[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
