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EPA Regulatory Actions for Unsponsored Chemicals
In the HPV Challenge Program, companies have sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts. Other chemicals, however, remained unsponsored in the voluntary program (6 pp., 42 KB, About PDF). Basic hazard data for these unsponsored chemicals are being obtained through regulatory efforts such as TSCA Section 4 Test Rules and TSCA Section 8(a)/8(d) Rules.
HPV TSCA Section 4 Test Rules
One regulatory strategy to collect additional HPV chemical information is through
TSCA Section 4 test rules. In order to promulgate a TSCA Section 4 test rule, certain risk-based and/or exposure-based findings for a chemical must be made as required by statute.
The first TSCA Section 4 Test Rule to collect chemical data for HPV unsponsored chemicals was issued on March 16, 2006 (71 FR 13708). This final rule required 52 manufacturers and processors of 17 HPV chemicals to conduct screening-level tests to collect physical/chemical properties, toxic effects data, and environmental fate information for these chemicals. On December 8, 2006, EPA issued a direct final rule that revoked testing requirements for one of the chemicals subject to the test rule (71 FR 71508).
The data obtained under the first test rule has provided critical information about 16 unsponsored chemicals, which will better enable the Agency to evaluate the potential risks of these substances and take any appropriate management actions regarding them. In addition to the first test rule, EPA is considering whether findings can be made to promulgate further TSCA Section 4 test rules for other unsponsored chemicals. A second test rule to obtain data for the next set of unsponsored HPV chemicals is slated for proposal in 2008, and a third test rule may follow for an additional group of unsponsored HPV chemicals.
HPV TSCA Section 8(a)/8(d) Rules
For chemicals that were unsponsored in voluntary portion of the program, EPA is collecting basic hazard data for these chemicals using regulatory efforts. A second regulatory option exists to collect health and environmental effects data for those unsponsored HPV chemicals for which statutory findings under TSCA Section 4 cannot readily be made. For those chemicals, EPA can request that the Interagency Testing Committee (ITC) add the chemicals to the TSCA Section 4(e) Priority Testing List. Based on the ITC listing, the Agency can then append the chemicals to a TSCA Section 8(a) Preliminary Assessment and Information Reporting (PAIR) rule and a TSCA Section 8(d) Health and Safety Data Reporting (HaSDR) rule.
Section 8(a) PAIR rules require producers and importers to submit to EPA one-time reports on production/importation volumes, end uses, and exposure-related data for the listed chemicals. Section 8(d) HaSDR rules require producers and importers to submit to EPA copies and lists of certain types of unpublished health and safety studies for the listed chemicals. Submitters under the HaSDR rule are also requested to provide robust summaries of health and environmental effects studies. Upon the receipt of HaSDR rule data, EPA will review all submitted chemical information for adequacy and make robust summaries of submitted data publicly available through HPVIS. Should information for any chemicals still be inadequate, EPA can evaluate PAIR rule data and other data to determine if findings can be made to include the chemicals in a TSCA Section 4 test rule.
A TSCA Section 8(a) rule (71 FR 47122) and a TSCA Section 8(d) rule (71 FR 47130) were issued on August 16, 2006, for 243 HPV chemicals that were not sponsored in the voluntary portion of the HPV Challenge Program. EPA later withdrew 33 of these chemicals from both the 8(a) PAIR and the 8(d) HaSDR rules in a final rule issued on September 29, 2006 (71 FR 57439). In a subsequent direct final rule issued on April 30, 2007, EPA removed two additional chemicals from the 8(a) PAIR and the 8(d) HaSDR rules (72 FR 21119). Data collected for the remaining chemicals are being reviewed by the Agency.