Date: Jan 05, 2009
On November 25, 2008 the U.S. Environmental Protection Agency (EPA) released its Proposed Approach for the Inorganic High Production Volume (IHPV) Challenge Program. This new IHPV program picks up on the theme of the voluntary HPV Challenge program, but may be an unexpected hardship for inorganic chemical manufacturers and importers who to date have not been required to provide extensive data sets for common chemicals already on the TSCA Inventory.
The IHPV program is just one of two enhancements EPA is proposing to the ongoing ChAMP program. The other is a TSCA Inventory Reset, which is discussed in the document found at http://www.khlaw.com/showPublication.aspx?show=2318. The EPA proposals are available at http://www.epa.gov/champ/.
EPA's proposed program is based on the design of the HPV Challenge program, which began in 1998 and was focused on organic high volume chemicals. Inorganic chemicals were specifically exempted from the original US HPV program (though some were included in the ICCA HPV program in Europe). During the HPV Challenge, industry compiled and summarized the available physical, chemical, and health and safety data for around 2200 organic chemicals. EPA considers this program a success, and it served as the basis for the ChAMP program, where EPA is using the compiled HPV data to develop hazard and risk characterizations and priorities for more in-depth analysis. By proposing to include the IHPV program as part of ChAMP, EPA is signaling that it believes the time has come to assess inorganic HPV chemicals in the same way that it looked at organic chemicals.
The Proposed IHPV Approach
There are three phases to the proposed program:
Phase I: IHPV Challenge: Develop, launch and sign-up (now through December 2009)
In this phase, IHPV chemicals will be identified by EPA and affected manufacturers and importers will be asked to "volunteer" to sponsor chemicals. While technically voluntary, EPA has indicated that it plans to initiate Section 4 and 8 rulemaking under TSCA to obtain information on unsponsored chemicals. EPA has issued two Section 4 final rules for unsponsored organic HPV chemicals, as well as Section 8 rules to request information on additional unsponsored chemicals, with more rules in development. So companies in effect are being given the choice of volunteering now or conduct more extensive testing later under regulatory mandate.
Phase II: Receive/Review Data: (~2010-2013)
Following closely on the organic HPV program, companies will compile and submit data on the physical/chemical properties, environmental fate, ecotoxicity and toxicity for each chemical. Modifications to the standard OECD screening level data requirements will be necessary in many cases since inorganic chemicals, especially metals and alloys, may not be amendable to standard test methodologies. As with the original HPV program, companies will find that forming consortia for related inorganic chemical substances provides the most advantageous means of collecting, compiling, and evaluating the data.
Phase III: Assessing and Reducing Risks (~2103-2015)
This third phase falls mainly within the responsibility of EPA as they use the compiled data to develop Risk Based Prioritizations (RBPs). Since the OECD screening data set focuses on provision of hazard data, EPA plans to rely on the 2011 IUR exposure data for inorganic chemicals in order to develop its RBPs. Based on the RBPs, EPA would initiate any action they deemed necessary, which could include rulemaking, restrictions, or requests for additional data. Finally, this third phase is also expected to include the development of Hazard Based Prioritizations (HBPs) for Moderate Production Volume (MPV) inorganic chemicals (i.e., those greater than 25,000 lbs but less than 1 million lbs per year).
Who is affected?
EPA defines inorganic chemicals according to the TSCA Inventory Update Rule (IUR) as substances that do not contain carbon, or contain carbon only in the form of carbonato [=CO3], cyano [-CN], cyanato [-OCN], isocyano [-NC], or isocyanato [-NCO] groups, or the chalcogen analogues of such groups. Thus, chemical substances following under the program would include metals, ammonia, minerals, and inorganic salts. Manufacturers or importers of these substances in the US in volumes greater than 1 million pounds would be asked to participate in the program. In addition, downstream users of these chemicals may also want to participate to assure that their supply of critical feedstock remain uninterrupted.
How can Keller and Heckman be of assistance to inorganic chemical manufacturers and importers?
Keller and Heckman has extensive experience and expertise in chemical control matters arising under the Toxic Substances Control Act (TSCA), as well as the voluntary HPV Challenge programs in the US and Europe. Several of our partners, many of whom have technical backgrounds and industry experience, have been involved with TSCA since its enactment some 30 years ago. Along with our legal staff, we have a preeminent in-house scientific staff conversant with all chemical control issues. Our unique combination of strong scientific and legal skills enables us to creatively address and resolve the complex TSCA issues that our clients continually face. Specific expertise relevant to the IHPV program includes:
Drafting consortium agreements: Keller and Heckman has drafted a large number of pre-consortia and consortia agreements under both the HPV Challenge and the REACH registration process. Based on our experience, a pre-consortium agreement is sometimes advantageous to preserve confidentiality and ensure the appropriate division of responsibilities and costs. A full consortium agreement will also be necessary to define the roles and responsibilities of the consortium members once the project is underway. The first step is to draft a consortium questionnaire that can be used to determine individual member company preferences for various consortium structure options. The next step is to draft the consortium agreement based on the questionnaire responses received from consortium member companies. Keller and Heckman has done this for dozens of consortia. While the US IHPV program itself does not foresee data having compensable value, any existing or newly conducted studies may possibly be compensable under the ongoing REACH program in Europe or in other REACH-type testing programs that may develop elsewhere. Therefore it is critical to pay close attention to how data ownership is determined within the constructs of the consortium.
Consortium management: Managing the consortium effectively is a critical element of its ability to successfully achieve the goals of the consortium, as well as those of the individual member companies. Keller and Heckman staff have managed the administrative and/or technical aspects of many consortia, with our involvement encompassing at least 20 consortia in the HPV, SIDS, BPD, PPP, and other regulatory arenas.
Technical advisors/data review: Keller and Heckman have served as technical advisors for well over 25 consortia. Our activities have included collection of data, performance of literature reviews, preparation of dossiers, evaluation of data quality using Klimisch criteria, preparation of robust study summaries, development of strategic test plans and waivers, conductance of any relevant exposure assessments, and preparation of hazard and risk assessments. Unlike some providers who simply input data, we have a reputation for understanding the complexities of the data, identifying potential technical issues while they still can be addressed, and providing added value to the technical program because of our greater understanding of the science.
Specific expertise with inorganic HPV chemicals: Inorganic chemicals differ significantly in many ways from organic chemicals. Many of the standard physical/chemical and environmental fate properties routinely tested for organic chemicals are either not relevant or are not easily testable for inorganic chemicals. The issue of speciation is also one that requires additional expertise when evaluating ecotoxicological and toxicological properties. We currently are working with several metals consortia for REACH compliance. We also conducted an extensive HPV evaluation for nearly two dozen inorganic fertilizer materials, which included data collection and dossier development.
Expertise with related chemical control programs: Keller and Heckman lawyers and scientists are experienced in the requirements and activities of chemical control programs worldwide. Therefore, we can readily determine how these other programs, for example the Canadian prioritization program and REACH in the EU, will impact both the organization of consortia and the availability and evaluation of data.
The Keller and Heckman IHPV Team
Keller and Heckman has a full staff of lawyers and scientists to assist companies in every facet of the new IHPV program. We can assist individual companies in determining their obligations under the program, as well as help identify partners for consortium formation. We can then prepare the consortium agreements and negotiate specific terms for membership, including how any data provided will be handled vis-a-vis their compensability in the related REACH activities of some consortium members. Keller and Heckman also provides full scientific services to ensure the best technical presentation of the data and any issues that might arise in the ongoing risk characterization process. A full listing of relevant lawyers and scientists can be found on our web site at Keller and Heckman Chemical Control Practice.