[Federal Register Volume 67, Number 98 (Tuesday, May 21, 2002)]
[Rules and Regulations]
[Pages 35724-35731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 58, 170, 171, 174, and 179

[Docket No. 99N-5556]
RIN 0910-AB94


Food Additives: Food Contact Substance Notification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations regarding the premarket notification process for 
food contact substances (FCSs) established by the Food and Drug 
Administration Modernization Act (FDAMA) of 1997. The notification 
process is the primary method for authorizing new uses of food 
additives that are FCSs. FDA is codifying regulations that identify the 
circumstances under which a food additive petition (FAP) will be 
required to authorize the use of an FCS; specify the information 
required in a notification for an FCS; describe the administration of 
the notification process; and establish the procedure by which the 
agency may deem a notification to be no longer effective.

DATES: This rule is effective June 20, 2002.

FOR FURTHER INFORMATION CONTACT: Mitchell A. Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-205), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
202-418-3083.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1997, FDAMA amended section 409 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C 348) to establish a premarket 
notification process as the primary method for authorizing new uses of 
food additives that are FCSs. In the proposed rule, published in the 
Federal Register of July 13, 2000 (65 FR 43269) (hereinafter referred 
to as the July 2000 proposal), FDA referred to a premarket notification 
for a food contact substance as a "PMN" and the process of 
premarket notification for such substances as the "PMN 
process." This document refers to a premarket notification for a 
food contact substance as an "FCN" and to the process as 
the food contact notification (FCN) process. This change responds to a 
request from the comments (see section II.H of this document). A 
"food contact substance" is defined in section 409(h)(6) of 
the act as "any substance intended for use as a component of 
materials used in manufacturing, packing, packaging, transporting, or 
holding food if such use is not intended to have any technical effect 
in such food." The FDAMA amendments and their legislative history 
make clear that the FCN process is to be the preferred process for 
authorizing new uses of food additives that are FCSs. Specifically, 
section 409(h)(3)(A) of the act states that the FCN process shall be 
utilized for authorizing the marketing of food additives that are FCSs 
except where the Secretary of Health and Human Services determines that 
the submission and review of a FAP is necessary to provide adequate 
assurance of safety, or where FDA and any manufacturer or supplier 
agree that a petition may be submitted. (See S. Rept. No. 105-43, 
105th Cong., 1st sess. 46 (1997); H. Rept. 105-306, 105th Cong., 
1st sess. 19 (1997).) FDA expects most new uses of FCSs that previously 
would have been regulated by issuance of a listing regulation in 
response to an FAP or would have been exempted from the requirement of 
a regulation under the threshold of regulation (TOR) process (21 CFR 
170.39) will be the subject of FCNs.
    The FCN program began operating on October 22, 1999, with the 
signing of FDA's Fiscal Year 2000 budget. This budget met the 
requirements under section 409(h)(5) of the act for funding the FCN 
program. On October 25, 1999, FDA sent letters to trade associations 
and persons with pending submissions (i.e., a food additive petition or 
a TOR exemption request) under active review by the agency to authorize 
use of an FCS. The letter stated that FDA expected to be ready to 
accept new FCNs on January 18, 2000, and requested that those persons 
with a pending submission for approval of an FCS under active review 
contact FDA prior to withdrawing such submission and converting it to 
an FCN. After October 25, 1999, FDA began working with the food 
packaging industry to convert these pending submissions under FDA 
review to FCNs.\1\
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    \1\Between October 25, 1999, and December 31, 2000, FDA and 
industry converted 58 FAPs and 19 TOR submissions to FCNs. FDA 
currently lists those FCNs that have become effective on its 
Internet site at http://www.cfsan.fda.gov/ï¿½7Edms/opa-fcn.html.
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    In the Federal Register of November 12, 1999 (64 FR 61648), FDA 
published a notice announcing the availability of a draft guidance on 
the chemistry and toxicology information that should be included in an 
FCN. In the November 12, 1999, notice FDA requested comments on the 
guidance documents and on the information collection burden associated 
with the FCN program.
    In addition, FDA published a direct final rule in the Federal 
Register of May 11, 2000 (65 FR 30352), that amended the agency's 
regulations on environmental impact considerations to permit 
manufacturers or suppliers to claim in FCNs the categorical exclusions 
currently applicable to FAPs and TOR exemption requests. The 
regulations in the May 11, 2000, direct final rule became effective on 
August 24, 2000.
    Finally, in the July 2000 proposal (65 FR 43377), the agency 
proposed regulations to implement the FCN process and announced the 
availability of an administrative guidance document concerning the FCN 
process.

II. Comments on the Proposed Rule

    The agency provided 75 days for comment on the proposed rule. FDA 
received comments from three trade associations representing the food 
packaging industry. In general, the comments supported the proposal. 
They also raised issues specific to the draft administrative guidance 
document announced with the proposed rule in the July 13, 2000, issue 
of the Federal Register (65 FR 43377) and the draft chemistry and 
toxicology guidance documents announced in the Federal Register of 
November 12, 1999 (64 FR 61648 ). In accordance with FDA's good 
guidance practice (GGP) regulations (21 CFR 10.115), such comments have 
been addressed by modification of the final toxicology and chemistry 
guidance documents announced in the Federal Register of April 11, 2002 
(67 FR 17703), and in FDA's revised

[[Page 35725]]

administrative guidance document, the availability of which is 
published elsewhere in this issue of the Federal Register. Comments 
also requested that FDA clarify several specific issues in the 
proposal. These issues and FDA's responses follow.
    (Comment 1) Two of the comments were concerned with the language in 
proposed  170.104(b) describing FDA's initial review 
of an FCN submission. Proposed  170.104(b) reads: "In 
order for the 120-day review period to begin FDA must accept that 
notification." The comments expressed the opinion that the 
language in proposed  170.104(b) could be read to mean that 
the 120-day review period for the FCN does not begin until after FDA 
"accepts" the submission as an FCN. These comments 
referenced the language in section 409(h)(2)(A) of the act that states 
that a "* * *  notification submitted under 
paragraph (1) shall become effective 120 days after the date of receipt 
by the Secretary * * *."
    FDA agrees with these comments that the 120-day review period for 
the FCN runs from the date of receipt of a complete notification. The 
purpose of  170.104(b) is to provide FDA with an 
opportunity to determine whether the submission is a complete 
notification and to ensure that FDA would not be required to review or 
object to an incomplete FCN. The following are examples of how 
FDA's initial review of FCN submissions has operated thus far and 
how FDA expects its initial review of FCNs to proceed in the future. 
FDA expects to determine whether an FCN is complete and reviewable 
within 30 days after receipt of a submission. If FDA finds that an FCN 
is complete and reviewable as received, then FDA will accept the FCN 
and the 120-day review period will continue to run from the date of 
receipt of the FCN. However, if FDA determines that, as submitted, an 
FCN is incomplete, the agency will request additional information from 
the manufacturer or supplier. If the information is submitted before 
FDA issues a nonacceptance letter, FDA will accept the now complete 
FCN, and the 120-day review period begins on the date of receipt of the 
additional information. If the required additional information is not 
submitted, and the FCN is not withdrawn, FDA will issue a nonacceptance 
letter. Issuance of the nonacceptance letter will complete the review 
of the FCN submission.
    In any case, the date of receipt of the complete FCN is the date of 
receipt for the purposes of section 409(h)(2) of the act. FDA is 
revising the language in  170.104(b) to clarify that the 
120-day review period begins on the date of receipt of a complete FCN 
and not on the date the FCN is accepted.
    (Comment 2) All three comments requested that FDA clarify that the 
requirements in proposed  170.101(c) regarding compliance 
with FDA's good laboratory practice regulations in part 58 (21 
CFR part 58) do not apply to analytical testing (e.g., migration 
testing). The comments noted that analytical testing had not been 
previously required to comply with part 58. One comment requested that 
FDA make this clarification by explicitly referencing the definition of 
nonclinical laboratory studies in  58.3.
    FDA agrees that, historically, it has not applied its good 
laboratory practice regulations to analytical testing such as migration 
testing. Therefore, FDA is revising  170.101(c) to 
explicitly reference the definition of nonclinical laboratory studies 
in  58.3(d).
    (Comment 3) All three comments requested that FDA make it clear 
that FCNs are required only for FCSs that are food additives. The 
comments referenced a statement in the preamble of the July 2000 
proposal (65 FR 43269 at 43274) that reads as follows 
"* * * Under section 409(a) of the act, in the 
absence of an effective notification an FCS cannot be legally 
marketed." One of the comments requested that FDA revise the 
referenced language to read as follows: "Under section 409(a) of 
the act, in the absence of an effective notification, an FCS that is a 
food additive cannot be legally marketed."
    FDA agrees with the comments that FCNs are required only for those 
FCSs that are food additives as defined by section 201(s) of the act 
(21 U.S.C. 321(s)). FDA intended the referenced statement to clarify 
that in cases where FDA objects to an FCN, the FCN cannot become 
effective. Because the language referred to was not in the codified 
portion of the proposed regulation, the agency is taking no further 
action in response to these comments.
    FDA also believes, however, that the language suggested by one 
comment is misleading because it implies that FCSs are authorized only 
through the FCN process. Although the FCN process is the primary means 
for authorizing new uses of FCSs, some new uses of FCSs still will be 
authorized through the petition process in section 409(b) of the act.
    (Comment 4) All three comments requested that FDA clarify the 
relationship of FDA Form 3480 to the recommendations in the 
agency's draft guidance documents for FCNs. The comment noted 
that adopting  170.101(e), as proposed, would require that 
a completed and signed FDA Form 3480 be included in an FCN. FDA Form 
3480 requires that manufacturers or suppliers list summary toxicology 
information on the FCS and its constituents. In addition, the comments 
noted, the draft guidance on toxicology information in an FCN advises 
that notifiers (i.e., manufacturers and suppliers) should provide a 
comprehensive toxicological profile for the FCS and its constituents. 
The comments expressed uncertainty about the level of detail required 
in FDA Form 3480. The comments noted that the draft toxicology guidance 
document appeared to request that some of the same information be 
included in both the comprehensive toxicology profile and the safety 
narrative, as is required in FDA Form 3480. Thus, a notifier might have 
to list the same information in two sections of a notification.
    FDA has revised FDA Form 3480 (Ref. 1) to minimize duplication of 
effort in developing the toxicology package for FCNs. FDA also has 
revised its guidance documents to assist manufacturers and suppliers in 
completing FDA Form 3480. Published elsewhere in this issue of the 
Federal Register, FDA is announcing the availability of administrative, 
chemistry, and toxicology guidance documents.
    (Comment 5) One comment requested that FDA make mandatory the 
issuance by the agency of a final letter for FCNs that become 
effective. The comment argued that the listing of notifications in 
FDA's inventory of effective notifications on the agency's 
Internet site may not be adequate to inform interested persons 
regarding the status of an FCN. In addition, the comment contended that 
listing of notifications on FDA's Internet site may not be 
completed in a timely manner.
    FDA disagrees with this comment. The statute does not require FDA 
to issue a letter at the conclusion of the review of an FCN. Indeed, no 
action is required by FDA for an FCN to become effective. FDA believes 
that issuance of final letters for effective FCNs has some value, but 
FDA is concerned that the issuance of such letters may consume limited 
resources that are necessary to complete a timely review of FCNs. 
Therefore, FDA is denying the request to require the agency to issue a 
final letter for effective notifications. However, as noted above, FDA 
has been reviewing FCNs since the program began operating and, since 
that time, FDA has consistently issued final letters and listed 
effective notifications on its Internet site in a timely manner. 
Accordingly, FDA expects to continue to issue final letters as long as 
the

[[Page 35726]]

resources necessary to do so do not prevent timely review of FCNs.
    (Comment 6) One comment requested that FDA provide an opportunity 
for a company to notify the agency of any change in name or corporate 
structure subsequent to its filing of an FCN. The comment also 
requested that FDA establish a procedure whereby FDA would change the 
name of the manufacturer in the listing of the FCN on FDA's 
Internet site and reissue the final letter for the FCN with the new 
company's name.
    The agency agrees in part with this comment. Under 
 170.100(d), manufacturers or suppliers are required to 
keep on file with FDA an address at which FDA may contact the 
manufacturer or supplier regarding the notification. FDA already had 
one experience with the sale of the manufacturing unit of a notified 
FCS from one company to another. In that case, the original 
manufacturer verified the sale and FDA changed the name of the 
manufacturer in the listing for the FCN on the agency's Internet 
site. FDA did not, however, reissue the final letter. FDA believes that 
reissuing final letters would be an ineffective use of its limited 
resources. Therefore, FDA will not reissue an updated final letter when 
the manufacturer or supplier of the FCN changes. FDA has included 
guidance on the above procedure in "Preparation of Premarket 
Notifications for Food Contact Substances: Administrative 
Recommendations," the availability of which is announced 
elsewhere in this issue of the Federal Register.
    FDA also is revising the language in all the regulations to replace 
the word "notifier" with the words "manufacturer or 
supplier." FDA believes "manufacturer or supplier" is 
more appropriate because it is the term used in section 409(h) of the 
act.
    (Comment 7) One comment requested that FDA clarify its position on 
the issue of transferability of FCNs. Specifically, the comment 
requests that FDA establish regulations to permit a manufacturer 
identified in an effective FCN to transfer the rights granted under an 
effective notification. The comment contended that licensing the 
manufacture of an FCS would maintain the safety of the FCS because it 
would continue to be manufactured in the manner reviewed by the agency.
    At the time of the proposal, FDA did not contemplate regulations to 
permit a subsequent manufacturer other than the manufacturer identified 
in the FCN to produce and market the FCS under that FCN and did not 
discuss such regulations in the proposed rule. Thus, FDA believes that 
the issues raised in this comment are outside the scope of the 
proposal. Currently, FDA requires any subsequent manufacturer who 
wishes to market an FCS for a use that is the subject of an already 
effective FCN to submit a notification to FDA. In addition, the 
manufacturer identified in an effective FCN may authorize other 
manufacturers to reference information contained in the effective FCN. 
Thus, other manufacturers may have to provide only limited additional 
information in subsequent FCNs but they must notify FDA separately and 
wait 120 days for their FCN to become effective. However, FDA is 
interested in hearing the views of other interested parties on this 
issue. Therefore, elsewhere in this issue of the Federal Register, FDA 
is publishing an advanced notice of proposed rulemaking requesting 
comments on the issue of transferability of FCNs.
    (Comment 8) All three comments requested FDA to replace the 
abbreviation "PMN" with "FCN" to represent a 
premarket notification for a food contact substance (also called a Food 
Contact Notification). The comments argued that this change will avoid 
confusing a premarket notification for a food contact substance with a 
"PMN" submitted to the U.S. Environmental Protection Agency 
(EPA).
    FDA already made this change in the operation of the FCN program, 
throughout this document, and where appropriate in the codified 
regulations. FDA also made other nonsubstantive editorial changes in 
the regulations.
    (Comment 9) In  170.100(a)(2), FDA is replacing the 
word "should" with "must." FDA is making this 
change to be consistent with the description of the provision in the 
proposed rule. In the preamble of the proposed rule, the agency stated 
that it would permit a manufacturer or supplier to incorporate by 
reference information in FDA's files where the submitter of the 
information has given the notifier permission to reference the 
information (65 FR 43269 at 43271). Requiring the manufacturer or 
supplier to establish that it has permission to incorporate certain 
information by reference also is consistent with standard FDA practice 
on incorporation by reference. (See 21 CFR 171.1(f); 21 CFR 314.420(d); 
21 CFR 571.1(f); 21 CFR 814.20(c).)

III. Summary and Conclusions

    The comments received in response to the July 2000 proposal 
requested changes to the proposed language in 
 170.101(c) and 170.104(b). In addition, FDA is 
revising certain language throughout the proposed regulations. Because 
no comments were received relating to the remaining regulations 
included in the July 2000 proposal, FDA is finalizing those regulations 
as proposed with only minor editorial changes. Listed below are the 
revisions that are being incorporated into this final rule, based on 
the comments received in response to the proposal:
    1. FDA is replacing the term "notifier" with the term 
"manufacturer or supplier" throughout the regulations to 
correspond with the language in section 409(h) of the act.
    2. FDA is revising the language in  170.101(c) to 
reference the definition of nonclinical laboratory studies in 
 58.3(d) to clarify that 170.101(c) does not apply to 
analytical testing to determine the functionality or to determine 
physical or chemical characteristics of the test article.
    3. FDA is revising the language in  170.104(b) to 
clarify that the 120-day review period for an FCN begins on the date 
FDA receives the complete FCN. Thus, where FDA receives an incomplete 
FCN, the 120-day review period begins when FDA receives the missing 
information.
    4. FDA is replacing the acronym "PMN" with 
"FCN" to refer to a premarket notification for a food 
contact substance (also known as a Food Contact Notification). FDA is 
using the acronym FCN throughout this document and in the codified 
regulations.
    5. In  170.100(a)(2) FDA is replacing the word 
"should" with "must."

IV. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown below with an estimate of the annual 
reporting burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Food Contact Substances Notification System.
    Description: Section 409(h) of the act establishes a premarket 
notification process for FCSs. Section 409(h)(6) of the act defines a 
"food contact substance" as "any substance intended 
for use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical

[[Page 35727]]

effect in such food." Section 409(h)(3) of the act requires that 
the notification process be used for authorizing the marketing of FCSs 
except where FDA determines that the submission and premarket review of 
an FAP under section 409(b) of the act is necessary to provide adequate 
assurance of safety or where FDA and the manufacturer or supplier agree 
that a petition should be submitted. Section 409(h)(1) of the act 
requires that a notification include information on the identity and 
the intended use of the FCS and the basis for the manufacturer's 
or supplier's determination that the FCS is safe under the 
intended conditions of use. Because section 409(h)(1) of the act 
references the general safety standard for food additives, the data in 
an FCN should be comparable to the data in an FAP. FDA is issuing 
regulations necessary to implement the FCN program that will largely 
replace the FAP process for those food additives that are FCSs.
    Also, FDA is requiring that an FCN include FDA Form 3480 entitled 
"Notification for New Use of a Food Contact Substance" 
(Ref. 1) and is requiring that a notification for a food contact 
substance formulation (NFCSF) include FDA Form 3479 entitled 
"Notification for a Food Contact Substance Formulation" 
(Ref. 2). These forms will serve to summarize pertinent information in 
the notification. FDA made Form 3480 available for public comment in 
the November 12, 1999 (64 FR 61648 at 61649), notice and Form 3479 
available for public comment in the July 2000 proposal (65 FR 43269 at 
43277). FDA believes that these forms will facilitate both preparation 
and review of notifications because the forms will serve to organize 
information necessary to support the safety of the use of the FCS. The 
burden of filling out the appropriate form has been included in the 
burden estimate for the notification.
    Description of Respondents: Manufacturers of food contact 
substances.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1.-Estimated Annual Reporting Burden\1\
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                                                                                 Annual Frequency
       21 CFR Section                     Form                    No. of             per        Total Annual       Hours per        Total Hours
                                                             Respondents      Response   Responses  Response
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170.106\2\                    FDA 3479                            200                   4                800                 2              1,600
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170.101\3,\\7\                FDA 3480                            200                   1                200                25              5,000
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170.101\4,\\7\                FDA 3480                             55                   2                110               120             13,200
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170.101\5,\\7\                FDA 3480                             45                   2                 90               150             13,500
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107.101\6,\\7\                FDA 3480                             16                   1                 16               150              2,400
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  Total                                                                                                           35,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Notifications for a food contact substance formulation. These notifications require only FDA Form 3479 ("Notification for a Food Contact
  Substance Formulation") to be filled out and documentation attached.
\3\ Duplicate notifications for uses of FCSs.
\4\ Notifications for uses that currently would be the subject of exemptions under 21 CFR 170.39 or very simple FAPs.
\5\ Notifications for uses that currently would be the subject of moderately complex FAPs.
\6\ Notifications for uses that currently would be the subject of more complex FAPs.
\7\ These notifications require the submission of FDA Form 3480 ("Notification for New Use of a Food Contact Substance").

    The above estimate is based on the types of submissions that FDA 
currently receives for food contact substances in the TOR and the FAP 
processes and the following assumptions and information:
    ï¿½ FDA estimates that the likely increase in FCNs over the 
number of FAPs and TOR requests will be approximately four times the 
highest recent annual influx of these submissions (50 and 54, 
respectively). This factor is based on an analysis of the number of 
companies producing various types of FCSs and the types of FCSs for 
which FAPs and TORs most commonly are submitted to FDA.
    ï¿½ Based on input from industry sources, FDA estimates that 
the agency will receive approximately 800 notifications annually for 
food contact substance formulations.
    ï¿½ FDA also has included 200 expected duplicate submissions in 
the second lowest tier. FDA expects that the burden for preparing these 
notifications primarily will consist of the manufacturer or supplier 
filling out FDA Form 3480, verifying that a previous notification is 
effective, and preparing necessary documentation.
    ï¿½ Based on the amount of data typically submitted in FAPs and 
TOR requests, FDA identified three other tiers of FCNs that represent 
escalating levels of burden required to collect information.
    ï¿½ FDA estimated the median number of hours necessary for 
collecting information for each type of notification within each of the 
three tiers based on input from industry sources.
    In the July 2000 proposal (65 FR 43269 at 43276), the agency 
requested comments on the proposed collection of information. On 
October 3, 2000, OMB filed comment on the information collection 
provisions, assigning OMB control number 0910-0447. OMB's 
comments stated that, "FDA shall evaluate the contents of this 
collection in light of any comments received regarding the information 
collection requirements contained in the rule. In addition, FDA shall 
address any issues related to reducing duplication between FDA and EPA 
related to this collection."
    FDA received no comments on the information collection requirements 
in the proposed rule. FDA continues to work with EPA and the U.S. 
Department of Agriculture (USDA) to eliminate areas of duplicative data 
collection and evaluation. Within the past 2 years USDA has eliminated 
its separate approval process for components of food contact materials 
that duplicated FDA's process. In addition, the Food Quality 
Protection Act of 1996 gave sole jurisdiction to EPA for certain 
substances formerly regulated by FDA as food additives and by EPA as 
pesticide chemicals. Currently, there is no significant duplication of 
data collection and evaluation for food contact substances among 
Federal agencies with jurisdiction. In addition, to avoid unnecessary 
duplication for

[[Page 35728]]

individual submissions, existing data will be used whenever possible by 
FDA in evaluating notifications for food contact substances.
    FDA submitted the information collection provisions of this final 
rule to OMB for review. Prior to the effective date of this final rule, 
FDA will publish a notice in the Federal Register announcing 
OMB's decision to approve, modify, or disapprove the information 
collection provisions in this final rule. An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

V. Analysis of Impacts

A. Final Regulatory Impact Analysis

    FDA has examined the economic implications of this final rule as 
required by 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 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 also is considered a significant regulatory action if it 
raises novel legal or policy issues. OMB determined that this final 
rule is a significant regulatory action as defined by Executive Order 
12866. Accordingly, OMB has reviewed this final rule and has approved 
its publication in the Federal Register.
    There were no comments that pertained directly or indirectly to the 
preliminary regulatory impact analysis (PRIA) so FDA has made no change 
in the evaluation of the regulation for the final regulatory impact 
analysis. The rulemaking was necessary to implement the FCN process 
established by FDAMA. The notification process largely will replace the 
FAP process for FCSs. The FCN process requires FDA to object within 120 
days to the notification of an FCS manufacturer or supplier that it 
intends to market a particular food contact substance for a specific 
use, or the substance may be marketed legally on the 121st day without 
issuance of a regulation.
    FDA estimates that the social benefits of the change in regime will 
be from new product innovation. The agency estimates that four times 
the current annual number of petitions and threshold of regulation 
exemptions will be introduced into the market, for a total of 416. The 
social costs from the change in regimes are the costs to submit 
duplicate notifications. The agency estimates that 50 percent of the 
total will be duplicates for a total social cost of $26,387,500. For a 
full explanation of the estimated costs and benefits of this final 
rule, see the preliminary regulatory impact assessment published in the 
July 2000 proposal (65 FR 43269 at 43277), which is incorporated by 
reference.

B. Final Regulatory Flexibility Analysis

1. Introduction
    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 of the 
rule on small entities.
2. Economic Effects on Small Entities
    There were no comments that pertained directly or indirectly to the 
initial regulatory flexibility analysis so FDA made no change in the 
evaluation of the regulation for the final regulatory flexibility 
analysis. The final rule could affect small businesses because new 
costs will be imposed that did not exist before the change in regimes. 
A small firm that wants to introduce a new FCS will have to produce 
more documentation after the final rule than before. However, because 
the final rule reduces the uncertainty about the period of evaluation 
of new uses of substances, firms that rely heavily on the authorization 
of a unique use of a substance stand to benefit the most. Because new 
small businesses may rely on innovation that requires new use 
authorization, they are more likely to benefit the most from the final 
rule. However, they also may incur proportionately greater costs than 
if they would have relied on rival firms to incur the authorization 
costs.
3. Regulatory Relief
    Because some small firms are expected to be adversely affected by 
the final rule, options for regulatory relief, such as a small business 
exemption, were addressed in the proposed rule. The benefit of this 
option is that small businesses would not incur an additional cost. The 
drawback is that small firms could copy and distribute themselves the 
substances being reviewed in response to the marketing submission of a 
competitor, thus, creating disincentives for new substance development 
by rival firms.
4. Description of Recordkeeping and Reporting
    There are no additional recordkeeping requirements for the final 
rule.
5. Summary
    FDA estimates that there will be no net costs to small businesses 
because of this final rule. If small business entities determine that 
the costs of notification outweigh the benefits, the small business 
entities could rely on existing authorized FCSs.

C. Unfunded Mandates

    Section 1531(a) of the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4), 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 one year. FDA has determined that this 
rule does not constitute a significant rule under the Unfunded Mandates 
Reform Act of 1995.

VI. Environmental Impact

    The agency previously reviewed the potential environmental effects 
of this final rule as announced in the July 2000 proposal (65 FR 
43269). The agency concluded 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.

VII. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. FDA Form No. 3480 "Notification for a New Use of A Food 
Contact Substance," Rev. 9/01.
    2. FDA Form No. 3479 "Notification for a Food Contact 
Substance Formulation," Rev. 5/00.

[[Page 35729]]

List of Subjects

21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.

21 CFR Part 58

    Laboratories, Reporting and recordkeeping requirements.

21 CFR Part 170

    Administrative practice and procedure, Food additives, Reporting 
and recordkeeping requirements.

21 CFR Part 171

    Administrative practice and procedure, Food additives.

21 CFR Part 174

    Food additives, Food packaging.

21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
20, 58, 170, 171, 174, and 179 are amended as follows:

PART 20-PUBLIC INFORMATION

    1. The authority citation for 21 CFR part 20 continues to read as 
follows:

    Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 
2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 
241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 
265, 300u-300u-5, 300aa-1.

    2. Section 20.100 is amended by adding paragraph (c)(41) to read as 
follows:


 20.100  Applicability; cross-reference to other 
regulations.

* * * * *
    (c) * * *
    (41) Premarket notifications for food contact substances, in 
 170.102 of this chapter.

PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY 
STUDIES

    3. The authority citation for 21 CFR part 58 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 
360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 
216, 262, 263b-263n.

    4. Section 58.3 is amended by adding paragraph (e)(23) to read as 
follows:


 58.3  Definitions.

* * * * *
    (e) * * *
    (23) A premarket notification for a food contact substance, 
described in part 170, subpart D, of this chapter.
* * * * *

PART 170-FOOD ADDITIVES

    5. The authority citation for 21 CFR part 170 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

    6. Section 170.3 is amended by revising paragraph (e)(2) and by 
adding paragraph (e)(3) to read as follows:


 170.3  Definitions.

* * * * *
    (e)(1) * * *
    (2) Uses of food additives not requiring a listing regulation. Use 
of a substance in a food contact article (e.g., food-packaging or food-
processing equipment) whereby the substance migrates, or may reasonably 
be expected to migrate, into food at such levels that the use has been 
exempted from regulation as a food additive under  170.39, 
and food contact substances used in accordance with a notification 
submitted under section 409(h) of the act that is effective.
    (3) A food contact substance is any substance that is intended for 
use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.
* * * * *

    7. Subpart D, consisting of  170.100 through 
170.106, is added to part 170 to read as follows:

Subpart D-Premarket Notifications

Sec.
170.100  Submission of a premarket notification for a food 
contact substance (FCN) to the Food and Drug Administration (FDA).
170.101  Information in a premarket notification for a food 
contact substance (FCN).
170.102  Confidentiality of information in a premarket 
notification for a food contact substance (FCN).
170.103  Withdrawal without prejudice of a premarket 
notification for a food contact substance (FCN).
170.104  Action on a premarket notification for a food contact 
substance (FCN).
170.105  The Food and Drug Administration's (FDA's) 
determination that a premarket notification for a food contact 
substance (FCN) is no longer effective.
170.106  Notification for a food contact substance formulation 
(NFCSF).

Subpart D-Premarket Notifications


 170.100  Submission of a premarket notification for a food 
contact substance (FCN) to the Food and Drug Administration (FDA).

    (a) An FCN is effective for the food contact substance manufactured 
or prepared by the manufacturer or supplier identified in the FCN 
submission. If another manufacturer or supplier wishes to market the 
same food contact substance for the same use, that manufacturer or 
supplier must also submit an FCN to FDA.
    (1) An FCN must contain all of the information described in 
 170.101.
    (2) An FCN may incorporate by reference any information in 
FDA's files provided that the manufacturer or supplier is 
authorized to reference the information. The FCN must include 
information establishing that the manufacturer or supplier is 
authorized to reference information in FDA's files.
    (3) Any material submitted in or referenced by an FCN that is in a 
foreign language must be accompanied by an English translation verified 
to be complete and accurate.
    (b) FDA may choose not to accept an FCN for either of the 
following:
    (1) A use of a food contact substance that is the subject of a 
regulation in parts 173 through 189 of this chapter; or
    (2) A use of a food contact substance that is the subject of an 
exemption under the threshold of regulation process described in 
 170.39.
    (c) A petition must be submitted under  171.1 of this 
chapter to authorize the safe use of a food contact substance in either 
of the following circumstances, unless FDA agrees to accept an FCN for 
the proposed use.
    (1) The use of the food contact substance increases the cumulative 
dietary concentration to a certain level. For a substance that is a 
biocide (e.g., it is intended to exert microbial toxicity), this level 
is equal to or greater than 200 parts per billion in the daily diet 
(0.6 milligram (mg)/person/day). For a substance that is not a biocide, 
this level is equal to or greater than 1 part per million in the daily 
diet (3 mg/person/day); or
    (2) There exists a bioassay on the food contact substance, FDA has 
not reviewed the bioassay, and the bioassay is not clearly negative for 
carcinogenic effects.
    (d) A manufacturer or supplier for which a notification is 
effective must keep a current address on file with FDA.
    (1) The current address may be either the manufacturer's (or 
supplier's) address or the address of the manufacturer's 
(or supplier's) agent.

[[Page 35730]]

    (2) FDA will deliver correspondence to the manufacturer's or 
supplier's current address.


 170.101  Information in a premarket notification for a 
food contact substance (FCN).

    An FCN must contain the following:
    (a) A comprehensive discussion of the basis for the 
manufacturer's or supplier's determination that the use of 
the food contact substance is safe. This discussion must:
    (1) Discuss all information and data submitted in the notification; 
and
    (2) Address any information and data that may appear to be 
inconsistent with the determination that the proposed use of the food 
contact substance is safe.
    (b) All data and other information that form the basis of the 
determination that the food contact substance is safe under the 
intended conditions of use. Data must include primary biological data 
and chemical data.
    (c) A good laboratory practice statement for each nonclinical 
laboratory study, as defined under  58.3(d) of this 
chapter, that is submitted as part of the FCN, in the form of either:
    (1) A signed statement that the study was conducted in compliance 
with the good laboratory practice regulations under part 58 of this 
chapter; or
    (2) A brief signed statement listing the reason(s) that the study 
was not conducted in compliance with part 58 of this chapter.
    (3) Data from any study conducted after 1978 but not conducted in 
compliance with part 58 of this chapter must be validated by an 
independent third party prior to submission to the Food and Drug 
Administration (FDA), and the report and signed certification of the 
validating party must be submitted as part of the notification.
    (d) Information to address FDA's responsibility under the 
National Environmental Policy Act, in the form of either:
    (1) A claim of categorical exclusion under  25.30 or 
 25.32 of this chapter; or
    (2) An environmental assessment complying with  25.40 
of this chapter.
    (e) A completed and signed FDA Form No. 3480.


 170.102  Confidentiality of information in a premarket 
notification for a food contact substance (FCN).

    (a) During the 120-day period of the Food and Drug Administration 
(FDA) review of an FCN, FDA will not disclose publicly any information 
in that FCN.
    (b) FDA will not disclose publicly the information in an FCN that 
is withdrawn prior to the completion of FDA's review.
    (c) Once FDA completes its review of an FCN, the agency will make 
its conclusion about the FCN publicly available. For example, if FDA 
objects to a notification 90 days after the date of receipt, the agency 
would make available its objection at that time.
    (d) By submitting an FCN to FDA, the manufacturer or supplier 
waives any claim to confidentiality of the information required to 
adequately describe the food contact substance and the intended 
conditions of use that are the subject of that FCN.
    (e) The following data and information in an FCN are available for 
public disclosure, unless extraordinary circumstances are shown, on the 
121st day after receipt of the notification by FDA, except that no data 
or information are available for public disclosure if the FCN is 
withdrawn under  170.103.
    (1) All safety and functionality data and information submitted 
with or incorporated by reference into the notification. Safety and 
functionality data include all studies and tests of a food contact 
substance on animals and humans and all studies and tests on a food 
contact substance for establishing identity, stability, purity, 
potency, performance, and usefulness.
    (2) A protocol for a test or study, unless it is exempt from 
disclosure under  20.61 of this chapter.
    (3) A list of all ingredients contained in a food contact 
substance, excluding information that is exempt from disclosure under 
 20.61 of this chapter. Where applicable, an ingredient 
list will be identified as incomplete.
    (4) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is exempt from disclosure under 
 20.61 of this chapter.
    (5) All correspondence and written summaries of oral discussions 
relating to the notification, except information that is exempt for 
disclosure under  20.61 of this chapter.
    (6) All other information not subject to an exemption from 
disclosure under subpart D of part 20 of this chapter.


 170.103  Withdrawal without prejudice of a premarket 
notification for a food contact substance (FCN).

    A manufacturer or supplier may withdraw an FCN without prejudice to 
a future submission to the Food and Drug Administration (FDA) if FDA 
has not completed review of the FCN. For the purpose of this section, 
FDA's review is completed when FDA has allowed 120 days to pass 
without objecting to the FCN or FDA has issued an objection letter.


 170.104  Action on a premarket notification for a food 
contact substance (FCN).

    (a) If the Food and Drug Administration (FDA) does not object to an 
FCN within the 120-day period for FDA review, the FCN becomes 
effective.
    (b) If an FCN is complete when received, the 120-day review period 
begins on the date FDA receives the FCN.
    (1) If any element required under  170.101 is missing 
from an FCN, then FDA will not accept that FCN and FDA will send an FCN 
nonacceptance letter to the manufacturer or supplier. If the 
manufacturer or supplier submits the missing information before FDA 
sends an FCN nonacceptance letter, the 120-day review period begins on 
the date of receipt of the missing information.
    (2) If FDA accepts an FCN, then FDA will acknowledge in writing its 
receipt of that FCN.
    (c) Objection to an FCN:
    (1) If FDA objects to an FCN, then FDA will send an FCN objection 
letter. The date of the letter will be the date of FDA's 
objection for purposes of section 409(h)(2)(A) of the act.
    (2) If FDA objects to an FCN within the 120-day period for FDA 
review, the FCN will not become effective.
    (3) FDA may object to an FCN if any part of FDA's 120-day 
review occurs during a period when this program is not funded as 
required in section 409(h)(5) of the act.
    (d) If FDA and a manufacturer or supplier agree that the notifier 
may submit a food additive petition proposing the approval of the food 
contact substance for the use in the manufacturer's or 
supplier's FCN, FDA will consider that FCN to be withdrawn by the 
manufacturer or supplier on the date the petition is received by FDA.


 170.105  The Food and Drug Administration's 
(FDA's) determination that a premarket notification for a food 
contact substance (FCN) is no longer effective.

    (a) If data or other information available to FDA, including data 
not submitted by the manufacturer or supplier, demonstrate that the 
intended use of the food contact substance is no longer safe, FDA may 
determine that the authorizing FCN is no longer effective.
    (b) If FDA determines that an FCN is no longer effective, FDA will 
inform the manufacturer or supplier in writing of the basis for that 
determination. FDA will give the manufacturer or supplier an 
opportunity to show why the FCN should continue to be effective and 
will

[[Page 35731]]

specify the time that the manufacturer or supplier will have to 
respond.
    (c) If the manufacturer or supplier fails to respond adequately to 
the safety concerns regarding the notified use, FDA will publish a 
notice of its determination that the FCN is no longer effective. FDA 
will publish this notice in the Federal Register, stating that a 
detailed summary of the basis for FDA's determination that the 
FCN is no longer effective has been placed on public display and that 
copies are available upon request. The date that the notice publishes 
in the Federal Register is the date on which the notification is no 
longer effective.
    (d) FDA's determination that an FCN is no longer effective is 
final agency action subject to judicial review.


 170.106  Notification for a food contact substance 
formulation (NFCSF).

    (a) In order for the Food and Drug Administration (FDA) to accept 
an NFCSF, any food additive that is a component of the formulation must 
be authorized for its intended use in that NFCSF.
    (b) FDA may publish a notice in the Federal Register stating that 
the agency has insufficient resources to review NFCSFs. From the date 
that this notice publishes in the Federal Register, FDA will no longer 
accept NFCSFs.
    (c) An NFCSF must contain the following:
    (1) A completed and signed FDA Form No. 3479; and
    (2) Any additional documentation required to establish that each 
component of the formulation already may be marketed legally for its 
intended use.

PART 171-FOOD ADDITIVE PETITIONS

    8. The authority citation for 21 CFR part 171 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 371.

    9. Section 171.1 is amended by revising paragraph (i)(1) to read as 
follows:


 171.1  Petitions.

* * * * *
    (i)(1)(i) Within 15 days after receipt, the Food and Drug 
Administration will notify the petitioner of the acceptance or 
nonacceptance of a petition, and if not accepted, the reasons therefor. 
If accepted, the petitioner will be sent a letter stating this and the 
date of the letter shall become the date of filing for the purposes of 
section 409(b)(5) of the act. In cases in which the Food and Drug 
Administration agrees that a premarket notification for a food contact 
substance (Food Contact Notification (FCN)) submitted under section 
409(h) of the act may be converted to a petition, the withdrawal date 
for the FCN will be deemed the date of receipt for the petition.
    (ii) If the petitioner desires, he may supplement a deficient 
petition after being notified regarding deficiencies. If the 
supplementary material or explanation of the petition is deemed 
acceptable, the petitioner shall be notified. The date of such 
notification becomes the date of filing. If the petitioner does not 
wish to supplement or explain the petition and requests in writing that 
it be filed as submitted, the petition shall be filed and the 
petitioner so notified.
    (iii) Notwithstanding paragraph (i)(1)(ii) of this section, the 
petition shall not be filed if the Food and Drug Administration 
determines that the use identified in the petition should be the 
subject of an FCN under section 409(h) of the act rather than a 
petition.
* * * * *

    10. Section 171.7 is amended by adding paragraph (c) to read as 
follows:


 171.7  Withdrawal of petition without prejudice.

* * * * *
    (c) Any petitioner who has a food additive petition pending before 
the agency and who subsequently submits a premarket notification for a 
food contact substance (FCN) for a use or uses described in such 
petition shall be deemed to have withdrawn the petition for such use or 
uses without prejudice to a future filing on the date the FCN is 
received by the Food and Drug Administration.

PART 174-INDIRECT FOOD ADDITIVES: GENERAL

    11. The authority citation for 21 CFR part 174 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 371.

    12. Section 174.5 is amended by adding paragraph (d)(5) to read as 
follows:


 174.5  General provisions applicable to indirect food 
additives.

* * * * *
    (d) * * *
    (5) Food contact substances used in accordance with an effective 
premarket notification for a food contact substance (FCN) submitted 
under section 409(h) of the act.

PART 179-IRRADIATION IN THE PRODUCTION, PROCESSING AND 
HANDLING OF FOOD

    13. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

    14. Section 179.25 is amended by revising paragraph (c) to read as 
follows:


 179.25  General provisions for food irradiation.

* * * * *
    (c) Packaging materials subjected to irradiation incidental to the 
radiation treatment and processing of prepackaged food shall be in 
compliance with  179.45, shall be the subject of an 
exemption for such use under  170.39 of this chapter, or 
shall be the subject of an effective premarket notification for a food 
contact substance for such use submitted under  170.100 of 
this chapter.
* * * * *

    Dated: September 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12661 Filed 5-20-02; 8:45 am]
BILLING CODE 4160-01-S