[Federal Register Volume 70, Number 115 (Thursday, June 16, 2005)]
[Rules and Regulations]
[Pages 35047-35048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12030]



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DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

50 CFR Part 648

[Docket No. 050613158-5158-01; I.D. 061305B]
RIN 0648-AT48


Magnuson-Stevens Fishery Conservation and Management Act 
Provisions; Fisheries of the Northeastern United States; Emergency 
Fishery Closure Due to the Presence of the Toxin that Causes Paralytic 
Shellfish Poisoning (PSP)

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

ACTION: Emergency action; request for comments.

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SUMMARY: NMFS is promulgating emergency regulations, at the request of 
the Food and Drug Administration (FDA), to close portions of Federal 
waters of the Gulf of Maine, Georges Bank, and southern New England to 
the harvest of shellfish (bivalves), with the exception of sea scallop 
adductor muscles harvested and shucked at sea, due to the presence in 
those waters of the toxin that causes paralytic shellfish poisoning 
(PSP). The concentrations of the toxin in the Federal waters is great 
enough to warrant a public health emergency. The closure will remain in 
effect until September 30, 2005, with the possibility of a reduction or 
an extension of the closure based upon FDA's determination that the 
concentration of the toxin in shellfish is at a level that is safe or 
unsafe, respectively, for human consumption.

DATES: Effective June 14, 2005 through September 30, 2005. Comments 
must be received by July 18, 2005.

ADDRESSES: Comments may be submitted by any of the following methods:
     E-mail: [email protected]. Include in the subject line 
the following: ``Comments on the Emergency Rule for Area Closure Due to 
PSP.''
     Federal e-Rulemaking Portal: http:/www.regulations.gov.
     Mail: Paper, disk, or CD-ROM comments should be sent to 
Patricia A. Kurkul, Regional Administrator, National Marine Fisheries 
Service, One Blackburn Drive, Gloucester, MA 01930. Mark the outside of 
the envelope ``Comments on the Emergency Rule for Area Closure Due to 
PSP.''
     Fax: (978) 281-9135.
    Copies of the emergency rule are available from Patricia A. Kurkul, 
Regional Administrator, National Marine Fisheries Service, One 
Blackburn Drive, Gloucester, MA 01930.

FOR FURTHER INFORMATION CONTACT: Brian Hooker, Fishery Policy Analyst, 
phone: (978) 281-9220, fax; (978) 281-9135.

SUPPLEMENTARY INFORMATION:

Background

    On June 10, 2005, FDA requested that NMFS close an area of Federal 
waters off the coasts of New Hampshire and Massachusetts to any 
harvesting of shellfish (bivalves) intended for human consumption. This 
includes surfclams, ocean quahogs, unshucked or ``roe-on'' scallops, 
and mussels. The only exception to this closure is for Atlantic sea 
scallops harvested for onboard shucking of the adductor muscle or 
``meat'' which is unaffected by the toxin. The text of the June 10, 
2005, FDA request is as follows:

June 10, 2005
Rebecca Lent, Ph.D.
Deputy Administrator
National Marine Fisheries Service
1315 East West Highway
Silver Spring, MD 20910

Dear Dr. Lent:

On behalf of Michael O. Leavitt, Secretary of Health and Human 
Services (HHS), the Food and Drug Administration (FDA) is requesting 
that the National Oceanic and Atmospheric Administration (NOAA)/
National Marine Fisheries Service (NMFS) of the Department of 
Commerce close waters of the north western Atlantic Ocean, as 
described below, to the harvesting of bivalve molluscan shellfish 
intended for human consumption. The States of Massachusetts, New 
Hampshire, and Maine are experiencing one of the largest toxic algal 
blooms (red tides) in their history. The red tide, which is 
responsible for the production of marine biotoxins that cause 
Paralytic Shellfish Poisoning (PSP) in persons consuming affected 
shellfish, has spread from State waters to Federal waters further 
offshore. In accordance with the National Shellfish Sanitation 
Program (NSSP), the States have closed affected waters within their 
jurisdiction. Closure of Federal waters is also necessary to address 
this public health emergency by ensuring that potentially unsafe 
bivalve molluscan shellfish are not harvested for human consumption.

FDA is requesting that NMFS close all waters south of 43 degrees 
north latitude, west of 69 degrees west longitude, north of 40 
degrees north latitude, and east of 71 degrees west longitude. This 
area is to be closed to the harvesting of all species of bivalve 
molluscan shellfish with the only exception of scallops that are 
harvested for onboard shucking of the adductor muscle. While FDA 
cannot predict how long the closure should remain in effect, it is 
reasonable that closure should at least extend for 2 to 3 months. 
Reopening the area should be based on test results from shellfish 
collected within the closed area. The closure does not include 
Federal waters off the coast of Maine because cell counts of the 
organism responsible for production of the dangerous marine biotoxin 
are at lower levels and the small fishery in these waters has been 
controlled through State and industry actions.

Given the severity of the illness associated with PSP, FDA requests 
that NMFS moves as quickly as possible to implement the closure. FDA 
stands ready to assist NMFS in whatever way it can. Please contact 
Paul DiStefano at 301-436-1410, of my staff, or me should you have 
any questions or need further assistance.

As always, FDA appreciates the support and cooperation provided by 
NMFS in our joint efforts to protect public health. We look forward 
to working with you to collect samples from the closure to better 
define the level of toxicity in shellfish meats and in our joint 
efforts to once again reopen the area for commercial harvest.

Sincerely,

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs.

    According to FDA, portions of the north western Atlantic Ocean are 
experiencing one of the largest toxic algal blooms (red tides) in 
history. The red tide is responsible for the production of marine 
biotoxins that cause PSP in persons consuming affected shellfish. It 
has spread from State waters to Federal waters further offshore. In 
accordance with the FDA's National Shellfish Sanitation Program (NSSP), 
the States have closed affected waters within their jurisdiction. 
Closure of the Federal waters is also necessary to address the public 
health emergency.
    While it is difficult to predict precisely how long the closure 
should remain in effect, FDA estimates that the closure should remain 
in effect at least 2 to 3 months. Thus, this closure will remain in 
effect until September 30, 2005, with the possibility of a reduction or 
an extension of the closure based upon FDA's determination that the 
concentration of the toxin in shellfish is at a level that is safe or 
unsafe, respectively, for human consumption.
    This action temporarily closes all Federal waters of the Exclusive 
Economic Zone (EEZ) of the Northeastern United States to any shellfish 
harvesting, with the exception of Atlantic sea scallops shucked at sea 
for their adductor muscles, in the area bound by the following 
coordinates in the order stated: (1) 43[deg]00' N. lat., 71[deg]00'

[[Page 35048]]

W. long.; (2) 43[deg]00' N. lat., 69[deg]00' W. long.; (3) 40[deg]00' 
N. lat., 69[deg]00' W. long.; (4) 40[deg]00' N. lat., 71[deg]00' W. 
long., and then ending at the first point.

Classification

    This action is issued pursuant to section 305(c) of the Magnuson-
Stevens Fishery Conservation and Management Act, 16 U.S.C. 1855(c).
    This rule has been determined to be not significant under Executive 
Order 12866.
    The Assistant Administrator for Fisheries, NOAA (AA), finds good 
cause under 5 U.S.C. 553(b)(B) to waive prior notice and the 
opportunity for public comment for this action, as prior notice and 
comment would be impracticable and contrary to the public interest. The 
action is in response to a public health emergency. The FDA has 
requested that NMFS move as quickly as possible to close a specified 
area to the harvest of shellfish, as shellfish harvested from that area 
could pose a public health risk if consumed. Any delay in implementing 
this rule could pose serious health risks to the public. For the 
reasons stated above, the AA also finds good cause to waive the delayed 
effectiveness period pursuant to 5 U.S.C. 553(d)(3).
    Since this emergency action is necessary to protect public health, 
a Regulatory Impact Review (RIR) in accordance with Executive Order 
12866 has not been completed. The RIR will be made available to the 
public once it has been completed.
    Because notice and opportunity for comment are not required 
pursuant to 5 U.S.C. 553 or any other law, the analytical requirements 
of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are 
inapplicable. Therefore, a regulatory flexibility analysis is not 
required and has not been prepared.

List of Subjects in 50 CFR Part 648

    Fisheries, Fishing, Reporting and recordkeeping requirements.

    Dated: June 14, 2005.
Rebecca Lent
Deputy Assistant Administrator for Regulatory Programs, National Marine 
Fisheries Service.

0
For the reasons set out in the preamble, 50 CFR part 648 is amended to 
read as follows:

PART 648--FISHERIES OF THE NORTHEASTERN UNITED STATES

0
1. The authority citation for part 648 continues to read as follows:

    Authority: 16 U.S.C. 1801 et seq.

0
2. In Sec.  648.14, paragraph (a)(166) is added to read as follows:


Sec.  648.14  Prohibitions.

    (a) * * *
    (166) Fish for, harvest, catch, possess, or attempt to fish for, 
harvest, catch, or possess any bivalve shellfish, including Atlantic 
surfclams, ocean quahogs, and mussels, with the exception of sea 
scallops harvested only for adductor muscles and shucked at sea, in the 
area of the U.S. Exclusive Economic Zone bound by the following 
coordinates in the order stated: 43[deg]00' N. lat., 71[deg]00' W. 
long.; 43[deg]00' N. lat., 69[deg]00' W. long.; 40[deg]00' N. lat., 
69[deg]00' W. long.; 40[deg]00' N. lat., 71[deg]00' W. long., and then 
ending at the first point.
* * * * *
[FR Doc. 05-12030 Filed 6-14-05; 3:36 pm]
BILLING CODE 3510-22-S