[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Notices]
[Pages 42869-42870]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-20481]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0316]
Guidance on Inspections of Firms Producing Food Products
Susceptible to Contamination With Allergenic Ingredients; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an inspection guidance entitled ``Guidance on
Inspections of Firms Producing Food Products Susceptible to
Contamination With Allergenic Ingredients.'' This guidance will assist
FDA investigators and inspectors in evaluating conditions that may
result in the introduction of undeclared allergens in foods.
DATES: Submit written or electronic comments on this guide at any time.
ADDRESSES: Submit written requests for single copies of the inspection
guidance entitled ``Guidance on Inspections of Firms Producing Food
Products Susceptible to Contamination With Allergenic Ingredients'' to
the Director, Division of Emergency and Investigational Operations
(HFC-130), Office of Regional Operations, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed
adhesive labels to assist that office in processing your request, or
fax your request to 301-443-6919. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guide.
Submit written comments concerning the guidance to the Dockets
Management Branch (HFS-305), Food and Drug Administration, 5630 Fishers
Lane, rm.1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Technical questions concerning food allergens: Kathy Gombas, Office
of Field Programs (HFS-615), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-205-4231, FAX 202-260-0136.
Questions concerning regulatory procedures: Barbara Marcelletti,
Office of Regional Operations (HFC-130), Office of Regulatory Affairs,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-5635, FAX 301-443-6919.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed an inspection guidance identifying the following
problem areas in the manufacture of foods that may result in undeclared
food allergens: (1) Products that contain one or more allergenic
ingredients, but the label does not declare the ingredient in the
ingredient label; (2) products that become contaminated with an
allergenic ingredient due to the firm's failure to exercise adequate
control procedures; (3) products that are contaminated with
[[Page 42870]]
an allergenic ingredient due to the nature of the product or the
process; (4) products that contain a flavor ingredient that has an
allergenic component, but the label of the product only declares the
flavor; and (5) products that contain a processing aid that has an
allergenic component, but the label does not declare it. FDA believes
there is scientific consensus that the following foods can cause
serious allergic reactions in some individuals and account for more
than 90 percent of all food allergies: Peanuts, soybeans, milk, eggs,
fish, crustacea, tree nuts, and wheat.
FDA is issuing this guidance as level 1 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115). This guidance
is reference material for investigators and other FDA personnel. The
guidance does not bind FDA and does not confer any rights, privileges,
benefits, or immunities for or on any person(s). An alternative
approach may be used if such an approach satisfies the requirements of
the applicable statutes, regulations, or both. The guidance will help
ensure more effective inspections and further FDA's efforts to prevent
potential serious allergic reactions in sensitive individuals resulting
from undeclared allergens in food. FDA is making this guidance document
effective immediately because public participation prior to its
implementation is not appropriate in these circumstances (21 CFR
10.115). Although the guidance document announced in this notice is
being implemented immediately, FDA is requesting comments on the
guidance. FDA will review all comments received, revise the guidance in
response to the comments as appropriate, and publish a notice of
availability if the guidance is revised.
II. Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written or electronic comments
regarding the guide. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments should be
identified with the docket number found in brackets in the heading of
this document. A copy of the guidance and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Copies of the guidance may also be downloaded to a personal
computer with access to the Internet. The Office of Regulatory Affairs
home page includes the guide and may be accessed at http://www.fda.gov/
ora under ``Inspectional References.''
Dated: July 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-20481 Filed 8-10-01; 11:07 am]
BILLING CODE 4160-01-S