[Federal Register Volume 65, Number 135 (Thursday, July 13, 2000)]
[Proposed Rules]
[Pages 43269-43284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17653]


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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]


Food Additives: Food Contact Substance Notification System

Agency: Food and Drug Administration, HHS.

Action: Proposed rule.

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Summary: The Food and Drug Administration (FDA) is proposing to 
implement the premarket notification process for food contact 
substances (FCS's) established by the Food and Drug Administration 
Modernization Act (FDAMA) of 1997. Once implemented, the notification 
process will be the primary method for authorizing new uses of food 
additives that are FCS's. FDA is proposing 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 no longer be effective. Additionally, 
FDA is announcing elsewhere in this issue of the Federal Register the 
availability of an administrative guidance document relating to the 
preparation of premarket notifications (PMN's).

Dates: Submit written comments by September 26, 2000, except that 
comments regarding information collection provisions should be 
submitted by August 14, 2000.

Addresses: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit written comments on the information 
collection requirements to the Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB), New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN: Desk 
Officer for FDA.

[[Page 43270]]


For Further Information Contact: Mitchell Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3083.

Supplementary Information:

I. Background

A. History

    In 1958, Congress amended the Federal Food, Drug, and Cosmetic Act 
(the act) to require premarket approval of food additives (sections 
201(s), 402(a)(2)(C), and 409 (21 U.S.C. 321(s), 342(a)(2)(C), and 
348)). ``Food additive'' is defined in section 201(s) of the act as 
``any substance the intended use of which results or may reasonably be 
expected to result, directly or indirectly, in its becoming a component 
or otherwise affecting the characteristics of any food * * *,'' unless 
such substance is generally recognized as safe (GRAS) by qualified 
experts or is prior sanctioned for its intended use. Under section 409 
of the act as originally established, food additives require premarket 
approval by FDA and publication of a regulation authorizing their 
intended use. Subsequently, in 1995, FDA codified a process, the 
``threshold of regulation'' process (Sec. 170.39 (21 CFR 170.39)), by 
which certain food additives may be exempted from the requirement of a 
listing regulation if the substance is expected to migrate to food at 
only negligible levels (60 FR 3658, July 17, 1995).
    More recently, FDAMA (Public Law 105-115) amended section 409 of 
the act to establish a PMN process as the primary method for 
authorizing new uses of food additives that are FCS's. 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.'' 
FDA expects most new uses of FCS's that previously would have been 
regulated by issuance of a listing regulation in response to a FAP or 
would have been exempted from the requirement of a regulation under the 
threshold of regulation process will be the subject of PMN's. 
Historically, FDA has used the term ``food contact material'' to refer 
to the ``materials'' mentioned in the definition of an FCS; a food 
contact material may consist of one or more food contact substances. 
For the purposes of this document a food contact material is any 
material intended for use in contact with food (e.g., packaging and 
food processing equipment).
    While developing this proposed rule, FDA convened a public meeting 
on March 12, 1999 (hereinafter referred to as the March 1999 public 
meeting), to provide interested parties with an opportunity to comment 
on FDA's current thinking on administration of the PMN process, and on 
the agency's recommendations on chemistry and toxicology data for 
PMN's. FDA has considered those comments in developing this proposal. 
FDA has filed copies of the transcript of the meeting and the comments 
received from interested parties with the Dockets Management Branch 
(address above) (Docket No. 99N-0235). The transcript and comments are 
available for public review at the Dockets Management Branch.

B. Scope of the PMN Process

    The FDAMA amendments and their legislative history make clear that 
the PMN process is to be the preferred process for authorizing new uses 
of FCS's. Specifically, section 409(h)(3)(A) of the act states that the 
PMN process shall be utilized for authorizing the marketing of FCS's 
except where the Secretary of Health and Human Services determines that 
the submission and review of a petition 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. 105-43, 
105th Cong., 1st sess. 46 (1997); H. Rept. 105-306, 105th Cong., 1st 
sess. 19 (1997).) Section 409(h)(3)(B) of the act authorizes FDA to 
issue regulations to identify those circumstances under which a 
petition shall be required, considering criteria such as probable 
exposure to and potential toxicity of the FCS (21 U.S.C. 348(h)(3)(B)). 
Below, FDA is proposing regulations identifying the circumstances in 
which a FAP would be required to authorize the use of an FCS.

C. Comparison to the Food Additive Petition Process

    Under the FAP process, a petitioner is required to show that the 
intended use of the food additive, including an FCS, is safe within the 
meaning of section 409(c)(3)(A) of the act. FAP's must contain 
information that addresses the identity of the food additive, the 
manufacture and the intended conditions of use of the food additive, 
and the safety of the food additive under its intended conditions of 
use. Within 15 days of receipt of the petition, FDA determines whether 
the information in the petition is adequate for filing and notifies the 
petitioner in writing. If the petition is filed, FDA publishes a notice 
in the Federal Register announcing the filing of the petition. Data and 
information submitted in a FAP are available for public disclosure once 
a filing notice for the petition has published. Once a petition is 
filed, FDA has up to 180 days to respond to the petition. If the 
petitioner delivers additional substantive information to the agency, 
either in response to agency questions or on the petitioner's own 
initiative, the petition is given a new filing date and the statutory 
clock begins to run anew. Once the agency concludes its review, the 
agency publishes an order in the Federal Register. Such order either 
includes a regulation that lists the conditions of use for the food 
additive FDA has determined to be safe or denies the petition and gives 
the reasons for the agency's decision. Importantly, regardless of the 
time that passes after the notice of filing publishes, a food additive 
may not be legally marketed for the petitioned use until FDA publishes 
an authorizing regulation.
    New section 409(h) of the act establishes a different process for 
food additives that are also FCS's. Under the PMN process for FCS's, a 
manufacturer or supplier of an FCS must notify FDA at least 120 days 
before marketing the FCS. The notification must include information on 
the identity and intended use of the FCS and describe the basis for the 
notifier's determination that the intended use is safe within the 
meaning of section 409(c)(3)(A) of the act. As with the FAP process, 
the burden is on the notifier to demonstrate the safety of the intended 
use of the FCS. If the information in the notification does not support 
the notifier's determination of safety, FDA has 120 days from the date 
of receipt of the notification to object and thereby, to prevent 
marketing of the substance. If the agency does not object to the 
notification within the 120 days, the substance may be legally marketed 
for the notified use. Section 409(h)(4) of the act requires FDA to keep 
confidential any information submitted in a premarket notification for 
the 120-day review period. Once the 120-day review period ends, 
information in the notification is disclosable except for trade secret 
and confidential commercial information.
    The FAP process and the PMN process have two important 
similarities. First, under both processes, the petitioner or notifier 
bears the burden of demonstrating that the intended use of the FCS is 
safe. Second, for both processes, the applicable safety standard

[[Page 43271]]

is the standard in section 409(c)(3)(A) of the act.
    There are also two important differences between the FAP process 
and the PMN process. First, in contrast to the petition process, in the 
PMN process, FDA is not required to publish an order announcing the 
agency's decision and, if appropriate, an authorizing regulation, in 
response to a notification. Second, under the petition process, once 
FDA publishes an authorizing regulation for a specific use of a food 
additive, any person may legally manufacture and market the food 
additive for the approved use. In contrast, under section 409(h)(6) of 
the act, a notification for an FCS is not effective for a similar or 
identical substance manufactured or prepared by anyone other than the 
manufacturer identified in the notification. Thus, additional 
manufacturers who wish to market the same FCS for the same use must 
also submit a notification to FDA.

II. Proposed Regulations for the Notification Process for Food 
Contact Substances

    This section discusses the regulations that FDA is proposing to 
implement the notification process for FCS's. Additionally, FDA is 
announcing elsewhere in this issue of the Federal Register the 
availability of an administrative guidance document relating to the 
preparation of PMN's. FDA has previously announced the availability of 
two draft guidance documents on FDA's recommendations for chemistry and 
toxicology information to be included in PMN's in a notice published in 
the Federal Register of November 12, 1999 (64 FR 61648). Finally, in a 
direct final rule and companion proposed rule published in the Federal 
Register of May 11, 2000 (65 FR 30352 and 65 FR 30366, respectively), 
FDA announced that it was amending its regulations on environmental 
impact considerations to permit notifiers to claim in PMN's the 
categorical exclusions currently applicable to FAP's and threshold of 
regulation exemption requests for FCS's.

A. The Definition of a Food Contact Substance

    The premarket notification process described in section 409(h) of 
the act applies only to food additives that are FCS's. As noted in 
section I.A of this document, an FCS 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 food. FDA is proposing to codify the 
statutory definition of an FCS in proposed Sec. 170.3(e)(3). In 
addition, FDA is proposing to amend the definition in Sec. 170.3(e)(2) 
Uses of food additives not requiring a listing regulation (21 CFR 
170.3(e)(2)) to include FCS's that are the subject of effective 
notifications. Notifications are required only for FCS's that are food 
additives; FCS's that are prior sanctioned or GRAS for their intended 
use do not require premarket notification to FDA.
    In the past, FDA has informally characterized a food additive as 
being a ``direct additive'' if it was intended to have a technical 
effect in food, a ``secondary direct additive'' if it was intended to 
have a technical effect on food during food processing but not in the 
finished food as consumed, or an ``indirect additive'' if it was 
intended to have a technical effect in a food contact material. Even 
though each of these types of food additives is regulated in separate 
sections of Title 21 of the Code of Federal Regulations, no definition 
for direct, secondary direct, or indirect food additives exists in the 
codified regulations or the statute. PMN's will be accepted for 
unapproved uses of food additives that meet the definition of an FCS 
regardless of the location in the Code of Federal Regulations of any 
related codified approval.
    In response to the March 1999 public meeting, FDA received comments 
from interested persons requesting that the agency accept notifications 
for two types of mixtures of FCS's. The first type of mixture of FCS's 
is a food contact substance ``formulation'' where all the FCS's in the 
mixture already may be legally marketed for their intended use in 
contact with food. FDA's current view on notifications for these 
mixtures, which will be referred to as ``formulations,'' is discussed 
in section III of this document.
    The second type of mixture of FCS's is a finished food contact 
material containing one or more FCS's that may not be legally marketed 
for their intended use at the time FDA receives the notification for 
the mixture, because the substances are unapproved food additives. FDA 
has tentatively concluded that a notification for a food contact 
material containing a new FCS may be submitted under section 409(h) of 
the act. FDA currently believes that a notification for a mixture of 
FCS's containing one or more new FCS's would be comparable to a FAP for 
the use of an indirect food additive in combination with a particular 
polymer or other food contact material. In this case, the types of 
polymers with which a petitioned substance is regulated for use 
represent a limitation on the conditions of use for which the 
petitioned substance is authorized. Therefore, FDA currently believes 
that the conditions of use for an FCS that is the subject of a PMN 
could include detailed specifications on the other FCS's that may be 
used in combination with the notified FCS. However, FDA is concerned 
that it could be burdensome for FDA to review within the review period 
for a PMN a notification for more than one new FCS in a food contact 
material. Therefore, FDA has tentatively decided that a separate 
notification must be submitted for each new FCS intended for use in a 
given food contact material. In other words, a food contact material 
that includes a new use for two or more FCS's would require the 
submission of a separate notification for each of the new uses. FDA 
believes that this approach will permit the agency to better manage its 
resources and its statutory obligations concerning the review of 
notifications for FCS's.

B. Notifications for Food Contact Substances: General

    Proposed Sec. 170.100 contains the general regulations for 
submitting a PMN. The agency is proposing in Sec. 170.100(a)(1) that a 
PMN contain all the information described in proposed Sec. 170.101. In 
addition, proposed Sec. 170.100(a)(2) states that a notifier may 
incorporate by reference any information in FDA files that is available 
to the notifier. This would include publicly disclosable material and 
material that the submitter of the information has given the notifier 
permission to reference. Finally, proposed Sec. 170.100(a)(3) requires 
that a notifier provide all relevant information in English. This 
latter requirement is comparable to the requirement in 21 CFR 171.1(a) 
for data submitted in a FAP.
    Proposed Sec. 170.100(b) describes the circumstances under which 
FDA may choose not to accept a PMN. Under proposed Sec. 170.100(b)(1) 
the submission of a PMN would be prohibited for any use of a substance 
that is already the subject of a regulation in 21 CFR parts 173 through 
189. Under proposed Sec. 170.100(b)(2) submission of a PMN would be 
prohibited for any use of a substance that is the subject of an 
exemption under the threshold of regulation process in Sec. 170.39. 
Authorizations under section 409(b) of the act and exemptions under 
Sec. 170.39 authorize the use of FCS's without regard to the 
manufacturer of the substance. Thus, a notification for a use already 
permitted by a regulation or an exemption would be redundant, and the 
review of such a notification would be

[[Page 43272]]

an inefficient use of agency resources. Moreover, such a notification 
could not be exclusive to the notifier and is therefore inconsistent 
with the FDAMA amendment to the statute. Therefore, FDA believes that 
it is appropriate to prohibit submission of a notification for a use of 
an FCS that is already permitted by a regulation or by an exemption. 
However, the agency requests comments regarding the appropriateness of 
FDA accepting PMN's for uses permitted by existing regulations or 
threshold of regulation (TOR) exemptions.
    Section 409(h)(3)(B) of the act authorizes FDA to issue regulations 
identifying the circumstances in which a FAP shall be required to 
provide adequate assurance of safety regarding the use of an FCS. 
Section 409(h)(3)(B) of the act directs FDA to consider criteria such 
as the probable consumption of the FCS and its potential toxicity in 
identifying when a petition shall be required.
    Based upon the information currently available, FDA believes that 
nearly all uses of FCS's would be the subject of PMN's. However, FDA 
believes there are circumstances in which submission and review of a 
FAP would be needed to assure safety. Therefore, the agency is 
proposing in Sec. 170.100(c) a regulation to define the limited 
circumstances in which a petition would be required. The proposed 
regulation also provides that if the agency is consulted prior to 
submission and determines that a notification is more appropriate, a 
petition would not be required even under the circumstances described 
in proposed Sec. 170.100(c). Proposed Sec. 170.100(c) lists two 
circumstances that FDA currently believes should presumptively require 
the submission of a FAP. These circumstances are as follows: (1) When 
the use of the FCS will increase the cumulative dietary concentration 
to the FCS from food uses to a level greater than 1 part per million 
(ppm) (3 mg/person/day) or, in the case of a biocide, to a level 
greater than 200 parts per billion (ppb) (0.6 mg/person/day); and (2) 
when there exists one or more bioassays on the FCS that the agency has 
not already reviewed and such studies are not clearly negative for 
carcinogenicity.
    Historically, FDA has based its recommendations for toxicity data 
to support the safe use of food additives on the estimated intake of 
the food additives. As a general rule, higher estimated intakes of 
substances in the diet pose both an increased risk of toxicity and a 
wider range of potential toxic effects. The maximum levels of 
cumulative dietary concentration identified above are levels at which 
the agency has historically requested more comprehensive toxicity 
testing in order to address a substance's potential to induce diverse 
toxic effects. To address the risk of these effects, FDA has asked for 
longer term toxicity studies and toxicity studies that measure a wider 
variety of toxic endpoints. The agency believes that this approach is 
sound, in that it has ensured the safety of additives permitted in the 
food supply. Thus, FDA continues to believe that uses of FCS's that 
have the potential for inducing diverse toxic effects of consequence to 
human health generally require longer term and more specialized 
toxicity testing to support their safe use. Where such toxicity testing 
is needed, the agency believes that submission, review, and approval of 
a food additive petition is appropriate because the petition process 
will afford FDA the time necessary to review the more extensive 
toxicity data package.
    FDA has tentatively concluded that a lower dietary concentration 
cutoff for PMN's for biocides is appropriate for substances that are 
toxic by design. Biocides are a class of FCS's that have the potential 
to raise safety concerns because their intended technical effect is 
microbial toxicity. Because of this expectation of greater toxicity for 
biocides, FDA has historically requested longer term and specialized 
toxicity testing for biocides at a dietary concentration of 200 ppb 
(0.6 mg/person/day), rather than the 1 ppm (3 mg/person/day) level that 
would apply to most other FCS's. Consistent with FDA's testing 
recommendations, FDA is proposing in Sec. 170.100(c)(1) that, for 
biocides, a petition be required where the maximum cumulative dietary 
concentration level is 200 ppb. FDA intends that this lower cut-off 
level would apply to substances used as FCS's primarily for their 
antimicrobial or fungicidal effects.
    The use of carcinogens as food additives is prohibited by the food 
additives anti-cancer clause in section 409(c)(3)(A) of the act (the 
so-called Delaney clause). FDA believes that, if data exist that may 
demonstrate that an FCS is carcinogenic, a thorough review of such data 
is appropriate and necessary to adequately assure safety and properly 
administer the statute. Therefore, in proposed Sec. 170.100(c)(2), FDA 
is proposing to require that the proposed use of an FCS be the subject 
of a petition when a bioassay on the FCS has not been reviewed by the 
agency and is not clearly negative for carcinogenicity.
    FDA's current view is that in some situations where exposure 
exceeds 1 ppm (3 mg/person /day) or in the case of biocides, 200 ppb 
(0.6 mg/person/day)), the agency's concerns about potential toxicity 
may be alleviated by other factors, and thus, a notification may be 
acceptable. For example, if the cumulative estimated daily intake 
(CEDI) is greater than 1 ppm (3mg/person/day) but the agency has 
established an applicable acceptable daily intake (ADI) for the 
substance that is greater than the CEDI, then a notification would 
likely be acceptable. FDA expects to make publicly available a database 
of ADI's and CEDI's for regulated, exempted, and notified FCS's to 
assist potential notifiers in preparing notifications and petitions for 
FCS's. Based on the above, FDA is proposing that in the situations 
described in proposed Sec. 170.100(c), a petition would be required 
unless FDA determines that a petition is not necessary to adequately 
assure safety even though the criteria of Sec. 170.100(c)(1) or (c)(2) 
are met. Although sponsors are not required to consult with the agency 
prior to submitting either a petition or a notification, FDA strongly 
encourages presubmission discussion of uses that fall within the bounds 
of those circumstances defined in proposed Sec. 170.100(c).
    In order for FDA to be able to contact a notifier to provide an 
opportunity for the notifier to respond to agency's concerns regarding 
a PMN, the agency must have current information on the person for whom 
the notification is effective. Therefore, under proposed 
Sec. 170.100(d), all notifiers would be required to inform FDA of any 
change in address.

C. Information Required in a Premarket Notification for an FCS

    The FDAMA amendments require that an FCS meet the safety standard 
for food additives generally that is set out in section 409(c)(3)(A) of 
the act. Under section 409(h)(1) of the act, a notification shall 
include the notifier's determination that the intended use of the FCS 
is safe under the standard of section 409(c)(3)(A), as well as the data 
and information that forms the basis of such determination and any 
information required by regulation to be submitted. In light of this 
safety standard, FDA has tentatively concluded that the information in 
a premarket notification should be comparable to that required in a FAP 
for the same use. In addition, because of the short review period for 
PMN's, FDA is proposing to require in proposed Sec. 170.101(a) that the 
notifier submit a comprehensive discussion of the data and information 
in the notification that forms the basis of the notifier's 
determination that the FCS is

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safe. Under proposed Sec. 170.101(a)(1), a discussion is comprehensive 
if it addresses all safety data in the notification. Although the 
discussion of every study or test need not be exhaustive, a notifier 
should include a thorough discussion of safety data that are important 
to the determination of safety. The notifier should also discuss in 
detail the notifier's basis for discounting or disregarding any data. 
To ensure a balanced evaluation of all existing data, FDA is also 
proposing to require in proposed Sec. 170.101(a)(2) that the notifier 
address in the comprehensive discussion any information that appears 
inconsistent with the notifier's determination that the use of the FCS 
is safe. Under this proposed system, if FDA determines that a 
notifier's discussion is not sufficiently comprehensive to show that 
the notifier has considered all relevant data and information, the 
agency would object to the notification on the basis that the 
notification does not include all required information.
    Proposed Sec. 170.101(b) would require the notifier to submit all 
data and information relevant to the safety determination for the 
intended use of the FCS. This requirement is comparable to the 
requirement in entry E. of the form in 21 CFR 171.1(c) for FAP's 
concerning detailed data derived from appropriate animal and other 
biological experiments related to the safety of the additive be 
submitted in a FAP. Under proposed Sec. 170.101(b), notifiers would be 
required to submit to FDA all primary biological and chemical data and 
information relevant to the safety of the intended use of the FCS. For 
example, notifications would include the primary data from relevant 
toxicity studies and from migration tests, including validation data. 
To assist notifiers in determining which data are relevant to the 
safety determination, in the Federal Register of November 12, 1999 (64 
FR 61648), FDA announced the availability of two guidance documents on 
the chemistry and toxicology information recommended for inclusion in 
PMN's. In addition, FDA is announcing elsewhere in this issue of the 
Federal Register the availability of an administrative guidance 
document relating to the preparation of PMN's. These guidance documents 
include general recommendations that will help notifiers to satisfy the 
requirements of proposed Sec. 170.101(b). For special circumstances not 
addressed in the guidance, notifiers are encouraged to consult with the 
agency prior to submitting a notification.
    Proposed Sec. 170.101(c) would require that all nonclinical 
laboratory studies submitted in a premarket notification be performed 
under good laboratory practices (GLP's) and include, for each study, a 
signed statement that the study has been performed under GLP's 
(proposed Sec. 170.101(c)(1)) or a statement identifying the deviations 
from GLP's that occurred along with an explanation of the reasons for 
the deviations (proposed Sec. 170.101(c)(2)). This section is 
comparable to Sec. 171.1(k) (21 CFR 171.1(k)) for FAP's and would 
ensure that data submitted in support of the safety of the use of an 
FCS meet appropriate minimum technical standards.
    In addition, proposed Sec. 170.101(c)(3) would require that the 
data in each study conducted since 1978 but not conducted under GLP's 
be validated by an independent third party prior to submission to FDA. 
Finally, proposed Sec. 170.101(c)(3) would require a signed 
certification from such a data validator. FDA has tentatively concluded 
that the requirement that such data be validated will ensure the 
reliability of data submitted in support of the safety of the use of an 
FCS. FDA currently believes that, because of the short time period for 
the review of notifications, it is necessary that data be validated in 
advance of submission to FDA.
    Under the National Environmental Policy Act (NEPA), FDA must 
consider the environmental impact of its actions; the effect of this 
obligation is that for covered actions, either an environmental 
assessment or a claim of categorical exclusion is required.
    In view of this NEPA obligation, FDA is taking two actions. First, 
in the Federal Register of May 11, 2000, FDA published a direct final 
rule (64 FR 30352) amending the agency's regulations in part 25 (21 CFR 
part 25), and a companion Notice of Proposed Rulemaking (65 FR 30366) 
proposing to amend the regulations in part 25. Specifically, the direct 
final rule amended, and the companion proposal proposed to amend, part 
25 by adding to the list of those actions that require an environmental 
assessment in Sec. 25.20 allowing a notification submitted under 
section 409(h) of the act to become effective, and by expanding the 
existing categorical exclusions in Sec. 25.32(i), (j), (k), (q), and 
(r) to include allowing a notification submitted under section 409(h) 
of the act to become effective. This will allow notifiers of FCS's to 
claim the categorical exclusions now available to sponsors of other 
requests for authorization of FCS's. Second, as part of this 
rulemaking, FDA is proposing in Sec. 170.101(d) that if the 
environmental component of a notification is missing or deficient under 
Sec. 25.40, the agency will not accept the notification for review. In 
cases where the agency does not accept a notification based on 
deficiencies in environmental information, FDA expects to inform the 
notifier in writing within 30 days of receipt of the submission.
    In response to the March 1999 public meeting, FDA received comments 
requesting that FDA consider incorporating standard forms in the 
requirements for information in PMN's. Although FDA currently believes 
that forms cannot replace a comprehensive discussion of the information 
in the notification or a discussion of the basis for a notifier's 
determination of safety, FDA tentatively agrees that forms may be 
useful in preparing and reviewing PMN's. Therefore, FDA is proposing in 
Sec. 170.101(e) to require the submission of FDA Form No. 3480 with all 
notifications for FCS's. FDA expects to make this form available via 
the agency's internet site (http://vm.cfsan.fda.gov). FDA Form No. 
3480, as well as FDA Form No. 3479 (see section III of this document), 
are undergoing review by the Office of Management and Budget as part of 
the paperwork reduction analysis (see section VII below) for this 
proposed rule.

D. Confidentiality of Information in a Premarket Notification for an 
FCS

    Section 409(h)(4) of the act prohibits FDA from publicly disclosing 
any information in a PMN for 120 days after submission of the PMN to 
FDA. FDA is proposing to codify in Sec. 170.102(a) the prohibition 
against disclosure of information in a notification. FDA currently 
believes that the intent of section 409(h)(4) of the act is to prevent 
the agency from disclosing information in a notification prior to 
completion of the agency's review. Therefore, FDA is proposing to add 
Sec. 170.102(b) which provides that the information in a notification 
that is withdrawn within 120 days after receipt, and before the agency 
has completed its review, will not be publicly available. Similarly, 
FDA believes that the agency's conclusion regarding a notification 
should be publicly available at the time such conclusion is reached. 
Therefore, FDA is proposing in Sec. 170.102(c) to provide that FDA's 
conclusion regarding a notification would be available at the time the 
agency's review is completed. However, FDA does not expect to actively 
disclose its conclusion regarding a notification; rather, FDA 
anticipates providing this information to

[[Page 43274]]

persons who contact the agency (i.e., by telephone, letter, or e-mail) 
after the conclusion of FDA's review.
    The agency is planning to establish a publicly available inventory 
of effective PMN's (discussed below). FDA has tentatively concluded 
that the inventory will include the information necessary to describe 
adequately the substance that is the subject of the notification and 
the use of that substance for which the notification is effective. Such 
information may include, but will not necessarily be limited to, the 
complete chemical identity of the FCS, the maximum use level in food 
contact materials, any limitations on the types of food that may 
contact materials containing the substance, and limitations on time and 
temperature conditions of use for the material containing the 
substance. FDA believes that the foregoing information is necessary to 
describe adequately the circumstances under which a given notification 
is effective and that any claim to confidentiality of such information 
would hamper the agency's ability to adequately communicate which 
notifications have become effective. Therefore, as proposed, 
Sec. 170.102(d) provides that by submitting a notification, the 
notifier waives any claim of confidentiality to the information 
required to describe adequately the FCS and the intended conditions of 
use that are the subject of the notification.
    FDA is proposing to codify in Sec. 170 102(e) the types of 
information in a PMN that will be publicly available once the 
statuatory 120-day review period is completed. The types of information 
listed in proposed Sec. 170.102(e) are comparable to the types of 
information contained in or relating to an FAP that generally are 
publicly available under Sec. 171.1 (h) either at the time the petition 
is filed or once the agency has rendered a decision on the petition. 
FDA has tentatively concluded that once the statuatory prohibition in 
section 409 (h) of the act against disclosure of information in a PMN 
expires, the disclosure of data and information in a PMN should be 
comparable to the disclosure of similar information when contained in 
an FAP. FDA specifically requests comments on all of the provisions of 
proposed Sec. 170.102

E. Withdrawal Without Prejudice

    Under proposed Sec. 170.103, FDA is proposing that a notifier may 
withdraw a PMN at any time during the 120 days after receipt of the 
notification by FDA, if FDA has not completed its review. For the 
purpose of this section, FDA's review is complete when FDA has allowed 
120 days to pass without objecting to the PMN, or when FDA has issued 
an objection letter. FDA tentatively believes that the outcome of the 
agency's review should be publicly available at the time it issues. As 
discussed above, FDA is proposing in Sec. 170.102(c) to protect from 
public disclosure the information in a PMN withdrawn within 120 days of 
receipt by FDA.

F. Action on a Notification for an FCS

    FDA currently plans to conduct an initial review of whether the 
basic informational items required under proposed Sec. 170.101 are in a 
notification for an FCS. If, during this initial review, FDA finds that 
one of the elements required under proposed Sec. 170.101 is missing, 
FDA believes that the agency should be able to decline to review such 
notification. Under proposed Sec. 170.104(b)(1), FDA would inform a 
notifier in writing that a clearly deficient notification has not been 
accepted. In addition, if a notifier supplements a deficient 
notification before FDA informs the notifier in writing under proposed 
Sec. 170.104(b)(1) then the date of receipt of the supplemental 
information would be the date of receipt of the notification for 
purposes of section 409(h)(1) of the act.
    If FDA accepts a PMN, FDA expects to acknowledge receipt of the PMN 
in writing within 30 days of receipt (see proposed Sec. 170.104(b)(2)). 
This acknowledgment would serve two purposes: First, the acknowledgment 
would inform the notifier of the date of receipt of the notification by 
FDA, and thereby the effective date of the notification if FDA does not 
object to the marketing of the substance; second, the acknowledgment 
would identify the substance and use that FDA understands are the 
subject of the notification. FDA intends to use this identity and use 
information in FDA's inventory of effective notifications (discussed 
below) if the notification becomes effective. If FDA determines during 
the course of review of a PMN that it is necessary to modify the 
description of the FCS or its intended use as conveyed in the 
acknowledgment letter, FDA intends to promptly inform the notifier of 
any such changes.
    If, after reviewing a notification, FDA does not agree that the 
notifier has demonstrated that the substance is safe under the intended 
conditions of use, FDA would inform the notifier in writing that FDA 
objects to the marketing of the substance for the use that is the 
subject of the notification and would describe the basis for the 
objection. Under proposed Sec. 170.104(c)(1), if FDA objects to a PMN, 
FDA will inform the notifier in writing. FDA has tentatively concluded 
that the date of the objection letter should be the date that the 
agency objects to the notification for the purposes of section 
409(h)(2)(A) of the act, and has proposed such an arrangement in 
Sec. 170.104(c)(1). FDA believes that this practice for objection dates 
will simplify management of the notification process. For purposes of 
clarity, FDA is also proposing in Sec. 170.104(c)(2) to restate the 
statutory outcome that, if FDA objects to a notification during the 
120-day review period, the notification would not become effective. 
Under section 409(a) of the act, in the absence of an effective 
notification, an FCS cannot be lawfully marketed.
    FDA currently believes that, if information on which the notifier's 
determination of safety is based is inadequate to support a safety 
determination, the agency would object, under section 409(h)(2)(B) of 
the act, to the notification on the basis that the use of the FCS has 
not been shown to be safe under the standard of section 409(c)(3)(A). 
FDA currently believes that, if the notifier's discussion of the data 
supporting the safety of the use of the FCS is not comprehensive, the 
agency would consider the notification inadequate to support the safety 
of the intended use of the FCS and would object to the notification on 
that basis.
    Section 409(h)(5)(A)(i) of the act states that the premarket 
notification program shall not operate in any fiscal year (FY) for 
which the program is not funded as described in section 409(h)(5). FDA 
currently believes that the agency must be able to object to a 
notification if the notification program ceases to operate before the 
end of the 120-day period after FDA's receipt of the notification in 
accordance with section 409(h)(5) of the act. Accordingly, proposed 
Sec. 170.104(c)(3) would authorize FDA to object to a premarket 
notification on the basis that some portion of the 120-day review 
period occurs during a period while the PMN program is not operating. 
Proposed Sec. 170.104(c)(3) would not, however, require FDA to object. 
For example, if FDA determines that it can complete its review of a PMN 
while the PMN program operates, the agency would not object to a 
notification solely on the basis of proposed Sec. 170.104(c)(3).
    Unlike the FAP process, there is no requirement under the PMN 
process that FDA publish either a filing notice or a final rule in the 
Federal Register in order to authorize the use of an FCS. Moreover, the 
statute does not require

[[Page 43275]]

FDA to issue a letter at the conclusion of the review of a 
notification, in contrast to the threshold of regulation process under 
Sec. 170.39. No action by FDA is required for a notification to become 
effective 120 days after receipt by the agency. However, FDA has 
considered information provided by the public at the March 1999 public 
meeting and has tentatively concluded that issuing a letter identifying 
the notification and the date on which the notification became 
effective may be valuable in bringing the review process to closure. 
Such a letter could also clarify the identity or intended use of the 
FCS if there is a need to do so. Therefore, FDA's current plan is to 
reissue the acknowledgment letter and to add a statement regarding the 
date on which the notification became effective and to describe any 
changes in identity or use of the FCS. Because FDA is concerned that 
the issuance of a final letter for every PMN may become an 
administrative burden on the agency, the agency is not proposing to 
make issuance of such a letter a requirement.
    In order to administer the PMN program efficiently, FDA has 
tentatively concluded that the agency should maintain a publicly 
available inventory of effective notifications. Such an inventory would 
permit both the regulated industry and the public readily to determine 
whether an effective notification exists for use of an FCS. As 
currently envisioned by the agency, the publicly available inventory 
would include such information as the identity of the substance, the 
notified use, the manufacturer identified in the notification, the 
effective date of the notification, and a tracking number identifying 
the notification. FDA expects to make the inventory of effective 
notifications available on the agency's Internet site (http://vm.cfsan.fda.gov). FDA is specifically requesting comments on the 
agency's plan for the inventory of effective notifications and on ways 
the agency may make the inventory most useful to the public.
    As noted, section 409(h)(3)(A) of the act requires that the 
notification process be utilized for authorizing new uses of food 
contact substances except where the agency determines that a FAP is 
necessary to provide adequate assurance of safety or where FDA and a 
manufacturer or supplier agree that such manufacturer or supplier may 
submit a petition. FDA currently believes that there may be some 
instances where a codified regulation may be in the best interest of 
the public and the agency, and in such cases, the agency would agree to 
accept a petition. However, FDA should not be required to review both a 
petition and a notification for the same use of an FCS. Thus, proposed 
Sec. 170.104(d) would provide that a premarket notification would be 
deemed withdrawn if FDA and a notifier agree under section 409(h)(3)(A) 
of the act that the notifier may submit a FAP proposing the approval of 
the FCS for the use described in the notification. FDA is also 
proposing to amend Sec. 171.1(i)(1) to ensure that FDA is not required 
to file a FAP for the use of an FCS that, under section 409(h)(3)(A) of 
the act, may be the subject of a notification.

G. Determination That a Premarket Notification Is No Longer Effective

    Section 409(i) of the act states that FDA shall by regulation 
prescribe the procedure by which the agency may deem a premarket 
notification to no longer be effective. If information becomes 
available that indicates that the use of an FCS that is the subject of 
an effective notification may no longer be considered safe, FDA 
believes that such information must be adequately addressed by the 
notifier for the notification to continue to be effective. Proposed 
Sec. 170.105(a) states that FDA may determine that a PMN is no longer 
effective if the available information demonstrates that the use of an 
FCS is no longer safe. Proposed Sec. 170.105(b) states that FDA would 
inform the notifier in writing of the agency's tentative conclusion 
that a notification is no longer effective, and would provide the basis 
for that conclusion. In addition, FDA will establish a timeframe for 
the notifier to respond to the agency's tentative conclusion. Under 
proposed Sec. 170.105(b) the notifier would be given an opportunity to 
address FDA's safety concerns. Under proposed Sec. 170.105(c), if the 
notifier is not able to address adequately FDA's concerns, FDA would 
publish a notice in the Federal Register stating the agency's 
conclusion that the notification is no longer effective. The date of 
such notice will be the date after which the notification shall no 
longer be effective. FDA has tentatively concluded that the agency's 
determination that a notification is no longer effective shall be the 
final agency action subject to judicial review (proposed 
Sec. 170.105(d)).

III. Notifications for Formulations

    As discussed above, in response to the March 1999 public meeting, 
the agency received comments requesting that the agency accept 
notifications for food contact substance formulations (NFCSF's). Such 
notifications would be distinct from notifications for FCS's in two 
ways. First, NFCSF's would be for a particular mixture of FCS's and 
would be for more than one FCS. Second, each of the substances in the 
formulation would already be authorized for its intended use in contact 
with food. Thus, FDA's evaluation of NFCSF's would be limited to a 
review of the basis for compliance with section 409 of the act.
    Because each substance in an NFCSF would already be authorized for 
its intended use, such notifications would not be required under 
section 409 of the act. Nor does the act require FDA to implement and 
operate such a program. Comments in response to the March 1999 public 
meeting stated that such notifications would be useful for facilitating 
trade in both food contact materials and in food, if FDA would choose 
to accept these notifications under the PMN process. FDA also believes 
that acceptance and review of NFCSF's will aid the agency in monitoring 
compliance within the regulated industry and provide the agency with 
better information on the types of food contact materials in use. 
Therefore, FDA is proposing, in Sec. 170.106(a), to accept NFCSF's 
where the notifier can establish that each of the components of the 
formulation is authorized for its intended use. However, FDA has 
serious concerns about the potential burden that accepting 
notifications for formulations could place on the agency. Therefore, 
proposed Sec. 170.106(b) states that the agency may decline to accept 
NFCSF's by publishing a notice in the Federal Register stating that the 
agency does not have sufficient resources to review such notifications. 
FDA believes that this level of notice is appropriate because there is 
no statutory requirement for FDA to accept NFCSF's.
    FDA's current view is that notifications for formulations would not 
require resubmission of the information supporting the safety of the 
intended use of each food contact substance in the formulation. FDA has 
tentatively concluded that a notifier for a formulation would 
ordinarily submit only a completed FDA Form No. 3479 and any additional 
information necessary to establish that the specific conditions of use 
in the formulation for each FCS are authorized. Also, in cases where 
the basis for compliance of an individual FCS in a formulation is an 
effective notification, a notifier would need to certify that he could 
rely on the notification cited. Therefore, under proposed 
Sec. 170.106(c), FDA would require that a notification for a food 
contact substance formulation include a completed FDA Form No. 3479 and 
any additional information to establish that

[[Page 43276]]

each of the components of the formulation is authorized for its 
intended use. FDA is specifically requesting comments on proposed 
Sec. 170.106.

IV. Transition Policy

    At the time the premarket notification program began to operate, 
the agency had an inventory of pending FAP's for the use of FCS's. FDA 
also had an inventory of pending TOR exemption requests (submitted 
under Sec. 170.39). FDA believes that nearly all of these petitions and 
exemption requests are for uses that would meet the criteria under 
proposed Sec. 170.100 for premarket notification.
    At any time that the PMN program is operational, a petitioner may 
withdraw a FAP or TOR request for the use of an FCS and resubmit the 
petition or request as a PMN. If a petitioner does not withdraw a 
petition and such petitioner submits a PMN for the same use, the 
petition would be deemed withdrawn under proposed Sec. 171.7(c) for the 
use or uses described in the notification. In a letter dated October 
25, 1999, FDA strongly encouraged petitioners and requesters under the 
threshold of regulation process to contact the agency prior to 
withdrawal of a petition or a TOR request to obtain specific guidance 
on conversion of the petition or request to a PMN. Finally, for some of 
the FAP's and TOR requests in the agency's inventory when the 
notification program began to operate, FDA was awaiting the submission 
of additional information that the agency has considered necessary to 
the safety determination. Any such information would be necessary to 
establish the safety of the intended use of the FCS if a petition or 
request were resubmitted as a notification.

V. Conforming Amendments

    FDA is proposing several conforming amendments to the agency's 
regulations to help to administer the PMN process and to clarify the 
application of the food additive regulations to FCS's.
    Section 20.100 cross-references regulations concerning the public 
availability of information in specific types of documents submitted to 
FDA. FDA is proposing to amend this section to cross-reference the 
regulations on the disclosure of information in PMN's under proposed 
Sec. 170.102.
    FDA is proposing to amend Sec. 58.3 (21 CFR 58.3) to add PMN's to 
the list of types of submissions that the agency classifies as 
``Applications for research or marketing permits.'' This amendment will 
make the appropriate provisions of the agency's GLP regulations 
applicable to PMN's.
    FCS's that are the subject of PMN's will not be listed in the food 
additive regulations for their intended uses. Therefore, FDA proposes 
to amend Secs. 174.5(d) and 179.25(c) (21 CFR 174.5(d) and 179.25(c)) 
to provide appropriate cross references for the use of an FCS that is 
the subject of an effective PMN.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review OMB under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520). A description of these provisions is 
given 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.
    FDA invites comments on the following: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Food Contact Substances Notification System
    Description: Section 409(h) of the act establishes a premarket 
notification process for FCS's. 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 effect in such food.'' Section 409(h)(3) of the act requires 
that the notification process be utilized for authorizing the marketing 
of FCS's except where FDA determines that the submission and premarket 
review of a FAP under section 409(b) of the act is necessary to provide 
adequate assurance of safety. Section 409(h)(1) of the act requires 
that a notification include information on the identity and the 
intended use of the food contact substance and the basis for the 
notifier's determination that the food contact substance 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 
a PMN should be comparable to the data in a FAP. FDA is proposing 
regulations necessary to implement the premarket notification program 
which will largely replace the FAP process for those food additives 
that are food contact substances. The collection of information 
associated with notifications for new uses of FCS's under section 409 
of the act has been previously announced for public comment in a notice 
published in the Federal Register of November 12, 1999 (64 FR 61648).
    FDA is also proposing to require that a notification for a food 
contact substance include FDA Form No. 3480 ``Notification for New Use 
of a Food Contact Substance'' and a notification for a formulation of a 
food contact material include FDA Form No. 3479 ``Notification for a 
Food Contact Substance Formulation'' that will serve to summarize 
pertinent information in the notification. FDA Form No. 3480 was made 
available for public comment in the November 12, 1999, notice. FDA 
believes that these forms will facilitate both preparation and review 
of notifications since 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            No. of         Annual Frequency      Total Annual          Hours per
         21 CFR Section                  Form             Respondents        per  Response         Responses           Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106\2\                                 FDA 3479                 200                   4                 800                   2               1,600
170.101\3\,\7\                             FDA 3480                 200                   1                 200                  25               5,000

[[Page 43277]]

 
170.101\4\,\7\                             FDA 3480                  55                   2                 110                 120              13,200
170.101\5\,\7\                             FDA 3480                  45                   2                  90                 150              13,500
170.101\6\,\7\                             FDA 3480                  16                   1                  16                 150               2,400
Total                                                                                                                                           35,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 No. 3479 (``Notification for a Food Contact
  Substance Formulation'') to be filled out and documentation attached.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that would currently be the subject of exemptions under 21 CFR 170.39 or very simple FAP's.
\5\ Notifications for uses that would currently be the subject of moderately complex FAP's.
\6\ Notifications for uses that would currently be the subject of more complex FAPs.
\7\ These notifications require the submission of FDA Form No. 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:
     FDA estimates that the likely increase in PMN's over the 
number of FAP's and TOR requests will be approximately four times the 
highest recent influx of these submissions (50 and 54, respectively). 
This factor is based on an analysis of the number of companies 
producing various types of food contact substances and the types of 
food contact substances for which FAP's and TOR's are most commonly 
submitted to FDA.
     Based on input from industry sources, FDA estimates that 
the agency will receive approximately 800 notifications annually for 
food contact substance formulations.
     FDA also has included 200 expected duplicate submissions 
in the second lowest tier. FDA expects that the burden for preparing 
these notifications will primarily consist of the notifier filling out 
FDA Form No. 3480, verifying that a previous notification is effective, 
and preparing necessary documentation.
     Based on the amount of data typically submitted in FAP's 
and TOR requests, FDA identified three other tiers of PMN's that 
represent escalating levels of burden required to collect information.
     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 compliance with the PRA (44 U.S.C. 3507(d)), the agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. Interested persons are requested to send comments 
regarding the information collection by August 14, 2000 to the Office 
of Information and Regulatory Affairs, OMB (address above), Attn: Desk 
Officer for FDA.

VII. Analysis of Impacts

A. Preliminary Regulatory Impact Analysis

    FDA has examined the economic implications of this proposed 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 is also considered a significant regulatory action if it 
raises novel legal or policy issues. The Administrator of the Office of 
Information and Regulatory Affairs of the Office of Management and 
Budget (OMB) has determined that this proposed rule is a significant 
regulatory action as defined by Executive Order 12866.
1. The Need for Regulation
    This notice proposes regulations that are needed to help implement 
the premarket notification process for food contact substances created 
by FDAMA. These premarket notifications will largely replace FAP's for 
food contact substances. In the petition process, FDA evaluates the 
safety of the proposed use of a food additive and, if FDA determines 
that the proposed use is safe, the agency issues a regulation 
authorizing the legal marketing of the product. Under the statute, FDA 
has an initial period of 90 days, which may be extended for an 
additional 90 days, in which to make a determination regarding the 
safety of the proposed use and publish an order stating the agency's 
determination. However, regardless of the time that actually passes 
after submission of a FAP, the FAP may not be legally marketed until 
FDA publishes an authorizing regulation. By contrast, the premarket 
notification provision of FDAMA requires FDA to object within 120 days 
to a manufacturer's notification that it intends to use a particular 
food contact substance for a particular use, or the substance may be 
legally marketed on the 121st day without issuance of a regulation.
    This notice also proposes regulations to implement the statutory 
requirement that information in a PMN not be publicly disclosed before 
completion of FDA's review. Under the petition process, the publication 
in the Federal Register of the notice of filing for the petition 
permits competitors of the petitioner to learn about the new food 
contact substance before authorization. Disclosure of a manufacturer's 
intent to market a substance before authorization lowers the 
competitive advantage of a new product, since a food additive 
regulation authorizes anyone to market the substance for its intended 
use. Under section 409(h) of the act and the proposed rule, a 
notification will be effective for the manufacturer named in the 
notification only, thereby protecting the commercial intent of the 
manufacturers of the new food contact substance during the period of 
review, and permitting the manufacturer of the new food contact 
substance to market the substance first.
    The implementing regulations propose binding criteria for the 
successful submission of notifications and a concrete framework for the 
resolution of routine questions or problems arising in the notification 
process. The notification process is more predictable than the

[[Page 43278]]

corresponding FAP process, because the notifier will have either an 
effective notification or FDA's objection within 120 days. The 
structure added by limited implementing regulations would enhance the 
predictability of that process and reduce the burden on all potential 
notifiers. Therefore, the proposed regulations implementing the 
statutory requirement for PMN's would help the agency to reduce delays 
in the marketing of new food contact substances. In the absence of the 
proposed rule, the agency would be less effective in achieving this 
goal.
    In the economic analysis of the proposed rule, the agency will not 
separate the benefits and costs of the statute from the benefits and 
costs of the regulations helping to implement the statute. The 
regulations and the statute are complementary and will be assessed 
together.
2. Regulatory Options
    FDA examined a range of regulatory options to demonstrate why the 
proposed action is most beneficial to the public. Not all of the 
options discussed below are currently legally available. FDA assesses 
options that are not legally available in order to elucidate its 
reasoning for the option that was chosen.
    a. No new regulatory activity. No additional social costs or 
benefits are associated with this option. Section 409 of the act does 
not require FDA to issue regulations to implement the notification 
process for food contact substances except for regulations prescribing 
the procedure by which a notification may be deemed no longer effective 
(section 409(i)(3)). The notification process for food contact 
substances begins to operate when the budgetary requirements of section 
409(h)(5) of the act are met whether or not FDA issues regulations.
    If no regulations exist to govern the notification program when it 
begins to operate, FDA will operate the program through guidance alone. 
This situation would provide the most discretion for FDA to deal with 
individual notifications but would provide less predictability for 
industry. Less predictability would create additional burden on the 
industry to prepare and manage notifications for review.
    As stated above, the proposed implementing regulations provide 
binding criteria for the successful submission of notifications and a 
concrete framework for the resolution of routine questions or problems 
arising in the notification process. The notification process is more 
predictable than the corresponding FAP process, because the notifier 
will have either an effective notification or FDA's objection within 
120 days. The structure added by limited implementing regulations will 
enhance the predictability of that process and reduce the burden on all 
potential notifiers. Furthermore, if the agency continued to rely on 
the current FAP procedure to approve food contact substances, there 
could be delays in meeting consumer demand when the agency's evaluation 
has not been completed within a predictable time; these delays could 
represent potentially significant avoidable costs. This 
unpredictability discourages new products when the food contact 
substance manufacturers do not believe their products can be brought to 
market within a reasonable time. When products are not brought to 
market, the public bears a social cost in terms of lost consumer 
satisfaction from the lack of desirable products. Although the public 
cost from new products not being brought to market are mostly unseen 
and are not measurable, they may be large.
    b. Modification of the petition process to require automatic 
authorization at the end. Although this option is not legally 
available, the public might have benefited if the current petition 
process were modified to require automatic authorization at the end of 
a specified review period. The period of evaluation for food contact 
substance petitions could be extended to 120 days, with automatic 
authorization granted for petitions that are not reviewed during this 
period. Extending the review period would provide the agency with 
additional time to review each petition and the requirement of 
automatic agency authorization at the end of the review period would 
create reliable expectations for petitioners. However, extending the 
period of evaluation would not address all of the problems that 
petitioners encounter in the current process. This option neglects the 
circumstance that certain information may be disclosed to competitors 
during the review process.
    c. Stricter requirements for data submission. The agency might have 
proposed to require that food contact substances meet stricter 
requirements for data submission than those it is proposing. For 
example, FDA might require additional validation for all data that form 
the basis of the determination that the food contact substance is safe 
for the intended use. The agency did not choose this option because 
additional data requirements would impose a cost by potentially 
delaying the introduction of beneficial substances.
    d. Deregulation--no requirement for a petition or a notification. 
Congress could legislate to dispense with the approval of new food 
contact substances through either petitions or notifications. The 
objection to this option is that the agency's review and authorization 
of food contact substances protects the public from harmful substances 
that might otherwise be introduced into the food supply and reduces the 
costs of private monitoring of the food supply. Protection in this 
context means that the agency requires that manufacturers of products 
under review by FDA demonstrate a reasonable certainty of no harm from 
the intended use of the product.
    With deregulation, consumers bear the risks when producers sell 
products that do not meet the regulatory standard of reasonable 
certainty of no harm. If the approval of new food contact substances 
were withdrawn, consumers would have to monitor the safety of the 
substances in the food supply. If products cause harm, consumers would 
have to rely on the tort system for redress. Consumers would have to 
prove that a harm was linked to the food contact substance based on a 
standard that might vary by jurisdiction or at the whim of a jury. 
Furthermore, proving the link between the substance and the harm could 
be extremely difficult. Private markets operate within the framework of 
legal institutions. The tort system of the common law evolved, in part, 
to provide remedies to injuries suffered in transactions in private 
markets. For instance, under this system, if a defective product 
injures someone, then the injured person may recover damages from the 
producer of the defective product. The recovery of damages requires the 
injured person to prove that his injuries were caused by the producer's 
product. Regardless of the legal standard chosen (negligence, warranty, 
or strict liability) the injured person must be able to link his injury 
to the specific product of a specific producer. Because legal 
proceedings are always retrospective and must have occurred after the 
plaintiff consumer has suffered an injury, the social cost under the 
tort system is the cost of the harm caused to the plaintiff and the 
cost of the legal proceedings.
    In most instances, consumers experiencing illness or other harm 
from food consumption do not recognize the illness as foodborne or are 
unable to link the illness to consumption of a particular food. This 
inability to connect illness and food or food contact substances exists 
because many symptoms do not occur immediately after consumption of the 
product. Many

[[Page 43279]]

consumers are never compensated, and in practice, the tort system is 
rarely used to remedy the harm that comes from unsafe foods or food 
additives. Therefore, the costs of private monitoring and enforcement 
of safety using the tort system in an unregulated market are probably 
substantially greater than the social costs of regulatory enforcement 
and the additional research costs needed to demonstrate with reasonable 
certainty that products are safe.

3. Benefits

    The benefits from the change to premarket notifications come from 
the increased innovation in the food contact substance market. 
Consumers want new and better food contact substances (or their 
properties) and receive benefits from them in the form of increased 
satisfaction. Although new substances will (on average) generate 
monetary benefits that exceed monetary costs--if not, new substances 
would not be introduced--it is difficult to place a monetary value on 
the full increase in consumer satisfaction from better food contact 
substances in the future. FDA therefore did not attempt to directly 
measure the increased consumer satisfaction arising from greater 
innovation in food contact substances. Instead, the agency estimated 
the benefits indirectly by the increase in innovation. FDA measured the 
benefits from the change to premarket notifications as the expected 
increase in the annual number of new notifications after the change. 
More product notifications to the agency imply more innovation, which 
in turn implies better products and greater consumer satisfaction.
    Determining the benefits without regard for the congressional 
requirement to change regimes, although it ignores the rationale and 
legal authority for the change, provides a simple measure of the 
consequences of the change to the system of premarket notifications for 
new food contact substances. The increase in notifications, however, 
may overstate innovation because: (1) Not all notifications will be for 
new products and (2) the new regime will require each manufacturer to 
submit a notification to obtain marketing approval so some duplication 
of firm and agency resources might occur when different manufacturers 
produce the same substances. Thus, the estimated benefit due to 
innovation represents a maximum.
    The agency estimated that the likely increase in submissions will 
be approximately four times the highest recent number of annual 
submissions for food contact substances (50 FAP's and 54 TOR 
submissions). Thus, for fiscal year (FY) 2000, FDA estimates that 416 
premarket notifications will be submitted (4 x 50 + 4 x 54). As 
explained above, the agency has not attempted to place a monetary value 
on the benefits from these submissions.
4. Costs
    The costs of the proposed rule are the costs incurred by firms that 
notify the agency of a new substance, but would not have had to under 
the previous regime. The firms that will bear this cost manufacture 
products identical to those that have already been through the 
notification process. These firms would formerly have been able to 
avoid the regulatory process altogether.
    The agency used the following calculation:
    Cost = (Number of Notifications) X (Hours/Notification) X (Hourly 
Rate to Prepare a Notification) + (Number of Notifications) X (Average 
Cost for Data Development)
    The agency determined the expected number of notifications for 
seven categories of notifications for those firms that are expected to 
make substances identical to those for which notifications have been 
received, the number of hours required to prepare the notification for 
each category, and the estimated average hourly cost to prepare the 
notification. In addition the agency estimated the average cost of 
developing the data for each type of submission.
    The total number of FAP's and TOR's received in FY 1998 and that 
would be affected by the change in regimes was 102. Based on petition 
data, these 102 were divided between petitions for components of food 
contact materials and petitions for substances used to manufacture food 
which do not have an intended effect in the food as consumed. The 
burden of the data collection for FAP's varies with the type of 
petition submitted. The following are the agency's estimates of the 
information collection burden for FAP's and TOR's.
    A TOR requires the least amount of time for the collection of 
information: approximately 88 hours per submission. Forty-nine TOR's 
were received in FY 1998, resulting in a burden of 4,664 hours.
    Category A. A simple indirect additive petition with minimal 
testing requirements (collection of identity information, genetic 
toxicity testing and administrative details) requires approximately 120 
hours per petition. Sixteen such petitions of this type were received 
in FY 1998, resulting in a burden of 1,920 hours. In addition, the 
average data collection costs for such petitions is about $12,500, 
resulting in a total dollar burden for data collection of $200,000 for 
FY 1998.
    Category B. An average indirect additive petition consisting of 
analytical work, 90-day feeding studies, toxicological review of study 
data, and internal review and the drafting of the petition, requires 
approximately 150 hours per petition. Twenty-two such petitions were 
received in FY 1998, resulting in a burden of 3,300 hours. In addition, 
the average data collection costs for such petitions is about $350,000, 
resulting in a total dollar burden for data collection of $7,700,000 
for FY 1998.
    Category C. For an indirect additive petition with complex 
analytical work, the estimated time requirement per petition is 
approximately 150 hours. Eleven such petitions were received in FY 
1998, resulting in a burden of 1,650 hours. In addition, the average 
data collection costs for such petitions is about $375,000, resulting 
in a total dollar burden for data collection of $4,125,000 for FY 1998.
    Category D. A petition for a major new component of food packaging, 
involving long-term feeding studies, toxicology review, analytical 
work, and administrative details, requires more hours and a larger 
dollar investment for data development. FDA does not expect to accept 
such petitions as notifications.
    Category E. A simple petition for a secondary direct food additive 
with minimal testing requirements (collection of identity information, 
minimal toxicity testing, analytical work and administrative details) 
requires approximately 120 hours per petition. One such petition was 
received in FY 1998, resulting in a burden of 120 hours. In addition, 
the average data collection costs for such petitions is about $12,500, 
resulting in a total dollar burden for data collection of $12,500 for 
FY 1998.
    Category F. An average secondary direct additive petition 
consisting of analytical work, 90-day feeding studies, toxicological 
review of study data, and internal review and the drafting of the 
petition, requires approximately 150 hours per petition. Two such 
petitions were received in FY 1998, resulting in a burden of 300 hours. 
In addition, the average data collection costs for such petitions is 
about $350,000, resulting in a total dollar burden for data collection 
of $700,000 for FY 1998.
    Furnishing the information required even in a simple indirect 
additive petition requires a team of professional employees, which may 
include toxicologists, chemists, environmental scientists, and lawyers. 
According to information provided by industry trade

[[Page 43280]]

associations, the collection of information, analytical work, 
toxicological review and administrative details involved in such a 
petition (Category A) average about 120 hours. In addition, such a 
petition requires an average of $12,500 for data development. Assuming 
that the aggregate professional hourly cost is $90, then the cost for 
submitting a simple petition is $10,800 (calculated by multiplying the 
hourly cost and the total hours) + $12,500 (for data development), for 
a total cost of $23,300.
    The following summaries list the TOR and petition categories and 
the cost for each, assuming an aggregate professional hourly cost of 
$90.

                      Table 2.--Categories of Food Contact Substance Submissions (Current)
----------------------------------------------------------------------------------------------------------------
     Submission Type       No. of Submissions        Total Hours          Cost of Hours          Other Costs
----------------------------------------------------------------------------------------------------------------
Threshold of regulation           49                 4,664               419,760                     0
Category A                         6                 1,920               172,800               200,000
Category B                        22                 3,300               297,000             7,700,000
Category C                        11                 1,650               148,500             4,125,000
Category D                         0                     0                     0                     0
Category E                         1                   120                10,800                12,500
Category F                         2                   300                27,000               700,000
Totals                                              11,954             1,075,860            12,737,500
----------------------------------------------------------------------------------------------------------------

    If, in a given fiscal year the expected number of PMN's has the 
same proportion of categories as does the FY 1998 petitions and TOR's, 
then the agency expects:

                     Table 3.--Categories of Food Contact Substance Submissions (Projected)
----------------------------------------------------------------------------------------------------------------
     Submission Type      No. of Notifications       Total Hours          Cost of Hours          Other Costs
----------------------------------------------------------------------------------------------------------------
Threshold of regulation          201                17,688             1,591,920                     0
Category A                        66                 7,920               712,800               825,000
Category B                        91                13,650             1,285,000            31,850,000
Category C                        46                 6,900               621,000            17,250,000
Category D                         0                     0                     0                     0
Category E                         4                   480                43,200                50,000
Category F                         8                 1,200               108,000             2,800,000
Totals                                              47,838             4,361,920            52,775,000
----------------------------------------------------------------------------------------------------------------

    FDA expects approximately 50 percent of new notifications to be 
duplicates of PMN's submitted for products that would have required 
only one authorization under the old regime. Comparable products that 
could have used authorizations for another firm's product now require 
separate authorizations. Therefore, 50 percent of the expected total 
cost is the social cost imposed on the industry because of the change 
in regimes, for a total expected social cost of $26,387,500. As with 
the estimate of benefits above, this estimate of social cost represents 
a maximum cost since duplicate notifications may not require 
development of new scientific data.
5. Summary of Benefits and Costs
    The social benefits of the proposed change in regime are from new 
product innovation. The agency estimates that four times the current 
number of petitions and TOR's 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 duplicate notifications for a maximum total social 
cost of $26,387,500.

B. Initial Regulatory Flexibility Analysis

1. Introduction
    FDA has examined the economic implications of these proposed rules 
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 lesson the economic effect of the rule on 
small entities.
2. Economic Effects on Small Entities
    We were unable to estimate how many small entities will be affected 
by this proposed regulation, because the universe of affected small 
entities might include any entities with a new idea. Past practice may 
not be a useful guide for estimating how many future entities will be 
affected. Some of these firms will now have to submit a PMN, when in 
the past they would not have had to. Because they will have to make a 
submission, the cost may act as a barrier and discourage them. On the 
other hand, firms that might not have submitted an application because 
the regime did not protect their ideas from copying, will now have some 
protection for their ideas by virtue of the new regime and thus be more 
likely to submit a PMN. We believe the net affect will be to encourage 
more innovation as reflected by more notifications.
3. Regulatory Relief
    Because some small firms are expected to be adversely affected by 
the proposed rule, options for regulatory relief, such as small 
business exemption, need to be addressed. The benefit of this option is 
that small businesses would not incur an additional cost. The drawback 
is that small firms could then copy and distribute themselves the 
substances being reviewed in response to the marketing submission of a 
competitor, creating disincentives for new substance development by 
rival firms.
4. Description of RecordKeeping and Reporting
    There are no additional recordkeeping requirements for the proposed 
rule.
5. Summary
    FDA estimates that there will be no additional direct costs to 
small businesses because of this rule. If small business entities 
determine that the costs of notification outweighed the

[[Page 43281]]

benefits, the small business entities could rely on existing authorized 
food contact substances.

C. Unfunded Mandates and Congressional Review

    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.
    The Small Business Regulatory Enforcement Fairness Act of 1996 
(Public Law 104-121) defines a major rule for the purpose of 
congressional review as having caused or being likely to cause one or 
more of the following: An annual effect on the economy of $100 million; 
a major increase in costs or prices; significant effects on 
competition, employment, productivity, or innovation; or significant 
effects on the ability of U.S.-based enterprises to compete with 
foreign-based enterprises in domestic or export markets. In accordance 
with the Small Business Regulatory Enforcement Fairness Act, OMB has 
determined that this proposed rule is not a major rule for the purpose 
of congressional review.

VIII. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Comments

    Interested persons may, on or before September 26, 2000, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposed rule, except that comments regarding the 
information collection provisions should be submitted on or before 
August 14, 2000. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Dockets Management 
Branch. (address above above) between 9 a.m. and 4 p.m., Monday through 
Friday.

X. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. FDA Form No. 3479 ``Notification for a Food Contact Substance 
Formulation,'' Rev. 9/99.
    2. FDA Form No. 3480 ``Notification for a New Use of A Food Contact 
Substance,'' Rev. 5/00.

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 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 it is 
proposed that 21 CFR parts 20, 58, 170, 171, 174, and 179 be 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, 264n, 265, 300u-300u-5, 300aa-1.
    2. Section 20.100 is amended by adding paragraph (c)(42) to read as 
follows:


Sec. 20.100  Applicability; cross-reference to other regulations.

* * * * *
    (c) * * *
    (42) Premarket notifications for food contact substances, in 
Sec. 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:


Sec. 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 
adding paragraph (e)(3) to read as follows:


Sec. 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 Sec. 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 Secs. 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 (PMN) to the Food and Drug Administration (FDA).
170.101  Information in a premarket notification for a food contact 
substance (PMN).

[[Page 43282]]

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

Subpart D--Premarket Notifications


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

    (a) A PMN is effective for the food contact substance manufactured 
or prepared by the manufacturer or supplier identified in the PMN 
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 a PMN to FDA.
    (1) A PMN must contain all of the information described in 
Sec. 170.101.
    (2) A PMN may incorporate by reference any information in FDA's 
files provided that the notifier is authorized to reference the 
information. The PMN should include information establishing that the 
notifier is authorized to reference information in FDA's files.
    (3) Any material submitted in or referenced by a PMN 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 a PMN 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 
Sec. 170.39.
    (c) A petition must be submitted under Sec. 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 a PMN 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 substances, FDA has 
not reviewed the bioassay, and the bioassay is not clearly negative for 
carcinogenic effects.
    (d) A notifier must keep a current address on file with FDA.
    (1) The current address may be either the notifier's address or the 
address of the notifier's agent.
    (2) FDA will deliver correspondence to the notifier's current 
address.


Sec. 170.101  Information in a premarket notification for a food 
contact substance (PMN).

    A PMN must contain the following:
    (a) A comprehensive discussion of the basis for the notifier'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 notifier's determination that the proposed use of 
the food contact substance is safe.
    (b) All data and other information that form the basis of the 
notifier's 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 that is submitted as part of the PMN, 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 Sec. 25.30 or Sec. 25.32 
of this chapter; or
    (2) An environmental assessment complying with Sec. 25.40 of this 
chapter.
    (e) A completed and signed FDA Form No. 3480.


Sec. 170.102  Confidentiality of information in a premarket 
notification for a food contact substance (PMN).

    (a) During the 120-day period of the Food and Drug Administration 
(FDA) review of a PMN, FDA will not publicly disclose any information 
in that PMN.
    (b) FDA will not publicly disclose the information in a PMN that is 
withdrawn prior to the completion of FDA's review.
    (c) Once FDA completes its review of a PMN, the agency will make 
its conclusion about the PMN 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 a PMN to FDA, the notifier 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 PMN.
    (e) The following data and information in a PMN are available for 
public disclosure, unless extraordinary circumstances are shown, on the 
121st day after receipt of the notification by FDA, unless the PMN is 
withdrawn under Sec. 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 
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 Sec. 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 
Sec. 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 
Sec. 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 Sec. 20.61.
    (6) All other information not subject to an exemption from 
disclosure under subpart D of part 20 of this chapter.


Sec. 170.103  Withdrawal without prejudice of a premarket notification 
for a food contact substance (PMN).

    A notifier may withdraw a PMN without prejudice to a future

[[Page 43283]]

submission to the Food and Drug Administration (FDA) if FDA has not 
completed review of the PMN. For the purpose of this section, FDA's 
review is completed when, FDA has allowed 120 days to pass without 
objecting to the PMN or FDA has issued an objection letter.


Sec. 170.104  Action on a premarket notification for a food contact 
substance (PMN).

    (a) If the Food and Drug Administration (FDA) does not object to a 
PMN within the 120-day period for FDA review, the PMN becomes 
effective.
    (b) In order for the 120-day review period to begin FDA must accept 
that notification.
    (1) If any element required under Sec. 170.101 is missing from a 
PMN, then FDA will not accept that PMN and FDA will send a PMN 
nonacceptance letter to the notifier. If the notifier submits the 
missing information before FDA sends a PMN nonacceptance letter, the 
date of receipt of the PMN will become the date of receipt of the 
missing information.
    (2) If FDA accepts a PMN, then FDA will acknowledge in writing its 
receipt of that PMN.
    (c) Objection to a PMN:
    (1) If FDA objects to a PMN, then FDA will send a PMN 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 a PMN within the 120-day period for FDA 
review, the PMN will not become effective.
    (3) FDA may object to a PMN 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 notifier agree that the notifier may submit a FAP 
proposing the approval of the food contact substance for the use in the 
notifier's PMN, FDA will consider that PMN to be withdrawn by the 
notifier on the date the petition is received by FDA.


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

    (a) If data or other information available to FDA, including data 
not submitted by the notifier, demonstrate that the intended use of the 
food contact substance is no longer safe, FDA may determine that the 
authorizing PMN is no longer effective.
    (b) If FDA determines that a PMN is no longer effective, FDA will 
inform the notifier in writing of the basis for that determination. FDA 
will give the notifier an opportunity to show why the PMN should 
continue to be effective and will specify the time that the notifier 
will have to respond.
    (c) If the notifier fails to respond adequately to the safety 
concerns regarding the notified use, FDA will publish a notice of its 
determination that the PMN 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 PMN 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 a PMN is no longer effective is final 
agency action subject to judicial review.


Sec. 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 NFCSF's. From the date 
that this notice publishes in the Federal Register, FDA will no longer 
accept NFCSF's.
    (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 legally marketed 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:


Sec. 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 submitted under 
section 409(h) of the act may be converted to a petition, the 
withdrawal date for the premarket notification will be deemed the date 
of receipt for the FAP.
    (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 a premarket notification under section 409(h) of the act 
rather than a FAP.
* * * * *
    10. Section 171.7 is amended by adding paragraph (c) to read as 
follows:


Sec. 171.7  Withdrawal of petition without prejudice.

* * * * *
    (c) Any petitioner who has a FAP pending before the agency and who 
subsequently submits a premarket notification 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 premarket notification is received by FDA.

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:


Sec. 174.5  General provisions applicable to indirect food additives.

* * * * *
    (d) * * *
    (5) Food contact substances used in accordance with an effective 
premarket notification 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:


[[Page 43284]]


    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:


Sec. 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 Sec. 179.45, shall be the subject of an exemption for 
such use under Sec. 170.39 of this chapter, or shall be the subject of 
an effective premarket notification for such use submitted under 
Sec. 170.100 of this chapter.
* * * * *

    Dated: January 24, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-17653 Filed 7-12-00; 8:45 am]
BILLING CODE 4160-01-F