[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46023-46024]
[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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

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 Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Page 40823]
[FR Doc No: 2021-16206]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8756-01-R6]

Clean Air Act Operating Permit Program; Petitions for Objection
to State Operating Permit for Sandy Creek Services LLC, Sandy Creek
Energy Station, Brazoria County, Texas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final order on petition for objection to Clean Air
Act title V operating permit.

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SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order dated June 30, 2021, granting a Petition dated January 16,
2018 from the Environmental Integrity Project and Sierra Club. The
Petition requested that the EPA object to a Clean Air Act (CAA) title V
operating permit issued by the Texas Commission on Environmental
Quality (TCEQ) to Sandy Creek Services LLC (Sandy Creek) for its Sandy
Creek Energy Station located in McLennan County, Texas.

ADDRESSES: The EPA requests that you contact the individual listed in
the FOR FURTHER INFORMATION CONTACT section to view copies of the final
Order, the Petition, and other supporting information. Out of an
abundance of caution for members of the public and our staff, the EPA
Region 6 office is currently closed to the public to reduce the risk of
transmitting COVID-19. Please call or email the contact listed below if
you need alternative access to the final Order and Petition, which are
available electronically at: https://www.epa.gov/title-v-operating-permits/title-v-petition-database.

FOR FURTHER INFORMATION CONTACT: Aimee Wilson, EPA Region 6 Office, Air
Permits Section,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The CAA affords EPA a 45-day period to
review and object to, as appropriate, operating permits proposed by
state permitting authorities under title V of the CAA. Section
505(b)(2) of the CAA authorizes any person to petition the EPA
Administrator to object to a title V operating permit within 60 days
after the expiration of the EPA's 45-day review period if the EPA has
not objected on its own initiative. Petitions must be based only on
objections to the permit that were raised with reasonable specificity
during the public comment period provided by the state, unless the
petitioner demonstrates that it was impracticable to raise these issues
during the comment period or unless the grounds for the issue arose
after this period.
    The EPA received the Petition from the Environmental Integrity
Project and Sierra Club dated January 16, 2018, requesting that the EPA
object to the issuance of operating permit no. O3336, issued by TCEQ to
the Sandy Creek Energy Station in McLennan County, Texas. The Petition
claims the proposed permit failed to incorporate certified permits by
rule (PBR) registrations as applicable requirements, and fails to
include monitoring, recordkeeping, and reporting requirements that
assure compliance with incorporated PBRs.
    On June 30, 2021, the EPA Administrator issued an Order granting
the Petition. The Order explains the basis for EPA's decision.

    Dated: July 22, 2021.
David Garcia,
Director, Air and Radiation Division, Region 6.
[FR Doc. 2021-16206 Filed 7-28-21; 8:45 am]
BILLING CODE 6560-50-P