U.S. Environmental Protection Agency New Chemicals Program PBT

Chapter 12

U.S. Environmental Protection Agency New Chemicals Program PBT Chemical Category Screening and Risk Management of New PBT Chemical Substances

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Kenneth T. Moss, Robert S. Boethling, J. Vincent Nabholz, and Charles M . Auer Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Washington, DC 20460

PBT chemical substances possess characteristics of persistence (P) in the environment, accumulation in biological organisms (bioaccumulation (B)), and toxicity (T) that make them priority pollutants and potential risks to humans and ecosystems. E P A has developed a category of PBT chemical substances, for the purposes of facilitating the assessment of new chemical substances under Toxic Substances Control Act (TSCA) section 5(e) prior to their entry into the marketplace. The category statement includes the boundary conditions, such as fish bioconcentration/bioaccumulation factors and environmental persistence values, that would determine inclusion in (or exclusion from) the category, and standard hazard and fate tests to address Ρ, B , and Τ concerns for the chemical substances fitting the category description. Chemicals exceeding the boundary conditions for Ρ, B, and T, based upon data or estimates from predictive tools and structure-activity relationships (SAR), will be identified for control as needed to reduce exposure, require testing to confirm a chemical's PBT status, and guide final regulatory action. Establishment of this category thus provides a vehicle by which the Agency may gauge the flow of PBT chemical substances through the T S C A New Chemicals Program and measure the results of its risk screening and risk management activities.

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U.S. government work. Published 2001 American Chemical Society

In Persistent, Bioaccumulative, and Toxic Chemicals II; Lipnick, R., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 2000.

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Background On November 17, 1998, the E P A published in the Federal Register a notice of availability and solicitation of public comment on a "Multimedia Strategy for Priority Persistent, Bioaccumulative, and Toxic Pollutants" (63 F R 63926). This Strategy formalizes a process for integration and coordination of Agency PBT-related activities under "an enduring cross-office system that will address cross-media issues associated with priority PBT pollutants" (see www.epa.gov/pbt/pbtstrat.htm). It was understood, however, that individual Agency program offices needed to operate within the parameters of their legislative mandates and established regulatory and policy frameworks. For some programs such as the Toxics Release Inventory under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA; Public Law 99-499, 42 U.S.C.A. § 11023) and the New Chemicals Program under section 5 of the Toxic Substances Control Act (TSCA; Public Law 94-469; 15 U.S.C.A. § 2604), actions involving PBTs are a historical reality and their experience has, in fact, largely shaped the Strategy. This chapter explores the development of technical criteria for a category of PBT chemical substances under the T S C A New Chemicals Program. The structure of the T S C A new chemicals review process and the tools used to implement it flow logically from its statutory purpose and suggest that the category approach outlined here is the most appropriate means of addressing potential concerns for substances possessing PBT characteristics.

Overview of the TSCA New Chemicals Process Under section 5(a) of TSCA, persons must notify E P A at least 90 days before manufacturing or importing a new chemical substance for non-exempt purposes. A new chemical substance, as defined in section 3(9) of T S C A , is any chemical that is not included on the Inventory compiled under section 8(b) of T S C A . Section 5 of T S C A gives E P A 90 days to review a Premanufacture Notice (PMN). However, the review period can be extended under section 5(c) for "good cause;" it may also be suspended voluntarily by the mutual consent of E P A and the P M N submitter. During the review period, the Agency may conclude that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health and environmental effects of that P M N substance, that the manufacturing, processing, distribution in commerce, use, or disposal of the substance may present an unreasonable risk of injury to human health or the environment, and/or that the P M N substance will be produced in substantial quantities and there may be significant or substantial human exposure to the substance or the P M N substance may reasonably be anticipated to enter the environment in substantial quantities. As a result, E P A may take action under section 5(e) or (f) to prohibit or limit the production, processing, distribution in commerce, use,


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and disposal of new chemical substances that raise health or environmental concerns, pending the development of testing necessary to address those concerns. If E P A has not taken action under section 5(e) or (f), the P M N submitter may manufacture or import the new chemical substance when the review period expires. No later than 30 days after the P M N submitter initiates manufacturing or importing, it must provide E P A with a notice of commencement of manufacture or import. Section 8(b) of T S C A provides that, upon receipt of such a notice, E P A must add the substance to the T S C A Inventory. Thereafter, other manufacturers and importers may engage in activities involving the new substance without submitting a P M N , unless the Agency has used its Significant New Use Rule (SNUR) authority under section 5(a)(2) to designate that a use of a chemical substance is a "significant new use." Section 5(a)(1)(B) of T S C A would then require persons to submit a Significant New Use Notice (SNUN) to E P A at least 90 days before they manufacture, import, or process the substance for that use. The required S N U N provides E P A with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs. More information on the T S C A new chemicals program is available through the Internet at www.epa.gov/opptintr/newchms.

History Since 1979, E P A has reviewed over 30,000 T S C A section 5 submissions for new chemical substances. During the intervening years, E P A has implemented various initiatives which have enabled the Agency to review a greater number of new chemicals more efficiently. In 1987, for example, EPA's Office of Toxic Substances (now the Office of Pollution Prevention and Toxics) first used its accumulated experience to group chemical substances with similar physicochemical, structural, and toxicological properties into working categories (Ref. 1; see also www.epa.gov/opptintr/newchms/chemcat). These categories, including the subject one for P B T chemical substances, are developed by E P A based on available data and experience reviewing PMNs on similar substances. Such groupings enable both P M N submitters and E P A reviewers to benefit from the accumulated data and decisional precedents and to facilitate the assessment of new chemical substances. Establishment of this P B T category alerts potential P M N submitters to possible assessment or regulatory issues associated with P B T new chemicals review. It also provides a vehicle by which the Agency may gauge the flow of PBT chemical substances through the T S C A New Chemicals Program and measure the results of its risk screening and risk management activities for this category of chemical substances; as such, it is a major element in the Agency's overall strategy to further reduce risks from P B T pollutants.



141 Development of this T S C A new P B T chemicals policy has occurred in coordination with US national, US/Canada binational, and international efforts to identify and control the environmental release of persistent organic pollutants (POPs). The P B T category description, in the form of an October 5, 1998 proposed Federal Register policy statement (63 F R 53417), was provided to the United Nations Environment Program (UNEP) Governing Council's Criteria Expert Group (CEG) for POPs, established at the first session of the Intergovernmental Negotiating Committee (INC). The C E G is an open-ended technical working group with a mandate to present to the INC proposals for science-based criteria and a procedure for identifying additional POPs as candidates for future international action. The C E G is to incorporate criteria pertaining to persistence, bioaccumulation, toxicity and exposure in different regions and should take into account the potential for regional and global transport, including dispersion mechanisms for the atmosphere and the hydrosphere, migratory species and the need to reflect possible influences of marine transport and tropical climates. At its first meeting, October 26-30, 1998 in Bangkok, the C E G recommended that the INC consider developing a provision encouraging countries and regions to include in their new chemicals schemes elements relating to development and introduction of new chemical POPs. The U S described its proposed TSCA P B T new chemicals category, and the full text of the October 5, 1998 policy statement was distributed to all delegations as a Conference Room Paper. The second meeting of the INC (January 25-29, 1999 in Nairobi) accepted the C E G ' s recommendation and will consider it further in its deliberations. At the third meeting of the INC (September 6-11,1999 in Geneva) additional discussion occurred on a proposed provision concerning the review of new chemicals and the consideration of persistence, bioaccumulation and toxicity in that review. The final policy statement on this PBT category was published in the U S Federal Register on November 4, 1999 (64 F R 60194) and represents the first formal statement of US national policy regarding new chemical POPs. Under our domestic program, the policy statement provides guidance criteria for persistence, bioaccumulation and toxicity for new chemicals and advises the industry about our regulatory approach for chemicals meeting the criteria. Internationally, the October 5, 1998 proposed policy statement alerted the parties involved in negotiation of the POPs Convention to the need for inclusion of a new chemicals provision in the Convention. The issuance of the final policy statement reaffirms US leadership on this issue and serves as a model for other countries in taking steps to discourage the introduction of POPs as new chemicals and pesticides.

Evaluation Criteria and Process for PBT Chemical Substances Generally, persistent bioaccumulators are chemical substances that partition to water, sediment or soil and are not removed at rates adequate to prevent their bioaccumulation in aquatic or terrestrial species. E P A has developed the following specific identification criteria and associated process for use in evaluating new chemical


142 substances. The category description draws upon ongoing international efforts as well as Agency efforts to craft a coordinated and scientifically supportable approach to identifying PBT chemical substances. NEW CHEMICALS PROGRAM PBT CATEGORY CRITERIA


T S C A Section 5 Control Action Level

Persistence (transformation half-life in aquatic environment) Bioaccumulation* (Fish B C F or B A F ) Toxicity

Moderate

High

>2 months

>6 months

>1000

>5000

Develop toxicity data where necessary, based upon various factors, including concerns for Persistence, Bioaccumulation, other physical/chemical factors, and toxicity.

* Chemicals must also meet criteria for M W (< 1000) and cross-sectional diameter (

U.S. Environmental Protection Agency New Chemicals Program PBT

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