CRE Review of CPMA's Comments to EPA.

The Color Pigment Manufacturers Association (CPMA), a trade association representing small, medium and large color pigment manufacturers in North America, responded to EPA's HPV NPRM by raising several serious problems with the proposed rule. Many of CPMA's concerns are also relevant to the HPV challenge program. Specific problems with EPA's rulemaking cited by CPMA included:

• Lack of appropriate notice and comment on the testing guideline rules;
• Lack of practical utility from a number of required tests.
• Duplication of information otherwise available to the Agency.
• Failure to minimize burden on small businesses.

Lack of Public Comment on Testing Guideline Rules. The Administrative Procedure Act sets requirements that federal agencies must adhere to in rulemakings, including providing for public notice and comment. CPMA's comments:

• Object to EPA's use of final testing guidance rules that were promulgated without allowing the opportunity for appropriate public notice and comment. CPMA stated, "...EPA has attempted to foreclose any comment on the actual tests and procedures included in the tests that are required under a TSCA test rule..."



• Reject EPA's contention that establishing the guidelines did not impose a burden. The CPMA comments explain that the TSCA test guidelines, "create, in effect, a required standard that must be met by hundreds of companies..." Furthermore, CPMA notes that, "The TSCA developmental neurotoxicity and chronic toxicity protocol are two examples of extremely expensive tests with controversial requirements. To state that a Final Rule such as this poses a burden on no-one and therefore does not deserve a reasonable notice and comment rule making process is obviously not true."

Many Required Tests Lack Practical Utility. The Paperwork Reduction Act and Data Quality Act require that data collected and disseminated by the government have practical utility. However, CPMA points out that a number of the tests that would be required by the proposed rule lack practical utility since, "there are obviously compounds for which many of the SIDS endpoints EPA has adopted do not apply."

The NPRM Would Duplicate Information Otherwise Available to EPA. The PRA requires that information collections not be unnecessarily duplicative of information otherwise available to the Agency. CPMA's comments advise EPA that, "We strongly believe the best way to avoid unnecessary and redundant testing...is to review products on the market carefully with industry in order to determine which tests, if any, are required to characterize the substance..."

CPMA also states that, "The testing protocol for HPV substances should begin with an understanding of the subject chemicals. Without such analysis much of the proposed testing may be unnecessary, wasted effort and resources, merely proving characteristics previously identified and well understood..."

Although EPA provided a potential exception for not testing for known endpoints, CPMA points out that, "The EPA does not, however, substantiate this statement [that participants in the voluntary Challenge Program need not test for some endpoints under certain conditions]. We find no reasonable method by which human experience could meet the data adequacy as such is now defined and enforced by EPA in its comments on robust summaries filed to date."

EPA Failed to Minimize Burden on Small Businesses. The PRA requires that agencies reduce to the extent practical the reporting burden, including with respect to small businesses. Furthermore, the PRA directs agencies to establish differing compliance or reporting requirements or timelines taking into account the resources available to responding parties. However, CPMA's comments state that, "The economics and problems posed by small batch manufacturing are not reflected in the operation of the HPV program."

CRE Recommendations

• Rulemaking on Testing Guidelines. EPA should conduct a rulemaking, including providing notice and comment in accordance with APA requirements, on the TSCA test guidelines. Use of the guidelines should be reversed until such a rulemaking is completed.



• Convene a Small Business Impact Review Panel. In accordance with the requirements of the Regulatory Flexibility Act, EPA should convene an interagency review panel to assess the impact of the HPV testing program on small chemical companies, particularly those companies which use batch process manufacturing.

Read CPMA's Comments to EPA.

Read CRE comments on EPA's HPV Rulemaking.

Comment on Item