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On April 15th congressional leaders were busy announcing legislation to tighten chemical regulatory policy in the U.S. The House of Representatives released a discussion draft of legislation to revise the Toxic Substances Control Act while the Senate released a draft bill to enact changes to the primary chemical control law that has been in effect since 1976. The draft legislation would appear to steer away from nano-specific regulations but many of the proposed changes will deeply impact the nanotechnology community. Recent presentations by EPA officials provide a richer understanding of the changes taking place within the Agency's approach to chemical regulatory policy and more specifically, where nanomaterials fit into that policy.
April 15th, 2010
2010 To Be a Busy Year for Regulation of Nanotechnology
For some time now the Environmental Protection Agency (EPA) has been evaluating its enforcement options for nanomaterials and it seems that 2010 will be the year that regulatory activities hit their stride.
EPA Administrator Lisa Jackson's speech to the Commonwealth Club of San Francisco in September set the tone for the Agency's 2010 regulatory plans by laying out principles for the safety assessments of chemical substances. The principles include: filling data gaps in health and safety data on high production volume chemicals; increased transparency of EPA risk regulatory decisions; increased reporting on nanoscale materials and increasing the public's access to information about chemicals.
More Nanomaterial Safety Data Needed
This theme was repeated several times by virtually every EPA speaker at the GlobalChem Conference recently held in Baltimore, MD. Jim Jones, Deputy Assistant Administrator of the Office of Prevention, Pesticides and Toxic Substances, reinforced Jackson's principles by indicating the Agency will strive to make risk-based regulatory decisions but reiterated that manufacturers should be responsible for providing safety data on new and existing chemical substances. He said green chemistry should be encouraged and provisions assuring transparency and public access to safety information should be established. Not wanting to miss an opportunity to garner fiscal support for the Agency's efforts, he also suggested the EPA "should be given a sustained source of funding for implementation."
Wendy Cleland-Hamnett, Director of the Office of Pollution Prevention & Toxics indicated that 2010 would be a very busy year for the Agency. She said there would be an "enhanced program" of new regulatory risk actions and she specifically called out lead, mercury, formaldehyde, PCBs, glymes and nanomaterials. Citing "disappointing results" for the voluntary Nanoscale Materials Stewardship Program (NMSP), Cleland-Hamnett detailed regulatory risk actions under development to ensure that existing nanomaterials receive appropriate regulatory review including: Section 5 SNURs; Section 8 Mandatory Data Submission; and Section 4 Test Rules.
Enforcement on Becomes a Priority
The EPA didn't get what it wanted in the way of a response to the NMSP and was disappointed that the submissions relied on existing information without many commitments to develop new safety data. As a result, regulations are under development to get the data needed for science-based decision-making.
The EPA Hot Topics session at GlobalChem drew overflow crowds of people wanting to gain a better understanding of the Agency's front-burner issues and they were not disappointed. Jim Willis, Director of the OPPT's Chemical Control Division provided insight on the reasons for disappointment in the NMSP submissions.
With 31 companies making submissions, 132 unique nanomaterials were identified (12 of 14 materials covered by the Organisation for Economic Co-operation and Development (OECD)) but only 58 TSCA chemicals were listed in the submissions.
To strengthen the existing data set for nanomaterials, Willis indicated there will be several steps taken by the Agency this year: Significant New Use Rules (SNURs) for any new nanomaterials on chemicals listed on the TSCA inventory; Section 4 Test Rules for data development needs; Section 8(a) rules to fill targeted data gaps for certain nanomaterials already on the market; and Strong engagement in international work, states and other federal agencies.
To assist the EPA with its decision-making, Willis suggested the need for specific tools to evaluate the safety of nanomaterials including: Predictive tools; Decision analysis tools; and Life-cycle analysis tools.
Surprisingly, the EPA has been quietly taking enforcement actions against nanomaterial producers over the last year. Two-thirds of all enforcement actions taken by the Agency last year fell into this category according to Michael Bellot, Chief of the Chemical Risk and Reporting Enforcement Branch in the Office of Enforcement and Compliance Assurance.
The regulatory actions planned in 2010 will be augmented with increased penalties of up to $37,500 per violation. To give enforcement officials even more ammunition, the Agency is planning to go after all economic benefits received from noncompliance in addition to the fines.
Confidential Business Information Claims Will Be Impacted
Just about anything on a Premanufacture Notice (PMN) submission can be claimed as confidential business information (CBI) but past failures on the part of EPA officials to challenge these claims may result in an overhaul to the Agency's CBI policies.
Scott Sherlock, Attorney Advisor for EPA's Environmental Assistance Division, spoke about the CBI difficulties encountered by the Agency in recent years. Citing regulatory restrictions and resource limitations, Sherlock said "CBI changes are necessary and appropriate to increase scrutiny of EHS data submissions for new and existing chemical substances."
In the last 165 filings confidentiality has been claimed for the CAS number or chemical substance name for 95 submissions. Future submissions will be different, however, as Sherlock announced that company names, contacts, and site addresses may no longer be considered confidential information. PMN submitters will need to scrutinize submissions for CBI claims and the EPA has asked that companies review previous CBI claims on PMNs in an effort to make more information publicly available.
Even within the chemical industry many have decried the overuse of CBI claims because it also prevents the EPA from sharing the information with other state and foreign governments. This ultimately leads to costly additional submissions by companies in order to meet regulatory requirements in other jurisdictions.
The Agency recently removed over 500 chemical substances from the confidential portion of the TSCA Inventory when it discovered that information claimed to be confidential on PMN submissions was publicly available on company web sites.
Given the climate for increased regulatory actions to bolster chemical safety efforts, the anticipated changes to TSCA and the new administration's desire for a more open and transparent decision-making process, we will probably be hearing more about additional regulatory actions in the days ahead.