US FDA FR re Food Irradiation

[Mike Grissom <mikeg@SLAC.Stanford.EDU>]

radsafe'ers,

The following extract is from Wednesday's US Federal
Register. You may find the entire document (available
on the Web as indicated below) of some special
interest considering the prominence of this subject of
late:

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Federal Register: February 17, 1999 (Volume 64,
 Number 31).
... Page: 7834-7837

          FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
                         21 CFR Part 179
                    [Docket No. 98N-1038]

     Irradiation in the Production, Processing, and
                         Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

SUMMARY: The Food and Drug Administration (FDA)
is considering proposing revisions of its labeling
requirements for foods treated with ionizing radiation.
FDA is publishing this advance notice of proposed
rulemaking (ANPRM) in response to the direction given
in the Joint Explanatory Statement of the Committee
of Conference that accompanied the Food and Drug
Administration Modernization Act of 1997 (FDAMA).
The FDAMA Joint Statement directed FDA to publish
for public comment proposed changes to current
regulations relating to the labeling of foods treated with
ionizing radiation. As a first step, the agency is
making available to the public, through this document,
various documents including the relevant text from the
FDAMA Joint Statement; prior FDA rulings regarding
food irradiation; recent submissions to FDA regarding
the labeling of irradiated foods, including a citizen
petition; a report of a meeting attended by FDA
representatives at which labeling of irradiated foods was
discussed; and other relevant materials. The agency
encourages interested persons to submit comments,
including pertinent data and information, to aid FDA's
consideration of revisions to the labeling requirements
for irradiated foods.

DATES: Written comments must be submitted by May
18, 1999.

ADDRESSES: Submit written comments and supporting
material to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Patricia A.
Hansen, Center for Food Safety and Applied Nutrition
(HFS-206), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 202-418-3093.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Through a series of proceedings under section 409 of
the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 348), FDA has approved the use of ionizing
radiation on various foods under specific conditions. These
approvals are codified in FDA's regulations at Sec. 179.26
(21 CFR 179.26).\1\ The agency's regulations require that
the label and labeling of retail packages or displays of
foods treated with ionizing radiation include both the
radura logo (the international symbol that indicates
radiation treatment) and a disclosure statement (either
"Treated with radiation" or "Treated by irradiation") in
addition to information required by other regulations
(Sec. 179.26(c)(1) and (c)(2)). The regulations require that
the logo be placed prominently and conspicuously in
conjunction with the required statement.
---------------------------------------------------------------------------
    \1\ Two of FDA's most recent approvals authorized the
use of irradiation to reduce microbial pathogens on meat
and poultry. Recently, the use of irradiation has received
increased attention as an important potential tool for
reducing foodborne illness.
---------------------------------------------------------------------------
    On November 21, 1997, President Clinton signed
FDAMA into law (Pub. L. 105-115). Section 306 of FDAMA
amended the act by adding section 403C (21 U.S.C.
342-3). Section 403C of the act addresses the disclosure
of irradiation on the labeling of food as follows:

    (a) No provision of section 201(n), 403(a), or 409 shall be
construed to require on the label or labeling of a food a
separate radiation disclosure statement that is more
prominent than the declaration of ingredients required by
section 403(i)(2).

    (b) In this section, the term `radiation disclosure
statement' means a written statement that discloses that a
food has been intentionally subject to irradiation.

    Although FDA's regulations did not specify how prominent
a radiation disclosure must be, the agency concluded there
was merit to having the regulation in Sec. 179.26 include the
prominence specification of the new statutory provision.
Accordingly, in the Federal Register of August 17, 1998
(63 FR 43875), FDA amended its labeling requirement for
irradiated foods to state that a radiation disclosure statement
is...[snip, much more follows in original]


----------
Most US Federal Register documents can be readily
found using the GPO Web site at URL:

http://www.access.gpo.gov/su_docs/aces/aces140.html


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