[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)]
[Notices]
[Pages 233-234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-086]



[[Page 233]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0433]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
February 4, 1998.
ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Threshold of Regulations for Substances Used in Food-Contact 
Articles--21 CFR 170.39--(OMB Control Number 0910-0298)-- Extension

    Under section 409(a) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 348(a)), the use of a food additive is deemed 
unsafe unless it either conforms to the terms of a regulation 
prescribing its use or to an exemption for investigational use. 
Consequently, the safety of the substance under its intended conditions 
of use must be established, and a food additive regulation issued, 
before the substance can be used in food. In accordance with section 
409 of the act, manufacturers of all components of a food-contact 
article (e.g., food packaging or food processing equipment) whose use 
meets the food additive definition in sections 201(s) of the act (21 
U.S.C. 321) must submit a petition establishing the safe conditions of 
use before such food-contact articles may be marketed, unless they are 
the subject of an exemption for investigational use under section 
409(i) of the act.
    Section 170.39 (21 CFR 170.39) establishes a process that provides 
a manufacturer with an opportunity to demonstrate that the likelihood 
or extent of migration to food of a substance used in a food-contact 
article is so trivial that the use need not be the subject of a food 
additive listing regulation (60 FR 36582, July 17, 1995). The agency 
has established two thresholds for the regulation of substances used in 
food-contact articles. The first exempts those substances used in food-
contact articles where the resulting dietary concentration is at or 
below 0.5 parts per billion. The second exempts regulated direct food 
additives for use in food-contact articles where the resulting dietary 
exposure is 1 percent or less of the acceptable daily intake for these 
substances.
    In order to determine whether the intended use of a substance in a 
food-contact article meets the threshold criteria, certain information 
specified in Sec. 170.39(c) must be submitted to FDA. This information 
includes: (1) The chemical composition of the substance for which the 
request is made, (2) detailed information on the conditions of use of 
the substance, (3) a clear statement of the basis for the request for 
exemption from regulation as a food additive, (4) data that will enable 
FDA to estimate the daily dietary concentration resulting from the 
proposed use of the substance, (5) results of a literature search for 
toxicological data on the substance and its impurities, and (6) 
information on the environmental impact that would result from the 
proposed use.
    FDA uses this information to determine whether the food-contact 
article meets the threshold criteria. Respondents to this information 
collection are individual manufacturers and suppliers of substances 
used in food-contact articles (i.e., food packaging and food processing 
equipment) or of the articles themselves.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
170.39                                 60               1              60              88           5,280       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    The previous annual reporting estimate is based on information 
received from representatives of the food packaging and processing 
industries and on agency records. FDA typically receives 60 threshold 
of regulation exemption requests per year. These requests require 
between 28 to 108 hours (h) to prepare.
    The agency received two comments to the Federal Register of 
December 10, 1996 (61 FR 65067), from two trade associations; one that 
represents the plastic food-packaging industry and one that represents 
companies that market packaged food. The issues raised by these 
comments, and the agency's response to them, are set forth as follows.
    1. One comment fully supported and endorsed the threshold of 
regulation process established by Sec. 170.39 but expressed the opinion 
that the current requirement that an environmental assessment (EA) 
accompany each exemption request is an undue paperwork burden. The 
comment expressed the view that the considerable effort involved in 
preparing an EA for

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every exemption request is grossly out of proportion to the minimal 
increment in protection of the environment that may be gained. The 
comment proposed an alternative approach whereby an EA would be 
required only in extraordinary circumstances (i.e., where significant 
adverse environmental impacts may occur that are not subject to 
regulation by other authorities).
    The comment did note that FDA had published a proposed rule 
(National Environmental Policy Act (NEPA): Proposed Revision of 
Policies and Procedures; in the Federal Register of April 3, 1996 (61 
FR 14922); republished May 1, 1996 (61 FR 19476), that would eliminate 
the requirement for EA's for certain types of actions resulting from 
requests for exemption from regulation as a food additive under 
Sec. 170.39 and that would also eliminate the requirement for 
information on possible environmental effects at the sites of 
manufacture of all FDA-regulated substances. This comment, submitted by 
a trade association, noted that the association also submitted a 
comment to the agency on the proposed NEPA rule. The association's 
comment on the proposed NEPA rule is essentially identical to the 
present comment outlined in the preceding paragraph.
    In the Federal Register of July 29, 1997 (62 FR 40570), the agency 
published a final rule revising its NEPA policies and procedures (``the 
final NEPA rule''). The final NEPA rule was issued after the agency 
reviewed and addressed the comments received on its April 3, 1996, 
proposed rule, including the comment submitted by the trade 
association, summarized previously.
    As discussed in detail in the preamble to the final NEPA rule (62 
FR 40579 through 40581), the agency agreed in part with the comment and 
expanded the scope of actions included in two categorical exclusions 
Sec. 25.32(i) and (j) (21 CFR 25.32(i) and (j)), including actions on 
requests for exemption from regulation under Sec. 170.39. However, as 
further discussed in the preamble to the final NEPA rule, the agency 
did not agree completely with this comment. Specifically, FDA concluded 
that certain classes of actions on food-contact materials should 
continue to require EA's and that the preparation of EA's for requests 
for these actions is not unduly burdensome for the industry. The 
Sec. 170.39 exemption requests that continue to require an EA are, for 
the most part, for actions on substances present at greater than 5 
percent of finished food-packaging materials that are not components of 
coatings and for actions on substances present at 5 percent or less of 
finished food-packaging materials that are not expected to remain with 
finished food-packaging materials through use by consumers. As the 
agency explained in the preamble to the final NEPA rule, actions on 
these types of substances have the potential for significant 
environmental impact, and such potential can be evaluated only by the 
agency's review of EA's prepared by requesters. In accordance with 21 
CFR 25.21, EA's are also required for those actions where extraordinary 
circumstances indicate that there may be significant environmental 
effects, even though the actions belong to a class that ordinarily 
would warrant exclusion from the requirement to prepare an EA. Guidance 
on preparing EA's is available from the Food and Drug Administration's 
Office of Premarket Approval (HFS-200), 200 C St. SW., Washington, DC 
20204.
    In addition to the review summarized previously that resulted in 
the agency expanding the scope of two categorical exclusions 
(Sec. 25.32(i) and (j)), the agency has also reviewed the types of uses 
of food-contact articles that have been the subject of exemption 
requests received since the threshold of regulation process was 
implemented on August 16, 1995. The agency estimates that the 
percentage of uses that will qualify for categorical exclusion under 
the agency's revised NEPA regulations may be as high as 8 percent. It 
is further estimated that those exemption requests that qualify for 
categorical exclusions will require, on average, 48 h to prepare as 
opposed to the 88 h typically required to prepare exemption requests 
that include an EA. This would represent a 45 percent reduction in 
paperwork burden for such requests. The overall paperwork burden 
associated with the threshold of regulation process would also decrease 
dramatically. Prior to implementation of the amended NEPA regulations, 
the annual industry burden associated with threshold of regulation 
exemption requests was estimated to be 5,280 h based on the assumption 
that the agency receives 60 requests per year and that each request 
requires on average 88 h to prepare. If, as projected, 87 percent of 
threshold of regulation exemption requests qualify for the categorical 
exclusions discussed previously, it is estimated that the overall 
paperwork burden would decrease to 3,200 h (52 requests x 48 h + 8 
requests x 88 h). This would represent a 39 percent overall reduction 
in paperwork burden.
    2. One comment asserted that the requirement that a manufacturer of 
a substance submit an exemption from regulation request to FDA is not 
necessary for the proper performance of FDA's functions. Instead, the 
comment argued that manufacturers should be able to make their own 
determination as to whether the use of a substance in a food contact 
article meets the criteria for exemption set out in Sec. 170.39. The 
comment further asserted that allowing self-determinations of exemption 
status would substantially reduce the burden on industry.
    FDA disagrees with this comment for several reasons. In the 
preamble to the final rule issuing Sec. 170.39, the agency responded in 
detail to comments recommending that manufacturers be permitted to 
determine themselves whether use of a substance is entitled to an 
exemption from the food additive listing regulation requirement (60 FR 
36582 at 36586 through 36587. In that response, the agency explained 
that under Monsanto v. Kennedy, 613 F. 2d 947 (D.C. Cir. 1979), only 
the Commissioner of Food and Drugs has the authority to exempt a 
substance from regulation as a food additive. The agency's response 
also discussed in detail the policy rationale underlying the procedure 
in Sec. 170.39 (i.e., that a process wherein the agency determines 
which substances will be exempt from regulation as food additives will 
be binding on the agency and will ensure more consistent exemption 
decisions). For the same reasons discussed in the preamble to the final 
rule, FDA concludes that this comment does not provide a basis for 
altering the information collection requirements of Sec. 170.39.

    Dated: December 24, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-086 Filed 1-2-98; 8:45 am]
BILLING CODE 4160-01-F