[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Rules and Regulations]
[Pages 67710-67713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32552]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is establishing January 
1, 1998, as its new uniform compliance date for all food labeling 
regulations that are issued after the publication of this final rule 
and before January 1, 1997. 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). With the adoption and 
implementation of those regulations, FDA is reinstating its previous 
practice of periodically announcing, as final rules, uniform compliance 
dates for food labeling regulations.

EFFECTIVE DATE: December 24, 1996.

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: 

I. Background

    In the Federal Register of April 15, 1996 (61 FR 16422), FDA 
published a notice of proposed rulemaking entitled ``Uniform Compliance 
Date for Food Labeling Regulations'' (hereinafter referred to as the 
compliance date proposal) to establish a new uniform compliance date of 
January 1, 1998. FDA proposed that the new uniform compliance date 
would apply to all FDA regulations issued after publication of a final 
rule to the rulemaking and before December 31, 1996, that require 
changes in food labels or labeling, except where special circumstances 
require a different compliance date. The agency also proposed to 
reinstate its previous practice of periodically announcing uniform 
compliance dates for food labeling regulations by final rule. 
Interested persons were given until July 1, 1996, to comment.
    FDA received five letters, each containing one or more comments, 
from trade associations and other representatives of the food industry, 
in response to the compliance date proposal. All of the comments 
supported the proposal generally. Some comments suggested modifications 
or revisions of aspects of the compliance date proposal. A summary of 
these comments and the agency's responses are provided below.

II. Comments

A. Uniform Compliance Date

    1. Four comments opposed establishing January 1, 1998, as the next 
uniform compliance date on the grounds that it resulted in a 
``compliance period'' that at its shortest possible length would be 
only 12 months long. The comments used the term ``compliance period'' 
to refer to the time interval between the publication of a final rule 
and the uniform compliance date; e.g., a final rule that publishes on 
December 30, 1996, would have a ``compliance period'' of just over 12 
months before the January 1, 1998, uniform compliance date. Two of the 
comments suggested that the compliance period should be a minimum of 18 
months and applicable to products labeled on or after the compliance 
date. One of these comments stated that the 18-month period for the 
final rules implementing the 1990 amendments provided sufficient time 
for manufacturers to process the required label changes such that 
incremental costs were minimized.
    One of the comments stated that 2 years would be more appropriate 
if FDA insists on having the compliance date apply to the initial date 
of introduction of the food product into interstate commerce. This 
latter comment supported its arguments by including with its submission 
information on the costs of complying with the proposals to implement 
the 1990 amendments that it had developed and submitted as comments in 
response to FDA's ``Regulatory Impact Analysis of the Proposed Rules to 
Amend the Food Labeling Regulations,'' which published in the Federal 
Register of November 27, 1991 (56 FR 60856). The comment noted that the 
evidence submitted had persuaded FDA to establish a compliance period 
of 18 months for those regulations. The other two comments also 
suggested a 2-year compliance period. One of the comments argued that 1 
year does not provide manufacturers with sufficient time to manage and 
exhaust existing label inventories. The comment stated that it 
anticipated that most manufacturers would be forced to request an 
extension of the uniform compliance date if FDA's final rule provided 
only a 12-month compliance period.
    FDA disagrees with the comments. A compliance period that is 18 
months or 2 years at its shortest is too long.
    The agency points out that the comments are primarily concerned 
with the minimum time that a firm might face in bringing its labeling 
into compliance if a labeling final regulation were to publish at the 
end of a compliance period cycle, e.g., December 30, 1996. 
Manufacturers would have 1 year and 1 day to comply with the January 1, 
1998, effective date. It is this time period that the comments claim is 
inadequate.
    However, in establishing the uniform compliance date, FDA must 
consider the costs and benefits to both the food producer and the 
consumer. That is why

[[Page 67711]]

the agency did not choose a minimum compliance period of only 6 months. 
A compliance period of 6 months would increase the benefit to the 
consumer but would result in an even greater cost to the food producers 
than caused by a compliance period of 12 months. Although a lengthier 
compliance period would reduce the cost to food producers, it would 
delay implementation of the labeling changes thus decreasing the value 
of any benefits to the consumer.
    The agency points out that the minimum compliance period of 1 year 
is the same compliance period that it used for all of its uniform 
effective date final rules, dating back to the 1970's, until it issued 
the labeling regulations that implemented the 1990 amendments. The 
agency is unaware, nor has anyone submitted, any information to 
demonstrate any problems with respect to bringing labels into 
compliance with the various uniform effective dates that it had 
established over the period of approximately 20 years during which it 
had announced uniform compliance dates. While there were instances in 
which the agency granted extensions beyond the uniform compliance date, 
generally firms came into compliance with little complaint to the 
agency. The agency is merely, as it proposed, reinstating its former 
practice.
    The agency acknowledges that an 18-month compliance period was 
given for the labeling final rules implementing the 1990 amendments. 
However, the agency points out that additional time was necessary in 
that instance because of the extensive changes being made in the 
labeling requirements, the complicated nature of those changes, and the 
fact that the changes affected the entire food industry. Future food 
labeling regulations promulgated by FDA will not likely be as 
complicated or as comprehensive. If such a situation were to arise, the 
agency can and will adjust the compliance period to fit that particular 
situation.
    FDA recognizes that some manufacturers believe that a 12-month 
compliance period for a particular regulation might create an economic 
hardship. The agency points out that any final rule that it promulgates 
is preceded by a proposal setting forth the labeling changes the agency 
intends to require. The proposal, as a general rule, precedes the final 
rule by a year or more and, therefore, gives manufacturers more than 
ample notice that they should start thinking about how they will 
respond if the changes are finalized.
    Finally, the agency reiterates its statement in the proposal 
concerning its willingness to consider comments (to a particular 
labeling proposal) as to why a particular labeling regulation should 
not be subject to the uniform compliance date and modify the effective 
date for an individual regulation accordingly.

B. Applicability of Compliance Date

    2. One comment urged that FDA make clear in its final rule the 
basis for the uniform compliance date, i.e., whether the uniform 
compliance date would apply to products labeled on or after the 
compliance date or to products introduced into interstate commerce on 
or after the compliance date. The comment stated that, if the 
compliance date applied to products labeled on or after that date, 18 
months would be adequate as the minimum compliance period. If, however, 
the compliance date applies to the initial date of introduction of the 
product into interstate commerce, the comment recommended that FDA 
establish the uniform compliance date as being no shorter than 2 years 
after any such labeling regulations are published as final rules. The 
comment argued that 2 years would provide an adequate opportunity for 
many food processors, especially those who manufacture seasonal 
products, to exhaust remaining label and package inventories before 
they would be required to introduce products with new labels and 
packages into interstate commerce.
    The agency advises that the uniform compliance date will apply to 
food products initially introduced into interstate commerce on or after 
that date. FDA does not agree with the suggestion that the compliance 
date be tied to the date that products are labeled. The agency has for 
many years used the date of initial introduction into interstate 
commerce as the effective date for compliance with regulations because 
the Federal Food, Drug, and Cosmetic Act (the act) applies to products 
when they are introduced or delivered for introduction into interstate 
commerce. Using the date of initial introduction into interstate 
commerce is a more efficient enforcement approach because this date is 
easier for FDA to determine (e.g., from shipping documents) than the 
date the food was labeled (e.g., from manufacturers' records that are 
not necessarily available to the agency). An exception to this approach 
was in the case of the 1990 amendments that established the effective 
date as the date on which the label was applied to the food (see 
section 10(a)(2) of the 1990 amendments). However, there is no 
indication in the 1990 amendments or in their legislative history that 
Congress intended this exception to change the approach to effective 
dates for labeling changes that the agency has traditionally used.

C. Safe Harbors

    3. One comment, which stated that the compliance date should apply 
to the date the food product is packaged, requested that the agency 
provide ``safe harbors'' for companies to follow in determining when 
their products will have been considered to have been introduced into 
interstate commerce if the agency concludes that the uniform effective 
date should be applicable to the initial introduction of a food product 
into interstate commerce. The comment stated that doing so would 
provide companies some assistance in coordinating label changes and in 
minimizing their costs.
    FDA presumes that the comment concerning ``safe harbor'' is asking 
FDA to define what is meant by ``initial introduction into interstate 
commerce.'' In other words, the comment is asking FDA to advise what a 
firm has to do to initially introduce a product into interstate 
commerce before a new uniform compliance date so that the product would 
not be subject to the requirements that become effective on the new 
uniform compliance date. FDA is concerned that an attempt to provide a 
detailed discussion of all instances that are considered or are not 
considered to represent ``initial introduction into interstate 
commerce'' would be incomplete and, therefore, misleading. A clear 
understanding of this term is available from the act and the applicable 
case law. Thus, FDA is not defining ``initial introduction into 
interstate commerce'' in this final rule.

D. Harmonious Uniform Compliance Date for U.S. Department of 
Agriculture (USDA)-FDA Food Labeling Regulations

    4. One comment urged that FDA work with USDA-Food Safety and 
Inspection Service to establish a harmonious uniform compliance date 
for all food labeling regulations.
    FDA agrees to the extent both agencies are issuing regulations that 
will affect similar foods or address similar concerns, it would be best 
for FDA and USDA to have a consistent uniform compliance date. However, 
FDA does not agree that it is necessary as part of this rulemaking to 
``establish a harmonious uniform compliance date for all food labeling 
regulations'' issued by the two agencies. Where it is appropriate, FDA 
works with USDA to coordinate, to the extent possible, the issuance of 
food labeling regulations. For example, in issuing regulations on

[[Page 67712]]

the nutrition labeling of foods, FDA and USDA coordinated the 
publication of proposals and final rules, including consideration of 
the best approaches for each to use to address specific issues, such as 
the nutrition facts format and the wording of nutrient content claims. 
However, even then, because of differences between the two agencies and 
their authorities, there were slight differences in the effective dates 
for their respective final rules concerning nutrition labeling.
    Moreover, to establish harmonious compliance dates as suggested by 
the comment would require a separate rulemaking on the part of USDA, 
which would act to delay final action on this rulemaking. Therefore, 
FDA concludes that it is not necessary or appropriate at this time for 
FDA and USDA to establish a harmonious uniform compliance date for 
their labeling regulations. FDA notes that comments on future FDA or 
USDA proposals are free to urge consistent effective dates as they 
consider appropriate.

E. Establishment of Future Uniform Compliance Dates

    5. Three of the comments specifically supported the agency's 
returning to its practice of periodically establishing uniform 
compliance dates and doing so as final rules without providing an 
opportunity for public comment. No comments were opposed.
    Having received only favorable comments that it reinstate this 
practice, FDA is announcing that it will establish future uniform 
compliance dates for its food labeling regulations under the provisions 
of Sec. 10.40(e)(1) (21 CFR 10.40(e)(1)). Section 10.40(e)(1) does 
provide for the submission of comments to the final rule. FDA will 
publish before December 31, 1996, a final rule establishing the next 
uniform compliance date of January 1, 2000, for all final regulations 
published in the Federal Register between January 1, 1997, and December 
31, 1998. After that, every other year, FDA will publish additional 
final rules to establish subsequent uniform compliance dates.

III. Environmental Impact

    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.

IV. Analysis of Impacts

    FDA has examined the economic implications of this final rule as 
required by Executive Order 12866 and the Regulatory Flexibility Act (5 
U.S.C. 606-612). Executive Order 12866 directs Federal 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 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 significant impact on a 
substantial number of small entities, the Regulatory Flexibility Act 
requires agencies to analyze options that would minimize the impact of 
that rule on small entities.
    Four of the comments stated that a uniform compliance date that 
provided a minimum compliance period of 12 months would have a 
substantial financial impact on the food industry.
    This final rule will potentially reduce costs by providing a 
uniform compliance date that will provide firms with the opportunity to 
combine required label changes in one label redesign effort rather than 
potentially suffering from sequential, duplicative efforts. Alternative 
approaches that FDA considered included 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 date 
but 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.
    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. Because the establishment of a uniform compliance date 
imposes neither costs nor benefits, the agency certifies that the final 
rule is not a significant rule as defined by Executive Order 12866, and 
finds under the Regulatory Flexibility Act that the final rule will not 
have a significant economic impact on a substantial number of small 
entities. Similarly, FDA has determined that this rule is not a major 
rule for the purpose of Congressional review (Pub. L. 104-121).

V. Conclusion

    Having considered all comments to the proposal on this matter, the 
agency has decided that a new uniform compliance date of January 1, 
1998, should be established for future FDA regulations requiring 
changes in food labels where special circumstances do not justify a 
different compliance date. The agency has selected January 1, 1998, to 
ensure adequate time for implementation of the pending changes in food 
labeling.
    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 new uniform compliance date will apply only to final FDA food 
labeling regulations published before January 1, 1997. Those 
regulations will specifically identify January 1, 1998, as their 
compliance date. If any food labeling regulation involves special 
circumstances that justify a compliance date other than January 1, 
1998, the agency will determine for that regulation an appropriate 
compliance date that will be specified when the regulation is 
published.
     This final rule is not intended to change existing requirements 
for compliance dates that have been set in final rules. Therefore, all 
final FDA regulations that have published in the Federal Register but 
that are not yet effective and that have effective dates other than 
January 1, 1998, will still go into effect on the date stated in the 
respective final rule.
    FDA is making this document effective upon publication because of 
the short time to January 1, 1997.
     In the absence of comments to the contrary and following 
publication of this final rule, FDA will 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 will 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. Subsequently, on or before December 31, 1998, FDA will issue 
a final rule establishing January 1, 2002, as the uniform compliance 
date for regulations published in the Federal

[[Page 67713]]

Register between January 1, 1999, and December 31, 2000.

    Dated: December 13, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-32552 Filed 12-23-96; 8:45 am]
BILLING CODE 4160-01-F