November 23, 1984

Mr. Steven Schatzow
Director
Office of Pesticide Programs
Environmental Protection Agency
Washington, D. C. 20460

Dear Mr. Schatzow:

This is in response to your letter of October 19, 1984, in which you expressed concern regarding the labeling provisions contained in the Occupational Safety and Health Administration (OSHA) final standard for ethylene oxide published June 22, 1984. We are in agreement with the contention, as expressed in your letter, that both legal and substantive conflicts presently exist between OSHA and Environmental Protection Agency (EPA) labeling provisions for ethylene oxide (EtO) that were not anticipated by OSHA. Specifically, OSHA agrees that failure to include an exception to the final EtO labeling requirements, as was included in the proposed rule, for registered pesticide products regulated by EPA has resulted in this conflict. It is our intent, therefore, to resolve this matter by amending the OSHA EtO final rule, as you have suggested, to include the following provision:

"The labeling requirements under this section do not apply where EtO is used as a pesticide, as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq), when it is labeled pursuant to that Act and regulations issued under that Act by the Environmental Protection Agency."

This exception was not adopted in the final EtO rule because OSHA had anticipated regulatory action by EPA that would have brought EPA's EtO labeling requirements into conformance with OSHA's, thus eliminating any foreseeable inconsistencies. Although EPA may in the future modify its requirements, OSHA agrees that it is necessary and appropriate at this time to administratively amend its EtO standard as discussed above. We intend to consult with EPA during development of this amendment.

Thank you for bringing this important matter to OSHA's attention.

Sincerely,



Gary A. Strobel
Special Assistant




October 19, 1984

Mr. Gary Strobel
Executive Director
Regulatory Review Committee
Occupational Safety and Health
Administration
Room S2316
200 Constitution Avenue, NW.
Washington, DC 20210

Dear Mr. Strobel:

I am writing to advise you of certain concerns which the Environmental Protection Agency has regarding one provision of the OSHA final standard concerning occupational exposure to ethylene oxide (EtO), 29 CFR 1910.1047, 49 FR 25796 et seq., June 22, 1984. The final standard for EtO includes a provision, 40 CFR 1910.1047(j)(1)(ii), which requires employers to "ensure that precautionary labels are affixed to all containers of EtO whose contents are capable of causing employee exposure at or above the action level." Although the proposed standard for EtO included an exception to this requirement for pesticide products registered and labeled pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the final standard deleted this exception. Thus, the OSHA final standard requires that further labeling be added to registered pesticide products containing EtO which currently bear labeling approved by EPA under FIFRA. Such a requirement poses both legal and substantive concerns.

To the extent that 1910.1047(j)(1) contemplates that the employer will be responsible for affixing additional labeling not included in the approved FIFRA labeling to individual pesticide containers, EPA believes that this provision is inconsistent with an existing statutory provision. Section 12(a)(2)(A) of FIFRA, 7 U.S.C. 136j(a)(2)(A), states, "It shall be unlawful for any person to detach, alter, deface, or destroy, in whole or in part, any labeling required under this Act." We believe that any employer or other user who affixes additional labeling to the container of a registered pesticide product would be violating this provision. While EPA could as a matter of prosecutorial discretion decline to apply this provision to user labeling when it is required by other Federal agencies, it is our view that permitting any alteration or amendment by a user of approved labeling for a registered pesticide product could have pernicious consequences. Label language is the principal mechanism by which EPA requires users of pesticide products to conform to the terms and conditions of registration.

In addition to this basic legal problem, EPA has an additional substantive concern about the specific label language which the OSHA EtO standard requires. Section 1910.1047(j)(1)(ii) requires that precautionary labeling for each affected product must, among other things, include the word "CAUTION." EPA Regulations, 40 CFR 162.10(h), establish specific requirements concerning the warnings and precautionary statements which must appear on pesticide labeling. A particular "human hazard signal word" is assigned to each pesticide depending on how it is classified with respect to toxicity. Ethylene oxide products fall within Toxicity Category I, the most stringent category, and must therefore state on the front panel of the label the signal word "DANGER." In contrast, the signal word "CAUTION" is utilized for products which fall within Toxicity Categories III and IV. In our experience, the human hazard signal word is one of the elements of the label with which applicators and users are most familiar. Because the human hazard signal word describes the intrinsic toxicity of a pesticide and thereby gives general guidance concerning the measure of care required in handling and using that pesticide, it is critical to avoid using signal words in a confusing manner. Indeed, 40 CFR 162.10(h)(1)(i)(E) expressly states that, "In no case shall more than one human hazard signal word appear on the front panel of a label."

For the reasons stated above, I hope OSHA will consider amending its final standard for EtO to include the exception to label requirements for registered pesticide products which was previously included in its proposed standard. Meanwhile, EPA is prepared to consult and cooperate with OSHA in developing an efficient and complementary approach to regulation of EtO products and their use. To this end, we are currently reviewing the approved labeling for pesticide products containing EtO to determine what changes may be required to facilitate implementation and enforcement of the OSHA standard.

Sincerely,



Steven Schatzow, Director
Office of Pesticide
Programs