The Environmental Protection Agency (EPA) resorted to regulatory action to collect risk data for the 267 high production volume (HPV) chemicals that were not voluntarily sponsored by companies under the HPV program. These test rules—promulgated under the authority of the Toxic Substances Control Act (TSCA), Section 4—would require manufacturers, importers, and processers of HPV chemicals to submit similar data as stipulated in the voluntary program.
The first proposed testing rule for 37 HPV chemicals was published in December 2000. When finalized in 2006, the number of chemicals included in the first final rule was reduced to 17 based on new information on annual production volumes, worker exposure, and commitments to the voluntary HPV Challenge Program. Click here to read PETA’s April 2001 comments on the first proposed test rule. Click here for the EPA’s May 2005 response to comments on the first proposed test rule.
A proposed rule on the second group of chemicals that was published in 2008 for 19 chemicals was finalized in January 2011. In PETA’s October 2008 comments on this second test rule, PETA stated that extensive animal testing was still being proposed for HPV chemicals and that the animal welfare guidelines from the EPA’s 1999 “Letter to Manufacturers/Importers” were not being integrated into the new test proposals. Further, existing toxicological data that could reduce the number of animals required in new testing was still being ignored. In its final rule, the EPA cited PETA’s comments in withdrawing its requirements for reproductive and developmental toxicity testing for two chemicals, sparing more than 1,000 animals.
A proposed rule on the third group of chemicals that was published in early 2010 for 29 chemicals is expected to be finalized in 2011. PETA submitted comments in May 2010 on the third group of chemicals, repeating many of the same concerns that were outlined in the second test rule comments. A fourth proposed test rule is expected in 2011 for 46 chemicals.
In March 2005, the American Chemistry Council (ACC), in cooperation with the Soap and Detergent Association and the Synthetic Organic Chemical Manufacturers Association, announced an industry-led initiative to create an extended HPV (EHPV) program to include 574 newly designated HPV chemicals. These chemicals were not classified as HPV at the beginning of the program because they were not produced or imported in quantities of 1 million or more pounds. However, they reached qualification by the EPA’s 2002 Inventory Update Rule. The EHPV program also broadened the existing HPV program by asking companies to provide use and exposure data for EHPV and original HPV chemicals, in addition to the toxicological hazard data collected under the original HPV program.
The ACC included animal welfare guidance for EHPV in which it urged participants to “consider the likelihood of potential human and environmental exposures; make maximum use of appropriate chemical categories (including retro-fitting ‘new’ HPV chemicals into existing categories); conduct comprehensive searches for existing data; coordinate closely with producers and programs in other regions; and use validated non-animal methods where accepted and appropriate.” The ACC went on to state that “by incorporating a use and exposure component, the EHPV Program will provide the type of information necessary for sponsors to justify claims for a reduced data set.” ACC member companies received an additional abridged version of the animal welfare guidance developed by PETA and other animal protection groups that were based on practical experience from the original HPV program and that expanded upon the guidance provided at the start of the program.
Although some EHPV data has been submitted to the EPA, the future of the program is uncertain. With the inception of the European Union’s mandatory regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in 2007, many global manufacturers and importers of chemicals have shifted their focus to developing data for REACH with the hope that the same data can be used to meet U.S. requirements. In December 2010, the European Chemicals Agency and the EPA signed a Statement of Intent that will help with the sharing of data.
On the heels of the HPV program, the Chemical Assessment and Management Program (ChAMP) was created by the EPA in 2007 to screen approximately 6,750 chemicals that are produced or imported in quantities of 25,000 pounds or greater a year. Many of these chemicals include HPV chemicals. Using screening level–information, the EPA would prioritize each chemical as a risk-based prioritization (RBP) or a hazard-based prioritization (HBP). Based on these categories, if a chemical was considered to be of “high” or “medium” priority, the EPA would determine if further data collection or regulatory actions are needed. Under the ChAMP program, the EPA made 220 RBPs and 83 HBPs in March 2009. Additional measures under ChAMP included updating the TSCA inventory to ensure that all chemicals in the marketplace were accounted for as well as developing an HPV-like program for inorganic chemicals.
According to the EPA’s website, “ChAMP has been superseded by the comprehensive approach to enhancing the Agency’s current chemicals management program announced by Administrator Lisa Jackson on September 29, 2009.” One part of this comprehensive approach is the posting of action plans for chemicals of concern that summarize available hazard, exposure, and use information; outline the risks that each chemical may present; and identify steps that the EPA is taking to address those concerns. As of March 2011, action plans for only eight chemicals or groups of chemicals have been posted with two more in development. PETA is reviewing these action plans to ensure that any proposed animal testing is minimized.