[Federal Register Volume 71, Number 88 (Monday, May 8, 2006)]
[Rules and Regulations]
[Pages 26677-26679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6743]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 417
[Docket No. 05-016N; FDMS Docket No. FSIS-2005-0035]
The Use of Ingredients of Potential Public Health Concern
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Compliance with the HACCP system regulations and request for
comment.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing
this document to inform establishments that prepare meat and poultry
products of the need to ensure that they maintain proper control over
the use of ingredients, especially those that present a potential
public health concern, and over the ingredient labeling of their
products. Establishments should ensure that their systems provide such
control as part of their next reassessment of their HACCP systems. FSIS
invites comments on the matters presented in this document.
DATES: The Agency must receive comments by July 7, 2006.
ADDRESSES: FSIS invites interested persons to submit comments on this
document. Comments may be submitted by any of the following methods:
Federal eRulemaking Portal: This Web site provides the ability to
type short comments directly into the comment field on this Web page or
attach a file for lengthier comments. FSIS prefers to receive comments
through the Federal eRulemaking Portal. Go to http://www.regulations.gov and, in the ``Search for Open Regulations'' box,
select ``Food Safety and Inspection Service'' from the agency drop-down
menu, and then click on ``Submit.'' In the Docket ID column, select the
Docket Number, FSIS-2005-0035, to submit or view public comments and to
view supporting and related materials available electronically. After
the close of the comment period, the docket can be viewed using the
``Advanced Search'' function in Regulations.gov.
Mail, including floppy disks or CD-ROM's, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture,
Food Safety and Inspection Service, 300 12th Street, SW., Room 102
Cotton Annex, Washington, DC 20250.
Electronic mail: [email protected]. All
submissions received must include the Agency name and docket number 05-
016N and FDMS Docket Number FSIS-2005-0035.
All comments submitted in response to this document, as well as
research and background information used by FSIS in developing this
document, will be posted to the regulations.gov Web site and on the
Agency's Web site at http://www.fsis.usda.gov/regulations_&_policies/2006_Notices_Index/index.asp. The background information and comments
also will be available for public inspection in the FSIS Docket Room at
the address listed above between 8:30 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Robert C. Post, Ph.D., Director,
Labeling and Consumer Protection Staff, Office of Policy, Program, and
Employee Development, Food Safety and Inspection Service, 1400
Independence Ave., SW., Room 602 Annex, Washington, DC 20250-3700;
(202) 205-0279.
SUPPLEMENTARY INFORMATION:
Background
FSIS administers a regulatory program under the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and Poultry Products
Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and
welfare of consumers by preventing the processing and distribution of
meat and poultry products that are unwholesome, adulterated, or
misbranded, or otherwise unfit for human food.
Under the Federal Meat Inspection Act (FMIA) and the Poultry
Products Inspection Act (PPIA), all ingredients used to formulate a
meat, poultry, or egg product must be declared in the ingredients
statement on product labeling. A product is misbranded under the FMIA,
PPIA, or EPIA when it contains ingredients that are permitted but are
not declared on product labeling.
In addition to avoiding misbranding, the Pathogen Reduction and
Hazard Analysis and Critical Control Point (HACCP) regulations (61 FR
38806, July
[[Page 26678]]
25, 1996) require that federally inspected establishments take
preventive and corrective measures at each stage of the food production
process where food safety hazards are reasonably likely to occur. The
preventative actions may be part of an establishments HACCP plan or a
prerequisite plan. A failure to adequately ensure that ingredients that
have the potential to cause food to be unsafe for human consumption
(including adverse reactions to food ingredients) are properly used in
meat and poultry products through one or more of these programs will
result in adulterated products. Allergenicity and the Food Allergen and
Consumer Protection Act of 2004.
There are many foods and food ingredients to which some individuals
may have some degree of intolerance or possible allergic reaction.
Thus, a lack of control over the use of these ingredients in the
production process or incomplete labeling may result in food that is
unsafe for consumption by some individuals. On January 1, 2006, the
Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004,
became effective. This act amends the Federal Food, Drug, and Cosmetic
Act to require that the label of an FDA regulated food that contains an
ingredient that is or contains protein from a ``major food allergen''
declare the presence of the allergen in the manner described by the
law. Congress passed this Act to make it easier for food allergic
consumers and their caregivers to identify and avoid foods that contain
major food allergens.
FALCPA identifies eight foods or food groups as the major food
allergens. They are milk, eggs, fish (e.g., bass, flounder, cod),
Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g.,
almonds, walnuts, pecans), peanuts, wheat, and soybeans. These foods
account for roughly 90 percent of all food allergies.
Foods in these main categories affect people in two main ways
1 2. Food allergies are immunologically mediated reactions
to foods or food constituents. These reactions are caused by
proteinaceous foods acting as an antigen to the human immune system.
These reactions can be severe.
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\1\ Taylor, S.L., 1987. Allergic and sensitivity reactions to
food components. In: Hathcock, J.N. (ed.): Nutritional Toxicology,
Vol. II. New York: Academic Press, pp. 173-198.
\2\ Lemke, P.J., and Taylor, S.L., 1994. Allergic reactions and
food intolerances. In: Kotsonis, F.N., Mackey, M., and Hjelle, J.
(eds.): Nutritional Toxicology. New York: Raven Press, pp. 117-137.
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Food intolerances are non-immunologically mediated reactions. They
are caused by a reaction to the chemical composition of a food itself
or to an additive, such as a preservative (e.g., sulfites) or a
flavoring (e.g., lactose).
There are many foods or food ingredients to which some individuals
may have some degree of intolerance or possible allergenic response.\3\
The manner that a person reacts to an allergen is highly
individualistic, varying in degree, onset time, location of reaction,
and the amount of the food needed to trigger the response. Because of
this concern and with the advent of FALCPA, it is the view of FSIS that
it is important for processors to review their processes to ensure that
those processes provide the basis for confidence that the intended
ingredients will be used, that the proper package will be used, and
that all ingredients will be correctly labeled on products, especially
those ingredients that contain protein such as those identified by
FALCPA.
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\3\ National Institutes of Allergy and Infectious Diseases, NIH,
USHHS, 1999. Health Matters Fact Sheet: Food Allergy and
Intolerances, January.
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Evaluation of Controls for Allergens Under HACCP Reassessment
Section 417.4(a)(3) states that every establishment shall reassess
the adequacy of its HACCP plan at least annually and whenever any
changes occur that could affect the hazard analysis or alter the HACCP
plan. The Agency has determined that failure of establishments to
control the use and declaration of the ingredients identified by FALCPA
represents information that could alter the hazard analysis and,
ultimately, the HACCP plans of any establishment that prepares meat and
poultry food products with ingredients that are potential sources of
food sensitivities and thus of public health concern.
Therefore, establishments that produce multi-ingredient products
should consider, as part of their next annual HACCP reassessment, their
control of ingredient use, particularly the use of those identified by
FALCPA, and what further actions should be taken to maintain proper
control through the production process. Establishments that prepare
meat and poultry products that have already taken into account in their
HACCP plans the need to control the use of ingredients need not give
special consideration to such ingredients in their next annual
reassessment. Establishments in both groups, however, may wish to use
this opportunity to review their processes to ensure that they include
mechanisms to control the use of all ingredients.
If the reassessment results in a determination by the establishment
that it needs to take additional steps to ensure proper ingredient use,
particularly the use of those identified in FALCPA, it must be
addressed through HACCP or a prerequisite program. For example, a
reassessment may reveal that the establishment uses ingredients
identified by FALCPA. As part of the reassessment, the establishment
may choose to verify that it has controls in place to ensure, or that
it has other means (through the use of a prerequisite program) of
ensuring, that the ingredients to be used in the product to be
produced, and only those ingredients, are available at the time of
production; that the list of these ingredients matches the ingredient
list on the label that is to be applied to the product; and that
records are produced and maintained to verify that the proper
ingredients are used.
FSIS Actions To Enforce and Facilitate Compliance With the Reassessment
and Labeling Requirements
The Agency will instruct inspection program personnel to verify, as
part of their review of the establishment's next annual hazard analysis
reassessment, that meat and poultry establishments have considered in
the reassessment the use of ingredients, particularly those identified
by FALCPA. Before performing that verification, inspection program
personnel will ensure that all establishments are aware that the Agency
has issued this document.
On an ongoing basis, FSIS inspection personnel will verify that
establishments' food safety systems are designed to ensure that product
that bears the mark of inspection is in the proper package and bears
the proper label, particularly when the product includes ingredients
that are capable of causing adverse reactions in sensitive individuals.
Paperwork Reduction Act
FSIS has reviewed the paperwork and recordkeeping requirements in
this document in accordance with the Paperwork Reduction Act and has
determined that the paperwork requirements for the regulations that
require meat and poultry establishments to reassess their HACCP Plans
have already been accounted for in the Pathogen Reduction/HACCP Systems
information collection approved by the Office of Management Budget
(OMB). The OMB approval number for the Pathogen Reduction/HACCP Systems
information collection is 0583-0103.
[[Page 26679]]
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and, in particular, minorities, women, and persons with
disabilities are aware of this notice, FSIS will announce it online
through the FSIS Web page located at http://www.fsis.usda.gov/regulations/2006_Notices_Index/.
FSIS will also make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free electronic mail subscription service consisting of industry,
trade, and farm groups, consumer interest groups, allied health
professionals, scientific professionals, and other individuals who have
requested to be included. The update is available on the FSIS Web page
located at http://www.fsis.usda.gov. Through the Listserv and its Web
page, FSIS is able to provide information to a much broader, more
diverse audience.
In addition, FSIS offers an electronic mail subscription service
which provides an automatic and customized notification when popular
pages are updated, including Federal Register publications and related
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/ and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives, and notices.
Customers can add or delete subscriptions themselves and have the
option to protect their accounts with passwords.
Done at Washington, DC on May 1, 2006.
Barbara J. Masters,
Administrator.
[FR Doc. E6-6743 Filed 5-5-06; 8:45 am]
BILLING CODE 3410-DM-P