Hazardous Substances and Articles: Administration and Enforcement Regulations

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.

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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,

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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