On August 10, 2007, a final rule for Airspace Docket No. 06-ANM-12, FAA Docket No. FAA-2006-26364 was published in the Federal Register (72 FR 44955), establishing Class E airspace in Beaver, UT. The longitude referencing V-293 was incorrect in that the longitude stated “* * * long. 133°00′00″ W.” instead of “* * * long.113°30′00″ W.” This action corrects that error.

In the Federal Register of November 7, 2000 (65 FR 66665), we (FDA) issued a proposed rule to revise our postmarketing reporting requirements to implement section 506C of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 356c). Section 506C of the act requires manufacturers who are the sole manufacturers of certain drug products to notify us at least 6 months before discontinuing manufacture of the products. Section 506C(a) applies to sole manufacturers of products that meet the following three criteria:

(1) The products are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition;

(2) The products must have been approved under section 505(b) or (j) of the act (21 U.S.C. 355(b) or (j)); and

(3) The products are not originally derived from human tissue and replaced by a recombinant product.

Under section 506C of the act, we may reduce the 6-month notification period if good cause exists for the reduction, and we must provide information to the public about the product discontinuance.

This final rule amends the postmarketing provisions of FDA regulations in § 314.81 (21 CFR 314.81) to require applicants who are sole manufacturers of certain drug products to notify us at least 6 months before discontinuing manufacture of the products. The 6-month notification period required by these regulations will give certain individuals who are currently taking affected medications that will be discontinued an opportunity to evaluate alternative therapeutic options, and will provide additional time for FDA to evaluate replacement products when available. Under § 314.91 (21 CFR 314.91), we may reduce the 6-month notification period when we find good cause exists for the reduction.

In this rulemaking, the agency finalizes all of the substantive provisions in the proposed rule. In addition, we have made some revisions, none of which changed the substantive requirements. One revision reflects a relatively minor change in administrative process. In that instance, for administrative efficiency, we have revised proposed §§ 314.81(b)(3)(iii)( b ) and 314.91(c)(3) to make the notification procedures for manufacturers planning to submit a notice of discontinuance (or a request for reduction in the discontinuance notification period) the same for drugs regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). As revised, manufacturers are to send notifications of discontinuance or requests for reduction in notification periods for all drugs subject to this rule, whether regulated by CDER or CBER, to the following designated offices:

(1) The Drug Shortage Coordinator at the address of Director of CDER;

(2) The Drug Registration and Listing Team, Division of Compliance Risk Management in CDER; and

(3) The director in the review division in CDER or CBER that is responsible for reviewing the application.

The final rule eliminates the proposed requirement to notify the Director of CBER.

We have also revised the proposed rule to change the manner in which the agency publicly discloses a list of all drug products to be discontinued under § 314.81(b)(3)(iii)( a ), as described in paragraph (b)(3)(iii)( c ) of § 314.81. In the preamble to the proposed rule, we stated that we would provide discontinuance information both on the Internet and in notices in the Federal Register . Since the proposed rule was published in November 2000, access to the Internet has dramatically increased. As a result, we believe that posting on the Internet is an effective means to distribute the discontinuance information to appropriate physician and patient organizations, as required by section 506C(c) of the act, and to the public. Therefore, we no longer plan to publish the discontinuance information in the Federal Register . This information will be distributed through posting on the Internet ( www.fda.gov/cder/drug/shortages/default.htm ).

As described in section I of this document, we are amending our postmarketing reporting requirements in § 314.81 to implement new statutory requirements under section 506C of the act. Section 314.81(b)(3)(iii) requires an applicant who is the sole manufacturer of an approved drug product to notify us in writing at least 6 months before discontinuing manufacture of the drug product if the drug product meets the following criteria:

(1) The product is life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition; and

(2) The product was not originally derived from human tissue and replaced by a recombinant product.

A life supporting or life sustaining drug is a drug product that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life. The phrase “debilitating disease or condition,” as stated in section 506C(a) of the act, means serious disease or condition.

Under section 506C(b) of the act, we may reduce the 6-month notification period if the manufacturer certifies that good cause exists for the reduction. We are adding § 314.91 to implement section 506C(b) of the act. Section 314.91 allows for a reduction in the 6-month discontinuance notification period, as required under § 314.81(b)(3)(iii)( a ), when we find good cause exists for the reduction. We may find good cause exists based on information certified by an applicant in a written request for a reduction of the discontinuance notification period. In limited circumstances, we may find good cause exists based on information already known to us (e.g., withdrawal of the drug from the market based upon formal regulatory action or resulting from consultations between the applicant and us).

To assist a manufacturer that is requesting a reduction in the notification period, § 314.91(c)(1) provides a template for certification that good cause exists. The following circumstances can establish good cause for a reduction in the discontinuance notification period:

• A public health problem may result from continuation of manufacturing for the 6-month period;

• A biomaterials shortage prevents the continuation of the manufacturing for the 6-month period;

• A liability problem may exist for the manufacturer if the manufacturing is continued for the 6-month period;

• Continuation of manufacturing for the 6-month period may cause substantial economic hardship for the manufacturer;

• The manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States Code (11 U.S.C. 701 et seq. and 1101 et seq. ); or

• The manufacturer can stop making the product but still distribute it to satisfy existing market need for 6 months.

• Other good cause exists for the reduction.

Section 506C(c) of the act states that, to the maximum extent practicable, we are to distribute information to appropriate physician and patient organizations about the discontinuation of products described in section 506C(a). To implement section 506C(c) of the act, we will, in accordance with § 314.81(b)(3)(iii)( c ), publicly disclose a list of all drug products to be discontinued under paragraph (b)(3)(iii)( a ) of § 314.81. If the notification period is reduced under § 314.91, we will state the reason(s) for the reduction and the anticipated date that manufacturing will cease. As described in the preamble to the proposed rule (65 FR 66665 at 66667), the listing of discontinued products will include the following information:

• The brand and generic name, the manufacturer, and indication(s) of the drug product;

• Whether a reduction in the notification period was granted by the agency under § 314.91;

• The reason(s) for a notification period of less than 6 months, if applicable; and

• Any additional information the agency may have regarding anticipated product availability.

We will post the discontinuance information on the Internet at www.fda.gov/cder/drug/shortages/default.htm .

We received written comments from three pharmaceutical companies and a patient advocacy organization. The comments generally sought clarification of terms and procedures described in the proposed rule. Comments from the patient advocacy organization included suggestions for ensuring that patients affected by the withdrawal of a drug product covered by this rule had sufficient opportunity to prepare for alternative treatment options as needed. A summary of the comments received and our responses follow.

(Comment 1) One comment urged companies to voluntarily give notice to the agency 1 year before discontinuing manufacture of a product, even though the act requires notification only 6 months before discontinuance.

Although we are retaining the 6-month notification period in the final rule, we agree that it would be beneficial if companies could, when possible, provide more than the 6-month notice required by statute. Section 506C of the act and § 314.81(b)(3)(iii) are clear that this is the minimum notification period, given that they require “ at least 6-months” notification (emphasis added). Earlier notification is permitted, and FDA encourages companies to provide us with as much advance notification as possible.

(Comment 2) One comment asked FDA to urge companies that intend to discontinue the manufacture of products to license the products to other pharmaceutical firms.

We agree that it could be in the interest of public health for manufacturers of products covered by this final rule to find alternative means of making these products available to patients, including the possibility of transferring the new drug application (NDA) or abbreviated new drug application (ANDA) for these products to other manufacturers. However, the act does not require an applicant covered by this rule to transfer an NDA or ANDA, or use any other means to ensure product availability. The act merely requires applicants to meet the notice requirements implemented by this rule. Therefore, while we agree that it would be preferable for manufacturers to find alternative ways to make these products available to patients, this regulation will not require such measures.

Proposed § 314.81(b)(3)(iii)( a ) states that an applicant who is the sole manufacturer of an approved drug product must notify FDA in writing at least 6 months before discontinuing manufacture of the drug product if that drug product meets the following criteria: (1) The drug product is life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition; and (2) the drug product was not originally derived from human tissue and replaced by a recombinant product.

(Comment 3) One comment expressed concern that while the “Orange Book” (FDA's publication on “Approved Drug Products with Therapeutic Equivalence Evaluations”) lists all drug products with approved NDAs and ANDAs, it is not possible to determine whether the listed approved products are, in fact, being manufactured. The comment therefore requested that we define sole manufacturer as “an applicant listed in the Orange Book who is the holder of the only listed approved application under section 505(b) or (j) of the act.”

We decline to adopt this definition of “sole manufacturer” for three reasons. First, agency experience indicates that sole manufacturers generally know that they are a sole manufacturer. Second, while the Orange Book is routinely updated, there may be, on occasion, delays in updating it because, for example, the agency may not always be notified about discontinuance of drug products in a timely fashion. Thus, the Orange Book would not be an appropriate singular source to determine which applicants are sole manufacturers. The comment's suggestion could also create potential confusion because some drugs are approved but not marketed, and are therefore placed in the “discontinued” section of the Orange Book. Finally, we note that there are other generally reliable sources for obtaining commercial manufacturing information that can adequately provide information on sole manufacturers, rendering the comment's suggestion unduly restrictive.

(Comment 4) One comment requested that we clarify the phrase “discontinuing manufacture.” The comment indicated that discontinuance and the 6-month notification period should apply when a manufacturer is ceasing production of a product with the intent of withdrawing the product from the market, not when there is a temporary cessation of manufacturing resulting, for example, from technical production difficulties.

We agree with the comment that the phrase “discontinuing manufacture” does not refer to temporary cessations of manufacturing. We intend to apply the provisions of final § 314.81(b)(3)(iii) to those instances where a manufacturer has made a decision to no longer market a drug product that is life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition. The provisions of § 314.81(b)(3)(iii) would not apply to situations described in the comment, such as temporary or intermittent manufacturing cessations due to planned or unplanned circumstances. Manufacturers who schedule a planned temporary manufacturing cessation but do not intend to permanently discontinue product manufacture are not subject to the provisions of this regulation. Normally, the supply of drug product available to patients under these circumstances would not be affected during the period of the planned manufacturing cessation. Similarly, manufacturers who experience an unplanned temporary manufacturing interruption but intend to continue manufacturing over the long term are not subject to this rule. We request that manufacturers who experience such an unplanned temporary manufacturing cessation keep the agency informed about the status of the shutdown because the duration of an unplanned shutdown may be unpredictable and could affect the availability of needed therapy for patients.

(Comment 5) In the preamble to the proposed rule, we interpreted the phrase “life supporting or life sustaining” drug as one that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life (65 FR 66665 at 66666). One comment suggested that we incorporate this interpretation into § 314.81(b)(3)(iii).

We decline to incorporate this interpretative language into the codified language in § 314.81(b)(3)(iii). The codified language parallels the statutory provision of section 506C(a) of the act. As the comment notes, the preamble to the proposed rule defined the term “life supporting or life sustaining drug” as a “drug product that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life” and explained the definition's origins. Rather than incorporating that language into the codified language, we intend to rely on the interpretation described in the preamble to the proposed rule for guidance in applying that language.

(Comment 6) One comment contended that the scope of the language “intended for use in the prevention of a serious disease or condition” in proposed § 314.81(b)(3)(iii)( a )( 1 ) is too broad and ambiguous. The comment expressed concern that the phrase “intended for use in prevention” could sweep into the rule's ambit drugs approved to treat less serious conditions where the less serious conditions are themselves a contributing factor or risk factor in the development of a serious disease or condition. The comment suggested that the phrase should be amended to apply only to products that are “specifically indicated in approved labeling for prevention or prophylaxis of a disease or condition that is, or has the potential in its fullest manifestation to be, chronically debilitating.”

We disagree with the comment's assertion that the phrase “intended for use in the prevention of a serious disease or condition” is ambiguous or overly broad. In general, we do not expect that drug products used to treat relatively minor diseases or conditions will fall within the scope of this rule solely because there is a prophylactic connection to a more serious disease or illness—however tenuous. For instance, antihistamines that treat allergic rhinitis would not generally fall under this rule, even though allergic rhinitis may be a trigger for asthma, a more serious disease or condition. In contrast, products that are intended for use in treating or preventing asthma would potentially fall under the scope of this rule. Accordingly, we have not adopted the comment's suggestion.

(Comment 7) One comment stated that a decision to discontinue manufacturing a product could occur “long after” the manufacturer produces the last lot. The comment requested that we clarify when the applicant should notify us in this situation. The comment does not provide any specific instances where a decision to discontinue manufacturing a product has occurred long after an applicant produced the last lot.

As we stated in response to comment 4, we intend to apply the provisions of § 314.81(b)(3)(iii) to those instances where a manufacturer has made a decision to no longer market a drug product that is life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition. If the decision to discontinue manufacturing is not a temporary or intermittent manufacturing cessation, we would expect manufacturers covered by this rule to notify the agency as soon as the decision has been made. We would expect that manufacturers would ordinarily have notified the agency before they had produced the last lot and that they will file a request for a reduction of the 6-month notification period if good cause exists for the reduction.

Under the scenario posed by the comment, the rule would require notification as soon as a decision not to resume manufacturing the drug has been made (i.e., to convert a temporary shutdown to a permanent one). In addition, the agency would expect manufacturers in such circumstances to be able to demonstrate that the shutdown was originally believed to be only temporary and to explain the change in circumstances.

(Comment 8) One comment requested that we clarify whether the 6-month notification period for discontinuing the manufacture of a product covered by this regulation (under § 314.81(b)(3)(iii)( a )) would run consecutively with the 6 months of continued marketing under new § 314.91(d)(6). Under § 314.91(d)(6), an applicant can establish good cause for a reduction in the notification period by certifying that it can stop manufacturing, but continue to distribute the drug product to satisfy existing market need for 6 months. The comment asked whether, in this “special instance,” the manufacturer would be “allowed 1 year of marketing after making the decision to withdraw the product.”

We believe the comment has misconstrued the nature of the statutory and regulatory scheme. These provisions do not operate to limit the period of continued marketing of the product. They simply require notification to FDA at least 6 months before cessation of manufacturing. Manufacturers may elect to give FDA notice of discontinuance more than 6 months before manufacturing ceases. Moreover, the length of time that a product remains on the market may vary with the amount of product in the supply chain at the time manufacturing is discontinued. The statute and § 314.91(d)(6) provide that demonstration of a manufacturer's ability to continue distribution of a drug product to satisfy existing market need for 6 months can be good cause for a reduction in the 6-month notification period. Section 314.91(d)(6) may shorten the minimum notification period, but only in situations where the applicant can continue distribution of the drug product to satisfy existing market need for at least 6 months. In this circumstance, the product would likely continue to be marketed for less than 12 months, i.e., the 6 months of continued marketing plus some reduced portion of the 6-month discontinuance notification period.

(Comment 9) One comment urged FDA to put the onus on manufacturers to prove that reduction of the 6-month notification period will not cause substantial physical and emotional harm to the patients who rely on the drug. The same comment stated the agency should create the highest hurdles for reducing the discontinuance notification period if the health and welfare of patients are at stake.

As reflected in the good cause provisions in § 314.91(d)(7), the statute provides several specific circumstances that may be considered good cause for reduction of the notification period, such as a public health problem that may result from continuation of manufacturing for the 6-month period; a biomaterials shortage; a liability problem; economic hardship; bankruptcy; or a manufacturer being able to continue distribution for 6 months. We agree that there should be a public health focus to establish good cause when requesting a reduction in the discontinuance notification period. Accordingly, we intend to apply the provisions in § 314.91(d)(7), a broad provision permitting reduction in the notification period for “other good cause,” consistent with the public health concerns expressed in the comment. Manufacturers seeking to establish good cause for reasons other than those specifically enumerated under § 314.91(d)(1) through (d)(6) will be expected to demonstrate that reducing the discontinuance notification period will not result in increased risk of harm to the health of patients who use the drug.

(Comment 10) One comment asked about the relationship between notification of discontinuance of manufacturing under this rule and removing a withdrawn product from the list of drugs submitted for purposes of drug registration and listing. Under current § 314.81(b)(3)(iii) (redesignated as § 314.81(b)(3)(iv) by this rulemaking), an applicant must submit Form FDA 2657 (Drug Product Listing) to the Drug Registration and Listing Team, Division of Compliance Risk Management and Surveillance (formerly the Drug Listing Branch 1 ), in CDER within 15 working days of the withdrawal from sale of a drug product. 2 The submission of this form notifies us that the drug product is no longer being marketed. The comment requested that we clarify whether sending the notice of discontinuation of manufacturing to the Drug Listing Branch will result in the delisting of the product, or whether additional correspondence with the Drug Listing Branch will be required.

The delisting process is separate from the notification of discontinuance process described in this rule. The notification of discontinuance is submitted under this rule at least 6 months before cessation of manufacturing. The notice of discontinuance does not take the place of a listing update submitted on a Form FDA 2657. In most cases where manufacturing is discontinued, the drug will continue to be marketed for at least 6 months or more and should remain listed during that time. The Form 2657 would need to be submitted later, within 15 days of withdrawal from the market of the drug, under current § 314.81(b)(3)(iii) (redesignated as § 314.81(b)(3)(iv) in this rule). In addition, while all drugs are subject to the listing requirements, the discontinuance provision applies only to those instances where the manufacturing of a single-source drug product that is life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition, will be discontinued.

(Comment 11) One comment asked why, under §§ 314.81(b)(3)(iii)( b ) and 314.91(c)(3) of the proposed rule, manufacturers of drugs regulated by CBER are not required to send the notification of discontinuance to the Drug Listing Branch, as are manufacturers of drugs regulated by CDER.

We agree that the requirement should be the same for drugs regulated by CBER and CDER. For administrative efficiency, we have revised §§ 314.81(b)(3)(iii)( b ) and 314.91(c)(3) to make the procedures for manufacturers to submit a notice of discontinuance (or a request for reduction in the discontinuance notification period) the same for drugs, whether they are regulated by CDER or CBER. As revised, for all drugs subject to this rule, manufacturers must send notifications of discontinuance or requests for reduction in notification periods, to the following designated CDER and CBER offices: (1) The CDER Drug Shortage Coordinator, at the address of the Director of CDER; (2) the CDER Drug Registration and Listing Team, Division of Compliance Risk Management and Surveillance; and (3) either the director of the review division in CDER that is responsible for reviewing the application or the director of the office in CBER that is responsible for reviewing the application. This final rule eliminates the proposed requirement to notify the Director of CBER for drug products regulated by CBER.

We encourage manufacturers who have questions about these processes to contact the Drug Shortage Coordinator at CDER.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule will result in minimal additional costs in about one instance per year to one manufacturer, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current (2006) Implicit Price Deflator for the Gross Domestic Product. We do not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

The final rule requires that manufacturers of certain drug products notify the agency at least 6 months before discontinuing their manufacture. As explained in section V of this document, the regulatory conditions that trigger this requirement occur only infrequently. Based on agency experience, we estimate that such circumstances occur no more than once per year. Moreover, the notification requirement will impose a significant burden only when market conditions deteriorate so quickly that firms could not foresee the desired action 6 months in advance. Most pharmaceutical firms rely on established long-term marketing plans.

Under certain specified circumstances, the rule permits us to reduce the notification period for good cause. Manufacturers can request a reduced notification period by submitting a written certification, based on considerations such as public health, legal liability, biomaterial shortage, or substantial economic hardship. A certification of substantial economic hardship will need to be supported by evidence demonstrating that the reduced notification period is necessary to avoid substantial economic hardship to the manufacturer.

This final 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 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting 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. OMB and FDA received no comments concerning the information collection provisions of the proposed rule.

Title : Applications for FDA Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements

Description : The final rule implements section 506C of the act and requires applicants who are the sole manufacturers of certain drug or biologic products to notify us at least 6 months before discontinuing the manufacture of the product. For the rule to apply, a product needs to meet the following three criteria:

(1) The product must be life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition;

(2) The product must have been approved by FDA under section 505(b) or 505(j) of the act; and

(3) The product must not have been originally derived from human tissue and replaced by a recombinant product.

The rule allows us to reduce the 6-month notification period if we find good cause for the reduction. An applicant may request that we reduce the notification period by certifying that good cause for the reduction exists. Under the rule, we will also publicly disclose information about the drugs that are discontinued under the rule. Existing regulations, which appear in part 314, establish postmarketing reporting requirements for approved drugs. Current § 314.81(b)(3)(iii) (OMB control no. 0910-0001), which is redesignated as § 314.81(b)(3)(iv) in this rule, requires an applicant to notify us within 15 working days of withdrawing a drug product from sale. This rule adds two new reporting requirements.

Under this rule, at least 6 months before an applicant intends to discontinue manufacture of a product, the applicant must send us written notification of the discontinuance. For drugs regulated by CDER or CBER, manufacturers must send notifications of discontinuance to the following designated offices: (1) The CDER Drug Shortage Coordinator at the address of the Director of CDER; (2) the CDER Drug Registration and Listing Team, Division of Compliance Risk Management and Surveillance in CDER; and (3) the director of either the CDER division or the CBER office that is responsible for reviewing the application. We require that the notification be sent to these offices to ensure that our efforts regarding the discontinuation of the product are commenced in a timely manner. We will work with members of the industry and with the applicant during the 6-month notification period to ease patient transition from the drug that will be discontinued to alternate therapy.

We may reduce the 6-month notification period if we find good cause for the reduction. As described in section 506C(b) of the act and new § 314.91, an applicant can request a reduction in the notification period for good cause by submitting written certification to the following designated offices: (1) The CDER Drug Shortage Coordinator at the address of the Director of CDER; (2) the CDER Drug Registration and Listing Team, Division of Compliance Risk Management and Surveillance in CDER; and (3) the director of either the CDER division or the CBER office that is responsible for reviewing the application, that good cause exists as follows:

• A public health problem may result from continuation of manufacturing for the 6-month period (§ 314.91(d)(1));

• A biomaterials shortage prevents the continuation of manufacturing for the 6-month period (§ 314.91(d)(2));

• A liability problem may exist for the manufacturer if the manufacturing is continued for the 6-month period (§ 314.91(d)(3));

• Continuation of the manufacturing for the 6-month period may cause substantial economic hardship for the manufacturer (§ 314.91(d)(4));

• The manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States Code (§ 314.91(d)(5));

• The manufacturer can stop making the product but still distribute it to satisfy existing market need for 6 months (§ 314.91(d)(6)); or

• Other good cause exists for a reduction in the notification period (§ 314.91(d)(7)).

With each certification described previously, the applicant must describe in detail the basis for the applicant's conclusion that such circumstances exist. We require that the written certification that good cause exists be submitted to the offices identified previously to ensure that our efforts regarding the discontinuation take place in a timely manner.

Description of Respondents : An applicant who is the sole manufacturer and who intends to discontinue marketing of a drug product that meets the following criteria: (1) Is life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition; (2) was approved by FDA under section 505(b) or (j) of the act; and (3) was not originally derived from human tissue and replaced by recombinant product.

Burden Estimate : Table 1 of this document provides an estimate of the annual reporting burden for notification of product discontinuance and certification of good cause under this rule.

Notification of Discontinuance : Based on data collected from the CDER drug shortage coordinator, CDER review divisions, and CBER review offices during 2003 through 2006, one applicant during each year discontinued the manufacture of one product meeting the criteria of section 506C of the act. Each applicant meeting the criteria is required under final § 314.81(b)(3)(iii) to notify the agency of the discontinuance at least 6 months before manufacturing ceased. Although the procedures for notifying the agency that are set forth in the final rule were not in place during 2003 through 2006, we estimate that the number of manufacturers who would be required to notify us of discontinuance would remain the same. Therefore, the number of respondents is estimated to be one. The total annual responses are the total number of notifications of discontinuance that are expected to be submitted to CDER or CBER in a year. During 2003 through 2006, an applicant would have been required to notify us annually of one product discontinuance under the procedures. We estimate that the total annual responses will remain the same, averaging one response per respondent. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a notification of product discontinuance, including the time it takes to gather and copy the statement. Based on experience in working with applicants regarding similar collections of information, we estimate that approximately 2 hours on average are needed per response. Therefore, we estimate that 2 hours will be spent per year by respondents notifying us of a product discontinuance under these regulations.

Certification of Good Cause : Based on data collected from the CDER drug shortage coordinator, CDER review divisions, and CBER review offices during 2003 through 2006, one applicant discontinued during each year the manufacture of one product meeting the criteria of section 506C of the act. Each applicant has the opportunity under § 314.91 to request a reduction in the 6-month notification period by certifying to us that good cause exists for the reduction. We do not expect that each eligible applicant will certify that good cause exists for a reduction. Furthermore, the number of applicants who are in a position to request a reduction is quite small. Therefore, the number of respondents is estimated to be one. The total annual responses are the total number of notifications of discontinuance that are expected to be submitted to us in a year. We estimate that the total annual responses will remain small, averaging one response per respondent. The hours per response is the estimated number of hours that a respondent spends preparing the detailed information certifying that good cause exists for a reduction in the notification period, including the time it takes to gather and copy the documents. Based on experience in working with applicants regarding similar collections of information, we estimate that approximately 16 hours on average are needed per response. Therefore, we estimate that 16 hours will be spent per year by respondents certifying that good cause exists for a reduction in the 6-month notification period under § 314.91.

The information collection provisions of this final rule have been submitted to OMB for review.

Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions of this final rule. 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.

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

We have 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.

Live organisms are used in the production of certain vaccine products. These live organisms are generally used as source material for further manufacture into final products used in the prevention, treatment, or cure of a disease or condition of human beings. Live organisms pose a challenge to manufacturers in the prevention of cross contamination of other products and manufacturing areas. Some live organisms used in manufacturing may be harmful to humans, especially immunocompromised patients. To ensure the safety of a biological product manufactured in the same building or area in which live organisms are utilized, tight controls are needed to avoid the release of any live organisms into the manufacturing environment and to prevent cross contamination of other products manufactured in the same building or area.

Current FDA regulations strictly limit how live vaccine processing may be performed. Current § 600.11(e)(4) (21 CFR 600.11(e)(4)) requires that: (1) Space used for processing a live vaccine must be decontaminated before processing is started and must not be used for any other purpose during the vaccine processing; (2) live vaccine processing areas must be isolated from and independent of any space used for any other purpose by being either in a separate building, in a separate wing of a building, or in quarters at the blind end of a corridor; (3) the processing area must include adequate space and equipment for all processing steps up to, but not including, filling into final containers; and (4) test procedures that potentially involve the presence of microorganisms other than the vaccine strains, or the use of tissue culture cell lines other than primary cultures, must not be conducted in space used for processing live vaccine.

We are revising § 600.11(e)(4) to allow greater flexibility for vaccine manufacturers regarding the buildings and equipment used for live vaccine processing. The revisions provide for the use of modern manufacturing approaches to assist vaccine manufacturers who engage in live vaccine processing, e.g., manufacturers of influenza virus vaccines. The revisions provide that live vaccine processing steps may be performed in multiproduct manufacturing buildings and areas when appropriate controls exist to prevent cross contamination of other products and areas. We recognize that advances in facility, utility, system, and equipment design, as well as in sterilization, decontamination, and disinfection technologies have increased the ability of manufacturers to control the manufacture of biological products and the equipment used in their manufacture. The use of appropriate controls, procedures, and processes provides an adequate degree of confidence that a product meets the expected levels of safety, purity, and potency. Areas of special concern, such as containment, decontamination, sterilization, and disinfection can be addressed using currently available controls, procedures, and processes. The scope of this regulation is limited to all live vaccine processing steps up to, but not including, filling into final containers. In section II of this document, we identify each of the changes included in this direct final rule.

We are revising § 600.11(e)(4) to require that live vaccine processing be performed under appropriate controls to prevent cross contamination of other products and other manufacturing areas within the building. We regard an area as a specific room or set of rooms within a building associated with the manufacturing of any one product or multiple products.

Revised § 600.11(e)(4)(i) is analogous to the preexisting § 600.11(e)(4). In revised § 600.11(e)(4)(i)(A), we provide that a manufacturer can use an area that is either in a separate building, in a separate wing of a building, or in quarters at the blind end of a corridor and includes adequate space and equipment for all processing steps up to, but not including, filling into final containers. In revised § 600.11(e)(4)(i)(B), we require that a manufacturer not use the manufacturing space for conducting test procedures that potentially involve the presence of microorganisms other than the vaccine strains or the use of tissue culture cell lines other than primary cultures.

In revised § 600.11(e)(4)(ii), if manufacturing is conducted in a multiproduct manufacturing building or area, we require appropriate controls including procedural controls, and where necessary, process containment, to prevent cross contamination of other products and other manufacturing areas within the building. In addition, we are requiring that all product, equipment, and personnel movement between distinct live vaccine processing areas and between live vaccine processing areas and other manufacturing areas up to, but not including, filling in containers, must be conducted under conditions that will prevent cross contamination of other products and manufacturing areas within the building, including the introduction of live vaccine organisms into these other areas. Process containment is a system designed to mechanically isolate equipment or an area that involves manufacturing using live vaccine organisms. Procedural controls establish and perform effective decontamination, sterilization, and disinfection, as well as execute manufacturing procedures in such a manner as to prevent cross contamination with live vaccine organisms.

As part of their procedural controls, manufacturers must have written procedures and effective processes in place to adequately remove or decontaminate live vaccine organisms from manufacturing areas and from equipment for subsequent manufacture of other products. Written procedures must be in place for verification that processes to remove or decontaminate live vaccine organisms have been followed. All potential routes of cross contamination to other manufacturing areas should be addressed, including movement of persons (e.g., technical, maintenance, delivery, management personnel, and visitors), equipment, and in-process materials. Live vaccine organisms should not be removed from designated areas unless this can be done in a manner that prevents the cross contamination of other products and manufacturing areas. These procedural controls will provide a level of assurance that products made in areas where live vaccines are manufactured remain safe, pure, and potent.

FDA is issuing this regulation under the biological products provisions of the Public Health Service Act (PHS Act) (42 U.S.C. 262 and 264), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321, 331, 351-353, 355, 360, 371, and 374). Under these provisions of the PHS Act and the act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, effective, pure, and potent, and to prevent the introduction, transmission, and spread of communicable disease.

In the Federal Register of November 21, 1997 (62 FR 62466), FDA described its procedures on when and how the agency will employ direct final rulemaking. We have determined that this rule is appropriate for direct final rulemaking because we believe that it includes only noncontroversial amendments and we anticipate no significant adverse comments. Consistent with our procedures on direct final rulemaking, FDA is publishing elsewhere in this issue of the Federal Register a companion proposed rule to amend FDA's regulations to allow greater flexibility in live vaccine processing. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event that the direct final rule is withdrawn because of any significant adverse comments. The comment period for the direct final rule runs concurrently with the companion proposed rule. Any comments received in response to the companion proposed rule will be considered as comments regarding the direct final rule.

We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register . If we receive any significant adverse comments, we intend to withdraw this direct final rule before its effective date by publication of a notice in the Federal Register . A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of a significant adverse comment.

If any significant adverse comments are received during the comment period, FDA will publish, before the effective date of this direct final rule, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures.

If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a confirmation document, before the effective date of the direct final rule, confirming the effective date.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this direct final rule will provide increased flexibility for the processing of live vaccines, it would decrease overall compliance costs. Therefore, the agency certifies that this direct final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current (2006) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this direct final rule to result in any 1-year expenditure that would meet or exceed this amount.

The agency has determined under 21 CFR 25.31(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.

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

This direct final rule contains no new collections of information. The collection of information under § 600.11(e)(4) is covered by OMB control numbers 0910-0139 (expires September 30, 2008) and 0910-0308 (expires July 31, 2008). Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

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

Under the Indian Housing Block Grant (IHBG) program, HUD makes assistance available to eligible Indian tribes for affordable housing activities. The amount of assistance made available to each Indian tribe is determined using an allocation formula, developed with the active participation of Indian tribes and using negotiated rulemaking procedures. An Indian tribe (or its tribally designated housing entity (TDHE)) may use its IHBG funds for a wide range of affordable housing activities, including the provision of project-based or tenant-based rental assistance for eligible families. The regulations governing the IHBG program are located in part 1000 of HUD's regulations in title 24 of the Code of Federal Regulations.

In 1986, Congress amended the Internal Revenue Code to create the Low Income Housing Tax Credit (LIHTC) (see 26 U.S.C. 42), a tax incentive to promote the development of affordable rental housing. Eligible projects receive Federal income tax credits over a 10-year period using a formula that, in part, takes into account certain eligible costs called “eligible basis.” Generally, Federal grants used with respect to a building, or for its operation thereof, result in a dollar-for-dollar decrease in eligible basis. However, the Internal Revenue Service (IRS) has recognized that certain types of Federal rental assistance payments are not Federal grants that require a reduction in a building's eligible basis. They include payments made pursuant to Section 8 of the United States Housing Act of 1937 (42 U.S.C. 1437f) (Section 8) and comparable programs or methods of rental assistance designated by the Secretary of the Treasury by publication in the Federal Register or in the Internal Revenue Bulletin. (See the income tax regulations at 26 CFR 1.42-16(b).)

HUD rental assistance programs (such as the project-based voucher program) address the requirements that apply when such program rental assistance is provided to tenants residing in LIHTC projects. However, the IHBG program regulations are silent with regard to the use of IHBG rental assistance in these projects. HUD has received requests from several Indian tribes and TDHEs that are IHBG recipients and wish to use their IHBG funds for LIHTC projects.

On June 8, 2007 (72 FR 31944), in response to these tribal requests, HUD published a proposed rule for public comment to specify the conditions under which IHBG funds may be used for tenant-based or project-based rental assistance.

This final rule follows publication of the June 8, 2007, proposed rule and adopts the proposed rule without change. The public comment period on the proposed rule closed on August 7, 2007. HUD received a single public comment from a state housing finance agency, expressing unqualified support for the proposed regulatory changes.

The final rule adds a new § 1000.103 to clarify that IHBG funds may be used for project-based or tenant-based rental assistance. Further, the final rule clarifies that IHBG funds may be used for project-based or tenant-based rental assistance that is administered in a manner consistent with Section 8. Only the Secretary of the Treasury may make a determination that project-based or tenant-based rental assistance complies with the income tax regulations at 26 CFR 1.42-16(b) and, therefore, will not reduce the building's eligible basis. This final rule will allow for such determination to be made. This final rule does not limit the range of eligible activities that an Indian tribe or TDHE may undertake. It merely clarifies one permissible use of IHBG funds.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) 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. This rule would clarify that IHBG funds may be used for project-based or tenant-based rental assistance that is provided in a manner consistent with assistance provided under Section 8 of the United States Housing Act of 1937 on behalf of a tenant receiving assistance under NAHASDA. This rule would not impose new requirements on IHBG program participants. Accordingly, the undersigned certifies that this rule will not have a significant economic impact on a substantial number of small entities.

A Finding of No Significant Impact (FONSI) with respect to the environment was made at the proposed rule stage in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI remains applicable to this final rule and is available for public inspection between the hours of 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the rule docket file by calling the Regulations Division at (202) 708-3055 (this is not a toll-free number).

Executive Order 13132 (entitled “Federalism”) prohibits, to the extent practicable and permitted by law, an agency from promulgating a regulation that has federalism implications and either imposes substantial direct compliance costs on state and local governments and is not required by statute, or preempts state law, unless the relevant requirements of section 6 of the Executive Order are met. This rule does not have federalism implications and does not impose substantial direct compliance costs on state and local governments or preempt State law within the meaning of the Executive Order.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments, and on the private sector. This rule would not impose any federal mandate on any state, local, or tribal government, or on the private sector, within the meaning of UMRA.

The Catalog of Federal Domestic Assistance number applicable to the program affected by this rule is 14.862.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Indiana program effective July 29, 1982. You can find background information on the Indiana program, including the Secretary's findings, the disposition of comments, and the conditions of approval, in the July 26, 1982, Federal Register (47 FR 32071). You can also find later actions concerning the Indiana program and program amendments at 30 CFR 914.10, 914.15, 914.16, and 914.17.

By letter dated December 11, 2006 (Administrative Record No. IND-1741), Indiana sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq. ) in response to a required program amendment at 30 CFR 914.16(ff) and to include changes made at its own initiative. The provisions of 312 Indiana Administrative Code (IAC) 25 that Indiana proposed to revise were: 312 IAC 25-1-57, definition of “government-financed construction”; 25-4-87, underground mining reclamation plans for siltation structures, impoundments, dams, embankments, and refuse piles; 25-5-16, requirements for performance bond release; 25-6-20, surface mining permanent and temporary impoundments; 25-6-66, surface mining primary roads; and 25-7-1, inspections of sites.

We announced receipt of the proposed amendment in the February 6, 2007, Federal Register (72 FR 5374). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on March 8, 2007. We received comments from two Federal agencies.

During our review of the amendment, we identified concerns about requirements for performance bond release. We notified Indiana of these concerns by letter dated May 9, 2007, (Administrative Record No. IND-1748). We also met with Indiana staff on June 26, 2007, to discuss the concerns regarding the amendment and corresponded with the State via email on June 23, 2007 (Administrative Record No. IND-1752). Indiana responded by email on July 24, 2007 (Administrative Record No. IND-1752), that it would not submit revisions to this portion of the amendment at this time and that we should proceed with processing the other portions of the amendment. Therefore, we are proceeding with the final rule Federal Register document.

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment with exceptions as described below. Any revisions that we do not specifically discuss below concern nonsubstantive wording or editorial changes.

Indiana made minor wording, editorial, punctuation, grammatical, restructuring, and recodification changes to the following previously-approved rules:

1. For example, 312 IAC 25-4-87(a)(2)(A) was restructured from:

2. For example, 312 IAC 25-5-16(b) was recodified as 312 IAC 25-5-16(c).

3. For example, at 312 IAC 25-6-20(a)(3)(C), the phrase “in lieu of” was replaced by the phrase “instead of”.

Because these changes are minor, we find that they will not make Indiana's previously approved rules less effective than the corresponding Federal regulations.

Indiana's rules listed in the table below contain language that is the same as or similar to the corresponding Federal regulations.

Because the above State rules contain language that is the same as or similar to the corresponding Federal regulations, we find that they are no less effective than the Federal counterpart regulations.

1. At subsection (g)(3), Indiana proposed to remove the following sentence:

There is no Federal counterpart to Indiana's rule at subsection (g)(3). On November 29, 2004 (69 FR 69283), we approved the removal of a similar requirement at 312 IAC 25-4-49(g)(3) for surface mining reclamation plans. Therefore, we find the revision made to previously approved 312 IAC 25-4-87(g)(3) will not make the Indiana rules less effective than the Federal regulations or SMCRA.

1. Indiana proposed to revise its rule at subsection (a) concerning what a permittee must include in the newspaper advertisement that is part of the bond release application. Currently, Indiana's rule requires the permittee to state in the newspaper advertisement that, “any person with a valid legal interest that might be adversely affected by release of bond, or the responsible officer or head of any federal, Indiana, or local governmental agency that has jurisdiction by law or is authorized to develop and enforce environmental standards with respect to the operations, may file written comments or objections or may request a public hearing or informal conference.” Indiana proposed to revise this requirement by deleting the words “informal conference.”

The counterpart Federal regulation at 30 CFR 800.40(a)(2) specifies that the advertisement must contain the name and address of the regulatory authority to which written comments, objections, or requests for public hearings and informal conferences on the specific bond release may be submitted pursuant to 30 CFR 800.40(f) and (h). The Federal regulation at 30 CFR 800.40(f) provides that certain persons may file written objections and request a “public hearing” regarding the proposed bond release. The Federal regulation at 30 CFR 800.40(h) provides that “without prejudice to the right of an objector or the applicant, the regulatory authority may hold an informal conference * * * to resolve such written objections.”

We find that Indiana's proposed revision is no less effective than the Federal regulation at 30 CFR 800.40(a)(2) because this Federal regulation does not require the newspaper advertisement to contain information on who may request a public hearing or informal conference. Instead, it requires the advertisement to contain information on where requests for public hearings or informal conferences may be submitted. Therefore, we are approving Indiana's revision.

2. Indiana proposed to add a new rule at subsection (b) that allows the director of IDNR to initiate an application for the release of bond. If a bond release application is initiated by the director of IDNR, the department will have to perform the notification and certification requirements otherwise imposed on the permittee. While the counterpart Federal regulation at 30 CFR 800.40(a) allows a permittee to file an application for bond release, the Federal regulations are silent as to whether a regulatory authority may initiate bond release proceedings. However, a similar provision was approved for the Kentucky program on December 31, 1990 (55 FR 53490) and the Illinois program on April 7, 2000 (65 FR 18239). Also, on September 14, 2004, we approved a similar change for Indiana's statute at IC 14-34-6-7 (69 FR 55348). We approved the statutory change with the understanding that Indiana would revise its implementing rule at 312 IAC 25-5-16. Indiana's revision at 312 IAC 25-5-16(b) meets this requirement.

Under Indiana's proposal, bond release proceedings initiated by the director of IDNR must conform to the same procedural steps as a bond release initiated by the permittee. Thus, the public participation and notification requirements of section 519 of SMCRA and the Federal regulation at 30 CFR 800.40 would still apply when the director of IDNR initiates a bond release in Indiana. For the above reasons, we find that allowing the director of IDNR to initiate bond release does not make Indiana's performance bond release requirements at 312 IAC 25-5-16(b) less effective than the Federal regulation at 30 CFR 800.40(a). Therefore, we are approving the new provision.

3. Indiana proposed to redesignate existing subsections (c) through (f) as new subsections (d) through (g) and to revise new subsection (d). Indiana also proposed to delete existing subsections (g) and (i) and to add new subsection (h). In addition, Indiana proposed to revise existing subsection (h) and redesignate it as new subsection (i). Finally, Indiana proposed to add new subsection (j).

In a letter dated May 9, 2007 (Administrative Record No. IND-1748), we notified Indiana that we completed our review of the State's proposed amendment and identified some provisions that appeared to be less effective than the Federal regulations. We also met with Indiana staff on June 26, 2007, to discuss our concerns regarding the amendment.

We advised Indiana that 312 IAC 25-5-16, starting at new subsection (d), contains deficiencies that include inappropriate reference citations and the removal and/or absence of required program provisions, thus making the Indiana rules less effective than the Federal regulations. During our discussions and in an email dated July 24, 2007 (Administrative Record No. IND-1752), Indiana advised us that it would submit revisions to the amendment to address these concerns at a later date and that we should proceed with processing the amendment. Therefore, we cannot approve Indiana's proposed revisions at 312 IAC 25-5-16 new subsections (d) through (j).

1. At subsection (a)(3)(B) regarding criteria for stability of impoundments, Indiana proposed to remove the language “and located where failure would not be expected to cause loss of life or serious property damage.”

The counterpart Federal regulation at 30 CFR 816.49(a)(4)(ii) does not contain the deleted language. Therefore, we find that the removal of the language will not make Indiana's rule at 312 IAC 25-6-20(a)(3)(B) less effective than the counterpart Federal regulation.

2. At subsection (a)(9)(E)(ii) regarding inspection of impoundments, Indiana proposed to add the following type of impoundment to its list of those non-hazardous impoundments that are exempt from its quarterly examination requirements:

The impoundments listed in subsection (a)(9)(E) are among those that do not meet the size or other criteria of 30 CFR 77.216(a) or do not meet the Class B or C criteria for dams in the NRCS publication, Technical Release No. 60.

There is no Federal counterpart to the added provision. The Federal regulation at 30 CFR 816.49(a)(12) requires quarterly inspections of impoundments for appearance of structural weakness and other hazardous conditions. Because incised structures do not have dams, there is no probability of impoundment failure. Therefore, we find that 312 IAC 25-6-20(a)(9)(E)(ii) is no less effective than the counterpart Federal regulation at 30 CFR 816.49(a)(12), and we are approving it.

At subsection (h)(1)(D)(i) regarding the definition of “abandoned site,” Indiana proposed to remove the language “or permit revocation proceedings have been initiated and are being pursued diligently.”

On November 29, 2004, we required Indiana to revise its regulation at 312 IAC 25-7-1(h)(1)(D)(i) to allow a site to be classified as abandoned only in cases where a permit has expired or been revoked (69 FR 69287). We codified this requirement at 30 CFR 914.16(ff). Indiana's removal of the above quoted language meets this requirement. Therefore, we find that 312 IAC 25-7-1(h)(1)(D)(i) is no less effective than 30 CFR 840.11(g)(4)(i), and we approve it. We are also removing the required amendment at 30 CFR 914.16(ff).

We asked for public comments on the amendment, but did not receive any.

On January 4, 2007, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Indiana program (Administrative Record No. IND-1744). We received comments from two agencies. The U.S. Department of the Interior Fish and Wildlife Service responded on January 22, 2007 (Administrative Record No. IND-1745), that it had no specific comments on the proposed amendment. The U.S. Department of Agriculture Forest Service (Forest Service) responded on February 9, 2007 (Administrative Record No. IND-1746), by recommending that Indiana retain, instead of deleting, the provision at 312 IAC 25-4-87(g)(3) that requires a permit application and prior approval from the director of IDNR before the construction of structures that impound less than 100 acre-feet of water. The Forest Service also recommended that Indiana add one or more criteria to 312 IAC 25-6-66(4) that encourages design parameters that foster the passage of aquatic organisms instead of having only criteria that approaches the design of water crossing structures strictly from an engineering standpoint. Because the Federal regulations do not contain requirements related to the Forest Service's above two recommendations, Indiana is not required to have them in the State's approved regulatory program. However, we sent a copy of the Forest Service's comments to Indiana for consideration.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Indiana proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment.

On January 4, 2007, under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from EPA (Administrative Record No. IND-1744). EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On January 4, 2007, we requested comments on Indiana's amendment (Administrative Record No. IND-1744), but neither responded to our request.

Based on our discussions in OSM's Findings III.A. through D.2., and E. and F. above, we approve those revisions to Indiana's rules sent to us on December 11, 2006. We do not approve Indiana's newly redesignated subsections (d) through (g) and (i) and new subsections (h) and (j) at 312 IAC 25-5-16 as discussed in OSM's Findings III.D.3. For those rules we approve, Indiana must fully promulgate them in identical form to the rules submitted to and reviewed by OSM and the public.

To implement our decision, we are amending the Federal regulations at 30 CFR part 914, which codify decisions concerning the Indiana program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

Section 503 of SMCRA provides that a State may not exercise jurisdiction under SMCRA unless the State program is approved by the Secretary. Similarly, 30 CFR 732.17(a) requires that any change to an approved State program be submitted to OSM for review as a program amendment. The Federal regulations at 30 CFR 732.17(g) prohibit any changes to approved State programs that are not approved by OSM. In the oversight of the Indiana program, we will recognize only the statutes, rules and other materials we have approved, together with any consistent implementing policies, directives and other materials. We will require Indiana to enforce only approved provisions.

The provisions in the rule based on counterpart Federal regulations do not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations. The revisions made at the initiative of the State that do not have Federal counterparts have also been reviewed and a determination made that they do not have takings implications. This determination is based on the fact that this rulemaking has no takings implications.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects 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. This determination is based on the fact that the Indiana program does not regulate coal exploration and surface coal mining and reclamation operations on Indian lands. Therefore, the Indiana program has no effect on federally-recognized Indian tribes.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior certifies that a portion of the provisions in this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because they are based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this part of the rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations. The Department of the Interior also certifies that the provisions in this rule that are not based upon counterpart Federal regulations 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. ). This determination is based upon the fact that the provisions are administrative and procedural in nature and are not expected to have a substantive effect on the regulated industry.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that a portion of the State provisions are based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule. For the portion of the State provisions that is not based upon counterpart Federal regulations, this determination is based upon the fact that the State provisions are administrative and procedural in nature and are not expected to have a substantive effect on the regulated industry.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that a portion of the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate. For the portion of the State provisions that is not based upon counterpart Federal regulations, this determination is based upon the fact that the State provisions are administrative and procedural in nature and are not expected to have a substantive effect on the regulated industry.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “* * * a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to the Act.” See 30 U.S.C. 1253(a) (1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Virginia program on December 15, 1981. You can find background information on the Virginia program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Virginia program in the December 15, 1981, Federal Register (46 FR 61088). You can also find later actions concerning Virginia's program and program amendments at 30 CFR 946.12, 946.13, and 946.15.

By letter dated March 12, 2007 (Administrative Record Number VA-1063), the Virginia Department of Mines, Minerals and Energy (DMME) submitted an amendment to the Virginia program. In its letter, the DMME stated that the program amendment revises the Virginia Coal Surface Mining Reclamation Regulations to be consistent with the time limits to request formal administrative review of agency decisions under the Virginia Act and regulations. The amendment also identifies the person with whom the request for review should be filed.

We announced receipt of the proposed amendment in the May 9, 2007, Federal Register (72 FR 26329). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment's adequacy. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on June 8, 2007.

This provision is amended at subsection (d) by adding the phrase “within 30 days of the Division's determination” to clarify the time limit within which a person may request a formal hearing to review a decision not to inspect or enforce. Subsection (d) is also amended to specify that all requests for hearings and appeals for review and reconsideration be filed with the Director, Division of Mined Land Reclamation.

As amended, 4 VAC 25-130-842.15(d) provides as follows:

The Federal regulations at 30 CFR 840.15 require that each State program “provide for public participation in enforcement of the State program consistent with that provided by 30 CFR parts 842, 843 and 845 and 43 CFR part 4.”

The counterpart Federal regulation pertaining to appeals of informal review decisions is at 30 CFR 842.15(d), which provides as follows:

With respect to anyone requesting formal review, but who was not served with the informal review decision, the Federal regulation and the proposed Virginia amendment are identical in providing a 30-day appeal period that runs from the date of the determination. However, the Federal and State provisions differ with respect to appeal times for persons who are served with the informal review decision. While the State amendment provides a 30-day appeal period commencing with the date of the informal review determination, the Federal regulation allows only a 20-day appeal period, but that period commences with the person's receipt of the decision. Even though Virginia would allow ten additional days to appeal, we were concerned that a person's appeal period could nearly expire before he or she receives the decision, which must only be sent to the appellant within 30 days of the informal review request, 4 VAC 25-130-842.15(b). To address that concern, the DMME submitted a document from its Procedures Manual. The document, entitled “Mailing-Administrative Decisions”, was issued on September 10, 2007, and states, in pertinent part, as follows:

If the DMME adheres to the policy quoted above, a person wishing to formally appeal an informal review decision should have at least 25 days to file his appeal after receipt of the decision, assuming the decision is mailed two days after its issuance, and assuming delivery occurs no later than 3 days after mailing. With the understanding that the DMME will apply this policy to informal review decisions, and that the DMME will serve all informal review decisions via certified mail, we find that the amendment to 4 VAC 25-130-842.15(d) is no less effective than the Federal regulations at 30 CFR 842.15(d) and 43 CFR 4.1282(b). The remainder of the amendment, pertaining to the identification of the entity with whom a request for review should be filed, is no less effective than the aforementioned Federal regulations. The amendment is, therefore, approved.

We asked for public comments on the amendment (Administrative Record Number VA-1068) and no comments were received.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, on March 16, 2007, we requested comments on the amendments from various Federal agencies with an actual or potential interest in the Virginia program (Administrative Record Number VA-1060). The United States Department of the Interior, Bureau of Land Management responded and stated that they found no inconsistencies with the proposed changes and the Federal Laws, which govern mining (Administrative Record No. 1067). The United States Department of Agriculture, Natural Resources Conservation Service responded and stated that they did not object to the amendment and deemed the changes appropriate.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Virginia proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment.

Under 30 CFR 732.17(h)(II)(i), we requested comments on the amendment from the EPA (Administrative Record number VA-1064). No comments were received.

Based on the above findings, we are approving the amendment sent to us by Virginia on March 12, 2007. To implement this decision, we are amending the Federal regulations at 30 CFR part 946, which codify decisions concerning the Virginia program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

The provisions in the rule based on counterpart Federal regulations do not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations. The revisions made at the initiative of the State that do not have Federal counterparts have also been reviewed and a determination made that they do not have takings implications. This determination is based on the fact that the provisions are administrative and procedural in nature and are not expected to have a substantive effect on the regulated industry.

This rule is exempt from review by the Office of Management and Budget under Executive Order 12866.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. The basis for this determination is that our decision is on a State regulatory program and does not involve Federal regulations involving Indian lands.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior certifies that a portion of the provisions in this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because they are based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations. The Department of the Interior also certifies that the provisions in this rule that are not based upon counterpart Federal regulations 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. ). This determination is based on the fact that the provisions are administrative and procedural in nature and are not expected to have a substantive effect on the regulated industry.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that a portion of the State provisions are based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule. For the portion of the State provisions that is not based upon counterpart Federal regulations, this determination is based upon the fact that the State provisions are administrative and procedural in nature and are not expected to have a substantive effect on the regulated industry.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that a portion of the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate. For the portion of the State provisions that is not based upon counterpart Federal regulations, this determination is based upon the fact that the State provisions are administrative and procedural in nature and are not expected to have a substantive effect on the regulated industry.

The old Brightman Street bascule bridge, across the Taunton River at mile 1.8, between Fall River and Somerset, Massachusetts, has a vertical clearance in the closed position of 27 feet at mean high water and 31 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.619.

The owner of the bridge, Massachusetts Highway Department (MHD), requested a temporary deviation to facilitate scheduled bridge maintenance and structural repairs to the sidewalks at the old Brightman Street bascule bridge.

Under this temporary deviation, in effect from 6 a.m. on October 13, 2007 through 5 p.m. on October 27, 2007, the old Brightman Street bascule bridge shall open on signal after at least a one-hour advance notice is given by calling the number posted at the bridge.

This work was scheduled during the time of year when the one upstream facility is closed and no deliveries are scheduled. The recreational boat marinas were contacted and have no objection to the one-hour advance notice.

An 18′ x 43′ construction work barge may be located in the channel during the prosecution of this bridge maintenance. The work barge will move upon request by calling the bridge tender either on the land line (508) 672-5111 or on VHF channels 13 and 16.

In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Should the bridge maintenance authorized by this temporary deviation be completed before the end of the effective period published in this notice, the Coast Guard will rescind the remainder of this temporary deviation, and the bridge shall be returned to its normal operating schedule. Notice of the above action shall be provided to the public in the Local Notice to Mariners and the Federal Register , where practicable.

Regulatory Information

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The U.S. 165 bridge was removed from the waterway and replaced by a fixed high-level bridge. Since the drawbridge no longer exists, the operating schedule in 33 CFR 117.483 for this bridge is no longer needed and is being removed. Notice and comment on this action is not necessary, as there is no need for the regulation to exist any longer.

For the same reason, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register .

On May 31, 2001 the Coast Guard issued a permit, later amended on March 20, 2006, for a fixed, high-level bridge to replace the U.S. 165 bridge, mile 110.1, on the Ouachita River at Columbia, LA. Land traffic has been shifted to the replacement bridge and the drawbridge, governed by 33 CFR 117.483, has been removed from the waterway.

This final rule amends 33 CFR 117.483 by removing the regulations covering U.S. 165 bridge, mile 110.1 at Columbia, as that bridge has been removed from the waterway.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

A special operating regulation was established for the drawbridge. This drawbridge has been removed from the waterway, making the regulation unnecessary. Vessel traffic can continue to pass under the new fixed bridge without interference. Therefore, we expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule, to remove an obsolete drawbridge regulation, will have no impact on any small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they may better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore this rule is categorically excluded under figure 2-1, paragraph 32(e) of the Instruction from further environmental documentation. Paragraph 32(e) excludes the promulgation of operating regulations or procedures for drawbridges from the environmental documentation requirements of the National Environmental Policy Act (NEPA). Since this regulation alters the normal operating conditions of the drawbridge, it falls within this exclusion. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

Transportation conformity is required under section 176(c) of the Clean Air Act (CAA or Act) to ensure that Federally supported highway, transit projects, and other activities are consistent with (“conform to”) the purpose of the SIP. Conformity currently applies to areas that are designated nonattainment and to areas that have been redesignated to attainment after 1990 (maintenance areas) with plans developed under section 175A of the CAA for the following transportation related criteria pollutants: Ozone, particulate matter (PM 2.5 and PM 10 ), carbon monoxide (CO), and nitrogen dioxide (NO 2 ).

Conformity to the purpose of the SIP means that transportation activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant national ambient air quality standards (NAAQS). The transportation conformity regulation is found in 40 CFR part 93 and provisions related to conformity SIPs are found in 40 CFR 51.390.

EPA promulgated the Federal transportation conformity criteria and procedures (the conformity rule) on November 24, 1993. Among other things, the rule required states to address all provisions of the conformity rule in their SIPs (conformity SIPs). Under 40 CFR 51.390, most sections of the conformity rule were required to be copied verbatim. States were also required to tailor all or portions of the following three sections of the conformity rule to meet their state's individual circumstances: 40 CFR 93.105, which addresses consultation procedures; 40 CFR 93.122(a)(4)(ii), which addresses written commitments to control measures that are not included in a metropolitan planning organization's (MPO's) transportation plan and transportation improvement program that must be obtained prior to a conformity determination, and the requirement that such commitments, when they exist, must be fulfilled; and 40 CFR 93.125(c), which addresses written commitments to mitigation measures that must be obtained prior to a project-level conformity determination, and the requirement that project sponsors must comply with such commitments, when they exist.

On August 10, 2005, the “Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users” (SAFETEA-LU) was signed into law. SAFETEA-LU revised section 176(c) of the Clean Air Act's transportation conformity provisions. One of the changes streamlines the requirements for conformity SIPs. Under SAFETEA-LU, states are required to address and tailor only three sections of the conformity rule in their conformity SIPs: 40 CFR 93.105, 40 CFR 93.122(a)(4)(ii), and, 40 CFR 93.125(c), described above. In general, states are no longer required to submit conformity SIP revisions that address the other sections of the conformity rule. These changes took effect on August 10, 2005, when SAFETEA-LU was signed into law.

The SIP revisions submitted to EPA on July 27, 2007, consist of the Kansas City and St. Louis Transportation Conformity Requirements (10 Code of State Regulations (CSR) 10-2.390, and 10 CSR 10-5.480, respectively). These rules replace the previous revision effective on December 30, 2005.

The Kansas City conformity rule will apply only if the area is designated or redesignated to nonattainment. The Kansas City area was previously a maintenance area for the 1-hour ozone standard. When the 1-hour ozone standard was revoked, conformity was no longer required. The area is currently designated attainment for the 8-hour ozone standard.

The revisions to the Kansas City and St. Louis conformity rules were updated to be consistent with the transportation conformity-related provisions of SAFETEA-LU as previously described in this document. Revisions were made to definitions, interagency consultation procedures (including processes, roles and responsibilities, consultation opportunities, recordkeeping and conflict resolution), and the requirements to fulfill commitments to control measures and mitigation measures.

The submittal documents public notice and hearing for this SIP revision in compliance with CAA section 110(l) and 40 CFR 51.102.

We have reviewed the submittal to assure consistency with the current Clean Air Act, as amended by SAFETEA-LU, and EPA regulations (40 CFR part 93 and 40 CFR 51.390) governing state procedures for transportation conformity and interagency consultation and have concluded that the submittal is approvable. Details of our review are set forth in a technical support document, which has been included in the docket for this action.

Under section 110(k) of the Act, and for the reasons set forth above, EPA is taking action to approve the Kansas City area and St. Louis area transportation conformity requirements as revisions to the Missouri SIP.

We do not expect objection to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submittal. If we receive adverse comments by November 19, 2007, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on December 17, 2007. This will incorporate these transportation conformity procedures into the federally-enforceable SIP and thereby replace the previous versions. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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

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

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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 CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 17, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On July 3, 2007 (72 FR 36413), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Virginia. The NPR proposed approval of amendments to Virginia's Section 111(d) Plan to control TRS from pulp and paper mills (9 VAC 5, Chapter 40, Article 13, Rule 4-13). The formal SIP revision was submitted by the Commonwealth of Virginia on June 20, 2005. Other specific requirements of Virginia's plan to control TRS from pulp and paper mills and the rational for EPA's proposed action are explained in the NPR and will not be restated here. No public comments were received on the NPR.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) ``privilege'' for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed.

Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information (1) that are generated or developed before the commencement of a voluntary environmental assessment; (2) that are prepared independently of the assessment process; (3) that demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts * * *.” The opinion concludes that “[r]egarding (10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving the amendments to an existing regulation (9 VAC 5, Chapter 40, Article 13, Rule 4-13) as a revision to the Virginia Section 111(d) Plan submitted on June 20, 2005.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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 CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 17, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action, approving the amendments to Virginia's Section 111(d) Plan, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Pursuant to FRA's direct final rulemaking procedures set forth at 49 CFR 211.33, FRA is issuing this document to inform the public that it has not received any comments or requests for an oral hearing on the direct final rule that was published in the Federal Register on August 9, 2007 (72 FR 44790). The direct final rule made technical amendments to Appendix D of 49 CFR Part 222 to update information contained in the appendix and inform the public of the most recent value of the Nationwide Significant Risk Threshold. As no comments or requests for an oral hearing were received by FRA, this document informs the public that the effective date of the direct final rule remains as October 9, 2007, the date specified in the rule.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://DocketsInfo.dot.gov .

Background

In February 2000, the U.S. Fish and Wildlife Service (Service or we) received a petition from the Mississippi Interstate Cooperative Resources Association (MICRA) to list the black carp ( Mylopharyngodon piceus ) under the injurious wildlife provision of the Lacey Act (18 U.S.C. 42). The petition was based upon concerns about the potential impacts of black carp on native freshwater mussels and snails in the Mississippi River basin. In October 2002, the Service received a petition signed by 25 members of Congress representing the Great Lakes region to add black, bighead, and silver carp to the list of injurious wildlife under the Lacey Act. A follow-up letter identified seven additional Legislators who supported the petition.

On June 2, 2000, we published in the Federal Register (65 FR 35314) an advance notice of proposed rulemaking (ANPR) to seek comments on whether or not we should propose to list black carp as injurious under the Lacey Act. The comment period on the ANPR was open for 60 days, until August 1, 2000. During that comment period, we received 124 comments. We considered those comments in our development of a proposed rule to add all forms of live black carp to the list of injurious fishes under the Lacey Act, which we published in the Federal Register on July 30, 2002 (67 FR 49280). We opened the public comment period on the proposed rule for 60 days, until September 30, 2002. We received 82 comments on the proposed rule. On June 4, 2003, in an effort to gather more economic and ecological information on our proposed action, we reopened the public comment period on the proposed rule for an additional 30 days, until August 4, 2003 (68 FR 33431). We received 21 comments during the reopened comment period. On August 30, 2005, we published in the Federal Register (70 FR 51326) a document announcing the availability of the draft environmental assessment and draft economic analysis, including the initial regulatory flexibility analysis, for the proposed rule, and seeking public comments on those draft documents and on listing only the diploid (fertile) form of black carp. The public comment period for this August 30, 2005, document was originally 60 days, ending October 31, 2005; however on October 27, 2005, we published a document (70 FR 61933) extending the comment period by an additional 45 days, until December 16, 2005. During the 105-day comment period, we received 89 comments. Therefore, in total, the Service received 316 comments during the four public comment periods.

We reviewed all comments we received for substantive issues and information regarding the injurious nature of black carp. Many States and conservation organizations support listing diploid and triploid black carp. Aquaculture industry groups and fish production facility owners do not support listing triploid black carp, but most are amenable to listing diploid black carp. We have grouped similar comments into issues; we present these issues and our responses below.

Many comments provided specific black carp scientific and economic data pertaining to use and alternatives to use, distribution, impacts, spread, level of risk of introduction, diploid and triploid fish, certification of triploid fish, and the potential effects of an injurious listing. We appreciate the information and data provided and have considered it in preparing our final determination to add live black carp, gametes, viable eggs, and hybrids to the list of injurious fishes under the Lacey Act.

Issue: Many respondents expressed concern about the potential negative impacts of black carp to mussels, the cultured pearl industry, snails, and water quality; declines in trust resources (imperiled mussels, birds, turtles, and fish) if black carp are introduced and the cascading impacts to tourism and recreation in local economies; costs to control black carp; and costs to eradicate (and mitigate impacts of) black carp from U.S. waters once introduced.

Response: The Service agrees with the respondents' comments on these issues. The biological characteristics of black carp and their potential to be injurious to the U.S. wildlife and wildlife resources are the bases for our decision to add live black carp to the list of injurious fishes under the Lacey Act. The likelihood or feasibility of eradication from natural waters due to a lack of tools, regardless of cost, was considered in our evaluation and is part of the basis for this final rule. Since eradication is highly unlikely, mitigation for impacts would be extremely difficult.

Issue: Many respondents expressed concern about the establishment of black carp in new areas through adjacent waterways, and about the ability of facilities to contain triploid or diploid black carp within their ponds due to the challenges of preventing release due to filter clogs, during levee problems, and during floods. These respondents felt that black carp would inevitably escape into U.S. waters.

Response: Based on the Service's finding, the ability and effectiveness of measures to prevent escape or establishment are low, and this issue is part of the basis for this final rule.

Issue: Several respondents stated that the ecological impacts of black carp are difficult to predict.

Response: The Lacey Act directs the Service to look at the injury or potential injury caused by a species when we are making a listing determination. Once we have determined that a species meets the standard of injuriousness under the Act, we must take the appropriate action to add it to the list of injurious wildlife. While the specific impacts of black carp (locations or species) are difficult to predict, black carp have had negative impacts on mollusk populations in similar habitats in other countries. Such impacts to mollusks are highly likely to occur in the United States. In addition, there are potential negative impacts to other species, such as fish, turtles, and nutrient cycles, if algae mats develop in the absence of filter-feeding mollusks.

Issue: Several respondents noted that the efficiency of black carp in controlling snails in culture ponds foreshadows the probable efficiency of black carp in eating mollusks in the wild.

Response: We agree; black carp are prolific eaters and are highly specialized to eat mollusks. Where mollusks are available, black carp will feed almost exclusively on them, and in similar quantities, whether the carp are diploid or triploid fish.

Issue: One respondent stated that it makes little difference what a species might do after it escapes and becomes entrenched in the wild if there is little or no threat that it will escape in the first place; with no threat, there is no need for rule.

Response: The Service disagrees with this comment. The impacts caused by an introduced species vary based on the life history of the introduced species, the level of infestation, and the impacts it causes on native wildlife and wildlife resources.

Furthermore, it may take many years to realize the full impacts of the introduction of aquatic species on wildlife and wildlife resources. We believe that preventing the introduction and spread of nonnative species is more cost-effective than trying to control an established invader. The recent captures of diploid and triploid black carp from the wild, perhaps dating back 10 years, confirm that black carp are escaping or being released into the environment. Additionally, there are numerous examples from other countries where black carp have become established in habitats similar to those found in the United States.

Issue: A few respondents stated that there is no evidence of impacts to native mussels and snails because there are no black carp in the wild. Additionally, several commenters noted that black carp have been in the United States for 30 years and haven't been found in the wild.

Response: While black carp were first imported in the 1980s, they weren't widely used and transported until the late 1990s. The first black carp found in the wild was in 2003; several more have been captured from natural waters of the United States since then. The potential risks of harm to native mollusks from black carp have been presented in peer-reviewed scientific research. This research, combined with the presence of black carp captured in natural waters of the United States, provides evidence sufficient to demonstrate that black carp will escape into the wild and injure native mussels and snails.

Issue: Several commenters stated that black carp impacts are strictly dependent on the number of fish present and that a few triploids would not have a considerable impact on native snails and mussels; hundreds of thousands would, but that would happen only if fertile diploid black carp would establish breeding populations.

Response: Given that the black carps’ diet consists primarily of mollusks, we find that non-breeding black carp are highly likely to have negative impacts on native mussels and snails, particularly in local areas. Triploid black carp, which can live 15 or more years, could have a considerable impact on local mollusk populations, as they feed almost exclusively on these types of organisms, including those designated as threatened and endangered species under the Endangered Species Act, and they would compete with native fish for food. Even a few introduced black carp could impact mollusk populations in local areas, as they have been shown to be effective at eating nearly all of the mollusks where they have been stocked.

Issue: Many respondents expressed concern that listing triploid and diploid black carp could result in unintended adverse environmental impacts. Restricting interstate transport of triploid black carp will create an incentive for States without farmers skilled in triploid technologies to produce, sell, and distribute greater numbers of fertile diploid black carp for use within States without a triploid supply, which would increase the chance of release of reproducing adults. Because producing diploids is easier, a final rule prohibiting importation and interstate transport of triploid and diploid black carp could result in greater numbers of fertile black carp being distributed in the United States.

Response: The Service acknowledges that by adding triploid and diploid black carp to the list of injurious wildlife, thereby prohibiting their importation and interstate transport, the risk of more diploids being utilized exists. However, the States regulate the fish allowed to be used in facilities within their State boundaries and could assess the acceptable level of environmental and economic risks of diploid carp in their permitting processes. Several States that currently import triploid black carp from Arkansas do possess diploids and could potentially produce triploids or diploids for use within State boundaries. We believe that prohibiting interstate transportation and importation of black carp by listing black carp as injurious under the Lacey Act is our best means of limiting the range expansion of that species.

Issue: Similarly, a few respondents expressed concerns regarding the potential for increased use of diploid black carp in Mississippi. They stated that by prohibiting interstate transportation of triploid and diploid black carp, catfish farmers in Mississippi would be forced to stock diploid black carp. Some Mississippi farmers possess diploid broodstock but have never spawned triploid black carp and may be unable for technical reasons to produce enough triploids for use by farmers in Mississippi.

Response: The Service shares this concern, and we hope that States will implement alternative control methods. In addition to the 5 years that have elapsed since our publication of the proposed rule, the effective date of the final rule is delayed 30 days after the date of its publication in the Federal Register , a delay which will assist industry and States in preparing for the effects resulting from the implementation of the final rule. Having found that black carp are injurious to the wildlife and wildlife resources of the United States, the Service has received no facts that would justify delaying the effective date of the final rule beyond the 30 days provided by law.

Issue: Some commenters expressed concern about being held responsible under the Lacey Act if black carp were inadvertently transported across state lines.

Response: Once the final rule is effective, any interstate transport without a valid permit of live black carp across state lines is a violation of the Lacey Act. The Service recognizes that there are situations where a person or company may inadvertently transport black carp across state lines, such as when transporting juvenile grass carp, which can be difficult to distinguish from juvenile black carp, or when transporting catfish to processing plants. The Service would welcome the opportunity to work with those affected by this rule to help develop best management practices and Hazard Analysis and Critical Control Point (HACCP) plans that may be implemented as a means of preventing the inadvertent transport of live black carp. The Service focuses its resources on investigating and prosecuting those who act without taking steps to comply with the law.

In addition, this rule prohibits the transportation of live black carp, gametes, and viable eggs. Transportation of dead black carp across state lines would not be a violation of law.

Issue: Several commenters relayed their concern about statements regarding parasite transmission from black carp and stated that there is no evidence that black carp are likely to infect other species with exotic diseases, serve as intermediate hosts, or otherwise transfer parasite diseases more so than any other fish species already present in natural systems. Parasites are irrelevant because not a single new disease organism has been linked to black carp imported in the last 25 years. A listing based on potential parasites does not make sense, because there is no disease inspection for any fish. In addition, black carp are more likely to reduce disease incidence in other fish species by controlling snails that may spread disease.

Response: While no new pathogen introductions are known to be attributed to black carp in the United States, Spring Viremia of Carp virus was recently discovered in the United States from other carps; if infected, black carp introduced to the wild could spread this virus. New importations of black carp for use as diploid broodstock could introduce new pathogens, but this is unlikely, as black carp are not currently imported. While it is possible that black carp may reduce disease incidence in other fish species by controlling snails that may spread disease, this possibility is extremely remote and unlikely outside of the context of aquaculture facilities because of the low probability of black carp locating and consuming a sufficient amount of disease-carrying snails in open waters to prevent the spread of disease to other fish species.

Issue: One commenter stated that the Service has no evidence that black carp serve as hosts for any parasite that infects humans, and that black carp would help break the parasite cycle if any existed. In addition, the commenter stated that black carp have been used to successfully control the snail host for Schistosoma problem in humans.

Response: Because black carp feed heavily on mollusks, the species serves as a reservoir host to many mollusk parasites, but black carp likely remains immune from the effects of the parasites and diseases. In certain parts of China, black carp have served as host to the Chinese liver fluke ( Clonorchis sinensis ), which causes Clonorchiasis, one of the most severe food-borne parasitic diseases of humans in China. Black carp have been reportedly used to successfully control snail hosts for Schistosoma in humans, which is a tropical and subtropical snail-borne disease that is most prevalent in sub- Saharan Africa as well as the Middle East, South America, Southeastern Asia, southern China, and the Caribbean. According to the World Health Organization and the U.S. Centers for Disease Control, this disease does not occur in the United States, although a U.S. citizen may contract the disease while traveling.

Issue: Several respondents asked if black carp would enter the upper reaches of tributaries where threatened and endangered mussels exist since they “inhabit lakes and lower reaches of large, fast moving rivers” (67 FR 49280).

Response: Black carp have the ability to populate many different habitat types where there is a viable food source, including the upper and middle reaches of rivers, lakes, and reservoirs. Many species of mollusks inhabit lakes and lower reaches of rivers, in addition to upper tributaries, so those species are at risk if black carp are introduced.

Issue: Based on our statement that native fish would have to compete with black carp for food, one commenter asked why native fish species are not currently wiping out native mussels.

Response: Black carp will eat mollusks if they are available, as black carp are highly adapted to eat primarily mussels and snails. Many native molluscivore fish do not feed as exclusively on mussels and snails as black carp. Black carp are generally known as feeding specialists with respect to mollusks, but there is a risk to other potential prey species if mollusks become limited. Black carp may switch, as they do in Asia, to eating crayfishes and other crustaceans, many of which are already imperiled in U.S. waters. Black carp have a larger gape width than most native molluscivores and pose a greater threat to a wide variety of native mussels and snails. There are no known native fish with black carp's combination of size, morphology, and diet. Consequently, black carp could put a whole new suite of species not currently subject to fish predation at considerable risk and thus change ecosystem function by altering the existing food web.

The 1993 Office of Technology Assessment review of the impacts of non-native species introductions concluded that such introductions “have had profound environmental consequences, exacting a significant toll on U.S. ecosystems.” There is perhaps no clearer indication of the disruption of ecosystem function than the endangerment or extinction of one of its component species. Published reviews of the factors cited in native fish species extinctions and endangerment found that non-native fish introductions were second only to habitat alteration. More recent publications suggest that in some waters non-native fish introductions may in fact be an even stronger driver of extinction and population decline than habitat alteration.

Issue: One respondent noted that the discussion of population abundance of native freshwater mussels must address the allowed commercial harvest of mussels over the years.

Response: States regulate their commercial harvests of freshwater mussels to promote sustainable mussel populations. For example, a State may restrict the size or the species of mussels that are harvested to ensure a viable breeding population in a given bed. When predation of mussels from black carp is discussed, we assume that freshwater mussel populations are regulated by States for sustainable commercial harvest, where allowed.

Issue: One commenter asked what it would cost the Service to control black carp if they invaded rivers with endangered mollusks because the Endangered Species Act would mandate actions to prevent extinction.

Response: The Service has not developed an estimate for what it would cost to control black carp in rivers. Currently, there are no effective methods available to control black carp in river systems, without considerable damage to other species and drinking water. We believe that control would be very costly in terms of the negative impacts of control methods to non-target species, as well as the costs of the methods. Recovery plans that are developed for threatened and endangered species include actions that restore species and their habitats to viable levels, analyze and reduce or remove threats to those species, and ensure that those species do not decline in status. If control of black carp was identified as a means to recover a species, we would work with partners to develop and implement control methods, if possible.

Issue: Many respondents stated that there is no control method comparable to the effectiveness of black carp in controlling parasites. Only black carp and shoreline treatments of lime and/or copper sulfate/citric acid are effective.

Response: We acknowledge that, by themselves, black carp may be more cost effective than any other single control method. Research has shown that copper sulfate and hydrated lime are 90 percent or more effective in controlling snails in ponds. In addition, several native fish species or their hybrids are still being evaluated as alternatives to black carp, and some have been shown to be moderately effective at controlling snails, although not as effective as black carp alone. Researchers have noted that a combination of biological and chemical controls may be most effective, as there are instances (high vegetation, for example) where black carp cannot completely control snails.

Issue: One commenter noted that copper sulfate has not been very effective at controlling snails in hybrid striped bass ponds.

Response: We appreciate all data provided.

Issue: Several respondents stated that the Food and Drug Administration has not approved any chemicals that can reduce snail populations to the point that snail-borne diseases are no longer a serious threat to fish ponds. Because no one has been able to find a native fish to replace black carp, black carp are the only means of protection against these parasites.

Response: The Service disagrees with this statement. There are several effective chemical treatments to reduce snails in fish ponds; within certain water quality parameters, copper sulfate and hydrated lime have been shown to be more than 90 percent effective in killing snail populations. Bayluscide®-M 70% WP is a chemical treatment (EPA Reg. No. 75394-1) that can be used to eliminate snails from ponds after a severe infestation when the pond production is a total loss, in order to restock catfish. Several fish species have been shown to consume snails, though not as effectively as black carp, including redear sunfish and hybrid redear sunfish. We believe that a combination of biological and chemical methods may be more effective at snail control than any one treatment approach.

Issue: One commenter stated that the State-run fish production facilities of Iowa, Kansas, Missouri, Montana, Nebraska, North Dakota, and South Dakota—which use prophylactic procedures, such as periodic pond draining—have not reported any problems with parasites.

Response: We appreciate all information provided.

Issue: Several respondents asked us to consider the take of protected birds infected with adult flukes, or to provide funding for the costs associated to rid flukes from these birds with a vaccine if black carp are listed as injurious, since the American white pelican and perhaps a few other bird species are a host for the fluke and spread it to open waters through defecations.

Response: Although American white pelicans and most other native bird species are protected by the Migratory Bird Treaty Act (16 U.S.C. 703-712), our Regional Migratory Bird Permit Offices do, in some cases, issue depredation permits to individuals experiencing economic losses caused by fish-eating birds at aquaculture facilities. However, it is not our policy to issue depredation permits for the take of migratory birds to reduce the occurrence of parasites. To learn more about migratory bird permits, go to: http://www.fws.gov/policy/724fw2.html. It is not the Service's mission to provide funds for commercial enterprises to reduce the occurrence of parasites.

Issue: Several respondents noted that the catfish industry needs black carp to control Bolbophorus , not to control the yellow grub.

Response: We recognize that there was confusion regarding the identity of the parasite causing problems in channel catfish, hybrid striped bass, and some baitfish ponds at the time we published the proposed rule (July 30, 2002, 67 FR 19280). Bolbophorus damnificus is listed later in this document as the primary parasite impacting catfish farms for which these farms may or do utilize black carp, although yellow grub ( Clinostomum marginatum ) has also impacted catfish facilities. Black carp are used to control yellow grub in hybrid striped bass and baitfish farms.

Issue: One commenter noted that there is a new host for Bolbophorus , a yet unidentified snail (perhaps Drepanotrema sp.) that was discovered in July 2003 in Arkansas catfish ponds and is not affected by copper sulfate.

Response: We acknowledge there may be other snail vectors for Bolbophorus . We have no information on this new snail or its potential impacts.

Issue: Several commenters noted that a snail, the red-rimmed melania ( Melanoides tuberculata ), has been found in at least 14 States and is a host for Centrocestus formosanus. Red-rimmed melania has an operculum that keeps chemicals from penetrating and killing it. Only black carp eat the red-rimmed melania; redear sunfish and freshwater drum will not eat this snail. Bayluscide would work, but cannot be used on farms that produce food fish.

Response: We understand that there are other trematode parasites that are of concern to commercial aquaculture production. The Service is also concerned about the impacts of those parasites on native species. However, the focus of this evaluation was on the injuriousness or potential injuriousness of all forms of black carp on the wildlife and wildlife resources of the United States.

Issue: Several respondents noted that, in addition to pelicans, there are other bird hosts of the snail trematodes.

Response: Research to date indicates that the American white pelican ( Pelecanus erythrorhynchos ) is the final host of Bolbophorus damnificus, while yellow grub is carried by the Great blue heron ( Ardea herodias ).

Issue: One respondent noted that hybrid striped bass farms are particularly dependent on black carp for control of the yellow grub ( Clinostomum complanatum ), which kills fingerlings and reduces adult marketability; that approximately 80 percent of fingerlings are protected from yellow grub by black carp; and that prior to importation of black carp in the early 1990s, it was common for a farm to lose as much as 50 percent of fingerlings to yellow grub.

Response: We note that C. marginatum is now the recognized species for yellow grub. Yellow grub impacts hybrid striped bass, and black carp may be the most effective single option to control the grub; however, other combinations of methods may be more effective than black carp.

Issue: Several respondents stated that the proposed rule ignores or is in direct opposition to the 1996 and 2001 U.S. Geological Survey (USGS) “Risk Assessment on Black Carp” that the Service helped prepare. The Service was asked to withdraw the proposed rule and instead implement the seven recommendations set forth in the 1996 and 2001 risk assessments.

Response: The purpose of creating the Aquatic Nuisance Species Task Force (ANSTF) Working Group, which drafted the 1996 “Risk Assessment on Black Carp,” was to evaluate the generic risk process methodology that was being developed for the ANSTF and to provide insights needed to adjust or correct the generic methodology. USGS led this Working Group. None of the black carp risk assessments were initiated or developed as injurious wildlife evaluation documents. The Service conducts its own evaluation to determine if a species meets the definition of injuriousness, and we used information that was relevant to the black carp injurious wildlife evaluation from the 1996 and 2001 USGS biological synopses and risk assessments and other sources. Because our authority allows us to regulate the importation and interstate transportation of listed injurious wildlife species, the Service did not request or endorse the development of the management recommendations for a regulatory process. The Service has contributed to implementing several of the management options identified in the 1996 and 2001 reports, and the options provided in all of the reports were considered in the rulemaking process. We also note that due to increased trematode infestations, the use of black carp has increased since the 1996 and 2001 recommendations were developed.

The eight recommendations from the Black Carp Working Group that were provided in addition to the 1996 risk assessment are listed below, with our responses. Note that at the time of the 1996 Working Group, black carp were in limited use for only yellow grub ( Clinostomum sp.) infestations.

(1) All 100-percent black carp (exclusive of brood stock) must be certified triploids.

Service comment : We have not been provided documentation that each State requires the use of certified triploids in culture ponds.

(2) Brood stock must be restricted to and maintained in aquaculture facilities where the probability of escape or flooding is essentially zero.

Service comment : We leave intrastate regulation of brood stock to the States. Interstate transport of black carp is prohibited under the Lacey Act.

(3) Develop a mechanism for verifying the location and distribution of all live black carp (diploids and triploids).

Service comment : To our knowledge, States that allow the use of black carp are not tracking the locations of black carp stockings, nor are they aware of the exact number of black carp stocked at any given time. This would be a time-consuming and difficult task to develop and maintain, and the Service does not believe that tracking black carp stocking is an effective way to protect the wildlife and wildlife resources of the United States from black carp.

(4) Research to date suggests that black carp may not be particularly efficient in controlling snail populations in U.S. aquaculture facilities. Further use of black carp, experimental or otherwise, for testing their effectiveness in the control of disease-carrying snails, such as the yellow grub ( Clinostomum sp.), must be restricted to triploid individuals.

Service comment : A great amount of new and revised data has been generated since the 1996 and 2001 biological synopses and risk assessments were conducted. Black carp have been found to be effective in controlling snails and are the preferred snail control in many catfish, hybrid striped bass, and other facilities. Some States restrict black carp use to triploids, while others permit diploids and triploids.

(5) Release of triploid black carp into any streams, lakes, or reservoirs should be prohibited until there is additional research demonstrating that any such introduction will be beneficial (i.e., effective in controlling zebra mussels and Asian clams) and will not cause significant harm to native mussel and snail populations.

Service comment : States have the authority to regulate releases of black carp. We do not believe that triploid (or diploid) black carp should ever be stocked in open waters. In its 2005 biological synopsis and risk assessment on black carp, USGS updated the potential impacts of black carp and indicated that both the diploid and triploid forms would be expected to consume large quantities of mollusks.

(6) Black carp as a pathway for disease should be further investigated. Until this is done, no additional stocks of black carp should be brought into the country unless additional precautions are taken (water changes, only healthy fish that have been inspected by a veterinarian, etc.).

Service comment : The Service is concerned about the pathogens that may be introduced through black carp importations or spread. We are not aware of any recent importations of black carp into the United States. The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service, recently published an interim rule restricting importations of certain species that may carry Spring Viraemia of Carp virus, but USDA did not include import restrictions on black carp.

(7) Produce an identification guide to distinguish black carp from native and other nonindigenous fishes to reduce any risk of misidentification. For example, if black carp do become more common in U.S. aquaculture, there is a risk that the species would be unintentionally introduced as “grass carp” to some areas.

Service comment : We provided funding to the U.S. Geological Survey (USGS) to produce an identification guide; this guide was completed by USGS and distributed by the Service and USGS in 2005.

(8) Establish a quality assurance and education program for the above recommendations.

Service comment : We believe that educational programs, best management practices, and quality assurance programs should be developed by those entities that use black carp to ensure adherence to the recommendations identified in the risk assessments.

Issue: One commenter asked which recommendations from the 1996 final report are being implemented by various States.

Response: The Service does not have information from all 50 States as to which recommendations identified in the 1996 risk assessment are being implemented.

Issue: Several respondents stated that the proposed rule should have discussed the risks of diploid and triploid black carp independently. Risks to mussels are substantially different, and regulation should distinguish between the actions and risks of diploids versus triploids.

Response: We analyzed the environmental impact of these two alternatives in the environmental assessment and determined that there are unacceptable risks to native wildlife and wildlife resources from both diploid and triploid black carp. While the introduction of diploid black carp to U.S. waters would likely have greater impacts in perpetuity on native mollusks, long-lived triploid black carp can also have substantial impacts, particularly in local areas where they could decimate mollusk populations. Where mollusks are available, black carp will feed almost exclusively on them, and in similar quantities, whether they are diploid or triploid fish.

Issue: Several respondents stated that the proposed rule overestimates the risk of black carp escape and establishment.

Response: We considered the risks of triploid and diploid black carp separately in the environmental assessment, but we did not see the need to discuss them separately in the rule. Black carp, whether diploid or triploid, have the potential to feed on large quantities of freshwater mussels and snails before they die of old age. We do not believe the risk of black carp escape and establishment was overestimated, particularly in light of ongoing captures of black carp from natural waters of the United States.

Issue: One commenter noted that the use of the term “established” implies a breeding population of black carp and that the risk assessment (1996) states that “assuming that there are no escapes * * * [it is] unlikely that a breeding population of black carp would become established in open U.S. waters.”

Response: The 1996 risk assessment does state that “Assuming that there are no escapes of diploid individuals from breeding stocks (and no unauthorized shipments and subsequent releases or stockings of diploids), it is unlikely that a breeding population of black carp would become established in open U.S. waters.” However, the updated 2005 Nico et al. biological synopsis and risk assessment also states that “black carp, whether introduced individuals or a reproducing population, could pose a serious threat to many of the remaining populations of endangered and threatened mollusks,” and “because of their size and feeding habits, black carp have the potential to impact individual species of mollusks, hastening the decline of imperiled species.” Furthermore, the 2005 document states that “there are now confirmed records of black carp in the wild and the increased frequency of captures, particularly of diploid individuals, suggest that a wild population may already be established in the Mississippi River basin.”

Due to the black carps’ longevity, size, and feeding habits, we believe that the introduction of individuals or populations of black carp in the United States is highly likely to hasten the decline of mollusk species.

Issue: One commenter stated that only triploid black carp are currently used for snail control in the United States and that these sterile fish are only allowed in Arkansas, Mississippi, and Missouri; about 30-50,000 black carp are utilized in any given year.

Response: We appreciate all data provided. We do note that North Carolina imports triploid black carp as well. If black carp are used at all, we hope that all States require the stocking of only certified triploid black carp; however, the Service has not been provided documentation from each State to that effect.

Issue: Several commenters stated that there is no case where the use of triploids has prevented the eventual escape and proliferation of exotic fishes.

Response: For this decision, we did not conduct a thorough evaluation of the effectiveness of triploidy in other fishes. Our analysis focused on the injuriousness or potential injuriousness of all forms of black carp.

Issue: Several respondents stated that juvenile black carp that have not yet reached an age to be ploidy evaluated have likely escaped from fish ponds. Consequently, diploid, as well as triploid, black carp have likely escaped into the wild.

Response: The Service acknowledges this possibility and also recognizes that industry has several safety measures in place to try to minimize escapes from ponds.

Issue: Several commenters stated that is incorrect to state or imply that the triploid grass carp program is a failure, because grass carp are found in natural waters due to a history of early introductions and intentional stockings of diploids and triploids.

Response: We do not view our Triploid Grass Carp Inspection and Certification Program as a failure. Presence of diploid and triploid grass carp in the United States is a combination of widespread intentional introductions for weed control and establishment of feral populations due to unintentional introduction or escape. Grass carp were widely distributed throughout the United States during the 1970s prior to the establishment of our Triploid Grass Carp Inspection and Certification Program, and stockings continue. Feral grass carp were reported from open river systems during the 1970s. It was not until 1983 that a private fish hatchery in Arkansas produced the first triploid grass carp on a commercially viable scale. In 1985, the Service established a triploid grass carp ploidy inspection program to aid States that wished to receive only triploid grass carp. The triploid certification program for grass carp is completely voluntary, and the purpose of the program is to assure State agencies that no diploids will be shipped to these States within the confidence limits (95 percent confidence protocol) of the program. Juvenile black carp look very similar to juvenile grass carp, and there is high likelihood of misidentification of the two species. In addition, black carp could establish and thrive in the United States in habitats similar to those utilized by grass carp.

Issue: A number of commenters stated that the current methods of producing triploid fish do not ensure all fish are triploid; there is a range of effectiveness of induction procedures.

Response: We have received comments from many people agreeing that current induction methods do not produce 100 percent triploid lots of fish; the ranges provided to the Service were from 60 percent to near 95 percent.

Issue: Several commenters noted that there is no evidence in the literature that triploid black carp are reverting to diploids and that the reproductive potential of triploid black carp is essentially zero.

Response: The peer-reviewed studies that have been conducted for triploidy in grass carp have not been done on black carp. We recognize that grass carp and black carp are similar animals, but we cannot assume the applicability of grass carp studies for black carp. To date, functional sterility has not been confirmed in triploid black carp. While the reproductive potential of triploid black carp was evaluated, the focus of our injurious wildlife evaluation was on the injuriousness or potential injuriousness of all forms of black carp on wildlife and wildlife resources of the United States.

Issue: One respondent stated that the proposed rule was written to mislead readers concerning the situation facing fish farmers, because it doesn't include available information on current uses of black carp and the need for this fish.

Response: The Service did not write the proposed rule to mislead readers; we used the most accurate information that was available when we wrote the proposed rule. The Service has also provided four opportunities for public comment in an effort to gain the best available scientific and economic information. In this final rule, we have used additional and new information provided during the last 4 years, since the proposed rule was published.

Issue: One respondent noted that black carp have been in the United States for 30 years and are not a popular food fish. If there was potential to raise them for food, farmers would have begun raising them by now. Further, if States are restricted to triploids, raising black carp as food fish would be even less likely due to the cost of raising triploid fish.

Response: We appreciate the information provided and note that if we were not listing black carp as injurious wildlife, anyone could raise black carp for any purpose, if regulations allow it. The Service received information that canned black carp were preferred over tuna in blind taste tests.

Issue: Numerous industry respondents asked the Service to consider listing only diploid black carp, not triploid black carp.

Response: We considered the alternative of listing only diploid black carp and specifically asked for comment and data on this alternative in the August 30, 2005, to December 16, 2005, public comment period (70 FR 51326). Our decision to list diploid and triploid black carp as injurious wildlife under the Lacey Act is based solely on the biological characteristics of the fishes and the need to protect our native wildlife and wildlife resources. We have substantial scientific data that describes the harm that black carp cause when introduced outside of their native range and are likely to cause if populations are introduced in U.S. waters.

Issue: Many respondents expressed concern about enforcement challenges for distinguishing triploids and incidental transport of black carp in other fish shipments, because it is difficult to distinguish them from juvenile grass carp.

Response: Because diploid and triploid black carp look identical, we agree it would be difficult for law enforcement to distinguish between the two. At various life stages, black carp could be mistaken for grass carp and moved to new waters. We considered this concern in our evaluation.

Issue: Many respondents expressed concern about introductions of black carp to new waters from contamination of baitfish or bait buckets.

Response: The Service is also concerned about black carp being moved to new areas through bait bucket transfers. We considered this concern in our evaluation.

Issue: Several commenters noted that the proposed rule will not result in the destruction of existing broodstock, and reproductively viable black carp will continue to be held within the borders of Arkansas and Mississippi, where they will continue to be spawned for aquaculture use within each respective State's borders. The proposed rule will in no way impact intrastate movement of black carp.

Response: The Service agrees with these comments. An injurious wildlife listing prohibits importation and interstate transport of a species. Any regulation pertaining to the possession or use of black carp within States continues to be the responsibility of each State. Each State has the right to determine if the fish remain legal within that State's borders. Assuming black carp are legal in a given State, owners retain the right to possess the fish and to use them in any legal way according to State laws.

Issue: Several commenters stated that the proposed rule was in error when stating that testing individual fish to verify triploidy is not economically feasible. Testing individual fish is the industry standard for grass carp.

Response: The Service acknowledges that under the current program protocols, producers test every fish for ploidy status prior to certification sampling. However, the Service protocol for certifying triploid grass carp is to test a subsample (120 of 1,500 or more fish) of the entire lot of fish, not to test every fish, unless specifically requested and reimbursed by a recipient or the producer. We do not feel the proposed rule was in error when it stated that “testing each fish would be cost-prohibitive.” Costs would increase if each fish were individually tested for certification. Some respondents indicated that due to increased costs, they would buy less expensive diploids rather than paying more for certified triploids. Given the increased cost of testing each fish, chemical control methods might be more cost effective.

Issue: Several respondents stated that the “Industry” is willing to pay for certification of triploid black carp so that no Federal cost would be associated.

Response: While the Service is pleased to hear some industry members would be willing to pay for certification of triploid black carp, we do not have the authority to require certification of triploid black carp. We sincerely hope all users of black carp are currently paying producers to obtain certified triploid black carp, regardless of a requirement from a Federal agency.

Issue: Several commenters stated that all States that allow the use of black carp (Arkansas, Florida, Louisiana, Mississippi, Missouri, North Carolina, Oklahoma, and Texas) require triploid certification.

Response: The Service has not been provided data from each State showing that they require triploid certification in order for a use permit to be issued. As previously mentioned, we evaluated the alternative of not adding triploid black carp to the list of injurious wildlife, but the data indicated that both triploid and diploid black carp are injurious or potentially injurious to the wildlife and wildlife resources of the United States.

Issue: A number of commenters asked the Service to reinstate the triploid black carp certification program. Concerns over potential environmental impacts could be ameliorated by a mandated sterile triploid black carp program. In addition, the Service was asked to allow reputable hatcheries to maintain diploid carp, but to restrict sale of black carp to triploids with quality control, inspection, and third-party certification.

Response: During the period that the Service inspected black carp for ploidy status (1993-1999), there was voluntary participation by fish farmers in the certification; not every farm participated and bought the more expensive triploids. Those inspections were discontinued after the Service was petitioned to list black carp as injurious under the Lacey Act, and we do not intend to re-initiate black carp triploid certifications. The effectiveness of any triploid certification program is dependent upon effective inspection, certification, and enforcement programs that prevent the intentional or unintentional shipment of diploid individuals as triploids. To date, functional sterility has not been confirmed in triploid black carp. We have not been provided documentation by each State that allows use of black carp showing that State requires testing and certification of every black carp as triploid. The process could be required by States prior to permitting the use of black carp.

The triploid certification program for grass carp is completely voluntary, and the purpose of the program is to assure States that, within the limits of the program, no diploids will be shipped to their States. Based on scientific investigations published in peer-reviewed literature, triploid grass carp are functionally sterile. However, the triploid induction process is less than 100-percent effective, resulting in diploid and triploid grass carp that must be correctly identified and separated.

Issue: Several commenters asked the Service to conduct an environmental assessment.

Response: The Service conducted an environmental assessment on the impact to the environment of three alternatives to listing black carp as an injurious species. The final environmental assessment and the “finding of no significant impact” (FONSI) can be obtained at http://www.fws.gov/contaminants/Issues/InvasiveSpecies.cfm.

Issue: On August 29, 2007, the Service received a “request for correction” under the Information Quality Act (IQA). As provided for in OMB's government-wide Information Quality Guidelines, we have elected to use the existing, parallel process to reply (i.e., we are responding to the substance of the request in this response to comments).

Response: The primary concerns raised in the IQA request and the information proposed for correction had already been provided to the Service during the three comment periods associated with the proposed rule, the draft economic analysis, the initial regulatory flexibility analysis, and the draft environmental assessment. Thus this information had already been considered, and in many cases incorporated, during preparation of our final listing determination, final economic analysis, Final Regulatory Flexibility Analysis, and final environmental assessment. The key issues raised included economic impacts associated with trematode range expansion; economic impacts to the hybrid striped bass industry; our estimates of black carp use; distributional impacts; black carp consumption rates; and average catfish price per pound. The final economic analysis addresses the potential trematode range expansion with the impacts of a 20 percent annual increase for 10 years. The economic impacts of restricting black carp use in the hybrid striped bass industry are analyzed with a wide range of potential acres affected due to the uncertainty of the amount of use of black carp in striped bass production. The Service reviewed the range of estimates of acreage using black carp to control trematodes and settled on the most reliable source for the final economic analysis. Black carp consumption of 3-4 pounds of mollusks per day was supported by research findings and therefore was used in the final economic analysis. The long-term average price per pound of catfish of 70 cents per pound was used for the final economic analysis. After all information received during the public comment periods was incorporated into the final economic analysis, the total economic effect for catfish ranged from $30.5 to $37.7 million dollars for a 10-year present value. The few additional details raised in the request that had not been raised explicitly within the context of public comment did not suggest the need for additional changes to our analysis.

We asked three scientists who have knowledge of fisheries biology or invasive species to provide peer review of the proposed rule (67 FR 49280, July 30, 2002). The three peer reviewers had a few technical comments, which we incorporated into this final rule. All three peer reviewers concluded that the data and analyses we used in the proposed rule were appropriate and the conclusions we drew were logical and reasonable.

The regulations contained in 50 CFR part 16 implement the Lacey Act (18 U.S.C. 42), as amended. Under the terms of the injurious wildlife provisions of the Lacey Act, the Secretary of the Interior is authorized to prohibit the importation and interstate transportation of species designated by the Secretary as injurious. Injurious wildlife are those species, offspring, and eggs that are injurious to wildlife and wildlife resources, to human beings, and to the interests of forestry, horticulture, or agriculture of the United States. Wild mammals, wild birds, fish, mollusks, crustaceans, amphibians, and reptiles are the only organisms that can be added to the injurious wildlife list. The lists of injurious wildlife are at 50 CFR 16.11-16.15.

By adding all forms of live black carp, gametes, viable eggs, and hybrids to the list of injurious wildlife, their importation into, or transportation between, States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States by any means whatsoever is prohibited, except by permit for zoological, educational, medical, or scientific purposes (in accordance with permit regulations at 50 CFR 16.22), or by Federal agencies without a permit solely for their own use. Federal agencies who wish to import live black carp, gametes, viable eggs, and hybrids for their own use must file a written declaration with the District Director of Customs and the U.S. Fish and Wildlife Service Inspector at the port of entry. The interstate transportation of any live black carp, gametes, viable eggs, and hybrids currently held in the United States for any purpose is prohibited without a permit. No live black carp, gametes, viable eggs, or hybrids imported or transported under permit may be sold, donated, traded, loaned, or transferred to any other person or institution unless such person or institution has a permit issued by the U.S. Fish and Wildlife Service. Any regulation pertaining to the possession or use of live black carp, gametes, viable eggs, and hybrids within States continues to be the responsibility of each State.

Black carp, a Cyprinid species also known as snail carp, black amur, or Chinese roach, is a freshwater fish that inhabits lakes and primarily lower reaches of large, fast-moving rivers and associated backwaters, including canals and reservoirs. Black carp can often exceed 1 meter (m) in length and weigh, on average, 15 kg (33 pounds). They reportedly can reach 1.5 m (5 feet) or more total length and weigh 70 kg (150 pounds) or more. In certain culture situations, black carp exhibit their most rapid increase in body length during ages 1 and 2 years, and their most rapid rate increase in body weight during ages 3 and 4 years. Fish stocked at lengths of around 13-15 cm have attained weights of nearly 4 kg after only 1 year. Individuals of the species are known to live to at least 15 years of age.

Black carp coloration varies from black to dark brown to greenish black on top and yellow to whitish on the underside. Pharyngeal (throat) teeth typically form a single row of 4 or 5 large molar-shaped teeth on each of their two arches. The size, number, and shape of the teeth change with age. Black carp adults and larger juveniles superficially appear very similar to grass carp ( Ctenopharyngodon idella ). Adult black carp may be distinguished from grass carp externally by the color and the more cylindrical form of the body, and internally by the pharyngeal teeth. Small juvenile black carp are more difficult to distinguish from young grass carp.

The species inhabits most major drainages of eastern Asia from about 22° N to about 51° N latitude. The natural range of black carp includes much of the eastern half of China, parts of far eastern Russia, and possibly northern Vietnam. Published records of black carp from Taiwan and Japan likely represent introductions.

Black carp typically inhabit the middle and bottom parts of the water column. Because of their large size, adults face few, if any, predators, though their drifting eggs and larvae are consumed by small fishes.

Black carp usually reach sexual maturity from 6 to 11 years of age, but can mature as young as 3 years of age. Males usually mature a year earlier than females. They reproduce annually in riverine environments. Pond-reared black carp can be induced to spawn two to three times a year. In their natural range, spawning occurs in late spring and summer, with water temperatures ranging from 20-30 °C and rising water levels. They spawn upstream in rivers and their eggs drift downstream. The eggs are carried by currents into floodplain lakes, smaller streams, and channels with little to no current. Female black carp produce 1-3 million eggs each year, depending on body size. Growth rates are dependent on food quantity and quality; black carp can weigh as much as 5 kg in 3 years. Black carp grow slowly if mollusks are not included in their diet.

Black carp feed on zooplankton and fingerlings when young. Larger juveniles and adult black carp are bottom feeders that almost exclusively eat mollusks (mussels and snails) when available, but can eat insects, shrimp, commercial fish feeds and macrophytes (aquatic plants). As adults, powerful teeth permit the black carp to crush the thick shells of large mollusks. Although black carp reportedly have small mouths for their size, they attain sizes and gape (mouth) widths much larger than most native mollusk-eating fish. Gape width increases with body length. Reports indicate that the fish can usually handle any food item that it can get into its mouth. Rates of consumption are varied in the literature, but a 4-year-old black carp was shown to eat, on average, 3 to 4 pounds of zebra mussels per day in pond culture.

Black carp originally entered the United States in 1973 as a “contaminant” in imported grass carp or other Chinese carp stocks. Black carp appear very similar to grass carp, specifically in terms of body size and shape, position and size of fins, and position and size of the eyes. Juveniles, in particular, are difficult to distinguish from young grass carp. The second introduction of black carp into the United States occurred in the early 1980s in Southeast fish production ponds for biological control of yellow grub ( Clinostomum marginatum ), a trematode parasite, and as a potential food fish. Black carp have become more commonly used and transported since the first importations, particularly in the late 1990s.

The predominant use of black carp in the United States is for biological control of snails that are intermediate hosts in the life cycle of several parasites, which affect cultured channel catfish ( Ictalurus punctatus ), hybrid striped bass ( Morone saxatilis crossed with M. chrysops ), and some baitfish (fathead minnow ( Pimephales promelas ), for example). Yellow grub is a parasite that infects fish, and can cause economic losses to baitfish and hybrid striped bass farmers. The life cycle of the grub involves snails and fishes as intermediate hosts and fish-eating birds as final hosts. A second trematode parasite, Bolbophorus damnificus (previously reported to be B. confusus ), has also appeared in snails in channel catfish culture ponds, primarily in 1999, but does not infect hybrid striped bass. Fathead minnows have been shown to carry B. damnificus and another Bolbophorus species, named “type 2”; this second species appears to infect hybrid striped bass. Mild active trematode infections reduce production by reducing feed consumption and increasing susceptibility to other bacterial infections or diseases. Fully developed metacercariae (parasite stage) does not appear to compromise the growth performance and health status of fish. Deleterious effects of B. damnificus are associated with the penetration of the parasite and the initial stages of encystment. Research has shown that once infected fish are removed from the source of the infection, chronic B. damnificus infections do not affect the growth potential of channel catfish or increase their susceptibility to Enteric Septicemia of Catfish (ESC).

Black carp have been or are currently being maintained in research and fish production facilities in at least Arkansas, Florida, Iowa, Louisiana, Mississippi, Missouri, North Carolina, Oklahoma, and Texas. According to data reported to the U.S. Geological Survey, as of 2005, black carp have been caught from natural waters in Missouri, Illinois, Louisiana, and Arkansas.

As early as 1994, black carp fingerlings were delivered with catfish into the State of Missouri. In 2000, black carp were identified in a dealer's bait fish load. At least 300-400 were delivered in one week alone, which were distributed to and sold by bait stores throughout the State. Hundreds of young black carp were also accidentally included in shipments of live baitfish sent from Arkansas to bait dealers in Missouri as early as 1994.

There is a report of approximately 30 black carp escaping into open waters of the United States in the Osage River (Missouri River drainage) in April 1994, though this report is disputed by the facility owner. The first black carp reported captured from the wild was in March 2003 from Horseshoe Lake, Illinois. Analysis indicated that the fish was a 4-year-old triploid, and thus could not have escaped in 1994. A 9-year old black carp was captured in lower Red River, Louisiana, in April 2004 by a commercial fisher; testing of eye fluid indicated the fish was likely diploid. A 7-year-old black carp was captured in the lower Red River, Louisiana, in May 2004; this fish was also likely diploid. In June 2004, one black carp was collected in the Mississippi River near Lock and Dam 24 in Clarksville, Missouri; ploidy testing of this specimen was not possible. Another black carp was also collected from the main channel of the Mississippi River in Louisiana, near Simmesport in July 2004. The commercial fisher who captured the specimen sold it as a grass carp. In August 2004, a diploid black carp was collected from the Atchafalaya River at Simmesport, Louisiana. On April 5, 2005, a black carp was found in the White River, just north of DeVall's Bluff, Arkansas; the fish was sold before ploidy could be tested. The source of the introduction of these wild-caught fish is unknown.

These records include only self-reported documentations of black carp found in the wild; other escapes and captures in the wild may have occurred but have not been reported. Recent reports indicate that commercial fishers working in the Atchafalaya River basin have been catching 8 to 15 black carp per year, of unknown ploidy, since the early 1990s. It is not known whether black carp are reproducing in the wild; it is difficult to capture small, juvenile fish, especially when numbers are low as they would be for a new introduction. However, the continued captures of adult black carp in Louisiana and in other parts of the Mississippi River basin suggest that the species is reproducing and may be established.

Black carp can either be triploids (presumed sterile) or diploids (capable of reproduction). Triploid fish are created by adding an additional chromosome set (3 total) to induce sterility. Triploidy is one management tool to prevent reproduction and control populations in stocked fish. Externally, triploid fish are indistinguishable from diploid fish. Fish farmers have been successful in inducing triploidy in both black carp and grass carp. Triploids can be distinguished from diploids by testing the red blood cells.

Fish ploidy (the number of sets of chromosomes in a cell or an organism) is most commonly tested during aquaculture production with a particle size analyzer (i.e., Coulter Counter® with channelyzer), which usually tests the red blood cell volume to determine if a fish is triploid or diploid. This method provides a rapid, relatively easy determination of ploidy. However, the size of blood cells differs naturally and there may be overlap between the size of diploid and triploid blood cells. Ploidy can also be tested using flow cytometry, one of the techniques having the greatest accuracy, which measures the amount of DNA in a blood or tissue cell. This method is more expensive and sample preparation takes longer.

In addition to black carp, snail populations in fish production ponds may be controlled by hydrated lime, copper sulfate, weed control, Bayluscide®-M 70% WP, crayfish, and potentially some native fish species. However, chemical treatment for snails can be limited in some areas, because chemical agents can be detrimental to fish or can have decreased effectiveness due to wind, temperature conditions, water chemistry, and pond size. Clearing of aquatic plants has been found to be effective in reducing snail numbers, but is time consuming in large-scale operations. Bayluscide-M 70% WP can be used as a molluscicide in aquaculture ponds, but fish from treated ponds cannot be harvested for 12 months. Also, Bayluscide®-M 70% WP is toxic to fingerlings and cannot be used near other sensitive fish species, such as paddlefish.

Black carp are used as a biological control because they eat infected snails in ponds but are not susceptible to the trematode. Controlling the trematodes by using black carp is preferable to other methods available for aquaculture producers. Other fishes that are indigenous to the United States, including the redear sunfish, redear hybrids, the pumpkinseed sunfish, and the freshwater drum, hold potential to be used for snail control in aquaculture ponds.

Where food is available, the black carp's range (survival and/or reproduction) in the United States would likely include most of the major tributaries of the large river systems, including the lower and upper Mississippi, Tennessee, White and Red in Arkansas, Sacramento/San Joaquin, Columbia, Snake, South Atlantic Gulf, and Great Lakes.

The likelihood of release or escape of black carp is high. Diploid and triploid black carp have been found in the wild. Currently, the predominant use of black carp in the United States is for biological control of snails that are intermediate hosts in the life cycle of a trematode that affects fish being farmed for human consumption (channel catfish) or to be stocked in waters (hybrid striped bass), and that use has increased since the late 1990s. To a lesser extent, black carp are used to control snails in baitfish production ponds. Ninety-five percent of the catfish farms in production are located in the southeastern United States. The most likely source of introduction of black carp is through human movement. Much of the Mississippi River delta region is at moderate to high risk of natural disaster, including tornados, floods, and hurricanes. A natural disaster in the Southeast region is likely to result in the release of black carp from fish farms through flooding. An additional, though lower, risk of release associated with fish farming includes the movement of live black carp from farm ponds to natural waterways via predatory birds and mammals. Black carp are farm-raised in aquaculture facilities throughout Asia and Eastern Europe for human consumption. If black carp become popular for human consumption in the United States and are farmed on a larger scale, the associated risks of release would be similar to those described above. However, the risks would be of greater magnitude, as the black carp would be stocked at aquaculture facilities at a higher rate than they are currently stocked for biological control purposes.

If black carp were introduced into the wild, they would likely survive or become established with or without reproduction. Moreover, black carp would likely spread throughout the large rivers of the United States, because no known limiting factors would preclude them from becoming established in U.S. waters. The black carp, a native of most Pacific drainages in eastern Asia, inhabits large river and lake habitats at the same latitudes as the United States and feeds on aquatic snails and mussels that are similar to those locally abundant in many of our rivers.

At various life stages, black carp could be mistaken for grass carp and moved to new waters through misidentification. They also could be moved to new areas through baitfish sales or bait bucket transfers.

Under artificial conditions, black carp have been crossed, with limited success, with grass carp, silver carp, bighead carp, common carp, and black bream ( Megalobrama terminalis ), but natural hybridization with other Asian carps has not been documented. Researchers have reported that offspring resulting from female black carp × male grass carp had pharyngeal teeth resembling those of black carp, but the pharyngeal teeth formula of hybrids was found to be highly variable. Teeth of hybrid individuals from the female grass carp × male black carp cross differed significantly from those of both parents. In these fish, the teeth were broad like that of black carp, but there was a small hook in the crown. Because of the variation, researchers could not predict what the type of feeding behavior and diet the hybrids would have in nature. Feeding habits of hybrids might be similar to those of pure black carp, thus eating primarily mollusks, or they might be closer to those of pure grass carp, consuming primarily aquatic vegetation, but the outcome of hybridization is unpredictable.

At all life stages, black carp will compete with native species for food. The fish can grow to lengths greater than 1 meter and could weigh from 30 to 150 pounds, depending upon age and food availability. Within their native range, black carp feed on species that are similar to our native mollusk species. Black carp are also known to eat freshwater shrimp, crawfish, and insects. Daily intake of food could be as high as 20 percent of body weight. Based on their feeding habits, black carp, if introduced or established, are highly likely to have a considerable impact on native mussel and snail populations. Entire beds of mussels may be very vulnerable to heavy predation by black carp. Mollusks are a food source for a variety of native animals, including fishes (redear sunfish, pumpkinseed sunfish, freshwater drum, snail bullhead, copper redhorse, river redhorse, robust redhorse, and several catfish and sucker species); river and lake turtles (sawbacks ( Graptemys spp.) and musk turtles ( Sternotherus spp.), including several that are Federally listed as endangered or threatened ( G. flavimaculata, G. oculifera and S. depressus ); birds (Everglades snail kite, scaup, limpkin, and canvasback); and mammals (raccoons, otters, and muskrats). Reduced mollusk abundance would result in reduced availability of food for those animals, and thus decrease biodiversity.

Although black carp reportedly have small mouths for their body size, they attain sizes much larger than most native mollusk-eating fish. There are no known native fish with the same combination of size, morphology, and diet. Consequently, black carp could put a whole new suite of species not currently subject to fish predation at substantial risk and thus considerably change ecosystem function by altering the existing food web.

Although their potential to cause habitat destruction is low, black carp would likely impact stream communities where snails play an important role as grazers of attached algae and mussels act as filters for phytoplankton. Reduction of snail and mussel populations in those ecosystems would likely facilitate production of algae mats that may upset the natural balance of wildlife habitats.

Black carp host many parasites and flukes, as well as bacterial and viral diseases that are likely to infect sport, food, or fish species on the Federal List of Endangered and Threatened Wildlife. They may also be immune, or serve as intermediate hosts, to the many parasites that use mollusks as intermediate hosts (some of which are harmful to humans). Black carp that are already in the United States pose little to no risk for introducing new pathogens, but any new imports could carry new pathogens. Black carp have been used to successfully control snail hosts for Schistosoma in humans, which according to the World Health Organization and the U.S. Centers for Disease Control does not occur in the United States, though a U.S. citizen may contract the disease while traveling.

The likelihood and magnitude of effects of black carp on threatened and endangered species is high. As molluscivores, black carp have the potential to negatively affect threatened and endangered mollusks, fish, turtles, and waterfowl that rely on mollusks as a food source. Locally, introduced black carp, whether diploid or triploid, could severely deplete mollusk populations and further imperil the 106 mussels and snails designated as threatened or endangered under the Endangered Species Act (ESA). The United States, particularly the Southeast, has one of the world's most diverse aquatic mollusk faunas. Currently, about 300 taxa of freshwater mussels are recognized nationwide, and nearly 67 percent of this fauna are vulnerable to extinction or already extinct. Seventy species of the 297 mussels native to the United States are designated as endangered or threatened species under the ESA, and many other species have declined in abundance and distribution. Our nation's freshwater snail diversity is about 600 species, or about 15 percent, of the world's diversity of this faunal group. Nearly 10 percent of all freshwater snails are extinct, and 25 freshwater snails are designated as threatened or endangered under the ESA in the United States. The rate of imperilment of snails exceeds every other major animal group in North America, even freshwater mussels, due to dam construction, other habitat alterations, and pollution.

Based on their food habits, habitat preferences, and longevity, black carp could become established with or without reproduction in the habitat supporting most of the federally protected freshwater mussels and about one-third of the federally protected freshwater snails. Black carp are likely to also further threaten numerous other potential candidates for Federal protection. The establishment of black carp populations, with or without reproduction, particularly in the Mississippi drainages, has the potential to reduce mollusk populations to levels that would necessitate protection under the ESA for additional mollusks and other animals that depend on mollusks for food. Since many freshwater mollusks require a fish as an intermediate host for reproduction, the mussels that require native fishes to reproduce are likely to rapidly decline if their fish hosts are affected by black carp.

Even a few introduced black carp could impact mollusk populations in local areas, as they have been shown to be effective at eating nearly all of the mollusks where they have been stocked. Freshwater mollusks play an important ecological role in maintaining the health of aquatic ecosystems.

To date, freshwater mollusks in the United States have not experienced the introduction of a nonindigenous invasive species in the form of a direct predator. Presence of diploid or triploid black carp could pose a serious threat to many of the remaining populations of endangered and threatened mollusks. Many species of native mollusk-eating fishes do not feed as exclusively on mussels and snails as black carp. Black carp are feeding specialists, but there is a risk that if mollusks become limited, black carp may switch to eating crayfishes and other crustaceans, many of which are imperiled. Black carp have a larger gape width than most native mollusk-eating fishes and pose a greater threat to native mussels and snails. The introduction of individuals or large populations of black carp in the Mississippi River could hasten the decline of mollusk species in the Mississippi River basin due to the black carp's longevity, size, and feeding habits. Entire beds of mussels may be very vulnerable to heavy predation by black carp.

Since some States allow diploid use of black carp, a reproducing population could become established in U.S. waters, thereby imperiling recovery of native freshwater mollusks that are designated as threatened or endangered species under the ESA and potentially degrading habitat for native fishes. Several States and the U.S. Fish and Wildlife Service are currently implementing programs to recover imperiled mollusk populations.

The introduction or establishment of black carp may have negative impacts on humans primarily from the loss of native aquatic mollusk biodiversity and abundance. Freshwater mollusks play an important ecological role in maintaining the health of aquatic ecosystems. These losses would affect the aesthetic, recreational, and economic values currently provided by native mollusks and healthy ecosystems. Educational values would also be diminished through the loss of biodiversity and ecosystem health. Black carp also have the potential to negatively affect the cultured pearl industry through predation on commercial mussel species.

Structural measures designed to prevent the escape or establishment of black carp in U.S. waters have proven to be ineffective, as black carp have been found in the wild. Most protective measures available to prevent escape of black carp from aquaculture facilities are expensive to install and maintain. Even with protective measures in place, it is unlikely these measures would eliminate risks of accidental escape from facilities; those facilities that are located in floodplains and susceptible to natural storm events are particularly vulnerable.

Since widespread surveys of U.S. waterways are not conducted to establish species” presence, barring a sporadic capture, it is unlikely that the existence of black carp would be discovered until the numbers were high enough to impact wildlife and wildlife resources. A delay in discovery would limit the ability and effectiveness to rapidly respond to the introduction and prevent establishment. It is highly unlikely that black carp could be eradicated from U.S. waterways, should they be introduced, unless they are found in unconnected waterbodies.

The ability to eradicate or control black carp populations depends on where they are found. If established in large lakes or river systems, eradication or control of black carp would be highly unlikely, and they would likely become permanent members of the fish community. No effective and feasible tools are currently available to manage black carp or other nonindigenous fish species, should they be introduced into river systems. Chemical piscicides are the best available option to reduce fish numbers, but their use on a largescale is prohibitively expensive, can cause mortality to non-target fish and aquatic species, is usually not accepted by the public, and requires repeated treatments. Chemicals rarely kill every fish, and not all life stages are equally susceptible to chemicals. Additionally, some areas cannot be effectively treated due the size of the area, the distribution of the target species, and the effects on the non-target species, for example.

Mollusk recovery programs require habitat restoration and removal of threats to the continued survival of the species. Re-establishment of extirpated mussel and snail populations, if biologically possible, is labor and cost intensive and would depend on eradication of black carp within the habitat of the mussels and snails.

Since effective measures to eradicate, manage, or control the spread of black carp once they are established with or without reproduction are not currently available, the ability to rehabilitate or recover ecosystems disturbed by the species is low. Significant risks associated with black carp escape relate to endangerment and local extinction of native mussels and snails. Re-establishment of extirpated mussel and snail populations, if biologically possible, is labor and cost intensive and would depend on prior eradication of black carp within the habitat.

There is little to no risk of new pathogens being spread by black carp, unless new fish are imported. Controlling the spread of pathogens once black carp have been introduced in the wild is impracticable as each infected fish would need to be captured to prevent spread. It would be highly unlikely that each infected fish could be captured. Further, the pathogen may have already been passed on to other fish species by the time the infected black carp have been discovered.

There is little, if any, ecological benefit from the introduction of black carp into open waters of the United States. While there are benefits to farmed fish from black carp introduction into aquaculture facilities, we have determined there are no ecological benefits to black carp introduction into natural waters of the United States. The introduction of black carp in open waters might provide a potential ecological benefit to native wildlife and wildlife resources if black carp could selectively consume non-native invasive mollusks, such as zebra mussels, without consuming native mollusks. However, there is no scientific evidence to support the notion that black carp would selectively prey on non-native invasive mollusks in open waters, and little evidence that they are capable of feeding on aggregate zebra mussels. The introduction of black carp in open waters might theoretically provide a potential ecological benefit to native wildlife by consuming snails that spread disease to other fish species, a function that black carp perform in aquaculture facilities such as fish ponds. However, outside of the context of aquaculture, the possibility of black carp locating and consuming a sufficient amount of disease-carrying snails to prevent the spread disease to other fish species is too remote and unlikely to be identified as a benefit.

We have received conflicting information on the effectiveness of triploidy induction techniques for black carp; some indicate effectiveness as high as 85-98 percent, while others experienced induction resulting in approximately 60 percent triploid fish lots. In general, and primarily for other fish species, the literature indicates that triploidy induction techniques usually do not produce 100 percent triploid fish.

As previously mentioned, fish ploidy (the number of sets of chromosomes in a cell or an organism) is most commonly tested during aquaculture production with a particle size analyzer ( i.e. , Coulter Counter® with channelyzer), which usually tests the red blood cell volume to determine if it a fish is triploid or diploid. Ploidy can also be tested using flow cytometry, which measures the amount of DNA in a blood or tissue cell. This method is more expensive and sample preparation takes longer. As in all analytical techniques, rigid protocols must be observed to ensure that one can distinguish between triploid and diploid fish. If cell volume overlaps between diploid and triploid fish, then there may be an inherent error in the methodology. While testing red blood cell volume has been shown to be effective in verifying ploidy status in other fish (90 to 93.8 percent for saugeyes), it has not been shown to be 100 percent effective for black carp.

Research conducted at the USGS’ Columbia Environmental Research Center demonstrated that the aquaculture industry standard for determining ploidy (i.e., the Coulter Counter® method) classified 1,000 black carp as triploid, but 2 of them were found to be diploid using flow cytometry. Followup sampling produced similar results and additional research is ongoing.

A small percentage of triploid fish produce functional sperm, but if spawning occurred, it is reported as highly unlikely that viable embryos would be produced (0.17 percent for grass carp). Other research, however, has shown that young have been produced. Extensive research has been conducted on triploid production of grass carp; that same level of research has not been conducted to validate that the grass carp methodology can be transferred to black carp.

While triploidy may impede breeding of black carp in the natural environment, non-breeding populations are still likely to have substantial negative impacts. Triploid black carp, which can live to be 15 or more years, can compete with native fish for food and locally prey on mollusks and fingerlings, including those designated as threatened and endangered species under the ESA.

While triploid black carp may not be able to reproduce, allowing black carp in commerce still presents problems. First, in order to have black carp for sale, someone must have reproducing pairs of the fish, which means that reproductively active fish could escape. Second, not all States require the use of certified triploids, so reproductively active fish could be found in otherwise triploid lots of fish. Finally, black carp will feed on native mollusks regardless of their reproductive capabilities. Black carp, whether diploid or triploid, have the potential to feed on large quantities of freshwater mussels and snails and have negative impacts on local native snail and mussel populations before they die of old age.

In summary, the Service finds all forms of live black carp, including gametes, viable eggs and hybrids, to be injurious to the interests of wildlife and wildlife resources of the United States because:

• Triploid and diploid black carp have escaped or been released into the wild;

• Black carp are highly likely to survive in U.S. waterways;

• Black carp are likely to spread because there are no known limiting factors;

• Black carp are highly likely to compete with native species, including threatened and endangered species, for food;

• Black carp are highly likely to feed on native mollusks, which is likely to negatively affect mollusks, as well as the native fish, turtles, and birds that rely on mollusks as a food source;

• It will be highly unlikely to prevent, eradicate, manage, or control the spread of black carp;

• It will be highly unlikely that ecosystems disturbed by the species would be rehabilitated or recovered;

• Non-breeding populations of black carp are likely to have substantial negative impacts on native snail and mussel populations, and

• There are no potential ecological benefits for U.S. waters from the introduction of black carp.

This rule contains potential information collection activity for FWS Form 3-200-42, Import/Acquisition/Transport of Injurious Wildlife. Completion of this form would be necessary to apply for a permit to import, or transport across State lines, any live black carp, gametes, viable eggs, or hybrids for scientific, medical, educational, or zoological purposes. The Service already has approval from the Office of Management and Budget (OMB) to collect information for this special use permit under OMB control number 1018-0093. This approval has been submitted to OMB for renewal. We 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.

(a) In accordance with the criteria in Executive Order 12866, OMB has designated this rule as a significant regulatory action. The following analysis presents summary impacts associated with the final rule. For the detailed economic analysis, refer to http://www.fws.gov/contaminants/ANS/ANSInjurious.cfm or contact the person listed under FOR FURTHER INFORMATION CONTACT .

Black carp are not marketed as a foodfish, nor are they exported by U.S. farmers. However, they are used by the aquaculture industry to control trematodes in fish ponds. Because numbers of domestic black carp broodstock are adequate, the aquaculture industry does not currently import black carp from sources outside the United States and most likely will not resume imports.

The implementation of this final rule will affect the importation and interstate transport of live black carp, gametes, viable eggs, and hybrids. Costs will increase for those businesses that can no longer use black carp to control snail populations. For aquaculture facilities in States with no in-State source of live black carp, they will no longer be able to import black carp to manage snail populations. If farmers cannot use black carp, they will use the most cost-efficient treatment that is suitable to their pond conditions (i.e., chemical control, native species as biological control, or a combination). Affected businesses are limited to those that (1) use black carp, (2) are located in a State that permits the use of black carp and does not produce black carp, and (3) produce black carp and ship black carp across State lines. States that do not allow the possession of any black carp include Alabama, Illinois, Indiana, Montana, New York, Ohio, and Tennessee. Businesses located in these States will not be affected. Furthermore, because black carp are produced within Arkansas, businesses located in that State will not incur additional costs, unless businesses inadvertently transport black carp across State lines and incur Lacey Act penalties.

To quantify the costs of listing diploid and triploid black carp as injurious wildlife on the aquaculture industry, the impacts on net revenue were estimated. Net revenue is the difference between the amount that farmers receive for their product and the costs incurred to produce that product. Impacts were quantified for the catfish and hybrid striped bass industries. Due to the lack of available data, the potential impacts to the baitfish industry were not estimated.

As noted by Tucker et al. (2004), “economic losses resulting from infectious diseases are difficult to quantify because record keeping varies among farmers and many diseases go unreported.” Estimating the potential impacts associated with adding black carp to the list of injurious species required a number of assumptions for the catfish, hybrid striped bass, and baitfish industries due to the uncertainties related to trematode outbreaks and the use of black carp to control those outbreaks. To account for these uncertainties, the economic analysis explored a variety of potential scenarios that may occur. The scenario with the maximum potential impact for each industry is presented below.

For the catfish industry, a number of assumptions were necessary. Assuming that (1) 4.1 percent of catfish farms use black carp, (2) demand for black carp will continue to increase 20 percent annually for the foreseeable future, (3) Arkansas continues producing triploid black carp, and (4) Alabama continues to prohibit black carp, then the estimated annualized lost net revenues will range between $22,061 and $454,201. Discounted at 3 percent, the 10-year present value impact will range between $483,000 and $9.9 million. Discounted at 7 percent, the 10-year present value impact will range between $391,000 and $8.0 million.

For the hybrid striped bass industry, the number of farms using black carp is unknown. Therefore, estimates were developed for three potential scenarios, including 10 percent, 26 percent, and 50 percent of hybrid striped bass farms using black carp. Due to limited data availability, the hybrid striped bass analysis assumes all States will be affected. Therefore, the impacts may be overestimated. Assuming (1) demand for black carp will increase 20 percent annually for the foreseeable future, and (2) 50 percent of hybrid striped bass farms use black carp, estimated annualized lost net revenues will be approximately $1.9 million. To calculate the present value for a 10-year time period, the social discount rates of 3 percent and 7 percent are applied per OMB guidance. Discounted at 3 percent, the 10-year present value impact to hybrid striped bass farms will be approximately $15.8 million. Discounted at 7 percent, the 10-year present value impact to hybrid striped bass farms will be approximately $12.9 million.

In addition to any increased losses associated with trematode outbreaks, farmers inadvertently shipping live black carp across State lines could face penalties for Lacey Act violations. The penalty for a Lacey Act violation is not more than 6 months in prison and a fine of not more than $5,000 for an individual and not more than $10,000 for an organization. The number of farmers that may inadvertently ship live black carp across State lines is unknown.

Businesses that produce black carp for sale across State lines will lose revenue from a smaller black carp market because they will no longer be able to ship across State lines. The potential impact is dependent on a variety of factors including the size of the market across State lines, the potential for businesses to increase production of black carp, and the potential for businesses to increase production of other species. Assuming the incidence of trematode outbreaks will increase at a rate of 20 percent per year, the impact to businesses producing black carp depends on whether they would have the capacity to increase black carp production. If businesses have the capacity to increase black carp production, then they would lose any potential increase in future revenue related to an increase in future demand for black carp. However, when the market for black carp is reduced due to this rule, businesses may also choose to increase production of other species. Thus, the response to a smaller black carp market is unknown, and the impacts to these businesses are uncertain.

While not entirely eliminating black carp as a threat to wildlife and wildlife resources, this final rule will reduce the pathways and chances for black carp being unintentionally introduced into river systems and tributaries. This analysis does not estimate the decreased probability of unintentional introduction, or the decreased probability of a black carp population becoming established. The quantified benefits of this rule focus on the replacement costs of freshwater mussels, as they may be impacted the most from black carp predation. While other mollusks would be at risk, specific damages for them will not be modeled due to a lack of relevant data. It is important to note that calculating the replacement costs for mussels does not fully value their benefits to the ecosystem, use values, and non-use values. It simply attempts to show the lost value of the mussels through their estimated replacement costs. Ecosystem benefits are not quantified.

The replacement costs outlined by the American Fisheries Society are composed of production costs, restocking costs, and administration costs. Table 1 shows the avoided replacement costs to native mussel populations if only one triploid black carp is prevented from unintentional introduction.

Several of the background documents for the ALWTRP and the take reduction planning process can be downloaded from the ALWTRP Web site at http://www.nero.noaa.gov/whaletrp/.

The ALWTRP was developed pursuant to section 118 of the Marine Mammal Protection Act (MMPA) to reduce the incidental mortality and serious injury of three endangered species of whales (right, fin, and humpback) due to incidental interaction with commercial fishing activities. In addition, the measures identified in the ALWTRP would provide conservation benefits to a fourth species (minke), which are neither listed as endangered nor threatened under the Endangered Species Act (ESA). The ALWTRP, implemented through regulations codified at 50 CFR 229.32, relies on a combination of fishing gear modifications and time/area closures to reduce the risk of whales becoming entangled in commercial fishing gear (and potentially suffering serious injury or mortality as a result).

On January 9, 2002, NMFS published the final rule to implement the ALWTRP's DAM program (67 FR 1133). On August 26, 2003, NMFS amended the regulations by publishing a final rule, which specifically identified gear modifications that may be allowed in a DAM zone (68 FR 51195). The DAM program provides specific authority for NMFS to restrict temporarily on an expedited basis the use of lobster trap/pot and anchored gillnet fishing gear in areas north of 40° N. lat. to protect right whales. Under the DAM program, NMFS may: (1) Require the removal of all lobster trap/pot and anchored gillnet fishing gear for a 15-day period; (2) allow lobster trap/pot and anchored gillnet fishing within a DAM zone with gear modifications determined by NMFS to sufficiently reduce the risk of entanglement; and/or (3) issue an alert to fishermen requesting the voluntary removal of all lobster trap/pot and anchored gillnet gear for a 15-day period and asking fishermen not to set any additional gear in the DAM zone during the 15-day period.

A DAM zone is triggered when NMFS receives a reliable report from a qualified individual of three or more right whales sighted within an area (75 nm 2 (139 km 2 )) such that right whale density is equal to or greater than 0.04 right whales per nm 2 (1.85 km 2 ). A qualified individual is an individual ascertained by NMFS to be reasonably able, through training or experience, to identify a right whale. Such individuals include, but are not limited to, NMFS staff, U.S. Coast Guard and Navy personnel trained in whale identification, scientific research survey personnel, whale watch operators and naturalists, and mariners trained in whale species identification through disentanglement training or some other training program deemed adequate by NMFS. A reliable report would be a credible right whale sighting.

On October 5, 2007, an aerial survey reported and aggregation of three right whales in the proximity of 44°15′ N latitude and 67°11′ W longitude. The position lies approximately 30nm southeast of Machias, Maine. After conducting an investigation, NMFS ascertained that the report came from a qualified individual and determined that the report was reliable. Thus, NMFS has received a reliable report from a qualified individual of the requisite right whale density to trigger the DAM provisions of the ALWTRP.

Once a DAM zone is triggered, NMFS determines whether to impose restrictions on fishing and/or fishing gear in the zone. This determination is based on the following factors, including but not limited to: the location of the DAM zone with respect to other fishery closure areas, weather conditions as they relate to the safety of human life at sea, the type and amount of gear already present in the area, and a review of recent right whale entanglement and mortality data.

NMFS has reviewed the factors and management options noted above relative to the DAM under consideration. As a result of this review, NMFS prohibits lobster trap/pot and anchored gillnet gear in this area during the 15-day restricted period unless it is modified in the manner described in this temporary rule.

The DAM Zone is bound by the following coordinates:

In addition to those gear modifications currently implemented under the ALWTRP at 50 CFR 229.32, the following gear modifications are required in the DAM zone. If the requirements and exceptions for gear modification in the DAM zone, as described below, differ from other ALWTRP requirements for any overlapping areas and times, then the more restrictive requirements will apply in the DAM zone.

Fishermen utilizing lobster trap/pot gear within the portion of the Northern Nearshore Lobster Waters that overlap with the DAM zone are required to utilize all of the following gear modifications while the DAM zone is in effect:

1. Groundlines must be made of either sinking or neutrally buoyant line. Floating groundlines are prohibited;

2. All buoy lines must be made of either sinking or neutrally buoyant line, except the bottom portion of the line, which may be a section of floating line not to exceed one-third the overall length of the buoy line;

3. Fishermen are allowed to use two buoy lines per trawl; and

4. A weak link with a maximum breaking strength of 600 lb (272.4 kg) must be placed at all buoys.

Fishermen utilizing lobster trap/pot gear within the portion of the Offshore Lobster Waters Area that overlap with the DAM zone are required to utilize all of the following gear modifications while the DAM zone is in effect:

1. Groundlines must be made of either sinking or neutrally buoyant line. Floating groundlines are prohibited;

2. All buoy lines must be made of either sinking or neutrally buoyant line, except the bottom portion of the line, which may be a section of floating line not to exceed one-third the overall length of the buoy line;

3. Fishermen are allowed to use two buoy lines per trawl; and

4. A weak link with a maximum breaking strength of 1,500 lb (680.4 kg) must be placed at all buoys.

Fishermen utilizing anchored gillnet gear within the portions of the Other Northeast Gillnet Waters Area that overlap with the DAM zone are required to utilize all the following gear modifications while the DAM zone is in effect:

1. Groundlines must be made of either sinking or neutrally buoyant line. Floating groundlines are prohibited;

2. All buoy lines must be made of either sinking or neutrally buoyant line, except the bottom portion of the line, which may be a section of floating line not to exceed one-third the overall length of the buoy line;

3. Fishermen are allowed to use two buoy lines per string;

4. Each net panel must have a total of five weak links with a maximum breaking strength of 1,100 lb (498.8 kg). Net panels are typically 50 fathoms (91.4 m) in length, but the weak link requirements would apply to all variations in panel size. These weak links must include three floatline weak links. The placement of the weak links on the floatline must be: One at the center of the net panel and one each as close as possible to each of the bridle ends of the net panel. The remaining two weak links must be placed in the center of each of the up and down lines at the panel ends;

5. A weak link with a maximum breaking strength of 1,100 lb (498.8 kg) must be placed at all buoys; and

6. All anchored gillnets, regardless of the number of net panels, must be securely anchored with the holding power of at least a 22 lb (10.0 kg) Danforth-style anchor at each end of the net string.

The restrictions will be in effect beginning at 0001 hours October 20, 2007, through 2400 hours November 3, 2007, unless terminated sooner or extended by NMFS through another notification in the Federal Register .

The restrictions will be announced to state officials, fishermen, ALWTRT members, and other interested parties through e-mail, phone contact, NOAA Web site, and other appropriate media immediately upon issuance of the rule by the AA.

In accordance with section 118(f)(9) of the MMPA, the Assistant Administrator (AA) for Fisheries has determined that this action is necessary to implement a take reduction plan to protect North Atlantic right whales.

Environmental Assessments for the DAM program were prepared on December 28, 2001, and August 6, 2003. This action falls within the scope of the analyses of these EAs, which are available from the agency upon request.

NMFS provided prior notice and an opportunity for public comment on the regulations establishing the criteria and procedures for implementing a DAM zone. Providing prior notice and opportunity for comment on this action, pursuant to those regulations, would be impracticable because it would prevent NMFS from executing its functions to protect and reduce serious injury and mortality of endangered right whales. The regulations establishing the DAM program are designed to enable the agency to help protect unexpected concentrations of right whales. In order to meet the goals of the DAM program, the agency needs to be able to create a DAM zone and implement restrictions on fishing gear as soon as possible once the criteria are triggered and NMFS determines that a DAM restricted zone is appropriate. If NMFS were to provide prior notice and an opportunity for public comment upon the creation of a DAM restricted zone, the aggregated right whales would be vulnerable to entanglement which could result in serious injury and mortality. Additionally, the right whales would most likely move on to another location before NMFS could implement the restrictions designed to protect them, thereby rendering the action obsolete. Therefore, pursuant to 5 U.S.C. 553(b)(B), the AA finds that good cause exists to waive prior notice and an opportunity to comment on this action to implement a DAM restricted zone to reduce the risk of entanglement of endangered right whales in commercial lobster trap/pot and anchored gillnet gear as such procedures would be impracticable.

For the same reasons, the AA finds that, under 5 U.S.C. 553(d)(3), good cause exists to waive the 30-day delay in effective date. If NMFS were to delay for 30 days the effective date of this action, the aggregated right whales would be vulnerable to entanglement, which could cause serious injury and mortality. Additionally, right whales would likely move to another location between the time NMFS approved the action creating the DAM restricted zone and the time it went into effect, thereby rendering the action obsolete and ineffective. Nevertheless, NMFS recognizes the need for fishermen to have time to either modify or remove (if not in compliance with the required restrictions) their gear from a DAM zone once one is approved. Thus, NMFS makes this action effective 2 days after the date of publication of this document in the Federal Register . NMFS will also endeavor to provide notice of this action to fishermen through other means upon issuance of the rule by the AA, thereby providing approximately 3 additional days of notice while the Office of the Federal Register processes the document for publication.

NMFS determined that the regulations establishing the DAM program and actions such as this one taken pursuant to those regulations are consistent to the maximum extent practicable with the enforceable policies of the approved coastal management program of the U.S. Atlantic coastal states. This determination was submitted for review by the responsible state agencies under section 307 of the Coastal Zone Management Act. Following state review of the regulations creating the DAM program, no state disagreed with NMFS' conclusion that the DAM program is consistent to the maximum extent practicable with the enforceable policies of the approved coastal management program for that state.

The DAM program under which NMFS is taking this action contains policies with federalism implications warranting preparation of a federalism assessment under Executive Order 13132. Accordingly, in October 2001 and March 2003, the Assistant Secretary for Intergovernmental and Legislative Affairs, Department of Commerce, provided notice of the DAM program and its amendments to the appropriate elected officials in states to be affected by actions taken pursuant to the DAM program. Federalism issues raised by state officials were addressed in the final rules implementing the DAM program. A copy of the federalism Summary Impact Statement for the final rules is available upon request ( ADDRESSES ).

The rule implementing the DAM program has been determined to be not significant under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 800.

The 2007 Pacific cod sideboard limits apportioned to non-AFA crab vessels catching Pacific cod for processing by the inshore component in the Western Regulatory Area of the GOA is 1,635 metric tons (mt) for the GOA, as established by the 2007 and 2008 harvest specifications for groundfish of the GOA (72 FR 9676, March 5, 2007).

In accordance with § 680.22(e)(2)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2007 Pacific cod sideboard limits apportioned to non-AFA crab vessels catching Pacific cod for processing by the inshore component in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a sideboard directed fishing allowance for Pacific cod as 1,625 mt in the Gulf of Alaska. The remaining 10 mt in the Gulf of Alaska will be set aside as bycatch to support other anticipated groundfish fisheries. In accordance with § 680.22(e)(3), the Regional Administrator finds that this sideboard directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by non-AFA crab vessels catching Pacific cod for processing by the inshore component in the Western Regulatory Area of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the sideboard directed fishing closure of Pacific cod apportioned to non-AFA crab vessels catching Pacific cod for processing by the inshore component in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 10, 2007.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 680.22 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2007 Pacific halibut PSC limit for vessels using trawl was established as 2,000 metric tons by the 2007 and 2008 harvest specifications for groundfish of the GOA (72 FR 9676, March 5, 2007, as corrected by 72 FR 13217, March 21, 2007). The fishery was closed on October 8, 2007 (72 FR 57888, October 11, 2007) and was reopened on October 10, 2007.

The Administrator, Alaska Region, has determined, in accordance with § 679.21(d)(7)(i), that the 2007 Pacific halibut PSC limit allocated to vessels using trawl gear in the GOA will soon be reached. Therefore, NMFS is prohibiting directed fishing for groundfish by vessels using trawl gear in the GOA, except for directed fishing for pollock by vessels using pelagic trawl gear in those portions of the GOA that remain open to directed fishing for pollock. This closure also does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Pilot Program for the Central GOA.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay closing directed fishing for groundfish by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 12, 2007.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.21 and is exempt from review under Executive Order 12866.