[Federal Register Volume 61, Number 204 (Monday, October 21, 1996)]
[Rules and Regulations]
[Pages 54549-54551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26824]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500


Hazardous Substances and Articles: Administration and Enforcement 
Regulations

AGENCY: Consumer Product Safety Commission.

ACTION: Revocation of statement of policy.

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SUMMARY: The Commission revokes the statement of policy under the 
Federal Hazardous Substances Act that sets forth examples of a hazard 
warning label acceptable for containers of ethylene glycol-base 
radiator antifreeze. The examples contain first aid instructions--to 
induce vomiting--that are no longer appropriate.

DATES: The revocation is effective October 21, 1996. It applies to 
products introduced into commerce on or after October 21, 1996.

FOR FURTHER INFORMATION CONTACT: Mary Toro, Division of Regulatory 
Management, Consumer Product Safety Commission, Washington, D.C. 20207; 
telephone (301) 504-0400 ext. 1378.

SUPPLEMENTARY INFORMATION:

A. Background

    Radiator antifreeze containing ethylene glycol is a hazardous 
substance which must be labeled in accordance with the requirements of 
the Federal Hazardous Substances Act (``FHSA''). Before the Consumer 
Product Safety Commission (``the Commission'') existed, the Food and 
Drug Administration (``FDA'') was responsible for implementing the 
FHSA. When Congress established the Commission it transferred to the 
Commission the authority to administer the FHSA. 15 U.S.C. 2079(a). In 
1967, the FDA issued a policy statement describing two labels for 
ethylene glycol-base radiator antifreeze that would meet the labeling 
requirements of the FHSA. 16 CFR 1500.132. The suggested labeling 
provides:

WARNING--HARMFUL OR FATAL IF SWALLOWED

    Do not drink antifreeze or solution. If swallowed, induce 
vomiting immediately.

[[Page 54550]]

Call a physician. Ethylene glycol base. Do not store in open or 
unlabeled containers. Keep out of reach of children.

Id. 1500.132(b)(1) (emphasis added). A slightly different example (also 
containing the underlined first aid instructions) is provided for 
antifreeze containing between 0.01 percent and 1 percent of sodium 
arsenate. Id. 1500.132(b)(2). As explained below, the Commission 
believes that the underlined first aid instruction to induce vomiting 
is no longer appropriate for ethylene glycol.

B. FHSA Requirements

    Under section 2(p)(1) of the FHSA, a hazardous substance (such as 
ethylene glycol-base radiator antifreeze) that is ``intended, or 
packaged in a form suitable, for use in the household or by children'' 
must bear appropriate hazard labeling. 15 U.S.C. 1261(p)(1). A 
hazardous substance that does not bear the labeling specified by 
section 2(p)(1) of the FHSA is misbranded and its introduction or 
receipt in interstate commerce is a prohibited act under the FHSA, 15 
U.S.C. 1263, subjecting the violator to certain penalties, 15 U.S.C. 
1264.
    To satisfy section 2(p)(1), the label on such a hazardous substance 
must provide: the name and place of the manufacturer, packer, 
distributor or seller; the chemical name of the hazardous substance; 
the appropriate signal word; a statement of the principal hazard or 
hazards; precautionary measures; first aid instruction when appropriate 
or necessary; the word ``poison'' if appropriate; instructions for 
handling and storage if necessary; the statement ``Keep out of reach of 
children'' or, if intended for children, directions for protection of 
children. 15 U.S.C. 1261(p)(1) (A)-(J).
    In addition to these requirements, ethylene glycol-base radiator 
antifreeze is also subject to special labeling requirements issued 
under section 3(b) of the FHSA. 15 U.S.C. 1262(b). According to these 
requirements, ethylene glycol and mixtures containing 10 percent or 
more by weight of ethylene glycol must be labeled with the signal word 
``warning'' and the statement ``Harmful or fatal if swallowed.'' 16 CFR 
1500.14(b)(2). A product that does not meet these requirements would be 
considered misbranded and subject to penalties. 15 U.S.C. 1262(b) and 
1263.
    The statement of policy that the Commission is revoking sets forth 
examples of a hazard warning label for ethylene glycol-base radiator 
antifreeze that would meet the FHSA requirements. Although the 
Commission is not specifying an alternative labeling example at this 
time, manufacturers continue to be responsible for properly labeling 
their product so that it meets the requirements of section 2(p)(1) of 
the FHSA and the additional requirements at 16 CFR 1500.14(b)(1).

C. New Information

    At the time FDA published the example of hazard labeling for 
ethylene glycol-base radiator antifreeze, the most common technique to 
reduce gastrointestinal absorption of most ingested poisons was to 
induce emesis (vomiting) with syrup of ipecac. However, current medical 
information indicates that this practice is often ineffective in 
reducing absorption of a toxin when administered more than one hour 
after ingestion. In addition, syrup of ipecac may not be appropriate in 
certain circumstances (e.g., certain pre-existing medical conditions, 
or ingestion of caustics, petroleum distillates, or chemicals known to 
induce seizures). Thus, the use of syrup of ipecac has declined, and 
the American Association of Poison Control Centers, PoisIndex, and the 
American Association of Pediatrics now recommend consulting a medical 
professional before inducing vomiting for ingestion of any toxic 
substance.
    For the following reasons, inducing emesis with syrup of ipecac is 
particularly inappropriate when ethylene glycol has been ingested:
    (1) Ethylene glycol is absorbed rapidly with blood levels reaching 
their peak 1 to 4 hours after ingestion. Since syrup of ipecac requires 
20-30 minutes to produce vomiting, it would probably only be effective 
if administered immediately.
    (2) Because ethylene glycol can itself cause nausea and vomiting, 
syrup of ipecac would provide no additional benefit.
    (3) With recent improvements in diagnostic techniques and medical 
treatment, the drawbacks of administering syrup of ipecac in an 
individual case weigh more strongly than they would have previously.
    (4) Ingestion of ethylene glycol can produce central nervous system 
(CNS) depression and seizures. When these are combined with the 
multiple episodes of vomiting that syrup of ipecac can induce, the risk 
of serious injury increases.
    For these reasons, the Commission no longer believes that the first 
aid instruction to induce vomiting when ethylene glycol has been 
ingested is proper.

D. Appropriate Labeling

    As stated above, revocation of the labeling example does not 
relieve manufacturers of their obligation to label ethylene glycol-
containing products appropriately. The Commission believes that other 
aspects of the labeling example continue to be appropriate. However, 
labeling must provide an alternative first aid instruction. The 
Commission suggests the statement ``If swallowed, IMMEDIATELY contact a 
poison control center, emergency treatment center, or physician.'' This 
statement is simply one possibility, and similar statements would also 
be appropriate.
    The Commission is not issuing a statement of policy providing a new 
labeling example. Currently, CPSC staff is revising the Commission's 
Hazardous Substances Labeling Guide (the ``Guide''). The Guide was 
originally developed in 1979 to assist manufacturers and staff in 
devising warning labels that would meet the requirements of the FHSA. 
Since that time, changes have occurred in toxicity data and labeling 
practices. The staff is revising the Guide to reflect those changes. 
The Guide should be finalized in 1998 and will address labeling for 
ethylene glycol-base antifreeze as well as other products.

E. Revocation

    As explained above, the Commission is revoking the suggested 
labeling for ethylene glycol-base radiator antifreeze because the first 
aid instruction is no longer medically appropriate. The Administrative 
Procedure Act (``APA'') generally requires agencies to publish a notice 
of proposed rulemaking and provide an opportunity for the public to 
comment before issuing or revoking regulations. 5 U.S.C. 553(b) and 
(c). However, notice and comment is not required for statements of 
policy. Id. 553(b)(3)(A). Because the labeling examples at 16 CFR 
1500.132 were issued as a statement of policy, the Commission is not 
providing for notice and comment.
    Similarly, the APA generally requires that rules be published at 
least 30 days before their effective date. 5 U.S.C. 553(d). However, 
this is not necessary for statements of policy. Id. 553(d)(2). 
Therefore, this revocation takes effect immediately.

F. Implementation

    The Commission recognizes that manufacturers have relied on the 
warning label examples for many years and that these companies will 
need time to change their product labels. Thus,

[[Page 54551]]

although the revocation is effective immediately, the Commission will 
delay enforcement to coincide with the product's annual production and 
packaging period. According to information provided by the industry to 
CPSC staff, annual production of the antifreeze begins in May, and 
labels are generally ordered prior to production. Therefore, ethylene 
glycol antifreeze introduced into commerce after April 1, 1997 will be 
expected to bear appropriate first aid instructions that satisfy the 
FHSA requirements. Until that time, the staff will work with affected 
manufacturers to develop appropriate labeling. This delay should allow 
sufficient time for manufacturers to make appropriate labeling changes 
before marketing their 1997 products.
    If a manufacturer anticipates difficulty meeting this enforcement 
date, he or she may request additional time by writing to David 
Schmeltzer, Assistant Executive Director for Compliance, Office of 
Compliance, U.S. Consumer Product Safety Commission, Washington, D.C. 
20207. Such requests must provide a full explanation and justification 
of the need for additional time and documentation of claims that the 
firm would experience financial hardship meeting the April 1, 1997 
date.

Reference Documents

    The following documents contain information relevant to this 
rulemaking proceeding and are available for inspection at the Office of 
the Secretary, Consumer Product Safety Commission, Washington, Room 
502, 4330 East-West Highway, Bethesda, Maryland 20814.
    1. Briefing Memorandum with attached briefing package, October 1, 
1996.
    2. Memorandum from Susan Aitken, Ph.D., ESPS, to Mary Ann Danello, 
Ph.D., Associate Executive Director ESPS, ``Toxicity and Treatment of 
Accidental Ingestions of Ethylene Glycol'' May 28, 1996.
    3. Memorandum from Robert Ochsman, Ph.D, to Susan Aitken, Ph.D., 
ESPS, ``Revised Warning Labels for Radiator Antifreeze Containing 
Ethylene Glycol,'' June 5, 1996.
    4. Memorandum from Robert Franklin, EPSS, to Susan Aitken, Ph.D., 
ESPS, ``Antifreeze Market Information,'' August 16, 1996.
    5. Memorandum from Robert Poth, Director CRM, Office of Compliance, 
``Revised First-Aid for Ethylene Glycol Antifreeze,'' August 27, 1996.

List of Subjects in 16 CFR Part 1500

    Consumer protection, Hazardous materials, Hazardous substances, 
Labeling, Packaging and containers, and Toxic substances.

Conclusion

    Under the authority of section 553 of the Administrative Procedure 
Act and sections 2(p)(1), 3(b) and 10(a) of the Federal Hazardous 
Substances Act (15 U.S.C. 1261(p)(1), 1262(b), 1269(a)), the Commission 
amends part 1500 of 16 CFR chapter II as follows:

PART 1500--[AMENDED]

    1. The authority for part 1500 continues to read as follows:

    Authority: 15 U.S.C. 1261-1278.


Sec. 1500.132  [Removed and reserved]

    2. Section 1500.132 is removed and reserved.

    Dated: October 15, 1996.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 96-26824 Filed 10-18-96; 8:45 am]
BILLING CODE 6355-01-P