[Federal Register: May 8, 2006 (Volume 71, Number 88)]
[Rules and Regulations]               
[Page 26677-26679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 


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: fsis.regulationscomments@fsis.usda.gov. 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.

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.



    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.

    \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.

    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 

    \3\ National Institutes of Allergy and Infectious Diseases, NIH, 
USHHS, 1999. Health Matters Fact Sheet: Food Allergy and 
Intolerances, January.

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,
[FR Doc. E6-6743 Filed 5-5-06; 8:45 am]