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Title: 04/07/1986 - Labeling and MSDS requirements for product containing trace quantities of ethylene oxide.; Criterion that must be satisfied in order to assert that a product or operation is exempt for the EtO Standard
Record Type: Interpretation	Standard Number: 1910.1200; 1910.1047(a)(2)

April 7, 1986 Ms. Diana L. Wilbur Director of Safety The Mogul Corporation P. O. Box 200 Chagrin Falls, Ohio 44022 Dear Ms. Wilbur: This is in response to your letter of September 9, 1985, concerning the Occupational Safety and Health Administration's (OSHA) standards for ethylene oxide (EtO) (29 CFR 1910.1047) and for hazard communications (29 CFR 1910.1200). I apologize for the delay in responding to your inquiry.

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With regard to your first question, the ethylene oxide standard in 29 CFR 1910.1047(a)(2) states:

(2) This section does not apply to the processing, use, or handling of products containing EtO where objective data are reasonably relied upon that demonstrate that the product is not capable of releasing EtO in airborne concentrations at or above the action level under the expected conditions of processing, use, or handling that will cause the greatest possible release.

The criterion that must be satisfied in order to assert that a particular product or operation is exempt from the EtO Standard under paragraph (a)(2) can be found in 29 CFR 1910.1047(k)(l) which states:
1. Where the processing, use, or handling of products made from or containing EtO are exempted from other requirements of this section under paragraph (a)(2) of this section, or where objective data have been relied on in lieu of initial monitoring under paragraph (d)(2)(ii) of this section, the employer shall establish and maintain an accurate record of objective data reasonably relied upon in support of the exemption.

2. This record shall include at least the following information:
   1. The product qualifying for exemption;
   2. The source of the objective data;
   3. The testing protocol, results of testing, and/or analysis of the material for the release of EtO;
   4. A description of the operation exempted and how the data
   5. Other data relevant to the operations, materials, processing, or employee exposures covered by the exemption.

3. The employer shall maintain this record for the duration of the employer's reliance upon such objective data.

You state in your letter that your supplier of the surfactants that contain EtO has made the determination that their product is exempt from the standard pursuant to paragraph (a)(2). Your supplier, therefore, is required under 29 CFR 1910.1047(a)(3) to maintain the records of objective data required in paragraph (k)(l) to support their claim that their product is exempt. Since your company formulates new products from the surfactants, the expected conditions of processing, use, or handling of your products may be different from those envisioned by your supplier, and thus may result in different levels of employee exposure to EtO. Therefore, in order to establish that your products are exempt under the provisions of paragraph (a)(2), a determination must be completed in accordance with paragraph (k)(1). If the expected condition of processing, use, or handling for your products are similar to the conditions assumed by the supplier for their products, then the supplier's data could be used as the basis for your determination. Also, you are required under paragraph (a)(3) to maintain the records of the data used to support your exemption claims for your products. You are not required to supply this data to your customers.

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With regard to your second question concerning labels, if you determine that your products are exempt from the EtO standard, then the label specified in 29 CFR 1919.1947(j)(l)(ii) is not required, since paragraph (k)(l)(ii) states:

(ii) The employer shall 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.

Concerning the development of material safety data sheets (MSDS) for your products, the hazard communication standard, 29 CFR 1910.1200. If your products are mixtures which have not been tested as a whole for health hazards, the hazard determination is conducted in accordance with paragraph 29 CFR 1910.1200(d)(5)(ii), which states:
(ii) If a mixture has not been tested as whole to determine whether the mixture is a health hazard, the mixture shall be assumed to present the same health hazard as do the components which comprise one percent (by weight or volume) or greater of the mixture, except that the mixture shall be assumed to present a carcinogenic hazard if it contains a component in concentrations of 0.1 percent of greater which is considered to be a carcinogen under paragraph (d)(4) of this section;

With the products mentioned in your letter, EtO may not have to appear on the MSDS, since EtO is present in the products in quantities less than 0.1 percent (EtO is a carcinogen). However, paragraph 29 CFR 1910.1200(d)(5)(iv) states:
(iv) If the employer has evidence to indicate that a component present in the mixture in concentrations of less than one percent (or in the case of carcinogens, less than 0.1 percent) could be released in concentrations which would exceed an established OSHA permissible exposure limit or ACGIH Threshold Limit Value; or could present a health hazard to employees in those concentrations, the mixture shall be assumed to present the same hazard.

Therefore, if any study indicates that a health hazard to employees exist at low levels of exposure to EtO (viz.; below the action level), then EtO would have to be included on the MSDS.

We hope that this information will be helpful to you. If we can be of further assistance, feel free to contact us.

Sincerely,

John B. Miles, Jr., Director
Directorate of Field Operations

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September 9, 1985

Mr. John Miles
United States
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, NW
Room N3603
Washington, DC 20210

Dear Mr. Miles: We recently received data from our supplier of some surfactants, containing ethylene oxide (at less than 0.001% levels) that supports an exemption under paragraph (a) (2) of 1910.1047. Thus we will maintain it in support of an exemption for our formulating plants. But we wonder if our customers are obliged to keep this data as well. We formulate these surfactants into products in 5 to 15% weight concentrations. Certainly our supplier's data would support an exemption for our customers as well. Is it necessary for us to send this data to our customers in support of an exemption, or do they even need an exemption. It is my understanding that our label need not carry a "contains ethylene oxide" label, nor will the Material Safety Data Sheet need to indicate ethylene oxide as a hazardous ingredient, so they could conceivably never know thy were handling a product which falls under this standard. Was the intent of this rule to regulate users of products with low levels of surfactants? Please advise.

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Sincerely,

Diana L. Wilbur
Director of Safety

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The original official public domain version of this document is available from OSHA at XXXOSHAURL.