We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “Docket No. FAA-2006-25658; Directorate Identifier 2006-NM-054-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc. ). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov, or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

On February 6, 2006, we issued AD 2006-04-06, amendment 39-14487 (71 FR 8439, February 17, 2006), for certain Airbus Model A318-100 series airplanes, Model A319-100 series airplanes, Model A320-111 airplanes, Model A320-200 series airplanes, and Model A321-100 series airplanes. That AD requires repetitive detailed inspections of the inboard flap trunnions for any wear marks and of the sliding panels for any cracking at the long edges; and corrective actions if necessary. That AD resulted from reports of wear damage to the inboard flap trunnions after incorporation of a terminating modification required by an earlier AD, which was superseded by AD 2006-04-06. We issued that AD to detect and correct wear of the inboard flap trunnions, which could lead to loss of flap surface control and consequently result in the flap detaching from the airplane. A detached flap could result in damage to the tail of the airplane.

Since we issued AD 2006-04-06, we determined that we inadvertently excluded Airbus Model A321-200 airplanes from the applicability of the existing AD. This proposed AD emulates the French airworthiness directive by listing Airbus Model A318, A319, A320, and A321 airplanes in lieu of including the dash numbers, as done in the existing AD.

In addition, in the existing AD we identified the inspection in paragraph (g) of the AD as a “detailed” inspection. Upon further review of the service bulletin, we have determined that the appropriate inspection type is “general visual.” We have revised paragraph (i) and the inspection definition in Note 4 of this proposed AD accordingly.

We have changed paragraph (i) of the existing AD, paragraph (j) of this proposed AD, by adding the words “if damaged” to clarify that replacing the sliding panel is required at the specified time if that condition is found.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. As described in this bilateral airworthiness agreement, the Direction Générale de l'Aviation Civile (DGAC) has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that AD action is necessary for airplanes of this type design that are certificated for operation in the United States.

This proposed AD would supersede AD 2006-04-06 and would continue to require repetitive inspections of the inboard flap trunnions for any wear marks and of the sliding panels for any cracking at the long edges; and corrective actions if necessary. This proposed AD would also add airplanes to the applicability of the existing AD, and would change the inspection type from detailed to general visual.

The following table provides the estimated costs for U.S. operators to comply with this proposed AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

In enacting the MUMS act (Pub. L. 108-282), Congress sought to encourage the development of animal drugs that are currently unavailable to minor species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major species afflicted with uncommon diseases or conditions (minor use). Congress recognized that the markets for drugs intended to treat these species, diseases, or conditions, are so small that there are often insufficient economic incentives to motivate sponsors to develop data to support approvals. Further, Congress recognized that some minor species populations are too small or their management systems too diverse to make it practical to conduct traditional studies to demonstrate safety and effectiveness of animal drugs for such uses. As a result of these limitations, sponsors have generally not been willing or able to collect data to support legal marketing of drugs for these species, diseases, or conditions. Consequently, Congress enacted the MUMS act, which amended the Federal Food, Drug, and Cosmetic Act to provide incentives to develop new animal drugs for minor species and minor use, while still ensuring appropriate safeguards for animal and human health.

The major incentives of the MUMS act include the following:

(1) Designation, established by section 573 of the act (21 U.S.C. 360ccc-2), which provides for eligibility for grants and contracts to defray the costs of qualified safety and effectiveness testing expenses and manufacturing expenses incurred in the development of designated new animal drugs. Designation also provides for eligibility for a 7-year period of exclusive marketing rights to enable sponsors to recover costs of drug development without competition. FDA proposed regulations to implement the designation provision of the act on September 27, 2005 (70 FR 56394) (the designation proposed rule).

(2) Conditional approval, established by section 571 of the act (21 U.S.C. 360ccc), which provides for animal drug marketing after all safety and manufacturing components of a new animal drug approval have met the standards of section 512 of the act (21 U.S.C. 360b). For the effectiveness component, a reasonable expectation of effectiveness must be established, after which sponsors have up to 5 years to complete the demonstration of effectiveness by the standards of section 512 of the act and achieve a full approval. Regulations to implement the conditional approval provision will be proposed in the future.

(3) Indexing, established under section 572 of the act (21 U.S.C. 360ccc-1), which provides for the legal marketing of unapproved new animal drugs intended for use in a minor species through an integrated process of agency and expert panel review.

At this time, FDA is issuing proposed regulations to implement the indexing provisions of the MUMS act. These regulations propose procedures and criteria for index listing a new animal drug for use in a minor species. They describe a process whereby the agency makes a determination regarding the following: (1) The eligibility of a new animal drug, (2) the selection of a qualified expert panel, and (3) the findings of the qualified expert panel.

Most of the proposed definitions are straightforward. The proposed definition of “qualified expert panel” is drawn from the statutory definition, given in section 572(d)(3) of the act. The proposed definition of “transgenic animal” comes from the statutory definition, given in section 571(j) of the act (21 U.S.C. 360ccc). The proposed definition of “intended use” is identical to one proposed with respect to the designation proposed rule of September 27, 2005 (70 FR 56394). The designation proposed rule also included definitions for the phrases “same intended use,” “same drug,” and “same dosage form” that would be applicable to all subparts of part 516, including the indexing regulations.

The proposed rule would require a foreign requestor or holder to name a permanent-resident U.S. agent so that the agency may ensure that notifications of decisions regarding indexing and all other communications with the requestor or holder are legally and effectively made.

The act provides that any person intending to file a request for eligibility or a request for addition to the index may have an opportunity to meet with the agency to discuss the requirements for indexing a new animal drug.

The act also provides that a requestor or holder be offered an informal conference in association with an agency decision to deny a request for a determination of eligibility to index, to deny a request for index listing or to remove an index listing. Proposed § 516.123 establishes the nature of and the procedures for requesting and conducting such conferences. FDA would give notice of the grounds for the initial decision and provide an opportunity to respond to that decision. As proposed, the conference's presiding officer would not have significantly participated in the initial decision, would prepare a written summary of the informal conference to share with the participants, and would issue a written report describing the basis for his or her findings. The proposed regulation also provides for an informal conference associated with a decision to terminate an investigational exemption for a new animal drug proposed for indexing or a decision not to affirm an expert panel because it does not meet the selection criteria of § 516.141. In the case of conferences associated with adverse agency decisions, the proposed regulation establishes that decisions to deny, remove, terminate, or not affirm will be made by the Director, Office of Minor Use and Minor Species Animal Drug Development (OMUMS) and a subsequent conference, if requested, will be conducted by the Director, Center for Veterinary Medicine or his designee, other than the Director, OMUMS. These procedures were adapted from the process for holding regulatory hearings before the agency under 21 CFR part 16.

As required by section 512(a)(1) of the act, a new animal drug may not be legally marketed unless it is the subject of an approved New Animal Drug Application (NADA), the subject of a conditionally approved NADA, or on FDA's list of legally marketed unapproved new animal drugs. The act contains two exemptions for drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. The first, in section 512(j) of the act, applies to new animal drugs generally, including animal feeds bearing or containing new animal drugs. FDA's regulations implementing this investigational use exemption are at part 511 (21 CFR part 511). The second, in section 572(g) of the act, is parallel to the first exemption but is for the purposes of indexing and applies only to minor species new animal drugs, including animal feeds bearing or containing such new animal drugs. Note that the coverage of these exemptions overlaps and, therefore, in some circumstances an investigational use might qualify for an exemption under either section 512(j) of the act or section 572(g) of the act.

Proposed § 516.125 would implement section 572(g) of the act. It states that certain investigational uses, although they involve a minor species new animal drug, are nonetheless subject to part 511. Such uses include investigations to demonstrate safety with respect to individuals exposed to the new animal drug through its manufacture and use under section 572(c)(1)(F) of the act, to conduct an environmental assessment under section 572(c)(1)(E) of the act, or to obtain approval of a new animal drug application or abbreviated new animal drug application under section 512(b) of the act. These investigational uses would be required to be conducted under part 511 because, whether these types of studies are conducted to support indexing or approval, the agency would evaluate the study results using the same standards. Thus, the agency believes it should apply the same substantive and procedural requirements for these investigational uses for minor species new animal drugs as it does for new animal drugs generally.

For other types of investigational uses, proposed § 516.125 establishes separate exemption regulations, although they are very similar to part 511. The agency believes the regulations should be similar because of the similarity of the purpose and the language of the two investigational use exemptions in the act. Proposed § 516.125 states that, with certain modifications, part 511 applies to minor species new animal drugs or animal feeds bearing or containing such new animal drugs intended for investigational use for all other purposes in support of a drug index listing (such as to demonstrate target animal safety and effectiveness). Among the proposed modifications is the need to specifically identify that the investigational use is in support of index listing, which would be done when labeling the drugs involved and when notifying the agency of the claimed investigational exemption. Another modification is that FDA would provide notice and an opportunity for an informal conference before terminating an investigational use exemption. While part 511 provides for notice and an opportunity for a hearing under 21 CFR part 16 concerning whether the exemption should be terminated, the administrative process in the proposed regulations reflects the fact that section 572 of the act provides for an informal conference with respect to other agency decisions regarding indexing, such as removal of a new animal drug from the index. FDA does not believe it should have an administrative process for terminating an investigational use exemption relating to indexing that is different from the informal conference process for other decisions relating to indexing.

To be added to the index, a new animal drug must meet certain criteria. The act establishes what can be described as a two-part regulatory decision-making process for determining whether these criteria have been met. The first part in this regulatory process is FDA's determination of whether the new animal drug is eligible for indexing. This involves an evaluation of most of the indexing criteria, with the major exceptions being target animal safety and effectiveness. The second part includes the agency's determination of the suitability of the qualified expert panel and a review of whether the new animal drug meets the statutory criteria regarding target animal safety and effectiveness.

The determination of eligibility for indexing is initiated by a request to the agency that must be accompanied by sufficient information to permit the agency to make an informed decision regarding the request. The information proposed by the agency to determine eligibility for indexing, described in proposed § 516.129(c), is based on the requirements of 572(c)(1) of the act. The categories of information are described below:

The act allows the indexing of new animal drugs that are intended for use in food-producing animals only in limited circumstances. The new animal drug must be for use in an early, non-food life stage of a minor species; it must be intended for use only in a hatchery, tank, pond, or other similar contained man-made structure; and there must be sufficient information to demonstrate food safety in accordance with the standards of section 512(d) of the act (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance).

When a new animal drug proposed for indexing is not intended for use in an early life stage of a food-producing minor species animal, the requestor must demonstrate that there is a reasonable certainty that the minor species or edible products from the minor species will not be consumed by humans or food-producing animals. For many minor species, this should be as straightforward as an affirmation that the species has never been traditionally consumed by humans and is not subject to being used in the feed of food-producing animals. A new animal drug intended for use in a wildlife species might be eligible for indexing if it could be demonstrated that there is a reasonable certainty that treated animals would not be subsequently harvested and consumed by humans or food-producing animals.

Under the proposed rule, FDA would rely on its existing regulations regarding the food safety standards of section 512(d) of the act, which are in part 514 (21 CFR part 514) at § 514.111, and be guided by relevant policies and guidance such as FDA's Guidance for Industry (GFI) #152.

Under the proposal, a request for eligibility would be required to contain either an environmental assessment or sufficient information to support a categorical exclusion from the requirement to prepare an environmental assessment. The proposal would rely on the process and the standards for environmental assessments that are already defined in part 25 (21 CFR part 25). It would also amend part 25 to have categorical exclusions relating to indexing that parallel those relating to new animal drug approvals.

As with new animal drug approvals, indexing includes a provision for a demonstration of safety to individuals exposed to the new animal drug during the drug's manufacture and use. FDA intends to rely on the same user safety standards for both drug approval and drug indexing.

The required chemistry, manufacturing, and control information, and the agency's review of that information, are much different for indexing than they are for approval.

A request for a determination of eligibility for a new animal drug for indexing must include “information regarding” the components and composition of the involved drug (section 572(c)(1)(C) of the act) and must also include “a description” of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new animal drug (section 572(c)(1)(D) of the act) for the purpose of determining whether the requestor has an understanding of current Good Manufacturing Practices (cGMPs) and has established appropriate specifications for the manufacture and control of the new animal drug (section 572(c)(2)(C) of the act). In addition, before a new animal drug can be added to the index, the requestor must make a commitment that the indexed drug will be manufactured in compliance with cGMPs (section 572(d)(1)(F) of the act).

In contrast, an NADA must include a “full list” of the articles used as components of the drug and “a full statement” of the composition of the drug (section 512(b)(1)(B), (C) of the act) as well as “a full description” of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new animal drug (section 512(b)(1)(D) of the act). These statutory requirements, as implemented by regulation (21 CFR 514.1(b)(4), (5)), result in a highly detailed NADA submission which must contain sufficient information to permit FDA to determine the adequacy of the “full description” with respect to preserving the identity, strength, quality, and purity of the subject new animal drug (see section 512(d)(1)(C) of the act).

As previously stated, FDA believes that the submission of chemistry, manufacturing, and control information for a new animal drug proposed for indexing that would meet the relevant statutory standard would consist of a comprehensive summary of the manufacturing process that is sufficient to permit a determination that the requestor understands cGMPs and has established appropriate specifications in accordance with that understanding. FDA believes that the “full description” and underlying confirmatory information that are required in an NADA would not be necessary in a request for determination of eligibility for indexing.

Proposed 21 CFR 516.129 also requires that a request for determination of eligibility contain the following: (1) Identification of the minor species or groups of minor species for which indexing is sought; (2) a statement of the intended use(s) in those species; (3) a statement of the conditions of use, such as dosage, route of administration, warnings, contraindications or other significant limitations associated with the intended use(s); (4) a brief discussion of the need for the drug for the intended use(s); and (5) an estimate of the anticipated annual distribution after indexing.

Additionally, the regulation provides that a single request for eligibility may involve only one drug (or combination of drugs) in one dosage form, may involve multiple intended uses or multiple minor species, may not involve a new animal drug that is contained in or a product of a transgenic animal, and may not involve the same drug in the same dosage form for the same intended use as a new animal drug that is already approved or conditionally approved.

FDA will deny a request for determination of eligibility if a requestor fails to submit information required by section 572(c)(1) of the act, or the submitted information, evaluated together with other information available to the agency, is insufficient to support a decision to grant a request in accordance with section 572(c)(2) of the act.

The new animal drug that is the subject of the request must be sufficiently characterized to enable the agency to determine whether the same drug in the same dosage form for the same intended use is already approved or conditionally approved. The proposed designation rule contains a definition of sameness regarding these three elements that would also apply to indexing (see proposed § 516.3 published in the Federal Register of September 27, 2005 (70 FR 56394)).

FDA believes that the estimate of the quantity of the indexed drug likely to be distributed on an annual basis following indexing is primarily required because of concern over extralabel use of indexed drugs, which is statutorily prohibited. The anticipated quantity to be distributed for the intended purpose(s) can serve as a baseline against which actual distribution can be measured. Significant differences between expected and actual distribution may indicate that an indexed drug is being used for other than its intended purposes. An estimation of the quantity of drug likely to be distributed may also inform decisions associated with the extent of environmental or user exposure following indexing.

As previously noted, a new animal drug which is contained in or is the product of a transgenic animal may not be indexed. A transgenic animal is defined, in section 571(j) of the act, as an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal; provided that the term “transgenic animal” does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding.

Under the proposal, FDA cannot determine a drug to be eligible for indexing if the information submitted in support of the request evaluated together with other information available to the agency is insufficient to do the following: (1) Demonstrate food safety in an early, non-food life stage of a food-producing minor species animal or demonstrate that there is a reasonable certainty that treated animals will not be consumed by humans or food-producing animals, (2) determine that the requestor has established appropriate specifications for the manufacture and control of the new animal drug, (3) demonstrate that the requestor has an understanding of current good manufacturing practices, or (4) determine that the new animal drug is safe with respect to individuals exposed to the new animal drug during manufacture or use; or the request fails to include an adequate environmental assessment or sufficient information to support a categorical exclusion from the requirement to prepare an environmental assessment.

In addition, under the proposal a request for a determination of eligibility for indexing may be denied if it contains any untrue statement of a material fact or omits material information.

Within 90 days after the submission of a request for a determination of eligibility for a non food-producing animal, or 180 days for a request for an early, non-food life stage of a food-producing animal, FDA must grant or deny the request and notify the requestor of its decision in writing. If FDA denies the request, the agency will provide due notice and an opportunity for an informal conference regarding its decision. A decision of FDA to deny a request for determination of eligibility for indexing following an informal conference would constitute the final agency action subject to judicial review.

Once a requestor has received a letter granting eligibility for indexing, as the first step in the process of requesting an index listing, it can propose a qualified expert panel. The panel, which operates external to FDA, plays a central role in the indexing process—evaluating target animal safety and effectiveness information and making a recommendation to FDA based on its evaluation. Section 572(d) of the act requires the agency to “define the criteria for selection of a qualified expert panel and the procedures for the operation of the panel.” The same section states that the panel is not subject to the Federal Advisory Committee Act, also known as FACA. Section 516.141 of the proposed implementing regulations describes the process for selecting the qualified expert panel and describes how the panel operates. It does this by stating the responsibilities of each of the parties involved—the requestor, FDA, the panel members, and the panel leader.

Because of the diverse nature of the products that are subject to indexing and anticipated differences in the availability and accessibility of experts qualified to review different product classes, the proposed rule does not specify the day-to-day operations of a qualified expert panel other than to require that the activities of the panel be conducted in accordance with generally accepted professional and ethical business practices and that one member of the panel be identified to serve as the “leader” of the review process. The leader would serve as the principal spokesperson for the panel and be responsible for submitting the panel's final written report to the requestor and maintaining records of the final report. In addition, the agency plans to issue guidance documents regarding other aspects of the operation of expert panels and the preparation of written reports.

In developing the selection criteria for the qualified expert panel, FDA adapted some aspects of the agency's implementation of section 523 of the act (21 U.S.C. 360m). That provision deals with FDA accreditation of persons in the private sector to conduct the initial pre-market review for certain medical devices. FDA also considered its use of advisory committees that review information and make recommendations to FDA on various technical and scientific issues relating to product approval. In addition, FDA tried to minimize the burden on the potential members to help ensure that qualified individuals will be willing to participate while still establishing adequate controls to help ensure that FDA obtains objective, high quality evaluations and recommendations.

To maintain the integrity of the review process, one proposed selection criterion is that a qualified expert panel member must not have a conflict of interest or the appearance of a conflict of interest, unless FDA makes a determination to allow participation notwithstanding an otherwise disqualifying financial interest. The proposed rule describes the factors that are, and are not, relevant to determining whether there is a conflict of interest or the appearance of a conflict of interest and identifies the information needed from potential panel members to support this determination by the agency. Proposed § 516.141(e)(7) requires qualified expert panel members to immediately notify the requestor and FDA of any change in conflict of interest status. For purposes of this regulation, the agency believes that this generally requires a panelist to report changes in his conflict of interest status within 30 days.

In selecting members for the qualified expert panel, the person requesting the index listing would be required to ensure that the members have the requisite scientific training and experience to evaluate the target animal safety and effectiveness of the new animal drug at issue for the proposed intended use. The group of identified experts would also be required to represent an adequate range of expertise to fully evaluate the product.

After identifying potential panel members, the requestor would be required to provide their names and addresses to FDA, along with sufficient information about each proposed member for FDA to determine whether the panel meets the selection criteria other than with respect to potential conflicts of interest. Each proposed panel member would provide information regarding potential conflicts of interest directly to the agency. If the agency determines that the qualified expert panel does not meet the selection criteria, it will provide information to the requestor so that a suitable panel can be proposed. For example, FDA may decline some candidates and request replacements or request that the panel include additional members to provide needed expertise. If the requestor disagrees with FDA's determination regarding the panel, under the proposal it may request review through an informal conference.

The work of the expert panel centers around its primary task, which is to prepare a written report that describes the panel's evaluation of all available target animal safety and effectiveness information relevant to the proposed use of the new animal drug and the panel's conclusions based on its evaluation. In preparing the written report, panel members would be required to review all relevant information provided by the requestor and should also consider any other relevant information otherwise known by panel members, including anecdotal information. Panel members would be required to participate in the preparation of the written report. Members could be paid a reasonable fee to serve on expert panels by the requestor.

The qualified expert panel's written report must meet the requirements of section 572(d)(2) of the act. Under proposed § 516.143, which would implement this provision, the report must describe the panel's evaluation of all available target animal safety and effectiveness information relevant to the proposed use of the new animal drug; provide citations of all literature reviewed and summaries of unpublished information considered; and state the panel's opinion regarding whether the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally approved new animal drug for the minor species in question. The purpose of these requirements is to provide sufficient information to permit the agency to assess the quality and quantity of the information relating to target animal safety and effectiveness of the new animal drug assessed by the panel. Therefore, the panel's evaluation should be such that FDA can understand the basis for the panel's conclusion regarding the drug's benefits and risks. If the expert panel concludes that the benefits of using the drug outweigh its risks, it would also be required to provide as part of the report either draft labeling, which includes all conditions of use deemed necessary by the expert panel to assure that the benefits of the drug will outweigh its risks, or narrative information on the basis of which such labeling can be drafted by the requestor. All panel members would be required to sign the report or otherwise approve it in writing.

As noted previously, the second part of the indexing regulatory process involves FDA's review of whether the new animal drug meets the statutory criteria regarding target animal safety and effectiveness information. FDA's review is based on the qualified expert panel's written report and recommendation. The agency's review begins with the requestor's submission asking for addition of the new animal drug to the index. This submission must contain the information required by section 572(d)(1) of the act. FDA's decision to grant or deny the request for indexing is governed by section 572(d)(4) of the act. Therefore, the request for addition to the index needs to contain sufficient information to permit FDA to grant the request. The sections of the proposed rule that implement these statutory provisions are sections 516.145 and 516.149, respectively.

The agency proposes that if a request for indexing fails to contain information required by § 516.145, FDA will not file or review it and will so notify the requestor within 30 days of receiving the request.

FDA must deny a request for indexing if the same drug in the same dosage form for the same intended use is approved or conditionally approved. While this is also a basis for denying eligibility for indexing, it is possible that a new animal drug may be approved or conditionally approved between the time that a determination for eligibility is made and the request for indexing is submitted, thus preventing the indexing of a new animal drug previously determined to be eligible.

It is also possible that new scientific information may arise between the time of a determination of eligibility and submission of a request for indexing. Section 572(d)(4) of the act (by reference to section 572(a) of the act) and proposed § 516.151 require the agency in reviewing a request for index listing to evaluate any new information together with the information available at the time of a determination of eligibility to determine whether the new animal drug is still eligible for indexing.

If a request for indexing fails to contain, or appropriately reference, information required by the statute, as implemented by proposed § 516.145, the agency would be required to deny the request.

In general, FDA intends to rely heavily on the recommendations of the qualified expert panel regarding target animal safety and effectiveness, including the necessary conditions of use. However, the written report of a qualified expert panel may not be sufficiently clear or complete with respect to the basis for a panel recommendation to index a new animal drug to permit FDA to make an informed decision regarding whether it agrees with the recommendation. In this case, FDA would either deny the request for indexing or, under proposed § 516.145(c), require that the requestor submit the information provided to the panel. It is also possible that, in some cases, the written report of an expert panel may be sufficiently clear and complete for the agency to make a decision regarding the panel recommendations, but the agency may disagree in whole or in part with the recommendations. Such disagreement may be based on the written report itself or the report along with additional information available to the agency. In such a case, FDA would deny the request. If FDA denies a request for addition to the index, the requestor could submit another request, which contains information to overcome the agency's grounds for denial.

One of the grounds for denying a request for addition to the index is that the qualified expert panel failed to meet one or more of the selection criteria. Proposed § 516.141 would require panel members to submit any new information regarding conflicts of interest to the agency so that FDA can determine whether a disqualifying conflict has arisen since the agency's initial review.

Under the proposal, and consistent with FDA's regulations governing new animal drug applications, FDA may also deny a request for addition to the index if it contains any untrue statement of a material fact or omits material information.

Within 180 days after the filing of a request for addition of a new animal drug to the index, FDA will grant or deny the request, and notify the person requesting indexing of FDA's decision in writing. If FDA denies the request for indexing of a new animal drug, the agency will provide due notice and an opportunity for an informal conference. A decision by FDA to deny a request to index a new animal drug following an informal conference will constitute final agency action subject to judicial review.

FDA proposes to meet the requirement of section 572(e)(2) of the act by maintaining and updating, at least annually, a publicly available list of indexed drugs. Each index listing would contain the following: (1) The name and address of the person who holds the index listing, (2) the name of the new animal drug and the intended use and conditions of use for which it is indexed, (3) product labeling, and (4) conditions and any limitations that the agency deems necessary regarding the use of the new animal drug.

As with approved new animal drugs, and as provided for by section 572(e)(3) of the act, there will almost certainly be a need to change the conditions under which a new animal drug is indexed or other aspects of an indexed drug at some point after indexing. The proposed regulations for making such changes are based on those governing new animal drug applications, although the proposed regulations are generally less burdensome than the regulatory requirements of the corresponding section of 21 CFR part 514.

Proposed § 516.161 provides for three classes of changes to indexed drugs.

The first class of changes involves the following: (1) The addition to labeling or prescription drug advertising of additional warning, contraindication, side effect, or cautionary information, (2) the deletion from labeling or prescription drug advertising of false, misleading, or unsupported indications for use or claims of effectiveness, or (3) changes in manufacturing methods or controls required to correct product or manufacturing defects that may result in serious adverse drug events. Changes of this nature should be made as soon as possible and a request for modification of an index listing containing information describing the need for the change should be concurrently submitted to the agency.

The second class of changes involves the following: (1) Addition of an intended use, (2) addition of a species, (3) addition or alteration of an active ingredient, (4) alteration of the concentration of an active ingredient, (5) alteration of the dose or dosage regimen, or (6) alteration of prescription or over-the-counter status. Changes of this nature can be made only after a request to make such a change has been granted by FDA. Each such change must go through the same review process as the original index listing. Therefore, the initial submission to FDA relating to such a change should be a request for a determination of eligibility for indexing that relates specifically to the proposed change. However, while the process for modifications to index listings of this kind follows the same process as a new index listing, much of the work to support the initial listing might also support the change to the listing and so would not have to be duplicated. Likewise, the panel that reviewed the original request for listing would likely be acceptable to review the proposed change as well. The agency notes, however, that the nature of the change or new information about, for example, the product's safety or effectiveness, may mean that previous work would no longer be adequate to support the change.

The third class of changes involves any change to the conditions established in labeling or otherwise described in the request for determination of eligibility or request for indexing at the time a new animal drug was indexed other than those noted above. Information describing such changes would be required to be submitted as part of the annual indexed drug experience report. These changes include changes to the formulation of the product or to the manufacturing methods or controls other than those to correct defects that may cause serious adverse drug events. Changes to the formulation or manufacturing process would be required to be reported at the same level of detail as the level of detail at which the formulation or manufacturing process were initially described in the request for determination of eligibility for indexing.

The proposed provisions under § 516.161 would apply only to modifications to the indexed drug. Regardless of which class of changes is requested, these provisions would not apply to changes that would cause an indexed drug to be a different drug (or different combination of drugs) or a different dosage form. In the case of such a submission, the agency would deny the request for modification and notify the holder that a new index listing is required for the new drug or dosage form. The designation proposed rule (September 27, 2005, 70 FR 56394) contains proposed definitions for “same drug” and “same dosage form.” The holder could then initiate the new listing by submitting a request for eligibility for the new drug or dosage form.

The agency proposes that, in order to meet the requirement of section 572(e)(1)(A) of the act, the owner of an index file supporting an index listing may transfer ownership of the file provided that the agency is appropriately notified of this. The agency would then update the index listing accordingly.

Section 572(i) of the act requires the maintenance of records and the submission of reports sufficient to permit a determination of whether an indexed drug should be removed from the index. The information FDA believes is necessary to make this determination is described in proposed § 516.165. This information would be similar in nature but less extensive than the information required with respect to approved new animal drugs. Most of the information required would be submitted annually, on, or within 60 days of, the anniversary date of the letter granting the request for indexing.

Under the proposed regulation, product or manufacturing defects that may result in serious adverse drug experiences must be reported to the appropriate FDA District Office or resident post within three working days of their discovery. Serious and unexpected adverse drug experiences must be reported to the Director, OMUMS within 15 working days of the index holder first receiving the information.

Distribution of an indexed drug by a distributor would be permissible provided that the holder of the index listing submits a special report at the time of initial distribution by the distributor containing the information required under proposed § 516.165. This includes a signed statement from the distributor that the indexed drug will be distributed and promoted only in accordance with the index listing.

The agency proposes that all other required information be submitted annually. This includes the following: The quantity of the drug distributed (domestically and for export), holder and distributor current package labeling with a summary of any changes in labeling since the previous annual report, a summary of changes in the manufacturing process (at the level of detail that the manufacturing process was described in the request for determination of eligibility) not already reported under proposed § 516.161, any pertinent safety or effectiveness information not previously reported, and any adverse drug experience information not previously reported.

Proposed § 516.167 provides for removal of a new animal drug from the index, after due notice to the holder of the index listing and an opportunity for an informal conference.

The proposed grounds for removal, which track those in the act, include that the same drug in the same dosage form for the same intended use has been approved or conditionally approved.

In accordance with section 572(f)(1) of the act, if FDA determines, subsequent to the indexing of a new animal drug, that the qualified expert panel failed to meet its applicable requirements, FDA would remove the drug from the index.

In light of the purpose of the MUMS act to increase the availability of legally marketed new animal drugs to treat minor species, the agency proposes to only partially remove an index listing if it believes that doing so would satisfactorily resolve a safety or effectiveness issue otherwise warranting complete removal of the drug from the index. For example, if an index listing provides for the use of a new animal drug in several minor species and new information indicates that the benefits of using the drug in one of those minor species does not outweigh its risks to that species, the agency may remove only the use of the new animal drug in that minor species from the index listing.

In accordance with section 572(f)(2) of the act, the regulation proposes that FDA may immediately suspend a new animal drug from the index if it determines that there is a reasonable probability that the use of the drug would present a risk to the health of humans or other animals. The agency would subsequently offer the holder of the index listing an opportunity for an informal conference.

A decision by FDA to remove a new animal drug from the index following an informal conference would constitute final agency action subject to judicial review.

This proposed regulation is based on § 514.11, which applies to new animal drug application files. It would apply to index files, which would encompass all data and information submitted to or incorporated by reference into the index file including requests for determination of eligibility for indexing, information supporting selection of expert panel members, requests for addition to the index, claimed investigational exemptions under proposed § 516.125, requests for modification to indexed drugs, reports submitted under proposed § 516.165, and master files.

FDA is proposing conforming changes to certain applicable sections of the Code of Federal Regulations (CFR) that would add a reference to new animal drugs that are index listed under section 572 of the act. The affected sections in title 21 of the CFR are:

§ 20.100 Applicability; cross-reference to other regulations.

§ 25.33 Animal drugs.

§ 201.105 Veterinary drugs.

§ 201.115 New drugs or new animal drugs.

§ 201.122 Drugs for processing, repacking, or manufacturing.

§ 202.1 Prescription-drug advertisements.

§ 207.21 Times for registration and drug listing.

§ 207.35 Notification of registrant; drug establishment registration number and drug listing number.

§ 225.1 Current good manufacturing practice.

§ 225.35 Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

§ 225.135 Work and storage areas.

§ 226.1 Current good manufacturing practice.

§ 500.25 Anthelmintic drugs for use in animals.

§ 500.26 Timed-release dosage form drugs.

§ 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.

§ 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.

§ 510.455 Requirements for free-choice medicated feeds.

§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the act.

§ 515.10 Medicated feed mill license applications.

§ 515.21 Refusal to approve a medicated feed mill license application.

§ 558.3 Definitions and general considerations applicable to this part.

§ 558.5 Requirements for liquid medicated feed.

§ 558.6 Veterinary feed directive drugs.

§ 589.1000 Gentian violet.

In § 201.105, FDA is also proposing to remove a reference to certification requirements applicable to preparations of antibiotic drugs. FDA no longer certifies or recognizes certification of antibiotic drugs.

In addition, FDA is proposing to remove the last sentence in § 500.25(c) because it cites § 514.9 which no longer exists. Labeling revisions for animal feeds bearing or containing anthelmintic drugs are now subject to the same requirements under 21 CFR 500.25 as dosage form drugs. Medicated animal feeds covered by approved applications are subject to the provisions of § 514.8 (d) and (e). Medicated animal feeds covered by an index listing are subject to the provisions of 21 CFR 516.161(b)(1).

FDA's authority for issuing this proposed rule is provided by the MUMS act (21 U.S.C. 360ccc et seq. ). When Congress passed the MUMS act, it directed FDA to publish implementing regulations (see 21 U.S.C. 360ccc note). In the context of the MUMS act, the statutory requirements of section 572 of the act, along with section 701(a) of the act (21 U.S.C. 371(a)) provide authority for this proposed rule. Section 701(a) authorizes the agency to issue regulations for the efficient enforcement of the act.

FDA has examined the impacts of the proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act (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; and distributive impacts and equity). The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities.

FDA tentatively finds that the proposed rule does not constitute an economically significant regulatory action as defined in 3(f)(1) of Executive Order 12866. We base this on the following analysis that estimates annual costs ranging from about $342,000 in the first year to about $735,000 in the 10th year. Similarly, the administrative costs are unlikely to have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that may result in an annual expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $115 million, using the most current (2003) implicit price deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount. As such, no further analysis of anticipated costs and benefits is required by the Unfunded Mandates Reform Act.

The proposed rule is expected to result in about 30 requestors, each averaging about 2 requests for a determination of eligibility for indexing of individual animal drugs annually, submitting a total of 60 requests annually. We estimate that requestors for 20 of these products will create and convene expert panels to review the safety and efficacy data. Further, the recommendations of these panels are expected to lead to the addition of 20 animal drug index listings each year.

This rule intends to create administrative practices and procedures for index listing a new animal drug for use in a minor species, thereby providing the benefit of a legal basis for marketing an unapproved new animal drug intended for use in a minor species. The need for the rule arises from the existence of some minor species populations that are too small to support traditional drug approval studies. The countervailing risk of this rule is that sponsors of animal drugs that are marginally economically viable could use this system to avoid the traditional animal drug approval process. Under this proposed rule, however, the voluntary indexing of a new animal drug for use in a minor species would only be allowed when the same drug in the same dosage form for the same intended use is not already approved or conditionally approved, thereby reducing this risk.

This section will describe and estimate the annual administrative costs by proposed provision for both producers of currently unapproved drugs that would request an index listing and FDA. First, we address the efforts required by requestors concerned with index listing. The estimates of the number of requestors, frequencies of responses, and hours per procedure for each of the provisions of the proposed rule were determined by Center for Veterinary Medicine personnel.

We estimate that, on average, two foreign requestors of drug indexing would need to hire a permanent resident agent to represent them. We expect this to require about 1 hour of administrative time for a requestor's management employee in regulatory affairs. We estimate the loaded wage estimate at $42.29 per hour (including a 30 percent increase for benefits) for regulatory affairs personnel. 1 This provision would cost the two requestors a total of about $85. We expect that a resident agent would expend only about 6 hours of administrative effort per year per indexed drug. We estimate the wage rate of the resident agent at $100 to $150 per hour, and use the midpoint, $125, for our calculations. Total annual costs for resident agents are estimated at $1,500 (two agents times 6 hours times $125 per hour) in the first year. In the 10th year this is expected to rise to about $15,000 as two more resident agents each provide 6 more hours of administrative effort each additional year. Due to the uncertainty in the costs for resident agents, we request public comment and data on this issue.

Proposed § 516.121 provides for one or more meetings between requestors and FDA to discuss the requirements for indexing a new animal drug. We estimate that 30 requestors will each request, on average, 2 meetings annually, for a total of 60 meetings. Preparation and participation in these meetings is estimated at 4 hours each, for an annual total of 240 hours. Proposed § 516.123 concerns informal conferences regarding agency administrative actions. These would include conferences to discuss a request for determination of eligibility that has been denied, the removal of an expert panel member, a request for indexing that was denied or an indexed drug that was removed from the list. We estimate that about three requestors would request one conference with FDA annually for any of these reasons. We expect that each requestor would expend about 8 hours (24 hours total) to prepare for and attend each of these conferences. The combined efforts for preparation and participation in all conferences are estimated at 264 hours (240 plus 24). At the same loaded wage estimate of $42.29 per hour, this provision is expected to cost about $11,200 annually.

For proposed § 516.125, we estimate that two requestors would each annually submit three notices of claimed investigational exemptions for new animal drugs for index listing. We estimate that each submission would require about 20 hours for regulatory affairs personnel to prepare. At the loaded wage estimate of $42.29 per hour, the total of 120 hours would cost about $5,100.

We estimate that about 30 requestors would each average about 2 requests for determination of eligibility for indexing of individual animal drugs annually, totaling to 60 requests annually for proposed § 516.129. At the loaded wage estimate of $42.29 per hour, and our estimate of 12 hours of preparation for each request, this provision would require about 720 hours equal to about $30,400. Included in this estimate of 60 requests are any resubmitted requests that were previously denied.

Proposed § 516.141 would require the creation of a qualified expert panel to review all information, provided by any source, relevant to a determination of the target animal safety and effectiveness of the new animal drug. FDA would be required to approve the panel members before the panel formally convened. We estimate that requestors of 20 animal drugs, or about one-third of the 60 animal drugs that annually are determined to be eligible for indexing, would create qualified expert panels to further study the safety and efficacy data. The creation of each panel by a requestor is estimated to take about 8 hours of effort by regulatory affairs personnel. At the same loaded wage estimate, these 160 hours would cost about $6,800 annually.

Proposed § 516.143 describes how the expert panel would prepare a written report for FDA with its findings concerning the new animal drug under consideration for index listing. The review of the relevant information and preparation of the report by each panel would take an estimated 80 hours. This equates to 1,600 hours for 20 panels. The proposed rule allows for fees to be paid to panel members for their time. We estimated the average wage rate for panel members at $100 to $150/hr, and use the midpoint ($125) in our calculations. At this wage, we estimate these activities to cost up to $200,000 annually for the total industry, or $10,000 per requestor for each animal drug under consideration. An additional 0.5 hours is estimated for recordkeeping of the final written report described in proposed § 516.143 by the panel leader. This would result in an additional $400 in costs annually. We request comment and data on the range of hourly wage rates for qualified panel members.

We estimate that the formal request for addition to the index, provided for in proposed § 516.145, would require about 12 hours to prepare. This would result in another 240 hours of effort (20 requests times 12 hours) for regulatory affairs personnel. We project the compliance cost of this effort at $10,200 annually.

We only expect to receive one request each for a modification to an indexed listed drug and a change in ownership of an index file annually (provided for in proposed §§ 516.161 and 516.163), and estimate the preparation of each to require 4 and 2 hours, respectively. In total, these compliance efforts would cost about $250 in the first year. Total modification requests and ownership change notifications are expected to increase by 1 each year so that 10 of each would be expected to be submitted in year 10. The cost of these provisions in year 10 is estimated at about $2,500.

This proposed rule would require, in § 516.165, that records and reports be created, submitted and retained by the holder of the indexed drug. These records include a 3-day indexed drug field alert report, a 15-day indexed drug field alert report and an annual indexed drug experience report. We expect that the vast majority of compliance efforts will be associated with the annual indexed drug experience report. Because the number of expected requests that are granted for addition to the index is 20 per year (on average, 20 requestors with 1 request granted each), the number of reports to be created, submitted and stored is also estimated at 20 per year. We estimate the reports for each index listing would require 8 hours annually, totally about 160 hours for all 20 listings. At the loaded wage estimate of $42.29 per hour, we estimate the first-year reporting costs at about $6,800. These annual costs will increase by an additional $6,800 each year as an additional 20 indexed drugs are added to the list. In year 10 we estimate the cost of this provision at about $67,700. Further, we expect that the maintenance of these records (recordkeeping) would require an additional hour of administrative time for each indexed drug listing. These additional 20 hours would cost about $850 at the same loaded wage estimate in the first year, and would also increase in succeeding years by an additional $850 as additional indexed drugs are added to the list. We estimate the cost of this provision in year 10 at about $8,500.

For those choosing to seek a MUMS index listing of an unapproved animal drug, total requestor compliance costs are expected to sum to about $273,000 in the first year. These costs would be borne by 30 requestors at an average cost per requestor of about $9,100 per indexed drug. Costs in succeeding years would be expected to increase slightly due to the annual reporting requirements for all indexed drugs resulting in year-10 costs of about $358,000.

The Government would also incur costs for this proposed rule. We expect that about 60 percent of a full-time equivalent employee at a GS-14 salary would be needed to handle the administrative work of the indexing of MUMS drugs in the first year. This would include all administrative efforts from responding to requests for presubmission meetings to making changes to approved indexed drugs. We estimate Government costs (including a 30 percent adjustment for benefits) of this provision at about $69,000 in the first year. In year 10 we estimate that up to four full time equivalent employees (one GS-14 position, two GS-13 positions and one GS-11 position) would be needed to administer the program. Including a 30 percent adjustment for benefits, we estimate that the cost to Government in year 10 could increase to about $378,000.

Total costs for this proposed rule would be the sum of private administrative and Government costs. Total costs are estimated to increase from $342,000 in the first year up to $735,000 in the 10th year.

The Regulatory Flexibility Act requires agencies to prepare a regulatory flexibility analysis if a rule is expected to have a significant economic impact on a substantial number of small entities. Although we believe it is unlikely that significant economic impacts would occur, the following constitutes the initial regulatory flexibility analysis.

One requirement of the Regulatory Flexibility Act is a succinct statement of any objectives of the rule. As stated previously in this analysis, with this rule the agency intends to create an administrative system, provided for by statute, that would allow for the legal marketing of unapproved animal drugs for intended uses in minor species in the U.S. that would otherwise not be economically viable under current market conditions.

The Regulatory Flexibility Act also requires a description of the small entities that would be affected by the rule, and an estimate of the number of small entities to which the rule would apply. The Small Business Administration (SBA) defines the criteria for small businesses using the North American Industrial Classification System (NAICS). For pharmaceutical preparation manufacturers (NAICS number 325412), SBA defines small businesses as those with less than 750 employees. Census data shows that 723 companies with 901 establishments represent this category. 2 While about two-thirds of the establishments would be considered small using the SBA criteria, the agency acknowledges that many requests for MUMS index listing would likely be received from multi-establishment companies that exceed the 750-employee limit on small businesses. Nonetheless, the average cost for a requestor that has two meetings with us, requests a determination of eligibility for indexing, creates and convenes a qualified panel of experts resulting in a written report, requests an addition to the index and keeps all necessary records, would be about $12,600. This cost per request represents about 1.5 percent of the revenues of the smallest set of establishments (those with one to four employees), and less than 0.4 percent of revenues of all larger establishments. These costs would not represent a significant economic impact on these firms, especially in light of the fact that they incur these expenses in order to realize increased sales revenue from the indexing. The firms submitting requests for index listing are expected to already have the necessary administrative personnel with the skills required to prepare the requests and fulfill reporting requirements as identified above.

The Regulatory Flexibility Act requires that the agency consider any alternatives to the proposed rule that would accomplish the objective while minimizing significant impacts of the rule. As stated previously, the agency believes that the proposed rule, due to the relatively small size of the costs, would not be likely to impose significant economic impacts on a substantial number of small businesses.

The statute that creates this system, Pub. L. 108-282, does not provide the agency a great deal of flexibility in the implementing regulations, such as in determining whether or not to use independent qualified expert panels to review the safety and efficacy data. We conclude that the proposed rule achieves the objective of increasing drug availability for minor species with minimal costs to industry while staying within the limits set by Pub. L. 108-282.

This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB), under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). A description of these provisions is given below with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA`s functions, including whether the information will have practical utility; (2) the accuracy of FDA`s estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques and other forms of information technology.

Title : Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 21 CFR Part 516

Description : The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize FDA to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats), as well as uncommon diseases in major animal species.

The MUMS act created three new sections to the act (section 571, 572, and 573), and this proposed rule is intended to implement section 572 of the act, which provides for an index of legally marketed unapproved new animal drugs for minor species. Participation in any part of the MUMS program is optional so the associated paperwork only applies to those who choose to participate. The proposed rule specifies, among other things, the criteria and procedures for requesting eligibility for indexing and for requesting addition to the index as well as the annual reporting requirements for index holders.

Under the new subpart C of part 516, proposed § 516.119 provides requirements for naming a permanent-resident U.S. agent by foreign drug companies, and § 516.121 would provide for informational meetings with FDA. Section 516.123 provides proposed requirements for requesting informal conferences regarding agency administrative actions and proposed § 516.125 provides for investigational use of new animal drugs intended for indexing. Provisions for requesting a determination of eligibility for indexing can be found under proposed § 516.129 and provisions for subsequent requests for addition to the index can be found under proposed § 516.145. A description of the written report required in § 516.145 can be found under proposed § 516.143. Under proposed § 516.141 are provisions for drug companies to nominate a qualified expert panel as well as the panel's recordkeeping requirements. This section would also call for the submission of a written conflict of interest statement to FDA by each proposed panel member. Index holders would be able to modify their index listing under proposed § 516.161 or change drug ownership under proposed § 516.163. Requirements for records and reports are proposed under § 516.165.

Description of Respondents : Pharmaceutical companies that sponsor new animal drugs.

Thus, FDA estimates the burden for this collection of information as follows:

The burden estimate for this reporting requirement was derived by our Office of Minor Use and Minor Species Animal Drug Development by extrapolating from relevant portions of the current Investigational New Animal Drug (INAD) and NADA reporting requirements for similar actions by a similar segment of the regulated industry and from previous interactions with the minor species community.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information collection provisions of this proposed rule to OMB for review.

We have carefully considered the potential environmental impacts of this rule and determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

We have analyzed this proposed rule in accordance with the principles in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have tentatively concluded that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement has not been prepared.

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

On November 5, 2001, the Department of Defense (DoD) published notice of a nationwide TRICARE Demonstration Project (66 FR 55928-55930). This demonstration was conducted under the authority of 10 U.S.C. 1092. In this demonstration project, DoD addressed unreasonable impediments to the continuity of health care encountered by certain family members of Reservists and National Guard called to active duty in support of a federal contingency operation for more than 30 days. On November 12, 2003, DoD published a notice (68 FR 64087) to extend through October 31, 2004, the demonstration project which was scheduled to end on November 1, 2003. On October 1, 2004, the DoD published another notice (69 FR 58895) extending the demonstration project, previously scheduled to end on October 31, 2004, to October 31, 2005. On October 12, 2005, DoD published a notice (70 FR 59320) to extend the demonstration project, previously scheduled to end on October 31, 2005, to October 31, 2007. The continued deployment of RC members in support of Operation Noble Eagle/Operation Enduring Freedom and Operation Iraqi Freedom warrants making permanent the Secretary's authority to exercise certain components of this demonstration project. Sections 704 and 705 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 provide DoD authority to make two components of the demonstration project permanent and amend section 1095d(a) and section 1079(h) of Title 10, United States Code, as appropriate. In accordance with these two statutory provisions, DoD proposes to implement this discretionary authority.

A. Waiver of deductible (paragraph 199.4(f)(2)(i)(H)). Eligible family members of RC sponsors called or ordered to active duty for more than 30 days in support of a federal contingency operation, who choose to participate in TRICARE Standard, may not be responsible for paying the annual TRICARE Standard deductible. By law, the TRICARE Standard deductible for active duty family members is $150 per individual, $300 per family ($50/$150 for E-4s and below) each fiscal year. Exercise of the authority to waive this annual deductible would appropriately limit out-of-pocket expenses for many Reserve and Guard family members, in consideration of the fact that many may have already paid annual deductibles under their civilian health plan.

B. Increased payment to providers (paragraph 199.14(j)). Executive of the authority contained in this program would allow an increase in TRICARE payments up to 115 percent of the TRICARE maximum allowable charge, less the applicable patient cost share if not previously waived under the first provision, for outpatient care received from a provider that does not participate (acept assignment) under TRICARE. This would help Reserve and Guard family members be able to continue to see civilian providers with whom they would ahve established relations and would promote access and clinically appropriate continuity of care.

Executive Order 12866 requires certain regulatory assessments for any significant regulatory action that would result in an annual effect on the economy of $100 million or more. The Congressional Review Act establishes certain procedures for major rules, defined as those with similar major impacts. The Regulatory Flexibility Act (RFA) requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation that would have significant impact on a substantial number of small entities. This proposed rule would not have an annual effect on the economy of $100 million or more. An IGCE estimates the annual cost for both of these provisions at less than $30 million.

This rule, however, does address a novel policy issues relating to waiving the deductibles for one category of family member beneficiaries and not others, as well as allowing providers who treat this same group of beneficiaries to receive reimbursement at a higher rate than providers who treat similar beneficiaries. Thus this rule has been reviewed by the Office of Management and Budget under E.O. 12866.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

We have examined the impact(s) of the proposed rule under Executive Order 13132 and it does not have policies that have federalism implications that would 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, therefore, consultation with State and local officials is not required.

Accordingly, 32 CFR part 199 is proposed to be amended as follows:

Invitation To Comment

We invite you to submit comments regarding these proposed regulations. To ensure that your comments have maximum effect in developing the final regulations, we urge you to identify clearly the specific section or sections of the proposed regulations that each of your comments addresses and to arrange your comments in the same order as the proposed regulations.

We invite you to assist us in complying with the specific requirements of Executive Order 12866 and its overall requirement of reducing regulatory burden that might result from these proposed regulations. Please let us know of any further opportunities we should take to reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

During and after the comment period, you may inspect all public comments about these proposed regulations in room 4W229, 400 Maryland Avenue, SW., Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Eastern time, Monday through Friday of each week except Federal holidays.

On request, we will supply an appropriate aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these proposed regulations. If you want to schedule an appointment for this type of aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

On March 6, 1997, the Secretary published final regulations (62 FR 10398) amending the provisions of EDGAR governing discretionary grant programs administered directly by us. These amendments established an approach by which the Secretary could use different types of selection criteria when evaluating a grant application. Specifically, § 75.200 was amended to permit the Secretary to use selection criteria based on statutory provisions in accordance with 34 CFR 75.209, selection criteria in program-specific regulations, selection criteria established under 34 CFR 75.210, or any combination of these. Section 75.210 provides a menu of selection criteria. For a competition, the Secretary selects from the menu one or more criteria that best enable us to identify the highest-quality applications consistent with the program purpose, statutory requirements, and any priorities established. Within each criterion, the Secretary may further define the criterion by selecting one or more specific factors.

At the time that these final regulations were published, we also amended, through notice and comment rulemaking, the regulations for a number of Department programs that contained program-specific selection criteria, so that these programs could use the criteria in 34 CFR 75.210, criteria based on statutory provisions, or the criteria in their program regulations for grant competitions. The MSAP regulations were not amended at that time.

This notice of proposed rulemaking would conform the MSAP regulations to those of the majority of other discretionary grant programs in the Department. We believe that by expanding the range of selection criteria that could be used in a specific grant competition, we will be able to administer the MSAP more effectively to best meet the program's statutory purposes and requirements and to better ensure that MSAP projects are effectively integrated with State and local reform activities.

We intend that the MSAP will use the selection criteria in 34 CFR 75.210 in conjunction with criteria based on the statute and in the program-specific regulations, not instead of them. In selecting a set of criteria and factors for a particular competition from among the selection criteria in the MSAP regulations and 34 CFR 75.210, or in establishing selection criteria based on statutory provisions governing the MSAP as described in 34 CFR 75.209, the Secretary would not solicit formal public comment but could draw on input from grantees and program beneficiaries; feedback from previous peer reviewers and program evaluators; discussions among Department employees, grantees, and program beneficiaries; and meetings, conferences, visits to grantees, and other forms of outreach and exchange with the relevant communities. We believe applicants would find that criteria selected in this manner for specific competitions would provide them with adequate guidance about review standards, and also with flexibility to design and propose the projects that they believe best serve their needs.

The Secretary is particularly interested in comments from potential grant applicants and intended program beneficiaries on this proposed approach. Do applicants or program beneficiaries support this approach? Are there any costs associated with shifting from using selection criteria tailored to individual programs to using a flexible menu of general selection criteria? If yes, what are those costs and does the benefit of the added flexibility of the proposed approach justify the costs? Would these proposed amendments have other effects?

We discuss substantive issues under the sections of the proposed regulations to which they pertain. Generally, we do not address proposed regulatory provisions that are technical or otherwise minor in effect.

Current Regulations: The current regulatory provisions in § 280.30 describe the way in which applications are evaluated by using the selection criteria in § 280.31 and the priorities described in § 280.32.

Proposed Regulations: Proposed § 280.30 would give the Secretary the flexibility to use selection criteria from § 280.31, from the approved menu of general selection criteria in 34 CFR 75.210 or from selection criteria based on statutory provisions governing the MSAP, established in accordance with 34 CFR 75.209. The Secretary also could use any combination of selection criteria from these sources. We would announce the selection criteria and the weighting factor for each criterion in the Federal Register notice announcing a grant competition for the MSAP.

Reasons: The Secretary believes that this change is necessary in order to provide the MSAP the same flexibility that is afforded many of the Department's discretionary grant programs in tailoring the selection criteria to be used to evaluate applications in a manner that helps to achieve results consistent with a program's statutory purpose. Additionally, this approach enables us to take into consideration current program needs, new research findings that relate to magnet schools, or other appropriate information in order to facilitate the selection of applications that show the greatest promise of effectively meeting the statutory purposes of the MSAP. Without this change, the MSAP would be limited to using only the selection criteria and factors in current § 280.31, whether or not their use continues to work well in the selection of new projects that are likely to be effective in achieving results.

An alternative approach would have been to propose specific changes to the selection criteria for the MSAP in § 280.31. We consider this approach less desirable because it would require new rulemaking every time that a change is made in the selection criteria, however modest that change might be. Such an approach would, of necessity, be time consuming and as a practical matter would restrict rather than enhance flexibility in considering input from sources such as school districts that are implementing magnet school programs, researchers, evaluators, policymakers, and others.

Current Regulations: The current regulations assign specific, mandatory point values to the selection criteria.

Proposed Regulations: The proposed regulations would remove these mandatory point values from the selection criteria.

Reasons: Removing the mandatory point values provides the Secretary flexibility to select specific point values from year to year to address program requirements and is consistent with the Department's approach for other discretionary grant programs that use selection criteria from 34 CFR 75.210 and selection criteria based on the statute, as set forth in 34 CFR 75.209, as well as selection criteria from program regulations.

Under Executive Order 12866, we have assessed the potential costs and benefits of this regulatory action.

The potential costs associated with the proposed regulations are those resulting from statutory requirements and those we have determined to be necessary for administering this program effectively and efficiently.

In assessing the potential costs and benefits—both quantitative and qualitative—of this regulatory action, we have determined that the benefits would justify the costs.

We have also determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

These proposed regulations affect only local educational agencies (LEAs) that are applying for assistance under the MSAP. The proposed regulations create flexibility for us to use selection criteria other than those in § 280.31 for a MSAP grant competition. We believe that any criterion from 34 CFR 75.209 or 34 CFR 75.210 that would be used in a future grant competition would not impose a financial burden that LEAs would not otherwise incur in the development and submission of a grant application under the MSAP and, under some circumstances, could reduce the financial burden of preparing a MSAP grant application by a modest amount if, for example, the use of this flexibility resulted in fewer criteria or factors to be addressed in a grant application.

Executive Order 12866 and the Presidential memorandum on “Plain Language in Government Writing” require each agency to write regulations that are easy to understand.

The Secretary invites comments on how to make these proposed regulations easier to understand, including answers to questions such as the following:

• Are the requirements in the proposed regulations clearly stated?

• Do the proposed regulations contain technical terms or other wording that interferes with their clarity?

• Does the format of the proposed regulations (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity?

• Would the proposed regulations be easier to understand if we divided them into more (but shorter) sections? (A “section” is preceded by the symbol “§ ” and a numbered heading; for example, § 280.30 How does the Secretary evaluate an application?

• Could the description of the proposed regulations in the SUPPLEMENTARY INFORMATION section of this preamble be more helpful in making the proposed regulations easier to understand? If so, how?

• What else could we do to make the proposed regulations easier to understand?

Send any comments that concern how the Department could make these proposed regulations easier to understand to the person listed in the ADDRESSES section of the preamble.

The Secretary certifies that these proposed regulations would not have a significant economic impact on a substantial number of small entities.

Small entities affected by these proposed regulations are small LEAs applying for Federal funds under this program. The changes will not have a significant economic impact on these LEAs in terms of the cost of applying for a MSAP grant.

These proposed regulations do not contain any information collection requirements.

This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

You may view this document, as well as all other Department of Education documents published in the Federal Register , in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/news/fedregister .

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.

You may also view this document in text or PDF at the following site: http://www.ed.gov/programs/magnet/applicant.html.

For the reasons discussed in the preamble, the Assistant Deputy Secretary for Innovation and Improvement proposes to amend part 280 of title 34 of the Code of Federal Regulations as follows:

Efficient processing of automation-rate flat-size mailpieces enables the Postal Service to process the substantial volume of polywrapped pieces on our equipment without causing jams, multiple feeds, and missorted mail. Automated flat sorting machines (AFSM 100) process the majority of our flat-size mail. We have moved many of our upgraded flat sorting machines (UFSM 1000) out of facilities where we use AFSM 100s. To improve our ability to process polywrapped pieces on our primary flat-mail processing equipment, we propose that all polywrap films used on automation-rate flat-size mail meet our revised standards. The new standards would eliminate the current difference in polywrap specifications for mail designed for processing on the AFSM 100 and the UFSM 1000.

In 2001, we ran extensive tests of flat-size mailpieces on our AFSM 100 machines. As a result, we added a specification for “blocking”—the chemical bonding of films to themselves—to our polywrap specifications to help prevent polywrapped pieces from sticking together during processing. But this simple change did not result in a noticeable improvement in the performance of polywrapped mailpieces.

Therefore, we initiated a test program to more accurately define the polywrap characteristics best suited to automated processing of flat-size mail. We performed complete testing on over 100 types of polywrap submitted by polywrap manufacturers. We then selected 46 films (polyethylene, polypropylene, and shrinkwrap) to test on the AFSM 100. We processed 500-piece test decks and collected extensive data to evaluate performance. Again, blocking was the physical attribute that most influenced processing compatibility.

As a result of the testing, we propose revised characteristics for polywrap materials used on automation-rate flat-size mailpieces. We would remove two characteristics, tensile strength and density, because they were irrelevant to performance. We also would remove the “USPS AFSM 100 Approved Polywrap” endorsement requirement. We would change the testing protocol to measure the minimum film-to-metal coefficient of friction to bring consistency to this characteristic across all polywrap manufacturers. We would broaden the film-to-film coefficient of friction, which should help mailers in bundling mailpieces by minimizing the instability of bundles as they exit their stacking equipment. While we would not change the blocking specification, we propose to change the method to measure blocking to more closely match the environment that mailpieces undergo during normal transportation and storage.

Currently, manufacturers requesting approval of their polywrap materials for automation-rate flat-size mail provide us with a certificate stating that their material complies with the polywrap specifications for AFSM 100 mailpieces. After manufacturers provide this certificate, we include the manufacturer's material in the list of approved polywrap for flat-size mailpieces mailed at automation discount rates.

To ensure that all manufacturers use the same criteria in meeting the new specifications, we have developed specification USPS-T-3204, “Test Procedures for Automatable Polywrap.” Manufacturers may obtain the new test procedures at http://ribbs.usps.gov (click on “Polywrap Manufacturers” in the left frame) or by contacting USPS Engineering at: Engineering, Flat Mail Technology, U.S. Postal Service, 8403 Lee Hwy, Merrifield VA 22082-8101.

The specification describes exact test procedures and acceptable values for polywrap film characteristics. Should the manufacturer not have the facilities or experience to conduct each of the test procedures in USPS-T-3204, the specification also provides a list of testing laboratories that have experience in conducting these tests.

Consistent with our current process, manufacturers would provide an updated certificate of conformance on their letterhead to USPS Mailing Standards after verifying that each polywrap film meets the new characteristics. The certificate of conformance must state the values for each of the six characteristics.

We encourage manufacturers to certify their polywrap under the new specifications as soon as possible. We also encourage mailers to use polywrap meeting the new specifications on their mailpieces as soon as practical. Beginning February 4, 2007, all polywrap films used on automation-rate flat-size mailpieces would have to meet the new standards.

Although we are exempt from the notice and comment requirements of the Administrative Procedure Act [5 U.S.C. of 553(b),(c)] regarding proposed rulemaking by 39 U.S.C. 410(a), we invite public comments on the following proposed revisions to Mailing Standards of the United States Postal Service , Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations . See 39 CFR 111.1.

Accordingly, 39 CFR part 111 is proposed to be amended as follows:

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

Today we are proposing to approve revisions to the SIP submitted by the state of Texas for the DFW nonattainment area as meeting 1-hour ozone serious area requirements. We are proposing to approve the 5% IOP plan for the nine counties that comprise the DFW 8-hour ozone nonattainment area. As an integral part of the 5% IOP plan, we are also proposing to approve the 2002 base year emissions inventory (EI) and the 2007 motor vehicle emissions budget (MVEB). Before approving the 5% IOP plan, we must approve all of the control measures relied upon in the 5% IOP plan. The majority of the control measures have already been approved in other Federal Register documents. We are proposing to approve three control measures which support the 5% IOP plan in today's action: A Federal consent decree concerning an Alcoa plant in Rockdale, Milam County; energy efficiency measures implemented within the DFW 8-hour ozone nonattainment area; and revisions to 30 TAC, Chapter 117, Control of Air Pollution From Nitrogen Compounds, concerning stationary reciprocating internal combustion engines operating within the DFW 8-hour ozone nonattainment area. We previously proposed to approve that Reasonably Available Control Technology (RACT) is in place for all major sources of volatile organic compounds (VOCs) in the DFW 1-hour ozone nonattainment area (66 FR 4756). Although we are not reopening the comment period on RACT, we intend to finalize our proposed approval at the same time we finalize this proposal. We are proposing to approve these revisions under section 110 and part D of the Act and EPA's regulations.

The EPA published the 8-hour ozone designations and the first phase governing implementation of the 8-hour ozone standard (phase I rule) in the Federal Register (FR) on April 30, 2004 (69 FR 23858 and 69 FR 23951, respectively). The DFW area was designated as nonattainment for the 8-hour ozone standard and comprises nine counties: Collin, Dallas, Denton, and Tarrant counties (these four constitute the 1-hour ozone nonattainment area, hereinafter referred to as the four core counties), and Ellis, Johnson, Kaufman, Parker and Rockwall counties. At the time of designation however, the four core counties remained in nonattainment for the 1-hour standard and had two outstanding 1-hour ozone obligations: (1) The area did not have an approved 1-hour ozone attainment demonstration; and (2) the area did not have approved RACT requirements for major sources of VOC emissions (VOC RACT).

The phase I rule revoked the 1-hour ozone standard (see 69 FR 23951). The phase I rule further provided three options for areas that had not met the 1-hour ozone attainment demonstration requirement: (1) Submit a 1-hour attainment demonstration no later than 1 year after designation; (2) Submit a Reasonable Further Progress (RFP) plan for the 8-hour National Ambient Air Quality Standards (NAAQS), no later than 1 year following designations for the 8-hour NAAQS, providing a 5% increment of emissions reduction from the area's 2002 EI; or (3) Submit an early 8-hour ozone attainment demonstration SIP that ensures that the first segment of RFP is achieved early (See 40 CFR 51.905(a)(ii)). Texas selected option 2, to submit the RFP plan providing a 5% increment of emissions reduction from the area's 2002 EI. This increment of emissions reduction is called the 5% IOP plan. Revisions in this rulemaking enable the DFW area to meet the 5% IOP, which fulfills the 1-hour ozone attainment demonstration obligation.

The phase I rule also provides that 1-hour ozone nonattainment areas are required to adopt and implement “applicable requirements” according to the area's classification under the 1-hour ozone standard for anti-backsliding purposes (see 40 CFR 51.905(a)(i)). On May 26, 2005, we determined that an area's 1-hour designation and classification as of June 15, 2004 would dictate what 1-hour obligations remain as “applicable requirements” under the phase I rule (70 FR 30592). The DFW 1-hour nonattainment area was still classified as serious on June 15, 2004, so the 1-hour ozone standard requirements applicable to the four core counties are those that apply to nonattainment areas classified as serious. The only outstanding “applicable requirement” for the four core counties is the VOC RACT. We noted above that we proposed to approve RACT for all major sources of VOCs in the 1-hour DFW nonattainment area on November 18, 2001 (66 FR 4756) and received no comments. Although we are not reopening the comment period on VOC RACT, we intend to finalize that proposed approval in the same rulemaking that we finalize this proposal.

The DFW area has satisfied all other serious area applicable requirements under the 1-hour ozone standard. See the area's Clean Fuels Fleet Program (February 7, 2001 at 66 FR 9203); the area's post 1996 Rate of Progress (ROP) plan and associated MVEBs (March 28, 2005 at 70 FR 15592); and the area's 15% ROP plan and associated MVEBs (April 12, 2005 at 70 FR 18993). For a complete list, see the Texas SIP map at http://www.epa.gov/earth1r6/6pd/air/sip/sip.htm.

Ozone is a gas composed of three oxygen atoms. At ground level, it is created by a chemical reaction between nitrogen oxides (NO X ) and VOCs in the presence of sunlight. Ozone and NO X are two of six common pollutants, also known as criteria pollutants, for which EPA has set NAAQS. Motor vehicle exhaust and industrial emissions, gasoline vapors, and chemical solvents as well as natural sources emit NO X and VOCs, help to form ozone. Sunlight and hot weather cause ground-level ozone to form in harmful concentrations in the air. As a result, ozone is known as a summertime air pollutant. Many urban areas tend to have high levels of ground-level ozone, but rural areas are also subject to increased ozone levels because wind carries ozone and its precursors hundreds of miles from their sources.

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

EPA issued a guidance memorandum on August 18, 2004  1 that outlines the criteria for 5% IOP plans. In brief summary, the guidance states that the reductions should be based on a 2002 EI, does not allow credit from Federal measures or measures in the SIP as of 2002, provides that the reductions occur by 2007, and allows use of NO X , VOCs, or some combination of both pollutants, to meet the 5% reduction. The steps involved in determining the emissions needed to meet the 5% reduction are the establishment of the 2002 baseline EI, calculation of the 5% reduction, and projection of the 2007 EI. We will present the 2002 and 2007 inventories, with a discussion of measures that will contribute to emission reductions in the area, and conclude by demonstrating the 5% reduction.

The Clean Air Act Amendments of 1990 has the requirement that EIs be prepared for ozone nonattainment areas. Because ozone is photochemically produced in the atmosphere when VOCs are mixed with NO X in the presence of sunlight, ozone EIs focus on these precursor pollutants. The EI identifies the source types present in an area, the amount of each pollutant emitted, and the types of processes and control devices employed at each plant or source category. The Act requires the inventories to be actual emissions. The 2002 EI will provide a baseline emission level for calculating reduction targets and the control strategies for achieving the required emission reductions. The inventory of emissions of VOC and NO X is summarized from the estimates developed for four general categories of emissions sources: Point, area, onroad mobile, and nonroad mobile.

Major point sources for inventory reporting in nonattainment areas are defined as industrial, commercial, or institutional sources that emit actual levels of criteria pollutants at or above 10 tons per year (tpy) of VOC, 25 tpy of NO X , or 100 tpy of other criteria pollutants.

The Texas Commission on Environmental Quality (TCEQ) collects data from sources identified as having triggered the levels of emissions indicated above. Data submitted is quality assured and entered into the State of Texas Air Reporting System. For more details, refer to the Technical Support Document (TSD).

A list of emissions by facility for all nine counties in the DFW nonattainment area is provided in Attachment 2 of the TSD. The State separately accounts for NO X emissions from the Alcoa facility, as it lies outside the DFW nonattainment area. The 5% guidance allows a nonattainment area to include VOC sources within 100 kilometers (km) and NO X sources within 200 km of the nonattainment area in calculations of IOP reductions. The Alcoa facility is 120 miles from DFW, thus only the NO X emissions are allowed. The NO X emissions for the entire facility are added to the DFW area's EI, as required by the guidance; these emissions are 23.17 tons per day (tpd). The 2002 point source inventory for NO X is 79.31 tpd and 28.31 tpd for VOCs; with Alcoa's emissions, the point source inventory for NO X is adjusted to 102.48 tpd.

Area sources have emissions below the point source reporting levels and are too numerous and/or too small to identify individually. Area sources include commercial, small-scale industrial, and residential categories that use materials or processes that generate emissions. Area sources are categorized by hydrocarbon evaporative emissions or fuel combustion emissions; examples include printing operations, house paints, gasoline service station underground tank filling and vehicle refueling, outdoor burning, structural fires, and wildfires.

Emissions for area sources are estimated as county-wide totals. These emissions, with some exceptions, may be calculated by an established, EPA approved, emission factor. Actual activity data is used when available, e.g. , gallons of gasoline sold in a county, number of wildfire acres burned, etc. When activity data is unavailable, surrogates such as county population and employment data by industry type are used. The methodology is provided in Appendix A of the submittal. A detailed listing of emissions by area source type for all nine counties in the DFW area is provided in Attachment 3 of the TSD. The State separately accounts for VOC emissions from the gas can rule (see paragraph B(3) below—portable fuel containers) within a 100 km radius outside the DFW area. The 2002 area source inventory, adjusted to include 4.52 tpd VOC emissions from the gas can rule, is 38.03 tpd of NO X and 208.92 tpd for VOCs.

Onroad mobile sources are automobiles, trucks, motorcycles, and other motor vehicles traveling on roadways. Combustion related emissions are estimated for vehicle engine exhaust, and evaporative hydrocarbon emissions are estimated for the fuel tank and other evaporative leak sources on the vehicle. The 2002 onroad mobile source EI was prepared by the North Central Texas Council of Governments (NCTCOG) and used the newest EPA onroad emission factor model, MOBILE6.2. Emission factors were applied to vehicle activity using the Texas Mobile Source Emission Software. Vehicle activity was generated using the DFW Regional Travel Model. Emissions were summarized in 24 one-hour periods and for a daily total for all counties identified in the analysis. Additional details are included in the TSD. The 2002 onroad mobile source inventory for NO X is 345.44 tpd and 156.34 tpd for VOCs.

Nonroad mobile sources are aircraft, railroad locomotives, recreational vehicles and boats, and a broad range of equipment, from 600-horsepower engines in the construction equipment class to one-horsepower string trimmers in the lawn and garden class. The EPA NONROAD model is used to calculate emissions for all nonroad mobile sources except aircraft, locomotives, and commercial marine vessels. This model generates emissions for equipment in the following classes: Agricultural, Commercial, Construction, Industrial/Oilfield, Lawn and Garden, Logging, and Railway Maintenance.

Emissions from commercial and military aircraft are calculated using the Federal Aviation Administration's Emissions and Dispersion Modeling System model, which uses actual recorded landing/takeoff (LTO) data and aircraft types to generate emissions. Smaller aircraft emissions are calculated using EPA emission factors and applicable LTO data. Emissions from ground support equipment at commercial airports are based on a recent survey in the DFW area.

Locomotive emissions are based on fuel use and track mileage and individual railroad lines were surveyed for actual data. The 2002 nonroad mobile source inventory is 136.24 tpd for NO X and 70.08 tpd for VOCs. See the TSD for more detailed information.

Although EPA's 5% guidance allows states to use EPA's draft 2002 National Emissions Inventory (NEI) for the 2002 baseline inventory, the TCEQ submitted their own 2002 EI for point, area, onroad mobile, and nonroad mobile sources for all nine counties in the DFW nonattainment area. The inventory is the peak ozone season daily average of actual emissions for each source and includes more accurate activity data than that available in EPA's NEI. The TCEQ's inventory of ozone precursors for all nine counties in the DFW nonattainment area is shown in Table 1; the point and area emissions are unadjusted for emissions outside the nonattainment area. This unadjusted EI is comprised of actual emissions within the nonattainment area, as required by the Act, which will provide the baseline emission level for calculating reduction targets and the control strategies for achieving the required emission reductions. We are proposing to approve the 2002 baseline EI.

The future year or 2007 inventory reflects growth and controls from measures already in the SIP or expected to occur due to Federal measures; these emissions are presented in Table 2, in contrast with the 2002 emission inventories.

Texas developed the 2007 point source EI by multiplying the 2002 baseline EI by growth factors that represent industrial expansion through 2007. This includes all of the NO X and VOC controls already in place, per State rules that require reductions between 2002 and 2007. The 2007 point source inventory is projected to be 83.52 tpd NO X and 30.42 tpd VOC. A detailed discussion of the future point source inventory is provided in the TSD.

The 2007 EI for area sources was projected using EPA's Economic Growth Analysis System (EGAS) growth factors, which contain individual growth factors for each category and forecasting year. This is the EPA standard and accepted method for developing future year EIs. The projected 2007 area source inventory is 39.64 tpd NO X and 215.91 tpd VOC.

The MOBILE6.2 model was used to estimate onroad emission factors for 2007. This model incorporates local information on fleet mix and activity data, and Federal, State and local measures that will be implemented by 2007. The projected 2007 onroad mobile inventory is 206.72 tpd NO X and 104.14 tpd VOC.

The 2007 EI for nonroad mobile sources was developed using the NONROAD model. Projected LTO data was used to develop the 2007 aircraft and ground support EIs, and railroad activity for 2007 was estimated using previous year surveys and data from local railroad lines. The projected 2007 nonroad mobile source inventory is 120.83 tpd NO X and 54.58 tpd VOC.

The motor vehicle emission budget (MVEB) establishes a ceiling for emissions from onroad mobile sources. The onroad EI in the SIP sets the MVEB, which is used to meet the EPA's transportation conformity requirements, found at 40 CFR part 51, subpart T and part 93, subpart A. EPA's conformity rules require that transportation plans and related projects result in emissions that do not exceed the MVEB established in the SIP.

The MVEBs for DFW were established by subtracting onroad emission reductions from the onroad mobile source EI for 2007. The Texas Emission Reduction Plan (TERP) is a NO X emission reduction strategy which can be applied toward the 5% IOP. The TERP assumes reductions of 22.2 tpd by 2007 and allocates 33.1% of the reductions to onroad mobile and 66.9% to nonroad mobile. The TCEQ has conservatively estimated TERP to provide onroad mobile NO X reductions of 5.4 tpd for the DFW area by June 15, 2007. The TERP applies specifically to NO X reductions and information on VOCs is not available. The MVEBs for DFW were found adequate for use in transportation conformity on June 01, 2005 (70 FR 31441). Table 3 documents the MVEBs that have been established by this SIP revision. EPA is proposing to approve these MVEBs and, upon final approval, all future transportation improvement programs, projects and plans for the DFW area will need to show conformity to the budgets in this plan; previous budgets approved or found adequate are not applicable.

The TERP, discussed briefly above, was established by the Texas Legislature with the enactment of Senate Bill 5 (SB5). The concept of this economic incentive program was approved into the Texas SIP on November 14, 2001 (66 FR 57159). State rules that govern TCEQ's administration of the TERP were approved into the SIP August 19, 2005 (70 FR 48647).

The TERP primarily addresses diesel emission reductions, while a small percentage of the program is allocated to energy efficiency. The TERP analyses for this program are found in the SIP narrative and a TCEQ Interoffice Memorandum dated August 16, 2004. Projected credits are based on cost per ton of previous projects. Considering diesel emission reduction projects recently funded and the approach established for allocating future TERP funds, we agree that TERP funding should be sufficient to achieve NO X reductions of 22.2 tpd in the DFW area by 2007. Additional detail is provided in the TSD.

The Texas Legislature enhanced the use of Energy Efficiency/Renewable Energy (EE/RE) programs for meeting TERP goals by requiring TCEQ to promote the use of energy efficiency as a way of meeting the NAAQS and to develop a method for calculating emissions reductions from energy efficiency. To achieve energy savings in new construction, SB 5 mandated statewide adoption of the International Residential Code (IRC) and the International Energy Conservation Code (IECC) for residential, commercial and industrial buildings, through new building code requirements (Texas Health and Safety Code, Chapter 388—Texas Building Energy Performance Standards), which are enforced by local jurisdictions. The emissions reductions relied upon in this 5% IOP plan occurred in 2003 because of the energy savings achieved by power plants and newly-constructed residential buildings.

These NO X reductions have already been achieved. To calculate the SIP credit for these NO X reductions, a method was developed by the Energy Systems Laboratory (ESL) of Texas A&M University, with assistance from EPA's Office of Atmospheric Programs, the TCEQ, and the Electric Reliability Council of Texas (ERCOT). We are proposing to find that the methodology for quantifying the completed emissions reductions for credit in the SIP is reasonable. See the TSD for additional information. The energy savings achieved provided NO X reductions at each power plant within the ERCOT region (the ERCOT serves about 85% of Texas, including the DFW nonattainment area) and reductions of natural gas within each county, statewide. The NO X reductions were due to EE measures in new construction for single and multi-family residences. The reductions in natural gas were due to the elimination of pilot lights in furnaces.

The TCEQ did not project 2007 NO X reductions from EE measures in the DFW nonattainment area. Rather, the State, using the above-described methodology, quantified the EE reductions that have already occurred by using several spreadsheet programs that conservatively calculated energy savings from the electricity and natural gas reductions for residential, commercial and industrial buildings. The measures were completed and the reductions occurred by 2003. These reductions have not been relied upon in another RFP/ROP plan for Texas and will not receive credit in another SIP. Therefore, the reductions are surplus. These measures have been implemented in residential construction, which has a lifetime beyond the term for which this credit is granted (2007) and are therefore permanent.

As indicated above, the NO X reductions have been achieved and were calculated to be 0.72 tpd in the DFW area. The total amount of NO X reductions calculated for the RFP, as shown in Table 8 below, is 27.59 tpd. The SIP credit for the emissions already achieved (0.72 tpd) is 2.6% of this total and therefore meets the 3% limit. Additional details are provided in the TSD.

EPA's approval of these SIP credits will not interfere with any applicable requirement concerning attainment or any other applicable requirement of the Act and the credits meet and comply with section 110(l) of the Act. We are proposing to approve the NO X emissions reductions achieved by the EE measures as credit in the SIP for 0.72 tpd because they contribute to attainment of the 8-hour ozone NAAQS, are permanent and surplus, and are relied upon in the 5% IOP plan. We propose to approve these NO X emission reductions of 0.72 tpd under sections 110 and part D of the Act.

On April 9, 2003, a Federal Consent Decree was signed with Alcoa that required the company to reduce NO X emissions from 3 boilers located at its facility in Milam County. These boilers are fired by locally mined lignite coal and provide power for the aluminum smelting operations. The facility is located nearly 120 miles outside of the DFW nonattainment area, which is within the 200 km radius for NO X emissions, but beyond the 100 km radius for VOCs. Texas chose to include emission reductions for just one of the boilers. Although Texas submitted NO X reductions of 3.9 tpd, we calculate 2.8 tpd reduction in NO X emissions that would be creditable toward the 5% IOP plan. Today we are proposing to approve the submission of the Federal consent decree concerning the Alcoa Rockdale, Milam County facility, as described in the SIP Narrative by the TCEQ, into the Texas SIP as a part of the 5% IOP plan for the purposes of establishing the quantifying methodology, the implementation, and making SIP-enforceable Alcoa's choice, as defined in the consent decree, to shut down one of the three boilers and replace one of the two remaining boilers with a circulating fluidized bed (CFB) boiler by June 15, 2007 as described in the SIP Narrative by the TCEQ, to ultimately achieve SIP credit for NO X emissions reductions of 2.8 tpd.

To receive credit for reductions, the total NO X emissions must be added to the inventory for the base year. Texas therefore added 23.17 tpd of NO X emissions to the 2002 inventory for Alcoa and took credit for NO X reductions of 3.9 tpd, but did not take credit for VOC reductions. These NO X reductions are also required to be permanent, enforceable, quantifiable and surplus.

The terms of the Federal consent decree are legally enforceable by EPA. Texas issued Permit No. 48437 to Alcoa that incorporates the terms of the consent decree, so the reductions are also enforceable by TCEQ. The consent decree and State Permit contain emission limits upon which to quantify the emission reductions. Texas included NO X emission reductions of 3.9 tpd by June 15, 2007.

The terms of the consent decree are also permanent. The consent decree remains in place until either the existing boilers achieve and maintain certain emission limitations for 24 months, the replacement boilers achieve and maintain certain emission limitations for 24 months, or the existing boilers have been permanently shut down. Additionally, the consent decree terminates only after all of the requirements of the consent decree, including those mentioned above, are incorporated into the Title V operating permit for the Rockdale facility.

The NO X reductions are surplus to the State's Regional Ozone plan, relied upon in all of the Texas ozone nonattainment areas but for the El Paso area, and which required a 50% reduction to utility NO X emissions in the selected East and Central Texas counties, a 30% NO X emission reduction to non-utility grandfathered sources in the selected East and Central Texas counties, NO X emissions reductions at Alcoa, Milam County and Eastman Chemical Company near Longview, Texas through Agreed Orders, and NO X emissions reductions through a state-wide water heater rule. EPA approved the Regional Ozone SIP on October 26, 2000, at 65 FR 64148. Some of the NO X reductions obtained through compliance with the Federal consent decree are not considered surplus and are not creditable. Alcoa however, agreed in the Federal consent decree to go beyond all applicable Federal requirements. At the time of the occurring violations addressed in the Federal consent decree, Alcoa as a lignite-burning facility would have been limited to 0.6 lbs/million Btu. A review of the Agreed Order approved by EPA as part of the Regional SIP allowed the facility 0.8 lbs/million Btu by 2002. The difference between 0.8 and 0.6 lbs/million Btu would not be creditable. Using a conservative assumption that Alcoa operated at 0.8 lbs/million Btu in 2002 and recognizing that Alcoa must reduce the operating rate to 0.1 lbs/million Btu, we calculated that 71% of the reductions reported by Texas would be available for credit (71% of 3.9 tpd). Therefore, EPA proposes to approve 2.8 tpd as creditable toward the 5% IOP. Calculations and additional detail are provided in the TSD.

Approving the Alcoa Federal consent decree into the DFW SIP for establishing and making enforceable a 2.8 tpd reduction in NO X emissions by shutting down one of the three boilers and replacing one of the two remaining boilers with a CFB boiler before June 15, 2007, improves the DFW SIP as it requires the affected source to reduce its NO X emissions beyond the level of compliance otherwise required by law and to incorporate those requirements into a Title V operating permit. We are proposing to approve these revisions to the Texas SIP because they will contribute to attainment of the 8-hour ozone NAAQS, because they meet the EPA rules and are consistent with EPA guidance, and were one of the control measures relied upon in the 5% IOP plan. As such, EPA's approval of this revision will not interfere with any applicable requirement concerning attainment or any other applicable requirement of the Act and it meets and complies with section 110(l) of the Act. We propose to approve these rules under section 110 and part D of the Act.

On May 13, 2005 the TCEQ Chairman submitted to us rule revisions to 30 TAC, Chapter 117, Control of Air Pollution From Nitrogen Compounds, concerning stationary reciprocating internal combustion (IC) engines operating within the DFW eight-hour ozone nonattainment area (the Chapter 117 SIP submittal). The Chapter 117 SIP submittal primarily addresses NO X emissions from IC engines with a horsepower rating greater than or equal to 300 hp in the nine Texas Counties of Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall, and Tarrant. The affected engines under the Chapter 117 SIP submittal are lean burn, rich burn, and dual-fuel (gas and liquid) fired lean burn engines. The rule revisions include more stringent NO X emissions limitations on lean burn and dual-fuel fired lean burn IC engines operating in Collin, Dallas, Denton, and Tarrant Counties and apply the limitations to those engines in Ellis, Johnson, Kaufman, Parker, and Rockwall Counties. They also impose new NO X emissions limitations on gas-fired rich burn IC engines in all nine counties of the DFW 8-hour ozone nonattainment area. See attachment 5 of the TSD for more information. The Chapter 117 SIP submittal should result in NO X reductions of 1.87 tpd by 2007 for the DFW eight-hour ozone nonattainment area. Today, we are proposing to approve the Chapter 117 SIP submittal as part of the 5% IOP plan.

The current Texas SIP contains no Federally-approved requirements for controlling NO X emissions from gas-fired rich burn, and gas-fired lean burn IC engines operating within Ellis, Johnson, Kaufman, Parker, and Rockwall counties. By approving the Chapter 117 SIP submittal, we will be improving the Texas SIP for enforcement and ozone attainment purposes. As such, EPA's approval of this revision will not interfere with any applicable requirement concerning attainment or any other applicable requirement of the Act and it meets and complies with section 110(l) of the Act.

On September 1, 2000 (65 FR 53172), EPA approved NO X emission specifications for IC engines as a part of the ozone control measures for the DFW one-hour ozone nonattainment area that included the four core counties—Collin, Dallas, Denton, and Tarrant. Table 4 contains a summary of the 65 FR 53172 rulemaking for IC engines operating in the four core counties.

On March 16, 2001 (66 FR 15195), EPA approved NO X emission specifications for IC engines as part of the ozone control measures for the DFW one-hour ozone nonattainment area that included the four core counties; Table 5 is a summary of the 66 FR 15195 rulemaking for IC engines operating in the four core counties.

The area in Tables 4 and 5 refers to the four core counties. Table 6 contains a summary of NO X control requirements for IC engines operating in the DFW eight-hour ozone nonattainment area under the Chapter 117 submittal being proposed for approval today.

As stated earlier, the Chapter 117 SIP submittal should result in NO X reductions of 1.87 tpd, and should assist in bringing the DFW area into attainment with the 8-hour ozone NAAQS.

The Chapter 117 SIP submittal requires the affected sources to reduce their NO X emissions. We are proposing to approve these revisions to the Texas SIP because they will contribute toward attainment of the 8-hour ozone NAAQS and were one of the control measures relied upon in the DFW 5% IOP Plan. This revision adds requirements for NO X emission limitations for rich burn IC engines in all nine counties. Additionally, the revisions impose a more stringent NO X emission limitation on lean burn and dual fired lean burn IC engines in the four core counties and extend the limitations to those engines in the five adjacent counties. We are proposing to approve these rules under section 110 and part D of the Act.

The TCEQ adopted regulations for portable fuel containers sold in Texas and EPA approved the rule, published February 10, 2005 (70 FR 7041). This will lower VOC emissions from portable fuel containers by an estimated 2.79 tpd within the nine-county nonattainment area and 0.63 tpd for counties outside of, but within a 100 km radius, of the nine-county area. As discussed earlier, the 5% guidance allows a nonattainment area to include VOC sources within 100 km of the nonattainment area in calculations of IOP reductions. There are 34 counties outside of the DFW 9-county area, that fall within 100 km of the nonattainment area. The VOC emissions from portable fuel containers within these 34 counties are added to the DFW area's EI, as required by the guidance; these emissions are 4.52 tpd. The 2002 baseline EI for VOCs is 459.15 tpd; with the portable fuel container emissions, the 2002 EI for VOCs is adjusted to 463.67 tpd. The total VOC emission reductions for 2007 are projected to be 3.42 tpd. Additional detail is provided in 70 FR 7041 and the TSD for this action.

Various rules for surface coating operations have been in effect for the four core counties in DFW, to meet 1-hour ozone nonattainment requirements. The State adopted a rule extending the requirements for surface coatings to the five newly designated 8-hour nonattainment counties. In a separate action, we approved Texas' SIP revision to extend the requirements for surface coatings to the five newly designated nonattainment counties, published January 19, 2006 (71 FR 3009). This will result in additional VOC reductions of 0.3 tpd for the area. Additional details are provided in 71 FR 3009 and the TSD for this action.

Rules are in effect for Stage I vapor recovery during gasoline unloading operations in the four core counties, with an exemption for operations with a throughput equal to or less than 10,000 gallons per month (gpm). The State adopted a rule revision to extend these requirements, with the 10,000 gpm exemption, to the five newly designated nonattainment counties. In a separate action, we approved Texas' SIP revision to extend Stage I requirements to the five newly designated nonattainment counties, published January 19, 2006 (71 FR 3009). This measure will result in VOC reductions of 2.09 tpd. Additional details are provided in 71 FR 3009 and the TSD for this action.

EPA's 5% guidance allows the reduction to be made with all VOC emission reductions, all NO X reductions, or a combination of VOC and NO X reductions that equal 5%. Texas chose to meet the 5% requirement by applying on a combination of VOC and NO X reductions, as shown in Tables 7 and 8.

The reductions submitted for new VOC and NO X measures are acceptable, with the exception of the amounts for Alcoa. As discussed above, we reduced the Alcoa NO X credit from 3.9 tpd to 2.8 tpd.

The 2002 baseline inventory is adjusted by adding the NO X emissions from Alcoa and VOC emissions from the portable fuel container rule. The adjusted baseline EI is the basis for performing the 5% reduction calculations. As shown in Table 8, the adjusted baseline inventory for VOC is 463.67 tpd and 622.22 tpd for NO X . The VOC control strategy reductions provide 5.81 tpd, which is 1.25% of the adjusted 2002 baseline for VOCs. The NO X reductions provide 27.59 tpd, which is 4.43% of the adjusted 2002 baseline for NO X . Per the 5% guidance, the sum of the percentage of the VOC reductions planned and the percentage of the NO X reductions planned must equal 5%. In this case, the sum of 1.25% + 4.43% = 5.68%, which meets the requirement and has a small surplus of 0.68%. Table 9 shows the 2007 target emission levels.

Per EPA's 5% guidance, states should ensure that the projected 2007 EI is at least 5% less than the 2002 EI. When 5% is subtracted from each of the adjusted 2002 inventories, the emissions for VOCs are 440.49 tpd and emissions for NO X are 591.11 tpd. The 2007 target emission levels are lower (shown in Table 10) and therefore meet the 5% guidance. This SIP revision demonstrates that the target level will be met and Texas has met the 5% increment of emission reduction.

Our analyses of the measures submitted and the calculation of reductions indicate that the State has satisfied the requirements of the 5% Increment of Progress Plan.

We are proposing to approve revisions to the SIP submitted by the State of Texas for the DFW nonattainment area as meeting 1-hour ozone serious area requirements. We are proposing to approve the 5% IOP plan, the revisions to the 2002 base year emissions inventory, the 2007 motor vehicle emissions budget, a Federal consent decree concerning an Alcoa plant in Rockdale, Milam County, energy efficiency measures, and revisions to 30 TAC, Chapter 117, Control of Air Pollution From Nitrogen Compounds, concerning stationary reciprocating IC engines operating within the DFW 8-hour ozone nonattainment area and incorporate these revisions into the Texas SIP. Although we are not reopening the comment period on RACT, we intend to finalize our proposed approval that RACT is in place for all major sources of VOCs in the DFW area in the final rulemaking for this proposal. We have evaluated these revisions and determined that they are consistent with the requirements of the Act and EPA's regulations, guidance and policy. These revisions fulfill the outstanding attainment demonstration obligation for the 1-hour ozone standard in the DFW nonattainment area and the outstanding obligation to adopt and implement all applicable requirements under the 1-hour ozone standard. We propose to approve these rules under section 110 and part D of the Act and EPA's regulations.

EPA is soliciting public comments on the issues discussed in this proposed rulemaking. These comments will be considered before EPA takes final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to the EPA Regional Office listed in the ADDRESSES section of this proposed rulemaking, or by submitting comments electronically, by mail, or through hand delivery/courier following the directions provided in the ADDRESSES section of this action.

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

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

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

On September 4, 1992, EPA promulgated 40 CFR part 55, 1 which established requirements to control air pollution from OCS sources in order to attain and maintain Federal and State ambient air quality standards and to comply with the provisions of part C of title I of the Act. Part 55 applies to all OCS sources offshore of the States except those located in the Gulf of Mexico west of 87.5 degrees longitude. Section 328 of the Act requires that for such sources located within 25 miles of a State's seaward boundary, the requirements shall be the same as would be applicable if the sources were located in the COA. Because the OCS requirements are based on onshore requirements, and onshore requirements may change, section 328(a)(1) requires that EPA update the OCS requirements as necessary to maintain consistency with onshore requirements.

Pursuant to § 55.12 of the OCS rule, consistency reviews will occur (1) at least annually; (2) upon receipt of a Notice of Intent under § 55.4; or (3) when a State or local agency submits a rule to EPA to be considered for incorporation by reference in part 55. This proposed action is being taken in response to the submittal of a Notice of Intent on March 22, 2006 by Shell Offshore, Inc. of Houston, Texas. Public comments received in writing within 30 days of publication of this proposed rule will be considered by EPA before publishing a final rule.

Section 328(a) of the Act requires that EPA establish requirements to control air pollution from OCS sources located within 25 miles of States' seaward boundaries that are the same as onshore requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into part 55 as they exist onshore. This limits EPA's flexibility in deciding which requirements will be incorporated into part 55 and prevents EPA from making substantive changes to the requirements it incorporates. As a result, EPA may be incorporating rules into part 55 that do not conform to all of EPA's State implementation plan (“SIP”) guidance or certain requirements of the Act.

Consistency updates may result in the inclusion of State or local rules or regulations into part 55, even though the same rules may ultimately be disapproved for inclusion as part of the SIP. Inclusion in the OCS rule does not imply that a rule meets the requirements of the Act for SIP approval, nor does it imply that the rule will be approved by EPA for inclusion in the SIP.

In updating 40 CFR part 55, EPA reviewed the rules submitted for inclusion in part 55 to ensure that they are rationally related to the attainment or maintenance of federal or state ambient air quality standards or part C of title I of the Act, that they are not designed expressly to prevent exploration and development of the OCS and that they are applicable to OCS sources. 40 CFR 55.1. EPA has also evaluated the rules to ensure they are not arbitrary or capricious. 40 CFR 55.12 (e). In addition, EPA has excluded administrative or procedural rules, 2 and requirements that regulate toxics which are not related to the attainment and maintenance of federal and state ambient air quality standards.

Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the Agency must determine whether the regulatory action is “significant” and therefore subject to Office of Management and Budget (“OMB”) review and the requirements of the Executive Order. The 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.

This action is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB Review. This rule implements requirements specifically and explicitly set forth by the Congress in section 328 of the Clean Air Act, without the exercise of any policy discretion by EPA. These OCS rules already apply in the COA, and EPA has no evidence to suggest that these OCS rules have created an adverse material effect. As required by section 328 of the Clean Air Act, this action simply updates the existing OCS requirements to make them consistent with rules in the COA.

The OMB has approved the information collection requirements contained in 40 CFR part 55, and by extension this update to the rules, under the provisions of the Paperwork Reduction Act , 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0249. Notice of OMB's approval of EPA Information Collection Request (“ICR”) No. 1601.06 was published in the Federal Register on March 1, 2006 (71 FR 10499-10500). The approval expires January 31, 2009.

As EPA previously indicated (70 FR 65897-65898 (November 1, 2005)), the annual public reporting and recordkeeping burden for collection of information under 40 CFR part 55 is estimated to average 549 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/or instrument, if applicable.

The Regulatory Flexibility Act (“RFA”) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant economic impact on a substantial number of small entities. This rule implements requirements specifically and explicitly set forth by the Congress in section 328 of the Clean Air Act, without the exercise of any policy discretion by EPA. These OCS rules already apply in the COA, and EPA has no evidence to suggest that these OCS rules have had a significant economic impact on a substantial number of small entities. As required by section 328 of the Clean Air Act, this action simply updates the existing OCS requirements to make them consistent with rules in the COA. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (“UMRA”), Pub. L. 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, EPA generally must prepare written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million of more in any one 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 regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

Today's proposed rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for state, local, or tribal governments or the private sector that may result in expenditures of $100 million or more for state, local, or tribal governments, in the aggregate, or to the private sector in any one year. This rule implements requirements specifically and explicitly set forth by the Congress in section 328 of the Clean Air Act without the exercise of any policy discretion by EPA. These OCS rules already apply in the COA, and EPA has no evidence to suggest that these OCS rules have created an adverse material effect. As required by section 328 of the Clean Air Act, this action simply updates the existing OCS requirements to make them consistent with rules in the COA.

Executive Orders 13132, entitled “Federalism” (4 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.”

This proposed rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This rule implements requirements specifically and explicitly set forth by the Congress in section 328 of the Clean Air Act, without the exercise of any policy discretion by EPA. As required by section 328 of the Clean Air Act, this rule simply updates the existing OCS rules to make them consistent with current COA requirements. This rule does not amend the existing provisions within 40 CFR part 55 enabling delegation of OCS regulations to a COA, and this rule does not require the COA to implement the OCS rules. Thus, Executive Order 13132 does not apply to this rule.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and state and local governments, EPA specifically solicits comments on this proposed rule from State and local officials.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (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.” This rule does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes and thus does not have “tribal implications,” within the meaning of Executive Order 13175. This rule implements requirements specifically and explicitly set forth by the Congress in section 328 of the Clean Air Act, without the exercise of any policy discretion by EPA. As required by section 328 of the Clean Air Act, this rule simply updates the existing OCS rules to make them consistent with current COA requirements. In addition, this rule does not impose substantial direct compliance costs on tribal governments, nor preempt tribal law. Consultation with Indian tribes is therefore not required under Executive Order 13175. Nonetheless, in the spirit of Executive Order 13175 and consistent with EPA policy to promote communications between EPA and tribes, EPA specifically solicits comments on this proposed rule from tribal officials

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (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 Agency 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 the Agency.

This proposed rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866. In addition, the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportional risk to children.

This proposed rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable laws or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decided not to use available and applicable voluntary consensus standards.

As discussed above, this rule implements requirements specifically and explicitly set forth by the Congress in section 328 of the Clean Air Act, without the exercise of any policy discretion by EPA. As required by section 328 of the Clean Air Act, this rule simply updates the existing OCS rules to make them consistent with current COA requirements. In the absence of a prior existing requirement for the state to use voluntary consensus standards and in light of the fact that EPA is required to make the OCS rules consistent with current COA requirements, it would be inconsistent with applicable law for EPA to use voluntary consensus standards in this action. Therefore, EPA is not considering the use of any voluntary consensus standards. EPA welcomes comments on this aspect of the proposed rulemaking and, specifically, invites the public to identify potentially-applicable voluntary consensus standards and to explain why such standards should be used in this regulation.

Title 40, chapter I of the Code of Federal Regulations, is proposed to be amended as follows:

We intend that any final action resulting from this proposal will be as accurate and as effective as possible. Therefore, comments or suggestions from the public, other concerned governmental agencies, the scientific community, industry, or any other interested party concerning this proposed rule are hereby solicited. Comments particularly are sought concerning:

(1) The reasons any habitat should or should not be determined to be critical habitat as provided by section 4 of the Act (16 U.S.C. 1531 et seq. ), including whether the benefit of designation will outweigh any threats to the species due to designation;

(2) Specific information on the amount and distribution of Catesbaea melanocarpa habitat, including areas occupied by C. melanocarpa at the time of listing and containing features essential to the conservation of the species, and areas not occupied at the listing that are essential to the conservation of the species and why;

(3) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat;

(4) We have not included lands containing features essential to the conservation of C. melanocarpa within the Gu´nica and Susúa Commonwealth Forests in Puerto Rico in this proposed designation because we believe that the Commonwealth Forests provide conservation management and protection for these features such that the specific areas do not meet the definition of critical habitat. We are seeking specific comments related to:

(a) Whether our determination to not include these specific areas in critical habitat is appropriate, and

(b) if our determination is not appropriate, then how should we define the specific areas essential to conservation of this plant.

(5) Any foreseeable economic, national security, or other potential impacts resulting from the proposed designation and, in particular, any impacts on small entities;

(6) Whether our approach to designating critical habitat could be improved or modified in any way to provide for greater public participation and understanding, or to assist us in accommodating public concerns and comments;

If you wish to comment, you may submit your comments and materials concerning this proposal by any one of several methods (see ADDRESSES section). Please submit electronic comments to marelisa_rivera@fws.gov in ASCII file format and avoid the use of special characters or any form of encryption. Please also include “Attn: Catesbaea melanocarpa ” in your e-mail subject header and your name and return address in the body of your message. If you do not receive a confirmation from the system that we have received your message, contact us directly by calling our Caribbean Fish and Wildlife Office at phone number 787-851-7297.

Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. We will not consider anonymous comments, and we will make all comments 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 Caribbean Fish and Wildlife Office (see ADDRESSES ).

Attention to and protection of habitat is paramount to successful conservation actions. The role that designation of critical habitat plays in protecting habitat of listed species, however, is often misunderstood. As discussed in more detail below in the discussion of exclusions under section 4(b)(2) of the Act, there are significant limitations on the regulatory effect of designation under section 7(a)(2) of the Act. In brief, (1) Designation provides additional protection to habitat only where there is a Federal nexus; (2) the protection is relevant only when, in the absence of designation, destruction or adverse modification of the critical habitat would take place (in other words, other statutory or regulatory protections, policies, or other factors relevant to agency decision-making would not prevent the destruction or adverse modification); and (3) designation of critical habitat triggers the prohibition of destruction or adverse modification of that habitat, but it does not require specific actions to restore or improve habitat.

Currently, only 475 species or 36 percent of the 1,310 listed species in the U.S. under the jurisdiction of the Service, have designated critical habitat. We address the habitat needs of all 1,310 listed species through conservation mechanisms such as listing, section 7 consultations, the section 4 recovery planning process, the section 9 protective prohibitions of unauthorized take, section 6 funding to the States, the section 10 incidental take permit process, and cooperative, non-regulatory efforts with private landowners. The Service believes that these measures may make the difference between extinction and survival for many species.

In considering exclusions of areas proposed for designation, we evaluated the benefits of designation in light of Gifford Pinchot Task Force v. U.S. Fish and Wildlife Service, 378 F. 3d 1059 (9th Cir 2004) (hereinafter Gifford Pinchot ). In that case, the Ninth Circuit invalidated the Service's regulation defining “destruction or adverse modification of critical habitat.” In response, on December 9, 2004, the Director issued guidance to be considered in making section 7 adverse modification determinations. This proposed critical habitat designation does not use the invalidated regulation in our consideration of the benefits of including areas in this final designation. The Service will carefully manage future consultations that analyze impacts to designated critical habitat, particularly those that appear to be resulting in an adverse modification determination. Such consultations will be reviewed by the Regional Office prior to finalizing to ensure that an adequate analysis has been conducted that is informed by the Director's guidance.

On the other hand, to the extent that designation of critical habitat provides protection, that protection can come at significant social and economic cost. In addition, the mere administrative process of designation of critical habitat is expensive, time-consuming, and controversial. The current statutory framework of critical habitat, combined with past judicial interpretations of the statute, make critical habitat the subject of excessive litigation. As a result, critical habitat designations are driven by litigation and courts rather than biology, and made at a time and under a time frame that limits our ability to obtain and evaluate the scientific and other information required to make the designation most meaningful.

In light of these circumstances, the Service believes that additional agency discretion would allow our focus to return to those actions that provide the greatest benefit to the species most in need of protection.

We have been inundated with lawsuits for our failure to designate critical habitat, and we face a growing number of lawsuits challenging critical habitat determinations once they are made. These lawsuits have subjected the Service to an ever-increasing series of court orders and court-approved settlement agreements, compliance with which now consumes nearly the entire listing program budget. This leaves the Service with little ability to prioritize its activities to direct scarce listing resources to the listing program actions with the most biologically urgent species conservation needs.

The consequence of the critical habitat litigation activity is that limited listing funds are used to defend active lawsuits, to respond to Notices of Intent (NOIs) to sue relative to critical habitat, and to comply with the growing number of adverse court orders. As a result, listing petition responses, the Service's own proposals to list critically imperiled species, and final listing determinations on existing proposals are all significantly delayed.

The accelerated schedules of court-ordered designations have left the Service with limited ability to provide for public participation or to ensure a defect-free rulemaking process before making decisions on listing and critical habitat proposals, due to the risks associated with noncompliance with judicially imposed deadlines. This in turn fosters a second round of litigation in which those who fear adverse impacts from critical habitat designations challenge those designations. The cycle of litigation appears endless and is very expensive, thus diverting resources from conservation actions that may provide relatively more benefit to imperiled species.

The costs resulting from the designation include legal costs, the cost of preparation and publication of the designation, the analysis of the economic effects and the cost of requesting and responding to public comment, and in some cases the costs of compliance with the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ). These costs, which are not required for many other conservation actions, directly reduce the funds available for direct and tangible conservation actions.

We intend to discuss topics directly relevant to the designation of critical habitat in this proposed rule. For more information on C. melanocarpa, including characteristics and life history, refer to the final listing rule published in the Federal Register on March 17, 1999 (64 FR 13116) and the final recovery plan (July 15, 2005).

C. melanocarpa is a perennial spiny shrub of the Madder family (Rubiaceae). Most members of this family are found in the tropics. The genus Catesbaea consists of 10 or more other species of spiny shrubs and is generally confined to the Antilles, but some may extend into the Bahamas and the Florida Keys (Breckon and Kolterman 1993, p. 1). C. melanocarpa is found in both dry and moist forest life zones in the Caribbean on the island of Puerto Rico (PR) and in the U.S. Virgin Islands (USVI). The dry forest life zone in PR and USVI occupies about 165,030 ha (407,798 acres) or 18 percent of PR and USVI. The moist forest life zone occupies 548,220 ha (1,354,681 acres) or 58 percent of PR and USVI.

C. melanocarpa is a branching shrub that may reach approximately 9.8 feet (ft) (3.0 meters (m)) in height. Spines are from 0.39 to 0.78 inches (in) (1.00 to 2.00 centimeters (cm)) long. Leaves are small, from 0.19 to 1.0 in (5.00 to 25.00 millimeters (mm)) long, and 0.07 to 0.58 in (2.00 to 15.00 mm) wide, often opposite. The flowers are white, solitary or paired, and almost lacking a stalk in the axils (angle formed by a leaf or branch with the stem) (Proctor 1991, p. 44).

Biological and ecological information on C. melanocarpa is scarce. In July 1992, Breckon and Kolterman (1993, p. 2) measured stem height and basal diameter for the 24 individuals known from St. Croix. Stem height ranged from 0.36 to 9.91 ft (0.11 to 3.02 m) and averaged 2.59 ft (0.79 m). Basal stem diameter ranged from 0.16 to 2.20 in (0.40 to 5.60 cm). In December 1992, reproduction was checked, and while no flowers were observed, many adults (greater than 1.64 ft (0.50 m) in height) were in fruit (Breckon and Kolterman 1993, p. 2). In St. Croix, we observed the species with fruit in early March 2006.

Only a few seed germination and propagation experiments have been conducted on C. melanocarpa (Breckon and Kolterman 1993, p. 2). In August 1988, seeds and plants were collected from the St. Croix location. Most of the transplanted seedlings have survived, and two have produced flowers and fruits. Of 57 seeds collected in December 1990, 92 percent germinated, but only five of the seedlings survived. In 1993, two fruits were collected. Ten seeds were obtained from these two fruits, but none germinated. Two plants previously germinated from St. Croix seeds were donated to the Gua nica Commonwealth Forest. These plants died before being planted. Fairchild Tropical Garden in Miami, Florida, collected seeds in 1994 or 1995 and had good germination and survival results (O'Reilly 2004).

The historical and current range of this species includes Halfpenny Bay in St. Croix, USVI; Gua nica and Susúa Commonwealth Forests and Peñones de Melones, PR; and Barbuda, Antigua, and Guadeloupe islands. Prior to 1995, C. melanocarpa was only known from Guánica, PR; St. Croix in the USVI; and Barbuda, Antigua, and Guadeloupe (Liogier and Martorell 1982, p. 172; Proctor 1991, p. 44; Breckon and Kolterman 1993, p. 1). Little was known about the status of this plant on the islands of Antigua, Barbuda, and Guadeloupe. One specimen, apparently originating from the Susúa Commonwealth Forest in Sabana Grande and Yauco, PR, was collected in 1974 and is located in the herbarium of the University of Puerto Rico in San Juan, PR. Because of the poor condition of the specimen, it was not possible to confirm its identification as C. melanocarpa (Breckon and Kolterman 1993, p. 1).

In St. Croix, USVI, C. melanocarpa was first collected in 1881 by the Danish collector Baron H.F.A. von Eggers (Proctor 1991, p. 43). The species was re-discovered in Halfpenny Bay by Rudy G. O'Reilly, Jr., who found a small population (approximately seven individuals) in a dry coastal plain located about 2.5 miles (4 km) south of Christiansted in August 1988 (Breckon and Kolterman 1993, pp. 1-2). Voucher specimens of these plants were collected by G.R. Proctor on September, 1988 (Proctor 1991, p. 43). The voucher describes the plants growing in pasture, shaded by Cassia poplyphylla (retama prieta) and other tall shrubs in the subtropical dry forest life zone. This population was estimated to consist of 24 individuals in July 1992 (Breckon and Kolterman 1993, p. 2). In October 2002, one hundred individuals were estimated to occur at this same location (Lombard 2002).

In Gua nica, PR, C. melanocarpa was first collected by the German collector Paul Sintenis in 1886 (Proctor 1991, p. 43). Based on information in the Natural Heritage Program of the Puerto Rico Department of Natural and Environmental Resources (DNER), two historical collections are reported from Gua nica: one in Cerro Montalva, west to Providencias Saltflats; and another at Punta Meseta, close to the Gua nica Lighthouse within the Gua nica Commonwealth Forest. Service biologists visited the last location on March 7, 2006 with personnel from the DNER and did not observe the species in the area. In 2001, C. melanocarpa was rediscovered at the Gua nica Commonwealth Forest (Trejo-Torres 2001, p. 62; Axelrod 2004; Trejo-Torres 2006) in the subtropical dry forest life zone. Service biologists visited the site in March 2006, and confirmed the presence of the species in a slope facing northwest of the Fuerte Trail. Approximately 12 individuals were found within the deciduous forest type. However, this does not represent a population estimate for this species at the Gua nica Commonwealth Forest. This forest contains habitat that is difficult to traverse. It is composed of dry shrub—scrub vegetation that is essentially a dense, thorny thicket of vegetation. Comprehensive surveys of the entire forest have not been conducted to determine all the locations of C. melanocarpa. Surveys thus far have been limited due to habitat constraints and resources to existing trails within the forests and have not been specifically designed yet to systematically look for C. melanocarpa. Axelrod (2004) anticipates, though, that this plant will be found in more locations in Gua nica Commonwealth Forest and other places as more inventories are conducted.

Within the subtropical moist forest life zone, the species has only been reported from the Susúa Commonwealth Forest. C. melanocarpa has been reported in Susúa twice in thirty years: in 1974 by Woodbury (Breckon and Kolterman 1993, p. 1) and in 2003 (Trejo-Torres 2003, 2006). The occurrence of C. melanocarpa in Susúa Commonwealth Forest was confirmed in 2003 when Trejo-Torres found the species in flower at the forest (Trejo-Torres 2003, 2006). Trejo-Torres submitted the collection voucher and the photography of the individual to the Service. Similar to the Gua nica Commonwealth Forest, we do not have a comprehensive population estimate for the Susúa Commonwealth Forest because systematic surveys of all suitable habitat have not been conducted. This forest also is composed of dense vegetation, making it difficult to traverse.

At the time of listing in 1999, C. melanocarpa was known from one individual located on the Peñones de Melones in Cabo Rojo, PR (about 16 miles (mi) or 25 kilometers (km) from Gua nica); about 24 individuals located on one privately owned farm in Halfpenny Bay near Christiansted in St. Croix, USVI; and an undetermined number of individuals on Barbuda, Antigua, and Guadeloupe (64 FR 13116, March 17, 1999; Puerto Rico Planning Board 1995, p. 29; Proctor 1991, p. 44; Breckon and Kolterman 1993, p. 1; USFWS 2005, p. 3). At the time of listing, Susúa Commonwealth Forest was recognized as part of the historical distribution of the species; however, the occurrence within the forest could not be confirmed since the collection material deposited at the herbarium in San Juan was in poor condition.

Currently, we have observed that the species, within U.S. jurisdiction (PR and USVI), occupies three discrete localities: (1) Approximately 100 individuals at a privately owned farm in Halfpenny Bay (Lombard 2002); (2) approximately 12 individuals located at the Fuerte Trail in Guánica Commonwealth Forest, Guánica, Guayanilla, and Yauco, PR (Axelrod 2004; Trejo-Torres 2001, p. 62), and (3) one individual located at the Susúa Commonwealth Forest, Sabana Grande and Yauco, PR (Trejo-Torres 2006).

The site in Peñones de Melones, where the species was reported in 1995, has experienced periodic land clearing activities and road construction based on our observations in 2002 and 2006 (Foote 2002; Axelrod 2004; Axelrod 2006). Several survey efforts have been conducted in the area by the Service and others; however, to date, no individuals of C. melanocarpa have been located (Foote 2002; Axelrod 2004; Axelrod 2006; Oikos Environmental Services 2005, p. 27).

C. melanocarpa has been found to occur only in the subtropical dry and subtropical moist forest life zones. Based on our field observations, the currently occupied sites for this plant all fall into these forest life zones, and have similar habitat characteristics. The subtropical dry forest is considered the driest life zone in PR and the USVI, receiving a mean annual rainfall ranging from 24 to 40 in (60 to 100 cm). Ewel and Whitmore (1973, pp. 10-20) described the vegetation in this zone as deciduous on most soils with most tree species dropping leaves during the dry season. The vegetation usually consists of a nearly continuous single-layered canopy with little ground cover. The leaves of dry forest species are often succulent or coriaceous (leathery), and species with spines and thorns are common. The vegetation in these areas is more xerophilous (drought resistant), and cacti are more abundant. Some common tree or shrub species of subtropical dry forest include: Prosopis juliflora (mesquite or bayahonda), Bursera simaruba (alma cigo), Cephalocereus royenii (sebuca n), Bucida buceras (u car), and Guaiacum officinalis (guayaca n). Tree heights usually do not exceed 49.2 ft (15 m), and crowns are typically broad, spreading, and flattened. Successional vegetation includes grasses, and the accumulated organic debris serves as fuel for human-induced fires (Ewel and Whitmore 1973, pp. 10-29). Extensive areas of this life zone in Puerto Rico lie over limestone. Within the subtropical dry forest life zone, the species currently occurs in Guánica Commonwealth Forest in PR and Halfpenny Bay in St. Croix, USVI.

In Halfpenny Bay, the currently known population consists of about 100 individuals located in a dry, coastal plain with soils belonging to the Glynn-Hogensborg Unit (NRCS 1998, pp. 63-64). The vegetation as observed by the Service in 2006 is composed of patches of dry woody vegetation (trees and shrubs), surrounded by grasses and C. melanocarpa is found under the canopy of these forested patches. The habitat characteristics of the site coincide with previous habitat descriptions for the species (Liogier and Martorell 1982, p. 172; USFWS 2005, p. 6). The average annual precipitation in the area ranges from 30.0 to 54.7 in (762.0 to 1389.0 mm) (NRCS 1998, pp. 63-64).

The currently known population in the Guánica Commonwealth Forest consists of approximately 12 individuals located on a slope northwest of the Fuerte Trail. In 2006, we observed that the vegetation within this locality is characterized by dry forest with semi-closed canopy on limestone soils and the species is found under the canopy. The Gua nica Commonwealth Forest is located in southwestern PR in the municipalities of Gua nica, Guayanilla, and Yauco. The forest was designated as a forest reserve in 1919 and a United Nations Biosphere Reserve in 1981. It is managed by the DNER. The Gua nica Forest supports a variety of vegetation types, including cactus scrub, littoral forest, deciduous forest, and semi-evergreen forest (Silander et al. 1986, pp. 60-66). The forest is underlain by limestone sedimentary rocks of Tertiary Period origin, and soils are shallow, well-drained, and alkaline (Silander et al. 1986, p. 51). Outcrops cover much of the area. Mean annual precipitation in the Guánica area is approximately 31 in (790 mm). C. melanocarpa is found in the deciduous forest. In this forest type, trees often reach 33 ft (10 m). Some associated tree and shrub species in this vegetation type are Bucida buceras (u car), Bursera simaruba (alma cigo), Coccoloba microstachya (uvillo), C. krugii , and Reynosia uncinata (chicharro n) (Silander et al. 1986, p. 69).

C. melanocarpa is currently known from Susu a Commonwealth Forest, which is within the subtropical moist life zone of Puerto Rico. The subtropical moist forest is delineated by a mean annual rainfall ranging from 39 to 86 in (100 to 220 cm) (Ewel and Whitmore 1973, pp. 20-29). Vegetation associations within this life zone are characterized by trees up to 65.6 ft (20 m) tall with rounded crowns. Many of the woody species are deciduous during the dry season and epiphytes are common. Some common tree or shrub species of subtropical moist forest include: Roystonea borinquena (palma real), Tabebuia heterophylla (roble blanco), Nectandra spp. (laurel), Erythrina poeppigiana (bucayo gigante), Inga vera (guaba), Inga laurina (guama ), and Didymopanax morototoni (yagrumo macho) (Ewel and Whitmore 1973, pp. 20-29). The Susúa Commonwealth Forest represents not only the influence of a climatic transition zone (dry to moist), but also a combination of volcanic and serpentine soils. Two vegetation associations (dry slope forest and gallery forest) have been delineated in the subtropical moist life zone (DNR 1976, p. 224). C. melanocarpa is found within the dry slope forest type. The climatic conditions and serpentine-derived soils contribute to more xeric conditions and a forest structure and species composition very similar to the Gua nica Commonwealth Forest. In 2001, Trejo-Torres (2003, 2006) rediscovered the species in the Susu a Commonwealth Forest. One individual in flower was located in the forest. The individual was found on a rocky ravine west of Quebrada los Peces, at the southwestern corner of the public forest. The habitat is described as low forest on serpentine soil.

In Pen ones de Melones, Cabo Rojo, PR, C. melanocarpa was discovered by Dr. F. Axelrod of the University of Puerto Rico in February 1995 (PRPB 1995, p. 29). The collection voucher deposited in the University of Puerto Rico in San Juan describes the location in Boquero n Ward, Cabo Rojo, PR, at the upper west slopes of Pen ones de Melones from 164 to 295 ft (50 to 90 m) above sea level. The voucher described the habitat as dry forget on limestone, and the collection was made from a 7 ft (2 m) shrub with green globose (spherical) fruit. The Pen ones de Melones area consists of several chains of limestone hills and drainages (ravines) surrounded by mangrove forests, mud flats, saltwater and freshwater lagoons, wooded lands, extensive pastures, and residential projects. The elevation ranges from 3.3 to 347.7 ft (1 to 106 m) above sea level. The limestone hill soils belong to San Germán Series (San Germán Stony Clay Loam or SmE) described as shallow and very shallow, strongly sloping and steep, well-drained, cobbly and stony soils on the limestone hills and mountains (Soil Conservation Survey 1965, pp. 114-115). Average annual precipitation in Cabo Rojo is approximately 34 in (874 mm) (USFWS 2004).

Several vegetation surveys have been conducted in the Pen ones de Melones area in the last 20 years. Dr. Axelrod reported 84 vascular plant species at the site in 1995 (PRPB 1995, pp. 25-29). In 2005, Dr. H.E. Quintero conducted a flora and fauna study at the site and found that vegetation types are not uniform and there were patches of distinct forests, woodlands, shrub lands, and grasslands (Oikos Environmental Services 2005, p. 10). In August 2002, Service biologists visited the Peñones de Melones area with Dr. Axelrod to identify the site where the species was discovered in 1995. The main part of the drainage, where C. melanocarpa was previously observed, showed signs of disturbance from periodic land clearing and road construction. They observed in August 2002 that the area had not been disturbed for several years and showed excessive growth of Acacia sp. in disturbed areas exposed to more sunlight. They noted that the area was covered with secondary vegetation with such species as Acacia farnesiana (aroma) and Prosopis juliflora (mesquite). Although the species was not found, Service biologists concluded that C. melanocarpa may be present, but the conditions of the habitat were not suitable to appropriately locate and identify the species (Foote 2002).

In 2004, Dr. Axelrod provided comments to the Service regarding the occurrence of the species in the Pen ones de Melones area. He reported that, since his report of the species on the north side of Punta Melones, he found it once again in 2002 in a ravine on the south side of Punta Melones. He reported that, when he returned to the site in 2004, the ravine on the south had been entirely bulldozed. In March 2006, Service biologists visited these two sites on three occasions. The drainage area facing north of the Pen ones de Melones (area reported by Axelrod in 1995) was searched for the species, as well as the hills, the slopes, and drainages facing south of the hills. The original site, the drainage area facing north, demonstrates vegetation characteristics consistent with previous land clearing activities. The area consists of dense woodland dominated by mesquite trees. The ravine and hillsides located to the south of Peñones de Melones have also been cleared by bulldozing activities and consist of dense woodlands dominated by mesquite trees in the lower area and a solid stand of fire bush ( Croton lucidus ) on the hillsides. Based on Service observations, the secondary dry forest vegetation that supported habitat for C. melanocarpa has been eliminated.

C. melanocarpa is threatened by small population sizes characterized by the limited number of individuals and distribution, habitat destruction or modification for residential and tourist development, fire, and catastrophic natural events such as hurricanes (USFWS 2005, p. 8). Periodic land-clearing activities have been documented by the Service and others in the Pen ones de Melones area in Cabo Rojo (Foote 2002; Axelrod 2004; 2006). The Halfpenny Bay site is a privately owned agricultural tract that is subject to intense but periodic grazing. Based on information gathered during our site visit, most of the site was burned by a human-induced fire in 1997 (Hamada 2006). This population is subject to impacts from cattle grazing activities as well as pressure for a golf course development (USFWS 2005, p. 8). The limited number of individuals and restricted distribution make the species vulnerable to catastrophic events, such as hurricane damage and human-induced fires.

For more information on previous Federal actions concerning C. melanocarpa , refer to the final listing rule (64 FR 13116, March 17, 1999). We listed C. melanocarpa as endangered under the Act on March 17, 1999 (64 FR 13116) and approved a final recovery plan for this plant on July 15, 2005 (USFWS 2005). In the 1999 final listing rule, we determined designation of critical habitat was not prudent. On September 17, 2004, the Center for Biological Diversity filed a lawsuit against the Department of the Interior and the Service [ Center for Biological Diversity v. Norton (CV-00293-JDB) (D.D.C.)], challenging the failure to designate critical habitat for C. melanocarpa. In a settlement agreement dated June 3, 2005, the Service agreed to reevaluate the prudency of critical habitat for this species and, if prudent, submit a proposed designation of critical habitat to the Federal Register by August 15, 2006, and a final designation by August 15, 2007.

Critical habitat is defined in section 3 of the Act as: (i) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features (I) Essential to the conservation of the species and (II) that may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring any endangered species or threatened species to the point at which the measures provided under the Act are no longer necessary.

Critical habitat receives protection under section 7 of the Act through the prohibition against destruction or adverse modification of critical habitat with regard to actions carried out, funded, or authorized by a Federal agency. Section 7 requires consultation on Federal actions that are likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow government or public access to private lands.

To be included in a critical habitat designation, the habitat within the area occupied by the species at the time it was listed must first have features that are essential to the conservation of the species. Critical habitat designations identify, to the extent known using the best scientific data available, habitat areas that provide essential life cycle needs of the species (areas on which are found the primary constituent elements (PCEs), as defined at 50 CFR 424.12(b)).

Habitat occupied at the time of listing may be included in critical habitat only if the essential features thereon may require special management or protection. Thus, we do not include areas where existing management is sufficient to conserve the species. [As discussed below, such areas may also be excluded from critical habitat.] Furthermore, when the best available scientific data do not demonstrate that the conservation needs of the species require additional areas, we will not designate critical habitat in areas outside the geographical area occupied by the species at the time of listing. However, an area that was not known to be occupied at the time of listing but is currently occupied by the species will likely be essential to the conservation of the species and, therefore, typically included in the critical habitat designation.

The Service's Policy on Information Standards Under the Endangered Species Act, published in the Federal Register on July 1, 1994 (59 FR 34271), and Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (P.L. 106-554; H.R. 5658) and the associated Information Quality Guidelines issued by the Service, provide criteria, establish procedures, and provide guidance to ensure that decisions made by the Service represent the best scientific data available. They require Service biologists to the extent consistent with the Act and with the use of the best scientific data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat. When determining which areas are critical habitat, a primary source of information is generally the listing package for the species. Additional information sources include the recovery plan for the species, articles in peer-reviewed journals, conservation plans developed by States and counties, scientific status surveys and studies, biological assessments, or other unpublished materials and expert opinion or personal knowledge. All information is used in accordance with the provisions of Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658) and the associated Information Quality Guidelines issued by the Service.

Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Habitat is often dynamic, and species may move from one area to another over time. Furthermore, we recognize that designation of critical habitat may not include all of the habitat areas that may eventually be determined to be necessary for the recovery of the species. For these reasons, critical habitat designations do not signal that habitat outside the designation is unimportant or may not be required for recovery.

Areas that support populations, but are outside the critical habitat designation, will continue to be subject to conservation actions implemented under section 7(a)(1) of the Act and to the regulatory protections afforded by the section 7(a)(2) jeopardy standard, as determined on the basis of the best available information at the time of the action. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans, or other species conservation planning efforts if new information available to these planning efforts calls for a different outcome.

Section 4(a)(3) of the Act and its implementing regulations (50 CFR 424.12) require that, to the maximum extent prudent and determinable, we designate critical habitat at the time a species is listed as endangered or threatened. Our regulations at 50 CFR 424.12(a)(1) state that the designation of critical habitat is not prudent when one or both of the following situations exist: (1) The species is threatened by taking or other activity and the identification of critical habitat can be expected to increase the degree of threat to the species; or (2) such designation of critical habitat would not be beneficial to the species. In our March 17, 1999, final rule (64 FR 13116), we determined that designating critical habitat was not prudent for C. melanocarpa because it would result in no known benefit to the species and could further pose a threat to the species through publication of site-specific localities.

We are already working with Federal and State agencies, private individuals, and organizations in carrying out conservation activities for C. melanocarpa, conducting surveys for additional occurrences, and assessing habitat conditions. However, critical habitat designation may be beneficial by providing additional information to individuals, local and State governments, and other entities engaged in long-range planning, because areas with features essential to the conservation of the species are clearly delineated and, to the extent currently feasible, the primary constituent elements of the habitat essential for conservation of the species are specifically identified. Furthermore, although the low numbers of this plant make it unlikely that its populations could withstand even moderate collecting pressure or vandalism, we do not have specific evidence of taking, collection, vandalism, trade, or unauthorized human disturbance and thus, we cannot say that designation would increase the likelihood of take.

Accordingly, we withdraw our previous determination that the designation of critical habitat will not benefit C. melanocarpa and will increase the degree of threat to the species. We determine that the designation of critical habitat is prudent for this species. At this time, we have sufficient information necessary to identify specific areas that meet the definition of critical habitat and are, therefore, proposing critical habitat for C. melanocarpa.

As required by section 4(b) of the Act, we use the best scientific data available in determining areas that were occupied at the time of listing that contain the features that are essential to the conservation of C. melanocarpa and other areas that are essential to the conservation of this species. We reviewed the approach to conservation of the species undertaken by local, State, and Federal agencies operating within the species' range since its listing, as well as the actions necessary for this plant's conservation as identified in the final recovery plan (USFWS 2005). We reviewed available information that pertains to the habitat requirements of this species. This information included: data from our files that we used for listing the species; peer-reviewed scientific publications; biological field surveys and reports; resource agencies' and universities' unpublished status reports; information and GIS maps (forest boundaries, topography, drainages, roads) from the Puerto Rico Planning Board and Puerto Rico Department of Natural and Environmental Resources; soil maps and manuals from Natural Resources Conservation Service (former Soil Conservation Service); U.S. Geological Survey topographic maps (scale 1:20,000); recent aerial photography; unpublished data and observations collected by Service biologists during recent field surveys; forest management plans from local agencies; the C. melanocarpa recovery plan; information received from and discussions with local (PR and USVI) botanists and researchers working with the species and its habitat; and herbarium collections. We also made several recent visits to all currently known localities (Halfpenny Bay, Peñones de Melones, Guánica Commonwealth Forest, and Susúa Commonwealth Forest) to gather abundance and distribution data and conduct habitat observations. Information from all sources was utilized to determine the species' range and habitat features needed to support life history functions essential to the conservation of the species.

Fewer than 115 individuals are known to occur in three discrete localities throughout PR and the USVI, and no additional sightings for the species have been reported in other areas. The locality where the majority of the individuals occur (about 100 plants) is a relatively small (50 ac, or 20 ha) privately owned cattle grazing parcel under current threat of development pressure in St. Croix. The two other localities are publicly owned and support the only known individuals of C. melanocarpa in PR. In the three areas, C. melanocarpa is associated with dry woody vegetation occupying the understory strata. The conservation of C. melanocarpa depends upon the protection of existing populations and the maintenance of ecological functions within these sites, including vegetation and soils characteristics essential to the conservation of the species. Therefore, we considered, but are not proposing any areas outside the geographical area presently occupied by the species.

In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12, we are required to base critical habitat determinations on the best scientific data available and to consider within areas occupied by the species at the time of listing those physical and biological features that are essential to the conservation of the species (PCEs), and that may require special management considerations or protection. These include, but are not limited to, space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for reproduction, germination, or seed dispersal; and habitats that are protected from disturbance or are representative of the historic geographical and ecological distributions of a species.

The specific PCEs required for C. melanocarpa are derived from the biological needs of the species, and include those habitat components needed for growth and development, flower production, pollination, seed set and fruit production, and genetic exchange. Although at present time the information on the species' biological and ecological needs is limited (USFWS 2005, p. 7), habitat characteristics supporting all three currently known localities are known. Additionally, individuals in all three localities have been documented in fruit or flower. The presence of sexual reproduction indicates that the species has the potential to produce viable populations, with the assistance of appropriate conservation strategies.

C. melanocarpa is currently known from both the subtropical dry forest and subtropical moist forest life zones of PR and the USVI. Except for one locality, the historical and current range of the species is within dry forest life zone. The Susúa Commonwealth Forest is the only locality that is not dry forest; however, based on our observations because of its serpentine soils, the vegetation structure and species composition are similar to dry forest habitat (Breckon and García 2001; Silander et al. 1986, p. 243). In all three localities, the species is under the canopy of trees and shrubs, and all localities in PR are forested hills associated with either limestone or serpentine soils. The locality in St. Croix, based on Service observations, is a coastal plain with patches or thickets of trees and shrubs characteristic of dry forest habitat.

Within the subtropical dry and moist forest life zones, C. melanocarpa has been reported from four discrete sites within the U.S. Caribbean: Halfpenny Bay, Peñones de Melones, the Guánica Commonwealth Forest, and the Susúa Commonwealth Forest. However, the species presently occupies only Halfpenny Bay in St. Croix, USVI, the Guánica Commonwealth Forest, PR, and the Susúa Commonwealth Forest, PR.

Vegetation at the Halfpenny Bay site comprised of dry thicket scrub vegetation, dominated by grasses with patches of trees and shrubs (USFWS 2005, pp. 6-7). Based on Service observations during a site visit conducted on March 1 and 2, 2006, C. melanocarpa is an understory species, currently growing below trees and shrubs characteristic of dry forest habitat. Associated flora include introduced grass species, Caesalpinia coriaria (dividive), Tamarindus indica (tamarind), Castela erecta (goat-bush), Acacia turtuosa (acacia), Cassia poplyphylla (retama prieta), Leucaena leucocephala (tan-tan), Randia aculeata (box-briar or tintillo), and Cordia alba (white manjack). Soils in the Halfpenny Bay site have been described as belonging to the Glynn-Hogensborg unit, which consists of very deep, well drained, nearly level to moderately steep soils (NRCS 1998, pp. 63-64).

We observed the vegetation within the Guánica Commonwealth Forest locality in 2006 as dry forest with semi-closed canopy on limestone soils. The species is found under the canopy. In this forest type, trees often reach 33 ft (10 m). Some associated dry forest vegetation in this locality include uvillo ( Coccoloba microstachya ), C. diversifolia (uvilla), Thouinia portoricensis (quebracho), Guettarda elliptica (cucubano liso), alhelí, Croton lucidus, Savia sessiliflora (amansa guapo), Pithecellobium unguis-cati (uña de gato), Guaiacum sanctum (guayacán), Leucaena leucocephala (zarcilla), among other common species (Trejo-Torres 2001, pp. 59-63).

Susúa Commonwealth Forest is located in southwestern Puerto Rico in the municipalities of Yauco and Sabana Grande. The Susúa Forest lies between the humid Central Cordillera and the dry coastal plains typical of the south coast. The forest represents not only the influence of a climatic transition zone (dry to moist), but also a combination of volcanic and serpentine soils (Department of Natural Resources 1976, p. 24). The majority of the forest (90 percent) is underlain by serpentine outcrop. The rest of the forest (10 percent) has nine other soil types that belong to the Caguabo-Múcaro association (Silander et al. 1986, p. 224-226; Soil Conservation Survey 1975, p. 9). These soils are described as slightly leached, loamy and clay, sticky and plastic soils underlain by hard or weathered rock at a depth of less than 30 inches (Soil Conservation Survey 1975, p. 9). Serpentine-derived soils create stressful conditions for the establishment and growth of plants, and their associated floras are characterized by high diversity and endemism (Cedeño-Maldonado and Breckon 1996, p. 348). Two vegetation associations (dry slope forest and gallery forest) have been delineated in the subtropical moist life zone (Department of Natural Resources 1976, p. 224). The trees are slender, open-crowned, and usually less than 39.4 ft (12m) tall. The forest floor is open because the excessively drained soil supports little herbaceous growth (Ewel and Whitmore 1973, p. 25). C. melanocarpa is found in the dry slope forest type. The climatic conditions and serpentine-derived soils contribute to more xeric conditions and a forest structure and species composition similar to the Guánica Commonwealth Forest based on observations by the Service and others (Silander et al. 1986, pp. 239-245; Breckon and García 2001).

In accordance with our regulations, we are required to identify the known physical and biological features (PCEs) essential to the conservation of C. melanocarpa. All proposed critical habitat for C. melanocarpa is occupied, within the species' current and historic geographic range, and contains sufficient PCEs to support at least one life history function.

Based on our current knowledge of the species and the requirements of the habitat to sustain the essential life history functions of the species, as discussed above, we have determined that C. melanocarpa 's PCEs are:

(1) Single-layered canopy forest with little ground cover and open forest floor that supports patches of dry vegetation with grasses, and

(2) Well to excessively drained, limestone and serpentine-derived soils (including soils of the San Germán, Nipe, and Rosario series and Glynn and Hogensborg series).

Open forest floor, canopy, and little ground cover are important requirements for an understory species like C. melanocarpa. Canopy provides shade and open forest floor reduces competition by herbaceous species. Limestone and serpentine derived soils that are well to excessively drained provide essential nutrients to this plant and sustain the dry conditions needed by the species. The proposed critical habitat in this rule has been determined to contain sufficient PCEs to support at least one life history function of C. melanocarpa.

As required by section 4(b)(1)(A) of the Act, we use the best scientific and commercial data available in determining areas that contain the features that are essential to the conservation of C. melanocarpa. We began our analysis by considering the historic distribution of the species and sites occupied by the species at the time of listing. The 1999 listing rule (64 FR 13116) identified two localities within U.S. jurisdiction as then occupied by the species: A 50-ac (20-ha) privately owned parcel in Halfpenny Bay in St. Croix, USVI; and a 330-ac (132-ha) property in Peñones de Melones in Cabo Rojo, PR. Both localities are found within the subtropical dry forest life zone and support habitat for the species. The final listing rule identified two historic collections: one in Guánica, PR, in 1886, and one in Susúa Commonwealth Forest, PR, in 1974. The Guánica Commonwealth Forest is within the subtropical dry forest life zone, and Susúa Commonwealth Forest is considered within the moist forest life zone. However, the Susúa Commonwealth Forest supports slopes with dry forest vegetation due to the climatic conditions and soil type. Both forests are similar in forest structure and species composition. Although both forests support habitat for C. melanocarpa, the presence of the species within these two forests was not corroborated at the time of listing. The rule noted that the Susúa specimen could not be confirmed as C. melanocarpa because of its poor condition (64 FR13116, March 17, 1999; Breckon and Kolterman 1993, p. 1).

We reviewed the approved final recovery plan to identify new records of occupancy of the species, biological information, and habitat characteristics (USFWS 2005, pp. 3-8). The plan identifies both downlisting and delisting criteria and emphasizes the importance of protecting existing populations within the range of this plant to prevent its extinction, decrease the threat to the species associated with catastrophic events, and to obtain sexual (seeds) and asexual (cuttings) propagation material to establish a propagation program for the species. The plan includes information provided by a peer reviewer during the comment period showing a recent collection of C. melanocarpa located at the Guánica Commonwealth Forest. This forest is located within the previously known distribution of the species and supports a historic collection of C. melanocarpa. A voucher of this collection is located in the herbarium of the University of Puerto Rico (UPR 2006).

We also reviewed other information (such as sighting records from herbariums, DNER maps, and office files) and scientific literature and reports to identify additional information available on species range and biological needs. The Service contacted all researchers that have reported the species in recent years and visited all reported sites to confirm sightings. Herbarium records for Guánica and Peñones de Melones describe the species growing in low forest or the understory of dry forest vegetation in limestone soils. The herbarium voucher for the species in Susúa describes the species growing in low forest on serpentine soils (Trejo-Torres 2003). Vegetation characteristics, climatic conditions, and soil type coincide with the previously described habitat for the species. We confirmed sightings in St. Croix and Guánica Commonwealth Forest. Although additional forested areas within the dry forest life zone and the moist forest life zone are present in PR and USVI, no additional sightings for the species have been reported in these other areas.

An area was considered for designation where it supported a population or occurrence and either (1) Possesses sufficient PCEs to support at least on life history function and was occupied at the time of listing or (2) is currently occupied. Information gathered by the Service and data collected during field visits resulted in this proposal regarding only three discrete areas in the U.S. Caribbean.

The Halfpenny Bay area was occupied at the time of listing and continues to be occupied currently. This area contains features that are essential to the conservation of C. melanocarpa that may require special management or protection. Another area that was occupied at the time of listing, located in Peñones de Melones in Cabo Rojo, PR, is not currently occupied by the species and has lost PCEs due to periodic land clearing activities with heavy machinery; it is not being proposed as critical habitat for the species due to lack of PCEs and lack of conservation value for the species.

The Guánica and Susúa Commonwealth forests have historical records of the species, and are currently occupied. Both areas are currently occupied by the species based on recent reports (Trejo-Torres 2001, p. 62; Trejo-Torres 2003; 2006) and site visits conducted by the Service in 2006.

These three areas (Halfpenny Bay and both Commonwealth forests) represent all known occurrences of this species in the wild within U.S. jurisdiction (currently known to be fewer than 115 individuals). Protecting individuals in the three localities is vital to maintain genetic representation of all known localities in the U.S. Caribbean. We have determined that it is essential to prevent extinction of this plant, by protecting and secure existing populations, establishing a propagation program, augmenting existing populations with propagated individuals, and establishing new self-sustainable populations in protected areas (USFWS 2005). We believe all three currently occupied areas presently contain essential habitat features for the species.

We reviewed existing management and conservation plans and management for C. melanocarpa to determine if any areas identified above as containing features essential to the conservation of the species did not meet the definition of critical habitat according to section 3(5)(A) of the Act. On the basis of this review, we believe that essential features within both Commonwealth Forests are adequately protected under the management of Puerto Rico DNER and the master plan for the Forests and do not require special management or protection. While these areas, which collectively total 14,575 ac (5,898 ha) contain the habitat features that are essential to the conservation of the subspecies, they are not being included in this proposal (see Application of section 3(5)(A) of the Act section) because they do not meet the definition of critical habitat under section 3(5)(A) of the Act.

When determining proposed critical habitat boundaries, we made every effort to avoid including within the boundaries of the map contained in this proposed rule areas already developed such as buildings, paved areas, and other structures in areas where the PCEs for C. melanocarpa are not present. The scale of the maps prepared under the parameters for publication within the Code of Federal Regulations may not reflect the exclusion of such developed areas. Any such structures and the land under them inadvertently left inside critical habitat boundaries shown on the maps of this proposed rule have been excluded by text in the proposed rule and are not proposed for designation as critical habitat. Therefore, Federal actions limited to these areas would not trigger section 7 consultation, unless they affect the species or primary constituent elements in adjacent critical habitat. To the extent feasible, we will continue, with the assistance of other State, Federal, and private researchers, to conduct surveys, research, and conservation actions on the species and its habitat in areas designated and not designated as critical habitat. We anticipate that the boundaries of the mapped units may be refined based on additional information received during the public comment period. If additional information becomes available on the species' biology, distribution, and threats, we will evaluate the need to revise critical habitat, or refine the boundaries of critical habitat as appropriate. Sites that are occupied by this plant that are not being designated for critical habitat will continue to receive protection under the Act's section 7 jeopardy standard where a Federal nexus may occur (see “Critical Habitat” section).

We are proposing to designate critical habitat on lands in need of special management or protection and on those that we have determined to be currently occupied by the species or occupied at the time of listing and which contain sufficient PCEs to support life history functions essential for the conservation of the species.

When designating critical habitat, we assess whether the areas determined to be occupied at the time of listing contain the PCEs that may require special management considerations or protection. As discussed in detail here and in the unit descriptions below, we find that all of the PCEs in Halfpenny Bay may require special management considerations or protection due to threats to the species or its habitat. Such management considerations and protections include: fencing off forest patches to exclude cattle, developing fire-breaks adjacent to existing roads and farm boundaries during dry season, establishing conservation agreements with landowners to protect individuals within the property, collecting seeds and cuttings to establish a propagation program, and establishing additional patches of forest vegetation to plant additional individuals to augment existing populations within the site

We are proposing Halfpenny Bay in Christiansted, St. Croix, USVI as critical habitat for C. melanocarpa. This critical habitat unit described below constitutes our best assessment at this time of areas we determined to be occupied at the time of listing, containing the primary constituent elements, and which may require special management. All of the areas identified in this rule as occupied, including those in the Commonwealth Forests managed by DNER that do not meet the definition of critical habitat (see Application of Section 3(5)(A) of the Act section), are necessary to conserve the species. Appropriate management and protection will support reproduction, recruitment, adaptation to catastrophic events and genetic diversity (Primack 2000, pp. 124-133; Falk et al. 1996, pp. 113-119) as identified using the best available data.

Table 1 provides the approximate area (acres, hectares) and land ownership of lands determined to meet the definition of critical habitat and proposed.

Below we provide a brief description and rationale for the proposed unit of critical habitat for C. melanocarpa.

The Halfpenny Bay critical habitat unit consists of an approximately 50-ac (20.23-ha) area on a privately owned agricultural tract located in a dry coastal plain about 2.48 miles (4 km) south of Christiansted, St. Croix, USVI. The area is delimited by Road 62 to the north, South Shore Road to the west, the local road to Halfpenny Bay to the east, and by the 10-meter (m) (33 ft) topographic contour line to the south. This unit encompasses the habitat features essential to the conservation of C. melanocarpa and does not contain manmade structures, such as existing private homes or barns. The species is located within dry thickets of scrub vegetation in this unit, which is dominated by grasses with patches of trees and shrubs. The unit contains PCEs 1 and 2 and is important to conserving the genetic diversity of this plant. Since this is the locality with the highest number of individuals (100 plants), we believe that it should be considered the core population to maintain genetic representation of this plant in the U.S. Caribbean. Propagation material, both sexual and asexual, should be collected from this population to augment the number of individuals in existing populations and establish new sustainable populations in protected areas in PR and the USVI.

At the time of the 1999 listing, the population was estimated at 24 individuals, but in 2002 the population was estimated at 100 individuals by a Service biologist (Lombard 2002). The presence of the species at this site was confirmed by the Service in March 2006. This population is the only one known in the U.S. Virgin Islands, has the highest number of individuals, and it has been documented in reproductive condition (with fruit and flowers). The site is currently threatened by periodic but intense grazing, human-induced fires, and potential of development for a tourist project (USFWS 2005, p. 8), and may require special management considerations or protection as discussed in the “Special Management Considerations or Protections” section above.

Section 7 of the Act requires Federal agencies, including the Service, to ensure that actions they fund, authorize, or carry out are not likely to destroy or adversely modify critical habitat. In our regulations at 50 CFR 402.02, we define destruction or adverse modification as “a direct or indirect alteration that appreciably diminishes the value of critical habitat for both the survival and recovery of a listed species. Such alterations include, but are not limited to, alterations adversely modifying any of those physical or biological features that were the basis for determining the habitat to be critical.” However, recent decisions by the 5th and 9th Circuit Court of Appeals have invalidated this definition (see Gifford Pinchot Task Force v. U.S. Fish and Wildlife Service , 378 F. 3d 1059 (9th Cir 2004) and Sierra Club v. U.S. Fish and Wildlife Service et al. , 245 F.3d 434, 442F (5th Cir 2001)). Pursuant to current national policy and the statutory provisions of the Act, destruction or adverse modification is determined on the basis of whether, with implementation of the proposed Federal action, the affected critical habitat would remain functional (or retain the current ability for the primary constituent elements to be functionally established) to serve the intended conservation role for the species.

Section 7(a) of the Act requires Federal agencies, including the Service, to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if any is proposed or designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402.

Section 7(a)(4) of the Act requires Federal agencies to confer with us on any action that is likely to jeopardize the continued existence of a proposed species or result in destruction or adverse modification of proposed critical habitat. This is a procedural requirement only. However, once a proposed species becomes listed, or proposed critical habitat is designated as final, the full prohibitions of section 7(a)(2) apply to any Federal action. The primary utility of the conference procedures is to maximize the opportunity for a Federal agency to adequately consider proposed species and critical habitat and avoid potential delays in implementing their proposed action because of the section 7(a)(2) compliance process, should those species be listed or the critical habitat designated.

Under conference procedures, the Service may provide advisory conservation recommendations to assist the agency in eliminating conflicts that may be caused by the proposed action. The Service may conduct either informal or formal conferences. Informal conferences are typically used if the proposed action is not likely to have any adverse effects to the proposed species or proposed critical habitat. Formal conferences are typically used when the Federal agency or the Service believes the proposed action is likely to cause adverse effects to proposed species or critical habitat, inclusive of those that may cause jeopardy or adverse modification.

The results of an informal conference are typically transmitted in a conference report, while the results of a formal conference are typically transmitted in a conference opinion. Conference opinions on proposed critical habitat are typically prepared according to 50 CFR 402.14, as if the proposed critical habitat were designated. We may adopt the conference opinion as the biological opinion when the critical habitat is designated, if no substantial new information or changes in the action alter the content of the opinion (see 50 CFR 402.10(d)). As noted above, any conservation recommendations in a conference report or opinion are strictly advisory.

If a species is listed or critical habitat is designated, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of such a species or to destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must enter into consultation with us. As a result of this consultation, compliance with the requirements of section 7(a)(2) will be documented through the Service's issuance of: (1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or (2) a biological opinion for Federal actions that may affect, but are likely to adversely affect, listed species or critical habitat.

When we issue a biological opinion concluding that a project is likely to result in jeopardy to a listed species or the destruction or adverse modification of critical habitat, we also provide reasonable and prudent alternatives to the project, if any are identifiable. “Reasonable and prudent alternatives” are defined at 50 CFR 402.02 as alternative actions identified during consultation that can be implemented in a manner consistent with the intended purpose of the action, that are consistent with the scope of the Federal agency's legal authority and jurisdiction, that are economically and technologically feasible, and that the Director believes would avoid jeopardy to the listed species or destruction or adverse modification of critical habitat. Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.

Regulations at 50 CFR 402.16 require Federal agencies to reinitiate consultation on previously reviewed actions in instances where a new species is listed or critical habitat is subsequently designated that may be affected and the Federal agency has retained discretionary involvement or control over the action or such discretionary involvement or control is authorized by law. Consequently, some Federal agencies may request reinitiation of consultation with us on actions for which formal consultation has been completed, if those actions may affect subsequently listed species or designated critical habitat or adversely modify or destroy proposed critical habitat.

Federal activities that may affect C. melanocarpa or its designated critical habitat will require section 7 consultation under the Act. Activities on State, Tribal, local or private lands requiring a Federal permit (such as a permit from the Corps under section 404 of the Clean Water Act or a permit under section 10(a)(1)(B) of the Act from the Service) or involving some other Federal action (such as funding from the Federal Highway Administration, Federal Aviation Administration, or the Federal Emergency Management Agency) will also be subject to the section 7 consultation process. Federal actions not affecting listed species or critical habitat, and actions on State, Tribal, local or private lands that are not federally funded, authorized, or permitted, do not require section 7 consultations.

Prior to and following designation of critical habitat, the Service has applied an analytical framework for C. melanocarpa jeopardy analyses that relies on the importance of core area populations to the survival and recovery of C. melanocarpa. The section 7(a)(2) analysis is focused not only on these populations but also on the habitat conditions necessary to support them.

The jeopardy analysis usually expresses the survival and recovery needs of C. melanocarpa in a qualitative fashion without making distinctions between what is necessary for survival and what is necessary for recovery. Generally, if a proposed Federal action is incompatible with the viability of the affected core area population(s), inclusive of associated habitat conditions, a jeopardy finding is warranted because of the relationship of each core area population to the survival and recovery of the species as a whole.

The analytical framework described in the Director's December 9, 2004, memorandum is used to complete section 7(a)(2) analyses for Federal actions affecting C. melanocarpa critical habitat. The key factor related to the adverse modification determination is whether, with implementation of the proposed Federal action, the affected critical habitat would remain functional (or retain the current ability for the PCEs to be functionally established) to serve the intended conservation role for the species. Generally, the conservation role of C. melanocarpa critical habitat units is to support viable core area populations.

Section 4(b)(8) of the Act requires us to briefly evaluate and describe in any proposed or final regulation that designates critical habitat those activities involving a Federal action that may destroy or adversely modify such habitat, or that may be affected by such designation. Activities that may destroy or adversely modify critical habitat may also jeopardize the continued existence of the species.

Activities that may destroy or adversely modify critical habitat are those that alter the PCEs to an extent that the conservation value of critical habitat for C. melanocarpa is appreciably reduced. Activities that, when carried out, funded, or authorized by a Federal agency, may affect critical habitat and therefore result in consultation for C. melanocarpa include, but are not limited to:

(1) Actions that would reduce or degrade dry thicket scrub areas dominated by patches of trees and shrubs in the Halfpenny Bay area. Such activities could include vegetation clearing, intensive and extensive cattle grazing activities, and fire. Dry forest species in the Caribbean are not fire-resistant species.

(2) Earth movement activities using heavy machinery within critical habitat that may result in changes in quantity and quality of soils within designated critical habitat.

We consider the proposed critical habitat to contain features essential to the conservation of C. melanocarpa and to be in the geographic range of the species. The Halfpenny Bay area was occupied by the species at the time of listing (64 FR 13116, March 17, 1999; Proctor 1991, pp. 43-44; Breckon and Kolterman 1993, p. 1). Federal agencies already consult with us on activities in areas currently occupied by C. melanocarpa, or if the species may be affected by the action, to ensure that their actions do not jeopardize the continued existence of C. melanocarpa.

Section 3(5)(A) of the Act defines critical habitat as the specific areas within the geographic area occupied by the species at the time of listing on which are found those physical and biological features (i) Essential to the conservation of the species and (ii) that may require special management considerations or protection. Therefore, areas within the geographical area occupied by the species at the time of listing that do not contain the features essential for the conservation of the species are not, by definition, critical habitat. Similarly, areas within the geographic area occupied by the species at the time of listing that do not require special management or protection also are not, by definition, critical habitat.

There are multiple ways to provide management for species habitat. Statutory and regulatory frameworks that exist at a local level can provide such protection and management, as can lack of pressure for change, such as areas too remote for anthropogenic disturbance. Finally, State, local, or private management plans as well as management under Federal agencies jurisdictions can provide protection and management to avoid the need for designation of critical habitat. When we consider a plan to determine its adequacy in protecting habitat, we consider whether the plan, as a whole will provide the same level of protection that designation of critical habitat would provide. The plan need not lead to exactly the same result as a designation in every individual application, as long as the protection it provides is equivalent, overall. In making this determination, we examine whether the plan provides management, protection, or enhancement of the PCEs that is at least equivalent to that provided by a critical habitat designation, and whether there is a reasonable expectation that the management, protection, or enhancement actions will continue into the foreseeable future. Each review is particular to the species and the plan, and some plans may be adequate for some species and inadequate for others.

We consider a current plan to provide adequate management or protection if it meets three criteria: (1) The plan is complete and provides the same or better level of protection from adverse modification or destruction than that provided through a consultation under section 7 of the Act; (2) there is a reasonable expectation that the conservation management strategies and actions will be implemented based on past practices, written guidance, or regulations; and (3) the plan provides conservation strategies and measures consistent with currently accepted principles of conservation biology.

We have determined that the lands containing the features essential to the conservation of C. melanocarpa within the Gua nica and Susúa Commonwealth forests do not meet the definition of critical habitat under section 3(5)(A) of the Act as those features do not require special management or protections. As such, they are not being included in this proposal. Both forests are public lands owned by the Commonwealth of Puerto Rico and managed by the DNER.

The DNER developed a master plan for the Commonwealth forests of Puerto Rico in 1976. The master plan identified soil and land types, climate, wildlife, vegetation, land use, recreation opportunities, and future research needs for all Commonweath forests, including Gua nica and Susúa forests. The master plan also identified management recommendations to address identified issues for each forest unit.

In Gua nica, the master plan identified special management considerations in accordance with the uniqueness of the forest, proposed to manage the forest and associated vegetation types for non-consumptive use by the public, and reserved and managed the entire unit as a wildlife sanctuary (DNR 1976, pp. 56-58). Because of the forest condition, it was designated as a United Biosphere Reserve in 1981 by the United Nations Educational, Scientific and Cultural Organization (UNESCO).

For Susúa, the master plan also identified special management considerations, including locating representative areas of all plant communities and rare and endangered species and limiting public use on these areas; not issuing new permits for transmission lines; and delineating all unique areas and preserving them in their natural condition (DNR 1976, pp. 230-232).

Both forests are currently managed as wildlife sanctuaries, protecting wildlife and plants in perpetuity and allowing only non-consumptive use by the public in designated areas and trails. Active management includes developing and maintaining fire breaks, conducting prescribed burning adjacent to roads to reduce fuel load, removing exotic plant species along roads, and promoting scientific data collection, and conducting outreach and education activities within adjacent communities. Forest management also provides opportunities for scientific research and the use of existing trails for passive recreation and education. The Gua nica Forest also provides for beach use. These current management activities have not been identified as threats for C. melanocarpa.

The Gua nica and Susúa Commonwealth forests and adjacent lands are designated as Critical Wildlife Areas (CWA) by the Commonwealth of Puerto Rico (DNER 2005, pp. 211 and 221). The CWA designation constitutes a special recognition by the Commonwealth with the purpose of providing information to Commonwealth and Federal agencies about the conservation needs of these areas and assisting permitting agencies in precluding negative impacts as a result of permit approvals or endorsements (DNER 2005, pp. 2-3).

Since 1984, the Service and DNER have a signed cooperative agreement pursuant to section 6(c) of the Act, establishing a partnership agreement for the purpose of implementing an endangered and threatened fish, wildlife and plants species conservation program in the Commonwealth of Puerto Rico. Both parties agree that programs of the Commonwealth of Puerto Rico are designed to assist resident endangered and threatened species; it is their mutual desire to work in harmony for the common purpose of planning, developing and conducting programs to protect, manage and enhance the populations of all resident endangered and threatened fish, wildlife and plants within the Commonwealth of Puerto Rico.

The DNER approved laws and regulations to protect threatened and endangered species within lands under their jurisdiction. In 1999, the Commonwealth of Puerto Rico approved Law Number 241, Wildlife Law of the Commonwealth of Puerto Rico (Ley de Vida Silvestre del Estado Libre Asociado de Puerto Rico—Ley Núm. 241 del 15 Ago. 1999). The purpose of this law is to protect, conserve, and enhance native and migratory wildlife species; declare all wildlife species within its jurisdiction as the property of Puerto Rico; regulate permits; regulate hunting activities; and regulate exotic species. In 2004, the DNER approved Commonwealth of Puerto Rico's Regulation Number 6766, which regulates the management of threatened and endangered species in Puerto Rico (Reglamento para Regir el Manejo de las Especies Vulnerables y en Peligro de Extinción en el Estado Libre Asociado de Puerto Rico—Núm. 6766 del 11 de Feb 2004). C. melanocarpa has been included in the list of protected species. Article 2.06 of this regulation prohibits collecting, cutting, and removing (among other activities) listed plant individuals within the jurisdiction of PR.

Threats identified for C. melanocarpa on the Gua nica and Susúa Commonwealth forests are human-induced fires during dry season and cutting of vegetation for trail and powerline maintenance. The DNER has regulatory mechanisms to protect individuals of C. melanocarpa from these threats within the forest boundaries, and forest managers are aware of the occupied localities within the forests. We believe that management guidelines for both forests, current local laws and regulations and the close coordination and excellent working partnership with DNER will adequately address identified threats to C. melanocarpa , features essential to its conservation, and its habitat on DNER lands. Therefore, we do not believe that special management or protection is required for C. melanocarpa and its primary constituent elements.

Recent, more extensive surveys conducted in Gua nica Commonwealth Forest have expanded the known range of other federally listed species such, as bariaco ( Trichilia triacantha ) and palo de rosa ( Ottoschulzia rhodoxylon ), and other State-protected species all previously known for only a few individuals within the forest. These surveys were conducted in areas not previously accessed and are a result of a graduate student's thesis work that has not been published yet. As stated earlier in this rule, past collections exist for Gua nica Commonwealth Forest. We believe additional occurrences of C. melanocarpa will be found in both forests. For example, when Trejo-Torres went to Gua nica in 2001, specifically to search for and identify the species, he accomplished confirmation on an individual. When Service biologists returned to Gu´nica Commonwealth Forest with this species' expert in 2006 to specifically search for this plant, they found 12 additional individuals in the vicinity.

We believe that extensive surveys in the Susúa Commonwealth Forest would also result in additional sightings of the species. It has been the Service's experience that, if extensive surveys are conducted additional individuals or populations may be found. For example, the endemic plant Calliandra locoensis was discovered in the Susúa Forest in 1991 (García and Kolterman 1992, pp. 57-60), and only one population was known at the time (Breckon and Kolterman 1994, p. CL-1). Recent additional survey efforts have resulted in three additional localities and about 1,000 individuals (Gonza lez 1998, pp. 41-42; Breckon and Kolterman 2000). Protection of such areas as the Commonwealth forests conveys stability of forest development, since most forest land in Puerto Rico was destroyed for agriculture. Forest reserves like Gua nica, protected since 1919, provide the necessary structure to support the conservation of the species.

Thus on the basis that Susu a and the Gua nica Commonwealth Forests are being adequately managed as wildlife sanctuaries by DNER, where they are protecting wildlife and plants in perpetuity and allowing only non-consumptive use by the public in designated areas and trails, we have determined that features essential to the conservation of C. melanocarpa on lands within these forests do not require special management considerations or protection. As such, these lands do not meet the definition of critical habitat for C. melanocarpa as defined in section 3(5)(A) of the Act and are not included in the proposal.

Most federally listed species in the United States will not recover without the cooperation of non-Federal landowners. More than 60 percent of the United States is privately owned (National Wilderness Institute 1995) and at least 80 percent of endangered or threatened species occur either partially or solely on private lands (Crouse et al. 2002). Stein et al. (1995) found that only about 12 percent of listed species were found almost exclusively on Federal lands (90 to 100 percent of their known occurrences restricted to Federal lands) and that 50 percent of federally listed species are not known to occur on Federal lands at all.

Given the distribution of listed species with respect to land ownership, conservation of listed species in many parts of the United States is dependent upon working partnerships with a wide variety of entities and the voluntary cooperation of many non-Federal landowners (Wilcove and Chen 1998; Crouse et al. 2002; James 2002). Building partnerships and promoting voluntary cooperation of landowners is essential to understanding the status of species on non-Federal lands and is necessary to implement recovery actions such as reintroducing listed species, habitat restoration, and habitat protection.

Many non-Federal landowners derive satisfaction from contributing to endangered species recovery. The Service promotes these private-sector efforts through the Four Cs philosophy—conservation through communication, consultation, and cooperation. This philosophy is evident in Service programs such as Habitat Conservation Plans (HCPs), Safe Harbors, Candidate Conservation Agreements, Candidate Conservation Agreements with Assurances, and conservation challenge cost-share. Many private landowners, however, are wary of the possible consequences of encouraging endangered species to their property, and there is mounting evidence that some regulatory actions by the Federal government, while well-intentioned and required by law, can (under certain circumstances) have unintended negative consequences for the conservation of species on private lands (Wilcove et al. 1996; Bean 2002; Conner and Mathews 2002; James 2002; Koch 2002; Brook et al. 2003). Many landowners fear a decline in their property value due to real or perceived restrictions on land-use options where threatened or endangered species are found. Consequently, harboring endangered species is viewed by many landowners as a liability, resulting in anti-conservation incentives because maintaining habitats that harbor endangered species represents a risk to future economic opportunities (Main et al. 1999; Brook et al. 2003).

The purpose of designating critical habitat is to contribute to the conservation of threatened and endangered species and the ecosystems upon which they depend. The outcome of the designation, triggering regulatory requirements for actions funded, authorized, or carried out by Federal agencies under section 7 of the Act, can sometimes be counterproductive to its intended purpose. According to some researchers, the designation of critical habitat on private lands significantly reduces the likelihood that landowners will support and carry out conservation actions (Main et al. 1999; Bean 2002; Brook et al. 2003). The magnitude of this negative outcome is greatly amplified in situations where active management measures (such as reintroduction, fire management, control of invasive species) are necessary for species conservation (Bean 2002).

Cooperative conservation is the foundation of the Service's actions to protect species, and the Service has many tools by which it can encourage and implement partnerships for conservation. These tools include conservation grants, funding for Partners for Fish and Wildlife Program, the Coastal Program, and cooperative-conservation challenge cost-share grants. Our Private Stewardship Grant Program and Landowner Incentive Program provide assistance to private landowners in their voluntary efforts to protect threatened, imperiled, and endangered species, including the development and implementation of Habitat Conservation Plans.

Conservation agreements with non-Federal landowners (such as HCPs, contractual conservation agreements, easements, and stakeholder-negotiated State regulations) enhance species conservation by extending species protections beyond those available through section 7 consultations. In the past decade, we have encouraged non-Federal landowners to enter into conservation agreements, based on a view that we can achieve greater species conservation on non-Federal land through such partnerships than we can through other methods (61 FR 63854; December 2, 1996).

An analysis of the economic impacts of proposing critical habitat for C. melanocarpa is being prepared. We will announce the availability of the draft economic analysis as soon as it is completed, at which time we will seek public review and comment. At that time, copies of the draft economic analysis will be available for downloading from the Internet at ­ http://www.southeast.fws.gov or by contacting the Caribbean Fish and Wildlife Office directly (see ADDRESSES ).

In accordance with our joint policy published in the Federal Register on July 1, 1994 (59 FR 34270), and based on our implementation of the Office of Management and Budget's Final Information Quality Bulletin for Peer Review, dated December 16, 2004, we will seek the expert opinions of at least five appropriate and independent peer reviewers regarding the science in this proposed rule. The purpose of such review is to ensure that our critical habitat designation is based on scientifically sound data, assumptions, and analyses. We will send copies of this proposed rule to these peer reviewers immediately following publication in the Federal Register . We will invite these peer reviewers to comment during the public comment period on the specific assumptions and conclusions regarding the proposed designation of critical habitat.

We will consider all comments and information received during the comment period on this proposed rule during preparation of a final rulemaking. Accordingly, the final decision may differ from this proposal.

The Act provides for one or more public hearings on this proposal, if requested. Requests for public hearings must be made in writing within 45 days of publication of this proposal in the Federal Register . We intend to schedule a public hearing on this proposal, if any are requested, once the draft economic analysis is available so that we can receive public comment on the draft economic analysis and proposed rule simultaneously. However, we can schedule a public hearing prior to that time, if specifically requested. We will announce the date, time, and place of the hearing in the Federal Register and local newspapers at least 15 days prior to the first hearing.

Executive Order 12866 requires each agency to write regulations and notices that are easy to understand. We invite your comments on how to make this proposed rule easier to understand, including answers to questions such as the following: (1) Are the requirements in the proposed rule clearly stated? (2) Does the proposed rule contain technical jargon that interferes with the clarity? (3) Does the format of the proposed rule (grouping and order of the sections, use of headings, paragraphing, and so forth) aid or reduce its clarity? (4) Is the description of the notice in the SUPPLEMENTARY INFORMATION section of the preamble helpful in understanding the proposed rule? (5) What else could we do to make this proposed rule easier to understand?

Send a copy of any comments on how we could make this proposed rule easier to understand to: Office of Regulatory Affairs, Department of the Interior, Room 7229, 1849 C Street, NW., Washington, DC 20240. You may e-mail your comments to this address: Exsec@ios.doi.gov.

In accordance with Executive Order 12866, this document is a significant rule in that it may raise novel legal and policy issues, but it is not anticipated to have an annual effect on the economy of $100 million or more or affect the economy in a material way. Due to the timeline for publication in the Federal Register , the Office of Management and Budget (OMB) has not formally reviewed this rule. We are preparing a draft economic analysis of this proposed action, which will be available for public comment, to determine the economic consequences of designating the specific area as critical habitat. This economic analysis also will be used to determine compliance with Executive Order 12866, Regulatory Flexibility Act, Small Business Regulatory Enforcement Fairness Act, and Executive Order 12630.

Within these areas, the types of Federal actions or authorized activities that we have identified as potential concerns are listed above in the “Adverse Modification Standard” section. The availability of the draft economic analysis will be announced in the Federal Register and in local newspapers so that it is available for public review and comments. When it is completed, the draft economic analysis can be obtained from the internet Web site at http://www.southeast.fws.gov or by contacting the Caribbean Fish and Wildlife Office directly (see ADDRESSES ).

Further, Executive Order 12866 directs Federal Agencies promulgating regulations to evaluate regulatory alternatives (Office of Management and Budget, Circular A-4, September 17, 2003). Pursuant to Circular A-4, once it has been determined that the Federal regulatory action is appropriate, the agency will need to consider alternative regulatory approaches. Since the determination of critical habitat is a statutory requirement pursuant to the Act, we must then evaluate alternative regulatory approaches, where feasible, when promulgating a designation of critical habitat.

In developing our designations of critical habitat, we consider economic impacts, impacts to national security, and other relevant impacts pursuant to section 4(b)(2) of the Act. Based on the discretion allowable under this provision, we may exclude any particular area from the designation of critical habitat providing that the benefits of such exclusion outweigh the benefits of specifying the area as critical habitat and that such exclusion would not result in the extinction of the species. As such, we believe that the evaluation of the inclusion or exclusion of particular areas, or combination thereof, in a designation constitutes our regulatory alternative analysis.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. , as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities (small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the Regulatory Flexibility Act (RFA) to require Federal agencies to provide a statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities.

At this time, the Service lacks the available economic information necessary to provide an adequate factual basis for the required RFA finding. Therefore, the RFA finding is deferred until completion of the draft economic analysis prepared in accordance with section 4(b)(2) of the Act and Executive Order 12866. This draft economic analysis will provide the required factual basis for the RFA finding. Upon completion of the draft economic analysis, the Service will publish a notice of availability of the draft economic analysis of the proposed designation and reopen the public comment period for the proposed designation. The Service will include with the notice of availability, as appropriate, an initial regulatory flexibility analysis or a certification that the rule will not have a significant economic impact on a substantial number of small entities accompanied by the factual basis for that determination. The Service has concluded that deferring the RFA finding until completion of the draft economic analysis is necessary to meet the purposes and requirements of the RFA. Deferring the RFA finding in this manner will ensure that the Service makes a sufficiently informed determination based on adequate economic information and provides the necessary opportunity for public comment.

On May 18, 2001, the President issued an Executive Order (E.O. 13211) on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This proposed rule to designate critical habitat for C. melanocarpa is a significant regulatory action under Executive Order 12866 as it may raise novel legal and policy issues. However, it is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required. We will further evaluate this in our draft economic analysis and revise this assessment if appropriate.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501), the Service makes the following findings:

(a) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, Tribal governments, or the private sector and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or Tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; AFDC work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) A condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”

The designation of critical habitat does not impose a legally binding duty on non-Federal government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply, nor would critical habitat shift the costs of the large entitlement programs listed above on to State governments.

(b) We do not believe that this rule will significantly or uniquely affect small governments because the publicly owned units are owned by the Commonwealth of Puerto Rico, which does not fit the definition of “small governmental jurisdiction.” As such, a Small Government Agency Plan is not required. We will, however, further evaluate this issue as we conduct our economic analysis and revise this assessment if appropriate.

In accordance with Executive Order 13132, the rule does not have significant Federalism effects. A Federalism assessment is not required. In keeping with DOI and Department of Commerce policy, we requested information from, and coordinated development of, this proposed critical habitat designation with appropriate State resource agencies in Puerto Rico and the U.S. Virgin Islands. The designation of critical habitat in areas currently occupied by C. melanocarpa imposes no additional restrictions to those currently in place and, therefore, has little incremental impact on State and local governments and their activities. The designation may have some benefit to these governments in that the areas that contain the features essential to the conservation of the species are more clearly defined, and the primary constituent elements of the habitat necessary to the conservation of the species are specifically identified. While making this definition and identification does not alter where and what federally sponsored activities may occur, it may assist these local governments in long-range planning (rather than waiting for case-by-case section 7 consultations to occur).

In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. We propose designating critical habitat in accordance with the provisions of the Act. This proposed rule uses standard property descriptions and identifies the primary constituent elements within the designated area to assist the public in understanding the habitat needs of C. melanocarpa.

This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act. This rule will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

It is our position that, outside the Tenth Circuit, we do not need to prepare environmental analyses as defined by the NEPA in connection with designating critical habitat under the Endangered Species Act of 1973, as amended. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This assertion was upheld in the courts of the Ninth Circuit ( Douglas County v. Babbitt , 48 F.3d 1495 (9th Cir. Ore. 1995), cert. denied 116 S. Ct. 698 (1996)).

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and the Department of Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. We have determined that there are no Tribal lands occupied at the time of listing containing the features essential for the conservation of C. melanocarpa and no Tribal lands that are unoccupied areas that are essential for the conservation of C. melanocarpa. Therefore, critical habitat for C. melanocarpa has not been proposed for designation on Tribal lands.

A complete list of all references cited in this rulemaking is available upon request from the Field Supervisor, Caribbean Fish and Wildlife Office (see ADDRESSES ).

The primary authors of this package are the staff of Caribbean Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT section).

Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

Section 4(b)(3)(A) of the Act (16 U.S.C. 1531 et seq. ) requires that we make a finding on whether a petition to list, delist, or reclassify a species presents substantial information to indicate the petitioned action may be warranted. To the maximum extent practicable, we must make the finding within 90 days of receiving the petition, and must promptly publish the finding in the Federal Register . If we find substantial information exists to support the petitioned action, we are required to promptly commence a status review of the species (50 CFR 424.14). “Substantial information” is defined in 50 CFR 424.14(b) as “that amount of information that would lead a reasonable person to believe that the measure proposed in the petition may be warranted.” Petitioners need not prove that the petitioned action is warranted to support a “substantial” finding; instead, the key consideration in evaluating a petition for substantiality involves demonstration of the reliability and adequacy of the information supporting the action advocated by the petition.

The factors for listing, delisting, or reclassifying a species are described at 50 CFR 424.11. We may delist a species only if the best scientific and commercial data available substantiate that it is neither endangered nor threatened. Delisting may be warranted as a result of: (1) Extinction, (2) recovery, and/or (3) a determination that the original data used for classification of the species as endangered or threatened were in error.

On July 7, 2005, we initiated a 5-year review of the island night lizard as required under section 4(c)(2)(A) of the Act. Pursuant to the terms of a settlement agreement in California State Grange , et al. v. Norton , No: 2:05-cv-00560-MCE-PAN (E.D. California), we will be completing that review by September 30, 2006. A status review is required for both the 5-year review and the 12-month finding. These reviews may utilize similar information and analyses. At the conclusion of these reviews, we will issue the 12-month finding on the petition, as provided in section 4(b)(3)(B) of the Act, and make the requisite recommendation under section 4(c)(2)(B) of the Act based on the results of the 5-year review.

The island night lizard occurs on San Clemente, San Nicolas, and Santa Barbara Islands (Bezy et al. 1980) and one small islet (Sutil Island) immediately adjacent to Santa Barbara Island (Fellers and Drost 1991). We listed the island night lizard as threatened on August 11, 1977, along with six other species of animals and plants that occur on the Channel Islands off the coast of southern California (42 FR 40682). We determined that the habitat used by the island night lizard was being modified by the browsing effect of feral goats ( Capra hircus ) and the rooting of feral pigs ( Sus scrofa ) (June 1, 1976, 41 FR 22073; 42 FR 40682). We stated that the habitats on Santa Barbara and San Nicolas Islands were already reduced and any future reduction would seriously imperil the island night lizard populations (41 FR 22073; 42 FR 40682). Island night lizard depredation by feral housecats ( Felis cattus ) on San Clemente Island and by alligator lizards ( Elgaria multicarinata webbii ) on San Nicolas Island were also identified as possible threats to the continued existence of the island night lizard (41 FR 22073; 42 FR 40682). In 1984, we published the Recovery Plan for the Endangered and Threatened Species of the California Channel Islands (Recovery Plan), which included the island night lizard (USFWS 1984). Critical habitat has not been designated for the island night lizard.

In making these findings regarding the island night lizard delisting petitions, we rely on information provided by the petitioners and evaluate that information in accordance with 50 CFR 424.14(b). The content of these findings summarize information included in the petitions, as well as information available to us at the time we reviewed the petitions. Our review for the purposes of a 90-day finding under section 4(b)(3)(A) of the Act and § 424.14(b) of our regulations is limited to a determination of whether the information in the petitions meets the “substantial scientific information” threshold. We do not conduct additional research at this point, nor do we subject the petitions to rigorous critical review. Rather, as the Act and regulations contemplate, at the 90-day finding, the key consideration in evaluating the petitions involves demonstration of the reliability and adequacy of the information supporting the action advanced by the petitions.

In determining whether a petition presents substantial information that the petitioned action may be warranted, in accordance with regulation (§ 424.14(b)(2)), we consider whether the petition:

(1) Clearly indicates the petitioned action and gives the scientific and common name of the species involved;

(2) Contains detailed narrative justification for the petitioned action 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;

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

Additionally, section 4(a)(1) of the Act requires that we determine whether a species is endangered or threatened based on one or more of the five following factors:

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; or

E. Other natural or manmade factors affecting its continued existence.

In determining whether a petition presents substantial information regarding threats faced by the species, we evaluate whether the petition provides any information relevant to those factors.

The first petition we received requesting that we remove the island night lizard from the List of Endangered and Threatened Wildlife and Plants (List) was from the National Wilderness Institute and was dated February 3, 1997. The petition maintains that the island night lizard has no significant identifiable threats, appears to have had a stable population since being listed, and should be delisted on the basis of data error. The petition restates information from the listing rule (42 FR 40682) and the Recovery Plan and does not provide any new information or documentation that would support delisting. The petition also notes that we identified the island night lizard in budget justifications as early as 1993 as a potential candidate for delisting. We acknowledged receipt of the petition in a letter to the National Wilderness Institute dated June 29, 1998, and indicated that due to low priority assigned to delisting activities in our Fiscal Year 1997 Listing Priority Guidance, we were not then able to act on the petition.

The first petition does not provide any information on or describe the past and present numbers and distribution, or status, of the species over all or a significant portion of its range. However, the petition does present claims regarding the first factor (the present or threatened destruction, modification, or curtailment of its habitat or range). The petition asserts that the island night lizard is not threatened by habitat modification by feral animals. To support this assertion, the first petition refers to the Recovery Plan (USFWS 1984). It states that the Recovery Plan presumed that the habitat modification resulting from feral species herbivory was the primary contributor to the decline of indigenous species such as the island night lizard, and notes that the Recovery Plan did not provide any data demonstrating a decline.

To support its view that habitat on San Clemente Island was not altered by grazing animals, the petition cites from the Recovery Plan in reference to San Clemente Island habitat: “* * * with habitat structure as the predominant influence on present distribution, it is possible to deduce the change from past habitat modification on the island. The optimum habitat, maritime desert scrub, Lycium phase, is largely the result of soil and climate conditions along the west coast of the island and probably has not been altered to the detriment of the lizards by grazing mammals.” However, the petition does not acknowledge the continuing text of this section of the Recovery Plan, which, for example, notes that there is no information on the status of island night lizards prior to ranching activities and the introduction of feral animals on San Clemente Island. The Recovery Plan also suggests that important changes to habitat structure occurred in upland areas on the southern half of San Clemente Island where grazing and soil erosion have replaced shrub and herbaceous vegetation with grassland, cholla cactus, and bare ground. The Recovery Plan further notes that rocky areas exposed by the loss of original vegetation are a deteriorated habitat for the island night lizard, and chaparral shrub vegetation is not sufficiently dense to provide full shelter for the island night lizard. The Recovery Plan concludes that the most extensive deterioration of island night lizard habitat occurred with the vegetation changes on rocky upland areas of the southern half of San Clemente Island.

The information presented in the first petition asserting that feral species herbivory did not alter island night lizard habitat does not accurately portray the discussion in the Recovery Plan and is out of context. We therefore conclude that the petition does not provide substantial information regarding the first factor (the present or threatened destruction, modification, or curtailment of its habitat or range). The petition did not provide any information concerning the second factor (overutilization for commercial, sporting, recreational, scientific, or educational purposes), the third factor (disease or predation); the fourth factor (inadequacy of existing regulatory mechanisms), or the fifth factor (other natural or manmade factors affecting their continued existence). We, therefore, conclude that the first petition does not provide substantial information or appropriate supporting documentation supporting its claim that feral species herbivory on San Clemente Island did not contribute to the decline of the island night lizard, and that the island night lizard was listed in error. The first petition does not provide any information on island night lizard habitat on San Nicolas Island or on Santa Barbara Island, nor does it address any other factors considered in a 90-day petition finding.

We received a second petition dated March 22, 2004, from the U.S. Navy, requesting that we delist the island night lizard on San Clemente Island and San Nicolas Island, California, as distinct population segments pursuant to section 4(b)(3) of the Act. The second petition provides a comprehensive summary of the species' status and population abundance information that has been collected since the island night lizard was listed. The petition also provides information on threats to the species. The information on species status, population abundance, and threats provided in the petition is accompanied by supporting documentation in the form of bibliographic references, many of which are included as appendices.

The following assertions of the second petition, along with the associated documentation, constitute substantial information warranting further analysis in a 12-month finding: (1) The primary threat, habitat destruction by feral ungulates on San Clemente Island, has been removed; (2) increases in the numbers of island night lizards on San Clemente Island are likely attributable to the removal of the feral ungulates and minimization of the potential impacts of military training operations; (3) there are minimal impacts from military activities on island night lizard on San Nicolas Island; (4) the effect of feral cat predation on island night lizard is either reduced (San Clemente Island) or minimal (San Nicolas Island); (5) the establishment of a sympatric relationship between island night lizard and alligator lizard suggests that the latter does not threaten the continued existence of the island night lizard; (6) continued monitoring has demonstrated that island night lizard populations on San Clemente Island and San Nicolas Island are stable and viable; (7) the island night lizard monitoring data for both San Clemente and San Nicolas Islands do not demonstrate that non-native vegetation adversely impacts the island night lizard populations; (8) since 1977, the only substantial change in plant communities on San Clemente Island has been habitat recovery as a result of the eradication of feral grazing animals; (9) the military administrative nature of the islands, the sensitivity towards natural resources, and the conservation goals outlined in San Clemente Island Integrated Natural Resources Management Plan (US Navy 2002) provide assurances that new introductions of non-native animals are unlikely to occur; and (10) investigations suggest that fires do not have detrimental effects to the species unless they result in long term modification of vegetation.

The second petition has thus presented information regarding the first factor (the present or threatened destruction, modification, or curtailment of its habitat or range), third factor (disease or predation), and the fifth factor (other natural or manmade factors affecting their continued existence) under section 4(a)(1) of the Act that we evaluate in determining whether substantial information indicates the petitioned action may be warranted. Regarding the first factor, the first petition claims that habitat was not altered by feral species herbivory but does not provide substantial information or appropriate supporting documentation. In contrast, the second petition provides documentation in the form of bibliographic references that cite biological studies on the species and Department of the Navy management plans for San Clemente and San Nicolas islands, some of which are included as appendices to the petition.

The second petition does not suggest the delisting of the island night lizard population on Santa Barbara Island. The second petition states that even though rabbits ( Oryctolagus cuniculus ) were eradicated on the island in 1981, the National Park Service informed the U.S. Navy that the lizard habitat has not improved as expected, and recent survey data from Santa Barbara Island have not been adequately analyzed.

Under the Act, a species is defined as including any subspecies and any distinct population segment (DPS) of a vertebrate species [16 U.S.C. 1532(16)]. To implement the measures prescribed by the Act and its Congressional guidance, we and the National Marine Fisheries Service (National Oceanic and Atmospheric Administration—Fisheries), developed a joint policy that addresses the recognition of DPSs of vertebrate species for potential listing and delisting actions (February 7, 1996, 61 FR 4722). The DPS policy specifies that we are to use two elements to assess whether a population segment under consideration for listing may be recognized as a DPS: (1) The population segment's discreteness from the remainder of the species to which it belongs; and (2) the significance of the population segment to the species to which it belongs. If we determine that a population segment meets the discreteness and significance standards and therefore qualifies as a DPS, then the level of threat to that population segment is evaluated based on the five listing factors established by the Act to determine whether listing or delisting the DPS is warranted.

The island night lizard is currently listed as a threatened species throughout its range, and we have not conducted an analysis to determine if the DPS policy is applicable to this species. The second petition asserts that the San Nicolas, San Clemente, and Santa Barbara Islands all qualify as DPSs. The second petition asserts that the three island night lizard populations are discrete from each other because (1) they are separated physically as islands of the Pacific Ocean, between which the lizards are not able to travel, and (2) they are separated administratively by ownership. The U.S. Navy administers San Clemente and San Nicolas Islands, and the National Park Service administers Santa Barbara Island.

The second petition also states that the three populations on the islands meet the significance element of the DPS policy based on two points. First, because the island night lizard is found on only three of the six California Channel Islands, the loss of one population segment may be considered a gap in the range of the species. Secondly, the second petition asserts that phenotypic differences, such as variation in scalation, body size, and clutch size, occur between the different island night lizard populations.

The Service has not analyzed the island night lizard to determine whether the separate populations constitute DPSs under our policy. The second petition has raised this issue and it is relevant to the status review and subsequent determination on the petition. Our 12-month finding will consider whether any of the island night lizard populations constitute a DPS.

We have reviewed both of the delisting petitions and their supporting documents as well as other information in our files. The first petition presents no information on the past and present numbers and distribution, or status of the species over all or a significant portion of its range, and limited information relevant to threats to the species. The limited information it presents in support of its view that island night lizard habitat on San Clemente Island was not altered by grazing animals misrepresents discussions in the Recovery Plan and is out of context, and was not accompanied by any other supporting documentation. Accordingly, we find that the first petition does not present substantial information indicating that delisting the island night lizard may be warranted.

For the reasons discussed above, we find that the second petition does present substantial information indicating that delisting the San Clemente and San Nicolas Islands populations may be warranted. Questions remain as to whether the island night lizard populations would qualify as distinct population segments. We believe it is appropriate to consider the information provided in the second petition, any other new information about this species, and the threats it may face in a status review, including information presented as to whether the island night lizard populations qualify as distinct population segments. We will issue a 12-month finding in accordance with section 4(b)(3)(B) of the Act as to whether delisting is warranted.

We are requesting information on the island night lizard throughout its range for the 12-month finding. We also will use that information for the ongoing 5-year review (70 FR 39327, July 7, 2005). When we make a finding that substantial information exists to indicate that listing or delisting 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 island night lizard throughout its range. This includes information regarding historical and current distribution, biology, ecology, ongoing conservation measures for the species and its habitat, and threats to the species and its habitat.

Additionally, we request any information regarding application of our policy regarding the recognition of distinct vertebrate population segments under the Act (61 FR 4722) to this particular situation. As stated in the policy, a population segment of a vertebrate species may be considered discrete if it satisfies either one of the following two conditions: (1) It is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors (quantitative measures of genetic or morphological discontinuity may provide evidence of this separation); or (2) it is delimited by international governmental boundaries within which significant differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist. The Service also considers available scientific evidence of a discrete population segment's significance to the taxon to which it belongs. This consideration may include, but is not limited to, the following: (1) Persistence of the discrete population segment in an ecological setting unusual or unique for the taxon, (2) evidence that loss of the discrete population segment would result in a significant gap in the range of a taxon, (3) evidence that the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historic range, or (4) evidence that the discrete population segment differs markedly from other populations of the species in its genetic characteristics. We request any additional information, comments, and suggestions from the public, State and Federal agencies, Tribes, the scientific community, industry or environmental entities, or any other interested parties concerning the status of the island night lizard, and whether the island night lizard populations constitute distinct population segments.

If you wish to provide information or comments relevant to the 12-month finding or 5-year review, you may submit your information, comments, and materials to the Field Supervisor, Carlsbad Fish and Wildlife Office (see ADDRESSES ). Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Respondents may request that we withhold their identity, as allowable by law. If you wish to withhold your name or address, you must state this request prominently at the beginning of your comment. 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 in this finding is available, upon request, from the Carlsbad Fish and Wildlife Office (see ADDRESSES ).

The primary author of this document is Sandy Vissman (see ADDRESSES ).

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

The Regional Administrator has made a preliminary determination that the Fixed Gear Sector Contract and Operations Plan is consistent with the goals of the FMP and other applicable law and is in compliance with the regulations governing the development and operation of a sector as specified under 50 CFR 648.87. The final rule implementing Amendment 13 (69 FR 22906, April 27, 2004) specified a process for the formation of sectors within the NE multispecies fishery and the allocation of TAC for specific groundfish species (or days-at-sea (DAS)), implemented restrictions that apply to all sectors, and authorized the first sector of the FMP (GB Cod Hook Sector).

If FW 42/FW 3 are approved as proposed, the Fixed Gear Sector would be an approved sector, and the regulations that would apply to the Fixed Gear Sector specify that: (1) Aall vessels with a valid limited access NE multispecies DAS permit are eligible to participate in the Sector, provided they have documented landings of GB cod through valid dealer reports submitted to NMFS of GB cod during FY 1996 through 2001 (regardless of gear fished); (2) membership in the Sector is voluntary, and each member would be required to remain in the Sector for the entire fishing year and could not fish outside the NE multispecies DAS program during the fishing year, unless certain conditions are met; (3) vessels fishing in the Sector (participating vessels) would be confined to fishing in the GB Cod Hook Sector Area, which is that portion of the GB cod stock area north of 39°00′ N. lat. and east of 71°40′ W. long; and (4) participating vessels would be required to comply with all pertinent Federal fishing regulations, unless specifically exempted by a Letter of Authorization, and the provisions of an approved Operations Plan. This current regulations that apply to all sectors would also apply to the Fixed Gear Sector.

Although FW 42/FW 3 would establish the Fixed Gear Sector, in order for GB cod to be allocated to the Fixed Gear Sector and the Fixed Gear Sector authorized to fish, the Fixed Gear Sector must submit an Operations Plan and Sector Contract to the Regional Administrator annually for approval. The Operations Plan and Sector Contract must contain certain elements, including a contract signed by all Sector participants and a plan containing the management rules that the Sector participants agree to abide by in order to avoid exceeding the allocated TAC. An additional analysis of the impacts of the Sector's proposed operations may be required in order to comply with the National Environmental Policy Act. Further, the public must be provided an opportunity to comment on the proposed Operations Plan and Sector Contract. The regulations require that, upon completion of the public comment period, the Regional Administrator will make a determination regarding approval of the Sector Contract and Operations Plan. If approved by the Regional Administrator, participating vessels would be authorized to fish under the terms of the Operations Plan and Sector Contract.

In anticipation of approval of the Fixed Gear Sector in FW 42/FW 3, the Fixed Gear Sector submitted an initial version of the Operations Plan, Sector Contract, and EA to NMFS on February 1, 2006. On June 13, 2006, the Fixed Gear Sector submitted a revised version, after making modifications to the Operations Plan and EA, and submitted a final version on June 28, 2006.

The Sector Agreement would be overseen by a Board of Directors and a Sector Manager. The Sector Agreement specifies, in accordance with Amendment 13, that the Sector's GB cod TAC would be based upon the number of Sector members and their historic landings of GB cod. The GB cod TAC is a “hard” TAC, meaning that, once the TAC is reached, Sector vessels could not fish under a DAS, possess or land GB cod or other regulated species managed under the FMP (regulated species), or use gear capable of catching groundfish (unless fishing under charter/party or recreational regulations).

As of June 28, 2006, two prospective Fixed Gear Sector members had signed the 2006 Sector Contract. The GB cod TAC calculation is based upon the historic cod landings of the participating Fixed Gear Sector vessels, using all gear. The allocation percentage is calculated by dividing the sum of total landings of GB cod by Sector members for FY 1996 through 2001, by the sum of the total accumulated landings of GB cod harvested by all NE multispecies vessels for the same time period (2,240,110 lb (1,016.1 mt)/ 113,278,842 lb (51,382.4 mt)). The resulting number is 1.98 percent. Based upon these two prospective Sector members, the Sector TAC of GB cod would be 121 mt (1.98 percent of the fishery-wide GB cod target TAC of 6,132 mt). The fishery-wide GB cod target TAC of 6,132 mt is less than the GB cod target TAC specified for 2006 (7,458 mt) because the 7,458 mt includes Canadian catch. That is, the fishery-wide GB cod target TAC of 6,132 mt was calculated by subtracting the GB cod TAC specified for Canada under the U.S./Canada Resource Sharing Understanding for FY 2006 (1,326 mt), from the overall GB cod target TAC of 7,458 mt specified by the New England Fishery Management Council (Council) for FY 2006 (71 FR 25095, April 28, 2006). If prospective members of the Sector change their minds about participating in the Fixed Gear Sector after the publication of this notice and prior to a final decision by the Regional Administrator, it is possible that the total number of participants in the Sector and the TAC for the Sector may be reduced from the numbers above.

The Fixed Gear Sector Agreement contains procedures for the enforcement of the Sector rules, a schedule of penalties, and provides the authority to the Fixed Gear Sector Manager to issue stop fishing orders to members of the Fixed Gear Sector. Participating vessels would be required to land fish only in designated landing ports and would be required to provide the Sector Manager with a copy of the Vessel Trip Report (VTR) within 48 hrhours of offloading. Dealers purchasing fish from participating vessels would be required to provide the Fixed Gear Sector Manager with a copy of the dealer report on a weekly basis. On a monthly basis, the Fixed Gear Sector Manager would transmit to NMFS a copy of the VTRs and the aggregate catch information from these reports. After 90 percent of the Fixed Gear Sector's allocation has been harvested, the Fixed Gear Sector Manager would be required to provide NMFS with aggregate reports on a weekly basis. A total of 1/12 of the Fixed Gear Sector's GB cod TAC, minus a reserve, would be allocated to each month of the fishing year. GB cod quota that is not landed during a given month would be rolled over into the following month. Once the aggregate monthly quota of GB cod is reached, for the remainder of the month, participating vessels could not fish under a NE multispecies DAS, possess or land GB cod or other regulated species, or use gear capable of catching regulated NE multispecies. Once the annual TAC of GB cod is reached, Fixed Gear Sector members could not fish under a NE multispecies DAS, possess or land GB cod or other regulated species, or use gear capable of catching regulated NE multispecies for the rest of the fishing year. The harvest rules would not preclude vessels from fishing under the charter/party or recreational regulations, provided the vessel fishes under the applicable charter/party and recreational rules on separate trips. For each fishing trip, participating vessels would be required to fish under the NE multispecies DAS program to account for any incidental groundfish species that they may catch while fishing for GB cod. In addition, participating vessels would be required to call the Sector Manager prior to leaving port. There would be no trip limit for GB cod for participating vessels. All legal-sized cod caught would be retained and landed and counted against the Fixed Gear Sector's aggregate allocation. Participating vessels would not be allowed to fish with or have on board gear other than jigs, non-automated demersal longline, handgear, or sink gillnets, and participating Fixed Gear Sector vessels fishing with hook gear would be exempt from the GB Seasonal Closure Area during May.

The Operations Plan submitted by the Fixed Gear Sector proposes that Sector members be allowed to fish in a geographic area that extends farther south (south to 35° 00′ N. Lat.) and west (to the coast) than does the area specified in the FW 42 proposed rule, which states that the Fixed Gear Sector would fish only in the GB Cod Hook Sector Area, which is substantially smaller, and does not include the areas to the south or west of GB. In FW 42, the Council proposed that the Fixed Gear Sector be required to fish in the GB Cod Hook Sector Area, and included such a requirement in the proposed regulations, because the GB Cod Hook Sector, which has very similar goals is subject to this requirement (i.e., targeting GB cod). FW 42, which proposes to create the GB Cod Fixed Gear Sector, did not describe or define a geographic area associated with the Fixed Gear Sector. For both Amendment 13 and FW 42 (proposed), the justification for defining the geographic area in the regulations, in contrast to defining the area only in the Operations Plan, is that the area where a sector fishes is one of the fundamental attributes that defines a sector. Because the Fixed Gear Sector Operations Plan proposes a geographic area that is different from that proposed in FW 42, NMFS is particularly interested in receiving public comments on this subject.

The EA prepared for the Fixed Gear Sector operations concludes that the biological impacts of the Fixed Gear Sector will be positive because the hard TAC for GB cod will ensure that the Fixed Gear Sector members will not be contributing to overfishing of GB cod, and the use of fixed gear will preclude the use of other gear that may have greater negative bycatch and habitat impacts. Implementation of the Fixed Gear Sector would have a positive impact on essential fish habitat (EFH) and bycatch by allowing a maximum number of hook or gillnet vessels to remain active in the fishery, rather than converting to (or leasing DAS to) other gear types that have greater impacts on EFH. DAS will provide two means of restricting both the landings and effort of the Fixed Gear Sector. Monthly quota targets would spread out the catch throughout the fishing year and prevent the harvest of the cod TAC in an intensive manner. The prohibition on discarding would reduce regulatory discarding, and the elimination of the daily trip limit would allows vessel to operate more efficiently. The analysis of economic impacts of the Fixed Gear Sector concludes that Fixed Gear Sector members would enable member businesses to remain economically viable by realizing higher economic returns, if the Fixed Gear Sector were implemented. The EAEnvironmental Assessment (EA) asserts that fishing in accordance with the Sector Agreement rules enables more adaptable and efficient harvesting of GB cod with fixed gear than would be possible if the vessels were fishing in accordance with the common pool (non-Sector) rules. The social benefits of the Fixed Gear Sector would accrue to Fixed Gear Sector members, as well as the Chatham/Harwichport, MA, community, which is highly dependent upon groundfish revenues. The EA concludes that the self-governing nature of the Fixed Gear Sector and the development of rules by the Fixed Gear Sector enables stewardship of the cod resource by Fixed Gear Sector members. The cumulative impacts of the Fixed Gear Sector are expected to be positive due to a positive biological impact, neutral impact on habitat, and a positive social and economic impact. In contrast, the cumulative impact of the no action alternative is estimated to be neutral, with negative social and economic impacts on the fixed gear fishery.

Should the Regional Administrator approve the Sector Agreement as proposed, a Letter of Authorization would be issued to each member of the Fixed Gear Sector exempting them, conditional upon their compliance with the Sector Agreement, from the GB cod possession restrictions and the requirements of the GOM trip limit exemption program, as specified in § 648.86(b).

Regulations under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) require publication of this notification to provide interested parties the opportunity to comment on proposed TAC allocations and plans of operation of sectors.

At this time, NMFS has not made a final determination that the measures this proposed rule would implement are consistent with the national standards of the Magnuson-Stevens Act and other applicable laws. NMFS, in making the final determination, will take into account the data, views, and comments received during the comment period.

This proposed rule has been determined to be not significant for the purposes of Executive Order (E.O.) 12866.

This proposed rule does not contain policies with federalism or “takings” implications as those terms are defined in E.O. 13132 and E.O. 12630, respectively.

An Initial Regulatory Flexibility Analysis (IRFA) was prepared, which has been modified by NMFS for this action, as required by section 603 of the Regulatory Flexibility Act (RFA). Below is a summary of the IRFA, which describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained in the preamble to this proposed rule and in the Executive Summary and section 3.0 of the EA prepared for this action. The Proposed Alternative would approve the Operations Plan for the 2006 fishing year and allocate a GB cod TAC of 121 mt to the Fixed Gear Sector. Once the GB cod TAC is reached, participating vessel would not be allowed to fish under a DAS, possess or land GB cod, or other regulated species managed under the FMP, or use gear capable of catching groundfish (unless fishing under recreational or charter/party regulations). Vessels intending to fish in the Fixed Gear Sector this fishing year may not fish for NE multispecies under a groundfish DAS this fishing year until the Sector Operations Plan is approved, and Fixed Gear Sector vessels may use either hook gear or gillnet gear only. Under the proposed Operations Plan, members using hook gear would be exempt from the May GB Seasonal Closure.

The Small Business Administration (SBA) size standard for small commercial fishing entities is $4 million in gross sales, and the size standard for small party/charter operators is $6.5 million. Available data for fishing year 2004 gross sales show that the maximum gross sales for any single commercial fishing vessel was $1.8 million, and the maximum gross sales for any affected party/charter vessel was $1.0 million. While an entity may own multiple vessels, available data make it difficult to determine which vessels may be controlled by a single entity. For this reason, each vessel is treated as a single entity for purposes of size determination and impact assessment. This means that all commercial and party/charter fishing entities would fall under the SBA size standard for small entities and, therefore, there is no differential impact between large and small entities.

The fixed gear fishermen and the Chatham/Harwichport communities are dependaent upon GB cod and other groundfish. The Amendment 13 restrictions that reduced the GB cod trip limit had a disproportionate affect on the Chatham fixed gear fishermen. According to Amendment 13, Chatham's overall community dependence on multispecies as a percentage of total fisheries revenues from federally permitted vessels averaged about 71 percent. Allocation of cod TAC to a sector and the development of alternative fishing restrictions would mitigate the impacts of Amendment 13. Specifically, the proposed Operations Plan enables Fixed Gear Sector members to fish under a set of rules crafted by Sector members in order to adapt to current economic and fishing conditions. This rule would enable Fixed Gear Sector members to remain economically viable by maximizing revenues and minimizing expenses in the short term, and help to maintain associated shoreside job opportunities.

Because of the time elapsed between the beginning of the fishing year on May 1, 2006, and the anticipated effective date of FW 42, as well as the fact that Sector members are not allowed to fish during the fishing year prior to the approval of the Sector Operations Plan, many prospective members were forced to choose between fishing during the summer and foregoing participation in the Fixed Gear Sector for FY 2006, or to abstain from fishing in order to preserve eligibility to participate in the Fixed Gear Sector. Because June, July, and August are traditionally the most profitable months of the fishing year, many fishermen could not afford to not fish, despite the economic benefits the Sector has to offer. Many fishermen make 50 percent or more of their annual income in those 3 months alone. Therefore, the number of vessels participating in the Fixed Gear Sector in FY 2006 is significantly lower than anticipated.

Under the No Action alternative, all Sector members would remain in the common pool of vessels and fish under all the rules implemented by Amendment 13 and subsequent Framework Adjustments, and there would be no allocation of GB cod to the Fixed Gear Sector. Because cod usually represents a high proportion of total fishing income for gillnet and hookgear vessels, revenues for such vessel owners are very sensitive to changes in cod trip limits. Under the scenario of reduced DAS anticipated under FW 42 and a restrictive daily trip limit that would be in place under the no action alternative, it is likely that Fixed Gear Sector vessels would experience revenue losses. It is more likely under the No Action alternative that disruption to the Chatham/Harwichport communities would occur.

This proposed rule contains no collection-of-information requirement subject to the Paperwork Reduction Act (PRA).