Senators unveil new bipartisan TSCA reform bill.

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After much anticipation, the long-awaited new version of the Senate bipartisan bill to modernize the Toxic Substances Control Act (TSCA) was released today by Senators Tom Udall (D-NM) and David Vitter (R-LA). The proposal, called the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” is a new version of the “Chemical Safety Improvement Act” (CSIA) introduced by Sens. Frank Lautenberg (D-NJ) and Vitter in May 2013.

Like the CSIA, today’s proposal sets a new safety standard of “no unreasonable risk of harm to health or the environment” from exposure of the chemical under the conditions of use, including to potentially susceptible populations – such as infants, pregnant women, the elderly, or workers – as identified by EPA. The bill authorizes EPA to obtain new information on chemicals throughout the safety evaluation process under TSCA § 4 and establishes a “tiered screening and testing” system. Under the bill’s safety evaluation process, articles can only be prohibited or “otherwise restrict[ed]” if EPA has “evidence of significant exposure to the chemical substance from such article.” To reduce duplicative testing, the Udall-Vitter proposal provides for a framework for the “fair and equitable reimbursement” of data development costs.

EPA would be required to establish a risk-based prioritization scheme of high- and low-priority substances within one year of enactment, and an interim list of 10 substances in each category. Additional prioritization milestones for three and five years after enactment are also specified. The bill provides various criteria for prioritization, including recommendations from states, hazard and exposure potential, etc. States would be able to seek judicial review of low-priority designations, and such designations “must be based on information sufficient to establish that the substance is likely to meet the safety standard.” The prioritization scheme also provides for an “additional priority” allowing companies to request the EPA to fast-track safety evaluations and determinations, which would be fully funded by user fees.

Significantly, the Udall-Vitter bill directs EPA to set up a user fee program to fund 25% of program costs including safety evaluations and regulations, up to $18 million. This fee authority would be collected and made available “only to the extent and in the amounts provided in advance” as appropriated by Congress.

The new proposal takes a somewhat different tack on state preemption than the CSIA. The enforcement of existing state statutes and administrative actions on specific substances will not be preempted until the effective date of the applicable federal action, e.g., an EPA Significant New Use Rule, test order, or safety determination. However, new state statutes or administrative actions prohibiting or restricting substances designated as high-priority would be preempted as soon as EPA commences a safety assessment. Like the original CSIA, the new bill provides for a system in which states may apply for a waiver from preemption, subject to various conditions. EPA’s waiver decisions would be subject to notice and comment and subject to judicial review.

In addition, the bill provides for an interagency “Sustainable Chemistry Program” to coordinate and support sustainable chemistry-related research, development, commercialization, education, etc., although “sustainable chemistry” is not defined.

Sen. Lautenberg, who passed away in June 2013, was a long-time champion of public health and environmental protection, including TSCA reform efforts. The invocation of Sen. Lautenberg’s legacy, however, may “inflame divisions” between Senator Barbara Boxer (D-CA) and other Democrats. Sen. Boxer vocally opposed the CSIA, criticizing that proposal’s preemption of state regulations. The California Attorney General has already written a sharp critique of the Udall-Vitter proposal, calling it an “unprecedented and unnecessary evisceration of state regulatory authority.”

Environmental and other advocacy groups, including the Environmental Working Group and Safer Chemicals, Healthy Families coalition, are already publicly opposing the new bill and calling for changes. Chemical industry groups, including the American Chemistry Council (ACC) and the Society of Chemical Manufacturers and Affiliates, are lauding it and pushing for its passage. The New York Times quoted Richard Denison, senior scientist at the Environmental Defense Fund, calling the bill “a solid compromise that would be much more protective of public health.” In the same article, ACC president Cal Dooley predicts the legislation could garner 70 votes on the Senate floor.

Sen. Udall also said that he is working with Rep. John Shimkus (R-IL) on related legislation in the House.

The Senate Environment and Public Works Committee is reportedly holding a hearing on TSCA on March 18. The late Sen. Lautenberg’s widow, Bonnie Englebardt Lautenberg, is expected to speak in favor of the Udall-Vitter bill. The draft legislation is available here, and a fact sheet prepared by Sens. Udall and Vitter is available here.

EPA agrees to clarify data requirement rule for antimicrobial pesticides.

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EPA and the American Chemistry Council (ACC) have reached a settlement regarding the ACC’s petition concerning data requirements for antimicrobial pesticides. This settlement addresses a Final Rule published by EPA on May 8, 2013, “Data Requirements for Antimicrobial Pesticides,” for which the ACC, the chemical industry trade group, sought judicial review in the U.S. Court of Appeals for the D.C. Circuit.

Under the settlement, EPA will within the next four months release for public comment a proposed guidance document, “Antimicrobial Pesticide Use Site Index.” This guidance will include “a compilation of existing antimicrobial pesticide use sites and identify how each use site fits within the 12 use patterns established in the regulation.” The Use Site Index will include the following descriptions, as set forth in the settlement:

  • Direct Food Use: a use is generally considered to be a direct food use if an antimicrobial pesticide is intended to be directly applied to food (defined for purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f)) or applied to a material or article for the purpose of treating food.
  • Indirect Food Use: a use is generally considered to be an indirect food use if the use involves application of the antimicrobial pesticide in or on a material or article that comes into contact with food and may result in residues in or on food, but the use is not intended for pesticidal treatment of food.
  • Nonfood Use: a use is generally considered to be a nonfood use when there is a reasonable certainty of no residues in or on food, for example because the antimicrobial pesticide is not expected to come into contact (directly or indirectly) with food as a result of its intended use.

In addition to the Site Index proposed guidance, the settlement agreement provides that EPA shall propose an interim guidance document and then a “correction to the Final Rule” regarding the 200 ppb level for antimicrobial residues in or on a food item, as established at 40 C.F.R. § 158.2230(d). Under the Final Rule, additional toxicology tests are required for indirect food uses with antimicrobial residue levels greater than 200 ppb. Within 60 days, EPA must issue an interim guidance document “explaining EPA’s interpretation of the 200 ppb level established in the Final Rule.” Within two and a half years, EPA must propose a “correction” to make “clear that the 200 ppb level established in the Final Rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity.”

EPA replaces Design for the Environment with new “Safer Choice” label.

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Today, EPA unveiled its new “Safer Choice” label, which replaces the Design for the Environment (DfE) label for cleaning and other chemical products that meet the agency’s standards for safer chemical ingredients. The new label underscores the program’s focus on human health and environmental safety standards with the hope of making it easier for families to choose safer products for families. EPA Administrator Gina McCarthy even appears with her dog in a short YouTube video to emphasize that children and pets are more vulnerable to chemicals.

The new “Safer Choice” label has different versions for products used in homes and for those used in office buildings, schools, and other institutions.

Speaking at a conference in Baltimore yesterday, Wendy Cleland-Hamnett, director of EPA’s Office of Pollution Prevention and Toxics, said the agency consulted with the Federal Trade Commission (FTC) in developing in the new logo to ensure that it would comply with the FTC’s Green Guides on environmental marketing claims.

EPA also introduced a new label to substantiate fragrance-free claims in Safer Choice products. The revised “Safer Choice Standard” [PDF] specifies changes related to the new fragrance-free standard. Products that qualify for the Safer Choice label are eligible for the additional fragrance-free certification and label if no fragrance materials are in the product ingredients.

In addition, the agency announced that it “is aligning across product types the requirements applied to labeled products that contain sensitizers that exceed the de minimis level (0.01%) in the end-use product.” All Safer Choice products, not just consumer products, will now be required to disclose on the label if fragrance materials that are skin sensitizers are present above the de minimis level. Manufacturers of such products will also be required to provide EPA with information that the sensitizing ingredients are:

  • critical to the fragrance essence or product identity;
  • otherwise in compliance with the fragrances criteria;
  • the subject of good faith explorations of alternatives; and
  • subject to a monitoring system that would alert the Agency if a user reports any adverse effects from the product.

The new label does not change other aspects of the DfE program, such as safer chemical criteria.

On the agency’s blog, Administrator McCarthy wrote that producers and retailers including Clorox, Walmart, and Wegmans are on board to start putting products with the new label on shelves this year.

Senior House Democrat on board with Republican proposal to reform TSCA.

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The passage of legislation to modernize the Toxic Substances Control Act (TSCA) looks a little more likely as a senior House Democrat has voiced positive feedback on the proposal offered by Rep. John Shimkus (R-IL), the head of the Subcommittee on Environment and the Economy.

According to Chemical Watch, Rep. Gene Green (D-TX), also a member of the Subcommittee, said that Rep. Shimkus’ more limited proposal to reform TSCA “works.” Rep. Green emphasized the need to “correct some of the things that are so outdated in TSCA,” as well as incorporating suggestions from Democrats. Rep. Green, whose district is home to several petrochemical companies, described TSCA reform as a “major issue,” and said he was “hopeful” that the issues that plagued the last attempt to modernize TSCA will not recur. As for state preemption, the main sticking point in last year’s negotiations, Rep. Green supported crafting legislation with bipartisan support as a first step before addressing preemption.

Chemical Watch also reported that Rep. Shimkus’ is currently “not committed to any timeline” for introducing legislation.

Canada begins phase-in of GHS with Hazardous Products Regulation.

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Earlier this month, Canada published final regulations implementing the Globally Harmonized System (GHS) for Classification and Labeling of Chemicals. The Hazardous Products Regulation (HPR) aligns closely with the United States’ Hazard Communication Standard and the United Nations’ fifth revision of the GHS. The HPR harmonizes criteria for hazard classification, labels, and safety data sheets, but will not otherwise change the roles and responsibilities for suppliers, employers and workers. A goal of GHS is to allow chemical suppliers to use “a single label and SDS for each hazardous product.”

Adoption of the HPR marks the beginning of Canada’s three-phase transition to GHS, similar to the U.S. approach to implementing GHS. Canada’s transition is scheduled to be completed by December 1, 2018.

California may add BPA to Prop. 65 list.

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On Friday, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that bisphenol A (BPA), a chemical found in common consumer products like food packaging and paper receipts, will be considered for possible listing under the state’s Proposition 65 program, which requires businesses to provide warnings for exposures to listed chemicals. The Developmental and Reproductive Toxicant Identification Committee (DARTIC), an advisory panel that helps OEHHA compile the list of chemicals known to cause reproductive toxicity, will meet on May 7, 2015 to “consider whether BPA has been clearly shown by scientifically valid testing according to generally accepted principles to cause female reproductive toxicity.”

In April 2013, BPA was added to the Prop. 65 list as a reproductive toxicant for development endpoints via the Prop. 65 “authoritative bodies” mechanism, based on the National Toxicology Project’s findings that BPA caused reproductive toxicity at high doses. However, California delisted BPA the next week, in response to a lawsuit brought by the American Chemistry Council, and simultaneously withdrew that attempt to list the chemical.

DARTIC will now be revisiting BPA per a 2009 request from the committee to reconsider the chemical “if additional epidemiological or other specific types of data on reproductive and developmental toxicity became available.” Substantial relevant data has become available since 2009, including a significant 2014 review of studies published from 2007-2013 concluding that BPA is a reproductive toxicant.

OEHHA has compiled hazard identification materials on BPA and female reproductive toxicity for the consideration of both DARTIC and the public. The agency is accepting comments on the hazard identification materials through April 6, 2015. These comments will be forwarded to DARTIC members before the May 7 meeting, and also posted online. Instructions for submitting comments are in the meeting notice.

The May 7 meeting will begin at 10:00am in the Coastal Hearing Room of the Cal/EPA Headquarters building, 1001 I Street, Sacramento, and will also be webcast. If DARTIC require more time for deliberations, the meeting will be continued on May 21 at the same location.

EPA’s chemicals outlook for 2015.

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Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention, writes in Chemical Watch that his highest priority in 2015 is “to continue building on the progress” of the last few years in making a “credible” program to manage existing chemicals, “despite the widely acknowledged shortcomings of the Toxic Substances Control Act (TSCA).” In his outlook for 2015, Assistant Administrator Jones highlighted progress on the TSCA Work Plan for Chemical Assessments as well as various regulatory actions.

Assistant Administrator Jones noted that in 2014, EPA completed final assessments on four chemical substances. Of those, the assessments for trichloroethylene (TCE) and methylene chloride (DCM) identified health risks to consumers and workers working with the chemicals. In 2015, the agency intends to negotiate for voluntary risk reduction measures with TCE and DCM manufacturers, but would turn to TSCA § 6 to mandate risk management – a regulatory tool EPA has not used in 28 years. Under the TSCA Work Plan, assessments scheduled for 2015 will address the following:

  • N-Methylpyrrolidone (NMP) in paint stripper products;
  • three clusters of related chemicals, used as flame retardants;
  • several uses of 1-Bromopropane (1-BP); including occupational uses of 1-BP in dry-cleaning and foam gluing operations, consumer uses in aerosol solvent cleaners and spray adhesives;
  • 1,4-Dioxane; and
  • long- and medium-chained chlorinated paraffins used as metal working and compounding agents and its effects on ecological receptors.

EPA has a variety of regulatory actions planned for 2015. The agency plans to finalize a rule regulating formaldehyde emissions from composite wood products, thus making national the emissions standard already in place in California. In addition, EPA will make a determination on “whether renovations in commercial and public buildings create a hazard from lead-based paint.” Assistant Administrator Jones also announced that the agency will, in late 2015 or early 2016, propose the modification of existing use authorizations for polychlorinated biphenyls (PCBs) in several contexts. Finally, Assistant Administrator jones noted that 2015 would mark a “turning point” for the agency’s green chemistry programs as incentives and obstacles to adoption of greener chemistries are identified.

Other items on EPA’s agenda for 2015 include:

EPA promulgates Significant New Use Rules for 27 PMN substances.

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In yesterday’s Federal Register, the EPA published Significant New Use Rules (SNUR) under the Toxic Substances Control Act (TSCA) for 27 substances that were already the subject of Premanufacture Notices (PMNs). Two of the substances – Phosphoric acid, iron (2+) lithium salt (1:1:1) and Polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) – are also subject to “risk-based” consent orders under TSCA section 5(e), requiring protective measures to limit exposures or otherwise mitigate the potential unreasonable risk to human health and the environment presented by the substances. For these substances, the SNURs designate the absence of those protective measures as a “significant new use.”

Under all of the SNURs, EPA must be notified at least 90 days before beginning to manufacture or process the specified chemicals in a “significant new use.” For the chemicals not subject to § 5(e) consent orders, any use deviating from the use scenario reported in the corresponding PMN is designated as a “significant new use.” Specific requirements for each chemical are specified in the regulatory text.

The SNUR was promulgated by Direct Final Rule, and will go into effect on April 3, 2015, unless adverse comments are submitted by March 4.

EPA proposes updates to Chemical Data Reporting rule.

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This week’s Federal Register includes notices from the EPA of two changes to the Chemical Data Reporting (CDR) rule, part of the Toxic Substances Control Act (TSCA). On Tuesday, EPA published a Direct Final Rule that adds six biobased chemicals to the list of chemicals that are partially exempt from certain reporting requirements. Today, EPA published a Notice that the agency has submitted an information collection request to the Office of Management and Budget (OMB).

EPA’s submission to OMB proposes a revision to a previously approved information collection request, which implemented the 2011 updates to the CDR. Information collection requests are reviewed and approved by OMB under the Paperwork Reduction Act. The new request reflects the reporting requirements for the 2016 submission period. The update is estimated to affect almost 5,000 entities once every five years.

The new partial exemptions stem from a petition filed by a group representing the biobased chemicals industry. The Direct Final Rule adds a “biodiesel” category to the list of partially exempt chemicals which are not subject to reporting requirements for processing and use information. Responding to the group’s petition, EPA determined that processing and use information for the six biobased chemicals were of “low current interest.” The chemicals affected are:

  • Fatty acids, tallow, Me esters.
  • Fatty acids, C14-18 and C16-18-unsatd., Me esters.
  • Fatty acids, C16-18 and C-18-unsatd., Me esters.
  • Soybean oil, Me esters.
  • Fatty acids, canola oil, Me esters.
  • Fatty acids, corn oil, Me esters.

The partial exemption puts the biodiesel industry on more equal footing with petroleum-based diesel manufacturers, whose “petroleum process streams” chemicals are already partially exempt.

The partial exemption Direct Final Rule goes into effect on March 30, 2015, unless adverse comments are received by February 26. Comments on the information collection request will be accepted through March 2, 2015.

Industry opposes proposed rule on nonylphenols and nonylphenol ethoxylates.

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Companies and trade groups representing industries ranging from automakers to cleaning products have pushed back against an EPA proposal that would restrict certain chemicals widely used in industrial applications and consumer products such as detergents, cosmetics, paints, and sealants. As Bloomberg BNA reports, industry commenters argue that their ongoing uses of the chemicals preclude EPA from issuing the proposed rule. The commenters also criticize EPA’s nomenclature convention, which they contend is not generally used or understood, as well as EPA’s reliance on Chemical Data Reporting Rule (CDR) results as a basis for the rulemaking.

In late September, we wrote that EPA released its proposed Significant New Use Rule (SNUR), under the Toxic Substances Control Act (TSCA), for nonylphenols (NPs) and nonyphenol ethoxylates (NPEs). EPA later extended the comments period for the proposed rule by 45 days, to January 15, 2015.

The proposed SNUR identifies by CAS number 13 “linear NPs and NPEs” for which any use is a significant new use, as well as two branched NPs, for which any use besides “as an intermediate or use as an epoxy cure catalyst” is a significant new use. However, commenters argue that “the global industry practice is to use CAS names” without distinguishing between “branched” or “linear” forms. The American Chemistry Council contends that EPA has not provided sufficient explanation and guidance on its “poorly-understood” naming convention regarding whether an alkyl chain is linear or branched.

Many commenters were highly critical of EPA’s method of evaluating whether the CAS numbers listed in the proposed SNUR were in commerce, stating that many were identified in ongoing uses and included in a variety of public databases. Various commenters also criticized EPA for using the proposed SNUR as a method of collecting use information.

Other comments reported specific ongoing uses of certain chemical substances by Chemical Abstract Service (CAS) Number.

The San Francisco Bay Regional Water Quality Control Board also weighed in to request that EPA not exempt articles from this SNUR, particularly toilet paper, which “has the potential to be a major source of pollution for aquatic resources receiving treated or untreated wastewater discharges.”