[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46023-46024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18972]


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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.

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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, 
[email protected].

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