EPA Finalizes List of 109 Chemicals To Undergo Endocrine Disruptor Screening

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By Patrick Ambrosio

The Environmental Protection Agency has finalized a list of 109 chemicals and pesticide active ingredients for inclusion in the Endocrine Disruptor Screening Program, according to a notice published June 14 in the Federal Register (78 Fed. Reg. 35,922).

The listed chemicals, the second group of substances selected for inclusion in the EDSP, will undergo Tier 1 screening, a battery of tests designed to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems.

EPA said it focused on priority drinking water contaminants and pesticides, including substances included on the third Contaminant Candidate List, a set of contaminants that are not currently subject to any national primary drinking water regulations but may require regulation under the Safe Drinking Water Act. The finalized List 2 includes the chemicals perchlorate, benzene, and methanol, as well as 41 substances that are listed as pesticide active ingredients.

The notice specifies that List 2 should not be interpreted as a list of known or likely endocrine disruptors.

The agency developed the EDSP after Congress passed authorizing legislation in 1996. The first test orders for the program were issued in October 2009.

EPA to Consider Advisory Panel Report

The Environmental Protection Agency told BNA in a June 13 email that the agency does not anticipate issuing Tier 1 test orders for the new list of chemicals until it has received a report from the FIFRA Scientific Advisory Panel.

The federal advisory panel met in May to discuss the performance of the Tier 1 battery in the screening of the initial list of 53 active and inert pesticide ingredients that were selected for inclusion in the EDSP (37 CRR 618, 5/27/13).

EPA said a final report from the SAP is due to the agency in September. The agency will fully consider the recommendations included in that report prior to issuing any additional Tier 1 test orders.

Steven Bennett, senior director of scientific affairs and sustainability at the Consumer Specialty Products Association, told BNA in a June 13 email that his organization hopes that EPA will “apply lessons learned” from the initial round of tests before issuing test orders for the List 2 substances.

CSPA is one of the three industry organizations that filed a 2011 petition requesting that EPA complete a full analysis of data generated for the List 1 pesticides before moving ahead with test orders on additional substances (35 CRR 665, 7/4/11).

The American Chemistry Council said in a statement June 14 that the organization encourages EPA to “fully evaluate” the performance of the Tier 1 tests and make adjustments before testing additional chemicals. Any tests that do not perform as intended should either be revised or replaced with validated approaches before additional testing is conducted, ACC said.

Industry Group Urges Pesticide Removal

Clare Thorp, senior director of human health policy at CropLife America, issued a June 13 statement echoing the suggestion that EPA should refrain from issuing additional test orders until reviewing the SAP recommendations on List 1.

Thorp said testing the List 2 substances before completing a full evaluation of the SAP's recommendations on the Tier 1 battery could result in “excessive, unnecessary practices that afford no additional benefits to the protection of human health and the environment.”

Thorp also said pesticides that do not pose a concern under the Safe Drinking Water Act should not be included in List 2, since EPA stated the focus was on drinking water contaminants. Including the pesticides on List 2 could indicate to the public that the pesticides present a drinking water concern, even though the pesticides have been tested under the Federal Insecticide, Fungicide, and Rodenticide Act, according to Thorp.

CropLife America also suggested that pesticides included on List 2 because of their status in the registration review process should be removed, Thorp said.

“It would make more sense to issue the test orders for these compounds at the end of their individual registration review process, whenever that falls due,” she said. “This would allow sufficient time to incorporate the SAP's opinion, and any subsequent revisions to the Tier 1 screening guidelines.”

Substances Removed From Draft List

EPA removed a total of 25 substances that were originally included in a November 2010 draft list (34 CRR 1121, 11/22/10).

The agency re-evaluated the draft list and removed 21 chemicals for which the agency was unable to clearly identify a manufacturer, importer, or registrant and four chemicals that are not likely to be biologically active or are incompatible with the Tier 1 tests.

Removal from List 2 does not imply that EPA has no interest in exploring the potential for endocrine disrupting activity of the 25 substances, according to the notice.

EPA also published a notice outlining the agency's policies and procedures for screening List 2 chemicals (78 Fed. Reg. 35,909).

The document includes information on how EPA will determine who will receive a test order, how recipients can respond to test orders, and how test orders can be contested.

The agency said it will attempt to identify and issue orders to “all significant manufacturers and importers” of List 2 substances.

OPP Database to be Used

The Office of Pesticide Programs' information network, an internal database, will be used to identify technical registrants who hold a registration for a product containing a listed chemical as an active ingredient. Test orders will be issued to all identified technical registrants, according to the notice.

Additionally, EPA will rely on information reported under the Toxic Substances Control Act inventory update reporting rule and information in the Toxic Release Inventory database to identify test order recipients for List 2 chemicals that are not used as pesticide active ingredients.

EPA added that it plans to post a list of all List 2 test order recipients on its website once the orders are sent out.

The White House Office of Management and Budget will need to approve an information collection request authorizing EPA's data collection activity before the test orders can be issued, according to EPA. The agency has submitted requests to collect additional data under the EDSP, according to a separate notice (78 Fed. Reg. 35,903).

The notice finalizing the second list of chemicals to undergo Tier 1 screening is available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-14232.pdf.

The notice outlining EPA's policies and procedures for screening the chemicals is available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-14228.pdf.

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