Chlorofluorocarbon Propellants in Self-Pressurized Containers; Addition to List of Essential Uses

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration-

21 CFR Part 2

[Docket No. 95P-0088]

Chlorofluorocarbon Propellants in Self-Pressurized Containers;

Addition to List of Essential Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to grant

the petition of Bryan Corp. (Bryan) to add sterile aerosol talc to the

list of products containing a chlorofluorocarbon (CFC) propellant for

an essential use. Essential use products are exempt from FDA's ban on

the use of CFC propellants in FDA-regulated products and the

Environmental Protection Agency's (EPA's) ban on the use of CFC's in

pressurized dispensers. This document proposes to amend FDA's

regulations governing use of CFC's to include sterile aerosol talc as

an essential use.

DATES: Written comments by April 1, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD-7), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-594-1049.

SUPPLEMENTARY INFORMATION:

I. Background

Under Sec. 2.125 (21 CFR 2.125), any food, drug, device, or

cosmetic in a self-pressurized container that contains a CFC propellant

for a nonessential use is adulterated and/or misbranded under the

Federal Food, Drug, and Cosmetic Act. This prohibition is based on

scientific research indicating that CFC's may reduce the amount of

ozone in the stratosphere and thereby increase the amount of

ultraviolet radiation reaching the earth. An increase in ultraviolet

radiation may increase the incidence of skin cancer, change the

climate, and produce other adverse effects of unknown magnitude on

humans, animals, and plants. Section 2.125(d) exempts from the

adulteration and misbranding provisions of Sec. 2.125(c) certain

products containing CFC propellants that FDA determines provide unique

health benefits that would not be available without the use of a CFC.

These products are referred to in the regulation as essential uses of

CFC's and are listed in Sec. 2.125(e).

Under Sec. 2.125(f), any person may petition the agency to request

additions to the list of uses considered essential. To demonstrate that

the use of a CFC is essential, the petition must be supported by an

adequate showing that: (1) There are no technically feasible

alternatives to the use of a CFC in the product; (2) the product

provides a substantial health, environmental, or other public benefit

unobtainable without the use of the CFC; and (3) the use does not

involve a significant release of CFC's into the atmosphere or, if it

does, the release is warranted by the consequence if the use were not

permitted.

EPA regulations implementing provisions of the Clean Air Act

contain a general ban on the use of CFC's in pressurized dispensers (40

CFR 82.64(c) and 82.66(d)). These regulations exempt from the general

ban ``medical devices'' that FDA considers essential and that are

listed in Sec. 2.125(e). Section 601(8) of the Clean Air Act (42 U.S.C.

7671(8)) defines ``medical device'' as any device (as defined in the

Federal Food, Drug, and Cosmetic Act), diagnostic product, drug (as

defined in the Federal Food, Drug, and Cosmetic Act), and drug delivery

system, if such device, product, drug, or drug delivery system uses a

class I or class II ozone-depleting substance for which no safe and

effective alternative has been developed (and where necessary, approved

by the Commissioner of Food and Drugs (the Commissioner)); and if such

device, product, drug, or drug delivery system has, after notice and

opportunity for public comment, been approved and determined to be

essential by the Commissioner in consultation with the Administrator of

EPA (the Administrator). Class I substances include CFC's, halons,

carbon tetrachloride, methyl chloroform, methyl bromide, and other

chemicals not relevant to this document (see 40 CFR part 82, appendix A

to subpart A). Class II substances include hydrochlorofluorocarbons

(HCFC's) (see 40 CFR part 82, appendix B to subpart A).

II. Petition Received by FDA

Bryan submitted a petition under Sec. 2.125(f) and 21 CFR part 10

requesting an addition to the list of CFC uses considered essential.

The petition is on file under the docket number appearing in the

heading of this document and may be seen in the Dockets Management

Branch (address above). The petition requested that sterile aerosol

talc be included in Sec. 2.125(e) as an essential use of CFC's. The

petition contained a discussion supporting the position that there are

no technically feasible alternatives to the use of CFC's in the

product. It included information showing that no alternative delivery

systems (e.g., the pneumatic atomizer) can assure consistent sterility.

The petition also stated that Bryan is unaware of any appropriate

substitute propellants (e.g., compressed gases). Also, the petition

stated that the product provides a substantial health benefit that

would not be obtainable without the use of CFC's. In this regard, the

petition contained information to support the use of this product in

the treatment of malignant pleural effusions, a condition in which

fluid accumulates in the space between the outside surface of the lung

and the inside surface of the chest wall (pleural cavity) as a result

of involvement by an underlying cancer. The petition also provided

information indicating that use of the product would involve a limited

release of CFC's into the atmosphere and the release is warranted by

the health benefits of the product.

III. FDA'S Review of the Petition

The agency has tentatively decided that for many patients suffering

from malignant pleural effusions, the use of sterile aerosol talc

provides a special benefit that would be unavailable without the use of

CFC's. Based on the evidence currently before it, FDA also agrees that

the use of CFC's for this product does not involve a significant

release of CFC's into the atmosphere. Therefore, FDA is proposing to

amend Sec. 2.125(e) to include sterile aerosol talc administered

intrapleurally by thoracoscopy for human use in the list of essential

uses of CFC propellants. A copy of this document has been provided to

the Administrator.

IV. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive

Order

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12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 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). The agency believes that

this proposed rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the proposed

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. Because the agency is not aware of any adverse

impact of this proposed rule will have on any small entities, the

agency certifies that the proposed rule will not have a significant

economic impact on a substantial number of small entities. Therefore,

under the Regulatory Flexibility Act, no further analysis is required.

V. Opportunity for Public Comment

Interested persons may, on or before April 1, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. 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 office above between 9

a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 2

Administrative practice and procedure, Cosmetics, Devices, Drugs,

Foods.

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 part 2 be amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

1. The authority citation for 21 CFR part 2 continues to read as

follows:

Authority: Secs. 201, 301, 305, 402, 408, 409, 501, 502, 505,

507, 512, 601, 701, 702, 704 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352, 355, 357,

360b, 361, 371, 372, 374); 15 U.S.C. 402, 409.

2. Section 2.125 is amended by adding new paragraph (e)(15) to read

as follows:

Sec. 2.125 Use of chlorofluorocarbon propellants in self-pressurized

containers.

* * * * *

(e) * * *

(15) Sterile aerosol talc administered intrapleurally by

thoracoscopy for human use.

* * * * *

Dated: February 22, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-4714 Filed 2-29-96; 8:45 am]

BILLING CODE 4160-01-F