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

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 Thus, EPA proposes to replace outdated references to old OSHA standards with the current NIOSH regulations on the certification and testing of respirators, as well as adding specific types of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.

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.”

First Priority Products listing proposed under CA’s Safer Consumer Products program.

Today, California’s Department of Toxic Substances Control (DTSC) announced that the comment period is now open for the first Priority Product listing regulation under the state’s Safer Consumer Products (SCP) program. The proposed regulation would establish a Priority Products list containing one item: children’s foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP). Both substances, which are used as flame retardants, are known to the state of California as carcinogenic and are associated with various other hazard traits, including genotoxicity, neurotoxicity, and reproductive toxicity. TDCPP and TCEP are described in the proposal’s accompanying Technical Report [PDF] as “easily released to indoor and outdoor environments” and “ubiquitous,” having been detected worldwide in homes, offices, and daycare centers, as well as in waterways, wildlife, and human breast milk.

The proposed listing encompasses products designed for children, toddlers, babies, or infants to nap or sleep on that incorporate polyurethane foam mats, pads, or pillows that contain TDCPP or TCEP. This includes, among other products: nap mats, soft-sided portable cribs, play pens, bassinets, co-sleepers, and baby or toddler foam pillows. The listing specifically excludes:

  • mattresses “as defined and covered by the requirements of CPSC 1632/1633”;
  • furniture regulated under California Technical Bulletin 117-2013; and
  • “[a]dd-on child restraint systems for use in motor vehicles and aircraft that are required to meet federal flammability standards.”

This is the first of three Priority Products that DTSC originally proposed, in draft form, more than two years ago. DTSC will list the other two Priority Products – spray polyurethane foam (SPF) systems containing unreacted diisocyanates and paint/varnish strippers and surface cleaners containing methylene chloride – through separate rulemaking proposals. Based on the Priority Products Work Plan released last year, the agency will identify as many as five additional Priority Products, drawn from the seven product categories ranging from Cleaning Products to Clothing, in 2016 and 2017.

The comment period runs through August 29, 2016. Once finalized, the Priority Products listing triggers the requirement that manufacturers submit a Preliminary Alternatives Analysis Report within 180 days after the effective date of the regulation.

Seventh Generation Settles “Natural” Claims Class Action For $4.5M

Consumers in this class action claimed that Seventh Generation Inc. deceptively labeled its cleaning products as “natural” even though they contained synthetic preservatives. Seventh Generation has agreed to pay $4.5 million to settle this case in New York federal court.

Seventh Generation makes several household cleaning items such as laundry detergent, glass cleaner, and dish soap. The products in question are natural laundry detergent, natural 4X concentrated laundry detergent, ultra power plus natural laundry detergent, natural dish liquid, and ultra power plus natural dish liquid. They were available for sale in stores such as Walgreens, Walmart, Target, Amazon.com, Bed Bath & Beyond, and Whole Foods.

The consumers alleged that the company incorrectly used the term “natural,” despite the fact that two of the ingredients — Methylisothiazolinone (“MIT”) or Benzisothiazolinone (“BIT”) — are synthetic. MIT and BIT are antimicrobial preservatives.

In its press release, Seventh Generation stood by its “natural” labeling, but cited burdensome litigation costs as its reason for settlement. Under the terms of the settlement, Seventh Generation will remove the “All Natural” and “100% Natural” claims, and will add clarifications about the non-toxic and hypoallergenic claims. Additionally, Seventh Generation will provide compensation to eligible claimants.

This lawsuit is one of several settled and pending cases against companies claiming that their products are natural, but contain synthetic substances. See Earth Friendly Settlement and Tom’s of Main Settlement.

The 2015 California Air Resources Board Consumer and Commercial Products Survey

The 2015 California Air Resources Board (“CARB”) Consumer and Commercial Products Survey (“Survey”) reporting period began on July 1, 2016 and must be completed by November 1, 2016. This is the final year of the CARB Survey program and is mandatory for all “responsible parties,” i.e. any company, firm, or establishment listed on a label that manufactured or sold consumer or commercial products in California during the 2015 calendar year. However, the 2015 Survey contains new exemptions for certain product categories that CARB determined have low or no volatile organic compound emissions, including certain adhesives, aerosols, and coatings.

For Responsible Parties who reported in 2013 and 2014, only sales information for 2015 is required, unless a change was made to an existing product or a new product was sold in 2015. For the data reporting instructions, please click this link. Penalties, including significant per day fines, can be assessed for those responsible parties who do not report to CARB.

Lautenberg Act: EPA releases Implementation Plan and other resources.

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.

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.

CPSC: No mandatory recall for Lumber Liquidators.

Last week, the U.S. Consumer Product Safety Committee (CPSC) declined to issue a mandatory recall but announced that Lumber Liquidators has agreed to not sell its inventory of laminate wood flooring imported from China. The announcement marked the end of the CPSC’s investigation of Lumber Liquidators, which was prompted by a March 2015 segment on 60 Minutes alleging that the company sold Chinese-made flooring with unsafe formaldehyde levels.

Lumber Liquidators has agreed to continue operating its “recall to test” program, offering free test kits to the over 600,000 consumers who purchased the flooring before the company stopped selling it in May 2015. If the test kit reveals elevated formaldehyde levels, Lumber Liquidator has agreed to cover the costs of helping homeowners conduct additional tests and any necessary remediation. So far, the testing program has analyzed indoor air quality in 17,000 homes and found elevated formaldehyde levels in about 1,300 of them; however, CPSC reports that “none of the floors tested above the remediation guideline.”

Based on its examination of the product and test data, CPSC concluded that the flooring does not contain unsafe levels of formaldehyde. According to a report from the Centers for Disease Control and Prevention’s National Center for Environmental Health/Agency for Toxic Substances and Disease Registry,

eye, nose, and throat irritation could occur with the higher formaldehyde emitting flooring samples in certain home environments. Irritation can happen in anyone, but is more likely among children, older adults, and people with respiratory issues, such as asthma or other breathing problems. Very high levels of formaldehyde in homes may also be associated with a small increase in cancer risk.

CPSC will continue to monitor test results and consider new information as it becomes available. Lumber Liquidators has also agreed that future flooring products will be subject to “enhanced supplier controls designed to achieve compliance with California formaldehyde requirements and any future federal requirements for laminate flooring.” In March, the company paid $2.5 million to settle the California Air Resources Board’s claims that the flooring exceeded state formaldehyde limits and reported in May that it will pay $26 million to settle related shareholder suits.

Bicameral, bipartisan deal reached on TSCA reform.

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.

Supreme Court denial upholds FTC on substantiating claims in advertising.

Green marketers take note: the Federal Trade Commission (FTC) won a recent victory at the Supreme Court on deceptive advertising, which means companies cannot advertise health benefits for their products without sufficient evidence.

On May 2, the Supreme Court denied POM Wonderful’s petition for certiorari, bringing to an end a six-year-long wrangle with the FTC over advertisements that claimed the company’s pomegranate juice was clinically proven as effective in fighting heart disease, prostate cancer, and erectile dysfunction.

The Supreme Court’s denial leaves in place the January 2015 decision [PDF] from the D.C. Circuit Court of Appeals, which upheld the Commission’s decision that POM misled consumers in violation of the FTC Act. Specifically, the D.C. Circuit upheld the Commission’s findings as to (1) establishment and efficacy claims made in POM’s advertising, as well as (2) inadequate substantiation for those claims.

The D.C. Circuit also affirmed the FTC’s cease and desist order [PDF], which requires POM to substantiate any future disease treatment and prevention claims with at least one randomized, well-controlled human trial, while other health benefit claims must be supported by competent and reliable scientific evidence.

In a statement, FTC Chairwoman Edith Ramirez lauded the Supreme Court’s move, saying the conclusion of the case “makes clear that companies like POM making serious health claims about food and nutritional supplement products must have rigorous scientific evidence to back them up.”