Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Notices 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.

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 foodcontact 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 foodcontact article meets the threshold

criteria, certain information specified in

§ 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

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

170.39 60 1 60 88 5,280

1There 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 § 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
234 Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Notices

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

§ 170.39 and that would also eliminate

the requirement for information on

possible environmental effects at the

sites of manufacture of all FDAregulated 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 § 25.32(i) and (j)

(21 CFR 25.32(i) and (j)), including

actions on requests for exemption from

regulation under § 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 foodcontact 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 § 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 foodpackaging materials that are not

expected to remain with finished foodpackaging 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 (§ 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 § 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 § 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 § 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

§ 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0374]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Latex Condoms; User Labeling;

Expiration Dating’’ has been approved