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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) has granted 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 amends FDA's regulations governing use of

CFC's to include sterile aerosol talc as an essential use.

EFFECTIVE DATE: June 4, 1996.

[[Page 25391]]

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

In the Federal Register of March 1, 1996 (61 FR 8002), FDA

published, in response to a citizen petition submitted by Bryan, a

proposed rule to amend Sec. 2.125 (21 CFR 2.125) to add sterile aerosol

talc administered intrapleurally by thoracoscopy for human use to the

list of products containing a CFC propellant for an essential use.

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, or misbranded, or both, 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 (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.

1-23, Rockville, MD 20857. 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.

Based on the evidence before it in the petition and in Bryan's new

drug application for the drug product, the agency has determined that

for many patients suffering from pleural effusions, the use of sterile

aerosol talc provides a special benefit that would be unavailable

without the use of CFC's. 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 amending 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 the proposed rule was provided to the Administrator.

Interested persons were given 30 days to comment on the proposed rule.

FDA received no comments on the proposed rule.

Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

Order 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 final rule is consistent with the regulatory philosophy and

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

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 this final rule will have on any small entities, the agency

certifies that the final 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.

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

[[Page 25392]]

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

2 is 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: May 15, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-12758 Filed 5-21-96; 8:45 am]

BILLING CODE 4160-01-F