Science advisors urge EPA to complete 1-BP risk assessment.

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The Chemical Safety Advisory Committee is urging the Environmental Protection Agency (EPA) to complete and publish its risk assessment of 1-bromopropane without delay, due to “the high risks of adverse effects” in occupational and consumer use scenarios that have already been evaluated. In meeting minutes [PDF] submitted to EPA last week, some Committee members commented that these risks might have been under-estimated. The chemical, also known as 1-BP, is used in spray adhesives, dry cleaning, and degreasing, and was among the chemicals identified in the 2012 Toxic Substances Control Act (TSCA) Work Plan.

The Committee, an independent panel of scientific advisors comprised of experts in toxicology, environmental risk assessment, exposure assessment and related fields, met in May to review the scientific and technical merit of EPA’s draft risk assessment for 1-BP, which was released in March 2016.

Overall, the Committee praised the draft risk assessment, concluding that “the conceptual model appropriately considers worker exposures and consumer uses, with the majority of exposure occurring via inhalation.” The Committee stressed the importance of including consumer uses with acute exposures, and several members called for better consideration of exposure from co-residence and community-level exposures near dry-cleaning facilities. The Committee provided recommendations “intended to improve the clarity and transparency of the scientific analyses,” including the adoption of systematic review processes to clarify how studies were selected and evaluated. Other recommendations include ways to refine occupational and consumer exposure assessments.

Under the new requirements of the Lautenberg Act, EPA must identify 10 Work Plan chemicals for risk evaluations to be initiated by December 2016. EPA will revamp the prioritization process for risk evaluations in 2017 and 2018, using new criteria to be established, through rule-making, by mid-June 2017.

EPA proposes updates to SNUR regulations on workplace protection and hazard communication.

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On July 28, EPA published a proposed rule updating the Significant New Use Rule (SNUR) regulations, which implement section 5(a)(2) of the Toxic Substances Control Act (TSCA). In announcing the proposal, EPA emphasized the need to harmonize regulations based on Occupational Safety and Health Administration (OSHA) standards for respiratory protection and hazard communication, which have both been updated since the SNUR regulations were last revised in 1989.

The proposed rule also contains several other changes meant to address “issues identified through EPA’s experience issuing and administering SNURs,” including changes to the bona fide intent to manufacture procedure. Additional, minor changes include correcting typographical errors, updating “material safety data sheet” or “MSDS” to “safety data sheet” or “SDS,” and revising language to “more accurately use the terms manufacture, manufacturer, and manufacturing.”

Notably, many of the proposed changes to the SNUR regulations will affect previously-issued SNURs.

EPA notes that, due to regulatory updates from both the National Institute for Occupational Safety and Health (NIOSH) and OSHA, the current regulatory language for protection in the workplace, concerning respiratory protection, is inconsistent with NIOSH and OSHA requirements. Thus, EPA proposes to replace outdated references to old OSHA standards with the current NIOSH regulations on the certification and testing of respirators, as well as adding specific types of NIOSH-certified respirators to the list of approved respirators. According to the proposed rule, companies subject to previously-issued SNURs containing respirator requirements can either follow the updated requirements or continue using the older respirators, if they are still available, without triggering a Significant New Use Notification (SNUN) requirement.

EPA also proposes to modify a subsection on airborne forms of chemicals by adding “particulate or aerosol,” “gas/vapor,” and combinations thereof.

The proposed rule further revises the workplace protection section by inserting the requirement that a hierarchy of controls – such as enclosure of operations, ventilation, and workplace policies and procedures – must be “considered and implemented to prevent exposure, where feasible” before using personal protective equipment (PPE) for worker protection. This change is reportedly in response to previous comments criticizing “EPA’s approach of exclusively identifying the absence of adequate personal protective equipment as a significant new use” as out of step with best practices in industrial hygiene. EPA notes that the new language has been incorporated in all new chemical SNURs issued since June 26, 2013 and is consistent with OSHA requirements.

The agency’s proposed updates on hazard communication are based on OSHA’s updates to its Hazard Communication Standard (HCS), which was itself modified, in 2012, to conform to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). EPA also proposes adding a new requirement which could be used in new SNURs for a written hazard communication program in each workplace in accordance with the OSHA HCS. Another proposed addition provides specific statements and warnings that could be required under a SNUR and “would be based on EPA’s risk assessment of the chemical substance and would be consistent with the OSHA HCS and GHS recommendations.”

In addition to the changes to the workplace protection and hazard communication revisions, EPA proposes various other modifications, including:

  • Bona fide procedure: Currently, when EPA issues a SNUR in which the chemical identity is withheld as confidential business information (CBI), manufacturers and processors may submit information to EPA to “determine whether their substance is subject to the SNUR.” EPA now proposes to amend the process to apply to other kinds of CBI, such as production volume limits, so EPA may inform bona fide submitters whether and how the SNUR applies to them, including any confidential significant new use designations.
  • Notice submission requirements: EPA proposes that notification submissions such as premanufacture notifications or low volume exemptions, among others, must include any SDS that has already been developed for the relevant chemical.

EPA has specifically requested comments on the following issues:

  • the use of “next generation” respirators;
  • the incorporation of the hierarchy of controls approach to worker protection in the SNUR requirements; and
  • “any suggested methods for minimizing respondent burden, including revisions to the automated collection techniques being used for submissions to EPA under TSCA, …the Agency’s Central Data Exchange (CDX) portal.”

The deadline for comments on the proposed rule is September 26, 2016.

First new chemical determinations released by EPA under amended TSCA.

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Last Friday, the U.S. EPA issued its first regulatory determinations for new chemical substances under the newly amended Toxic Substances Control Act (TSCA). EPA published premanufacture notices (PMNs) for four new chemicals, concluding that all four were “not likely to present an unreasonable risk” to human health or the environment. The decision means that manufacturers and importers may make or import the chemicals, which will be used as lubricants, plastics additives, and in combination with other substances to make polymers.

For all four new chemicals, the agency found low potential for both human health and environmental hazards. Two of the chemicals were “very persistent,” but the agency found that neither presented an unreasonable risk due to “low potential for bioaccumulation,” as well as low health and environmental hazards.

These actions are the agency’s first under “TSCA 2.0,” after the Frank R. Lautenberg Chemical Safety for the 21st Century Act went into effect last month. As reported by Greenwire, the American Chemistry Council lauded the new chemical determinations as “an example of the new law already working.” The environmental advocacy nonprofit EDF praised the EPA’s openness while criticizing the agency on other issues, including the withholding of confidential business information (CBI), use of estimated data, providing only summaries of the determination documents, and “cursory consideration of exposure and exposed subpopulations.”

Lautenberg Act: EPA releases Implementation Plan and other resources.

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Following President Obama’s signing, last week, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has begun to roll out a variety of resources to help stakeholders understand this update to the Toxic Substances Control Act (TSCA). Today, EPA posted its Implementation Plan for the Lautenberg Act, a “roadmap of major activities EPA will focus on during the initial year implementation.” The requirements and goals outlined in the Plan are based on deadlines set in the statute. The agency noted that the Plan is a “living document” that will be updated over time.

Notably, the Plan states that the Lautenberg Act’s passage “effectively resets the 90-day review period” for submitted Premanufacture Notices (PMNs). As an “Immediate Action” under the Plan, EPA’s goal is to meet the “applicable” deadlines for reviewing and making affirmative determinations on all PMNs and Significant New Use Notifications (SNUNs). The agency says it “will make every effort to complete its review and make a determination within the remaining time under the original deadline.”

Another “Immediate Action” under the Plan is the routine review and making of determinations on new confidentiality claims for the identities of chemicals offered for commercial distribution. These Confidential Business Information (CBI) claims must receive a determination within 90 days and upheld claims will result in the chemical receiving a unique identifier and associated information. EPA also set a goal of creating a plan to link such associated information in 30 days, by mid-July. For CBI claims not related to chemical identity, EPA is required to review and make determinations for at least 25% of new claims, with a goal of developing an approach for routine review by mid-July. EPA plans to provide additional information on required statements and certifications for asserted CBI claims by mid-July as well.

The new law allows EPA to publish proposed and final rules, under Section 6, for chemicals with risk assessments completed prior to the enactment of the Lautenberg Act. These rules must be consistent with the scope of the risk assessments, “even if they do not cover all conditions of use.” EPA has set “Immediate Action” goals to address the identified risks associated with trichloroethylene (TCE), methylene chloride (MC), and N-methylpyrrolidone (NMP), with various proposed and final rules anticipated to be released from October through December 2017.

Other mandatory actions to be completed within the first year of implementation include:

  • Scope of Initial Risk Evaluations: The scope of the first ten Work Plan chemicals’ risk evaluations will be published in mid-June 2017.
  • Annual Plan for Risk Evaluations: The first annual plan, providing updates on evaluations to be started or completed each calendar year, among other things, will be due January 2017.
  • Additions to Mercury Export Ban: The initial list of mercury compounds prohibited from export is slated for publication mid-September 2016.
  • Mercury Inventory: EPA must publish an inventory of mercury supply, use, and trade in the U.S. by April 1, 2017, and update it every three years thereafter.
  • Small Business Definitions: By mid-December 2016, EPA must review the standards for identifying small manufacturers and processors and determine whether revisions are warranted.
  • Report to Congress: EPA’s first report to Congress must be submitted by mid-December 2016. The report must address the agency’s capacity and resources needed to conduct risk evaluations and issue rules addressing unreasonable risks, as well as EPA’s capacity to conduct industry-requested risk evaluations, the likely demand for such requests, and anticipated schedule for meeting that demand.

Beyond the first year of implementation, the Plan outlines “Framework Actions” that will guide the program on a longer-term basis. These are all on the same timeframe and include:

  • Initial Risk Evaluations: The list of ten Work Plan chemicals will be published in December 2016, with scope of assessments published in June 2017, as mentioned above.
  • Prioritization Process Rule: The Proposed Rule establishing EPA’s process and criteria for prioritizing chemicals for risk evaluations is expected by mid-December 2016; the Final Rule in June 2017.
  • Risk Evaluation Process Rule: The Proposed Rule establishing EPA’s process for evaluating the risk of high priority chemicals is expected in mid-December 2016; the Final Rule in June 2017.
  • Fees Rule: EPA plans to meet and consult with industry in developing the rules for collecting newly-authorized fees, including those for industry-requested risk evaluations, which must be fully funded by fees. The Proposed Rule is expected mid-December 2016 and the Final Rule in June 2017.
  • Inventory Rule: This rule will collect information via required industry reporting on chemicals manufactured or processed in the last ten years to determine which chemicals on the TSCA Inventory are “active” or “inactive.” Publication of the Proposed Rule is slated for mid-December 2016 and the Final Rule in June 2017.
  • Science Advisory Committee on Chemicals: This committee will be established to provide independent advice and scientific and technical expertise on the law’s implementation. EPA aims to establish the Committee by mid-December 2016, six months before the statutory deadline. The agency plans to publish the applicable Federal Register notice in early September 2016, with public comment accepted through early November 2016.

“Later Mandatory Actions” designated in the Plan include the publication of an Alternative Testing Methods Strategy by June 2018 and negotiated rulemaking on byproducts reporting for Chemical Data Reporting (CDR), with a Proposed Rule (by negotiating process) anticipated in June 2019.

In addition, EPA will hold an informational overview of the Lautenberg Act by webinar tomorrow, June 30, at 2:00 p.m. EST. The webinar will be accessible here: http://epawebconferencing.acms.com/overviewreform/. Audio will be available by phone by dialing 866-299-3188 and entering the code 2025648098#.

Other resources from EPA’s website about the Lautenberg Act include a summary of key provisions, a Frequently Asked Questions document, and the full text of the Act itself.

President Obama to sign Lautenberg Act tomorrow.

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The White House has announced that on Wednesday, June 22, President Obama will sign into law the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” the long-awaited update to the 40-year-old Toxic Substances Control Act (TSCA). The Senate passed the Lautenberg Act by voice vote on June 6, two weeks after the House approved the negotiated legislation. Both houses of Congress approved different versions of the bill in 2015, but were unable to reach a deal to reconcile the legislation until last month.

The bipartisan bill gives EPA new authority to regulate chemicals based on impacts to health and the environment, not cost, and order testing via order rather than rulemaking. Existing chemicals in commerce will be screened and prioritized for risk assessment, and industry will be allowed to apply for fee-funded expedited assessments. Fees for new and existing chemicals will be collected into a “TSCA Implementation Fund” to defray about 25% (initially $25 million annually) of the program cost. For new chemicals, EPA will be required to make an affirmative safety finding that the substance is not likely to present an unreasonable risk. The Lautenberg Act also provides for an “Inventory reset” under Section 8 of TSCA, requiring industry to report to EPA which Inventory chemicals they have manufactured or imported in the previous ten years. Most claims of Confidential Business Information (CBI), which allow companies to avoid disclosing certain information to EPA, will now have to be substantiated when made and will expire after ten years unless re-substantiated. EPA will be required to review and approve or deny past CBI claims for chemical identities on the Inventory.

The preemption of state and local laws was a major sticking point throughout TSCA reform negotiations, resulting in a complicated system of limited preemption. Generally, restrictions by states will not be preempted until EPA takes action on a particular substance, while reporting, monitoring, and disclosure requirements will not be affected. State actions in effect by April 22, 2016, or actions taken under a law in effect on August 31, 2003, will not be preempted. The Act also provides for a process under which states can seek waivers from preemption.

After the Lautenberg Act is signed into law, EPA will soon face a variety of tough implementation challenges. Within the first six months, EPA must designate ten chemicals from the Work Plan for risk assessment. Within the first year, EPA must develop guidance for industry-initiated risk evaluations and rules for Inventory reset reporting, prioritization of chemicals, and risk evaluation process.

Whether EPA will receive adequate funding from Congress to achieve all these goals remains to be seen; the Lautenberg Act does not permit EPA to assess fees unless Congress has appropriated at least the amount appropriated for the “Chemical Risk Review and Reduction” program project in FY 2014. Last week, the Senate Appropriations Committee reported out its appropriations bill for FY 2017, which included language to meet that requirement.

Bicameral, bipartisan deal reached on TSCA reform.

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Today, a bipartisan group of lawmakers announced that a deal was reached to modernize the Toxic Substances Control Act (TSCA), with changes to reconcile the House and Senate legislation “pretty much agreed to,” according to Senate Environment and Public Works Chair Jim Inhofe (R-OK).

House Democrats Frank Pallone (D-NJ) and Paul Tonko (D-NY) immediately responded by criticizing the deal as “weaker than current law.” The Representatives blamed House Republicans for “walk[ing] away from a bipartisan deal we agreed to last month.” Earlier this week, 40 House Democrats sent a letter urging Rep. Pallone to support a proposal backed by the Humane Society of the United States to reduce animal testing.

While no details on the content of the deal were released, Rep. John Shimkus (R-IL) said the legislative language would be released within a few days.

Sen. Inhofe said the negotiated bill could pass both chambers of Congress by the end of next week.

Senators reach deal on TSCA reform.

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Senators central to the effort to modernize the Toxic Substances Control Act (TSCA) have reportedly reached a deal that will allow the stalled legislation to move forward. Senate Environment and Public Works Chair Jim Inhofe (R-CA) and Ranking Member Barbara Boxer (D-CA), who has been a fierce critic of the Senate proposal, announced on Friday that they had “reached an agreement on key sticking points of the TSCA reform bill.” The content of the agreement has not yet been made public, but according to Politico’s Morning Energy, it involves “some resolution on Senate language calling for state action on high-priority chemicals to be paused while EPA performs a risk review.” A Senate aide told Politico that the final text will take most of this week to finalize.

The next step will be to win House approval before both chambers get the chance to vote on the negotiated legislation. A bi-partisan group of House Energy and Commerce Committee members also released a statement on Friday, calling the deal “an important step forward” and calling for “keeping the momentum going.”

TSCA reform reconciliation might be ready as soon as May 9.

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Despite perennially familiar optimistic comments, Congress is heading into a weeklong recess with no deal on overhauling the Toxic Substances Control Act (TSCA). As we have previously discussed, both chambers have approved legislation to update the law, but differences between the two bills have yet to be reconciled. Nevertheless, lawmakers continue to claim that progress is being made. While a push to wrap up negotiations before the recess failed, legislators hope to reach an agreement as soon as the week of May 9, when Congress is back in session.

Rep. John Shimkus (R-IL), chair of the House Energy and Commerce Committee’s Environment and the Economy Subcommittee told Bloomberg BNA that legislators are still trying to reach a “middle ground” on state preemption. This month, environmentalists have raised new concerns with the legislation, with the Waterkeeper Alliance opposing to the so-called “Monsanto provision,” flagged in February by the New York Times, and the Natural Resources Defense Council criticizing the legislation’s high standard for the Environmental Protection Agency (EPA) to regulate chemicals in imports, including articles, through Significant New Use Rules (SNURs). Vermont’s Congressional delegation has also written to reconciliation leaders, arguing for the importance of TSCA reform from the perspective of a state currently grappling with reports of drinking and surface water contaminated with perfluorooctanoic acid (PFOA). Their letter [PDF] calls for preserving state authorities and supports letters previously submitted by EPA Administrator Gina McCarthy and state Attorneys General.

Although lawmakers from both parties have insisted that negotiations are not to be held to any timeline, the number of weeks left on the legislative calendar is dwindling rapidly.

EPA grants partial exemption from Chemical Data Reporting rule for six biodiesel chemicals.

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Today, EPA announced that six biodiesel chemicals will be partially exempt from certain reporting requirements of the Chemical Data Reporting (CDR) rule, under section 8(a) of the Toxic Substances Control Act (TSCA). The Final Rule amends the list of chemical substances exempt from submitting processing and use information by adding the six chemicals, all of which are involved in the production of biodiesel. These chemicals will still be subject to other CDR reporting requirements, on facility and manufacturing and import volume information.

The affected chemicals and their Chemical Abstract Services Registry Numbers (CASRNs) are:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (CASRN 67762-26-9);
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CASRN 67762-38-3);
  • Fatty acids, canola oil, methyl esters (CASRN 129828-16-6);
  • Fatty acids, corn oil, methyl esters (CASRN 515152-40-6);
  • Fatty acids, tallow, methyl esters (CASRN 61788-61-2); and
  • Soybean oil, methyl esters (CASRN 67784-80-9).

This partial exemption was granted as part of the petition process for “Low Current Interest” chemicals developed in 2003. Under this process, EPA considers the “totality of information” available for a particular substance and certain considerations, defined in the regulations, including the availability of other risk screening information and whether potential risks of the substance are adequately managed, in determining the agency’s “current assessment of the need for collecting CDR processing and use information.” The agency stresses that this process is not necessarily based on potential risks, and interest may increase in the future, in which case the agency would reconsider the applicability of the partial exemption.

In this case, EPA determined that it had low current interest in processing and use information for the six substances. The analyses (“Review Reports”) for the individual chemicals are available at docket number EPA-HQ-OPPT-2014-0809.

These chemicals were requested to be added to the partial exemption list in a petition submitted by a biofuels industry group in October 2014. EPA initially granted the petition in a Direct Final Rule published in January 2015, but withdrew the rule in March 2015 after receiving an adverse comment to the Direct Final Rule. The agency proposed to make the same additions to the partial exemption list in a Proposed Rule published July 22, 2015; the Final Rule announced today makes no changes from that Proposed Rule. However, the Final Rule does discuss comments submitted by the petitioner arguing that these biodiesel chemicals should be treated similarly to comparable “petroleum process” chemicals, which the EPA has designated partially exempt because the agency “believes worker exposure is diminished.” The agency made “no determination” on the petitioner’s argument that the biodiesel chemicals should be partially exempt because they share similar manufacturing conditions, properties, and uses as petroleum process chemicals, since the issue is “moot” as the agency is now granting equivalent partial exemption under the “Low Current Interest” process.

The EPA signed the Final Rule on March 22, 2016. The partial exemption goes into effect when the rule is published in the Federal Register, which should be well before the June 1 start of the 2016 CDR reporting cycle.

EPA and others weigh in on TSCA reform, but no reconciliation in sight.

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Although both chambers of Congress approved legislation in 2015 to modernize the Toxic Substances Control Act (TSCA), there has been little proof of progress towards reconciling the two bills, while stakeholders, including the United States Environmental Protection Agency (EPA), have been active in providing feedback and recommendations to legislators. However, Senator James Inhofe (R-OK), Chairman of the Senate Environment and Public Works Committee, recently told Bloomberg BNA that an agreement on merging the bills could happen before the next Congressional recess.

Overall, the EPA prefers the Senate version of legislation to update TSCA, according to a letter [PDF] sent earlier this year to Congressional leaders. EPA Administrator Gina McCarthy provided the Agency’s most comprehensive comments to date on the TSCA modernization bills passed by both houses of Congress in a letter dated January 20, 2016 but not made public until the beginning of March. The letter stops short of expressly recommending that the Senate bill be adopted as the framework for final legislation, but voices the EPA’s preference for various aspects of the Senate version while also approving certain provisions found in both bills. The EPA’s comments are based on the Administration’s previously discussed principles for TSCA reform, and were submitted to help negotiators reconcile the two bills, emphasizing that “[t]he lack of a workable safety standard, deadlines to review and act on existing chemicals, and a consistent source of funding are all fundamental flaws in TSCA that should be addressed.”

In particular, the EPA expressed support for the following aspects of the Senate bill:

  • Deadlines for chemical assessments and a requirement to repopulate the high-priority list until all chemicals on the TSCA Inventory have been evaluated;
  • Considerations EPA must assess in choosing a risk management measure, including costs and benefits of alternative ways to achieve the safety standard, based on reasonably available information;
  • Prioritizing chemicals for review based on manufacturer requests, subject to a cap on the number of manufacturer-initiated evaluations and funding from requestors;
  • Authorizing fee collection for the cost of reviewing confidential business information (CBI) claims, section 5 notices, prioritization decisions, safety assessments, and rulemakings;
  • Regulatory flexibility under a new section 6(d), providing “catch-all” regulatory authorities;
  • Affirmative safety determinations for new chemicals;
  • Strengthened civil and criminal enforcement authorities; and
  • Clarifying the types of state laws that are intended to be protected from federal preemption.

However, the EPA also wrote that it “strongly prefers the House bill” on the matter of implementation, because the Senate version’s deadlines and procedural requirements “may unnecessarily slow progress on more substantive issues, limit the EPA’s flexibility to allocate resources appropriately, and lead to burdensome litigation.” The letter also identifies some areas where both bills need improvement, or where the Senate version was not singled out as preferable, such as new use notification requirements for chemicals in articles.

The Hill reported that, after receiving the letter and incorporating suggestions from it, leaders of the House Energy and Commerce Committee Fred Upton (R-MI) and Frank Pallone Jr. (D-NJ) “sent an offer to the Senate …as the first formal step in negotiating toward a bill.” This offer addressed EPA’s main concerns by, for example, capping the number of industry-initiated risk evaluations, increasing funding for the program, and providing for safety determinations for new chemicals. The offer was reportedly made at the end of February but there have not been any public reports on whether the Senate responded or whether any other progress has been made since early March.

Plans to merge the competing bills might have been thrown off track earlier this month following reporting from the New York Times on a provision in the House legislation that “could help shield [Monsanto] from legal liability” related to its manufacture of polychlorinated biphenyls (PCBs). The article has drawn criticism of the House bill from some NGOs and even Presidential candidate Hillary Clinton.

Meanwhile, even more stakeholders have weighed in with their concerns and priorities. Environmental regulators from eight states, including California and New York, submitted a letter in early February focusing on the bills’ approaches to preemption issues. In late February, the American Alliance for Innovation, an umbrella group of dozens of trade associations, outlined its priorities for consideration in conference discussions.

Although Congress is perhaps closer than ever to passing a TSCA modernization bill, there has been little indication that legislators are making progress in getting legislation to the President’s desk. These most recent stakeholder comments may be just what Congress needs to speed up the process.