[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
[Rules and Regulations]
[Pages 71015-71016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33984]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98N-1149]
Uniform Compliance Date for Food Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is establishing January
1, 2002, as the uniform compliance date for food labeling regulations
that are issued between January 1, 1999, and December 31, 2000. FDA
periodically announces uniform compliance dates for new food labeling
requirements to minimize the economic impact of label changes. On
December 27, 1996, FDA established January 1, 2000, as the uniform
compliance date for food labeling regulations that issued between
January 1, 1997, and December 31, 1998.
DATES: This regulation is effective December 23, 1998. Submit written
comments by March 8, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Hilario R. Duncan, Center for Food
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-8281.
SUPPLEMENTARY INFORMATION: FDA periodically issues regulations
requiring changes in the labeling of food. If the effective dates of
these labeling changes were not coordinated, the cumulative economic
impact on the food industry of having to respond separately to each
change would be substantial. Therefore, the agency periodically has
announced uniform compliance dates for new food labeling requirements
(see e.g., the Federal Registers of October 19, 1984 (49 FR 41019),
December 24, 1996 (61 FR 67710), and December 27, 1996 (61 FR 68145)).
Use of a uniform compliance date provides for an orderly and economical
industry adjustment to new labeling requirements by allowing sufficient
lead time to plan for the use of existing label inventories and the
development of new labeling materials. This policy serves consumers'
interests as well because the cost of multiple short-term label
revisions that would otherwise occur would likely be passed on to
consumers in the form of higher prices.
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.
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
FDA has examined the economic implications of this final rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs 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, safety, distributive, and equity
effects). Executive Order 12866 classifies a rule as ``economically
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 some sector of the economy in a material way, or
adversely affecting jobs or competition. A regulation is considered a
``significant'' regulatory action under Executive Order 12866 if it
raises novel legal or policy issues. FDA finds that this final rule is
neither an economically significant rule nor a significant regulatory
action as defined by Executive Order 12866. In addition, in accordance
with the Small Business Regulatory Enforcement Fairness Act of 1996,
the administration of the Office of Management and Budget has
determined that this final rule is not a major rule for purposes of
congressional review. The establishment of a uniform compliance date
does not impose either costs or benefits. For future labeling
requirements, FDA will assess the costs and benefits of the uniform
compliance date as well as the option of setting other dates.
Because FDA has issued this final rule without first publishing a
general notice of proposed rulemaking, a final regulatory analysis is
not required by the Regulatory Flexibility Act (5 U.S.C. 601-612).
Nonetheless, the uniform compliance date does not impose any burden on
small entities. The agency will assess the costs and benefits of
setting alternative dates as part of the regulatory flexibility
analyses of future labeling regulations.
This action is not intended to change existing requirements for
compliance dates contained in final rules published before publication
of this final rule. Therefore, all final FDA regulations published in
the Federal Register before December 23, 1998, will still go into
effect on the date stated in the respective final rule.
The agency generally encourages industry to comply with new
labeling regulations as quickly as feasible, however. Thus, when
industry members voluntarily change their labels, it is appropriate
that they incorporate any new requirements that have been published as
final regulations up to that time.
In rulemaking that began with publication of a proposal on April
15, 1996 (61 FR 16422), and ended with a final rule on December 24,
1996 (61 FR 67710), FDA provided notice and an opportunity for comment
on the practice of establishing uniform compliance dates by issuance of
a final rule announcing the date. Receiving no comments objecting to
this practice, FDA finds any further rulemaking
[[Page 71016]]
unnecessary for establishment of the uniform compliance date.
Nonetheless, under 21 CFR 10.40(e)(1), FDA is providing an opportunity
for comment on whether this uniform compliance date should be modified
or revoked.
Interested persons may, on or before March 8, 1999, 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. After its review of any comments
received to this final rule, FDA will either publish a document
providing its conclusions concerning the comments or will initiate
document and comment rulemaking to modify or revoke the uniform
compliance date established by this final rule.
The new uniform compliance date will apply only to final FDA food
labeling regulations that require changes in the labeling of food
products and that publish after January 1, 1999, and before December
31, 2000. Those regulations will specifically identify January 1, 2002,
as their compliance date. All food products subject to the January 1,
2002, compliance date must comply with the appropriate regulations when
initially introduced into interstate commerce on or after January 1,
2002. If any food labeling regulation involves special circumstances
that justify a compliance date other than January 1, 2002, the agency
will determine for that regulation an appropriate compliance date,
which will be specified when the final regulation is published.
Dated: December 15, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-33984 Filed 12-22-98; 8:45 am]
BILLING CODE 4160-01-F