National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; emergency action; extension of effective period.
The regulations contained in the temporary rule, emergency action, published on October 18, 2005, at the request of the U.S. Food and Drug Administration (FDA), which are scheduled to expire on December 31, 2005, are extended through June 30, 2006. In the October 18, 2005, action, NMFS reinstated and corrected the temporary regulations published on September 9, 2005, which reopened a portion of Federal waters of the Gulf of Maine, Georges Bank, and southern New England that it had previously closed from June 14 through September 30, 2005, to the harvest for human consumption of certain bivalve molluscan shellfish due to the presence in those waters of the toxin that causes Paralytic Shellfish Poisoning (PSP). The FDA has determined that there is insufficient analytical data to support the scheduled reopening of the entire area to all bivalve molluscan shellfish fishing on January 1, 2006.
The temporary emergency action published on October 18, 2005 (70 FR 60450), is effective from October 18, 2005, through June 30, 2006.
Copies of the small entity compliance guide prepared for the October 18, 2005, reinstatement of the September 9, 2005, emergency action, are available from Patricia A. Kurkul, Regional Administrator, National Marine Fisheries Service, One Blackburn Drive, Gloucester, MA 01930. The small entity compliance guide/permit holder letter is also accessible via the Internet at http://www.nero.noaa.gov. Copies of the emergency rule and environmental assessment are available from Patricia Start Printed Page 76714A. Kurkul, at the mailing address specified above.Start Further Info
FOR FURTHER INFORMATION CONTACT:
E. Martin Jaffe, Fishery Policy Analyst, (978) 281-9272.End Further Info End Preamble Start Supplemental Information
Toxic algal blooms are responsible for the marine toxin that causes PSP in persons consuming affected shellfish. People have become seriously ill and some have died from consuming affected shellfish under similar circumstances.
On June 10, 2005, the FDA requested that NMFS issue an emergency rule to close an area of Federal waters to the harvesting of bivalve molluscan shellfish intended for human consumption because of toxic algal blooms off the coasts of New Hampshire and Massachusetts. This closure prohibited harvests of shellfish such as Atlantic surfclams and ocean quahogs, as well as scallop viscera. The emergency rule for the action, published in the Federal Register on June 16, 2005 (70 FR 35047), stated it would be in effect from June 14 through September 30, 2005, unless extended. The emergency rule was modified on July 7, 2005 (70 FR 39192) to allow for the collection of biological samples by commercial fishing vessels issued a Letter of Authorization signed by the Regional Administrator.
The action temporarily closed all Federal waters of the Exclusive Economic Zone of the northeastern United States to any bivalve molluscan shellfish harvesting, except for Atlantic sea scallops shucked at sea for their adductor muscles, in the area bound by the following coordinates in the order stated: (1) 43°00′ N. lat., 71°00′ W. long.; (2) 43°00′ N. lat., 69°00′ W. long.; (3) 40°00′ N. lat., 69°00′ W. long.; (4) 40°00′ N. lat., 71°00′ W. long.; and (5) ending at the first point. The scallop adductor muscle, or “meat,” is unaffected by the toxin. Further details of the original closure may be found in the preambles of the June 16, 2005, and the July 7, 2005, rules, and are not repeated here.
As a result of tests conducted by the FDA in cooperation with NMFS and the fishing industry, it was determined that toxin levels in a portion of the closure area (described below) were well below those known to cause human illness. With the exception of whole and roe-on scallops, the FDA determined that harvesting of bivalve molluscan shellfish for human consumption from the area described was once again safe.
At the FDA's request, on September 9, 2005, NMFS reopened those waters south of 41°39′ N. lat., west of 69°00′ W. long., north of 40°00′ N. lat., and east of 71°00′ W. long. (70 FR 53580). Because scallop viscera and roe are capable of retaining PSP toxins longer than other species of molluscan shellfish, scallop harvesting was permitted only in the reopened area for the purpose of shucking of the adductor muscle; however, although this limitation was discussed in the preamble of the September 9, 2005, temporary rule, it was inadvertently omitted from the regulatory text.
In the absence of further notice from the FDA, the entire temporary closure would have expired on October 1, 2005. FDA determined on September 23, 2005, that there were insufficient analytical data to support the scheduled reopening of the entire area to all bivalve molluscan shellfish on October 1, 2005; therefore, it requested that NMFS continue the regulations through December 31, 2005. Based on this request, NMFS issued additional temporary rules (70 FR 57517 and 70 FR 60450) to extend the prohibitions through December 31, 2005.
In the absence of further notice from the FDA, the entire temporary closure would have expired on January 1, 2006. FDA has once again determined that there are insufficient analytical data to support the scheduled reopening of the entire area to all bivalve molluscan shellfish on January 1, 2006, and has requested that NMFS continue the regulations, which NMFS agrees to do through June 30, 2006.
This action is issued pursuant to section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1855(c) (Magnuson-Stevens Act).
The original emergency closure was in response to a public health emergency. Pursuant to section 305(c)(3)(C) of the Magnuson-Stevens Act, the closure to the harvest of shellfish, as modified on September 9, 2005, and as reinstated on October 18, 2005, may remain in effect until the circumstances that created the emergency no longer exist, provided that the public has an opportunity to comment after the regulation is published, and, in the case of a public health emergency, the Secretary of Health and Human Services concurs with the Commerce Secretary's action. The public had opportunities to comment on the published regulations and one comment was received. The commenter expressed her reluctance to agree with reopening a portion of the closure without seeing the results of the FDA's tests. While NMFS is the agency with authority to promulgate the emergency regulations, it modified the regulations on September 9, 2005, at the behest of the FDA, after the FDA had determined that the results of its tests warranted such action. Accordingly, the Secretary of Health and Human Services and the Secretary of Commerce concur that the emergency regulations, as modified on September 9, 2005, and as reinstated on October 18, 2005, should continue through June 30, 2006. If warranted, the regulations may be terminated at an earlier date, pursuant to section 305(c)(3)(D) of the Magnuson-Stevens Act, by publication in the Federal Register of a notice of termination, or extended further, if necessary, to ensure the safety of human health.
The October 18, 2005, rule was determined to be not significant under Executive Order 12866.Start Signature
Dated: December 21, 2005.
Deputy Assistant Administrator for Operations, National Marine Fisheries Service.
[FR Doc. 05-24519 Filed 12-22-05; 1:23 pm]
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