[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]
=======================================================================
-----------------------------------------------------------------------
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, 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
