20096 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 201, 369, 501, 740,

and 801

[Docket No. 93N–0442]

Warning Statements for Products

Containing or Manufactured With

Chlorofluorocarbons and Other OzoneDepleting Substances

AGENCY: Food and Drug Administration,

HHS.

ACTION: Interim rule; opportunity for

comment.

SUMMARY: The Food and Drug

Administration (FDA) is issuing interim

regulations governing warning

statements for products containing or

manufactured with chlorofluorocarbons

(CFC’s) and other ozone-depleting

substances. The amendments prescribe

specific warning statements and

additional labeling statements for

physicians and patients. These

additional statements direct patients to

consult their physicians before

discontinuing use of a prescription

medical product because of concerns

about the product’s effect on the

environment and public health. The

interim rule also provides warning

statements for over-the-counter (OTC)

drug and device products and directs

patients to consult their physicians,

health professional, or suppliers with

questions about the products. In

addition, the interim rule revises certain

regulations concerning foods, cosmetics,

and animal foods in a self-pressurized

container with a CFC propellant in

order to be consistent with current

statutory requirements. FDA is issuing

these regulations as an interim rule with

opportunity for public comment.

DATES: Interim rule effective May 17,

1996; comments by August 1, 1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., 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

On February 11, 1993 (58 FR 8136),

the Environmental Protection Agency

(EPA) issued final regulations requiring,

among other things, a warning statement

on all products containing or

manufactured with specific ozonedepleting substances. In general, the

EPA regulations require each container

or product containing or manufactured

with CFC’s, halons, carbon

tetrachloride, and methyl chloroform to

bear the following warning statement

(58 FR 8136 at 8165):

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

EPA issued the rule under section 611

of the Clean Air Act (42 U.S.C. 7671(j)),

which requires the warning statements

on all products containing or

manufactured with CFC’s on or after

May 15, 1993. In promulgating the rule,

EPA noted that several comments had

argued that certain prescription medical

products, such as metered-dose

inhalers, should be exempt from the

labeling requirements because they are

essential to the health of patients. The

comments indicated that a warning

statement might lead some patients to

avoid their medication because of

concerns about the product’s effect on

the environment or alarm over the

words ‘‘harms public health.’’ EPA

stated that it understood the importance

of such products to patients as well as

the need to ‘‘tailor the labeling

requirement to avoid unduly alarming

patients,’’ but also stated that it lacked

the authority to exempt prescription

medical products from the labeling

requirement (see 58 FR 8136 at 8155).

Consequently, EPA indicated that the

statutorily required warning statement

could appear on supplemental printed

material intended for physicians rather

than patients, provided that the

supplemental printed material intended

for patients contain similar warning

language without the words ‘‘warning’’

and ‘‘harms public health’’ (see 58 FR

8136 at 8156). EPA also indicated that

manufacturers of prescription medical

products could supplement this

information with additional information

for patients. EPA anticipated that FDA

would provide the specific additional

language (see 58 FR 8136 at 8156). On

June 29, 1993 (58 FR 34812, corrected

on July 29, 1993, 58 FR 40656), FDA

published a notice in the Federal

Register setting out alternative labeling

warning language designed not to cause

undue patient alarm. The warnings were

essentially identical to the warnings

contained in this interim rule. As part

of the notice, FDA requested comments

about CFC warning statements. These

comments are summarized and

responded to in section III of this

preamble.

Since 1977 (42 FR 22018, April 29,

1977), FDA has required, with a few

exceptions, that OTC human drug and

nonrestricted device products

containing CFC propellants be labeled

with a warning (21 CFR 369.21 and

801.425). In addition, FDA established

regulations in §§ 101.17(c), 501.17(c),

and 740.11(c) (21 CFR 101.17(c),

501.17(c), and 740.11(c)) that required

that the package of a food, animal food,

or cosmetic in a self-pressurized

container in which the propellant

consists in whole or in part of a fully

halogenated CFC bear the following

warning statement:

Warning: Contains a chlorofluorocarbon

that may harm the public health and

environment by reducing ozone in the upper

atmosphere.

These regulations also provided

requirements for placement and

conspicuousness of the warning

statement. The required warning

statement applied only to selfpressurized containers that use CFC as

a propellant. For example, for foods, the

use of the warning statement was not

required when the CFC was used as a

stabilizer in food toppings and spreads

(§ 101.17(c)(3)).

Since 1978 (43 FR 11301, March 17,

1978), FDA has prohibited the use of

CFC propellants in most products it

regulates (21 CFR 189.191, 300.100,

500.49, 700.23, and 801.417), except

those listed as essential uses of CFC’s in

§ 2.125 (21 CFR 2.125). Nonessential

uses, which were prohibited by the 1978

final rule, included CFC use as a

propellant in self-pressurized containers

for foods and cosmetics. The

prohibitions against nonessential uses of

CFC’s, set out in § 2.125(c), provide that

‘‘any food, drug, device, or cosmetic in

a self-pressurized container that

contains a chlorofluorocarbon

propellant is adulterated and/or

misbranded in violation of the act

* * *.’’ Section 2.125(e) exempts

certain essential uses of CFC’s from the

adulteration and misbranding

provisions of § 2.125(c). Further,

§ 2.125(f) specifically provides for the

filing of a petition in accordance with

21 CFR part 10 to provide for the listing

of additional essential uses so as not to

subject the new use to the adulteration

and misbranding provisions in

§ 2.125(c).

FDA notes that all of the essential

uses of CFC’s exempted from the

adulteration and misbranding

provisions of § 2.125 that are listed in

§ 2.125(e) apply to drug products. No
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 20097

essential uses of CFC’s for foods,

cosmetics, or animal foods in selfpressurized containers have been

identified.

II. Description of the Interim Rule

This interim rule describes the

warning statements that should

accompany human prescription drug,

biologic, and device products, and

restricted device products (hereafter

referred to as ‘‘prescription human

medical products’’), OTC drug and

device products, and animal drug

products that contain or are

manufactured with CFC’s, halons,

carbon tetrachloride, methyl

chloroform, and any other class I ozonedepleting substance designated by the

EPA Administrator. (A list of class I

ozone-depleting substances can be

found in 40 CFR part 82, appendix A to

subpart A, and any later EPA

rulemaking adding other ozonedepleting substances.)

The interim rule provides two options

for labeling prescription human medical

products and OTC drugs and devices.

The first option is EPA’s warning

statement:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

The second option for prescription

human medical products contains

FDA’s additional language for the

alternative warning statements. These

warning statements are intended for

physician labeling and patient labeling.

The warning for the physician

package insert would be used in

conjunction with an alternative warning

statement that would appear on patient

labeling as stated in the EPA final

regulation (58 FR 8136 at 8166). These

alternative warning statements would be

written so that patients do not cease

using their medications because of

concerns over the products’ effect on the

environment or alarm over the words

‘‘harms public health’’ without first

consulting their physicians. Instead,

patients would be able to discuss their

concerns with their physicians or, in the

case of OTC drug or device products,

another health professional or suppliers,

and, if they wish, consider the use of

alternative treatments. Also, physicians

would be alerted to products that

contain ozone-depleting substances.

FDA believes that these warning

statements will enable patients,

physicians, pharmacists, other health

professionals, and suppliers (in the case

of devices) to make informed decisions.

Animal drug products manufactured

with CFC’s or other ozone-depleting

products are required to use EPA’s

warning statement because the optimal

alternative labeling statement is

restricted to human medical products.

A. Prescription Human Medical

Products

For prescription human drug

products, new § 201.320 (21 CFR

201.320) provides both the EPA warning

statement and FDA’s alternative

warning statements. New § 801.443 (21

CFR 801.443) provides the same two

options for prescription and restricted

devices. A biological product regulated

as a drug or a device would use

whichever labeling applies to the

particular biological product. Under

new §§ 201.320 and 801.443, all

prescription drug and device products

and restricted devices containing or

manufactured with CFC’s, halons,

carbon tetrachloride, methyl

chloroform, or any other class I ozonedepleting substance designated by the

EPA Administrator shall use the EPA

warning statement or specified

alternative warning statements. For the

first option for a warning statement,

new §§ 201.320(a) and 801.443(a)

provide the EPA warning statement

quoted earlier in this preamble.

Under new §§ 201.320(a)(2) and

801.443(a)(2), the warning statement

shall be clearly legible and conspicuous

on the product, its immediate container,

its outer packaging, or other labeling,

and appear with such prominence and

conspicuousness as to render it likely to

be read and understood by consumers

under normal conditions of purchase.

For the second option, new

§§ 201.320(b)(1) and 801.443(b)(1)

provide FDA’s alternative warning

statements for supplemental printed

materials intended for physicians and

for patients. For patient labeling, the

warning statement would appear on the

product, its packaging, or supplemental

printed material intended for the patient

and would read as follows:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or name of other class I substance,

if applicable].

This product contains [or is manufactured

with, if applicable] [insert name of

substance], a substance which harms the

environment by destroying ozone in the

upper atmosphere.

Your physician has determined that this

product is likely to help your personal

health. USE THIS PRODUCT AS DIRECTED,

UNLESS INSTRUCTED TO DO OTHERWISE

BY YOUR PHYSICIAN. If you have any

questions about alternatives, consult with

your physician.

These statements are designed to

explain that the Clean Air Act requires

the warning statement, but that patients

should continue to use the prescription

medical product unless instructed

otherwise by their physicians. The

labeling for the physician would be

placed on the physician package insert

after the ‘‘How supplied’’ section on the

label describing the special handling

and storage conditions.

For the package insert for the

physician, the warning statement would

state that:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or name of other class I substance,

if applicable].

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

A notice similar to the above WARNING

has been placed in the information for the

patient [or patient information leaflet, if

applicable] of this product under

Environmental Protection Agency (EPA)

regulations. The patient’s warning states that

the patient should consult his or her

physician if there are questions about

alternatives.

For the second option, for the

alternative placement on supplemental

printed material described in new

§§ 201.320(b) and 801.443(b), the

interim rule specifies a particular

location for the warning statement

intended for the physician; provided,

however, that a person places the

statement intended for the patient on

the product, its packaging, or

supplemental printed material for the

patient. The warning label shall be

clearly legible and conspicuous on the

product, its immediate container, or

other labeling as to render it likely to be

read and understood by consumers

under normal conditions of purchase.

FDA further advises all parties that new

§§ 201.320 and 801.443 do not replace

or relieve a party from the requirements

under 40 CFR part 82.

FDA notes that EPA’s regulations (58

FR 8136 at 8166 (40 CFR 82.108(c)))

state that, for prescription human

medical products that FDA finds to be

essential for patient health, the warning

statement may be placed in

supplemental printed material intended

to be read by the prescribing physician,

as long as the alternative statement is

placed on the product, its packaging, or

supplemental printed material intended

to be read by the patient at time of

purchase. The agency believes that new

§§ 201.320 and 801.443 are consistent
20098 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

with these EPA requirements. However,

FDA declines at this time to determine

which products are essential for public

health. The Clean Air Act requires that

the warning labels be on all products

containing or manufactured with CFC’s

on or after May 15, 1993. FDA believes

it would be impractical and unnecessary

to engage in case-by-case determinations

of which medical products are essential

to public health before permitting

alternative warning statements. Thus,

until FDA can establish criteria and

make individualized determinations as

to whether a drug is essential to public

health, the most prudent course of

action is to presume, for purpose of the

warning statement, that all prescription

human medical products are essential to

public health.

B. OTC Drug and Device Products

This interim rule also removes the

existing CFC warning statement for OTC

drug products at 21 CFR 369.21 in favor

of revised warning statements at new

§ 201.320 (a) and (c). This interim rule

also removes the existing warning

statement at 21 CFR 801.425 for

nonrestricted devices in favor of a

revised warning statement at new

§ 801.63 (21 CFR 801.63). Under new

§§ 201.320 and 801.63, an OTC drug or

device product that contains or is

manufactured with CFC’s or other class

I substances may use the EPA warning

statement or, as an alternative, state:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or other class I substance, if

applicable]:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

CONSULT WITH YOUR PHYSICIAN OR

HEALTH PROFESSIONAL IF YOU HAVE

ANY QUESTION ABOUT THE USE OF THIS

PRODUCT.

For OTC devices, the sentence of the

label shall state:

CONSULT WITH YOUR PHYSICIAN,

HEALTH PROFESSIONAL, OR SUPPLIER IF

YOU HAVE ANY QUESTION ABOUT THE

USE OF THIS PRODUCT.

The warning statement shall appear

on the product, its immediate container,

its packaging, or other labeling on or

within the package from which the drug

is dispensed, and must also be

prominent and conspicuous so as to

render it likely to be read and

understood by consumers under normal

conditions of purchase. This statement

also must be consistent with EPA’s

regulations at 40 CFR part 82.

The agency believes that these

warning statements for OTC drug and

device products, like those for

prescription human medical products,

enable patients, physicians, and other

health professionals to appreciate

environmental concerns and will also

avoid unduly alarming patients.

C. Foods, Cosmetics, and Animal Foods

As noted above, no essential uses of

CFC’s for foods, cosmetics, or animal

foods have been identified. Any uses of

CFC’s or of other class I substances

deemed to be appropriate in the

manufacture of foods, cosmetics, and

animal foods, or the indirect use of such

substances as additives in the

manufacture of packaging materials

intended to be used for foods and

animal foods, will subject the foods,

cosmetics, and food-packaging materials

to the labeling requirements established

by EPA in 40 CFR part 82. Such EPA

warning statement, as cited above in the

discussion on prescription and OTC

medical products, must be prominent

and conspicuous so as to render it easily

read and understood by consumers

under ordinary conditions of purchase.

Because the EPA warning statement is

applicable to all products

‘‘manufactured with’’ or ‘‘that contain

CFC’s or other class I substances,’’ the

current exemption for CFC’s used as a

stabilizer in food toppings and spreads

is no longer appropriate and such foods

must comply with the applicable

labeling requirements set forth in 40

CFR part 82. Thus, FDA is removing the

specific requirement for the CFC

warning statement for foods, cosmetics,

and animal foods in §§ 101.17(c),

740.11(c), and 501.17 and the

exemption for toppings and spreads in

§ 101.17(c)(3). In addition, FDA is

revising these sections to reference the

EPA labeling requirements designated

for CFC’s and other class I substances in

40 CFR part 82.

III. Comments

In the Federal Register of June 29,

1993 (58 FR 34812), FDA published a

notice setting out alternative labeling

warnings, designed not to cause undue

patient alarm, that comply with the EPA

regulation, and that are acceptable to

FDA. As part of the notice, FDA

requested comments about the labeling

warning statements, which were nearly

identical to the warnings contained in

this interim rule. These comments are

summarized and addressed below.

1. One comment suggested that use of

the FDA alternative warnings be made

mandatory. The comment stated that if

manufacturers did not opt for the FDA

alternative warning, and used the EPA

warning instead, this could cause undue

concern and result in patients stopping

medication.

FDA believes that manufacturers

should have the option of using the

warning statement that best meets their

particular needs. FDA does not believe

that a manufacturer will use the EPA

warning if there is any real likelihood

that the warning’s use will cause its

customers to cease using the

manufacturer’s product.

2. Two comments said that, due to the

small size of some containers for

products with CFC’s, any labeling rule

should allow for alternative placement

of the warning on outer packaging or

other labeling.

FDA considered these concerns

during the drafting of this interim rule,

and the interim rule does allow such

alternative placement.

3. One comment suggested that the

phrase in the patient warning on

prescription drug labeling ‘‘[i]f you have

any questions about alternatives please

consult with your physician’’ was too

succinct and that the warning should

indicate that alternative delivery

systems for the drug product may be

available and that an alternative therapy

may not be necessary.

FDA believes that patients will

understand that the alternatives

available may include alternative

delivery systems for the same drug

substance and that any need for

additional clarity is outweighed by the

necessity of keeping this general

warning concise.

4. Another comment suggested that

the patient warning statement was not

sufficiently inclusive in directing

patients to contact their physician or

pharmacist. The comment suggested

that labeling refer to ‘‘physician or

health professional’’ so as to refer to

other health care professionals, such as

physician’s assistants or nurses, who

can and do provide patients with

information on drug products and

medical devices.

FDA agrees with this comment in

regard to OTC products. Health care

professionals, other than physicians and

pharmacists, are competent to advise

patients on OTC therapies. However, in

regard to prescription products, FDA

believes that, in such a brief warning,

the modification may cause confusion

and may cause consumers to direct

questions to health care professionals

other than the prescribing physician (or

other authorized prescribing

practitioner) and dispensing pharmacist.

In such event, the patient could receive

inadequate or inappropriate advice.

5. Several comments stated that the

physician package insert does not alert
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 20099

the physician to the fact that patients

have been instructed to consult with

their physician about possible

alternatives. Two comments suggested

that the warning on the physician

package insert contain the following

additional sentence: ‘‘The patient has

been instructed to consult with you if

they have questions about alternatives.’’

FDA agrees with the comment and

has reworded the warning in the

physician package insert with language

to that effect.

Another comment suggested that the

proposed OTC drug product warning

was unduly worrisome to consumers

and that a warning similar to the

alternative warning contained in patient

labeling for prescription products be

allowed for OTC drug products.

EPA’s regulations allow an exception

to the general rule of requiring the EPA

warning only on patient labeling for

prescription products when the EPA

warning is contained in the physician

labeling for the product. No similar

exception is provided for OTC drug

products; therefore, the warning

suggested in the comment would not be

in compliance with EPA regulations.

IV. Implementation Scheme

FDA advises applicants who have an

approved new drug application (NDA)

and whose products contain or are

manufactured with CFC’s or other

ozone-depleting substances to use the

existing procedures in 21 CFR 314.70(c)

(supplements for changes that may be

made before FDA approval) to notify the

agency of any labeling changes to add a

CFC warning statement. Applicants who

have an approved abbreviated new drug

application (ANDA) should follow the

same procedures (see 21 CFR 314.97).

Applicants who have submitted either

an NDA or ANDA but have not received

approval should, if necessary, amend

their applications to notify FDA about

the warning statement(s) they intend to

use. Applicants should submit such

amendments in accordance with 21 CFR

314.60 or 314.96, whichever is

appropriate.

Applicants who hold an approved

product license application (PLA) and

whose products contain or are

manufactured with CFC’s or other

ozone-depleting substances are to follow

the guidance offered in this interim rule.

Revision of labeling to accommodate

this warning statement may be

implemented without preclearance from

the Center for Biologics Evaluation and

Research (CBER) and submitted to the

file as final printed labeling provided

that the placement of such information

does not interfere with or render less

prominent any information required by

biologics labeling regulations (21 CFR

610.60 through 610.65)).

Applicants who have submitted a

PLA but have not yet received approval

should, if necessary, amend their

applications to notify CBER about

inclusion of the required warning

statement(s) they intend to use. Such

amendments should be submitted under

the applicable reference number.

Applicants who have submitted

premarket approval applications

(PMA’s) for medical devices but have

not received approval should, if

necessary, amend their applications to

notify FDA about the warning

statement(s) they intend to use.

Applicants should submit such

amendments in accordance with 21 CFR

814.37. With respect to approved

PMA’s, applicants should use the

procedures in 21 CFR 814.39 to notify

the agency of any labeling changes to

add a CFC warning. Applicants who

have received premarket clearance

pursuant to 21 U.S.C. 360(k) (‘‘510(k)

clearance’’) do not need to file a new

510(k) submission requesting new

clearance if this rule only results in the

addition of the warning statement to the

labeling.

FDA advises applicants who have an

approved new animal drug application

(NADA) and whose products contain or

are manufactured with CFC’s or other

ozone-depleting products to use the

existing procedures as identified in 21

CFR 514.8(e) (supplements for changes

which may be made before FDA

approval) to notify the agency of any

labeling changes made to add the CFC

warning statement. FDA advises

applicants who have submitted an

NADA but have not received approval

should, if necessary, amend their

applications to reflect the required label

warning. No notification to the agency

is necessary for foods, cosmetics, or

animal foods.

Manufacturers who amended their

labeling to conform with the June 29,

1993, notice and who have an approved

marketing application for their product

should submit a supplemental

application to bring their labeling into

compliance with this interim rule. Such

manufacturers may continue to use their

current stocks of labeling that comply

with the June 29, 1993, notice until

those stocks are exhausted.

V. Effective Date and Opportunity for

Public Comment

For the reasons described in this

section, FDA is issuing these

requirements as an interim rule with an

opportunity for public comment. In

view of the May 15, 1993, statutory

warning label requirement, the agency is

issuing these requirements at this time,

but FDA will consider modifications to

the regulations based on issues raised

during the comment period and

experience gained under the interim

rule.

The Administrative Procedure Act

provides an exception to notice and

comment rulemaking when an agency,

for good cause, finds that the notice and

comment procedures are impracticable,

unnecessary, or contrary to the public

interest (see 5 U.S.C. 553(b)(B)). For this

interim rule, FDA finds that notice and

comment procedures would be

impracticable for a CFC warning

statement requirement because the

Clean Air Act requires such warning

statements to be placed on products

containing or manufactured with CFC’s

or other ozone-depleting substances by

May 15, 1993.

FDA also finds that notice and

comment rulemaking to be unnecessary

and contrary to the public interest. The

interim rule permits parties to use the

EPA warning statement or an alternative

FDA statement. FDA has no authority to

change or modify the warning

statements established in EPA’s

regulations, and, in this interim rule,

offers, but does not require, the use of

an alternative statement. Consequently,

because one warning statement is

established by another agency and

because the alternative warning

statement is optional, FDA believes that

notice and comment procedures are

unnecessary. Furthermore, FDA believes

that, without the availability of the

alternative warning statement, patients

who are concerned about a medical

product’s impact on the environment

and public health might inappropriately

refrain from taking their medication.

This interim rule provides an alternative

warning statement that encourages

patients to continue taking their

medication and to consult their

physicians, pharmacists, other health

professionals, or, in the case of devices,

their suppliers, concerning the

product’s effect on the environment or

public health. It would, therefore, be

contrary to the public interest to delay

the implementation of this rule pending

notice and comment rulemaking.

FDA believes, however, that it should

invite and consider public comment on

its practices and procedures for these

CFC warning statements. Interested

persons may, on or before August 1,

1996, submit to the Dockets

Management Branch (address above)

comments regarding this interim rule.

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
20100 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

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.

VI. Analysis of Impacts

FDA has examined the impacts of the

interim 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 interim rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

interim 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. The regulatory impact analysis

(RIA) (January 1993) that accompanied

EPA’s rule that implemented section

611 of the Clean Air Act specifically

accounted for cost increases for

‘‘medical aerosols, including metereddose inhalation devices, contraceptive

foams, topical antibiotics, and local

anesthetics’’ (page 15 of the RIA). A

copy of this RIA is available for

examination under Public Docket No.

A–91–60 at the U.S. Environmental

Protection Agency, rm. M–1500,

Waterside Mall (Ground Floor), 401 M

St. SW., Washington, DC 20460. Other

FDA-regulated products are accounted

for under separate industry

subgroupings. The compliance costs for

these labeling changes have thus been

accounted for, and this interim rule

adds no additional burden or cost. Thus,

the agency certifies that the interim rule

does not constitute a major rule as

defined in Executive Order 12866. The

agency further certifies that the interim

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.

VII. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(11) 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.

List of Subjects

21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

21 CFR Part 201

Drugs, Labeling, Reporting and

recordkeeping requirements.

21 CFR Part 369

Labeling, Medical devices, Over-thecounter drugs.

21 CFR Part 501

Animal foods, Labeling, Packaging

and containers, Reporting and

recordkeeping requirements.

21 CFR Part 740

Cosmetics, Labeling.

21 CFR Part 801

Labeling, Medical devices, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, the Fair Packaging

and Labeling Act, and under authority

delegated to the Commissioner of Food

and Drugs, 21 CFR parts 101, 201, 369,

501, 740, and 801 are amended as

follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

2. Section 101.17 is amended by

revising paragraph (c) to read as follows:

§ 101.17 Food labeling warning and notice

statements.

* * * * *

(c) Food containing or manufactured

with a chlorofluorocarbon or other

ozone-depleting substance. Labeling

requirements for foods that contain or

are manufactured with a

chlorofluorocarbon or other ozonedepleting substance designated by the

Environmental Protection Agency (EPA)

are set forth in 40 CFR part 82.

* * * * *

PART 201—LABELING

3. The authority citation for 21 CFR

part 201 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 508, 510, 512, 530–542, 701,

704, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 355, 356, 357, 358, 360, 360b, 360gg–

360ss, 371, 374, 379e); secs. 215, 301, 351,

361 of the Public Health Service Act (42

U.S.C. 216, 241, 262, 264).

4. New § 201.320 is added to subpart

G to read as follows:

§ 201.320 Warning statements for drug

products containing or manufactured with

chlorofluorocarbons or other ozonedepleting substances.

(a)(1) All drug products containing or

manufactured with chlorofluorocarbons,

halons, carbon tetrachloride, methyl

chloride, or any other class I substance

designated by the Environmental

Protection Agency (EPA) shall, except as

provided in paragraph (b) or (c) of this

section, bear the following warning

statement:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and the

environment by destroying ozone in the

upper atmosphere.

(2) The warning statement shall be

clearly legible and conspicuous on the

product, its immediate container, its

outer packaging, or other labeling in

accordance with the requirements of 40

CFR part 82 and appear with such

prominence and conspicuousness as to

render it likely to be read and

understood by consumers under normal

conditions of purchase.

(b)(1) For prescription drug products

for human use, the following alternative

warning statement may be used:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or name of other class I substance,

if applicable]:

This product contains [or is

manufactured with, if applicable] [insert

name of substance], a substance which

harms the environment by destroying

ozone in the upper atmosphere.

Your physician has determined that this

product is likely to help your personal

health. USE THIS PRODUCT AS DIRECTED,

UNLESS INSTRUCTED TO DO OTHERWISE

BY YOUR PHYSICIAN. If you have any

questions about alternatives, consult with

your physician.

(2) The warning statement shall be

clearly legible and conspicuous on the

product, its immediate container, its

outer packaging, or other labeling in

accordance with the requirements of 40

CFR part 82 and appear with such

prominence and conspicuousness as to

render it likely to be read and

understood by consumers under normal

conditions of purchase.

(3) If the warning statement in

paragraph (b)(1) of this section is used,

the following warning statement must
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 20101

be placed on the package labeling

intended to be read by the physician

(physician package insert) after the

‘‘How supplied’’ section, which

describes special handling and storage

conditions on the physician labeling:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or name of other class I substance,

if applicable]:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and the

environment by destroying ozone in the

upper atmosphere.

A notice similar to the above WARNING

has been placed in the information for the

patient [or patient information leaflet, if

applicable] of this product under the

Environmental Protection Agency’s (EPA’s)

regulations. The patient’s warning states that

the patient should consult his or her

physician if there are questions about

alternatives.

(c)(1) For over-the-counter drug

products for human use, the following

alternative warning statement may be

used:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or other class I substance, if

applicable]:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

CONSULT WITH YOUR PHYSICIAN OR

HEALTH PROFESSIONAL IF YOU HAVE

ANY QUESTION ABOUT THE USE OF THIS

PRODUCT.

(2) The warning statement shall be

clearly legible and conspicuous on the

product, its immediate container, its

outer packaging, or other labeling in

accordance with the requirements of 40

CFR part 82 and appear with such

prominence and conspicuousness as to

render it likely to be read and

understood by consumers under normal

conditions of purchase.

(d) This section does not replace or

relieve a person from any requirements

imposed under 40 CFR part 82.

PART 369—INTERPRETATIVE

STATEMENTS RE WARNINGS ON

DRUGS AND DEVICES FOR OVERTHE-COUNTER SALE

5. The authority citation for 21 CFR

part 369 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 353, 355, 356, 357, 371).

§ 369.21 [Amended]

6. Section 369.21 Drugs; warning and

caution statements required by

regulations is amended in paragraph (d)

in the warning section for ‘‘DRUGS IN

DISPENSERS PRESSURIZED BY

GASEOUS PROPELLANTS * * *’’ by

removing the five undesignated

paragraphs after the introductory text of

paragraph (d).

PART 501—ANIMAL FOOD LABELING

7. The authority citation for 21 CFR

part 501 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

8. Section 501.17 is amended by

revising paragraph (c) to read as follows:

§ 501.17 Animal food labeling warning

statements.

* * * * *

(c) Animal food containing or

manufactured with a

chlorofluorocarbon or other ozonedepleting substance. Labeling

requirements for animal foods that

contain or are manufactured with a

chlorofluorocarbon or other ozonedepleting substance designated by the

Environmental Protection Agency (EPA)

are set forth in 40 CFR part 82.

PART 740—COSMETIC PRODUCT

WARNING STATEMENTS

9. The authority citation for 21 CFR

part 740 continues to read as follows:

Authority: Secs. 201, 301, 502, 505, 601,

602, 701, 704 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 352, 355,

361, 362, 371, 374).

10. Section 740.11 is amended by

revising paragraph (c) to read as follows:

§ 740.11 Cosmetics in self-pressurized

containers.

* * * * *

(c) Labeling requirements for

cosmetics packaged in a selfpressurized container containing or

manufactured with a chlorofluorocarbon

propellant or other ozone-depleting

substance designated by the

Environmental Protection Agency (EPA)

are set forth in 40 CFR part 82.

PART 801—LABELING

11. The authority citation for 21 CFR

part 801 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 507,

519, 520, 701, 704 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 357, 360i, 360j, 371, 374).

12. New § 801.63 is added to subpart

C to read as follows:

§ 801.63 Medical devices; warning

statements for devices containing or

manufactured with chlorofluorocarbons and

other class I ozone-depleting substances.

(a) All over-the-counter devices

containing or manufactured with

chlorofluorocarbons, halons, carbon

tetrachloride, methyl chloride, or any

other class I substance designated by the

Environmental Protection Agency (EPA)

shall carry one of the following

warnings:

(1) The EPA warning statement:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

(2) The alternative statement:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or other class I substance, if

applicable]:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

CONSULT WITH YOUR PHYSICIAN,

HEALTH PROFESSIONAL, OR SUPPLIER IF

YOU HAVE ANY QUESTION ABOUT THE

USE OF THIS PRODUCT.

(b) The warning statement shall be

clearly legible and conspicuous on the

product, its immediate container, its

outer packaging, or other labeling in

accordance with the requirements of 40

CFR part 82 and appear with such

prominence and conspicuousness as to

render it likely to be read and

understood by consumers under normal

conditions of purchase. This provision

does not replace or relieve a person

from any requirements imposed under

40 CFR part 82.

§ 801.425 [Removed]

13. Section 801.425 Nonrestricted

devices in self-pressurized containers

with chlorofluorocarbon propellants is

removed from subpart H.

14. New § 801.433 is added to subpart

H to read as follows:

§ 801.433 Warning statements for

prescription and restricted device products

containing or manufactured with

chlorofluorocarbons or other ozonedepleting substances.

(a)(1) All prescription and restricted

device products containing or

manufactured with chlorofluorocarbons,

halons, carbon tetrachloride, methyl

chloride, or any other class I substance

designated by the Environmental
20102 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

Protection Agency (EPA) shall, except as

provided in paragraph (b) of this

section, bear the following warning

statement:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

(2) The warning statement shall be

clearly legible and conspicuous on the

product, its immediate container, its

outer packaging, or other labeling in

accordance with the requirements of 40

CFR part 82 and appear with such

prominence and conspicuousness as to

render it likely to be read and

understood by consumers under normal

conditions of purchase.

(b)(1) For prescription and restricted

device products, the following

alternative warning statement may be

used:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or name of other class I substance,

if applicable]:

This product contains [or is manufactured

with, if applicable] [insert name of

substance], a substance which harms the

environment by destroying ozone in the

upper atmosphere.

Your physician has determined that this

product is likely to help your personal

health. USE THIS PRODUCT AS DIRECTED,

UNLESS INSTRUCTED TO DO OTHERWISE

BY YOUR PHYSICIAN. If you have any

questions about alternatives, consult with

your physician.

(2) The warning statement shall be

clearly legible and conspicuous on the

product, its immediate container, its

outer packaging, or other labeling in

accordance with the requirements of 40

CFR part 82 and appear with such

prominence and conspicuousness as to

render it likely to be read and

understood by consumers under normal

conditions of purchase.

(3) If the warning statement in

paragraph (b)(1) of this section is used,

the following warning statement must

be placed on the package labeling

intended to be read by the physician

(physician package insert) after the

‘‘How supplied’’ section, which

describes special handling and storage

conditions on the physician labeling:

Note: The indented statement below is

required by the Federal government’s Clean

Air Act for all products containing or

manufactured with chlorofluorocarbons

(CFC’s) [or name of other class I substance,

if applicable]:

Warning: Contains [or Manufactured with,

if applicable] [insert name of substance], a

substance which harms public health and

environment by destroying ozone in the

upper atmosphere.

A notice similar to the above WARNING

has been placed in the information for the

patient [or patient information leaflet, if

applicable] of this product under

Environmental Protection Agency (EPA)

regulations. The patient’s warning states that

the patient should consult his or her

physician if there are questions about

alternatives.

(c) This section does not replace or

relieve a person from any requirements

imposed under 40 CFR part 82.

Dated: April 16, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10961 Filed 5–2–96; 8:45 am]

BILLING CODE 4160–01–P