[Federal Register Volume 63, Number 158 (Monday, August 17, 1998)]
[Rules and Regulations]
[Pages 43875-43876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Dockte No. 98N-0392]


Irradiation in the Production, Processing and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations on labeling requirements for foods treated with 
irradiation. This action is intended to clarify the agency's 
regulations following enactment of the FDA Modernization Act of 1997 
(FDAMA). FDAMA adds a new section to the Federal Food, Drug, and 
Cosmetic Act (the act); this new section addresses the prominence of 
radiation disclosure statements on the labeling of food.
DATES: The regulation is effective August 17, 1998. Submit written 
comments on or before September 16, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Nega Beru, Center for Food Safety and 
Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-418-3097.

SUPPLEMENTARY INFORMATION:

I. Background

    Through a series of proceedings under section 409 of the act (21 
U.S.C. 348), FDA has approved the use of ionizing radiation for various 
food uses (see Sec. 179.26 (21 CFR 179.26)). The agency's regulations 
require that the label and labeling of retail packages of foods treated 
with ionizing radiation include both the radura logo, which is 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)). The regulations require that the logo be placed 
prominently and conspicuously in conjunction with the required 
statement. The regulation does not specify the prominence of the 
disclosure statement, either generally or relative to other information 
required in the label and labeling.
    On November 21, 1997, President Clinton signed into law FDAMA (Pub. 
L. 105-115). Section 306 of FDAMA amends the act by adding section 403C 
(21 U.S.C. 341 et seq.). 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.
    As noted, FDA's current regulations do not specify how prominent a 
radiation disclosure statement must be, and thus, the current 
regulation could simply be read to include the requirement imposed by 
new section 403C of the act. However, the agency believes that there is 
merit to having the regulation in Sec. 179.26 include the prominence 
specification of the new statutory provision. Accordingly, FDA is 
amending the labeling requirement for irradiated foods to include a 
statement that a radiation disclosure statement is not required to be 
any more prominent than the declaration of ingredients required under 
the applicable regulations issued under section 403(i)(2) of the act 
(21 U.S.C. 343(i)(2)).
    The agency has determined under 21 CFR 25.30(k) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

II. Analysis of Economic Impacts

A. Benefit-Cost Analysis

    FDA has examined the impacts of the final rule under Executive 
Order 12866. Executive Order 12866 directs Federal agencies to assess 
the cost and benefits of available regulatory alternatives and when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects; distributive impacts; and equity). According 
to Executive Order 12866, a regulatory action is ``significant'' if it 
meets any one of a number of specified conditions, including having an 
annual effect on the economy of $100 million, adversely affecting in a 
material way a sector of the economy, competition, or jobs, or if it 
raises novel legal or policy issues. FDA finds that this final rule is 
not a significant regulatory action as defined by Executive Order 
12866. In addition, it has been determined that this final rule is not 
a major rule for the purpose of congressional review.
    The final rule is offered to clarify the existing labeling 
requirements for irradiated foods. The rule will not require on the 
label or labeling of a food a separate radiation disclosure statement 
that is more prominent than

[[Page 43876]]

the declaration of ingredients. Therefore, it will not result in 
regulatory changes for firms and thus, will not result in any costs to 
firms. Firms will still be able to communicate the same information in 
the same manner to consumers.

B. Small Entity Analysis

    FDA has examined the impacts of the final rule under the Regulatory 
Flexibility Act. The Regulatory Flexibility Act (5 U.S.C. 601-612) 
requires Federal agencies to consider alternatives that would minimize 
the economic impact of their regulations on small businesses and other 
small entities. In compliance with the Regulatory Flexibility Act, FDA 
finds that this final rule will not have a significant impact on a 
substantial number of small entities.
    The final rule is offered to clarify the existing label 
requirements. The rule to not require a separate disclosure statement 
that is more prominent than the declaration of ingredients will not 
result in any costs to firm. Therefore, this rule will not have a 
significant impact on a substantial number of small entities. 
Accordingly, under the Regulatory Flexibility Act, the agency certifies 
that this final rule will not have a significant economic impact on a 
substantial number of entities.

C. Unfunded Mandates Act of 1995

    FDA has examined the impacts of this final rule under the Unfunded 
Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This rule does not 
trigger the requirement for a written statement under section 201(a) of 
the UMRA because it does not impose a mandate that results in an 
expenditure of $100 million or more by State, local, and tribal 
governments in the aggregate, or by the private sector, in any 1 year.

III. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by OMB under the Paperwork Reduction Act of 1995 is not 
required.

IV. Comments

    Because the amendments set forth in this document incorporate the 
language of section 306 of FDAMA into Sec. 179.26, FDA finds, for good 
cause, that notice and public procedure are unnecessary and, therefore, 
are not required under 5 U.S.C. 553. Nonetheless, under 21 CFR 
10.40(e), FDA is providing an opportunity for comment on whether the 
regulations set forth in this document should be modified or revoked.
    Interested persons may, on or before September 16, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this final rule. 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. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday though Friday.

 List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
179 is amended as follows:

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

    1. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

    2. Section 179.26 is amended by adding a sentence at the end of 
paragraph (c)(1) to read as follows:


Sec.  179.26  Ionizing radiation for the treatment of food.

* * * * *
    (c) * * * (1) * * * The radiation disclosure statement is not 
required to be more prominent than the declaration of ingredients 
required under Sec. 101.4 of this chapter. As used in this provision, 
the term ``radiation disclosure statement'' means the written statement 
that discloses that a food has been intentionally subject to 
irradiation.
* * * * *

    Dated: August 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21998 Filed 8-14-98; 8:45 am]
BILLING CODE 4160-01-F