80_FR_46171 80 FR 46023 - Understanding Potential Intervention Measures To Reduce the Risk of Foodborne Illness From Consumption of Cheese Manufactured From Unpasteurized Milk

80 FR 46023 - Understanding Potential Intervention Measures To Reduce the Risk of Foodborne Illness From Consumption of Cheese Manufactured From Unpasteurized Milk

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

Page Range46023-46024
FR Document2015-18972

The Food and Drug Administration (FDA or we) is requesting comments and scientific data and information that would assist us in identifying and evaluating intervention measures that might have an effect on the presence of bacterial pathogens in cheeses manufactured from unpasteurized milk. We are taking this action in light of scientific data on potential health risks associated with consumption of cheese made from unpasteurized milk.

Federal Register, Volume 80 Issue 148 (Monday, August 3, 2015)
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46023-46024]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18972]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2596]


Understanding Potential Intervention Measures To Reduce the Risk 
of Foodborne Illness From Consumption of Cheese Manufactured From 
Unpasteurized Milk

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and 
information.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is requesting 
comments and scientific data and information that would assist us in 
identifying and evaluating intervention measures that might have an 
effect on the presence of bacterial pathogens in cheeses manufactured 
from unpasteurized milk. We are taking this action in light of 
scientific data on potential health risks associated with consumption 
of cheese made from unpasteurized milk.

DATES: Submit either electronic or written comments and scientific data 
and information by November 2, 2015.

ADDRESSES: Submit electronic comments and scientific data and 
information to http://www.regulations.gov. Submit written comments and 
scientific data and information to Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Andrew Yeung, Center for Food Safety 
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1541, 
andrew.yeung@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    A 2012 review of outbreaks of foodborne illness that occurred in 
the United States between 1993 and 2006 that were attributed to dairy 
products determined that more than 50 percent of the outbreaks reviewed 
in the study involved cheese, with the remaining outbreaks being 
attributable to fluid milk (Ref. 1). Forty-two percent of the 65 
cheese-associated outbreaks (i.e., 27 outbreaks) were attributable to 
products manufactured from unpasteurized milk, even though the 
contribution of unpasteurized dairy products to all dairy product 
consumption in the United States during the time period under study was 
estimated at below 1 percent (on a weight or volume base) (Ref. 1). The 
65 analyzed outbreaks due to cheese made from unpasteurized milk 
resulted in 641 associated illnesses with 131 hospitalizations (i.e., a 
hospitalization rate of more than 20 percent). Pathogens associated 
with these outbreaks included Listeria monocytogenes, Escherichia coli 
(E. coli) O157, Salmonella, and others (Ref. 1). All of these pathogens 
can cause significant illness and even death.
    FDA and Health Canada recently collaborated on the development of a 
model to evaluate the impact of factors, such as the microbiological 
status of milk used in cheese production, various cheese manufacturing 
steps, conditions during distribution and storage, and cross-
contamination during processing and handling, on the public health risk 
of listeriosis from consumption of soft-ripened cheese. Elsewhere in 
this issue of the Federal Register, we are announcing the release of 
the ``Joint Food and Drug Administration/Health Canada--Sant[eacute] 
Canada Quantitative Assessment of the Risk of Listeriosis From Soft-
Ripened Cheese Consumption in the United States and Canada'' (the FDA/
Health Canada QRA) (Ref. 2).
    FDA establishes food standards of identity, to promote honesty and 
fair dealing in the interest of consumers, under the authority set 
forth in section 401 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 341). Some of these standards of identity (e.g., 
the standard of identity for soft-ripened cheese in Sec.  133.182 (21 
CFR 133.182)) permit the manufacture of cheese from unpasteurized milk. 
These standards of identity specify that the process for cheese 
manufactured from unpasteurized milk include an aging period. A typical 
aging period is not less than 60 days at not less than 35 [deg]F (see 
Sec.  133.182(a) in the standard of identity for soft-ripened cheese).
    The aging period for cheese manufactured from unpasteurized milk 
was presumed to act as a control measure to reduce the risk that 
pathogens would be present when the cheese was consumed. However, the 
available data and information raise questions about the safety of 
cheese manufactured from unpasteurized milk, even when aged. For 
example, research has demonstrated that pathogens such as E. coli 
O157:H7 can survive a 60-day aging period in a hard cheese such as 
Cheddar cheese (Refs. 3 and 4). In addition, a 1997 memorandum from a 
subcommittee of the National Advisory Committee on Microbiological 
Criteria for Foods stated that the scientific literature confirms that 
pathogens can survive the 60-day aging process for cheeses manufactured 
using unpasteurized milk (Ref. 5). More recently, the results of the 
FDA/Health Canada QRA suggest that the 60-day aging period for soft-
ripened cheese may increase the risk of listeriosis from consumption of 
soft-ripened cheese by allowing more time for L. monocytogenes, if 
present, to multiply (rather than decrease) as the soft-ripened cheese 
ages (Ref. 6).
    FDA recognizes that there is broad diversity in cheese 
manufacturing operations and approaches and that many factors go into 
ensuring the safety of the food. Many types of raw milk cheeses are 
made using traditional methods that require a successful balance 
involving the quality of the milk, the equipment, and the environment, 
including ensuring the presence of bacteria critical to the nature of 
the cheese while preventing the introduction or growth of pathogens. In 
issuing this call for data and information, we are particularly 
interested in learning more about the standards and practices in use by 
the growing artisanal cheese manufacturing community.

[[Page 46024]]

II. Request for Comments, Scientific Data, and Information

    We are continuing to evaluate the safety of processes for the 
manufacture of cheese, particularly processes for the manufacture of 
cheese from unpasteurized milk. We are requesting comments and 
scientific data and other information to:
     Understand what (if any) aspects of the current regulatory 
framework for the production of cheese manufactured from unpasteurized 
milk act as an impediment to efficient and effective control measures 
to significantly minimize pathogens that may be present in 
unpasteurized milk.
     Understand current practices to reduce the potential for 
foodborne illness during the manufacture of cheese from unpasteurized 
milk. To what extent do producers of cheese manufactured from 
unpasteurized milk solely rely on an aging period to significantly 
minimize pathogens that may be present in unpasteurized cheese? If such 
producers rely on control measures other than the aging process, what 
are those control measures and what is the prevalence of those control 
measures among such producers? How effective and practical are these 
control measures?
     Understand the availability and feasibility of various 
treatments (e.g., to achieve bacterial reductions of from 100- to 
1,000,000-fold) that could reduce the risk of listeriosis and other 
foodborne illness from the consumption of all types of cheeses 
manufactured from unpasteurized milk. We are aware of non-thermal 
control measures such as added substances (such as bacteriocins, 
lactoferrins, lysozyme, other enzymes, and salt), bactofugation, carbon 
dioxide, high hydrostatic pressure, microfiltration, microwave, pulsed 
electric field, pulsed light, ultrasound, and ultraviolet light. 
However, we would like to receive additional data regarding the 
efficacy, on a consistent basis, of such treatments when used to 
minimize the broad spectrum of pathogens that may be present in 
unpasteurized milk.
     Evaluate the impact of the currently required 60-day 
minimum aging period for soft-ripened cheese on pathogens other than L. 
monocytogenes in soft-ripened cheese. For example, how does the minimum 
aging period affect the safety of the cheese with respect to pathogens 
other than L. monocytogenes? Are there alternatives to the currently 
required 60-day aging period for soft-ripened cheese that would ensure 
the safety of such cheese with respect to these pathogens?
     Evaluate the impact on pathogens of a minimum aging period 
for all those cheeses that are subject to a required minimum aging 
period through an applicable standard of identity. As discussed in 
section I, research and a literature review show that pathogens can 
survive the 60-day aging process for cheeses manufactured using 
unpasteurized milk. For pathogens other than L. monocytogenes, is a 60-
day aging period effective in adequately reducing a broad spectrum of 
pathogens that could be in cheese manufactured from unpasteurized milk?
     Determine whether, consistent with modern international 
approaches to food safety (Ref. 7), a performance objective (or 
standard) for L. monocytogenes should be used as a replacement for the 
60-day aging requirement and whether a second performance standard for 
Gram-negative enteric pathogens should also be used. If a second 
performance standard is used for Gram-negative enteric pathogens, which 
Gram-negative pathogen should be specified?
     Understand the prevalence of testing during manufacture 
(e.g., testing for pathogens of each lot of cheese manufactured from 
unpasteurized milk and of bulk shipments of unpasteurized milk). If 
testing is not currently being used, how practical would such testing 
be? How much would it cost?
     Determine the extent to which consumers understand the 
risk of foodborne listeriosis or other illness from consumption of 
cheese manufactured from unpasteurized milk. To what extent are 
consumers aware that an aging process has had (and may continue to 
have) a role in food safety as well as a role in the particular type of 
cheese produced? To what extent do consumers consider whether a cheese 
is made from pasteurized or unpasteurized milk in making purchase 
decisions?

III. Comments

    Interested persons may submit either electronic comments and 
scientific data and information regarding this document to http://www.regulations.gov or written comments and scientific data and 
information to the Division of Dockets Management (see ADDRESSES). It 
is only necessary to send one set of comments. Identify submissions 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday, and will 
be posted to the docket at http://www.regulations.gov.

X. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. (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. Langer, A. J., T. Ayers, J. Grass, et al., ``Nonpasteurized Dairy 
Products, Disease Outbreaks, and State Laws--United States, 1993-
2006,'' Emerging Infectious Disease 18(3): 385-391, 2012.
2. FDA and Health Canada, ``Joint Food and Drug Administration/
Health Canada--Sant[eacute] Canada Quantitative Assessment of the 
Risk of Listeriosis from Soft-Ripened Cheese Consumption in the 
United States and Canada.'' Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm 
(2015).
3. Reitsma, C.J. and D.R. Henning, ``Survival of Enterohemorrhagic 
Escherichia coli O157:H7 During the Manufacture and Curing of 
Cheddar Cheese,'' Journal of Food Protection, 59(5): 460-464, 1996.
4. Schlesser, J.E., R, Gerdes, S. Ravishankar, et al, ``Survival of 
a Five-Strain Cocktail of Escherichia coli O157:H7 During the 60-Day 
Aging Period of Cheddar Cheese Made from Unpasteurized Milk,'' 
Journal of Food Protection, 69(5):990-998, 2006.
5. Memorandum from Chair, Cheese Subcommittee of the National 
Advisory Committee on Microbiological Criteria for Foods to Chair, 
National Advisory Committee on Microbiological Criteria for Foods, 
``Review of Scientific Literature Regarding the Sixty-Day Aging 
Process for Hard Cheese,'' April 3, 1997.
6. FDA and Health Canada, ``Joint Food and Drug Administration/
Health Canada--Sant[eacute] Canada Quantitative Assessment of the 
Risk of Listeriosis from Soft-Ripened Cheese Consumption in the 
United States and Canada: Interpretative Summary.'' Accessible at 
http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm 
(2015).
7. Codex Alimentarius Commission, ``Principles and Guidelines for 
the Establishment and Application of Microbiological Criteria 
Related to Foods, CAC/GL 21-1997,'' 1997.

    Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18972 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P



                                                                                 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices                                              46023

                                                  from locations, and monitoring product                   information to http://                                dealing in the interest of consumers,
                                                  disposition. The direct hours spent on                   www.regulations.gov. Submit written                   under the authority set forth in section
                                                  each such recall will be billed at the                   comments and scientific data and                      401 of the Federal Food, Drug, and
                                                  appropriate hourly rate shown in table                   information to Division of Dockets                    Cosmetic Act (the FD&C Act) (21 U.S.C.
                                                  2 of this document.                                      Management (HFA–305), Food and Drug                   341). Some of these standards of
                                                                                                           Administration, 5630 Fishers Lane, Rm.                identity (e.g., the standard of identity for
                                                  V. How must the fees be paid?
                                                                                                           1061, Rockville, MD 20852.                            soft-ripened cheese in § 133.182 (21 CFR
                                                    An invoice will be sent to the                         FOR FURTHER INFORMATION CONTACT:                      133.182)) permit the manufacture of
                                                  responsible party for paying the fee after               Andrew Yeung, Center for Food Safety                  cheese from unpasteurized milk. These
                                                  FDA completes the work on which the                      and Applied Nutrition (HFS–316), Food                 standards of identity specify that the
                                                  invoice is based. Payment must be made                   and Drug Administration, 5100 Paint
                                                  within 90 days of the invoice date in                                                                          process for cheese manufactured from
                                                                                                           Branch Pkwy., College Park, MD 20740–                 unpasteurized milk include an aging
                                                  U.S. currency by check, bank draft, or                   3835, 240–402–1541, andrew.yeung@
                                                  U.S. postal money order payable to the                                                                         period. A typical aging period is not less
                                                                                                           fda.hhs.gov.                                          than 60 days at not less than 35 °F (see
                                                  order of the Food and Drug
                                                  Administration. Detailed payment                         SUPPLEMENTARY INFORMATION:                            § 133.182(a) in the standard of identity
                                                  information will be included with the                                                                          for soft-ripened cheese).
                                                                                                           I. Background
                                                  invoice when it is issued.                                                                                        The aging period for cheese
                                                                                                              A 2012 review of outbreaks of                      manufactured from unpasteurized milk
                                                  VI. What are the consequences of not                     foodborne illness that occurred in the
                                                  paying these fees?                                                                                             was presumed to act as a control
                                                                                                           United States between 1993 and 2006
                                                                                                                                                                 measure to reduce the risk that
                                                    Under section 743(e)(2) of the FD&C                    that were attributed to dairy products
                                                                                                                                                                 pathogens would be present when the
                                                  Act, any fee that is not paid within 30                  determined that more than 50 percent of
                                                                                                           the outbreaks reviewed in the study                   cheese was consumed. However, the
                                                  days after it is due shall be treated as a
                                                                                                           involved cheese, with the remaining                   available data and information raise
                                                  claim of the U.S. Government subject to
                                                  provisions of subchapter II of chapter 37                outbreaks being attributable to fluid                 questions about the safety of cheese
                                                  of title 31, United States Code.                         milk (Ref. 1). Forty-two percent of the               manufactured from unpasteurized milk,
                                                                                                           65 cheese-associated outbreaks (i.e., 27              even when aged. For example, research
                                                    Dated: July 28, 2015.                                                                                        has demonstrated that pathogens such
                                                  Leslie Kux,
                                                                                                           outbreaks) were attributable to products
                                                                                                           manufactured from unpasteurized milk,                 as E. coli O157:H7 can survive a 60-day
                                                  Associate Commissioner for Policy.                                                                             aging period in a hard cheese such as
                                                                                                           even though the contribution of
                                                  [FR Doc. 2015–18906 Filed 7–31–15; 8:45 am]                                                                    Cheddar cheese (Refs. 3 and 4). In
                                                                                                           unpasteurized dairy products to all
                                                  BILLING CODE 4164–01–P
                                                                                                           dairy product consumption in the                      addition, a 1997 memorandum from a
                                                                                                           United States during the time period                  subcommittee of the National Advisory
                                                                                                           under study was estimated at below 1                  Committee on Microbiological Criteria
                                                  DEPARTMENT OF HEALTH AND                                                                                       for Foods stated that the scientific
                                                                                                           percent (on a weight or volume base)
                                                  HUMAN SERVICES
                                                                                                           (Ref. 1). The 65 analyzed outbreaks due               literature confirms that pathogens can
                                                  Food and Drug Administration                             to cheese made from unpasteurized milk                survive the 60-day aging process for
                                                                                                           resulted in 641 associated illnesses with             cheeses manufactured using
                                                  [Docket No. FDA–2015–N–2596]                             131 hospitalizations (i.e., a                         unpasteurized milk (Ref. 5). More
                                                                                                           hospitalization rate of more than 20                  recently, the results of the FDA/Health
                                                  Understanding Potential Intervention
                                                                                                           percent). Pathogens associated with                   Canada QRA suggest that the 60-day
                                                  Measures To Reduce the Risk of
                                                  Foodborne Illness From Consumption                       these outbreaks included Listeria                     aging period for soft-ripened cheese may
                                                  of Cheese Manufactured From                              monocytogenes, Escherichia coli (E.                   increase the risk of listeriosis from
                                                  Unpasteurized Milk                                       coli) O157, Salmonella, and others (Ref.              consumption of soft-ripened cheese by
                                                                                                           1). All of these pathogens can cause                  allowing more time for L.
                                                  AGENCY:    Food and Drug Administration,                 significant illness and even death.                   monocytogenes, if present, to multiply
                                                  HHS.                                                        FDA and Health Canada recently                     (rather than decrease) as the soft-
                                                  ACTION: Notice; request for comments                     collaborated on the development of a                  ripened cheese ages (Ref. 6).
                                                  and for scientific data and information.                 model to evaluate the impact of factors,
                                                                                                           such as the microbiological status of                    FDA recognizes that there is broad
                                                  SUMMARY:   The Food and Drug                             milk used in cheese production, various               diversity in cheese manufacturing
                                                  Administration (FDA or we) is                            cheese manufacturing steps, conditions                operations and approaches and that
                                                  requesting comments and scientific data                  during distribution and storage, and                  many factors go into ensuring the safety
                                                  and information that would assist us in                  cross-contamination during processing                 of the food. Many types of raw milk
                                                  identifying and evaluating intervention                  and handling, on the public health risk               cheeses are made using traditional
                                                  measures that might have an effect on                    of listeriosis from consumption of soft-              methods that require a successful
                                                  the presence of bacterial pathogens in                   ripened cheese. Elsewhere in this issue               balance involving the quality of the
                                                  cheeses manufactured from                                of the Federal Register, we are                       milk, the equipment, and the
                                                  unpasteurized milk. We are taking this                   announcing the release of the ‘‘Joint                 environment, including ensuring the
                                                  action in light of scientific data on                    Food and Drug Administration/Health                   presence of bacteria critical to the
                                                  potential health risks associated with                                                                         nature of the cheese while preventing
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                           Canada—Santé Canada Quantitative
                                                  consumption of cheese made from                          Assessment of the Risk of Listeriosis                 the introduction or growth of pathogens.
                                                  unpasteurized milk.                                      From Soft-Ripened Cheese                              In issuing this call for data and
                                                  DATES: Submit either electronic or                       Consumption in the United States and                  information, we are particularly
                                                  written comments and scientific data                     Canada’’ (the FDA/Health Canada QRA)                  interested in learning more about the
                                                  and information by November 2, 2015.                     (Ref. 2).                                             standards and practices in use by the
                                                  ADDRESSES: Submit electronic                                FDA establishes food standards of                  growing artisanal cheese manufacturing
                                                  comments and scientific data and                         identity, to promote honesty and fair                 community.


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                                                  46024                          Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices

                                                  II. Request for Comments, Scientific                        • Evaluate the impact on pathogens of              X. References
                                                  Data, and Information                                    a minimum aging period for all those                    The following references are on
                                                     We are continuing to evaluate the                     cheeses that are subject to a required                display in the Division of Dockets
                                                  safety of processes for the manufacture                  minimum aging period through an                       Management (see ADDRESSES) and are
                                                  of cheese, particularly processes for the                applicable standard of identity. As                   available for viewing by interested
                                                  manufacture of cheese from                               discussed in section I, research and a                persons between 9 a.m. and 4 p.m.,
                                                  unpasteurized milk. We are requesting                    literature review show that pathogens                 Monday through Friday; they are also
                                                  comments and scientific data and other                   can survive the 60-day aging process for              available electronically at http://
                                                  information to:                                          cheeses manufactured using                            www.regulations.gov. (FDA has verified
                                                     • Understand what (if any) aspects of                 unpasteurized milk. For pathogens other               the Web site addresses, but we are not
                                                  the current regulatory framework for the                 than L. monocytogenes, is a 60-day                    responsible for any subsequent changes
                                                  production of cheese manufactured                        aging period effective in adequately                  to the Web sites after this document
                                                  from unpasteurized milk act as an                        reducing a broad spectrum of pathogens                publishes in the Federal Register.)
                                                  impediment to efficient and effective                    that could be in cheese manufactured
                                                                                                                                                                 1. Langer, A. J., T. Ayers, J. Grass, et al.,
                                                  control measures to significantly                        from unpasteurized milk?                                   ‘‘Nonpasteurized Dairy Products, Disease
                                                  minimize pathogens that may be present                      • Determine whether, consistent with                    Outbreaks, and State Laws—United
                                                  in unpasteurized milk.                                   modern international approaches to                         States, 1993–2006,’’ Emerging Infectious
                                                     • Understand current practices to                     food safety (Ref. 7), a performance                        Disease 18(3): 385–391, 2012.
                                                  reduce the potential for foodborne                       objective (or standard) for L.                        2. FDA and Health Canada, ‘‘Joint Food and
                                                                                                                                                                      Drug Administration/Health Canada—
                                                  illness during the manufacture of cheese                 monocytogenes should be used as a                          Santé Canada Quantitative Assessment
                                                  from unpasteurized milk. To what                         replacement for the 60-day aging                           of the Risk of Listeriosis from Soft-
                                                  extent do producers of cheese                            requirement and whether a second                           Ripened Cheese Consumption in the
                                                  manufactured from unpasteurized milk                     performance standard for Gram-negative                     United States and Canada.’’ Accessible at
                                                  solely rely on an aging period to                        enteric pathogens should also be used.                     http://www.fda.gov/Food/FoodScience
                                                  significantly minimize pathogens that                    If a second performance standard is                        Research/RiskSafetyAssessment/
                                                  may be present in unpasteurized                          used for Gram-negative enteric                             default.htm and http://www.fda.gov/
                                                  cheese? If such producers rely on                        pathogens, which Gram-negative                             ScienceResearch/SpecialTopics/Peer
                                                                                                                                                                      ReviewofScientificInformationand
                                                  control measures other than the aging                    pathogen should be specified?                              Assessments/ucm079120.htm (2015).
                                                  process, what are those control                             • Understand the prevalence of                     3. Reitsma, C.J. and D.R. Henning, ‘‘Survival
                                                  measures and what is the prevalence of                   testing during manufacture (e.g., testing                  of Enterohemorrhagic Escherichia coli
                                                  those control measures among such                        for pathogens of each lot of cheese                        O157:H7 During the Manufacture and
                                                  producers? How effective and practical                   manufactured from unpasteurized milk                       Curing of Cheddar Cheese,’’ Journal of
                                                  are these control measures?                                                                                         Food Protection, 59(5): 460–464, 1996.
                                                                                                           and of bulk shipments of unpasteurized
                                                     • Understand the availability and                     milk). If testing is not currently being
                                                                                                                                                                 4. Schlesser, J.E., R, Gerdes, S. Ravishankar,
                                                  feasibility of various treatments (e.g., to                                                                         et al, ‘‘Survival of a Five-Strain Cocktail
                                                                                                           used, how practical would such testing                     of Escherichia coli O157:H7 During the
                                                  achieve bacterial reductions of from                     be? How much would it cost?                                60-Day Aging Period of Cheddar Cheese
                                                  100- to 1,000,000-fold) that could                                                                                  Made from Unpasteurized Milk,’’ Journal
                                                  reduce the risk of listeriosis and other                    • Determine the extent to which
                                                                                                                                                                      of Food Protection, 69(5):990–998, 2006.
                                                  foodborne illness from the consumption                   consumers understand the risk of                      5. Memorandum from Chair, Cheese
                                                  of all types of cheeses manufactured                     foodborne listeriosis or other illness                     Subcommittee of the National Advisory
                                                  from unpasteurized milk. We are aware                    from consumption of cheese                                 Committee on Microbiological Criteria
                                                  of non-thermal control measures such as                  manufactured from unpasteurized milk.                      for Foods to Chair, National Advisory
                                                  added substances (such as bacteriocins,                  To what extent are consumers aware                         Committee on Microbiological Criteria
                                                  lactoferrins, lysozyme, other enzymes,                   that an aging process has had (and may                     for Foods, ‘‘Review of Scientific
                                                                                                           continue to have) a role in food safety                    Literature Regarding the Sixty-Day Aging
                                                  and salt), bactofugation, carbon dioxide,                                                                           Process for Hard Cheese,’’ April 3, 1997.
                                                  high hydrostatic pressure,                               as well as a role in the particular type
                                                                                                                                                                 6. FDA and Health Canada, ‘‘Joint Food and
                                                  microfiltration, microwave, pulsed                       of cheese produced? To what extent do                      Drug Administration/Health Canada—
                                                  electric field, pulsed light, ultrasound,                consumers consider whether a cheese is                     Santé Canada Quantitative Assessment
                                                  and ultraviolet light. However, we                       made from pasteurized or unpasteurized                     of the Risk of Listeriosis from Soft-
                                                  would like to receive additional data                    milk in making purchase decisions?                         Ripened Cheese Consumption in the
                                                  regarding the efficacy, on a consistent                                                                             United States and Canada: Interpretative
                                                                                                           III. Comments                                              Summary.’’ Accessible at http://
                                                  basis, of such treatments when used to
                                                                                                                                                                      www.fda.gov/Food/
                                                  minimize the broad spectrum of                              Interested persons may submit either                    FoodScienceResearch/
                                                  pathogens that may be present in                         electronic comments and scientific data                    RiskSafetyAssessment/default.htm and
                                                  unpasteurized milk.                                      and information regarding this                             http://www.fda.gov/ScienceResearch/
                                                     • Evaluate the impact of the currently                document to http://www.regulations.gov                     SpecialTopics/PeerReviewofScientific
                                                  required 60-day minimum aging period                     or written comments and scientific data                    InformationandAssessments/
                                                  for soft-ripened cheese on pathogens                     and information to the Division of                         ucm079120.htm (2015).
                                                  other than L. monocytogenes in soft-                     Dockets Management (see ADDRESSES). It                7. Codex Alimentarius Commission,
                                                  ripened cheese. For example, how does                    is only necessary to send one set of                       ‘‘Principles and Guidelines for the
                                                                                                                                                                      Establishment and Application of
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  the minimum aging period affect the                      comments. Identify submissions with                        Microbiological Criteria Related to
                                                  safety of the cheese with respect to                     the docket number found in brackets in                     Foods, CAC/GL 21–1997,’’ 1997.
                                                  pathogens other than L. monocytogenes?                   the heading of this document. Received
                                                  Are there alternatives to the currently                  comments may be seen in the Division                    Dated: July 29, 2015.
                                                  required 60-day aging period for soft-                   of Dockets Management between 9 a.m.                  Leslie Kux,
                                                  ripened cheese that would ensure the                     and 4 p.m., Monday through Friday, and                Associate Commissioner for Policy.
                                                  safety of such cheese with respect to                    will be posted to the docket at http://               [FR Doc. 2015–18972 Filed 7–31–15; 8:45 am]
                                                  these pathogens?                                         www.regulations.gov.                                  BILLING CODE 4164–01–P




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Document Created: 2018-02-23 10:52:01
Document Modified: 2018-02-23 10:52:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments and for scientific data and information.
DatesSubmit either electronic or written comments and scientific data and information by November 2, 2015.
ContactAndrew Yeung, Center for Food Safety and Applied Nutrition (HFS-316), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1541, [email protected]
FR Citation80 FR 46023 

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