[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

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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