EPA Won’t Issue Fourth Rule to Obtain Data on High Production Volume Chemicals

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By Pat Rizzuto  

Feb. 20 --The Environmental Protection Agency won't issue a fourth regulation requiring basic human health and environmental toxicity and physical-chemical data on high production volume (HPV) chemicals.

Obtaining and reviewing basic physical-chemical data along with human health and environmental toxicity data on the high production volume chemicals is a lower priority than are other efforts, the agency told Bloomberg BNA Feb. 14 in response to e-mailed questions.

The EPA will formally withdraw the regulatory package it proposed in 2011, which combined testing requirements and significant new use rules (SNURs), the agency told Bloomberg BNA Feb. 20 in an e-email.

The agency has not, however, developed a timeline for withdrawing those rules, the EPA said.

Until the new use rules are withdrawn, companies that make any of the 22 chemicals regulated under the proposed SNURs would have to report their exports of those compounds in accordance with Section 12(b) of the Toxic Substances Control Act, according to the agency. Export notifications are required on any chemical for which SNURs--or other regulations authorized by the new chemicals section of TSCA--have been proposed or promulgated, the EPA explains on its export notification website.

Risk Assessments Higher Priority

The EPA said one example of a higher priority is an initiative the agency launched in 2012 to assess and, if necessary manage, the risks of 83 chemicals .

The lower-priority regulation that the agency will formally withdraw is a proposal to combine--for the first time--two types of regulations .

The agency had proposed to regulate the chemicals through either a Section 4 test rule that would mandate basic health, environmental, and physiochemical data on the compounds, or through SNURs, which would restrict new uses of the chemical and not allow them until data needed to evaluate their safety was provided to the agency. SNURs are issued under Section 5 of TSCA.

EDF Disappointed

Richard Denison, a senior scientist with the Environmental Defense Fund, told Bloomberg BNA he was distressed to learn of the EPA's decision.

A report, Toxic Ignorance: The Continuing Absence of Basic Health Testing for Top-Selling Chemicals in the United States, which the Environmental Defense Fund released in 1997, and subsequent analyses by industry and the EPA, spurred the agency, the American Chemistry Council, EDF and animal welfare groups to develop a voluntary data-collection program for HPV chemicals .

Initially, with support from chemical trade associations, companies that did not voluntarily sponsor--provide the EPA with requested data--were to be compelled to do so through the follow-up HPV rules the agency agreed to issue.

Rule No Longer Needed

By 2011, when the EPA proposed its 4th HPV test rule, some companies and trade associations, such as the American Chemistry Council and the Society of Chemical Manufacturers and Affiliates (SOCMA), told the agency the rulemaking was no longer needed. By then the European Union's Registration, Evaluation and Authorization of Chemicals (REACH) regulation was in force.

The test rule proposal would require the development and submission of studies that, for certain substances, the European Chemicals Agency (ECHA) already is likely to possess or will receive in the near future under REACH, the American Chemistry Council wrote in comments on the 4th HPV proposal.

ECHA probably already has information on these test rule substances that would satisfy the EPA needs, SOCMA told the agency.

REACH has not, however, made data on chemicals as widely available as anticipated, chemical industry, EPA, ECHA and other officials have said in meetings Bloomberg BNA has attended in recent years.

Uncertainty on Data

Nor can the EPA--years after the HPV program was launched--say how much information the program has actually provided, nor describe the quality of that information, Denison said.

He referred to HPV data submissions that the Environmental Defense Fund tracked for years and recent statistics the agency provided Bloomberg BNA.

Of the 2,238 chemicals sponsored through the voluntary part of the HPV initiative, either the EPA or the Organization for Economic Cooperation and Development (OECD) received data for 1,843 chemicals, or 82 percent, the agency said.

However, the chemicals may not have complete data on each of the six types of human health and environmental characteristics, the EPA said. The six types of tests make up OECD's Screening Information Data Set (SIDS), a battery of tests designed to provide sufficient information to screen chemicals for potential human health or ecological concerns.

EPA does have a complete data set for 21 of the 44 HPV chemicals that were subject to the three test rules it has issued.

Testing is continuing for the remaining 23 HPV chemical substances, the agency said.


To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

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