EPA Issues TSCA Rules to Regulate 243 "Orphan" HPV chemicals

Date: Aug 25, 2006

On August 16, 2006, the U.S. Environmental Protection Agency (EPA) published in the Federal Register two final Toxic Substance Control Act (TSCA) rules that require manufacturers and importers of 243 high production volume (HPV) chemicals to submit to the Agency any unpublished health and safety as well as production volume and exposure data. These rules are intended to capture HPV chemicals that no company had committed to sponsor during the voluntary HPV Challenge Program (i.e., "orphaned" chemicals). EPA had published a final TSCA section 4 test rule in March of this year requiring specific testing for 17 unsponsored chemicals. These data call-in requests are likely the beginning of a process under which EPA will publish additional section 4 test rules.

The first rule, a TSCA section 8(d) Health and Safety Data Reporting rule, requires manufacturers and importers to submit to EPA or list all unpublished environmental fate, health effects, and environmental effects studies on the listed 243 chemicals by November 14, 2006. Only studies in which the chemical is greater than or equal to 90% of the test substance by purity and that were conducted according to TSCA, FIFRA, OECD, or other internationally accepted test guidelines or consensus standards are subject to this requirement. In addition to the actual study report, EPA requests that a robust summary of each study be prepared and submitted (under the voluntary program companies only were required to submit the robust summaries and not the complete reports). Studies and summaries may be submitted in hard copy or, if desired, using the EPA's High Production Volume Information System (HPVIS).

The second rule is a TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule for the same 243 chemicals. The PAIR rule requires manufacturers and importers to submit to EPA a one-time report on general production/importation volume, as well as end use and exposure related information. Volumes are to be for the latest complete corporate fiscal year. A separate PAIR form must be completed for each substance and must be submitted by November 14, 2006.

Producers of any of the 243 listed chemicals have until August 30, 2006 to request that specific chemicals be withdrawn from the 8(d) or PAIR rules. However, they must provide a detailed rationale for withdrawal. For example, in some cases chemicals that were committed for sponsorship during the voluntary program may have been carried over into the new rules if documents have not yet been submitted or were submitted late in the process. Chemicals that are "no longer HPV" also should be eligible for removal from these rules.

Another important document was posted on the EPA HPV web site in August (www.epa.gov/chemrtk/pubs/general/hpvpolcy2.htm). EPA posted an amended policy indicating that EPA will still accept new voluntary "viable commitments" to the HPV Challenge for chemicals listed in the 8(d) and PAIR rules. However, companies must volunteer to sponsor these chemicals "within 14 days following publication" of the rules, i.e., by August 30, 2006. These "viable commitments" will allow EPA to remove the sponsored chemicals from the 8(d) and PAIR rules. Companies making these commitments have slightly less onerous data submission requirements; however, this information must still be submitted to EPA no later than 60 days past the effective date of the two rules. Since the effective date is September 15, 2006, companies would have until November 14, 2006 to submit robust summaries of all available studies and a testing plan for addressing data gaps.

If you would like additional information on the 8(d) and PAIR rules, the section 4 Final Test Rule, or any HPV-related issue, please contact Tom Berger at berger@khlaw.com or 202-434-4285.