[Federal Register Volume 64, Number 13 (Thursday, January 21, 1999)]
[Notices]
[Pages 3300-3301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98P-0504]


Performance Standard for Vibrio Vulnificus; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has received a petition 
from the Center for Science in the Public Interest (CSPI) requesting 
that the agency establish a performance standard of ``nondetectable'' 
for the marine bacterium Vibrio vulnificus in raw molluscan shellfish 
harvested from waters that have been linked to illnesses from this 
organism. FDA is requesting information and views from the general 
public on CSPI's request and on several specific questions relating to 
the petition.

DATES: Submit written comments by April 21, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Patricia S. Schwartz, Center for Food 
Safety and Applied Nutrition (HFS-401), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3133.

SUPPLEMENTARY INFORMATION:

I. Background

    V. vulnificus is a marine bacterium that can cause infection in 
humans as a result of contact through cuts or wounds and consumption of 
food containing the organism. The association of foodborne illness with 
V. vulnificus is relatively recent; the first reported cases occurred 
in the 1970's. To date, the food almost exclusively associated with 
illness from V. vulnificus is raw oysters harvested from States 
bordering on the Gulf of Mexico. However, the bacterium is also found 
in marine waters and in shellfish outside the Gulf region, although raw 
oysters from waters outside the Gulf region have not been definitively 
implicated in any cases of illness.
    While V. vulnificus can infrequently cause gastroenteritis in 
healthy individuals, it can cause much more serious, sometimes deadly, 
septicemia in certain compromised individuals. The conditions that FDA 
believes put consumers at risk for septicemia from V. vulnificus 
include alcoholic liver disease, diabetes, hemochromatosis, chronic 
hepatitis B and C, and depressed immune system function. However, the 
majority of cases of septicemia have occurred in consumers with 
alcoholic liver disease. FDA estimates that the at-risk population in 
the United States falls within a range of 12 to 30 million. The number 
of septicemia cases reported from V. vulnificus each year range from a 
low of 9 in 1990 and 1991 to a high of 33 in 1996. Septicemia in 
medically compromised individuals has proven fatal in about 50 percent 
of reported cases. The agency's policy since 1993 has been that at-risk 
individuals should only consume molluscan shellfish that have been 
adequately cooked, as thorough cooking kills V. vulnificus.
    FDA is supporting ongoing research directed toward answering 
several questions about V. vulnificus, including research: (1) To 
identify the characteristics of those strains of V. vulnificus that are 
pathogenic to humans, (2) to describe the effect of environmental 
conditions on the occurrence of these strains in water and in 
shellfish, (3) to determine whether there is an infectious dose or 
doses of the organism in susceptible humans, (4) to determine whether 
there are other factors or conditions that may put consumers at risk of 
septicemia; and (5) research on other matters. To date, FDA has 
cosponsored two national scientific workshops on V. vulnificus to 
determine what is known and what needs to be learned about this 
organism.
    In addition, since 1993, the agency has expended considerable 
effort on education directed toward at-risk populations to warn them to 
avoid raw shellfish. Recently, the agency has supported point-of-
purchase advisories directed toward at-risk individuals.
    FDA has also worked with the Interstate Shellfish Sanitation 
Conference (ISSC), a cooperative entity (whose members include FDA, the 
States, and the shellfish industry) dedicated to the production of safe 
and sanitary molluscan shellfish, to address issues related to V. 
vulnificus. The agency participated with the ISSC in developing the 
post-harvest refrigeration requirements that were established by the 
ISSC for V. vulnificus in oysters. Together with the ISSC, FDA is 
currently studying the levels of these organisms in oysters to which 
consumers are exposed at retail.
    FDA recognizes that innovative post-harvest technologies may also 
reduce or eliminate V. vulnificus from raw oysters. To foster this 
approach, the agency has provided labeling advice to a company that is 
marketing oysters that have been subject to a post-harvest treatment 
involving low temperature pasteurization (see the following 
paragraphs). The agency hopes that companies pursuing other potential 
post-harvest technologies will also seek FDA's labeling assistance.

II. The Citizen's Petition

    On June 29, 1998, CSPI filed a citizen petition that requests that 
FDA issue regulations under the Federal Food, Drug, and Cosmetic Act or 
Public Health Service Act requiring nondetectable levels of V. 
vulnificus in raw molluscan shellfish harvested from waters that have 
been linked to illnesses or deaths

[[Page 3301]]

from this bacterium. V. vulnificus may be detected in virtually all 
oysters from such waters, at least during warm weather months. Thus, 
the practical effect of mandating a performance standard of 
``nondetectable'' would be to impose post-harvest treatment 
requirements on all oysters from these waters.
    The petition cites one such post-harvest treatment, that of the 
AmeriPure Co., which involves a mild heat treatment of in-shell oysters 
that is capable of killing V. vulnificus. FDA has reviewed data 
submitted by the AmeriPure Co. and those data do indicate that its 
process is capable of reducing V. vulnificus in oysters to 
nondetectable levels.

III. Request for Information and Views

    Under FDA's administrative regulations (21 CFR 10.30(h)(3)), the 
agency, when reviewing a petition, may employ various procedures, 
including publishing a Federal Register notice asking for information 
and views. Accordingly, FDA is hereby soliciting comment on the issues 
raised by the CSPI petition. However, FDA is especially interested in 
comments, with supporting data where appropriate, on the following 
questions:
    1. Is the AmeriPure Co. technology readily employable by the 
shellfish industry; if not, what barriers exist, and what steps could 
be taken to reduce or eliminate those barriers?
    2. Other than the AmeriPure Co. process, what technologies, both 
present and anticipated, could significantly reduce the number of V. 
vulnificus in oysters while retaining the sensory qualities of a raw 
oyster? What is known about the ability of such technologies to reduce 
the number of V. vulnificus to nondetectable levels?
    3. How reliable are such technologies? May they practically be 
required for an entire industry or a significant portion of that 
industry?
    4. Would a performance standard have to be as low as 
``nondetectable?'' Do data exist that would permit the setting of a 
performance standard above ``nondetectable?'' If so, at what level? 
Should the fact that V. vulnificus is found at low levels (less than 
100 Most Probable Number/gram) in oysters in months (January and 
February) in which there have been no reported illnesses be taken into 
account when establishing a performance standard or level?
    5. Should a performance standard apply to all raw molluscan 
shellfish or only to oysters?
    6. What would be the quantifiable and nonquantifiable costs of a 
performance standard? Who would bear the costs? What would be the 
effect on costs, and the distribution of costs, if there was only one, 
patented process that could be used to meet the performance standard? 
What would the effect on costs be if a standard of ``nondetectable'' 
were put in place for all pathogens or for all raw molluscan shellfish?
    7. What would be the quantifiable and nonquantifiable benefits of a 
performance standard? Who would enjoy the benefits?
    8. Another marine pathogen, V. parahaemolyticus, has caused over 
700 reported cases of illness (gastroenteritis) during 1997 and 1998. 
There has been one death reported to the Centers for Disease Control 
and Prevention and several hospitalizations. Illnesses from V. 
parahaemolyticus have occurred from oysters harvested outside of the 
Gulf of Mexico region.
    Should a performance standard apply only to V. vulnificus or should 
it apply to other Vibrio species that post-harvest treatment might be 
able to reduce to nondetectable levels?

IV. Request for Comments

     Interested persons may, on or before April 21, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this notice. Two copies of any comments are to be submitted, except 
that individuals may submit one 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 office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: January 13, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1361 Filed 1-20-99; 8:45 am]
BILLING CODE 4160-01-F