the basis of available information, we would agree that the introduction and spread of eastern cottontails has been a factor in reducing the occurrence of the New England cottontail within its historic range. Tens of thousands of individuals of four or five different subspecies of S. floridanus were introduced to the Northeast, beginning on Nantucket Island, Massachusetts, in 1899 (Johnston 1972), and continuing elsewhere in Massachusetts, Connecticut, New Hampshire, and Rhode Island until the 1960s. In States where researchers and State wildlife agencies reported the New England cottontail had been the predominant or the only cottontail encountered during the early- to mid-1900s, by the latter half of the century the eastern cottontail had become by far the most common rabbit (Johnston 1972; Tracy 1995; Cardoza, in litt. 1999). Maine, where the eastern cottontail is not known to occur, is the only exception to this pattern. In summary, Johnston (1972) reported that this occupation of new areas by S. floridanus seemed to be at the expense of S. transitionalis.

Although the precise mechanism explaining how eastern cottontails displace New England cottontails is not known, it is well established that as the range of the eastern cottontail expanded, that of the indigenous New England cottontail declined. Probert and Litvaitis (1996) found that eastern cottontails, though larger, were not physically dominant over New England cottontails. Rather, they believe that eastern cottontails are able to exploit a broader set of ecological conditions and, through more efficient or rapid use of available resources, they have been able to replace New England cottontails in many habitats. Eastern cottontails appear capable of occupying a wider range of available habitat types and can occupy disturbance patches earlier than New England cottontails. Once established, the highly fecund eastern cottontails are not readily displaced by the New England cottontails.

Our review of available information indicates there are other natural and man-made factors that may be affecting the status of the New England cottontail. Winter severity, measured by persistence of snow cover, is believed to affect New England cottontail survival. Villafuerte et al. (1997) found that snow cover reduces the availability of high-quality foods, and likely results in rabbits becoming weakened nutritionally. In a weakened state, rabbits are more vulnerable to predation. Brown and Litvaitis (1995) found that during winters with prolonged snow cover, a greater proportion of the cottontails in their study were killed by predators. Litvaitis and Johnston (2002) speculate that snow cover may explain the largely coastal distribution of this species in the Northeast (generally less snow falls and persists in coastal versus interior areas) and may be an important factor defining the northern limit of its range. The preceding studies suggest that during winters with heavy snowfall, New England cottontail numbers will be reduced, and the combined effects of snowfall and habitat fragmentation will affect the persistence of populations in smaller patches.

State wildlife agencies report that road kills are an important source for obtaining specimens of rabbits, including the New England cottontail. Road-killed rabbits were second only to hunting mortality as a source for obtaining cottontail specimens in an ongoing distributional study of eastern and New England cottontails in Connecticut (Walter et al. 2001). The degree to which New England cottontail populations are affected by vehicular mortality is unknown, but roads may be an important limitation for dispersing individuals.

Litvaitis and Johnson (2002) note that cottontails are often found in habitats that have invasive plant species, such as honeysuckle ( Lonicera spp.). Whether exotic plant species have a positive or negative effect on the New England cottontail is presently unknown.

We have reviewed the petition, the literature cited in the petition, and other literature and information available in our files. On the basis of our review, we find that the petition presents substantial information indicating that listing the New England cottontail may be warranted. The main threat to the species appears to be loss of habitat through forest succession, fragmentation, and conversion to other uses. This loss of habitat has contributed to a reduction in the range of the species and a reduction in numbers. Ongoing competition with eastern cottontails that have been introduced into areas that are outside their native range also appears to be having a negative impact on the New England cottontail.

We have reviewed the available information to determine if the existing and foreseeable threats pose an emergency. We have determined that an emergency listing is not warranted at this time, because many scattered occurrences of the New England cottontail are still known to occur across its range, and some are on protected lands. However, if at any time we determine that emergency listing of the New England cottontail is warranted, we will seek to initiate an emergency listing.

The petitioners also requested that critical habitat be designated for this subspecies. We always consider the need for critical habitat designation when listing species. If we determine in our 12-month finding that listing the New England cottontail is warranted, we will address the designation of critical habitat in the subsequent proposed rule or as funding allows.

When we make a finding that substantial information exists to indicate that listing a species may be warranted, we are required to promptly commence a review of the status of the species. To ensure that the status review is complete and based on the best available scientific and commercial information, we are soliciting information on the New England cottontail. We request any additional information, comments, and suggestions from the public, other concerned governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning the status of the New England cottontail. We are seeking information regarding historic and current status and distribution, the species' biology and ecology, ongoing conservation measures for the species and its habitat, and threats to the species and its habitat.

If you wish to comment or provide information, you may submit your comments and materials concerning this finding to the Field Supervisor (see ADDRESSES section). Our practice is to make comments and materials provided, including names and home addresses of respondents, available for public review during regular business hours. Respondents may request that we withhold a respondent's identity, to the extent allowable by law. If you wish us to withhold your name or address, you must state this request prominently at the beginning of your submission. However, we will not consider anonymous comments. To the extent consistent with applicable law, we will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the above address.

A complete list of all references cited herein is available upon request from the Field Supervisor (see ADDRESSES section).

The primary author of this document is Michael J. Amaral, New England Field Office (see ADDRESSES section).

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ).