EPA HPV Chemicals Program Start Date Extended To November 2001

The Environmental Protection Agency is extending by two years the start date of its Chemical Right-To-Know High Production Volume Challenge testing program, the agency announced at a stakeholders meeting in Washington, D.C. Nov. 8.

The new November 2001 start date is a result of concerns from Congressional members and animal welfare groups, including the Doris Day Animal League and People for the Ethical Treatment of Animals (PETA), that the testing program would duplicate earlier safety tests and require unnecessary testing on animals.

EPA opted to delay the inauguration of the HPV program, which originally was set for this month, to allow time for validation and approval of non-animal testing methods. Under the program, companies are asked to sponsor safety testing on 2,800 high-volume chemicals, including salicylic acid, lactic acid, ethyl alcohol and caffeine (¹ (Also see "EPA Requests Manufacturers Conduct Safety Testing On HPV Chemicals" - Pink Sheet, 25 Jan, 1999.)).

"Individual chemicals (i.e., those HPV chemicals not proposed for testing in a category) that require further testing on animals shall be deferred until November 2001," EPA states in an Oct. 14 letter to stakeholders.

"Testing of closed system intermediates, which present less risk of exposure, shall be deferred until 2003," EPA says. Companies should allow 120 days between the posting of test plans on the Internet for comment and implementation, the agency reminds participants.

Addressing the concern that additional tests may be duplicative, EPA urges the use of "existing and scientifically adequate" databases to "minimize further testing." A list of suggested sources includes National Toxicology Program Technical Reports, the Hazardous Substances Data Bank, Medline and screening data for substances on FDA's GRAS (generally recognized as safe and effective) list of food additives.

"Participants reviewing the adequacy of existing data for these chemicals should specifically consider whether the information available makes it unnecessary to proceed with further testing involving animals," EPA states. "Before generating new information, participants should further consider whether any additional information obtained would be useful or relevant."

Speaking at the stakeholders meeting, PETA Federal Agency Liaison Jessica Sandler said she is pleased with EPA's decision to accept information from international databases the agency "previously refused to recognize." PETA will continue to monitor test plans and urge companies to conduct thorough searches of databases and privately held files to "absolutely minimize the number of animal tests."

EPA also is promoting the development and scientific validation of non-animal alternatives through infusion of federal research dollars from the agency itself, the National Institute of Environmental Health Sciences and NTP.

NIEHS and NTP will commit at least $1.5 mil. in FY 2000 and $3 mil. in FY 2001 to such research, while EPA will provide an additional $250,000 this fiscal year and will seek a similar amount next year, according to the agency. The new funding is separate from monies earmarked for NIH's Inter-Agency Coordinating Committee for the Validation of Alternative Methods, EPA notes.

An advanced notice of proposed rulemaking on the HPV chemical program is expected to be published in the Federal Register by Dec. 1, with a proposed rule to follow. The proposed rule is under review by the Office of Management & Budget.

"The ANPR will review the framework of the program and talk about the connections to the rule," EPA Office of Pollution Prevention & Toxic Chemical Control Division Director Charlie Auer said.

"It will point to the proposed rule currently in progress as well as the possible need for additional test rules to the extent that there are other chemicals not included in the rule that remain unsponsored and if there are problems meeting commitments," Auer stated.

The agency has recruited sponsors for 1,176 of the chemicals from 221 companies and 60 consortia. Participating personal care companies include Procter & Gamble, Andrew Jergens, Dial and Henkel.

Companies have until Dec. 1 to voluntarily register for the program and sponsor the outstanding ingredients before participation becomes mandatory. The Nov. 10 stakeholders meeting, which was sponsored by the Doris Day Animal League, was the last in a series of five meetings. A second wave of stakeholders meetings will commence in February.