[Federal Register Volume 64, Number 31 (Wednesday, February 17, 1999)]
[Proposed Rules]
[Pages 7834-7837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3714]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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.
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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.
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\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.
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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
[[Page 7835]]
not required to be any more prominent than the declaration of
ingredients required under section 403(i)(2) of the act.
Although section 403C of the act addressed only the prominence of
the radiation disclosure statements, the language in the FDAMA Joint
Statement (H. Rept. 105-399, 105th Cong., 1st sess., at 98-99) directed
FDA to publish for public comment proposed changes to current
regulations relating to labeling of foods treated with ionizing
radiation. Specifically, the Joint Statement directed that, ``The
public comment process should be utilized by the Secretary to provide
an opportunity to comment on whether the regulations should be amended
to revise the prescribed nomenclature for the labeling of irradiated
foods and on whether such labeling requirements should expire at a
specified date in the future.'' The FDAMA Joint Statement also
indicated that, ``The conferees intend for any required irradiation
disclosure to be of a type and character such that it would not be
perceived to be a warning or give rise to inappropriate consumer
anxiety.'' (Ref. 1.)
FDA notes that the law requires that irradiation labeling
statements, like other labeling statements, be truthful and not
misleading (403(a)(1) of the act). The agency also notes that over the
years, it has received letters expressing a variety of views regarding
the labeling of irradiated foods. However, at this time, FDA is not
aware of a consensus regarding specific changes in the labeling of
irradiated food that would best accomplish the intent of the conferees
and also satisfy the requirements of the act and other agency
regulations regarding the labeling of food in general. Therefore, the
agency is publishing this ANPRM to request public comment on whether
revisions to the current labeling requirements for irradiated foods are
needed to accomplish these objectives and, if so, what form such
revisions might take.
II. Background on FDA's Labeling Requirements for Irradiated Foods
As noted, over the years, FDA has issued several rules that address
the labeling of irradiated foods. In the Federal Register of February
14, 1984 (49 FR 5714), FDA published a proposal to approve the use of
ionizing radiation on several foods; that proposal did not include a
requirement for labeling disclosing the use of ionizing radiation (Ref.
2). The agency received over 5,000 comments on this proposal, among
them, numerous comments on the issue of labeling irradiated foods.
Based on the comments and information received in response to the 1984
proposal and on further analysis, FDA published a final rule in the
Federal Register of April 18, 1986 (51 FR 13376) (the 1986 rule),
requiring that the labeling of retail packages and displays of
irradiated food bear both the radura logo and a radiation disclosure
statement (Ref. 3). The agency had concluded that labeling indicating
treatment of food with radiation was necessary to prevent misbranding
of irradiated foods. In response to the 1986 rule, FDA received various
submissions commenting on, and objecting to, different aspects of that
rule, including the labeling requirements. In the Federal Register of
December 30, 1988 (53 FR 53176) (the 1988 response to objections), FDA
discussed several comments and objections to the labeling requirements
of the 1986 rule and concluded that the information submitted in the
comments and objections provided no basis to change those requirements.
Thus, the agency reaffirmed its earlier decision (Ref. 4).\2\
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\2\ As discussed in both the 1986 final rule and the 1988
response to objections, FDA concluded that labeling of irradiated
foods was necessary because such processing is a material fact that
must be disclosed to the consumer to prevent deception. The agency
determined that irradiation is a form of processing that can produce
significant changes in certain characteristics of a food, such as
the organoleptic (e.g., taste, smell, texture) or holding
properties, in a manner that is not obvious to the consumer in the
absence of labeling. That is, in the absence of labeling indicating
that the food has been irradiated, the implied representation to
consumers is that the food has not been processed.
On the other hand, FDA recognized that irradiation of an
ingredient in a multiple ingredient food represented a different
situation because such a food has obviously been processed, and
concluded that consumers would not need special labeling to
recognize that fact. Therefore, the agency did not require special
labeling of a food that contained an irradiated ingredient but that
had not itself been irradiated. FDA also concluded that the labeling
requirements for irradiated ingredients in a multiple ingredient
food should be the same as for any other processed ingredients,
namely, that they be declared by their common or usual name without
any requirement for stating whether they were processed (see 51 FR
13376 at 13389 and 53 FR 53176 at 53205).
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In the preamble to the 1986 rule, FDA emphasized that the required
label statement (``Treated with radiation'' or ``Treated by
irradiation'') could be augmented by optional statements that describe
the type of radiation used or explain the reason for irradiation,
provided such statements were truthful and not misleading. That is,
manufacturers could include in product labeling statements such as
``treated with X-radiation'' or ``treated with electron beam
radiation,'' provided that the more specific description was
applicable. Similarly, manufacturers could include statements such as
``treated with radiation to extend shelf-life'' or ``treated by
irradiation to control pathogens,'' provided the more specific
statement truthfully described the primary purpose of the treatment
(Ref. 3).
FDA further concluded that the best way to convey to consumers the
factual information that a food had been irradiated was to require
labeling with the radura logo, which would indicate that the food had
been processed by irradiation (but which would not be interpreted as a
warning or erroneously associated with the idea that radioactivity is
in the food). However, because the radura logo was not in common use at
that time and, thus would not be recognized, FDA also required a
disclosure statement, linked with the radura, so that consumers would
understand its meaning. At that time, the agency believed that consumer
awareness of irradiated foods and the meaning of the radura logo would
increase as irradiated foods entered the marketplace and that, in time,
a separate disclosure statement would no longer be necessary. Thus, the
requirement for a separate disclosure statement initially was to expire
on April 18, 1988. However, the agency subsequently extended the
requirement for a disclosure statement (Ref. 5: 53 FR 12757, April 18,
1988) and later made the requirement permanent (Ref. 6: 55 FR 14415,
April 18, 1990), having determined, at that time, that the public was
not sufficiently familiar with the meaning of the radura logo for it to
be used without a statement.
III. Other Views on Labeling Requirements for Irradiated Foods
FDA has recently received several submissions from individuals and
various organizations concerning the labeling of irradiated foods. The
following list summarizes these submissions.
1. ``Identifying, Addressing and Overcoming Consumer Concerns.'' A
Roundtable on Food Irradiation, convened by Public Voice for Food
Health Policy, the National Food Processors Association, and the
International Food Information Council, February 18 and 19, 1998 (Ref.
7). This report summarizes the discussion by invited participants
regarding consumer concerns about food irradiation. According to the
report:
Roundtable participants generally agreed that irradiated foods
should continue to be labeled, subject to existing exceptions.
However, participants were open to variations on existing label
language--such as cold pasteurization (irradiation)--that would
provide an informative, truthful and
[[Page 7836]]
non-threatening way to notify consumers that a particular product
has been irradiated.
2. A letter from Senator Tom Harkin, dated January 21, 1998 (Ref.
8), and FDA's March 27, 1998, response to Senator Harkin (Ref. 9).
Senator Harkin expresses concern that the current labeling requirements
``foster baseless fears,'' and requests that FDA proceed quickly to
``finalize a new rule providing for more appropriate labeling of foods
processed with ionizing irradiation.'' Senator Harkin also suggests the
use of alternative terms as ``cold pasteurization'' or ``electronic
pasteurization'' in any irradiation disclosure statement.
3. An excerpt from ``Food Labeling for the 21st Century: A Global
Agenda for Action,'' A Report by the Center for Science in the Public
Interest (CSPI), May 1998 (Ref. 10). This report includes a discussion
of the labeling of irradiated foods and food ingredients. As part of
the report's recommendations, CSPI states that,
Any foods, or any foods containing ingredients, that have been
treated by irradiation should be labeled with a written statement on
the principal display panel indicating such treatment. The statement
should be easy to read and placed in close proximity to the name of
the food and accompanied by the international symbol. If the food is
unpackaged, this information should be clearly displayed on a poster
in plain view and adjacent to where the product is displayed for
sale.
4. A citizen petition from the National Food Processors
Association, dated May 21, 1998 (Ref. 11). This petition requests that
FDA remove the labeling requirements for irradiated foods, stating,
among other things, that ``the required radiation statement causes
consumer concern about a non-existent hazard, at the expense of
discouraging a process that can mitigate very real safety hazards.''
5. A letter from Burrell J. Smittle, Florida Linear Accelerator,
dated September 3, 1998 (Ref. 12), expressing the opinion that no
radiation disclosure statement should be required.
6. A letter from Consumer Alert, dated September 15, 1998 (Ref.
13), stating support for the position that the radiation disclosure
statement should not be more prominent than the declaration of
ingredients.
7. A letter from the National Consumers League, dated September 16,
1998 (Ref. 14), expressing the opinion that the radiation disclosure
statement should be more prominent than the declaration of ingredients.
8. A section of the ``Codex General Standard for Labelling of
Prepackaged Foods,'' Codex Alimentarius Commission,\3\ 1995 (Ref. 15)
and a summary list of the labeling requirements for irradiated foods in
various countries (Ref. 16). Under the provisions of the Codex
standard, a written radiation disclosure statement is to be used on the
label of irradiated foods; the use of the radura symbol, however, is
optional. Of the countries included in the summary list, all require a
label statement, and none rely on the radura logo alone. In addition,
most of these countries require that the label statement use wording
similar to that required by FDA's regulations (i.e., the use of a word
comparable to ``irradiation'' or ``radiation'').
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\3\ The Codex Alimentarius Commission is an international
consensus standards body organized under the auspices of the Food
and Agriculture Organization of the United Nations (FAO) and the
World Health Organization (WHO).
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IV. Request for Comments
As previously discussed, FDA is publishing this ANPRM to request
public comment on whether revisions of the current labeling
requirements for irradiated foods are needed to accomplish the
objectives outlined in the FDAMA Joint Statement and the labeling
requirements of the act, and, if so, what form such revisions might
take. In keeping with the FDAMA Joint Statement, FDA is soliciting
comments on two issues: (1) Whether the wording of the current
radiation disclosure statement should be revised, and (2) whether such
labeling requirements should expire at a specified date in the future.
To better assist FDA in formulating specific revisions that would
accomplish the objectives outlined in the FDAMA Joint Statement and
also satisfy the requirements of the act and the agency's other
regulations regarding the labeling of food in general, the agency
encourages interested persons to address the following questions in
their comments:
(1) Does the current radiation disclosure statement convey
meaningful information to consumers in a truthful and nonmisleading
manner?
(2) How do consumers perceive the current radiation disclosure
statement--as informational, as a warning, or as something else?
(3) Does the wording of the current radiation disclosure statement
cause ``inappropriate anxiety'' among consumers? What are examples of
``inappropriate anxiety''?
(4) What specific alternate wording for a radiation disclosure
statement would convey meaningful information to consumers, in a
truthful and nonmisleading manner, and in a more accurate or less
threatening way than the current wording?
(5) Would consumers be misled by the absence of a radiation
disclosure statement in the labeling of irradiated foods? Are consumers
misled by the presence of such a statement?
(6) With respect to foods containing irradiated ingredients, are
consumers misled by the absence of a radiation disclosure statement?
Would consumers be misled by the presence of such a statement?
(7) What is the level of direct consumer experience with irradiated
foods that are labeled as such?
(8) What is the effect of the current required labeling on the use
of irradiation? Does the current required labeling discourage the use
of irradiation?
(9) What do consumers understand to be the effect of irradiation on
food? For example, what do consumers understand about the effect of
irradiation on the numbers of harmful microorganisms in or on food?
(10) Do consumers readily recognize the radura logo?
(11) Do consumers understand the logo to mean that a food has been
irradiated?
(12) Do consumers perceive the radura logo as informational, as a
warning, or as something else?
(13) Should any requirement for a radiation disclosure statement
expire at a specified date in the future?
(14) If so, on what criteria should the expiration be based?
(15) If the expiration of labeling requirements for irradiated
foods is to be based on consumer familiarity with the radura logo and
understanding of its meaning, what evidence of familiarity and
understanding would be sufficient to allow these requirements to
expire?
FDA strongly encourages the submission of the results of any focus
group or other consumer perception studies regarding irradiated foods
and the labeling of such foods. In addition, FDA encourages those
persons who suggest a revision of the radiation disclosure statement
also to submit a brief discussion of the advantages of their suggestion
over the current statement. Finally, FDA encourages interested persons
to submit information regarding the prevalence of irradiated foods in
the marketplace and information regarding the level of consumer
experience and awareness of irradiated foods and irradiation
processing.
V. Comments
Interested persons may, on or before May 18, 1999, submit to the
Dockets
[[Page 7837]]
Management Branch, written comments on this ANPRM and supporting
material. Two copies of any comment 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.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
VI. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Conference Report on S. 830, Food and Drug Administration
Modernization Act of 1997, 143 Cong. Rec. H10452, 10477 (November 9,
1997).
2. ``Irradiation in the Production, Processing, and Handling of
Food; Proposed Rule,'' FDA, Federal Register, February 14, 1984 (49
FR 5714).
3. ``Irradiation in the Production, Processing, and Handling of
Food; Final Rule,'' FDA, Federal Register, April 18, 1986 (51 FR
13376).
4. ``Irradiation in the Production, Processing, and Handling of
Food; Final Rule; Denial of Request for Hearing and Response to
Objection,'' FDA, Federal Register, December 30, 1988 (53 FR 53176).
5. ``Irradiation in the Production, Processing, and Handling of
Food; Final Rule,'' FDA, Federal Register, April 18, 1988 (53 FR
12757).
6. ``Irradiation in the Production, Processing, and Handling of
Food; Final Rule,'' FDA, Federal Register, April 18, 1990 (55 FR
14415).
7. ``Identifying, Addressing and Overcoming Consumer Concerns.''
A Roundtable on Food Irradiation, convened by Public Voice for Food
Health Policy, the National Food Processors Association, and the
International Food Information Council, February 18 and 19, 1998.
8. Letter from Senator Tom Harkin to Michael Friedman, FDA,
January 21, 1998.
9. Letter from Diane E. Thompson, FDA, to Senator Tom Harkin,
March 27, 1998.
10. ``Food Labeling for the 21st Century: A Global Agenda for
Action,'' by the Center for Science in the Public Interest, May
1998.
11. Citizen Petition from John R. Cady, National Food Processors
Association to FDA, May 21, 1998.
12. Letter from Burrell J. Smittle, Florida Linear Accelerator
to Dockets Management Branch, FDA, September 3, 1998.
13. Letter from Barbara Rippel, Consumer Alert to Dockets
Management Branch, FDA, September 15, 1998.
14. Letter from Linda F. Golodner, National Consumers League to
Dockets Management Branch, FDA, September 16, 1998.
15. Codex General Standard for Labelling of Prepackaged Foods,
Joint FAO/WHO Food Standards Programme, Codex Alimentarius
Commission, Rome, 1995.
16. ``Present Status of Labelling Requirements in Various
Countries,'' October 16, 1998.
Dated: February 8, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-3714 Filed 2-16-99; 8:45 am]
BILLING CODE 4160-01-F
