Proposed reporting requirements for nanomaterials released.

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Companies that manufacture, import or process nanoscale materials would be subject to reporting requirements under a new proposed rule released today by EPA. EPA is proposing reporting obligations concerning use, exposure, and other factors under section 8(a) of the Toxic Substances Control Act (TSCA). The proposed rule would apply to nanoscale chemical substances in the marketplace that have unique properties related to their size. The agency intends to use this information to determine if any further action under TSCA is needed.

Under the proposed rule [pre-publication version, PDF], companies would be required to report if they manufactured or processed a “discrete form” of a reportable nanoscale substance during the three years preceding the rule’s final effective date. EPA also proposes a continuing reporting requirement for companies intending to manufacture or process a discrete form of a reportable chemical substance after the rule’s final effective date. These manufacturers or processors would be required to report to EPA 135 days before the commencement of manufacturing or processing.

To the extent that it is known or reasonably ascertainable to the reporter, companies would have to submit the following information:

  • Specific chemical identity;
  • Material characteristics like morphology and surface modifications;
  • Physical and chemical properties;
  • Maximum weight percentage of impurities and byproducts;
  • Production volumes;
  • Use information;
  • Detailed methods of manufacturing or processing;
  • Exposure information, including estimates of numbers of individuals exposed in the workplace or in other scenarios;
  • Release information, including estimates of amounts released;
  • Risk management practices, such as protective equipment or hazard warnings; and
  • Existing data concerning environmental and health effects.

Generally, nanoscale materials are chemical substances that have structures with dimensions “at the nanoscale,” meaning 1-100 nanometers (nm), and may have properties different from the same chemicals with structures at a larger scale, such as greater strength or lighter weight.  The proposed rule would apply to substances that are:

  • Solid at 25°C and atmospheric pressure; and are
  • Manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100nm and exhibit unique and novel characteristics or properties because of their size.

The proposed reporting requirements apply to “discrete forms” of reportable chemical substances. In some cases, companies would be required to report separately for multiple nanoscale forms of the same chemical substance. The agency’s intent is to focus on “intentionally manufactured chemical substances at the nanoscale,” so unintended variations in particle sizes between production batches, for example, should not trigger § 8(a) reporting. EPA proposes to distinguish between these “discrete forms” based on a combination of the following three factors:

  1. a change in process to affect a change in size and/or a change in properties of the chemical substances manufactured at the nanoscale;
  2. a change in mean particle size of 10% or greater; and
  3. the measured change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values.

Other examples of discrete forms include nanomaterials with different morphologies (spheres vs. rods) and nanoscale forms of the same material but coated with different substances.

The proposed rule applies to mixtures, including when nanomaterials are manufactured or processed “solely as a component of a mixture, encapsulated material, or composite.” However, if a nanomaterial is incorporated into a mixture, encapsulated material, or composite by the nanomaterial’s manufacturer, the incorporation step does not have to be separately reported.

EPA proposes to apply a modified version of the existing small manufacturer/processor exemption to § 8(a) requirements. Because nanoscale materials are produced at much lower production volumes, EPA seeks to eliminate the 100,000 pound volume threshold for exempted small manufacturers or processors. Instead, a company could qualify as a small manufacturer/processor if it has “sales of less than $4 million” per year.

The proposed rule also excludes certain substances, including nanoclays, DNA, RNA, proteins, and chemical substances “which dissociate completely in water to form ions that are smaller than 1 nanometer.” Certain reporting which would be duplicative is also excepted; e.g., companies that submitted information under EPA’s voluntary Nanoscale Materials Stewardship Program do not need to re-submit, nor do submitters of Premanufacture Notices (PMNs) filed since January 1, 2005.

Information would be collected electronically, using a modified version of the reporting form used by the voluntary NMSP initiative, and compatible with EPA’s existing Central Data Exchange (CDX) and Chemical Information Submission System (CISS), both used for other TSCA reporting. EPA is not proposing an inventory for nanoscale materials, although non-confidential information collected through this proposed rule would be published in ChemView.

In addition to the above proposed reporting requirements, EPA is seeking input on various related issues, including “the possibility of a future rule that would require periodic reporting of chemical substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data Reporting (CDR) rule.”

EPA is accepting comments on the proposed rule for 90 days following its publication in the Federal Register. The agency also anticipates holding a public meeting during the comment period.

EPA completes risk assessment for n-methylpyrrolidone (NMP).

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EPA has made more progress with its Toxic Substances Control Act (TSCA) Work Plan with yesterday’s release of the agency’s final risk assessment for N-Methylpyrrolidone (NMP) or 1-methyl-2-pyrrolidinone, a chemical commonly used in paint and coating removal products. NMP is estimated to be used at over 184 million pounds per year, in paint strippers, agricultural chemicals, electronic cleaning, and petrochemical processing. The risk assessment identifies developmental toxicity risks for pregnant women and women of child-bearing age who have high exposure to NMP, as either consumers or workers. Risks were identified for both acute and chronic exposures, although acute exposure risks could be mitigated by using chemical-resistant gloves and using NMP products for less than four hours a day.

EPA is considering a range of voluntary and regulatory actions to reduce risks from NMP exposure. This is the fifth final risk assessment completed under the TSCA Work Plan.

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.

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.

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.