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 surprise for inorganic chemical manufacturers and importers who to date have not been required to provide extensive data sets for common chemicals already on the Toxic Substances Control Act (TSCA) Inventory. It is EPA's way to approach chemical management, rather than adopt the REACH approach now ongoing in Europe.
The IHPV program is just one of two enhancements EPA is proposing to the ongoing Chemical Assessment and Management (ChAMP) program. The other is a TSCA Inventory Reset. 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 will be in a position of coercive voluntarianism.
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 elemental and alloy substances, 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 supplies of feedstock remain uninterrupted.
What will it accomplish?
Alas, that is the $64,000 question (or perhaps with inflation it is now the $64,000,000 question). EPA clearly considers that the voluntary organic HPV program has been a success, despite the fact that much of it remains uncompleted more than 3 years after it was scheduled to end (which already included a 2 year extension). The non-profit group, Environmental Defense Fund, whose report "Toxic Ignorance" was the impetus for beginning the original HPV program in 1998, has given the program mixed reviews. The goal is to compile health and safety data on all of the highest production chemicals in use, with the ultimate objective of eliminating those that are excessively risky.
Will this do it? Is the EPA and industry credible in convincing the public that they are ensuring safety of all chemicals on the market? What do you think?
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