[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