[Federal Register: May 21, 2002 (Volume 67, Number 98)]
[&thnsp;Rules and Regulations]
[Page 35724-35731]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my02-6]
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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/∼dms/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 §&thnsp;170.104(b) describing FDA’s initial review
of an FCN submission. Proposed §&thnsp;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 §&thnsp;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 §&thnsp;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 §&thnsp;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 §&thnsp;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 §&thnsp;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 §&thnsp;170.101(c) to
explicitly reference the definition of nonclinical laboratory studies
in §&thnsp;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 §&thnsp;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
§&thnsp;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 §&thnsp;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
§§&thnsp;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 §&thnsp;170.101(c) to
reference the definition of nonclinical laboratory studies in
§&thnsp;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 §&thnsp;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 §&thnsp;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 &chyph;per Total Annual Hours per Total Hours
&chyph;Respondents &chyph;Response &chyph;Responses &chyph;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\&thnsp;There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\&thnsp;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\&thnsp;Duplicate notifications for uses of FCSs.
\4\&thnsp;Notifications for uses that currently would be the subject of exemptions under 21 CFR 170.39 or very simple FAPs.
\5\&thnsp;Notifications for uses that currently would be the subject of moderately complex FAPs.
\6\&thnsp;Notifications for uses that currently would be the subject of more complex FAPs.
\7\&thnsp;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:
&sbull; 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.
&sbull; Based on input from industry sources, FDA estimates that
the agency will receive approximately 800 notifications annually for
food contact substance formulations.
&sbull; 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.
&sbull; 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.
&sbull; 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:
§&thnsp;20.100 Applicability; cross-reference to other
regulations.
* * * * *
(c) * * *
(41) Premarket notifications for food contact substances, in
§&thnsp;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:
§&thnsp;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:
§&thnsp;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 §&thnsp;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 §§&thnsp;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
§&thnsp;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
§&thnsp;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
§&thnsp;170.39.
(c) A petition must be submitted under §&thnsp;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.
§&thnsp;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 §&thnsp;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 §&thnsp;25.30 or
§&thnsp;25.32 of this chapter; or
(2) An environmental assessment complying with §&thnsp;25.40
of this chapter.
(e) A completed and signed FDA Form No. 3480.
§&thnsp;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 §&thnsp;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 §&thnsp;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
§&thnsp;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
§&thnsp;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 §&thnsp;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.
§&thnsp;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.
§&thnsp;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 §&thnsp;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.
§&thnsp;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.
§&thnsp;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:
§&thnsp;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:
§&thnsp;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:
§&thnsp;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:
§&thnsp;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 §&thnsp;179.45, shall be the subject of an
exemption for such use under §&thnsp;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 §&thnsp;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
Preparation of Food Contact Notifications: Administrative May 21, 2002
Food Contact Substance Notification System; Notice of Availability May 21, 2002
Food Contact Notification System - Proposed Rule July 13, 2000