[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Notices]
[Pages 42869-42870]
From the Federal Register Online via the Government Publishing 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