96-10961. Warning Statements for Products Containing or Manufactured With Chlorofluorocarbons and Other Ozone-Depleting Substances  

  • [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]
    
    
    
    
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    Part VII
    
    
    
    
    
    Department of Health and Human Services
    
    
    
    
    
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    Food and Drug Administration
    
    
    
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    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
    
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    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
    
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    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
    
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    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
    
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    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
    
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    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
    
    

Document Information

Effective Date:
5/17/1996
Published:
05/03/1996
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Interim rule; opportunity for comment.
Document Number:
96-10961
Dates:
Interim rule effective May 17, 1996; comments by August 1, 1996.
Pages:
20096-20102 (7 pages)
Docket Numbers:
Docket No. 93N-0442
PDF File:
96-10961.pdf
CFR: (8)
21 CFR 101.17
21 CFR 201.320
21 CFR 369.21
21 CFR 501.17
21 CFR 740.11
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