[Federal Register Volume 64, Number 143 (Tuesday, July 27, 1999)]
[Notices]
[Page 40612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19061]



[[Page 40612]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2214]


Antimicrobial Food Additives--Guidance; 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 a guidance document entitled ``Antimicrobial Food 
Additives--Guidance.'' This document is intended to clarify FDA's 
jurisdiction over antimicrobials that are used in or on food, including 
those used in or on edible food, in water that contacts edible food, 
and those used in the manufacture of, or in or on, food-contact 
articles, subsequent to the enactment of the Food Quality Protection 
Act of 1996 (FQPA), and the Antimicrobial Regulation Technical 
Corrections Act of 1998 (ARTCA).

DATES: Written comments concerning this guidance may be submitted at 
any time.

ADDRESSES: Written comments concerning this guidance may be submitted 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. Submit written requests for single 
copies of the guidance to the Office of Premarket Approval (HFS-200), 
Food and Drug Administration, 200 C St. SW., Washington DC 20204, or by 
telephone to the Office of Premarket Approval at 202-418-3100 (voice), 
or FAX 202-418-3131. All requests should identify the guidance by its 
title of ``Antimicrobial Food Additives--Guidance.'' See the 
Supplementary Information section for electronic access to this 
guidance.

FOR FURTHER INFORMATION CONTACT: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 200 C 
St. SW., Washington DC 20204-0001, 202-418-3098.

SUPPLEMENTARY INFORMATION:

I. Background

    The FQPA, enacted on August 3, 1996, changed, among other things, 
the definitions of ``food additive'' and ``pesticide chemical'' in the 
Federal Food, Drug, and Cosmetic Act (the act) (section 201(s) and (q) 
respectively (21 U.S.C. 321(s) and (q)). These changes had a 
significant impact on the regulatory authority for many antimicrobial 
products that are used in food-contact applications. ARTCA, enacted on 
October 30, 1998, further amended the definition of a ``pesticide 
chemical,'' under section 201(q) of the act, and the transitional 
provisions under section 408(j) of the act (21 U.S.C. 340a(j)). ARTCA, 
in part, transferred authority for certain food-contact antimicrobials 
from the Environmental Protection Agency (EPA) back to FDA.
    FDA is announcing availability of a guidance document entitled 
``Antimicrobial Food Additives--Guidance'' that is intended to clarify 
FDA's jurisdiction over antimicrobials, subsequent to the passage of 
FQPA and ARTCA, that are used in food, or that may become components of 
food as a result of their intended use. The food-related uses of 
antimicrobial products that have been specifically excluded from FDA's 
regulatory authority by ARTCA are also discussed. In addition, this 
document provides guidance on the meaning of certain terms that are 
important in delineating the jurisdiction of FDA and EPA.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the agency's regulatory authority over certain antimicrobials used in 
or on food, or as food-contact substances. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute, regulations, or both.
    The guidance document entitled ``Antimicrobial Food Additives--
Guidance'' is a level 1 guidance under the agency's good guidance 
practices (62 FR 8961, February 27, 1997). Level 1 guidance documents 
are generally subject to public comment prior to finalizing. However, 
public comment prior to implementation of this guidance document is not 
required because there is a new statutory requirement that requires 
immediate implementation.

III. Comments 

    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding the 
guidance document. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The guidance document and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday. 
Such comments will be considered when determining whether to amend the 
guidance.

IV. Electronic Access

    The guidance may also be accessed at the Center for Food Safety and 
Applied Nutrition home page on the World Wide Web at ``http://
www.fda.gov/cfsan''.

    Dated: July 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19061 Filed 7-26-99; 8:45 am]
BILLING CODE 4160-01-F