[Federal Register Volume 65, Number 92 (Thursday, May 11, 2000)]
[Proposed Rules]
[Pages 30366-30369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11750]


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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; Companion to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
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. This proposed rule 
is a companion document to the direct final rule

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published elsewhere in this issue of the Federal Register.

DATES: Submit written comments on this proposed rule by July 25, 2000. 
If FDA receives no significant adverse comment on the provisions of 
these regulations 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 in the direct final rule ends. The direct final rule will be 
effective August 24, 2000.

ADDRESSES: Submit written comments on this companion proposed 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

A. Rulemaking

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. The direct final rule and this companion proposed rule are 
substantively identical. FDA is publishing the direct final rule 
because the rule contains noncontroversial changes, and FDA anticipates 
that it will receive no significant adverse comments. If no significant 
adverse comment is received in response to the direct final rule, no 
further action will be taken related to this proposed rule. Instead, 
FDA will publish a confirmation document within 30 days after the 
comment period ends confirming that the direct final rule will go into 
effect on August 24, 2000. Additional information about FDA's direct 
final rulemaking procedures is set forth in a guidance published in the 
Federal Register of November 21, 1997 (62 FR 62466).
    The comment period for this companion proposed rule runs 
concurrently with the direct final rule's comment period. Any comments 
received under this companion proposed rule will also be considered as 
comments regarding the direct final rule. If FDA receives any 
significant adverse comment regarding either this proposed rule or the 
direct final rule, FDA will publish a document withdrawing the direct 
final rule within 30 days after the comment period ends and will 
proceed to respond to all of the comments under this companion proposed 
rule using customary notice-and-comment procedures. 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 a 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 
adverse under this procedure. For example, a comment recommending a 
rule change in addition to the rule will not be considered a 
significant adverse comment, unless the comment states 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.

B. Background

    In 1958, Congress amended the act to require premarket approval of 
food additives (sections 201(s), 402(a)(2)(C), and 409 of the act (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 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 
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 the 
direct final rule and this 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 below, FDA has concluded that 
agency activities under section 409(h) of the act are subject to NEPA's 
procedural requirements. Furthermore, as also discussed below, FDA 
currently expects that most PMN's will be subject to a categorical 
exclusion (see 40 CFR 1508.4; Secs. 25.30 and 25.32 (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

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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 below, 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 that 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 
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 companion proposed rule proposes to amend 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 
anticipates that a majority of PMN's will be subject to a categorical 
exclusion.

III. Analysis of Economic impacts

A. Benefit-Cost Analysis

    FDA has examined the economic implications of this companion 
proposed 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 companion proposed 
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 million (adjusted annually for 
inflation) in any 1 year.'' FDA has determined that this companion 
proposed 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 companion proposed rule is not a major rule for 
the purpose of congressional review.
    The companion proposed 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

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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 companion 
proposed 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 
companion proposed rule will not have a significant impact on a 
substantial number of small entities.
    This companion proposed 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 proposed rule will not result in any additional 
costs to any firm. Therefore, this proposed rule will not have a 
significant impact on a substantial number of small entities.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this companion proposed rule 
contains no collection of information. Therefore, clearance by the 
Office of Management and Budget under the Paperwork Reduction Act of 
1995 is not required.

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

VI. Comments

    Interested persons may, by July 24, 2000, submit to the Dockets 
Management Branch (address above) written comments regarding this 
proposal. This comment period runs concurrently with the comment period 
for the direct final 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 
received comments will be considered as comments regarding the direct 
final rule and this proposed rule. In the event the direct final rule 
is withdrawn, all comments received will be considered comments on this 
proposed rule.

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, it is 
proposed that 21 CFR part 25 be 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 an 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. 00-11750 Filed 5-10-00; 8:45 am]
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