[Federal Register Volume 65, Number 92 (Thursday, May 11, 2000)]
[Rules and Regulations]
[Pages 30352-30355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 25

[Docket No. 00N-0085]


National Environmental Policy Act; Food Contact Substance 
Notification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations on environmental impact considerations as part of the 
agency's implementation of the FDA Modernization Act (FDAMA) of 1997. 
FDAMA amended the Federal Food, Drug, and Cosmetic Act (the act) to 
establish a notification process for food contact substances (FCS); 
this process will be the primary method for authorizing new uses of 
food additives that are FCS, and it will largely replace the existing 
food additive petition process for such substances. The regulations 
will expand the existing categorical exclusions to include allowing a 
notification submitted under the act to become effective and will amend 
the list of those actions that require an environmental assessment (EA) 
to add allowing a notification under the act to become effective in 
cases where a categorical exclusion doesn't apply. This will allow 
notifiers of FCS to claim the categorical exclusions now available to 
sponsors of other requests for authorization of FCS. Elsewhere in this 
issue of the Federal Register, FDA is publishing a companion proposed 
rule, under FDA's usual procedures for notice and comment to provide a 
procedural framework to finalize the rule in the event the agency 
receives any significant adverse comment and withdraws the direct final 
rule.

DATES: This rule is effective August 24, 2000. Submit written comments 
by July 25, 2000. If FDA receives no significant adverse comments 
within the specified comment period, the agency intends to publish a 
document confirming the effective date of the final rule in the Federal 
Register within 30 days after the comment period on this direct final 
rule ends. If timely significant adverse comments are received, the 
agency will publish a document in the Federal Register withdrawing this 
direct final rule before its effective date.

ADDRESSES: Submit written comments on the direct final rule to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mitchell A. Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3083.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In 1958, Congress amended the act to require premarket approval of 
food additives (sections 201(s), 402(a)(2)(C), and 409 (21 U.S.C. 
321(s), 342(a)(2)(C), and 348)). ``Food additive'' is defined in 
section 201(s) of the act as ``any substance the intended use of which 
results or may reasonably be expected to result, directly or 
indirectly, in its becoming a component or otherwise affecting the 
characteristics of any food,'' unless, among other reasons, such 
substance is generally recognized as safe (GRAS) by qualified experts 
or is prior sanctioned for its intended use. Under section 409 of the 
act as originally established, food additives require premarket 
approval by FDA and publication of a regulation authorizing their 
intended use. Subsequently, in 1995, FDA codified a process, the 
``threshold of regulation'' process (21 CFR 170.39), by which certain 
food additives may be exempted from the requirement of a listing 
regulation if the

[[Page 30353]]

substance is expected to migrate to food at only negligible levels (60 
FR 36582, July 17, 1995).
    More recently, FDAMA amended section 409 of the act to establish a 
premarket notification (PMN) process as the primary method for 
authorizing new uses of food additives that are FCS. FDA expects most 
new uses of FCS that previously would have been regulated by issuance 
of a listing regulation in response to a food additive petition or 
would have been exempted from the requirement of a regulation under the 
threshold of regulation process will be the subject of PMN's.
    As part of the agency's process of implementing FDAMA's amendments 
to section 409 of the act, FDA convened a public meeting on March 12, 
1999, to provide interested parties with an opportunity to comment on 
FDA's current thinking on administration of the PMN process. As a 
result of the March 12, 1999, public meeting, FDA received comments on 
the applicability of the National Environmental Policy Act (NEPA) (42 
U.S.C. 4321 et seq. (1998)) to the notification process for food 
contact substances. FDA has considered those comments in developing 
this direct final rule and the companion proposed rule. FDA has filed 
copies of the transcript of the meeting and the comments received from 
interested parties with the Dockets Management Branch (address above) 
(Docket No. 99N-0235). The transcript and comments are available for 
public review at the Dockets Management Branch.

II. Analysis of the Applicability of NEPA to the Notification 
Process

    As part of implementing the FDAMA amendments on food contact 
substances, FDA has considered the applicability of NEPA to the PMN 
process. As discussed in more detail in this section, FDA has concluded 
that agency activities under section 409(h) of the act are subject to 
NEPA's procedural requirements. Furthermore, as also discussed in this 
section, FDA currently expects that most PMN's will be subject to a 
categorical exclusion. (See 40 CFR 1508.4; 21 CFR 25.30 and 25.32.)
    Congress enacted NEPA in 1969 to ensure that Federal Government 
agencies consider the environmental effects of proposed Federal 
actions. NEPA's purpose is to ensure that ``the Agency, in reaching its 
decision, will have available, and will carefully consider, detailed 
information concerning significant environmental impacts.'' (Robertson 
v. Methow Valley Citizens Council, 490 U.S. 332, 349 (1989).) NEPA 
requires agencies to ``include in every recommendation or report on 
proposals for legislation and other major federal actions significantly 
affecting the quality of the human environment, a detailed statement by 
the responsible official on * * * the environmental impact of the 
proposed action * * *. '' (See 42 U.S.C. 4332(2)(C).) Regulations 
implementing NEPA define ``major federal action'' as:

    * * * actions with effects that may be major and which are 
potentially subject to Federal control and responsibility. Major 
reinforces but does not have a meaning independent of significantly 
(40 CFR 1508.27). Actions include the circumstance where the 
responsible officials fail to act and that failure to act is 
reviewable by courts or administrative tribunals under the 
Administrative Procedure Act or other applicable law as Agency 
action (40 CFR 1508.18).

    FDA has concluded that under the NEPA implementing regulations, 
NEPA applies to FDA's decision not to object to a PMN. Under section 
409(h) of the act, if FDA does not object to an FCS notification within 
120 days of filing, the notification becomes effective and the 
substance may legally be marketed for the notified use. As discussed in 
more detail, under the relevant case law, FDA has concluded that this 
inaction constitutes final agency action under the Administrative 
Procedure Act (APA). As a final agency action, FDA's decision not to 
object is subject to NEPA's procedural requirements.
    Under the APA, unless otherwise provided by statute, only ``final 
Agency action'' is subject to judicial review (5 U.S.C. 704). The 
Supreme Court recently held that to meet the finality requirement, 
agency action ``must mark the consummation of the Agency's decision 
making process--it must not be of a merely tentative or interlocutory 
nature,'' and ``must be one by which rights or obligations have been 
determined, or from which legal consequences will flow.'' (Bennett v. 
Spear, 520 U.S. 154, 177 (1997).) Both conditions must be satisfied for 
agency action to be considered ``final.'' Id. Inaction under section 
409(h) of the act meets both parts of this test. First, the 
consummation requirement is met because, by operation of law, if FDA 
does not object, the agency can be considered to have reached its 
conclusion about the safety of the substance. Second, the determination 
of rights and obligations requirement is met because, under section 
409(h)(2)(A) of the act, the notifier may now market the FCS for the 
notified use in the United States. This authorization for marketing is 
a ``direct and appreciable'' legal consequence of the agency's decision 
not to object. Id. at 178.
    FDA currently believes that a notification for a food contact 
substance must contain either an EA or a claim of categorical 
exclusion. If the environmental component of a notification is missing 
or deficient under 21 CFR 25.40, the agency will not accept the 
notification for review. In cases where the agency does not accept a 
notification based on deficiencies in environmental information, FDA 
expects to inform the notifier in writing within 30 days of receipt of 
the submission.
    In adopting procedures to implement NEPA, Federal agencies are 
directed to reduce paperwork (40 CFR 1500.4 and 1500.2(b)) and to 
reduce delay (40 CFR 1500.5) by using several means, including the use 
of categorical exclusions. A categorical exclusion is a category of 
actions which do not individually or cumulatively have a significant 
effect on the human environment and for which neither an EA nor an 
Environmental Impact Statement (EIS) is required (40 CFR 1508.4).
    FDA has identified a number of categorical exclusions in its 
environmental regulations in part 25 (21 CFR part 25), including some 
specified uses of certain food packaging materials when approval is 
sought through the food additive petition process or exemption through 
the threshold of regulation process. For example, when the substance is 
a component of a coating of a finished food-packaging material or is 
present in such material at not greater than 5 percent-by-weight, and 
it is expected to remain with the finished food contact material 
through use by the consumer, neither an EA nor EIS is required to be 
submitted (Sec. 25.32(i)).
    This direct final rule amends Sec. 25.20(i) to add allowing a 
notification submitted under section 409(h) of the act to become 
effective to the list of those actions that require an EA. In addition 
this document will expand the existing categorical exclusions in 
Sec. 25.32(i), (j), (k), (q), and (r) to include allowing a 
notification submitted under section 409(h) of the act to become 
effective. Any existing categorical exclusions for food additive 
petitions or threshold of regulation exemption requests for such food 
contact materials could logically be extended to cover PMN's for such 
materials because the effects on the environment of allowing marketing 
of the substances--regardless of the process of authorization--are 
comparable in either case. Based on FDA's experience, the agency

[[Page 30354]]

anticipates that a majority of PMN's will be subject to a categorical 
exclusion.

III. Rulemaking Action

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
described when and how it will employ direct final rulemaking. FDA 
believes that this rule is appropriate for direct final rulemaking 
because FDA views this rule as making noncontroversial amendments to an 
existing regulation, and FDA anticipates no significant adverse 
comment. Consistent with FDA's procedures on direct final rulemaking, 
elsewhere in this issue of the Federal Register, FDA is publishing a 
companion proposed rule to amend the existing relevant regulations in 
part 25. The companion proposed rule is identical to the direct final 
rule. The companion proposed rule provides a procedural framework 
within which the rule may be finalized in the event that the direct 
final rule is withdrawn because of any significant adverse comment. The 
comment period for the direct final rule runs concurrently with the 
comment period of the companion proposed rule. Any comments received 
under the companion proposed rule will be considered as comments 
regarding the direct final rule.
    FDA is providing a comment period on the direct final rule of 75 
days after May 11, 2000. If the agency receives any significant adverse 
comments, FDA intends to withdraw this final rule by publication of a 
document in the Federal Register within 30 days after the comment 
period ends. A significant adverse comment is a comment that explains 
why the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or would be ineffective or unacceptable 
without change. In determining whether a significant adverse comment is 
sufficient to terminate a direct final rulemaking, FDA will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-comment process. Comments that are 
frivolous, insubstantial, or outside the scope of the rule will not be 
considered significant or adverse under this procedure. For example, a 
comment requesting an amendment of part 25 requirements for food 
additive petitions will not be considered a significant adverse comment 
because it is outside the scope of the direct final rule. On the other 
hand, a comment recommending an additional change to the rule may be 
considered a significant adverse comment if the comment explains why 
the rule would be ineffective without the additional change. In 
addition, if a significant adverse comment applies to an amendment, 
paragraph, or section of this rule and that provision can be severed 
from the remainder of the rule, FDA may adopt as final those provisions 
of the rule that are not the subject of a significant adverse comment.
    If FDA withdraws the direct final rule, all comments received will 
be considered under the companion proposed rule in developing a final 
rule under the usual notice-and-comment procedures of the APA (5 U.S.C. 
552 et seq.). If FDA receives no significant adverse comment during the 
specified comment period, FDA intends to publish a confirmation 
document in the Federal Register within 30 days after the comment 
period ends. Because the direct final rule grants an exemption from the 
requirement to file an EA, under 5 U.S.C. 553(d), the rule may be made 
immediately effective. Therefore, FDA intends to make the direct final 
rule effective on the date the confirmation document is published in 
the Federal Register.

IV. Analysis of Economic Impacts

A. Benefit-Cost Analysis

    FDA has examined the economic implications of this final rule under 
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 the regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; 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, adversely affecting a 
sector of the economy in a material way, adversely affecting 
competition, or adversely affecting jobs. A regulation is also 
considered significant if it raises novel legal or policy issues. FDA 
has determined that this final rule is not a significant regulatory 
action as defined by Executive Order 12866.
    The Unfunded Mandates Reform Act of 1995 (Public Law 104-4), 
requiring cost-benefit and other analyses, in section 1531(a) defines a 
significant rule as ``a Federal mandate that may result in the 
expenditure by State, local, and tribal governments in the aggregate, 
or by the private sector, of $100,000,000 (adjusted annually for 
inflation) in any 1 year.'' FDA has determined that this final rule 
does not constitute a significant rule under the Unfunded Mandates 
Reform Act.
    The Small Business Regulatory Enforcement Fairness Act of 1996 
(Public Law 104-121) defines a major rule for the purpose of 
congressional review as having caused or being likely to cause one or 
more of the following: An annual effect on the economy of $100 million; 
a major increase in costs or prices; significant effects on 
competition, employment, productivity, or innovation; or significant 
effects on the ability of U.S.-based enterprises to compete with 
foreign-based enterprises in domestic or export markets. In accordance 
with the Small Business Regulatory Enforcement Fairness Act, FDA has 
determined that this final rule is not a major rule for the purpose of 
congressional review.
    The final rule allows firms using the new notification process for 
food contact substances to claim the same categorical exclusions from 
the requirement of an EA that are currently applicable for food 
additive petitions and threshold of regulation exemption requests for 
the same uses. The rule therefore imposes no additional costs on 
producers or consumers.

B. Small Entity Analysis

    FDA has examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would lessen the economic effect on the rule on 
small entities. The agency certifies that this final rule will not have 
a significant impact on a substantial number of small entities.
    This final rule will permit notifiers under the new notification 
process for FCS to claim the same categorical exclusions from the 
requirement of an EA that are currently applicable for food additive 
petitions and threshold of regulation exemption requests for the same 
uses. The final rule will not result in any additional costs to any 
firm. Therefore, this final rule will not have a significant impact on 
a substantial number of small entities.

V. Paperwork Reduction Act of 1995

    This direct 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.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on

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the human environment. Therefore, neither an environmental assessment 
nor an environmental impact statement is required.

VII. Comments

    Interested persons may, on or before July 25, 2000, submit to the 
Dockets Management Branch (address above) written comments regarding 
this direct final rule. This comment period runs concurrently with the 
comment period for the companion proposed rule. Two copies of any 
comment 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday. All comments received will be considered comments 
regarding the proposed rule and this direct final rule. In the event 
the direct final rule is withdrawn, all comments received regarding the 
companion proposed rule and the direct final rule will be considered 
comments on the proposed rule.

VIII. Report to Congress

    For purposes of congressional review requirements under 5 U.S.C. 
801-808, the report to Congress for this direct final rule will be 
issued when FDA confirms the effective date of this rule. Thus, no 
report is due at this time. If, however, a significant adverse comment 
is received, the agency will withdraw this direct final rule and no 
report will be issued to Congress.

List of Subjects in 21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 25 is amended as follows:

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

    1. The authority citation for 21 CFR part 25 continues to read as 
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 
Comp., p. 356-360.


    2. Section 25.20 is amended by revising paragraph (i) to read as 
follows:


Sec. 25.20  Actions requiring preparation of an environmental 
assessment.

* * * * *
    (i) Approval of food additive petitions and color additive 
petitions, approval of requests for exemptions for investigational use 
of food additives, the granting of requests for exemption from 
regulation as a food additive under Sec. 170.39 of this chapter, and 
allowing notifications submitted under 21 U.S.C. 348(h) to become 
effective, unless categorically excluded in Sec. 25.32(b), (c), (i), 
(j), (k), (l), (o), (q), or (r).
* * * * *

    3. Section 25.32 is amended by revising paragraphs (i), (j), (k), 
(q), and (r) to read as follows:


Sec. 25.32  Foods, food additives, and color additives.

* * * * *
    (i) Approval of a food additive petition or GRAS affirmation 
petition, the granting of a request for exemption from regulation as a 
food additive under Sec. 170.39 of this chapter, or allowing a 
notification submitted under 21 U.S.C. 348(h) to become effective, when 
the substance is present in finished food-packaging material at not 
greater than 5 percent-by-weight and is expected to remain with 
finished food-packaging material through use by consumers or when the 
substance is a component of a coating of a finished food-packaging 
material.
    (j) Approval of a food additive petition or GRAS affirmation 
petition, the granting of a request for exemption from regulation as a 
food additive under Sec. 170.39 of this chapter, or allowing a 
notification submitted under 21 U.S.C. 348(h) to become effective, when 
the substance is to be used as a component of a food-contact surface of 
permanent or semipermanent equipment or of another food-contact article 
intended for repeated use.
    (k) Approval of a food additive petition, color additive petition, 
or GRAS affirmation petition, or allowing a notification submitted 
under 21 U.S.C. 348(h) to become effective, for substances added 
directly to food that are intended to remain in food through ingestion 
by consumers and that are not intended to replace macronutrients in 
food.
* * * * *
    (q) Approval of a food additive petition, the granting of a request 
for exemption from regulation as a food additive under Sec. 170.39 of 
this chapter, or allowing a notification submitted under 21 U.S.C. 
348(h) to become effective for a substance registered by the 
Environmental Protection Agency under FIFRA for the same use requested 
in the petition, request for exemption, or notification.
    (r) Approval of a food additive petition, color additive, GRAS 
affirmation petition, or allowing a notification submitted under 21 
U.S.C. 348(h) to become effective for a substance that occurs naturally 
in the environment, when the action does not alter significantly the 
concentration or distribution of the substance, its metabolites, or 
degradation products in the environment.

    Dated: January 24, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-11749 Filed 5-10-00; 8:45 am]
BILLING CODE 4160-01-F