[Federal Register Volume 61, Number 73 (Monday, April 15, 1996)]
[Proposed Rules]
[Pages 16422-16423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9319]



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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
establish January 1, 1998, as its new uniform compliance date for all 
food labeling regulations that are issued after the publication of a 
final rule based on this proposal and before January 1, 1997. FDA 
periodically has 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). With the adoption and implementation of 
those regulations, FDA is proposing to establish a new uniform 
compliance date.

DATES: Written comments by July 1, 1996. FDA is proposing that January 
1, 1998, be the new uniform compliance date for food labeling 
regulations published after the publication of a final rule based on 
this proposal and before January 1, 1997, except as otherwise provided 
in individual regulations.

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 packaged food. If these labeling 
changes were effective on separate dates, the cumulative economic 
impact on the food industry of frequent changes would be substantial. 
Therefore, the agency periodically has announced uniform compliance 
dates for new food labeling requirements (see, e.g., the Federal 
Register of October 19, 1984 (49 FR 41019)). 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 increased cost of multiple short-term 
label revisions that would otherwise occur would likely be passed on to 
consumers in the form of higher food prices.
    -The last uniform compliance date was January 1, 1993, which FDA 
established on January 4, 1990 (55 FR 276). The agency did not issue a 
new uniform compliance date in 1992 because of the pending issuance of 
a number of new final regulations implementing the 1990 amendments. The 
regulations implementing the 1990 amendments became effective May 8, 
1994.
    -The agency has tentatively decided to establish a new uniform 
compliance date of January 1, 1998. If adopted, this date will apply to 
all FDA regulations requiring changes in food labels, except where 
special circumstances require a different compliance date. The agency 
has tentatively selected January 1, 1998, to ensure that manufacturers 
have adequate time to make any changes in food labeling that may be 
required by FDA final regulations published after the publication of a 
final rule based on this proposal and before January 1, 1997.
    -The agency generally encourages industry to comply with new 
labeling regulations as quickly as is 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.
    -The uniform compliance date that FDA adopts in response to this 
proposal will apply to final FDA food labeling regulations published 
after its adoption and before January 1, 1997. Moreover, FDA will 
consider adopting a consistent effective date in any rulemakings in 
which it publishes a final rule before it completes the present 
proceeding.
    -Previously, FDA has established the uniform compliance date by 
issuance of a final rule without providing an opportunity for comment. 
Because of the passage of time since the agency had last established a 
uniform compliance date, the agency believes it appropriate to 
establish the new uniform compliance date of January 1, 1998, through 
the issuance of this notice of proposed rulemaking and an opportunity 
for comment. FDA intends, however, to return to its former practice of 
establishing uniform compliance dates through issuance of a final rule 
without the opportunity for comment. Thus, for example, on or before 
December 31, 1996, FDA intends to issue a final rule establishing 
January 1, 2000, as the uniform compliance date for regulations 
published in the Federal Register between January 1, 1997, and December 
31, 1998.
    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 impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 and safety, and other 
advantages; distributive impacts; and equity). The Regulatory 
Flexibility Act requires agencies to analyze regulatory options that 
would minimize any significant impact of a rule on small entities.
    -The agency estimates that this proposed rule would reduce costs by 
providing a uniform compliance date that will permit an orderly and 
economical industry adjustment to any new labeling requirements by 
allowing sufficient lead time to plan for the use of existing label 
inventories and the development of new labeling materials. Alternative 
approaches that FDA considered include setting a uniform compliance 
date such that firms have either more or less time to comply with 
labeling regulations. In general, providing a minimum compliance period 
of 2 years would be half as expensive as the proposed compliance

[[Page 16423]]

date, but it would delay implementation of labeling changes thus 
decreasing the value of any benefits. A minimum compliance period of 6 
months, although providing earlier labeling changes that would increase 
the value of the benefits, would be twice as expensive as the proposed 
1 year.
    -Therefore, the agency finds that the proposed rule is not a 
significant regulatory action as defined by the Executive Order. 
Similarly, the agency certifies that the proposed rule will not have a 
significant economic impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required.
     -This proposed action is not intended to change existing 
requirements for compliance dates contained in final rules published 
before the publication of a final rule in this proceeding. Therefore, 
all final FDA regulations published in the Federal Register before 
April 15, 1996, that have effective dates other than January 1, 1998, 
will still go into effect on the date stated in the respective final 
rule.
    Interested persons may, on or before July 1, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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 through Friday.

    Dated: April 10, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-9319 Filed 4-10-96; 5:08 pm]
BILLING CODE 4160-01-F