Senate committee holds hearing on Udall-Vitter TSCA reform bill.

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Today, the Senate Environment and Public Works Committee held a legislative hearing on the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” the proposal to modernize the Toxic Substances Control Act (TSCA) introduced last week by Senators David Vitter (R-LA) and Tom Udall (D-NM).

Lawmakers heard from Bonnie Englebardt Lautenberg, widow of the late Senator Frank Lautenberg (D-NJ), who said that her husband wanted chemical safety reform to be his “final, enduring legacy,” and warned that opposing the bill would “let the perfect be the enemy of the good.” Other lawmakers and witnesses also emphasized compromise and pragmatism in supporting the legislation. Sen. Vitter called the proposal “the only realistic shot we have at reforming a very broken and dysfunctional system.” Environmental Defense Fund Senior Scientist Richard Denison’s testimony [PDF] characterized Udall-Vitter as “a solid compromise that fixes the biggest problems with our current law” and “the best opportunity ever to reform” TSCA. Sen. Udall called for compromise, approvingly cited today’s New York Times editorial making recommendations for the bill, and suggested that it might be possible to compromise on changes such as co-enforcement, the timing of state preemption, and the minimum number of chemicals to be reviewed.

EPA Assistant Administrator of the Office of Chemical Safety and Pollution Prevention Jim Jones testified that the agency has no position on the Udall-Vitter bill, but that the legislation is consistent with the Obama Administration’s “essential principles” for TSCA reform.

As expected, the issue of state preemption emerged as the main focus of debate during the hearing. In his testimony [PDF], Maryland Attorney General Brian Frosh called the legislation an “evisceration of state authority.” Sen. Cory Booker (D-NJ), who occupies Sen. Lautenberg’s Senate seat, called the bill’s preemption provisions “a serious problem.”

At today’s hearing, Senator Barbara Boxer (D-CA) voiced her opposition to the Udall-Vitter plan, saying in her opening statement that the bill “fails to provide the public health protections needed and is worse than current law,” and noting opposition from over 450 organizations, including Attorneys General from eight states, the Environmental Working Group, Physicians for Social Responsibility, and the United Steelworkers.

Senators Boxer and Edward Markey (D-MA), who introduced a competing plan last week, continued to argue for their proposal’s key points and critique the Udall-Vitter bill. In a press conference yesterday, the Senators said that amending the Udall-Vitter bill to incorporate elements from their proposal would make the legislation acceptable. These elements include nixing state preemption, setting tighter deadlines for EPA action, and directing EPA to regulate asbestos and persistent, bioaccumulative and toxic (PBT) chemicals.

Sen. Boxer also claimed that the proposed legislation was drafted by the American Chemistry Council (ACC), a major industry lobbying group, although Sen. Udall’s staff disputed this, saying that input was taken from the ACC along with other stakeholders, such as the environmental group Natural Resources Defense Council.

EPA and FDA announce data sharing agreement for CBI.

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Today, EPA and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to share data on pesticides and toxic substances. According to a notice published last month in the Federal Register, in response to the FDA’s spring 2014 request, EPA will grant FDA access to information collected under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including information claimed by submitters as Confidential Business Information (CBI). This data-sharing initiative “is intended to maximize the utility of data collected under those statutes, and enhance the efficiency of the participants’ regulatory processes and facilitate better risk management activities.” The MOU applies specifically to EPA’s Office of Chemical Safety and Pollution Prevention and FDA’s Foods and Veterinary Medicine Program, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine.

FDA and EPA “have complementary roles” regulating substances incorporated into food (including animal feed), animal drugs, and cosmetics. Antimicrobial food wash products, for example, must meet different standards for safety and non-adulteration of food (FDA), and no adverse environmental effects (EPA).

The MOU covers the sharing of non-public information exempt from public disclosure, including CBI and “confidential commercial information” (CCI). Information will be shared “on a reciprocal and as-needed basis” for substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. The MOU provides that each agency will develop internal procedures and designate liaison officers for the information-sharing exchanges and to protect against unauthorized disclosure of CBI or CCI. Appendices to the MOU establish a framework process for information sharing, including specific language to be used in requesting information or responding to a request.

The MOU does not specify any limits as to programmatic uses for shared information. The disclosure of non-public information remains governed by applicable laws and regulations, and non-public information may not be disclosed further or shared with personnel at the other agency that have not been authorized to access non-public information. If EPA requests information from FDA identified as a trade secret, FDA will assess whether the information is in fact trade secret. TSCA/FIFRA-designated CBI requested by FDA will have to be returned to EPA or destroyed when no longer needed. Either agency may choose not to share requested information, or may choose to limit the scope of information provided in response to a request. The agencies may also protect information “in connection with research that has not been peer reviewed.”

Comments period extended for proposed perfluorinated chemicals SNUR.

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EPA is extending the comment period for its proposed Significant New Use Rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances. The proposed SNUR, which was first released in January, designates as significant new uses the manufacturing or processing of certain LCPFACs for any use not ongoing after 2015, and any other LCPFACs for which there are currently no ongoing uses. The proposed SNUR also makes inapplicable the exemption for importing articles containing LCPFACs and carpets containing PFAS. EPA is extending the comment period because the agency received “several comments asserting that there may be significant implications for the supply chain.”

The comment period originally ran until March 23, 2015, but is now extended until June 26, 2015. The Federal Register notice of the extension is scheduled to be published on March 16, but is currently available in pre-publication form [PDF].

Senators Boxer and Markey introduce competing TSCA reform bill.

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Today, Senators Barbara Boxer (D-CA), Ranking Member of the Senate Environment and Public Works Committee, and Edward Markey (D-MA), Ranking Member of the Subcommittee on Superfund, Waste Management, and Regulatory Oversight, introduced a new proposal to modernize the Toxic Substances Control Act (TSCA). The “Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act” is named after Alan Reinstein, who died in 2006 of asbestos exposure-caused mesothelioma, and Trevor Schaefer, a brain cancer survivor and advocate for safety from environmental and chemical exposures. The bill aims to strengthen the standard EPA uses to assess chemical safety; increase the speed at which the agency conducts chemical assessments; and preserve the states’ ability to regulate chemicals at the state level and co-enforce federal law.

The introduction comes just two days after the debut of the industry-supported “Frank R. Lautenberg Chemical Safety for the 21st Century Act” by Senators Tom Udall (D-NM) and David Vitter (R-LA). In a statement responding to the Udall-Vitter proposal, Sen. Boxer said, “It is clear that in its present form, this bill fails to provide the protections needed and is worse than current law.”

The text of the Boxer-Markey bill has not yet been made publicly available, but a one-page summary [PDF] has been released, and the Environmental Working Group (EWG) has also posted a comparison between the Boxer-Markey and Udall-Vitter proposal. Highlights of the Boxer-Markey plan include:

  • Stronger standard for chemical safety: The bill will adopt a heightened safety standard for EPA’s chemical safety assessment, using the “reasonable certainty of no harm” threshold currently used in reviewing pesticide safety.
  • Expedited reviews for asbestos and persistent, bioaccumulative toxic chemicals: The bill will provide for an “expedited safety review” process to speed safety assessments (and subsequent regulations) for asbestos and the class of chemicals known as persistent, bioaccumulative and toxic (PBT).
  • State preemption and co-enforcement: States would not be preempted from enacting and enforcing their own restrictions on chemicals, or from co-enforcing federal requirements.
  • Risk of chemical spills: In prioritizing chemicals for assessment, EPA would be required to consider the risk of unplanned releases to the environment, like last year’s spill of the coal cleaning chemical MCHM in West Virginia’s Elk River.
  • Industry user fees: According to the EWG, Boxer-Markey will require industry “to provide the funding necessary to do timely safety reviews.”

Along with the Boxer-Markey proposal, the early response to the Udall-Vitter plan from other stakeholders has coalesced around a few main points, particularly insistence on preserving state authority and co-enforcement. In addition, Senator Tom Carper (D-DE), a co-sponsor of the Udall-Vitter bill, is advocating [PDF] for the public review of EPA’s designations of chemicals as “low priority.” Environmental and public health groups have sharply criticized the bipartisan proposal, but some are still optimistic that further negotiations could resolve the bill’s problems.

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.