[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