Congressional subcommittee reviews CSIA, EPA reveals its views.

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As we reported last week, the House Subcommittee on Environment and the Economy held a hearing to review the Chemical Safety Improvement Act (S. 1009) (CSIA) on November 13, 2013. At the hearing, EPA for the first time revealed its views on a number of CSIA provisions, although it has not developed a formal position on the Act.

Jim Jones, EPA assistant administrator of the Office of Chemical Safety and Pollution Prevention, was among the ten witnesses who testified at the hearing. During the questioning period of the hearing, Jones identified areas of CSIA that were improvements over TSCA, such as the requirement under Section 5 for an affirmative finding of safety by EPA on new chemical notifications, the ability to use order authority under Section 4 to obtain testing, and the ability to share confidential business information (CBI) with states.

Jones also identified issues that warranted further discussion, such as whether the requirement under Section 6 for extensive analysis of alternatives could lead to “paralysis by analysis,” whether judicial review of “low priority” decisions should be barred, and whether consideration of vulnerable populations under safety assessments should be extended to safety determinations and risk management actions. In addition, Jones called for a better balance of preemption issues, stronger deadlines, and clearer testing requirements under Section 4.

At the hearing, Senator Tom Udall (D-NM) said that he and Senator David Vitter (R-LA) were focused on three main issues: making sure EPA has the tools it needs to protect citizens and review the existing chemicals in commerce, preserving private rights of action against companies, and protecting the ability of states to safeguard their citizens. A day earlier, Sen. Vitter had made a renewed push for the CSIA’s passage, following a National Research Council (NRC) report that recommended improvements in the EPA’s assessment of inorganic arsenic. Sen. Vitter cited the report as a “prime example of why EPA’s risks assessments are flawed,” and called it “embarrassing” that EPA needed supervision in one of its key roles.

However, the overall tone at the hearing was very courteous among the Committee members and between the Chair and the witnesses. Sen. Vitter stressed his and Sen. Udall’s willingness to work with anyone committed to meaningful bipartisan reform, and most of those present at the hearing promised continued attempts to reach a consensus bill.

Congress making progress on amending TSCA reform bill.

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Congress continues to make progress in addressing concerns about the Chemical Safety Improvement Act (CSIA), with one congressional aide close to the process telling ChemicalWatch last week that “all the concerns and issues are solvable.” However, industry and NGO sources say the remaining issues that need to be dealt with make it unlikely that the TSCA reform bill will pass before the end of this year.

The CSIA is currently before the Senate Environment and Public Works (EPW) Committee, chaired by Barbara Boxer (D-CA). In August, Sen. Boxer dropped her opposition to the CSIA and promoted “fast-tracking” the compromise bill. However, Sen. Boxer has said that the bipartisan bill can move forward only if the Toxic Substances Control Act (TSCA) is amended to incorporate some “basic principles” such as specific protection for vulnerable populations, more definite time frames for EPA action, and holding all responsible parties accountable in cases of harm.  Most importantly, Sen. Boxer wants the bill’s language to ensure that state laws such as California’s Proposition 65 are not preempted.

Staff from the offices of Senators David Vitter (R-LA) and Tom Udall (D-NM), who co-sponsor the CSIA, have been working together on revisions to address concerns raised by Sen. Boxer and NGOs. As we previously reported, Sen. Vitter has said that the CSIA is not intended to eliminate private rights of action under state tort law, or remove the authority of any state to protect their water, air, or citizens.

The Congressional aide that spoke to ChemicalWatch said that whether the bill will be marked up this year depends largely on the EPW Committee’s other agenda items. Both industry and NGO sources do not expect passage of a TSCA reform bill this year, although prospects seem better for passage during the second year of the 113th Congress. Meanwhile, the House Subcommittee on Environment and the Economy, which held three informational hearings on TSCA this year, plans to hold its first hearing on the CSIA on November 13.

EPA agrees to update enforcement guidance for FIFRA and TSCA.

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The Environmental Protection Agency (EPA) has agreed to update its enforcement guidance for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) following a report [PDF] from the agency’s Office of Inspector General (OIG) released on September 27, 2013. The report contained findings and recommendations related to FIFRA and TSCA good faith reductions and “ability to pay” penalties, based on the OIG’s review of 23 FIFRA cases and 20 TSCA cases (13 lead disclosure and 7 PCB cases).

The OIG found that EPA regions differed in how they assessed FIFRA and TSCA enforcement penalty reductions; some appeared to justify reductions automatically, without considering the good faith compliance efforts of the violators. Because of the lack of adequate guidance and supporting documentation for determining and justifying good faith penalty reductions, there is a risk that EPA might treat violators inequitably and might be losing opportunities to fully collect all penalties due. Based on the OIG’s findings and recommendations, EPA has agreed to reissue the enforcement policy document GM-88, “Documenting Penalty Calculations and Justifications in EPA Enforcement Actions.”

The OIG also found that EPA’s enforcement response and penalty policy for lead-based paint disclosure rule to address violators who are unable to pay penalties is inadequate. Specifically, no guidance exists for applying non-monetary penalty alternatives (such as public service or delayed payment plans) when violators do not have the cash to pay the penalty. EPA has agreed to evaluate whether additional guidance is needed to clarify whether non-monetary alternatives must meet the agency’s existing Supplemental Environmental Projects policy.

In addition, the OIG report found that EPA’s “INDIPAY” economic model may be limited in its ability to help teams evaluate individuals’ claims of inability to afford penalties or clean-up costs. According to the OIG, the INDIPAY model does not assess an individual’s assets and should be updated to improve its accuracy. Furthermore, the report found that EPA does not provide adequate guidance or case development training to help regional teams evaluate ability to pay cases. In order to improve the agency’s consistency in handling the growing number of ability to pay cases, EPA has agreed to provide regional staff with updated training for case development of ability to pay claims. EPA also agreed to update its 1986 document “Guidance on Determining a Violator’s Ability to Pay a Civil Penalty” [PDF] to further improve guidance on evaluating ability to pay cases and address the inadequacies of the INDIPAY model.

EPA issues SNUR restricting imports of allegedly harmful category of chemicals used in carpets.

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The U.S. Environmental Protection Agency (EPA) announced on Monday that it will soon finalize a Significant New Use Rule (SNUR) that will allow the agency to restrict imports of potentially harmful long-chain perfluoralkyl carboxylates (LCPFACs) that could be used in carpets. The regulation will require companies to submit a notification 90 days in advance of manufacturing, importing, or processing LCPFACs that will be used as part of carpets or carpet treatment products. LCPFACs, a sub-category of perfluorinated chemical (PFC), include perfluorooctanoic acid (PFOA, also known as “C8”), other higher homologues, and their salts and precursors.

The final rule [PDF], which is authorized under the Toxic Substances Control Act (TSCA), was originally proposed in August 2012, following the U.S. chemical industry’s voluntary phase-out of these chemicals. In 2006, the eight major U.S. manufacturers of fluoropolymers and telomers committed to the EPA’s voluntary 2010/2015 PFOA Stewardship Program. The companies committed to achieving a 95% reduction in emissions and product content levels of PFOA and related substances by 2010, and elimination of such chemicals by 2015.

While the new final rule makes TSCA’s articles exemption inapplicable to imports of LCPFACs in carpets, other articles containing LCPFACs are not affected. EPA has previously issued three other SNURS addressing perfluoroalkyl sulfonates (PFAS), another sub-category of PFC. The new rule will add new chemicals to the existing PFAS SNUR and amend the SNUR to include ”processing” in the definition of “significant new use” for PFAS chemicals. EPA anticipates proposing another SNUR on additional PFCs in early 2014 as well as SNURs on other chemicals that will include imported products.

As part of its long term action plan regarding long-chain PFCs, EPA will also evaluate the effects of such chemicals on children and other sub-populations Although long-chain PFCs have not been found to cause significant adverse effects in the general human population, they have caused reproductive, developmental, and systemic toxic effects on laboratory animals, bioaccumulate in humans and wildlife, and are persistent in the environment. Therefore, EPA anticipates that continued exposure could result in adverse outcomes.

Further information on the new final rule and other actions EPA has taken on perfluorinated chemicals can be found at: http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/pfcs.html#final.

House Subcommittee convenes hearing on role of TSCA preemption.

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On September 18, 2013, the House Energy and Commerce Subcommittee on Environment and the Economy held its third in a series of hearings on Toxic Substances Control Act (TSCA) issues. The hearing focused on TSCA’s section 6, which relates to unreasonable risk from existing chemical substances, and section 18, which relates to preemption.

Section 6 has become a focal point for determining TSCA’s effectiveness in regulating hazardous chemicals. During the hearing, members of the subcommittee discussed the concepts of “unreasonable risk” and “least burdensome” alternatives, which have been pivotal in how the EPA approaches restricting or banning chemical use. Other issues raised by members of the subcommittee include whether the section 6 standard should be changed to eliminate cost-benefit analysis when EPA regulates existing chemicals, and the effects of the Corrosion Proof Fittings decision on EPA’s willingness to use its section 6 authority. Members disagreed over which aspect of the decision was more problematic—the court’s interpretation of the “least burdensome” requirement or the deficiencies in EPA rulemakings.

Section 18, which addresses when TSCA can pre-empt state law, has become particularly contentious in discussions about the draft Chemical Safety Improvement Act (CSIA). In the absence of federal action, U.S. states have enacted many local laws regulating certain chemicals, and they are concerned that proposed changes to TSCA might prevent these state laws from working effectively. Specific issues raised regarding TSCA preemption include the need for automobile manufacturers to have one national program for chemical regulation and for states to have access to confidential business information (CBI) in order to protect human health and the environment.

The Subcommittee’s background memorandum and an archived webcast of the September 18, 2013 hearing are available online.

US EPA unveils ChemView, substance information web portal.

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The U.S. Environmental Protection Agency (EPA) has launched ChemView, a web portal that will serve as a hub for chemical-specific regulatory information developed by EPA, as well as data collected under the Toxic Substances Control Act (TSCA).

The portal presents key health and safety data in a format that allows users to compare chemicals by their use as well as their health and environmental effects. ChemView will also allow searches by chemical name or Chemical Abstracts Service (CAS) number, use, hazard effect or regulatory action. Users can customize their views of the information on individual chemicals, or compare multiple chemicals by use, hazard effect or other criteria. Links to background documents are also provided for more detail.

At this time, ChemView contains:

  • test rule data for 90 chemicals;
  • hazard characterizations for 1,016 chemicals;
  • Design for the Environment (DfE) Alternatives Assessments for 48 chemicals; and
  • Significant New Use Rules (SNURs) for 349 chemicals that did not go through pre-market EPA review – the so-called existing chemicals.

It also links to other data, including:

  • health and safety studies submitted under TSCA section 8(d) for 140 chemicals;
  • substantial risk reports submitted under TSCA section 8(e) for 261 chemicals;
  • high production volume voluntary submissions for 1,169 chemicals;
  • Integrated Risk Information System (IRIS) assessments for 548 chemicals;
  • DfE list of safer chemical ingredients for 602 chemicals;
  • Chemical Data Reporting information for 7,221 chemicals; and
  • Toxics Release Inventory data for 611 chemicals.

EPA said that in the months ahead, it will be continuously adding additional chemicals, functionality and links. When fully developed, the portal will hold data on thousands of chemicals. The agency stated that increasing health and safety information, as well as identifying safer chemical ingredients, would help manufacturers and retailers better differentiate their products by using safer ingredients.

The agency has considered stakeholder input in the design of the site and is currently seeking comments from the public on its usability.

A Look Back at the Senate’s TSCA Reform Hearing and Reactions.

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Last month, we reported that the U.S. Senate Committee on Environment and Public Works had scheduled a full-committee hearing on various legislative proposals to reform TSCA. The hearing on July 31 consisted of three panels with a total of 19 witnesses including public health advocates, legal and health experts, representatives from state government and the private sector. The hearings and archived webcast are available online.

At the hearing, Committee Chair Barbara Boxer (D-CA) expressed her continued support for the Safe Chemicals Act (S. 696) and criticized the bipartisan Chemical Security Improvement Act (“CSIA,” S. 1009). Sen. Boxer took particular issue with the legislation’s effect on preempting state laws such as California’s Proposition 65, but nevertheless, vowed to continue working on the bill with the hope of enacting TSCA reform as soon as possible. Senator David Vitter (R-LA), a co-author of CSIA, said that he was already at work with Senator Tom Udall (D-NM) on amending his legislation to address the preemption concern.

Since the hearing, Congress has been in recess and there has been little news on how the amendment process is going. In the meantime, the CSIA’s advocates and detractors continue to make their case in the public forum. Last week, Steve Owens, who served as EPA assistant administrator for the Office of Chemical Safety and Pollution Prevention during President Obama’s first term, wrote on RealClearPolicy in support of the bill. Owens played down preemption concerns, arguing that TSCA was originally intended to preempt state efforts and that the CSIA provides for states to apply to EPA for a waiver that would keep state laws in place. He also pointed out that the CSIA’s sponsors had pledged to amend the bill to address other preemption issues. Earlier this month, Alex Formuzis of the Environmental Working Group criticized the CSIA and called on members of the public health and environmental community to rally behind Sen. Boxer’s efforts in shepherding strong TSCA reform legislation to the Senate floor. In California, state legislators introduced a mostly symbolic resolution that calls on Congress and the President to “respect the rights of states to protect the health of their citizens” and not enact the CSIA in its current form.

EPA Proposes Rules to Limit Formaldehyde in Wood Products.

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Last week, EPA released two new proposed rules to set and certify formaldehyde emissions standards in wood products. EPA developed the rules to implement the Formaldehyde Standards for Composite Wood Products Act (“the Act”), which added Title VI to the Toxic Substances Control Act (“TSCA”). The proposed rules would apply to domestic and imported hardwood plywood, medium-density fiberboard, particleboard, and finished goods – such as furniture – containing such products.

The emissions standards are established by the Act and match the limits already in place in California for wood products sold in the state. EPA’s proposed rules are designed to align with California’s program, but differ in how laminated products are defined and regulated. The proposal exempts laminated products “in which a wood veneer is attached to a compliant and certified platform using a [no-added formaldehyde-based] resin.”

The first proposed rule [PDF] requires that all wood products made in or imported into the U.S. be certified by a third party as compliant with the formaldehyde emission standards. The proposal imposes testing and product labeling requirements, a prohibition on product stockpiling, and provisions related to chain-of-custody documentation, recordkeeping, and enforcement. The proposed rule also provides incentives similar to the ones in place in California for the use of ultra low-emitting formaldehyde (“ULEF”) resins and no-added formaldehyde (“NAF”) resins.

The second proposed rule establishes a framework for third-party certification of compliant wood products, and is also meant to align with California’s existing requirements. Under the proposed rule, EPA-recognized accreditation bodies would evaluate and approve third-party certifiers (“TPCs”). Both the accreditation bodies and TPCs would be required to follow “voluntary consensus standards” established by the International Organization for Standardization (“ISO”) and International Electrotechnical Commission (“IEC”) related to assessing conformity, performing investigations, etc. The proposed rule requires that accreditation bodies conduct certain oversight activities, including recordkeeping, reporting to EPA, and auditing of TPCs and their testing laboratories. EPA could also independently oversee accreditation bodies and TPCs.

The proposed rules were released in pre-publication format and have yet to appear in the Federal Register. Once they are published, the proposed rules will also be accessible on Regulations.gov under the following docket numbers: EPA-HQ-OPPT-2012-0018 and EPA-HQ-OPPT-2011-0380.

Senators Announce Bipartisan Bill to Modernize TSCA.

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The prospects for TSCA reform just improved considerably with Wednesday’s announcement of a bipartisan agreement to overhaul the chemical safety law.

Sen. Frank Lautenberg (D-NJ) and Sen. David Vitter (R-LA) led a group of 16 senators from both parties in unveiling the Chemical Safety Improvement Act of 2013 [PDF]. The compromise legislation has already been praised by industry groups, including the American Chemistry Council, as well as public health advocates like the Environmental Defense Fund.

The Act’s chief innovation is its framework for ensuring that all chemicals are screened for safety to human health and the environment. Under the new legislation, EPA would make safety determinations for chemicals based on intended conditions of use and a risk-based assessment integrating hazard, use, and exposure information.

New chemicals would have to first pass safety screening before entering the market. Chemicals already in commerce would also undergo safety evaluations, which would be prioritized based on the substance’s risk to human health and the environment, and high-priority chemicals would undergo further safety testing by EPA. In an effort to reduce duplicative testing, EPA would be authorized to rely on existing information as well as to collect safety data from chemical manufacturers. In addition, EPA would be required to evaluate risks to vulnerable populations, like children or pregnant women, in assessing the safety of each chemical.

The bill also authorizes EPA to employ a wide range of risk management measures on unsafe chemicals, from ordering additional labeling requirements to imposing an all-out ban.

As we previously reported, Sen. Lautenberg introduced a similar bill to modernize TSCA in April, but it only won support among his fellow Democrats. The new compromise bill was criticized by the Environmental Working Group as “unacceptably weak,” but its bipartisan support means it likely has a better chance at approval in the Senate.

TSCA Reform Debuts in the 113th Congress.

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Last week, Sen. Frank Lautenberg (D-NJ) and Sen. Kirsten Gillibrand (D-NY) introduced the Safe Chemicals Act of 2013, which would overhaul the Toxic Substances Control Act (“TSCA”). The Safe Chemicals Act is identical to legislation approved last year by the Senate Environment and Public Works Committee.

The Safe Chemicals Act grants greater authority to the EPA to:

  • evaluate the safety of chemicals based on risk;
  • update EPA’s TSCA Inventory, first focusing review on priority chemicals;
  • order additional testing of chemicals when existing health and safety data is inadequate;
  • require regular use reporting;
  • impose a broad range of risk-management controls for chemicals that fail to meet safety standards; and
  • establish a public database of safety determinations and health and safety data.

The legislation’s focus on risk combines both hazard- and exposure-based methods of safety assessment. Under the bill’s new safety standard, EPA must determine that there is “reasonable certainty that no harm will result to human health or the environment from aggregate exposure” to evaluated chemicals. Such safety determinations must also follow recommendations on “best available science” from the National Academy of Sciences. EPA would evaluate and make safety determinations for all chemicals in the TSCA Inventory based on a priority classification scheme which uses existing data and considers the following factors: potential impacts on human health and the environment; hazard potential, including “designations of hazard characteristics by other authoritative entities”; potential for exposure; and measurements of exposure for any given pathway, if available. For chemicals that do not meet the safety standard, EPA would be able to implement controls ranging from requiring warning labels to imposing an outright manufacturing ban.

The proposed regular use reporting would apply to manufacturers and processors, and is similar to the existing Chemical Data Reporting rule. The bill also incorporates amendments made in committee to last year’s bill which aim to better protect manufacturers’ confidential business information, including specific protections applicable to certain types of information, like “[p]recise information describing the manufacture, processing, or distribution of a chemical substance or mixture” or marketing and sales data.

Lautenberg, who has announced he will retire in 2014, has introduced several TSCA reform bills during his career, and hopes to make the Safe Chemicals Act his “signature legislation for his final term in office.” Twenty-seven other members of the Senate’s Democratic caucus have joined Lautenberg and Gillibrand in sponsoring this bill. Sen. David Vitter (R-LA) has already announced his intention to introduce a competing bill for this Congress; he led Republican efforts on TSCA modernization in the 112th Congress.

The full text of the Safe Chemicals Act is available on Sen. Lautenberg’s website.