[Federal Register Volume 61, Number 250 (Friday, December 27, 1996)]
[Rules and Regulations]
[Pages 68145-68146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32884]
[[Page 68145]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 96N-0094]
Uniform Compliance Date for Food Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing January
1, 2000, as the uniform compliance date for food labeling regulations
that are issued between January 1, 1997, and December 31, 1998. FDA has
periodically announced uniform compliance dates for new food labeling
requirements to minimize the economic impact of label changes. In 1992,
FDA suspended this practice pending the issuance of regulations
implementing the Nutrition Labeling and Education Act of 1990 (the 1990
amendments). FDA recently reinstated this practice of with the
establishment of a uniform compliance date of January 1, 1998.
DATES: Effective December 27, 1996; written comments by March 13, 1997.
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: Gerad L. McCowin, Center for Food
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4561.
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) and
December 24, 1996 (61 FR 67710). 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.
During the 1980's and into the early 1990's, FDA periodically
issued final rules announcing new uniform compliance dates for food
labeling regulations. The agency suspended the issuance of uniform
compliance date final rules in 1992 because of the pending issuance of
a number of new final regulations implementing the 1990 amendments.
Most of these regulations are now in place and effective.
In the Federal Register of April 15, 1996 (61 FR 16422), FDA issued
a proposal entitled ``Uniform Compliance Date for Food Labeling
Regulations.'' In that document, FDA, among other things, proposed to
reinstate its practice of periodically issuing uniform compliance dates
as final rules. The comments to the proposal fully supported the
agency's doing so. With the publication of this final rule, FDA is
reinstating this practice.
The agency has determined under 21 CFR 25.24(a)(11) 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.
FDA has examined the economic implications of this final rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select the regulatory approach that maximizes net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). Executive Order
12866 classifies a rule as significant if it meets any one of a number
of specified conditions, including having an annual effect on the
economy of $100 million or adversely affecting in a material way a
sector of the economy, competition, or jobs, or if it raises novel
legal or policy issues. If a rule has a significant impact on a
substantial number of small entities, the Regulatory Flexibility Act
requires agencies to analyze options that would minimize the economic
impact of that rule on small entities.
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 options of setting alternative dates, especially with regard to the
impact on small entities. Therefore, the agency finds that the final
rule is not a significant rule as defined by Executive Order 12866.
Similarly, the agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
It has also determined that the rule is not a major rule for the
purpose of congressional review (Pub. L. 104-121).
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 27, 1996 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.
Because FDA has already provided notice and an opportunity for
comment on the practice of establishing uniform compliance dates by
issuance of a final rule announcing the date, it finds any further
rulemaking unnecessary. 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 13, 1997 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 notice providing
its conclusions concerning the comments or will initiate notice 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, 1997, and before January 1,
1999. Those regulations will specifically identify January 1, 2000, as
their compliance date. All food products subject to the January 1,
2000, compliance date must comply with the
[[Page 68146]]
appropriate regulations when initially introduced into interstate
commerce on or after January 1, 2000. If any food labeling regulation
involves special circumstances that justify a compliance date other
than January 1, 2000, the agency will determine for that regulation an
appropriate compliance date, which will be specified when the final
regulation is published.
Dated: December 20, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32884 Filed 12-26-96; 8:45 am]
BILLING CODE 4160-01-F
