Senator Lautenberg Proposes Revised TSCA Legislation For 112th Congress
Beveridge & Diamond, P.C., April 22, 2011
On April 14, 2011, Senator Lautenberg (D-NJ) introduced the “Safe Chemicals Act of 2011” (“SCA 2011”), S. 847,1 a revised version of his 2010 legislation to overhaul the Toxic Substances Control Act (“TSCA”). Senator Lautenberg is the Chairman of the Senate Environment and Public Works Committee’s Subcommittee on Superfund, Toxics, and Environmental Health. The bill is cosponsored by four others, including Senator Boxer (D-CA), who chairs the full Committee.2 More information about the similar Senate bill introduced in 2010 is available here.3
As with the previous version, SCA 2011 would place the burden of proof on chemical manufacturers and processors to show that their chemicals meet a new safety standard in order for those chemicals to enter or stay on the market. Overall, SCA 2011 is similar to the bill that was introduced in 2010, but several differences, particularly regarding mixtures and prioritization, are noted below.
- Unlike the previous version, SCA 2011 would not specifically amend the definition of “chemical substance” to include chemicals in articles. However, chemical substances imported as part of an article would be subject to the same requirements as if they had been imported in bulk, except as EPA and Customs and Border Protection could provide by rule.
- While current TSCA allows testing and reporting rules and control actions to be issued for mixtures, EPA rarely does so. SCA 2011 deletes a number of the previous version’s requirements for mixtures, staying closer to the TSCA status quo. It would allow EPA to take actions relating to mixtures in the same manner as actions relating to chemical substances if EPA determined that doing so would be reasonable and efficient.
- SCA 2011, like its predecessor, would allow EPA to determine that nanoscale versions of existing macroscale chemicals are new chemicals.4
New Prioritization Scheme
- EPA would have to assign 20-30 persistent, bioaccumulative, toxic, and potentially high-exposure chemicals within one year after enactment to “priority class 1” for “immediate” (within eighteen months) risk management actions.
- EPA would have to assign an undetermined number of chemicals to “priority class 2” for safety standard determinations, with new chemicals being added to this class 2 list over time as determinations are completed.
- EPA would assign the lowest risk chemicals to “priority class 3” if it determined they have “intrinsic properties” such that they would pose no risk at anticipated exposure levels and use patterns.
- Presumably, most chemicals would not fall into any of these classes.
- SCA 2011 would amend the current standard for action under TSCA, “unreasonable risk of injury to health or the environment,” to require an EPA determination that a chemical presents a “reasonable certainty that no harm will result to human health or the environment,” considering aggregate exposure and, to the extent practical, cumulative exposure (including exposures from FDA-regulated uses and from house dust) and the health of vulnerable populations.
- For new chemicals, EPA could alternatively determine that the chemical (including its metabolites or degradation products) is not expected to manufactured or released into the environment in high volumes, known to be toxic or persistent and bioaccumulative, or found in biomonitoring studies.
Minimum Data Set
- SCA 2011 would require EPA to develop, within one year, a standard minimum data set to be required from manufacturers and processors for
- All new chemicals, to be submitted with premanufacture notifications;
- All new uses of chemicals for which EPA has made a safety standard determination;
- Chemicals on the priority class 1, 2, or 3 lists, to be submitted within 18 months after listing (note that only priority class 2 may have been intended); and
- All other existing chemicals, to be submitted within five years after enactment. Most chemicals would be subject to this requirement. There would be no exemptions for low-risk chemicals, such as polymers or low volume chemicals.
- Data compensation would be available for the minimum data sets, in a manner as prescribed under the current TSCA.
- SCA 2011 would require EPA to conduct safety standard determinations of chemicals on the priority class 2 list. As with the previous version of the legislation, the burden of proof would be on manufacturers and processors to submit information within 30 months of listing showing that their chemicals meet the safety standard.
- SCA 2011 would require EPA to complete its safety determinations within one year of receiving a complete submission (extended from 180 days in the previous version) and to renew the determinations every 15 years.
- As under the previous version of the SCA, an affirmative safety determination would have to identify the uses evaluated and any conditions needed to ensure that the safety standard is met, which could include a wide variety of restrictions. Any other uses would become subject to new use notification requirements.
- A negative determination would lead to a ban on manufacture, processing, or distribution within one year unless, within that time, EPA determined that the chemical would meet the safety standard (e.g., due to intervening controls). A negative determination would not be subject to judicial review.
EPA Data Authority
- The provisions of SCA 2011 are similar to those of its predecessor with regard to information gathering. SCA 2011 would require manufacturers and processors of existing chemicals to submit to EPA within one year of enactment either a detailed declaration of current manufacture or processing, or a declaration of cessation of manufacturing or processing. The declaration of current manufacture or processing would have to be updated every three years or upon certain new information. The same declaration would be required for new uses of existing chemicals for which EPA has not made a safety determination, including uses not ongoing at the time of enactment and ongoing uses at a significantly increased volume.
- SCA 2011 would also give EPA authority to issue orders for chemical testing without having to undertake a full rulemaking process, and to make testing and other data publicly available online.
Confidential Business Information
- Like the prior version, SCA 2011 would declare certain information ineligible for confidentiality protection, including chemical identity (except for new chemicals); health and safety studies for commercial chemicals; and information indicating the presence of a chemical in a consumer article intended for use by children or to which children may reasonably be exposed.
- EPA would have to specify by rule within one year of enactment the types of information for which it would not prospectively specify the term of confidentiality. All other eligible types of information would have a maximum confidentiality protection period of five years.
- EPA would be able to determine that information previously considered to be entitled to confidentiality protection is no longer entitled to that protection.
- EPA’s safety determinations could impose a wide range of conditions to ensure that chemicals meet the safety standard, with no express provision for notice and comment rulemaking procedures.
- If EPA were to determine that a chemical would not meet the safety standard without additional controls and another agency could take action to address the aggregate and cumulative exposures to the chemical, EPA would have to request that the other agency take action. The other agency would be required to take the action, if appropriate. If the other agency did not take action, EPA could do so.
- SCA 2011 would require EPA to identify localities subject to disproportionate exposure to toxic substances (“hot spots”) and to develop action plans to reduce the disproportional exposures.
- SCA 2011 would change the current TSCA judicial review standard requiring “substantial evidence” for many TSCA actions to the more common “arbitrary or capricious” standard of review.
Other Changes to TSCA
- SCA 2011 would give EPA authority to order recalls or other actions in case of imminent harm.
- SCA 2011 would implement the Stockholm Convention,5 LRTAP POPs Protocol,6 and Rotterdam Convention,7 once ratified by the Senate.
- EPA would be required to establish a Children’s Environmental Health Research Program, which would include biomonitoring research, and a green chemistry and engineering program to create market incentives for development of safer alternatives to existing chemicals.
- SCA 2011 would delete TSCA’s current preemption provision and allow states and localities to adopt and enforce their own chemical laws, regulations, or standards unless compliance with both the state or local standards and the SCA 2011 standard would be impossible.
- EPA could require payment of fees from any person required to submit data.
Reception and Prospects
SCA 2011 comes soon after the Senate’s first TSCA hearing of the 112th Congress, on February 3, 2011. At that hearing a main theme was that TSCA legislation could be passed, despite the results of the 2010 elections.8
However, it is clear that SCA 2011 has not resolved all of the disagreements that attended last year’s TSCA legislative proposals. The American Chemistry Council for one, stated in response to the bill’s release that “it appears many of our concerns have not been addressed in this new version, and the bill introduced today could put American innovation and jobs at risk.”9 The NGO umbrella group Safer Chemicals, Healthy Families, on the other hand, said SCA 2011 showed its sponsors’ “clear intention to protect families from toxic chemicals linked to serious health problems” and “predict[ed] action in this Congress despite the partisan divide.”10
With the Republican majority in the House of Representatives unlikely to consider TSCA legislation this Congress, passage of SCA 2011 is unlikely. Nevertheless, SCA 2011 will probably stimulate efforts by stakeholders to educate Congress and each other on a variety of approaches to overhauling TSCA that can address the deficiencies in the current statute while obtaining sufficient support to be enacted.
For more information about the Safe Chemicals Act of 2011, please contact Mark Duvall, firstname.lastname@example.org, or Alexandra Wyatt, email@example.com.
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1 The Safe Chemicals Act of 2011 is available at http://lautenberg.senate.gov/assets/SafeChem.pdf. A summary is available at http://lautenberg.senate.gov/assets/SafeChem-Summary.pdf.
2 As of the publication of this alert, the other cosponsors of SCA 2011 are Senators Franken (D-MN), Klobuchar (D-MN), and Schumer (D-NY). The 2010 SCA did not have any co-sponsors.
3 See Beveridge & Diamond, P.C., Proposed Legislation Would Overhaul TSCA, April 23, 2010, http://www.bdlaw.com/news-852.html; see also Beveridge & Diamond, P.C., Prospects for TSCA Legislation in the 112th Congress, Jan. 28, 2011, http://www.bdlaw.com/news-1049.html.
4 See Beveridge & Diamond, P.C., Proposed TSCA Amendments Would Target Nanomaterials, June 2, 2010, http://www.bdlaw.com/news-891.html.
5 Stockholm Convention on Persistent Organic Pollutants, 40 I.L.M. 532 (2001).
6 Protocol on Persistent Organic Pollutants to the Convention on Long-Range Transboundary Air Pollution, 37 I.L.M. 505 (1998).
7 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, 38 I.L.M. 1 (1999).
8 See Beveridge & Diamond, P.C., Senate Holds First Hearing of the 112th Congress on TSCA Modernization, Feb. 15, 2011, http://www.bdlaw.com/news-1072.html.
9 Press Release, American Chemistry Council, ACC Responds to Introduction of Senator Lautenberg’s Chemical Safety Legislation, Apr. 14, 2011, http://www.americanchemistry.com/s_acc/
10 Press Release, Safer Chemicals, Healthy Families, “Safe Chemicals Act of 2011” Introduced Today; Legislation Would Protect American Families from Toxic Chemicals, Apr. 14, 2011, http://www.saferchemicals.org/2011/04/