[Federal Register Volume 61, Number 87 (Friday, May 3, 1996)]
[Rules and Regulations]
[Pages 20096-20102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10961]
[[Page 20095]]
_______________________________________________________________________
Part VII
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 101, 201, 369 et al.
Warning Statements for Products Containing or Manufactured With
Chlorofluorocarbons and Other Ozone-Depleting Substances; Interim Rule
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and
Regulations
[[Page 20096]]
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 Ozone-Depleting Substances
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim rule; opportunity for comment.
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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 ozone-depleting 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 Secs. 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 self-pressurized 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 (Sec. 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 Sec. 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
Sec. 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 Sec. 2.125(c). Further,
Sec. 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 Sec. 2.125(c).
FDA notes that all of the essential uses of CFC's exempted from the
adulteration and misbranding provisions of Sec. 2.125 that are listed
in Sec. 2.125(e) apply to drug products. No
[[Page 20097]]
essential uses of CFC's for foods, cosmetics, or animal foods in self-
pressurized 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 ozone-
depleting 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
ozone-depleting 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 Sec. 201.320 (21 CFR
201.320) provides both the EPA warning statement and FDA's alternative
warning statements. New Sec. 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 Secs. 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 ozone-depleting
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 Secs. 201.320(a) and 801.443(a)
provide the EPA warning statement quoted earlier in this preamble.
Under new Secs. 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 Secs. 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 Secs. 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 Secs. 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 Secs. 201.320 and 801.443 are consistent
[[Page 20098]]
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 Sec. 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
Sec. 801.63 (21 CFR 801.63). Under new Secs. 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
Secs. 101.17(c), 740.11(c), and 501.17 and the exemption for toppings
and spreads in Sec. 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
[[Page 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
[[Page 20100]]
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 metered-dose 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-the-counter 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:
Sec. 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 ozone-
depleting 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 Sec. 201.320 is added to subpart G to read as follows:
Sec. 201.320 Warning statements for drug products containing or
manufactured with chlorofluorocarbons or other ozone-depleting
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
[[Page 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 OVER-THE-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).
Sec. 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:
Sec. 501.17 Animal food labeling warning statements.
* * * * *
(c) Animal food containing or manufactured with a
chlorofluorocarbon or other ozone-depleting substance. Labeling
requirements for animal foods that contain or are manufactured with a
chlorofluorocarbon or other ozone-depleting 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:
Sec. 740.11 Cosmetics in self-pressurized containers.
* * * * *
(c) Labeling requirements for cosmetics packaged in a self-
pressurized 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 Sec. 801.63 is added to subpart C to read as follows:
Sec. 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.
Sec. 801.425 [Removed]
13. Section 801.425 Nonrestricted devices in self-pressurized
containers with chlorofluorocarbon propellants is removed from subpart
H.
14. New Sec. 801.433 is added to subpart H to read as follows:
Sec. 801.433 Warning statements for prescription and restricted device
products containing or manufactured with chlorofluorocarbons or other
ozone-depleting 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
[[Page 20102]]
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
