        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Food and Drug Administration
        21 CFR Chapter I
        [Docket No. 2005N-0147]
        Sprout Safety Public Meeting

          AGENCY:
          Food and Drug Administration, HHS.

          ACTION:
          Notice of public meeting; request for comments.

          SUMMARY:
          The Food and Drug Administration (FDA) is announcing a public meeting to elicit information on the current science related to foodborne illness associated with the consumption of sprouts.  In October 2004, FDA released a produce safety action plan entitled “Produce Safety from Production to Consumption:   2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption” (Produce Action Plan).  One item in the Produce Action Plan is to initiate rulemaking to minimize foodborne illness associated with the consumption of sprouted seeds.  However, because of the complexities of the issues and the uncertainty about what the current science could support, FDA believes that it would be of value to hold a public meeting to gather information relevant to a possible regulation.  We request that those who speak at the meeting, or otherwise provide FDA with their comments, focus on the questions relating to the microbial safety of seeds destined for sprouting and sprouted seeds set out in section II of this document.

          DATES:

          The public meeting will be held in College Park, MD, on Tuesday, May 17, 2005, from 8:30 a.m. to 5 p.m.  We request that everyone planning to attend the meeting register prior to the meeting.  For security reasons and due to space limitations, we recommend that you register at least 5 business days before the meeting. You may register via the Internet and also by fax until close of business 5 days before the meeting, provided that space is available (see FOR FURTHER INFORMATION CONTACT).  In addition to participating in the public meeting, you may submit written or electronic comments until July 18, 2005.

          ADDRESSES:
          The public meeting will be held at the Harvey W. Wiley Federal Bldg., Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740-3835.

          Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  Submit electronic comments to http://www.fda.gov/dockets/ecomments.

          FOR FURTHER INFORMATION CONTACT:

          Amy L. Green, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 301-436-2025, FAX: 301-436-2651, or e-mail: amy.green@fda.hhs.gov.

        SUPPLEMENTARY INFORMATION:
        I.  Background

        Since 1996, FDA has responded to 27 outbreaks of foodborne illness in the United States for which raw or lightly cooked sprouts were the confirmed or suspected vehicle for the illness.  During this 9-year period, sprouts accounted for 40 percent of all foodborne illness outbreaks associated with fresh produce and approximately 20 percent of the reported illnesses. The 27 outbreaks accounted for an estimated 1,636 reported cases of illness.  Although the sprouts associated with these outbreaks have been primarily alfalfa, clover, or mung bean sprouts,   FDA is concerned about the foodborne illness risk associated with all types of raw and lightly cooked sprouts.  Thus, the agency has issued several advisories that warn consumers of the risks associated with consumption of raw or lightly cooked sprouts.  The sprouts involved with the outbreaks have been generally of U.S. origin while the seeds from which the sprouts have been produced have been primarily of non-U.S. origin. To date, the causative agents have been Salmonella and Escherichia coli O157.
        Sprouts present a special food safety challenge because the conditions that promote sprouting of the seed (e.g., temperature, humidity, available nutrients) also promote the growth of pathogens if pathogens are present.  Seed appears to be the source of contamination in most of the foodborne illness outbreaks associated with sprout consumption.  However, insanitary conditions at the sprouting facility appear to have exacerbated any seed contamination problems.

        In October 1999, FDA issued a guidance entitled “Guidance for Industry:  Reducing Microbial Food Safety Hazards for Sprouted Seeds.” This guidance recommends preventive controls to assist all parties involved in the production of sprouts (seed producers, seed conditioners and distributors, and sprout producers) to reduce the risk of sprouts serving as a vehicle for foodborne illness.  The guidance is available at http://vm.cfsan.fda.gov/~dms/sprougd1.html.  Specific recommendations in this guidance include development and implementation of good agricultural practices and good manufacturing practices in the production and handling of seeds and sprouts, seed disinfection treatments, and microbial testing of spent irrigation water before the sprouts enter the food supply.  At the same time, FDA issued a second guidance entitled “Guidance for Industry:  Sampling and Microbial Testing of Spent Irrigation Water during Sprout Production,” which contains recommendations to assist sprout producers in testing spent irrigation water for pathogens before sprout products enter the food supply.  This second guidance is available at http://vm.cfsan.fda.gov/~dms/sprougd2.html.  FDA also served as a technical consultant to the California Department of Health Services, who, in cooperation with the sprout industry, developed a video to advise the sprout industry on how to produce safer product.
        For several years following release of FDA's guidance documents, foodborne illness outbreaks associated with alfalfa and clover sprouts appeared to diminish.  In 2000, there was only one sprout-associated outbreak, compared to 6 outbreaks in 1999.  Between 2000 and 2002, salmonellosis emerged as a foodborne illness associated with consumption of raw or lightly cooked mung bean sprouts.  Recently, alfalfa sprouts remerged as a significant vehicle for foodborne illness, with 5 outbreaks in 2003 and 2 outbreaks in 2004.
        We have observed a downward trend in the average number of cases associated with an outbreak since issuance of FDA's sprout guidances. Between 1996 and 1999, there were 14 outbreaks with 1,364 reported illnesses, an average of 97 cases per outbreak. Since FDA issued its sprout guidances, there have been 13 outbreaks with 272 reported illnesses, an average of 21 cases per outbreak.
        FDA believes that the 1999 sprout guidances have had a significant positive effect on reducing both the number of outbreaks associated with sprouts and on the number of cases per outbreak.  However, based on continuing outbreaks associated with raw and lightly cooked sprouts, the agency is concerned that further action may be needed to ensure sustained adoption of effective preventive controls by the seed and sprout industry as a whole.  In October 2004, FDA released the Produce Action Plan. Now, FDA is considering whether a proposed regulation is needed to codify and expand on the existing sprout guidance.
        FDA believes that a good first step to improving the safety of sprouts is to engage and solicit the views of other Government agencies at the Federal (Environmental Protection Agency, U.S. Department of Agriculture, Centers for Disease Control), state, and local levels, from industry, from consumer groups, and from the public generally about the current science relating to preventing or minimizing foodborne illness associated with the consumption of sprouts.  The public meeting and period for submission of written comments are intended to provide that opportunity.  FDA requests that comments presented at the public meeting or otherwise communicated to the agency focus on the questions set out in section II of this document.
        II. Questions
        1.  What concepts or underlying principles should guide efforts to improve the safety of sprouts?
        2.  Which practices primarily contribute to the contamination with harmful pathogens of seeds used for sprouting?  Which intervention strategies can help prevent, reduce, or control this contamination of seeds used for sprouting?  Where appropriate, identify barriers to adopting effective preventive controls for this contamination, and, if possible, suggest mechanisms to overcome these barriers.
        3.  Which practices primarily contribute to the contamination with harmful pathogens of sprouts?  Which intervention strategies can help prevent, reduce, or control the contamination of sprouts?  Where appropriate, identify barriers to adopting effective preventive controls for this contamination, and, if possible, suggest mechanisms to overcome these barriers.

        4.  Do the preventive controls recommended in FDA's sprout guidances (http://vm.cfsan.fda.gov/~dms/sprougd1.html and http://vm.cfsan.fda.gov/~dms/sprougd2.html) need to be expanded or otherwise revised?  If yes, please describe generally the areas that need expansion or other revision.
        4.  Although FDA's current recommendations address practices by all parties, efforts to promote adoption of effective preventive controls have focused largely on sprouting facilities.  What can or should be done to increase the involvement of producers of seeds for sprouting and seed distributors to ensure the safety of sprouts?
        5. Is a regulation likely to be an effective means of achieving the goal of minimizing foodborne illness associated with the consumption of sprouts?  If not, what is likely to be an effective approach?
        6.  How can progress toward the overarching goal (to minimize foodborne illness associated with sprout consumption) be effectively measured?

        7.  There is broad variation within the seed and sprout industry, including variations in size of establishments, the types of seeds and sprouts produced, the practices used in production, and, possibly, variations in the vulnerability of a particular type of seed or sprout to microbial hazards or in the effectiveness of particular interventions.  How, if at all, should the actions to improve the safety of seeds for sprouting be structured to take into account such variation?  For example, should there be different sets of interventions for identifiable segments of the seed industry?  Similarly, how, if at all, should the actions to improve the safety of sprouts be structured to take into account such variation?  For example, should there be different sets of interventions for identifiable segments of the sprouts industry? If yes, please describe.
        8.  Are there existing food safety systems or standards (such as international standards) that FDA should consider as part of the agency's efforts to minimize foodborne illness associated with the consumption of sprouts?  Please identify these systems or standards and explain how their consideration might contribute to this effort.
        III. Registration and Requests for Oral Presentations
        You may register through FDA's Web site http://www.cfsan.fda.gov/ and choose “Public Meetings,” by fax, or e-mail (see FOR FURTHER INFORMATION CONTACT).  For security reasons and due to space limitations, we recommend that you register at least 5 days before the meeting.  Registration will be accepted on a first-come basis; if you need special accommodations due to a disability, please inform the contact person at least 7 days in advance (see FOR FURTHER INFORMATION CONTACT).  There is no registration fee for this public meeting, but early registration is encouraged because space is limited.  In addition, early registration will expedite entry into the building and its parking area.  If you require parking, please include the vehicle make and tag number, if known, on your registration form.  Because the meeting will be held in a Federal building, you should also bring a photo ID and plan for adequate time to pass through security screening systems.
        If you would like to make oral comments at the meeting, please specify your interest in speaking when you register. The amount of time for each oral presentation may be limited based upon the number of requests to speak.  FDA encourages individuals or firms with relevant data or information to present such information at the meeting or in written comments to the record.
        IV. Transcripts

        A transcript will be made of the proceedings of the meeting.  Transcripts of the meeting may be requested in writing from FDA's Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 30 working days after the meeting at a cost of 10 cents a page. The transcript of the public meeting and all comments submitted will be available for public examination at the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
        V. Comments

        In addition to presenting oral comments at the public meeting, interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the subject of this meeting.  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 the 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.

          Dated: April 18, 2005.
          Jeffrey Shuren,
          Assistant Commissioner for Policy.

      [FR Doc. 05-8103  Filed 4-19-05; 2:04 pm]
      BILLING CODE 4160-01-S


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 648
        [I.D. 020402B]
        New England Fishery Management Council; Public Meeting

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Public meeting.

          SUMMARY:
          The New England Fishery Management Council (Council) will hold a 2-day Council meeting on February 26 and 27, 2002, to consider actions affecting New England fisheries in the U.S. exclusive economic zone (EEZ).

          DATES:
          The meeting will be held on Tuesday and Wednesday, February 26 and 27, 2002.  The meeting will begin at 9:00 a.m. on Tuesday and 8:30 a.m. on Wednesday.

          ADDRESSES:
          The meeting will be held at the Sheraton Ferncroft Hotel, 50 Ferncroft Road, Danvers, MA 01923; telephone (978) 777-2500.  Requests for special accommodations should be addressed to the New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950; telephone (978) 465-0492.

          FOR FURTHER INFORMATION CONTACT:
          Paul J. Howard, Executive Director, New England Fishery Management Council, (978) 465-0492.

        SUPPLEMENTARY INFORMATION:
        Tuesday, February 26, 2002
        Following introductions, the Council will consider final adoption of the Deep-Sea Red Crab Fishery Management Plan (FMP) documents, including a  description of measures, draft regulations, and summary of impacts.  The FMP contains measures to implement a controlled access program for the directed red crab fishery, a target total allowable catch level, days-at-sea limits, trip limits, and trap limits for vessels in the controlled access program.  If adopted by the Council, the FMP will be forwarded to the Secretary of Commerce for consideration.  The Skate Committee will ask for approval of the Draft Skate FMP and Draft Environmental Impact Statement, including the identification of preferred alternatives and a public hearing document.  The discussion will include review and approval of the Habitat Committee's recommendations for the designation of skate Essential Fish Habitat.
        Following these reports, the Council will discuss the possibility of future action concerning the scheduled annual review of the status of whiting stocks and the effectiveness of whiting management measures.  These issues will be discussed in the context of the 2003 whiting default measures in the Northeast Multispecies FMP and whether action is necessary to revise those measures.  The Council’s Research Steering Committee will provide a brief update on its most recent activities.  The Scallop Committee intends to ask for approval of additional management alternatives to be included in Draft Amendment 10 to the Atlantic Sea Scallop FMP and analyzed in the Draft Supplemental Environmental Impact Statement.  Primary issues include alternatives to minimize bycatch and minimize adverse impacts on habitat in the sea scallop fishery.  Prior to adjourning for the day, the Council will review and possibly approve a proposal to improve the enforceability of measures to address operator permit sanctions.  The Council is considering endorsing an action that would hold fishing boat owners and operators responsible for individuals onboard vessels who are known by the owners or operators to have had their operator’s permit suspended or revoked because of fishing violations.
        Wednesday, February 27, 2002
        The remainder of the Council meeting will focus on addressing issues associated with Amendment 13 to the Northeast Multispecies FMP.  These include a review of events associated with recent litigation, a possible consideration and approval of groundfish status determination criteria for use in Amendment 13, the approval of Amendment 13 goals and objectives and the approval of Groundfish Committee recommendations for an amendment development process.
        Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subjects of formal action during this meeting.  Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.

        The New England Council will consider public comments at a minimum of two Council meetings before making recommendations to the NMFS Regional Administrator on any framework adjustment to a fishery management plan.  If the Regional Administrator concurs with the adjustment proposed by the Council, the Regional Administrator may publish the action either as proposed or final regulations in the Federal Register.   Documents pertaining to framework adjustments are available for public review 7 days prior to a final vote by the Council.
        Special Accommodations

        This meeting is physically accessible to people with disabilities.  Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (see ADDRESSES) at least 5 days prior to the meeting date.

          Dated:  February 7, 2002.
          Bruce C. Morehead,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 02-3488 Filed 2-8-02; 12:33 pm]
      BILLING CODE  3510-22-S


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 300
        [FRL-6861-8]
        National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List

          AGENCY:
          The Environmental Protection Agency (EPA).

          ACTION:
          Proposed Deletion of the Wheeling Disposal Service Company, Incorporated, Landfill Site (site) from the National Priorities List (NPL).

          SUMMARY:

          The EPA Region VII proposes to delete the Wheeling Disposal Service Company, Incorporated, Landfill site from the NPL and requests public comment on this action. The NPL constitutes Appendix B to Part 300 of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended. The EPA has determined that the site poses no significant threat to public health or the environment, as defined by CERCLA; and therefore, further remedial measures pursuant to CERCLA are not appropriate.

          We are publishing this rule without prior proposal because the Agency views this as a noncontroversial revision and anticipates no dissenting comments. A detailed rationale for this approval is set forth in the direct final rule that appears elsewhere in this issue of the Federal Register. If no dissenting comments are received, no further activity is contemplated. If EPA receives dissenting comments, the direct final action will be withdrawn, and all public comments received will be addressed in a subsequent final rule based on this proposed rule. The EPA will not institute a second comment period. Any parties interested in commenting should do so at this time.

          DATES:
          Comments concerning this Action must be received by October 2, 2000.

          ADDRESSES:
          Comments may be mailed to Catherine Barrett, Remedial Project Manager, Superfund Division, Missouri/Kansas Remedial Branch, U.S. Environmental Protection Agency, Region VII, 901 North 5th Street, Kansas City, Kansas 66101. Comprehensive information on this site is available through the public docket which is available for viewing at the Site Information Repository at U.S. EPA Region VII, Superfund Division Records Center, 901 North 5th Street, Kansas City, Kansas 66101 or Wheeling Local Repository, Rolling Hills Library, 514 West Main Street, Savannah, Missouri.

          FOR FURTHER INFORMATION CONTACT:
          Catherine Barrett, Remedial Project Manager, Superfund Division, U.S. Environmental Protection Agency, 901 North 5th Street, Kansas City, Kansas 66101, telephone (913) 551-7704, fax (913) 551-7063.

        SUPPLEMENTARY INFORMATION:

        For additional information, see the Direct Final Action which is located in the Rules Section of this Federal Register.

          Dated: August 18, 2000.
          William Rice,
          Acting Regional Administrator, Region VII.

      [FR Doc. 00-22378 Filed 8-30-00; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 229
        [Docket No. 001128334-1239-04; I.D. 092401E]
        RIN 0648-AN88
        Marine Mammals; Atlantic Large Whale Take Reduction Plan (ALWTRP) Regulations; Seasonal Area Management (SAM) Program

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Advance notice of proposed rulemaking (ANPR); notice of intent (NOI) to prepare an Environmental Impact Statement (EIS); request for comments.

          SUMMARY:
          NMFS is preparing regulations to implement a Seasonal Area Management (SAM) program to seasonally limit fishing operations in certain areas, which was identified as a measure under the reasonable and prudent alternative (RPA) contained in the Biological Opinions (BOs) prepared for the Federal Northeast multispecies (multispecies), monkfish, spiny dogfish, and American lobster (lobster) fisheries under the Endangered Species Act (ESA).  The SAM program is intended to provide endangered western North Atlantic right whales (right whales) protection from entanglement with fishing gear used in those fisheries.  The measures that have been identified for proposed rulemaking would require the reduction, elimination, and/or modification of certain types of fixed gear (i.e., gillnets and lobster traps) in specific areas off the Atlantic coast of the United States during times of the year when right whales are known to be present in significant concentrations.  NMFS also announces its intention to prepare an Environmental Impact Statement (EIS) for the SAM regulations, in accordance with the National Environmental Policy Act (NEPA), to analyze impacts to the environment of the management alternatives under consideration.

          DATES:

          Written comments must be received at the appropriate address or facsimile (fax) number (see ADDRESSES) no later than 5 p.m. local time on November 2, 2001.

          ADDRESSES:
          Written comments should be sent to:  Mary Colligan, Acting Assistant Administrator for Protected Resources, Northeast Region, NMFS, One Blackburn Drive, Gloucester, MA 01930.  Comments may also be sent via fax to 978-281-9394.  Comments submitted via e-mail or Internet will not be accepted.  Copies of the BOs may be requested from the above address or can be downloaded from the internet at the following website: http://www.nmfs.noaa.gov/prot_res/overview/publicat.html.

          FOR FURTHER INFORMATION CONTACT:
          Gregg LaMontagne, NMFS, Northeast Region, 978-281-9291, fax 978-281-9394; Katherine Wang, NMFS, Southeast Region, 727-570-5312; or Patricia Lawson, NMFS, Office of Protected Resources, 301-713-2322.

        SUPPLEMENTARY INFORMATION:
        Background

        In compliance with the Endangered Species Act (ESA)(16 U.S.C. 1531 et seq.) section 7 consultation procedures, NMFS prepared Biological Opinions (BOs) for the continued authorization of Federal fisheries under the Fishery Management Plans for the multispecies, spiny dogfish, and monkfish fisheries, and under the Federal regulations for the lobster fishery, to assess the impacts of those fisheries on species protected under the ESA.  Previous ESA section 7 consultations on those fisheries incorporated the Atlantic Large Whale Take Reduction Plan (ALWTRP) as an RPA to avoid the likelihood of jeopardy to right whales from the multispecies, dogfish, and monkfish gillnet fisheries and the lobster trap fishery.  NMFS published a proposed rule on April 7, 1997 (62 FR 16519), followed by an interim final rule on July 22, 1997 (62 FR 39157), that contained the provisions of the ALWTRP and implementing regulations.  NMFS published an interim final rule that implemented time and area closures, gear requirements, and a prohibition on storing inactive gear at sea, and contained other, non-regulatory measures (e.g., gear research, public outreach, scientific research) intended to reduce serious injury and mortality to four large whale stocks, including right whales. ÿ09
        On February 16, 1999, NMFS published a final rule (64 FR 7529) that made changes to the interim final rule implementing the ALWTRP.  On December 21, 2000, NMFS published an interim final rule (65 FR 80368) to implement additional measures (buoy line weak links, net panel weak links with anchoring systems, restrictions on numbers of buoy lines, and gear marking requirements) in response to continued entanglements of right whales with gear used in the multispecies, monkfish, spiny dogfish, and lobster trap fisheries. ÿ09

        NMFS reinitiated consultation on May 4, 2000, for the northeast multispecies, spiny dogfish and monkfish gillnet fisheries, and on June 22, 2000, for the Federal regulations for the lobster fishery, following new whale entanglements resulting in serious injuries, at least one right whale mortality in gillnet gear, new information indicating a declining status for western North Atlantic right whales (Caswell et al. 1999), and revisions to the ALWTRP.  In previous consultations, the ALWTRP had been accepted as a reasonable and prudent alternative (RPA) to avoid the likelihood of jeopardy to right whales from these four fisheries. Given the new information on the declining status of the right whale population and continued entanglements (suggesting possible failure of the RPA to avoid jeopardy to right whales), reinitiation of consultation was necessary to reevaluate the potential impact of these gillnet fisheries and the lobster trap fishery on right whales, and to assess the ability of the RPA to avoid the likelihood of jeopardy.  The BOs resulting from these consultations were issued on June 15, 2001.
        Biological Opinions
        The BOs prepared during the most recent consultation provided information on the status of all protected species that occur in western North Atlantic waters where the multispecies, spiny dogfish, monkfish, and American lobster trap fisheries operate, based on the best information available.  The BOs treated the western North Atlantic right whale population as a recovery unit whose survival and recovery is critical to the survival and recovery of the species as a whole.  Any activity that would appreciably reduce the likelihood that a recovery unit would survive and recover in the wild would also appreciably reduce the species’ likelihood of survival and recovery in the wild.  The BOs focused on the western North Atlantic recovery unit of right whales, which is the recovery unit that occurs in the area where these fisheries operate. ÿ09
        Western North Atlantic right whales have been protected from whaling for more than 50 years, yet there is no evidence of their recovery.  Based on recent estimates, the western North Atlantic population numbers about 300 individuals.  Right whales may be adversely affected by habitat degradation, habitat exclusion, acoustic disturbance, harassment, or reduction in prey resources resulting from a variety of activities, including the operation of fisheries.  The major known sources of human-caused mortality and injury of right whales include entanglement in commercial fishing gear and ship strikes.  Caswell et al. (1999), which is cited in the BOs, concluded that reduction of such mortalities would significantly improve the species’ chances for survival. ÿ09
        Environmental baseline analyses for BOs includes the past and present impacts of all state, Federal or private actions and other human activities in the action area; the anticipated impacts of all proposed Federal projects in the action area that have already undergone section 7 consultation; and the impact of state or private actions that are contemporaneous with the consultation in process (50 CFR 402.02).  The environmental baselines for the BOs included the impacts of several activities that may affect the survival and recovery of threatened and endangered species in the action area and that fell into the following three general categories: Vessel operations, fisheries, and recovery activities associated with those impacts.  Other environmental impacts include the effects of dredging, disposal, ocean dumping, and sonic activity.  A number of factors in the existing baseline for right whales left considerable concern.  For example, the western North Atlantic right whale population continues to decline, and, despite measures developed as a result of the initial ALWTRP, entanglements of right whales in fishing gear continue to occur. ÿ09
        The BOs specifically examined whether the multispecies, monkfish, spiny dogfish, and/or lobster fisheries are likely to jeopardize the continued existence of any ESA-listed species.  Factors considered included the degree of overlap between the operation of the fisheries under consultation and areas where protected species occur, past interactions between protected species and gear used in the fisheries, the known effects of gear interactions on protected species, and the effects of incorporating the existing ALWRTP measures.  Based on this analysis, NMFS concluded that:  ÿ09
        1.  Gillnet gear used in the multispecies, spiny dogfish, and monkfish fisheries poses an entanglement risk to protected species; ÿ09
        2.  Trap gear used in the lobster fishery poses an entanglement risk to protected species; ÿ09
        3.  Baleen whales are more likely to become entangled in gillnet gear, as opposed to toothed whales (e.g., sperm whales), given baleen whales’ method of feeding;  ÿ09
        4.  Of the baleen whales, right whales and humpback whales are most likely to interact with multispecies, spiny dogfish, and monkfish gillnet fisheries and the lobster trap fishery, since those whales commonly occur in areas and at times where those fisheries operate; ÿ09
        5.  Although directed effort in the spiny dogfish and monkfish fisheries is expected to be reduced over the next few years in an effort to rebuild those stocks, even the reduced amount of effort that is expected could still pose an entanglement risk for protected species; and ÿ09
        6.  Modification of the multispecies, spiny dogfish, and monkfish gillnet fisheries and the lobster trap fishery by the existing ALWTRP measures is not expected to remove all risk of gear interactions with protected species,  given that the existing modifications of the ALWTRP do not apply to gillnet gear fished in the Mid-Atlantic or Southeast, where right and humpback whales may also occur.  In addition, gear modifications as required by the ALWTRP have only recently been implemented (i.e., as a result of the December 21, 2000, interim final rule). ÿ09
        Based on those six factors, the BOs concluded that gillnet and trap activities under the four fisheries as currently conducted are likely to jeopardize the continued existence of the right whale, but are not likely to destroy or adversely modify designated critical habitat; and may adversely affect, but are not likely to jeopardize, the continued existence of humpback, fin, blue, sei and sperm whales.  Therefore, the potential for gear entanglements of right whales as a result of these fisheries must be further reduced by additional measures to reduce interaction between right whales and multispecies, monkfish, and spiny dogfish gillnets and lobster trap gear in areas and times of high right whale abundance, and by implementing gear modifications based on recent technological advances. ÿ09
        The BOs also considered cumulative effects, which include the effects of future state, tribal, local or private actions that are reasonably certain to occur in the action area.  Future Federal actions that are unrelated to the proposed action were not considered because they require separate consultation under section 7 of the ESA.  Past and present impacts of non-Federal actions were also not included in the cumulative effects, because they are part of the environmental baseline.  In the BOs, NMFS considered the following: State-water fisheries, the maritime industry, pollution, catastrophic events such as oil spills, noise pollution, and similar activities or occurrences in Canadian waters. ÿ09
        The BOs concluded that the multispecies, spiny dogfish, monkfish, and lobster fisheries use gear that can cause serious injury and mortality to whales if entanglements occur.  Gear interactions are more likely to occur if gear is concentrated in areas and at times that endangered whales occur in significant numbers.  Right whales are vulnerable to entanglement in this type of gear while they are foraging.  ÿ09

        In view of the right whale’s decline and probability of extinction if the population decline continues, any entanglement that causes serious injury and/or mortality may reduce appreciably the likelihood of survival and recovery of this species.  Measures developed thus far under the ALWTRP are not expected to prevent all entanglements of right whales in gillnet or lobster trap gear, since these measures are not applicable to all areas where right whale distribution overlaps the use of these gear types.  Given the known human-caused sources of right whale mortality, their small population size, and their low reproductive rate, the loss of even one right whale, particularly a reproductively active female, may reduce appreciably the likelihood of the survival and recovery of this species. ÿ09
        Given the current critical status of the right whale population and the aggregate effects of human-caused mortality that has led to the species’ current status, the risk of incidental mortality caused by the multispecies, spiny dogfish, monkfish or lobster fisheries as currently prosecuted should be reduced.  These fisheries take place in areas frequented by right whales and use sink gillnet gear and lobster trap gear, which are known to cause serious injury and mortality to right whales. ÿ09
        Reasonable and Prudent Alternative
        Regulations implementing section 7 of the ESA (50 CFR 402.02) define the RPA as alternative actions, identified during formal consultation, that:  (1) can be implemented in a manner consistent with the intended purpose of the action; (2) can be implemented consistent with the scope of the action agency’s legal authority and jurisdiction; (3) are economically and technologically feasible; and (4) avoid the likelihood of jeopardizing the continued existence of listed species or resulting in the destruction or adverse modification of critical habitat.  As a result of the consultation and the finding of jeopardy for right whales, NMFS developed a single RPA with multiple management components that collectively are designed to avoid the likelihood of continued jeopardy for right whales and to allow the continued authorization of the four fisheries for which consultation was conducted. ÿ09
        The RPA measures are intended, in combination, to avoid the potential for gillnet and lobster trap interactions with right whales, minimize adverse effects when and if interactions with these fishing gear types do occur, and mitigate any unavoidable entanglements of right whales with these gear types.  The measures under the RPA are:  Seasonal and Dynamic Area Management programs (SAM and DAM, respectively), an expansion of gillnet and lobster trap gear modifications to Mid-Atlantic waters, and modification of fishing practices in Southeastern U.S. waters, continued gear research and modifications, and additional measures to implement and monitor the effectiveness of the RPA. ÿ09
        Both SAM and DAM are intended to reduce the potential for interactions of right whales with gillnet and lobster trap gear.  NMFS will use data on seasonal concentrations of right whales obtained from aerial surveys to implement annual area-specific gear restrictions and/or closures.  The SAM program would be implemented through proposed and final rulemaking, which will require the preparation of an EIS and is the subject of this ANPR and NOI.  To supplement the SAM program, NMFS is proposing in a separate proposed rule to further develop and implement the DAM program, which would be responsive to concentrations of right whales that would not otherwise be protected by the SAM measures.  NMFS will identify criteria for triggering DAM in the separate proposed rule.  The DAM measures are not the subject of this ANPR and NOI. ÿ09
        Concurrent with this ANPR/NOI and the DAM proposed rule, NMFS is proposing to expand the gillnet and lobster trap gear modifications outlined in the December 21, 2000, interim final rule to include Mid-Atlantic and Southeast waters.  NMFS will also host a workshop to investigate options for gillnet and lobster trap gear modifications to prevent serious injury to right whales that may become entangled in that gear and will expand research and testing on the feasibility of eliminating floating line in the anchor and buoy lines of gillnet gear and lobster trap gear by replacing it with neutrally buoyant line.  NMFS will continue research on weak-link floatlines in gillnet gear to investigate the possibility of reducing the strength of gillnet floatlines, which are known to be a problem in the entanglement of large whales.  NMFS will also continue research on line that could be used in gillnets to eliminate external plastic floats when combined with properly placed weak links.  Gear modification requirements will be implemented through proposed and final rulemaking and are not the subject of this ANPR and NOI. ÿ09
        In addition to this ANPR/NOI and the proposed rules for DAM and gear modifications, which are components of the RPA designed to reduce the potential for entanglement of right whales, NMFS will conduct the following activities to implement and monitor the RPA measures. NMFS will provide guidance to participants in the multispecies, spiny dogfish, monkfish and lobster fisheries on the requirement to report incidental takes of marine mammals and will send a letter to all permit holders in these fisheries detailing the protocol for reporting entangled or stranded whales.  NMFS will also monitor and evaluate the effectiveness of the measures prescribed in the RPA, including SAM, DAM, and gear modifications and research.  If a right whale is killed or seriously injured by (1) multispecies, spiny dogfish, or monkfish gillnet gear, or by lobster trap gear; (2) gear that is identifiable as being approved for use in the multispecies, spiny dogfish, monkfish or lobster fisheries; or (3) fishing gear that cannot be identified as being associated with a specific fishery, NMFS will consider it evidence that the measures outlined in the RPA are not demonstrably effective at reducing right whale injuries or death.  Similarly, if NMFS does not observe a decrease in observed entanglements and scarification (scarring of the whale due to gear entanglements and/or interactions), NMFS will consider that the performance standards outlined in the RPA have not been met. ÿ09

        NMFS has determined that the management actions outlined in the RPA collectively avoid jeopardy.  Further information on the RPA is available in the BOs (see ADDRESSES).
        Marine Mammal Protection Act

        Pursuant to section 118 of the Marine Mammal Protection Act (MMPA), NMFS convened the Atlantic Large Whale Take Reduction Team (ALWTRT) to develop a plan for reducing the incidental by-catch of large whales in commercial fisheries along the Atlantic coast.  The ALWTRT consists of representatives from the fishing industry, the New England and Mid-Atlantic Fishery Management Councils, state and Federal resource management agencies, the scientific community, and conservation organizations.  The immediate goal of the ALWTRT, in accordance with the 1994 amendments to the MMPA, was to draft an ALWTRP to reduce the incidental take of the four primary large whale species that interact with fisheries--the North Atlantic right whale (Eubalaena glacialis), humpback whale (Megaptera novaeangliea), fin whale (Balaenoptera physalus), and minke whale (Balaenoptera acutorostrata)--to a level less than the potential biological removal level (PBR) within 6 months of implementation of the ALWTRT’s plan. Potential biological removal level means the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population.  The 1994 amendments to the MMPA established the goal to achieve a zero mortality rate goal (ZMRG) to be achieved within 5 years of ALWTRP implementation.  For right whales, these two goals are essentially the same, because PBR has been defined as zero.  Since the current incidental take for right whales exceeds the PBR and does not achieve ZMRG, additional risk reduction is necessary in order to meet the objectives of the MMPA. ÿ09
        Proposed SAM Program

        As described above, NMFS proposes to implement two additional types of gear restrictions.  One or more areas with predictable annual concentrations of right whales will be considered for SAM.  These areas would have pre-established boundaries, and their closing and opening dates will be specified in advance of the right whales’ expected arrival.  This is an expansion of the management approach that established the existing Cape Cod Bay and Great South Channel restricted areas designed to protect right whales.  Areas without predictable concentrations of right whales will be potential candidates for DAM.  Under DAM, restrictions in addition to those already in place under SAM would not be implemented unless and until concentrations of right whales are found to be present by qualified individuals.  If such concentrations are observed and the triggering criteria are met, NMFS will invoke a temporary restricted area around the animals through publication of notification in the Federal Register.  The fishing industry and public will also be made aware of the restricted areas through other notification means, such as NOAA Weather broadcasts.  Regulations implementing the DAM program will be the subject of a separate rulemaking. ÿ09
        To implement SAM, NMFS must specify the area(s) and times that right whales can reasonably be predicted to occur on an annual basis.  After NMFS has identified such area(s) and time(s), the degree of gear restriction within the area(s) must be determined.  The intent is to make the area(s) large enough to adequately protect right whales, but not so large that they restrict gear use with little or no benefit to the whales.  Similarly, gear use in the identified SAM area(s) must be restricted long enough to provide right whales protection from gear entanglements, but no longer than necessary.  Finally, the level of gear restrictions necessary within the SAM area(s) must be sufficient to ensure that serious injury or mortality to right whales is avoided.  These issues, and the alternatives that NMFS has identified to address them, are the subject of the remainder of this ANPR and NOI. ÿ09
        Alternatives Under Consideration for Rulemaking
        The SAM alternatives vary by: (1) geographic area, (2) gear restrictions, and (3) time intervals.  NMFS has analyzed aerial survey data collected from 1999-2001 in the area from south of Nantucket northward to the Bay of Fundy, and from the New England coast eastward to the Hague Line, to determine seasonal and spatial patterns of right whale occurrence and concentration.  The analytical process was to:  (1) Identify right whale sightings that met the trigger criterion for considering concentrations in need of protection; (2) define the size of a core area of right whale occurrence and then draw a 15-nm radius buffer circle around that core area; (3) for each year of survey data, draw a polygon around the circular buffer zones and join the overlapping polygons to create a potential SAM area; (4) overlay all three year’s potential SAM areas, identify and eliminate those areas with sightings in only 1 year, and draw an outline around that potential SAM area; and (5) adjust the area to match existing closures and zones, such as the existing Northeast multispecies closed areas.  The triggering criterion was a sighting of three or more right whales sufficiently close to one another to achieve a density of 0.04 right whales/nm2, which would equal a minimum of three right whales within 75 nm2.  While this approach could not entirely exclude any area, since survey data are sparse from some areas of the Gulf of Maine, it did identify those areas that are likely to be optimal for the SAM program, based on the best information available.  Details of NMFS’ analysis will be included in the EIS. ÿ09
        At least 1,307 right whale observations were made during the 3 years of aerial surveys, distributed among 784 group sightings.  Few were seen in March (1.8 percent) or July (5.6 percent); most were seen in May (43.8 percent), June (32.3 percent), and April (16.4 percent), though this was due in part to greater survey effort in May-June.  Sightings in March-April tended to be in the areas surrounding Cape Cod (e.g., Provincetown Slope).  However, by May right whales were regularly sighted along the northern edge of Georges Bank and in the Great South Channel.  Right whales were consistently seen in all 3 years in this area and into Wilkinson Basin through June, with some tendency for them to be seen farther to the north as the season progressed.  During 1999-2000, concentrations were found episodically in the Cashes Ledge area--specifically in April 1999 and June 2000.  Similar concentrations in the Cashes Ledge area were not found in 2001. ÿ09
        Concentrations of right whales that would have met the triggering criterion (events) occurred 149 times during 1999-2001.  Events peaked in May (45.0 percent), followed by June (29.5 percent).  The fewest events occurred in March (4.0 percent) and July (6.0 percent).  The average number of right whales included in each event was 6.2, and varied little between years. ÿ09
        Overlaying 3 years of SAM zones that could be drawn from the survey data suggests that there is similarity between years in habitat use in areas outside of the Great South Channel and Cape Cod Bay. Right whales were consistently seen in all 3 years in the area from Cape Cod eastward to the Hague line, but were seen only sporadically in the north (e.g., the Cashes Ledge Area).  NMFS then derived a composite SAM zone, built from the three annual SAMs, which includes almost all of the right whale sightings during 1999-2001.  One possible SAM zone resulting from NMFS’ analysis, which would encompass all of the events recorded during April-July 1999-2001, had a total area of about 10,200 nm2, not including other closed areas.  If the zone were expanded to encompass the buffer area around the events, its area would increase to about 17,000 nm2.  ÿ09
        When the SAM boundaries were smoothed and realigned with existing management zones in the Gulf of Maine, analysis of the data suggested the possibility of two smaller SAM zones.  One is a core zone of about 7,000 nm2, stretching from Cape Cod eastward to the Hague Line, with a consistent pattern of right whale sightings over all 3 survey years.  The second is a northern zone of about 1,700 nm2, which would cover additional right whale sightings that occurred sporadically in some months of 2 of the 3 survey years. ÿ09
        The core zone, in combination with the Cape Cod Bay and Great South Channel closures, would encompass all but 15 of the 149 events during 1999-2001.  All events from 2001 would be included in this area.  Of the 784 group right whale sightings, only 94 (12 percent) would occur outside of this zone.  Within this core zone, right whales were more likely to be seen in the western part of this area (near Cape Cod Bay and the Great South Channel) in March-April than in May-July.  This suggests that there is a possible east-west break point in the seasonal distribution within the core zone at about 69.4° W longitude. ÿ09

        In summary, NMFS’ initial analysis suggests that there are areas within the Gulf of Maine other than Cape Cod Bay and the Great South Channel where right whales can be expected to occur each spring.  Thus, gear restrictions within at least the core SAM zone, or some similarly configured zone, could significantly buffer right whales from interactions with fishing gear.  The potential benefits of a northern SAM zone are less clear at this time.  While the northern zone identified in NMFS’ preliminary analysis would encompass additional events not included in the core zone, NMFS does not know at this time whether these events represent a predictable distribution pattern. ÿ09
        The SAM zones described above are among the alternatives that NMFS will consider in the EIS.  Other alternatives would be variations of these zones.  For example, the core zone could be subdivided such that different subzones would be closed at different time intervals, to match more precisely the historically determined areas of right whale concentration at given times of the year. Four possible variations on gear restrictions and times are:
        1.  A SAM zone with gear restrictions throughout the designated time frame. ÿ09
        2.  A SAM zone with gear restrictions lifted sequentially over time, as right whale concentrations move through the zone. ÿ09
        3.  A SAM zone with no gear restrictions initially, but with gear restrictions that would be put in place as right whale concentrations appear in the zone and would then be lifted as right whale concentrations leave the zone. ÿ09
        4.  A SAM zone divided into predetermined sections (subzones), with all dates for gear restrictions in each subzone predetermined. ÿ09
        Other alternatives or variations of the above alternatives identified through the NEPA scoping process for the EIS may also  be considered.  Gear restrictions within the SAM zone(s) could range from total prohibition of gillnet and lobster trap gear within the zone(s); to allowing only gear that has been modified to present a relatively low risk of causing serious injury or mortality to right whales to be fished within the zone(s); to allowing unmodified gear to be fished, but at reduced concentrations and/or using modified practices (e.g., tending gillnets).   ÿ09
        At the June 2001, ALWTRT meeting, team members discussed at length gear modifications that could be used as gear restrictions within SAM zones to reduce the risk of causing serious injury or mortality to right whales.  The items listed below were discussed but are not necessarily consensus recommendations of the ALWTRT. The following gillnet gear modifications to reduce risk of entanglement were discussed: (1) net tending or generally remaining close enough to the gear to respond should the nets entangle an animal, (2) additional floatline weak links, exact number to be determined, above the number required by the current regulations, (3) use of neutrally buoyant or sinking line for buoy lines and groundlines connecting nets and anchors, (4) limit effort or the amount of net based on vessel size, and (5) limit the type or quantity of net allowed.
        The following lobster trap gear modifications to reduce risk of entanglement were discussed: (1) reduced strength buoy line weak link for the offshore lobster fisheries, (2) neutrally buoyant or sinking groundline for nearshore and offshore lobster fisheries, and (3) additional weak link options.  Through this ANPR and NOI, NMFS is also requesting comments on any additional gear modification concepts for further consideration and development. ÿ09
        The EIS will also analyze the impacts of the SAM alternatives on other aspects of the human environment, including their impacts to participants of the multispecies, monkfish, spiny dogfish, and lobster fisheries.  NMFS is requesting comments from the public on these and other possible alternatives for SAM that would comply with the RPA requirements to protect right whales.
        References:
        Caswell, H., M. Fujiwara, and S. Brault. 1999. Declining survival probability threatens the North Atlantic right whale. Proc. Nat. Acad. Sci. 96: 3308-3313. ÿ09
        Anticipated Regulatory Changes to Implement SAM
        Although NMFS is still developing the alternatives to be thoroughly analyzed in the EIS, NMFS expects that the final SAM measures will require that regulations at 50 CFR part 229 be amended as follows: ÿ09
        § 229.32 Atlantic large whale take reduction plan regulations.
        1.  Paragraph (c) would be amended to include any additional restrictions to lobster gear or its use, specific to SAM, if such restrictions are necessary in order for that gear to be used within a SAM zone. ÿ09
        2.  Paragraph (d) would be amended to include any additional restrictions to anchored gillnet gear or its use, specific to SAM, if such restrictions are necessary in order for that gear to be used within a SAM zone.ÿ09 ÿ09
        3.  Paragraph (g) would be redesignated paragraph (h) and a new paragraph (g) would be added to define the boundaries of the SAM zone(s) and any subzones; define the times of the year that the SAM zone(s) and any subzones would require restrictions in the use of gillnet and lobster trap gear; and provide procedures that NMFS will use to implement and lift gear restrictions within the SAM zone(s) or subzones. ÿ09
        Specifics of the regulatory changes will be described in a proposed rule, and if adopted would be implemented through a final rule.  No scoping meetings will be held.  NMFS invites comments, through this document, on its identified proposed rulemaking and the scope of the draft EIS to be prepared.

          Authority:
          16 U.S.C. 1361 et seq.

          Dated: September 28, 2001.
          William T. Hogarth,
          Assistant Administrator for Fisheries, National Marine Fisheries Service.

      [FR Doc. 01-24910 Filed 10-1-01; 2:59 pm]
      BILLING CODE  3510-22-S