Risk Assessment of the Public Health Impact from Foodborne Listeria Monocytogenes in Soft-Ripened Cheese: Request for Comments and for Scientific Data and Information, 67310-67311 [E7-23104]
Download as PDF
<![CDATA[
ebenthall on PRODPC61 with NOTICES
67310
Federal Register / Vol. 72, No. 228 / Wednesday, November 28, 2007 / Notices
includes records of individuals who
have received and are receiving benefits
under the Social Security Act. SSA will
extract employer identity information
from the Earnings Recording and SelfEmployment Income System, SSA/0SR
60–0059, referred to as the Master
Earnings File (MEF) published at 71 FR
1819 (January 11, 2006) and maintained
at the NCC. This file contains earnings
records of individuals including
identifying information of their
employees.
CMS will utilize a database, Medicare
Advantage Prescription Drug System
(MARx) CMS System No. 09–70–4001,
published at 70 FR 60530 (October 18,
2005), maintained at the CMS Data
Center, located in Baltimore, Maryland,
of the GHP information received from
employers containing verified instances
of employment and GHP coverage for
Medicare beneficiaries and Medicareeligible spouses identified from the IMF
and MEF extracts.
CMS will match GHP information
against the Medicare Multi Carrier
Claims System (MCS) (formerly known
as Carrier Medicare Claims Records),
CMS System No. 09–70–0501,
published at 71 FR 64968 (November 6,
2006), maintained at the CMS Data
Center, located in Baltimore, Maryland.
These files contain information received
from employers containing verified
instances of employment and GHP
coverage for Medicare beneficiaries and
Medicare-eligible spouses identified
from the IMF and MEF extracts.
CMS will match GHP information
against the Fiscal Intermediary Shared
System (FISS) (formerly known as
Intermediary Medicare Claims Records,
CMS System No. 09–70–0503,
published at 71 FR 64961 (November 6,
2006), maintained at the CMS Data
Center, located in Baltimore, Maryland.
This file contains information or records
needed to properly process and pay
Medicare benefits to, or on behalf of,
eligible individuals. The file is accessed
when a claim is submitted for payment.
CMS will match GHP information
against the CWF, CMS System No. 09–
70–0526, published at 71 FR 64955
(November 6, 2006), which is the
repository database for all current
hospital and medical coverage MSP
information. These files contain
information or records needed to
properly process and pay medical
insurance benefits to, or on behalf of,
entitled beneficiaries who have
submitted claims for Medicare Medical
Insurance Benefits (Medicare Part B).
The file is accessed when a claim is
submitted for payment.
CMS will match GHP information
against the National Claims History
VerDate Aug<31>2005
15:18 Nov 27, 2007
Jkt 214001
(NCH), which is contained in the
National Claims History File, CMS
System No. 09–70–0558, published at
71 FR 67137 (November 20, 2006),
maintained at the CMS Data Center,
located in Baltimore, Maryland. NCH
contains records needed to facilitate
obtaining Medicare utilization review
data that can be used to study the
operation and effectiveness of the
Medicare program.
INCLUSIVE DATES OF THE MATCH:
The Matching Program shall become
effective 40 days after the report of the
Matching Program is sent to OMB and
Congress, or 30 days after publication in
the FR, whichever is later. The matching
program will continue for 18 months
from the effective date and may be
extended for an additional 12 months
thereafter, if certain conditions are met.
[FR Doc. E7–23139 Filed 11–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0432]
Risk Assessment of the Public Health
Impact from Foodborne Listeria
Monocytogenes in Soft-Ripened
Cheese: Request for Comments and
for Scientific Data and Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for comments
and for scientific data and information.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is requesting
comments and scientific data and
information that would assist the agency
in its plans to conduct a risk assessment
for Listeria monocytogenes in softripened cheese. The purpose of the risk
assessment is to ascertain the impact on
public health from the reduction and/or
prevention of L. monocytogenes growth
and recontamination during the
manufacturing and/or processing of softripened cheese.
DATES: Submit comments and scientific
data and information by January 28,
2008.
ADDRESSES: 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. Submit
electronic comments, data, and
information to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS–06),
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740, 301–436–2290.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human
Services’ Healthy People 2010 is a
comprehensive set of disease prevention
and health promotion objectives for the
Nation to achieve over the first decade
of the new century. Created by scientists
both inside and outside of Government,
it identifies a wide range of public
health priorities and specific,
measurable objectives. One of these
objectives calls on Federal food safety
agencies to reduce foodborne listeriosis
(Ref. 1). In support of this goal, in 2003,
FDA issued an assessment of the
relative risk to the public health from
foodborne L. monocytogenes among
selected categories of ready-to-eat (RTE)
foods (Listeria risk assessment) (Ref. 2).
The Listeria risk assessment formed the
basis of the 2003 FDA/Centers for
Disease Control and Prevention (CDC)
Listeria Action Plan (Ref. 3), which
identifies prevention and control
activities that FDA and CDC will take to
reduce the incidence of foodborne
listeriosis in the United States. The
Public Health Risk Assessment: Listeria
monocytogenes in Soft-Ripened Cheese
supports the agency’s commitment to
fulfilling the Listeria Action Plan.
The 2003 Listeria risk assessment
provided the first quantitative estimate
of the relative risk of listeriosis from
consumption of a variety of RTE foods.
Among the dairy foods, soft unripened
cheese was considered to present a high
risk, and fresh soft cheese, semi-soft
cheese, and soft-ripened cheese was
considered to present a moderate risk of
listeriosis. This risk assessment
estimated that the risk of listeriosis from
the consumption of fresh soft cheese
made using unpasteurized (raw) milk
could be as much as 40-fold higher than
the risk from consumption of these
cheeses made from pasteurized milk.
The United States (U.S.) and Canada
have experienced sporadic illnesses and
outbreaks of listeriosis associated with
the consumption of cheese. In both
countries, there is a strong
epidemiological correlation between
consumption of soft cheese and
listeriosis. For example, a 1985 outbreak
of listeriosis associated with the
consumption of a Mexican-style soft
cheese resulted in 142 illnesses in Los
Angeles (Ref. 4), a similar outbreak in
2000 in North Carolina resulted in 12
illnesses, and a 2002 soft cheese-
E:\FR\FM\28NON1.SGM
28NON1
Federal Register / Vol. 72, No. 228 / Wednesday, November 28, 2007 / Notices
associated outbreak in Quebec resulted
in 17 illnesses including 2 premature
births (Ref. 5). Both FDA and Health
Canada (HC) continue to evaluate the
safety of soft cheese, particularly soft
cheese made from unpasteurized milk.
As a followup to the Listeria risk
assessment, FDA and HC have agreed to
collaborate on the development of a
model for the production of soft-ripened
cheese that will evaluate the public
health impact of factors such as the
microbiological status of milk used in
cheese production, the impact of
various cheese manufacturing steps,
conditions during distribution and
storage, and cross contamination during
processing and handling. The risk
assessment model also will be used to
evaluate the effectiveness of various
process changes and intervention
strategies in reducing human illness.
Specifically, the objectives of the
Listeria in soft-ripened cheese risk
assessment model are to quantitatively
evaluate the impact on public health of
the following: (1) Variations in L.
monocytogenes levels in the raw
materials used to produce cheese; (2)
changes in L. monocytogenes levels as a
result of growth, inactivation, or recontamination at each step of the
manufacturing process, between final
packaging and sale at retail, and
between retail sale and consumption;
and (3) the impact of various
intervention and control strategies.
ebenthall on PRODPC61 with NOTICES
II. Request for Comment and for
Scientific Data and Information
FDA requests comments on the risk
assessment approach outlined
previously in this document and the
submission of data and information
relevant to the risk assessment. The
agency specifically requests information
for the following:
(1) Characteristics of the
manufacturing and marketing processes
for soft-ripened cheese including:
• The number of large and small
(artisan) facilities producing softripened cheese in the U.S. and Canada,
and
• The amount of soft-ripened cheese
produced each year in the U.S. and
Canada by large and small facilities
including information on different sizes
of cheese that are produced and the
relative production volumes for these
sizes.
(2) Factors that influence the levels of
L. monocytogenes in milk used for
cheese manufacturing including:
• On-farm practices that influence the
frequency and level of L. monocytogenes
in raw milk used for cheese making,
VerDate Aug<31>2005
15:18 Nov 27, 2007
Jkt 214001
• L. monocytogenes levels and/or
frequencies in raw milk in the U.S. and
Canada,
• Bulk tank sizes and mixing
practices used by large and small
manufacturers,
• Growth of L. monocytogenes in raw
milk,
• Conditions of storage (temperatures
and times) encountered by milk prior to
cheese manufacture, and
• The identity and effectiveness of
processes other than pasteurization used
to treat raw milk prior to cheese making.
(3) Factors that influence the levels of
L. monocytogenes in products during
cheese manufacturing including:
• Changes in L. monocytogenes levels
and frequency (i.e., growth, inactivation,
or re-contamination) at each step in
cheese manufacturing (i.e., during curd
formation, ripening, packaging, aging);
• Conditions of storage (temperatures
and times) encountered during postproduction holding at the producer; and
• Pathways for transfer of L.
monocytogenes to soft-ripened cheese
from environmental sources during
packaging, cutting, transport, and
handling at retail, including data on
frequencies or amounts of transfer.
(4) Factors that influence the levels of
L. monocytogenes in cheese postproduction including:
• Levels and/or frequencies of L.
monocytogenes that occur in cheese at
retail; and
• The conditions (temperature and
time) encountered during transport and
storage throughout the distribution
process, including at retail, in the U.S.
and Canada.
(5) Factors the influence the levels of
L. monocytogenes in cheese at
consumption including:
• Storage conditions (temperature
and times) encountered in consumers’
homes, and
• Consumption patterns for soft
cheese (including serving size and
frequency) in the U.S. and Canada.
(6) The identity and effectiveness of
control measures or interventions to
reduce levels and frequency of L.
monocytogenes in cheese during
processing, manufacturing, packaging,
storage, and transportation prior to retail
sale.
(7) Any other data related to the
occurrence, growth, and control of L.
monocytogenes in soft-ripened cheese.
Interested persons should submit
comments, scientific data, and
information to the Division of Dockets
Management (see ADDRESSES). Three
copies of all comments, scientific data,
and information are to be submitted.
Individuals submitting written
information or anyone submitting
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
67311
electronic comments may submit one
copy. Submissions are to be identified
with the docket number found in
brackets in the heading of this
document and may be accompanied by
supporting information. Received
submissions may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Information submitted after the closing
date will not be considered, except by
petition under 21 CFR 10.30.
III. References
The following references are 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 nonFDA
Web sites after this document publishes
in the Federal Register.)
1. U.S. Department of Health and Human
Services, Healthy People 2010, vol. 1,
Washington, DC, 2000, https://
www.healthypeople.gov.
2. U.S. Department of Health and Human
Services and U.S. Department of Agriculture/
Food Safety and Inspection Service,
‘‘Quantitative Assessment of Relative Risk to
Public Health from Foodborne Listeria
monocytogenes Among Selected Categories
of Ready-to-Eat Foods,’’ September 2003,
https://www.foodsafety.gov/~dms/lmr2toc.html.
3. U.S. Department of Health and Human
Services, Food and Drug Administration/
Centers for Disease Control and Prevention,
‘‘Reducing the Risk of Listeria
monocytogenes FDA/CDC 2003 Update of the
Listeria Action Plan,’’ November 2003, https://
www.cfsan.fda.gov/~dms/lmr2plan.html.
4. Linnan et al., ‘‘Epidemic Listeriosis
Associated With Mexican-Style Cheese,’’
New England Journal of Medicine, 319
(13):823–8, 1988.
5. Gaulin et al., ‘‘First Documented
Outbreak of Listeria monocytogenes in
Quebec, 2002,’’ Canada Communicable
Disease Report, 29 (21):181–6, 2003.
Dated: November 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23104 Filed 11–27–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\28NON1.SGM
28NON1
]]>Agencies
[Federal Register Volume 72, Number 228 (Wednesday, November 28, 2007)]
[Notices]
[Pages 67310-67311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23104]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0432]
Risk Assessment of the Public Health Impact from Foodborne
Listeria Monocytogenes in Soft-Ripened Cheese: 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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting comments
and scientific data and information that would assist the agency in its
plans to conduct a risk assessment for Listeria monocytogenes in soft-
ripened cheese. The purpose of the risk assessment is to ascertain the
impact on public health from the reduction and/or prevention of L.
monocytogenes growth and recontamination during the manufacturing and/
or processing of soft-ripened cheese.
DATES: Submit comments and scientific data and information by January
28, 2008.
ADDRESSES: 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.
Submit electronic comments, data, and information to either https://
www.fda.gov/dockets/ecomments or https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS-06), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2290.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human Services' Healthy People 2010 is
a comprehensive set of disease prevention and health promotion
objectives for the Nation to achieve over the first decade of the new
century. Created by scientists both inside and outside of Government,
it identifies a wide range of public health priorities and specific,
measurable objectives. One of these objectives calls on Federal food
safety agencies to reduce foodborne listeriosis (Ref. 1). In support of
this goal, in 2003, FDA issued an assessment of the relative risk to
the public health from foodborne L. monocytogenes among selected
categories of ready-to-eat (RTE) foods (Listeria risk assessment) (Ref.
2). The Listeria risk assessment formed the basis of the 2003 FDA/
Centers for Disease Control and Prevention (CDC) Listeria Action Plan
(Ref. 3), which identifies prevention and control activities that FDA
and CDC will take to reduce the incidence of foodborne listeriosis in
the United States. The Public Health Risk Assessment: Listeria
monocytogenes in Soft-Ripened Cheese supports the agency's commitment
to fulfilling the Listeria Action Plan.
The 2003 Listeria risk assessment provided the first quantitative
estimate of the relative risk of listeriosis from consumption of a
variety of RTE foods. Among the dairy foods, soft unripened cheese was
considered to present a high risk, and fresh soft cheese, semi-soft
cheese, and soft-ripened cheese was considered to present a moderate
risk of listeriosis. This risk assessment estimated that the risk of
listeriosis from the consumption of fresh soft cheese made using
unpasteurized (raw) milk could be as much as 40-fold higher than the
risk from consumption of these cheeses made from pasteurized milk.
The United States (U.S.) and Canada have experienced sporadic
illnesses and outbreaks of listeriosis associated with the consumption
of cheese. In both countries, there is a strong epidemiological
correlation between consumption of soft cheese and listeriosis. For
example, a 1985 outbreak of listeriosis associated with the consumption
of a Mexican-style soft cheese resulted in 142 illnesses in Los Angeles
(Ref. 4), a similar outbreak in 2000 in North Carolina resulted in 12
illnesses, and a 2002 soft cheese-
[[Page 67311]]
associated outbreak in Quebec resulted in 17 illnesses including 2
premature births (Ref. 5). Both FDA and Health Canada (HC) continue to
evaluate the safety of soft cheese, particularly soft cheese made from
unpasteurized milk.
As a followup to the Listeria risk assessment, FDA and HC have
agreed to collaborate on the development of a model for the production
of soft-ripened cheese that will evaluate the public health impact of
factors such as the microbiological status of milk used in cheese
production, the impact of various cheese manufacturing steps,
conditions during distribution and storage, and cross contamination
during processing and handling. The risk assessment model also will be
used to evaluate the effectiveness of various process changes and
intervention strategies in reducing human illness.
Specifically, the objectives of the Listeria in soft-ripened cheese
risk assessment model are to quantitatively evaluate the impact on
public health of the following: (1) Variations in L. monocytogenes
levels in the raw materials used to produce cheese; (2) changes in L.
monocytogenes levels as a result of growth, inactivation, or re-
contamination at each step of the manufacturing process, between final
packaging and sale at retail, and between retail sale and consumption;
and (3) the impact of various intervention and control strategies.
II. Request for Comment and for Scientific Data and Information
FDA requests comments on the risk assessment approach outlined
previously in this document and the submission of data and information
relevant to the risk assessment. The agency specifically requests
information for the following:
(1) Characteristics of the manufacturing and marketing processes
for soft-ripened cheese including:
The number of large and small (artisan) facilities
producing soft-ripened cheese in the U.S. and Canada, and
The amount of soft-ripened cheese produced each year in
the U.S. and Canada by large and small facilities including information
on different sizes of cheese that are produced and the relative
production volumes for these sizes.
(2) Factors that influence the levels of L. monocytogenes in milk
used for cheese manufacturing including:
On-farm practices that influence the frequency and level
of L. monocytogenes in raw milk used for cheese making,
L. monocytogenes levels and/or frequencies in raw milk in
the U.S. and Canada,
Bulk tank sizes and mixing practices used by large and
small manufacturers,
Growth of L. monocytogenes in raw milk,
Conditions of storage (temperatures and times) encountered
by milk prior to cheese manufacture, and
The identity and effectiveness of processes other than
pasteurization used to treat raw milk prior to cheese making.
(3) Factors that influence the levels of L. monocytogenes in
products during cheese manufacturing including:
Changes in L. monocytogenes levels and frequency (i.e.,
growth, inactivation, or re-contamination) at each step in cheese
manufacturing (i.e., during curd formation, ripening, packaging,
aging);
Conditions of storage (temperatures and times) encountered
during post-production holding at the producer; and
Pathways for transfer of L. monocytogenes to soft-ripened
cheese from environmental sources during packaging, cutting, transport,
and handling at retail, including data on frequencies or amounts of
transfer.
(4) Factors that influence the levels of L. monocytogenes in cheese
post-production including:
Levels and/or frequencies of L. monocytogenes that occur
in cheese at retail; and
The conditions (temperature and time) encountered during
transport and storage throughout the distribution process, including at
retail, in the U.S. and Canada.
(5) Factors the influence the levels of L. monocytogenes in cheese
at consumption including:
Storage conditions (temperature and times) encountered in
consumers' homes, and
Consumption patterns for soft cheese (including serving
size and frequency) in the U.S. and Canada.
(6) The identity and effectiveness of control measures or
interventions to reduce levels and frequency of L. monocytogenes in
cheese during processing, manufacturing, packaging, storage, and
transportation prior to retail sale.
(7) Any other data related to the occurrence, growth, and control
of L. monocytogenes in soft-ripened cheese.
Interested persons should submit comments, scientific data, and
information to the Division of Dockets Management (see ADDRESSES).
Three copies of all comments, scientific data, and information are to
be submitted. Individuals submitting written information or anyone
submitting electronic comments may submit one copy. Submissions are to
be identified with the docket number found in brackets in the heading
of this document and may be accompanied by supporting information.
Received submissions may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Information submitted
after the closing date will not be considered, except by petition under
21 CFR 10.30.
III. References
The following references are 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 nonFDA Web sites after this document publishes in the
Federal Register.)
1. U.S. Department of Health and Human Services, Healthy People
2010, vol. 1, Washington, DC, 2000, https://www.healthypeople.gov.
2. U.S. Department of Health and Human Services and U.S.
Department of Agriculture/Food Safety and Inspection Service,
``Quantitative Assessment of Relative Risk to Public Health from
Foodborne Listeria monocytogenes Among Selected Categories of Ready-
to-Eat Foods,'' September 2003, https://www.foodsafety.gov/~dms/lmr2-
toc.html.
3. U.S. Department of Health and Human Services, Food and Drug
Administration/Centers for Disease Control and Prevention,
``Reducing the Risk of Listeria monocytogenes FDA/CDC 2003 Update of
the Listeria Action Plan,'' November 2003, https://www.cfsan.fda.gov/
~dms/lmr2plan.html.
4. Linnan et al., ``Epidemic Listeriosis Associated With
Mexican-Style Cheese,'' New England Journal of Medicine, 319
(13):823-8, 1988.
5. Gaulin et al., ``First Documented Outbreak of Listeria
monocytogenes in Quebec, 2002,'' Canada Communicable Disease Report,
29 (21):181-6, 2003.
Dated: November 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23104 Filed 11-27-07; 8:45 am]
BILLING CODE 4160-01-S
