EPA Has Received Data on Half of Chemicals Slated for Risk Assessments in 2013, 2014

By Pat Rizzuto  

Chemical manufacturers have provided the Environmental Protection Agency with data on half of the 18 chemicals for which the agency sought information for risk assessments in 2013 and 2014.

“Submissions have been received and posted to the docket on 1,1,2-trichloroethane, 1,2-dichloroethane, 4-tert-octylphenol, the four ethanone fragrance chemicals, 2,6-di-tert-butyl-4-sec-butylphenol, and 1-bromopropane,” EPA said in a Sept. 27 response to emailed questions. The agency has not posted additional information since that date.

EPA is processing a large data submission from the Silicones Environmental, Health, and Safety Council, which should be available soon, the agency told BNA.

“All of the information being received is being placed in docket EPA-HQ-OPPT-2011-0516 unless there are copyright concerns or claims of confidential business information,” EPA said.

The agency provided the information in response to questions about the status of data it has received for its June 1 request that chemical manufacturers provide information by Aug. 31 relevant to the risks 18 compounds may or may not pose to human health or the environment (36 CRR 608, 6/4/12).

The 18 chemicals were selected from a list of 83 compounds for which EPA's Office of Pollution Prevention and Toxics (OPPT) plans to conduct risk assessments over the next several years (36 CRR 269, 3/5/12).

OPPT intends to assess the risks of the 18 chemicals in 2013 and 2014.

Effort to Examine Chemicals on Market.

OPPT's risk assessment effort is part of the agency's initiative, announced in 2009, to increase its examinations of chemicals that are on the U.S. market and to regulate them when necessary (33 CRR 993, 10/12/09).

Some companies and trade associations have requested meetings with OPPT to discuss providing additional information about the 18 compounds, EPA said.

Scott Jensen, a spokesman for the American Chemistry Council, told BNA Oct. 4 that providing EPA with information on half of the 18 chemicals within the limited amount of time the agency gave manufacturers to respond demonstrates industry's interest and engagement with this effort.

ACC does not have specific information about why the agency has not received more information about additional chemicals, Jensen said. Some companies may not have information different from or in addition to what EPA already has, he said.

Further, companies may be sorting out data-ownership issues related to the European Union's REACH law (Regulation No. 1907/2006 on the registration, evaluation, and authorization of chemicals), he said.

The European Chemicals Agency is collecting extensive information about chemicals under that law. However, companies may not use that same data for other purposes unless they generated or otherwise own it or have rights to it based on agreements they signed with other manufacturers of the same chemical.

Exposure, Use, Toxicity Data.

Types of information EPA has received include exposure, use, and toxicity data or references to where such information can be found.

For example, the Rubber Manufacturers Association told EPA 4-tert-octylphenol is primarily used to make resins used in the interior portion and sidewall of tires to help prevent them from degrading.

The resins are not used in tire tread and therefore are not released into the environment through abrasion during the life of the tire, the group said.

The association referred EPA to several studies, including a Norwegian analysis of rubber crumb used as artificial turf infill. That study found “exposure to humans via inhalation, dermal, and ingestion pathways presented a low risk,” the association said.

Groups Provide Data on Tests.

The Alkylphenols & Ethoxylates Research Council provided EPA with information on three aquatic toxicity tests, which it said found “no adverse biological effects.”

The International Fragrance Association North America and Research Institute for Fragrance Materials provided EPA information on four fragrance chemicals: ethanone, 1-(1,2,3,4,5,6,7,8-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl)-4-sec-butyl-2,6-di-tert-butylphenol; ethanone, 1-(1,2,3,4,5,6,7,8-octahydro- 2,3,5,5-tetramethyl-2-naphthalenyl)-; ethanone, 1-(1,2,3,5,6,7,8,8a-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl)-; and ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl).

None of these chemicals is made or sold in the U.S. market as individual fragrances, the association and research institute said.

Rather they are constituents of another fragrance ingredient, called OTNE for its predominant isomer, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthyl)ethan-1-one, that increasingly is being used in Europe and North America. OTNE use increased in North America from 700 tons in 2000 to 2,800 tons in 2011, the fragrance association and institute said.

Groups Challenge EPA Findings.

The groups challenged EPA's preliminary conclusions about the aquatic toxicity, environmental persistence, and bioaccumulation potential of OTNE.

Models EPA uses to predict such characteristics suggest they pose much greater environmental hazards than are shown in studies, the fragrance association and institute said, providing references to that research along with a prepublication draft environmental risk assessment of OTNE.

Information EPA has received is available at Docket ID No. EPA-HQ-OPPT-2011-0516 via http://www.regulations.gov.

By Pat Rizzuto  

Comments from the Rubber Manufacturers Association are available at http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2011-0516-0022.

Comments from the Alkylphenols & Ethoxylates Research Council are available at http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2011-0516-0021.

Information from the International Fragrance Association North America and Research Institute for Fragrance Materials is available at http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2011-0516-0020.