EPA Mandates Skin Absorption Tests

It is important for companies to understand the new tiered system to determine their regulatory obligations

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By Lynn Bergeson

On April 26, 2004, the United States Environmental Protection Agency (EPA) issued a final rule under the Toxic Substances Control Act (TSCA) requiring manufacturers and processors of 34 chemicals to conduct in vitro dermal-absorption-rate testing. OSHA has identified the data necessary for these chemicals and intends to use the data obtained under the rule to evaluate the need for "skin designations." Such skin designations alert employers, industrial hygienists and workers to the potential exposure to a chemical via absorption through the skin. A skin designation may result in changed workplace practices and enhanced personal protective equipment. The rule covers significantly more entities than previous TSCA rules. So, it is important for companies to understand the new tiered system to determine their regulatory obligations.

Broader testing

Firms that "manufacture or intend to manufacture, or process or intend to process" any chemical substance listed under the rule at any time from May 26, 2004, to the end of the test data "reimbursement period" are subject to the rule. This period begins when the last completed non-duplicative test is submitted to EPA and ends after an amount of time equal to that which had been required to develop the data, or five years, whichever is longer. TSCA requires "fair and equitable" reimbursement from manufacturers and processors for test costs incurred by those who are developing or submitting the data.

The test requirements will not apply to entities if the presence of a chemical cannot be ascertained "based on all information in your possession or control, as well as all information that a reasonable person similarly situated might be expected to possess, control, or know, or could obtain without an unreasonable burden."

Of significant interest, EPA has divided the companies subject to the rule into two tiers and set forth different regulatory obligations for the tiers.

Tier 1 entities are defined as those that manufacture or intend to manufacture a test rule substance, and that are not listed under Tier 2.

Tier 2 includes those firms not initially required to comply, and distinguishes between manufacturers and processors. Tier 2A entities are defined as those who manufacture or intend to manufacture a test rule substance solely as a byproduct; an impurity; a naturally occurring substance; a non-isolated intermediate; a component of a Class 2 substance (a variable-composition material or a complex combination of materials that separately can be considered a chemical substance); in amounts less than 1,100 lb (500 kg) annually; or in small quantities solely for research and development. Tier 2B entities are those that process or intend to process a test rule substance.

Tier 2A companies do not need to take any action unless no Tier 1 manufacturer notifies EPA of its intent to conduct testing, and EPA publishes a Federal Register notice directing Tier 2A entities to submit a letter of intent to test or an exemption application. Tier 2B entities need not take any action unless no Tier 1 or 2A manufacturer notifies EPA of its intent to conduct testing, and EPA publishes a Federal Register notice directing Tier 2B persons to submit a letter of intent to test or an exemption application.

Testing requirements

EPA mandates that the chemicals be tested according to the in vitro dermal-absorption-rate test standard set forth in the regulations implementing the final rule. The rule describes the procedures for measuring a permeability constant and two short-term absorption rates for liquid chemicals. EPA estimates that the total cost of providing test data on the 34 chemicals is about $34,000 per chemical.

Any firm that exports or intends to export one of the chemical substances identified in the final test rule is subject to the export notification requirements of TSCA Section 12(b).

Chemical Processing readers are advised to review the final test rule to assess whether and, if so, how it applies to their manufacturing operations.

Lynn Bergeson is a founding shareholder of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm concentrating on industrial and agricultural chemical, medical device and diagnostic product approval and regulation; product defense; and associated business issues. The views expressed herein are solely those of the author.

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