Risk Assessment on Norovirus in Bivalve Molluscan Shellfish: Request for Comments and for Scientific Data and Information, 65200-65203 [2011-27101]
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elements from E2B(R2) and E2B(R3) and
is intended to assist reporters and
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II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
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is only necessary to send one set of
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Identify comments with the docket
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comments may be seen in the Division
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and 4 p.m., Monday through Friday.
III. Electronic Access
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[Docket No. FDA–2011–N–0002]
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[FR Doc. 2011–27209 Filed 10–19–11; 8:45 am]
Dated: October 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Risk Assessment on Norovirus in
Bivalve Molluscan Shellfish: Request
for Comments and for Scientific Data
and Information
[FR Doc. 2011–27147 Filed 10–19–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0731]
AGENCY:
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Food and Drug Administration,
HHS.
Notice; request for comments
and for scientific data and information.
ACTION:
The Food and Drug
Administration (FDA) is undertaking a
collaboration with Health Canada, the
Canadian Food Inspection Agency,
Environment Canada, and Fisheries and
SUMMARY:
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Oceans Canada, to conduct a
quantitative food safety risk assessment
on norovirus in bivalve molluscan
shellfish, specifically, oysters, clams,
and mussels. FDA, on behalf of the
collaborative team, is requesting
submission of comments and scientific
data and information that would assist
in the development of the risk
assessment.
DATES: Submit either electronic or
written comments and scientific data
and information by January 18, 2012.
ADDRESSES: Submit electronic
comments and scientific data and
information to https://
www.regulations.gov. Submit written
comments and scientific data and
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jane
M. Van Doren, Center for Food Safety
and Applied Nutrition (HFS—005),
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740, 240–402–2927.
SUPPLEMENTARY INFORMATION:
I. Background
Noroviruses constitute a genus of
genetically diverse, single-stranded
ribonucleic acid (RNA) viruses
belonging to the family Caliciviridae
(Ref. 1). Noroviruses cause millions of
cases of acute gastroenteritis in the
United States and thousands of cases in
Canada annually (Refs. 2 to 4). The
viruses can be transmitted through
consumption of norovirus-contaminated
food or water, through person-to-person
contact, or through contact with
contaminated surfaces (Refs. 1 and 5).
Most norovirus outbreaks attributed to
bivalve molluscan shellfish
consumption have been traced to
contamination during growth and
harvest (Refs. 1 and 6). Bivalve
molluscan shellfish are typically grown
in estuaries, which may contain
norovirus-contaminated human fecal
material from municipal wastewater
outfalls, combined sewer overflow, or
non-point sources of pollution
including human waste discharged from
marine vessels (Refs. 6 to 8). Under
some conditions, bivalve molluscan
shellfish bioaccumulate waste
contaminants (Ref. 9), thereby
increasing the contaminant level in the
bivalve molluscan shellfish relative to
that in the water.
Both the United States and Canada
have developed detailed guidelines, in
collaboration with their respective
federal, state or provincial, tribal, and
industry partners, to help ensure
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shellfish food safety. The requirements
described in these documents (Refs. 10
and 11) reflect a risk-based approach to
reduce levels of indicator organisms,
including total and fecal coliforms,
thereby decreasing the probability of
pathogenic contamination of shellfish.
FDA, in collaboration with Health
Canada, the Canadian Food Inspection
Agency, Environment Canada, and
Fisheries and Oceans Canada (the joint
U.S.-Canada risk assessment team), is
planning to conduct a quantitative risk
assessment that can be used to evaluate
the impact of preventive practices and
controls on the risk of human norovirus
illness associated with consumption of
bivalve molluscan shellfish. The risk
assessment will focus on norovirus
contamination of bivalve molluscan
shellfish arising from growth, harvest,
and post-harvest processing. This risk
assessment will focus on oysters, clams,
and mussels. The principal objectives of
this risk assessment are to:
• Evaluate the relative impact of
selected factors (e.g., size of the
community contributing to the
municipal wastewater catchment,
wastewater treatment, water
temperature in bivalve molluscan
shellfish growing and harvest areas,
harvest season, post-harvest processes,
food production practices, and
consumption patterns) on the risk of
human norovirus illness associated with
the consumption of bivalve molluscan
shellfish;
• Assess the impact on the level of
risk of specified control measures
currently used to mitigate risks from
norovirus contamination of bivalve
molluscan shellfish growing waters
including those recommended by
National Shellfish Sanitation Program
(NSSP) and Canadian Shellfish
Sanitation Program (CSSP);
• Identify additional preventive
practices and controls that could be
implemented in the future; and
• Inform the development of a Food
Safety Objective (Ref. 12) for norovirus
contamination in bivalve molluscan
shellfish and/or a Performance
Objective (Ref. 12) for bivalve molluscan
shellfish growth and harvest waters.
Contamination arising from
transmission of norovirus from infected
or ill food workers in food
manufacturing or retail establishments
to bivalve molluscan shellfish is outside
the scope of this risk assessment.
II. Request for Comments, Scientific
Data, and Information
FDA, on behalf of the joint U.S.Canada risk assessment team, is
requesting comments, scientific data,
and information to be considered in the
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design and development of the risk
assessment. Data that include
measurements of norovirus or enteric
viral surrogate should identify the
methods of analysis and detection,
virus/surrogate and genotype detected,
and recovery rate, if available (e.g.,
analysis of single oyster diverticulum
using real-time reverse transcription
quantitative polymerase chain reaction
(RT-qPCR) for norovirus GII with 80%
recovery). Areas of particular interest
include epidemiology of norovirus
illness, pre-harvest preventive practice
and controls, post-harvest preventive
practices and controls, food preparation
and consumption practices, and the
relationship between norovirus dose
and adverse health effects.
A. Epidemiology of Norovirus Illness
We request data and information
about the following aspects of the
epidemiology of norovirus illness:
1. Patterns of transmission of
norovirus in different settings, such as
in a community, a nursing facility, or a
household;
2. Proportion of norovirus illness due
to person-to-person transmission, food
consumption, and bivalve molluscan
shellfish consumption;
3. Proportion and determinants of
individual resistance to norovirus
infection;
4. Underreporting rate for norovirus
illnesses arising from consumption of
norovirus-contaminated food in United
States or Canada; and
5. Models describing the transmission
of norovirus in a population.
B. Preventive Practices and Controls and
Other Factors Influencing Bivalve
Molluscan Shellfish Contamination
Levels
We request data and information
about the following aspects of
preventive practices and controls and
other factors influencing bivalve
molluscan shellfish contamination
levels:
1. Prevalence of different types of
treatment in municipal wastewater
treatment (WWT) facilities in the United
States and Canada, their relative size
(population served), and their location
relative to bivalve molluscan shellfish
growing/harvest areas. Data submitted
should also include information about
treatment process(es) (e.g.,
sequence,timing, and/or concentration
of bacteria/viral reducing agent) and
effluent flow (volumerates of flow
observed in the facility and the factors
that influence the rate);
2. Norovirus or enteric viral surrogate
loads in raw wastewater and treated
effluent from municipal WWT facilities
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as a function of type of treatment, water
temperature, and season. Data should
include the date and time of the
measurement, volume rate of flow,
weather, size of the community served,
and the presence of norovirus outbreaks
in the population at the time of
measurement (if known). FDA
specifically requests comparisons of
norovirus or enteric viral surrogate
loads in raw wastewater and WWT
effluent obtained during the same time
period and from the same facility;
3. Experimental data and models
describing dilution of WWT effluent in
the estuary (e.g., water exchange rate
and tidal flush volume) for a
representative estuary or estuaries in
general. Information should include
details on calculations used within the
model;
4. Experimental data and models
describing norovirus or enteric viral
surrogate loss processes that may occur
in an estuary, including inactivation by
ultraviolet radiation or sunlight,
association with particulate followed by
sedimentation, and predation by marine
organisms. Data submitted should
include experimental conditions and
ranges (e.g., water temperature, water
salinity, season, and estuary water
exchange rate);
5. Concentration of norovirus or
enteric viral surrogates in sediments,
events that cause re-suspension of
sediment, and data describing the
relationship between nearby sediment
and the concentration of norovirus or
enteric viral surrogates in bivalve
molluscan shellfish. Data submitted
should include information about the
sediment sampled (e.g., depth,
temperature, water salinity, season) and
shellfish sampled (e.g., nutrient
availability, growth substrate, water
temperature, water salinity, season,
species, and animal variance), if
applicable;
6. Characteristics of sites where
stratification of WWT effluent discharge
in the water column occurs (e.g.,
temperature, salinity, depth, surface
winds, storm activity, local
hydrodynamics, and outfall design) and
the impact of these characteristics on
norovirus or enteric viral surrogate
concentrations in bivalve molluscan
shellfish growing/harvest areas (e.g.,
plume movement and mixing);
7. Norovirus or enteric viral surrogate
loads from marine vessel discharge,
combined sewer overflow, or other
sporadic events that might contaminate
bivalve molluscan shellfish growing/
harvest areas;
8. Uptake rate of norovirus or enteric
viral surrogates by bivalve molluscan
shellfish and determinations of the
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bioaccumulation factor (BAF). Data and
information should include a
description of the impacts of pathogen
particle association, concentration of the
pathogen in the water surrounding the
bivalve molluscan shellfish, nutrient
availability, growth substrate, water
temperature, water salinity, season,
species, and animal variance on this rate
and the BAF. Data submitted should
specify the experimental conditions
during which uptake was measured
(e.g., batch feeding, flow-through
feeding, or natural environmental
conditions);
9. Inactivation rate of norovirus or
enteric viral surrogates within bivalve
molluscan shellfish, including the
impacts of nutrient availability, growth
substrate, water temperature, water
salinity, season, species, and animal
variance on this rate. Data submitted
should specify the experimental
conditions during which inactivation
was measured (e.g., batch, flow-through,
or natural environmental conditions);
10. Elimination rate of norovirus or
enteric viral surrogates from bivalve
molluscan shellfish including the
impacts of nutrient availability, growth
substrate, water temperature, water
salinity, season, species, and animal
variance on this rate. Data submitted
should specify the experimental
conditions during which elimination
was measured (e.g., batch, flow-through,
or natural environmental conditions);
and
11. Models that specifically address
uptake, inactivation and elimination of
norovirus or enteric viral surrogates by
bivalve molluscan shellfish.
C. Post-Harvest Preventive Practice and
Controls and Other Factors Influencing
Bivalve Molluscan Shellfish
Contamination Levels
We request data and information
about the following aspects of postharvest preventive practice and controls
and other factors influencing bivalve
molluscan shellfish contamination
levels:
1. Regional and seasonal landings of
bivalve molluscan shellfish species in
the United States and Canada;
2. Prevalence and concentration of
norovirus or enteric viral surrogates in
bivalve molluscan shellfish at the time
of harvest, classified by species,
location, and seasonal landing;
3. Proportion of bivalve molluscan
shellfish, by species, that undergo wet
storage, relaying and depuration and the
conditions (e.g., times and
temperatures) of these practices as
applied by the shellfish industry. Data
are also requested to determine whether
shellfish undergoing these different
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treatments preferentially serve different
postmarkets (e.g., raw/cooked);
4. Experimental data and models that
describe the impact of wet storage,
relaying, and depuration on the
concentration of norovirus or enteric
viral surrogate in bivalve molluscan
shellfish. Data submitted should specify
process and experimental conditions
including parameter ranges (e.g.,
process time, water temperature, water
salinity, nutrient availability, growth
substrate, species, and season) as well as
animal variance;
5. Proportion of bivalve molluscan
shellfish, by species, that undergo high
hydrostatic pressure (HHP), mild heat,
irradiation, freezing, or other
postharvest processes. Data are also
requested to determine whether bivalve
molluscan shellfish undergoing these
different treatments preferentially serve
different postmarkets (e.g., raw/cooked);
6. Protocols/conditions and parameter
ranges for HHP, mild heat, irradiation,
freezing, or other postharvest processes
as applied to bivalve molluscan
shellfish by the shellfish industry; and
7. Experimental data and models that
describe the impact of HHP, mild heat,
irradiation, freezing, or other postharvest processes on the concentration
of norovirus or enteric viral surrogate in
bivalve molluscan shellfish. Data
submitted should specify the processing
and experimental conditions, parameter
ranges (e.g., time, pressure and
temperature), species, and animal
variance.
D. Preventive Practice and Controls and
Other Factors Influencing Bivalve
Molluscan Shellfish Contamination
Levels During Food Preparation and
Bivalve Molluscan Shellfish
Consumption Data
We request data and information
about the following aspects of
preventive practice and controls and
other factors influencing bivalve
molluscan shellfish contamination
levels during food preparation and
bivalve molluscan shellfish
consumption:
1. Proportion of bivalve molluscan
shellfish, by species, eaten raw and
cooked, including method of cooking
(e.g., steaming, frying, or baking);
2. Distribution of bivalve molluscan
shellfish meal sizes, categorized by
species, with regard to season, region,
and preparation technique;
3. Distribution of temperatures and
times associated with cooking methods
(e.g., steaming, frying, or baking) for
bivalve molluscan shellfish, by species;
4. Experimental data and models
describing the impact of food
preparation technique on the
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concentration of norovirus or enteric
viral surrogates in bivalve molluscan
shellfish, by species. Data submitted
should include food preparation and
cooking parameters and ranges (e.g.,
temperature and time); and
5. Prevalence distribution of
norovirus or enteric viral surrogate in
bivalve molluscan shellfish, by species,
at the point of consumption as a
function of season, region and
preparation technique.
E. Relationship Between Norovirus Dose
and Adverse Human Health Effects
We request data and information
about the following aspects of the
relationship between norovirus dose
and adverse human health effects
including:
1. Human or animal studies that
describe the relationship between
norovirus dose and the probability and
severity of human illness;
2. Human norovirus outbreak data
that describe the relationship between
norovirus dose and the probability and
severity of human illness; and
3. Epidemiological and mechanistic
data identifying/describing different
rates of illness or health outcomes for
particular populations (e.g., vulnerable/
susceptible populations and resistant
populations) exposed to norovirus.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments and scientific data and
information regarding this document. It
is only necessary to send one set of
comments and scientific data and
information. It is no longer necessary to
send two copies of mailed comments
and scientific data and information.
Identify comments and scientific data
and information with the docket
number found in brackets in the
heading of this document. Received
comments and scientific data and
information may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Centers for Disease Control and
Prevention, Norovirus Technical Fact
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Sheet, https://www.cdc.gov/ncidod/dvrd/
revb/gastro/norovirus-factsheet.htm.
2. Centers for Disease Control and
Prevention, Norovirus: Surveillance,
Disease Burden, and Disease Reduction
Activities, https://www.cdc.gov/ncidod/
dvrd/revb/gastro/norovirus-survdisease-burden.htm.
3. National Microbiology Laboratory
and Public Health Agency of Canada,
National Enteric Surveillance Program,
‘‘Annual Summary of Laboratory
Surveillance Data for Enteric Pathogens
in Canada,’’ 2009.
4. Majowicz, S.E., V.L. Edge, A. Fazil,
et al., ‘‘Estimating the Under-Reporting
Rate for Infectious Gastrointestinal
Illness in Ontario,’’ Canadian Journal of
Public Health, vol. 96, pp. 178–181,
2005.
5. Gerba, C.P. and D. Kayed,
‘‘Caliciviruses: A Major Cause of
Foodborne Illness,’’ Journal of Food
Science, vol. 68, pp. 1136–1142, 2003.
6. Kohn, M.A., T.A. Farley, T. Ando,
et al., ‘‘An Outbreak of Norwalk Virus
Gastroenteritis Associated With Eating
Oysters: Implications for Maintaining
Safe Oyster Beds,’’ Journal of the
American Medical Association, vol. 273,
pp. 466–471, 1995.
7. Shieh, Y.C., R.S. Baric, J.W. Woods,
et al., ‘‘Molecular Surveillance of
Enterovirus and Norwalk-Like Virus in
Oysters Relocated to a MunicipalSewage-Impacted Gulf Estuary,’’
Applied and Environmental
Microbiology, vol. 69, pp. 7130–7136,
2003.
8. J.A. Lowther, K. Henshilwood, and
D.N. Lees, ‘‘Determination of Norovirus
Contamination in Oysters From Two
Commercial Harvesting Areas Over an
Extended Period, Using
Semiquantitative Real-Time Reverse
Transcription PCR,’’ Journal of Food
Protection, vol. 71, pp. 1427–1433,
2008.
9. Burkhardt, W., III and K. Calci,
‘‘Selective Accumulation May Account
for Shellfish-Associated Viral Illness,’’
Applied Environmental Microbiology,
vol. 66, pp. 1375–1378, 2000.
10. National Shellfish Sanitation
Program (NSSP) Guide for the Control of
Molluscan Shellfish 2009 Revision,
https://www.fda.gov/Food/FoodSafety/
Product-SpecificInformation/Seafood/
FederalStatePrograms/
NationalShellfishSanitationProgram/
ucm046353.htm.
11. Canadian Shellfish Sanitation
Program (CSSP) Manual of Operations,
https://www.inspection.gc.ca/english/
fssa/fispoi/man/cssppccsm/shemolalle.
pdf.
12. Joint Food and Agriculture
Organization of the United Nations/
World Health Organization Food
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Standards Program, Codex Alimentarius
Commission Procedural Manual, 20th
ed. 113, 2011, ftp://ftp.fao.org/codex/
Publications/ProcManuals/Manual_20e.
pdf.
Dated: October 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27101 Filed 10–19–11; 8:45 am]
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20OCN1
Agencies
[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Notices]
[Pages 65200-65203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0731]
Risk Assessment on Norovirus in Bivalve Molluscan Shellfish:
Request for Comments and for Scientific Data and Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments and for scientific data and
information.
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SUMMARY: The Food and Drug Administration (FDA) is undertaking a
collaboration with Health Canada, the Canadian Food Inspection Agency,
Environment Canada, and Fisheries and Oceans Canada, to conduct a
quantitative food safety risk assessment on norovirus in bivalve
molluscan shellfish, specifically, oysters, clams, and mussels. FDA, on
behalf of the collaborative team, is requesting submission of comments
and scientific data and information that would assist in the
development of the risk assessment.
DATES: Submit either electronic or written comments and scientific data
and information by January 18, 2012.
ADDRESSES: Submit electronic comments and scientific data and
information to https://www.regulations.gov. Submit written comments and
scientific data and information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jane M. Van Doren, Center for Food
Safety and Applied Nutrition (HFS--005), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.
SUPPLEMENTARY INFORMATION:
I. Background
Noroviruses constitute a genus of genetically diverse, single-
stranded ribonucleic acid (RNA) viruses belonging to the family
Caliciviridae (Ref. 1). Noroviruses cause millions of cases of acute
gastroenteritis in the United States and thousands of cases in Canada
annually (Refs. 2 to 4). The viruses can be transmitted through
consumption of norovirus-contaminated food or water, through person-to-
person contact, or through contact with contaminated surfaces (Refs. 1
and 5). Most norovirus outbreaks attributed to bivalve molluscan
shellfish consumption have been traced to contamination during growth
and harvest (Refs. 1 and 6). Bivalve molluscan shellfish are typically
grown in estuaries, which may contain norovirus-contaminated human
fecal material from municipal wastewater outfalls, combined sewer
overflow, or non-point sources of pollution including human waste
discharged from marine vessels (Refs. 6 to 8). Under some conditions,
bivalve molluscan shellfish bioaccumulate waste contaminants (Ref. 9),
thereby increasing the contaminant level in the bivalve molluscan
shellfish relative to that in the water.
Both the United States and Canada have developed detailed
guidelines, in collaboration with their respective federal, state or
provincial, tribal, and industry partners, to help ensure
[[Page 65201]]
shellfish food safety. The requirements described in these documents
(Refs. 10 and 11) reflect a risk-based approach to reduce levels of
indicator organisms, including total and fecal coliforms, thereby
decreasing the probability of pathogenic contamination of shellfish.
FDA, in collaboration with Health Canada, the Canadian Food
Inspection Agency, Environment Canada, and Fisheries and Oceans Canada
(the joint U.S.-Canada risk assessment team), is planning to conduct a
quantitative risk assessment that can be used to evaluate the impact of
preventive practices and controls on the risk of human norovirus
illness associated with consumption of bivalve molluscan shellfish. The
risk assessment will focus on norovirus contamination of bivalve
molluscan shellfish arising from growth, harvest, and post-harvest
processing. This risk assessment will focus on oysters, clams, and
mussels. The principal objectives of this risk assessment are to:
Evaluate the relative impact of selected factors (e.g.,
size of the community contributing to the municipal wastewater
catchment, wastewater treatment, water temperature in bivalve molluscan
shellfish growing and harvest areas, harvest season, post-harvest
processes, food production practices, and consumption patterns) on the
risk of human norovirus illness associated with the consumption of
bivalve molluscan shellfish;
Assess the impact on the level of risk of specified
control measures currently used to mitigate risks from norovirus
contamination of bivalve molluscan shellfish growing waters including
those recommended by National Shellfish Sanitation Program (NSSP) and
Canadian Shellfish Sanitation Program (CSSP);
Identify additional preventive practices and controls that
could be implemented in the future; and
Inform the development of a Food Safety Objective (Ref.
12) for norovirus contamination in bivalve molluscan shellfish and/or a
Performance Objective (Ref. 12) for bivalve molluscan shellfish growth
and harvest waters.
Contamination arising from transmission of norovirus from infected or
ill food workers in food manufacturing or retail establishments to
bivalve molluscan shellfish is outside the scope of this risk
assessment.
II. Request for Comments, Scientific Data, and Information
FDA, on behalf of the joint U.S.-Canada risk assessment team, is
requesting comments, scientific data, and information to be considered
in the design and development of the risk assessment. Data that include
measurements of norovirus or enteric viral surrogate should identify
the methods of analysis and detection, virus/surrogate and genotype
detected, and recovery rate, if available (e.g., analysis of single
oyster diverticulum using real-time reverse transcription quantitative
polymerase chain reaction (RT-qPCR) for norovirus GII with 80%
recovery). Areas of particular interest include epidemiology of
norovirus illness, pre-harvest preventive practice and controls, post-
harvest preventive practices and controls, food preparation and
consumption practices, and the relationship between norovirus dose and
adverse health effects.
A. Epidemiology of Norovirus Illness
We request data and information about the following aspects of the
epidemiology of norovirus illness:
1. Patterns of transmission of norovirus in different settings,
such as in a community, a nursing facility, or a household;
2. Proportion of norovirus illness due to person-to-person
transmission, food consumption, and bivalve molluscan shellfish
consumption;
3. Proportion and determinants of individual resistance to
norovirus infection;
4. Underreporting rate for norovirus illnesses arising from
consumption of norovirus-contaminated food in United States or Canada;
and
5. Models describing the transmission of norovirus in a population.
B. Preventive Practices and Controls and Other Factors Influencing
Bivalve Molluscan Shellfish Contamination Levels
We request data and information about the following aspects of
preventive practices and controls and other factors influencing bivalve
molluscan shellfish contamination levels:
1. Prevalence of different types of treatment in municipal
wastewater treatment (WWT) facilities in the United States and Canada,
their relative size (population served), and their location relative to
bivalve molluscan shellfish growing/harvest areas. Data submitted
should also include information about treatment process(es) (e.g.,
sequence,timing, and/or concentration of bacteria/viral reducing agent)
and effluent flow (volumerates of flow observed in the facility and the
factors that influence the rate);
2. Norovirus or enteric viral surrogate loads in raw wastewater and
treated effluent from municipal WWT facilities as a function of type of
treatment, water temperature, and season. Data should include the date
and time of the measurement, volume rate of flow, weather, size of the
community served, and the presence of norovirus outbreaks in the
population at the time of measurement (if known). FDA specifically
requests comparisons of norovirus or enteric viral surrogate loads in
raw wastewater and WWT effluent obtained during the same time period
and from the same facility;
3. Experimental data and models describing dilution of WWT effluent
in the estuary (e.g., water exchange rate and tidal flush volume) for a
representative estuary or estuaries in general. Information should
include details on calculations used within the model;
4. Experimental data and models describing norovirus or enteric
viral surrogate loss processes that may occur in an estuary, including
inactivation by ultraviolet radiation or sunlight, association with
particulate followed by sedimentation, and predation by marine
organisms. Data submitted should include experimental conditions and
ranges (e.g., water temperature, water salinity, season, and estuary
water exchange rate);
5. Concentration of norovirus or enteric viral surrogates in
sediments, events that cause re-suspension of sediment, and data
describing the relationship between nearby sediment and the
concentration of norovirus or enteric viral surrogates in bivalve
molluscan shellfish. Data submitted should include information about
the sediment sampled (e.g., depth, temperature, water salinity, season)
and shellfish sampled (e.g., nutrient availability, growth substrate,
water temperature, water salinity, season, species, and animal
variance), if applicable;
6. Characteristics of sites where stratification of WWT effluent
discharge in the water column occurs (e.g., temperature, salinity,
depth, surface winds, storm activity, local hydrodynamics, and outfall
design) and the impact of these characteristics on norovirus or enteric
viral surrogate concentrations in bivalve molluscan shellfish growing/
harvest areas (e.g., plume movement and mixing);
7. Norovirus or enteric viral surrogate loads from marine vessel
discharge, combined sewer overflow, or other sporadic events that might
contaminate bivalve molluscan shellfish growing/harvest areas;
8. Uptake rate of norovirus or enteric viral surrogates by bivalve
molluscan shellfish and determinations of the
[[Page 65202]]
bioaccumulation factor (BAF). Data and information should include a
description of the impacts of pathogen particle association,
concentration of the pathogen in the water surrounding the bivalve
molluscan shellfish, nutrient availability, growth substrate, water
temperature, water salinity, season, species, and animal variance on
this rate and the BAF. Data submitted should specify the experimental
conditions during which uptake was measured (e.g., batch feeding, flow-
through feeding, or natural environmental conditions);
9. Inactivation rate of norovirus or enteric viral surrogates
within bivalve molluscan shellfish, including the impacts of nutrient
availability, growth substrate, water temperature, water salinity,
season, species, and animal variance on this rate. Data submitted
should specify the experimental conditions during which inactivation
was measured (e.g., batch, flow-through, or natural environmental
conditions);
10. Elimination rate of norovirus or enteric viral surrogates from
bivalve molluscan shellfish including the impacts of nutrient
availability, growth substrate, water temperature, water salinity,
season, species, and animal variance on this rate. Data submitted
should specify the experimental conditions during which elimination was
measured (e.g., batch, flow-through, or natural environmental
conditions); and
11. Models that specifically address uptake, inactivation and
elimination of norovirus or enteric viral surrogates by bivalve
molluscan shellfish.
C. Post-Harvest Preventive Practice and Controls and Other Factors
Influencing Bivalve Molluscan Shellfish Contamination Levels
We request data and information about the following aspects of
post-harvest preventive practice and controls and other factors
influencing bivalve molluscan shellfish contamination levels:
1. Regional and seasonal landings of bivalve molluscan shellfish
species in the United States and Canada;
2. Prevalence and concentration of norovirus or enteric viral
surrogates in bivalve molluscan shellfish at the time of harvest,
classified by species, location, and seasonal landing;
3. Proportion of bivalve molluscan shellfish, by species, that
undergo wet storage, relaying and depuration and the conditions (e.g.,
times and temperatures) of these practices as applied by the shellfish
industry. Data are also requested to determine whether shellfish
undergoing these different treatments preferentially serve different
postmarkets (e.g., raw/cooked);
4. Experimental data and models that describe the impact of wet
storage, relaying, and depuration on the concentration of norovirus or
enteric viral surrogate in bivalve molluscan shellfish. Data submitted
should specify process and experimental conditions including parameter
ranges (e.g., process time, water temperature, water salinity, nutrient
availability, growth substrate, species, and season) as well as animal
variance;
5. Proportion of bivalve molluscan shellfish, by species, that
undergo high hydrostatic pressure (HHP), mild heat, irradiation,
freezing, or other postharvest processes. Data are also requested to
determine whether bivalve molluscan shellfish undergoing these
different treatments preferentially serve different postmarkets (e.g.,
raw/cooked);
6. Protocols/conditions and parameter ranges for HHP, mild heat,
irradiation, freezing, or other postharvest processes as applied to
bivalve molluscan shellfish by the shellfish industry; and
7. Experimental data and models that describe the impact of HHP,
mild heat, irradiation, freezing, or other post-harvest processes on
the concentration of norovirus or enteric viral surrogate in bivalve
molluscan shellfish. Data submitted should specify the processing and
experimental conditions, parameter ranges (e.g., time, pressure and
temperature), species, and animal variance.
D. Preventive Practice and Controls and Other Factors Influencing
Bivalve Molluscan Shellfish Contamination Levels During Food
Preparation and Bivalve Molluscan Shellfish Consumption Data
We request data and information about the following aspects of
preventive practice and controls and other factors influencing bivalve
molluscan shellfish contamination levels during food preparation and
bivalve molluscan shellfish consumption:
1. Proportion of bivalve molluscan shellfish, by species, eaten raw
and cooked, including method of cooking (e.g., steaming, frying, or
baking);
2. Distribution of bivalve molluscan shellfish meal sizes,
categorized by species, with regard to season, region, and preparation
technique;
3. Distribution of temperatures and times associated with cooking
methods (e.g., steaming, frying, or baking) for bivalve molluscan
shellfish, by species;
4. Experimental data and models describing the impact of food
preparation technique on the concentration of norovirus or enteric
viral surrogates in bivalve molluscan shellfish, by species. Data
submitted should include food preparation and cooking parameters and
ranges (e.g., temperature and time); and
5. Prevalence distribution of norovirus or enteric viral surrogate
in bivalve molluscan shellfish, by species, at the point of consumption
as a function of season, region and preparation technique.
E. Relationship Between Norovirus Dose and Adverse Human Health Effects
We request data and information about the following aspects of the
relationship between norovirus dose and adverse human health effects
including:
1. Human or animal studies that describe the relationship between
norovirus dose and the probability and severity of human illness;
2. Human norovirus outbreak data that describe the relationship
between norovirus dose and the probability and severity of human
illness; and
3. Epidemiological and mechanistic data identifying/describing
different rates of illness or health outcomes for particular
populations (e.g., vulnerable/susceptible populations and resistant
populations) exposed to norovirus.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments and scientific
data and information regarding this document. It is only necessary to
send one set of comments and scientific data and information. It is no
longer necessary to send two copies of mailed comments and scientific
data and information. Identify comments and scientific data and
information with the docket number found in brackets in the heading of
this document. Received comments and scientific data and information
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
IV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. Centers for Disease Control and Prevention, Norovirus Technical
Fact
[[Page 65203]]
Sheet, https://www.cdc.gov/ncidod/dvrd/revb/gastro/norovirus-factsheet.htm.
2. Centers for Disease Control and Prevention, Norovirus:
Surveillance, Disease Burden, and Disease Reduction Activities, https://www.cdc.gov/ncidod/dvrd/revb/gastro/norovirus-surv-disease-burden.htm.
3. National Microbiology Laboratory and Public Health Agency of
Canada, National Enteric Surveillance Program, ``Annual Summary of
Laboratory Surveillance Data for Enteric Pathogens in Canada,'' 2009.
4. Majowicz, S.E., V.L. Edge, A. Fazil, et al., ``Estimating the
Under-Reporting Rate for Infectious Gastrointestinal Illness in
Ontario,'' Canadian Journal of Public Health, vol. 96, pp. 178-181,
2005.
5. Gerba, C.P. and D. Kayed, ``Caliciviruses: A Major Cause of
Foodborne Illness,'' Journal of Food Science, vol. 68, pp. 1136-1142,
2003.
6. Kohn, M.A., T.A. Farley, T. Ando, et al., ``An Outbreak of
Norwalk Virus Gastroenteritis Associated With Eating Oysters:
Implications for Maintaining Safe Oyster Beds,'' Journal of the
American Medical Association, vol. 273, pp. 466-471, 1995.
7. Shieh, Y.C., R.S. Baric, J.W. Woods, et al., ``Molecular
Surveillance of Enterovirus and Norwalk-Like Virus in Oysters Relocated
to a Municipal-Sewage-Impacted Gulf Estuary,'' Applied and
Environmental Microbiology, vol. 69, pp. 7130-7136, 2003.
8. J.A. Lowther, K. Henshilwood, and D.N. Lees, ``Determination of
Norovirus Contamination in Oysters From Two Commercial Harvesting Areas
Over an Extended Period, Using Semiquantitative Real-Time Reverse
Transcription PCR,'' Journal of Food Protection, vol. 71, pp. 1427-
1433, 2008.
9. Burkhardt, W., III and K. Calci, ``Selective Accumulation May
Account for Shellfish-Associated Viral Illness,'' Applied Environmental
Microbiology, vol. 66, pp. 1375-1378, 2000.
10. National Shellfish Sanitation Program (NSSP) Guide for the
Control of Molluscan Shellfish 2009 Revision, https://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/FederalStatePrograms/NationalShellfishSanitationProgram/ucm046353.htm.
11. Canadian Shellfish Sanitation Program (CSSP) Manual of
Operations, https://www.inspection.gc.ca/english/fssa/fispoi/man/cssppccsm/shemolalle.pdf.
12. Joint Food and Agriculture Organization of the United Nations/
World Health Organization Food Standards Program, Codex Alimentarius
Commission Procedural Manual, 20th ed. 113, 2011, ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_20e.pdf.
Dated: October 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27101 Filed 10-19-11; 8:45 am]
BILLING CODE 4160-01-P