No orphan left behind: Health and environmental NGOs support EPA’s proposed paired rules to address high production volume “orphan” chemicals

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

Environmental Defense Fund today submitted comments along with 15 other health, environmental justice and state and national environmental organizations, in support of EPA’s proposed rule to address the final batch of 45 “orphan” chemicals that were never sponsored under the agency’s earlier High Production Volume (HPV) Challenge Program.

An earlier post to this blog highlighted and applauded the novel, innovative and efficient approach EPA has proposed, which actually entails the coupling of two rules:

(1) a test rule for 23 of these HPV chemicals for which EPA can make the requisite exposure findings to require testing, combined with:

(2) a Significant New Use Rule (SNUR) for the other 22 HPV chemicals for which EPA cannot presently make such findings, which requires companies to notify EPA if their production or use of those chemicals changes so as to increase the potential for exposure and then warrant testing.

The comments we filed today reiterate our strong support for this approach – and propose that the same approach be extended to several additional batches of HPV chemicals that still lack a basic set of hazard data.

Background on the HPV Challenge Program

The HPV Challenge Program was initiated in 1998 to develop and make public a base set of hazard information on HPV chemicals:  those produced or imported in amounts of one million pounds or more per year.

The starting list for the program was the roughly 2,800 chemicals reported at HPV levels in the 1990 Inventory Update Reporting (IUR) cycle.  Although the HPV Challenge Program ultimately led to the sponsoring of approximately 2,200 chemicals, it by no means successfully addressed all HPV chemicals.  In addition to sponsored chemicals that have yet to be tested or for which incomplete data sets were provided (see our report card on the program here), hundreds of chemicals were never sponsored and came to be known as “orphan chemicals.”

EPA has slowly progressed in addressing those orphan chemicals that have continued to be produced at HPV levels, through this and three previous test rules published in the Federal Register.  When this fourth rule is finalized (hopefully including both a test rule and an accompanying Significant New Use Rule (SNUR)), EPA indicates that will conclude its efforts to address these orphan chemicals.  EPA has also indicated it may use this same paired-rule approach to address HPV chemicals reported in future cycles of the Chemical Data Reporting (CDR) rule for which a base set of hazard information is not publicly available.

Why we support the proposed rule

The final versions of previous test rules for earlier batches of HPV orphan chemicals were issued without an accompanying SNUR, and hence did not address those orphan HPV chemicals initially included in the proposed rule, but for which EPA was unable to make the exposure findings needed to justify issuance of a test rule under the Toxic Substances Control Act (TSCA).  That approach leaves open the possibility that production or use of such chemicals could expand in the future, perhaps presenting significant exposure potential, without EPA learning of such expansion in a timely manner and having the ability to require development of basic hazard information on those chemicals.  EPA needs sufficient information to screen such chemicals to determine if they may pose risks to human health or the environment.

Given that HPV chemicals are, by definition, produced in aggregate volumes equal to or greater than one million pounds per year, we strongly support the proposal that EPA – when unable at present to require testing – at least be able to review the risks associated with a significant new use of such a chemical before that new use is initiated.  Using the combination of a test rule and a SNUR is a more thorough approach to getting the information needed to identify the potential risks posed by these 45 chemicals, and will better allow EPA to fulfill its responsibility to protect human and environmental health from hazardous chemicals.

Suggested improvements to the proposed rule

While we strongly support the current proposed rule, we believe this same approach needs to be expanded to all other groups of chemicals that were originally included in the HPV Challenge Program, but for which a base set of hazard data has yet to be developed and made public.  While not all the chemicals in these groups are “orphans” under the program, the data gaps that remain for them even many years after the HPV Challenge Program has run its course are unacceptable and warrant urgent action.

In our comments, we argue that EPA should issue paired SNURs and test rules for each of the following additional groups of HPV chemicals that either were removed from, or have yet to be adequately tested under, the HPV Challenge Program:

  • A SNUR should be issued to require EPA notification of significant changes in production or use of those chemicals included in previous proposed rules on HPV orphan chemicals, but not retained in the corresponding final rules, due to a lack of sufficient evidence of substantial human exposure or environmental release.
  • A SNUR should also be issued for chemicals that were initially identified as being HPV, but were designated no longer HPV based on production volume data that emerged later through Inventory Update Rule (IUR) reporting; our concern with relying on those data is the infrequent, spotty nature of the reporting that compromises EPA’s ability to accurately capture their actual production volume.
  • A test rule should be issued for chemicals that were sponsored through the HPV Challenge Program (or a sister OECD program), but for which a base set of hazard information is still lacking; where EPA cannot make the requisite exposure findings to justify a test rule, a SNUR should be issued as EPA has proposed for the last batch of orphan HPV chemicals.

See our comments for all the details!


This entry was posted in Health policy, Regulation and tagged , , , , , . Bookmark the permalink. Both comments and trackbacks are currently closed.