[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
