EU court rules on notification requirements for REACH articles.

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Under Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, notifications are required for components of complex products that meet the 0.1% threshold concentration for certain chemicals, the European Court of Justice (ECJ) has ruled. The court’s decision, issued last week, overturns guidance issued in 2011 by the European Commission and European Chemicals Agency (ECHA). Interpreting Articles 7(2) and 33 of REACH, which require disclosures when an article contains more than 0.1% by weight of Substances of Very High Concern (SVHC), the ECJ found that “there is no need to draw a distinction …between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner.” Thus, notification duties apply based on the concentration of SVHCs in component articles that make up a complex product, rather than the complex product’s total weight.

According to the court, a “complex product” is “made up of a number of manufactured objects meeting the criteria laid down in Article 3(3),” which defines an “article” as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” Further,

It is therefore only if the production of an object using a combination of more than one article gives that object a special shape, surface or design which is more decisive for its function than its chemical composition that that object may be classified as an article. Accordingly, unlike a simple assembly process, that production process must alter the shape, surface or design of the articles used as components.

Article 7(2) requires producers and importers of articles to notify ECHA if an SVHC is present at a level greater than 0.1% and totals over one tonne per year. Under Article 33, suppliers must inform recipients of articles containing SVHCs at this level, and provide similar information in response to consumer inquiries within 45 days.

The court ruled that a “producer’s duty to notify covers only those articles which the producer itself has made or assembled,” while third-party assemblers must make notifications for complex products it assembles. Importers are subject to notification duties for articles that comprise components of complex products. Suppliers’ notification duties, which include providing the name of the SVHC, apply “to all operators along the supply chain.”

The ECJ’s decision affirms the position of France, Belgium, Denmark, Germany, Austria, Sweden, and Norway, and is in line with the opinion published in February by an ECJ Advocate General, a legal advisor to the court. According to Chemical Watch, ECHA said it will begin the process of revising its guidance in light of the ECJ’s ruling.

Alternatives Assessments for flame retardants in flexible polyurethane foam and printed circuit boards finalized.

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Yesterday, EPA released two final Alternatives Assessment reports, for flame retardants used in flexible polyurethane foam and printed circuit boards, as well as a technical correction to an alternatives assessment report on bisphenol A (BPA) in thermal paper. These reports were developed under the agency’s Design for Environment (DfE) program to characterize chemical hazards and identify safer chemicals, and continue EPA’s scrutiny of flame retardant chemicals.

The final Alternatives Assessment for flame retardants used in flexible polyurethane foam finalizes the draft update, released in June 2014, to a 2005 report on the flame retardant pentabromodiphenyl ether (pentaBDE). PentaBDE was voluntarily phased out by industry in the U.S. in 2004, and is subject to a proposed Significant New Use Rule and section 4 test rule under the Toxic Substances Control Act (TSCA) as part of the EPA’s Polybrominated Diphenyl Ethers (PBDEs) Action Plan. The final report evaluates 19 alternatives, including one non-proprietary mixture and two proprietary mixtures, and covers all upholstered consumer products containing flexible polyurethane foam, including car seats and nursing pillows. In addition, EPA released a document responding to public comments to the draft report [PDF].

EPA also finalized its Alternatives Assessment report for flame retardants in printed circuit boards used in electronic products, like computers and cell phones, and released a response to comments on the 2014 draft report [PDF]. The Alternatives Assessment was published in draft form in December 2014 as an update to a draft first released in 2008. As in the 2014 draft, the final Alternatives Assessment focuses on alternatives to tetrabromobisphenol-A (TBBPA), a commonly used halogenated flame retardant which is also the subject of a recently released TSCA Work Plan Problem Formulation and Initial Assessment. Based on a confidential study and comment submitted following the release of the 2014 draft report, the final Alternatives Assessment changed the skin sensitization designation for magnesium hydroxide from Moderate to Low. Responding to another comment, EPA elaborated on performance testing of halogen-free flame-retardant printed circuit boards, which reportedly “found that the eight halogen-free flame retardant laminates tested generally outperformed the traditional… laminate control.”

The technical correction revises a final Alternatives Assessment report for BPA in thermal paper originally released in January 2014. BPA, a high production volume (HPV) chemical, is commonly used as a developer in thermal paper, like cash register receipts. The correction changes the developmental toxicity designation of one alternative, Pergafast 201, from High to Moderate. The change is based on further analysis of new data submitted in response to the draft report.

EPA releases initial TSCA Work Plan assessments of four flame retardants.

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Last week, EPA released preliminary assessment documents for four structurally similar flame retardant chemical clusters. These documents represent the first step in the Toxic Substances Control Act (TSCA) Work Plan Chemical assessment process for these substances, which were all on the Work Plan list. The TSCA Work Plan is the agency’s program to evaluate potential risks of existing chemicals, first introduced in 2012 and updated in 2014. The notice of the availability of these assessments will be published in the Federal Register on August 18.

EPA released Problem Formulations and Initial Assessments for three flame retardant chemical clusters:

  • Tetrabromobisphenol A (TBBPA), also known as Brominated Bisphenol A – used in plastics and printed circuit boards;
  • Chlorinated phosphate esters – used in furniture foams and textiles; and
  • Cyclic aliphatic bromides/hexabromocyclododecane (HBCD) – used in expanded polystyrene foams and polystyrene foam products.

The Problem Formulations and Initial Assessments discuss likely exposure and hazard scenarios to workers and consumers, based on current production, use, and exposure information. These assessments aim to identify scenarios where further risk analysis may be necessary. In the case of these three flame retardants, EPA will conduct assessments of risk to human health (workers and consumers) and the environment. EPA will accept public comment on these Problem Formulations and Initial Assessments for 60 days.

In addition, EPA released a Data Needs Assessment for the Brominated Phthalates (TBB and TBPH) cluster of flame retardants used in polyurethane foam products. After reviewing previous assessments of this cluster, EPA identified critical gaps in existing data on toxicity, exposure, and commercial mixtures. The Data Needs Assessment for brominated phthalates is meant to guide the collection of additional data and information and provide stakeholders and the public with the opportunity to submit data or information that may fill the identified gaps. As information is identified or submitted, the agency will “continue to evaluate the adequacy of the database to conduct a risk assessment that can inform decision making.” Public comment on the Data Needs Assessment will be accepted for 120 days.

EPA to hold training webinars on TSCA section 5 e-PMN electronic reporting system.

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Today, U.S. EPA announced a series of webinars to assist submitters with the agency’s new web-based system for Toxic Substances Control Act (TSCA) Section 5 submissions. The new electronic reporting system, finalized by rule last month, applies to premanufacture notices (PMNs) and certain other § 5 notices and support documents. The three webinars will walk submitters through the process of registering with EPA’s Central Data Exchange (CDX) and using the new, cloud-based e-PMN software to complete PMNs and other submissions. The webinars are scheduled for August 26, September 16, and September 30; audio recordings and slides will be posted online for those unable to attend.

OSHA releases Hazard Communication Standard inspection procedures.

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The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has released a new Directive outlining the changes in enforcement caused by the modification of the Hazard Communication Standard (HCS 2012) to harmonize with the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The new Directive, titled Inspection Procedures for the Hazard Communication Standard (HCS 2012), describes how to determine if a violation has occurred under the revised standard as well as how it will be enforced both during its transition period and after full implementation.

The Inspection Procedures note that HCS 2012 is based on GHS Revision 3 (2009), not the more recent Revisions 4 or 5 issued by the UN in 2011 and 2013, respectively. The Directive notes that using a more recent version of GHS may result in noncompliance with HCS 2012 “if it contradicts or casts doubt on OSHA required information.” Notably, OSHA requires that precautionary and hazard statements incorporated from GHS be changed to mandatory, e.g., “should” must be replaced with “shall.”

The Directive provides significant discussion on hazard classification under the revised standard. Classification must be based on criteria specific to each hazard class, and evaluations must “consider all available data on the hazards.” Other considerations include quality and quantity of data and positive and negative results in a single weight-of-evidence determination. Detailed evaluation procedures are included in the Directive’s appendices. In terms of inspection guidelines, the Directive notes that “[t]he adequacy of a company’s hazard classification should be assessed primarily by examining the outcome of that classification.”

The HCS 2012 labeling and SDS requirements went into effect on June 1, 2015 (except for distributors, for whom labeling requirements do not apply until December 1, 2015). However, where a company has “exercised ‘reasonable diligence’ and ‘good faith’ to obtain HCS 2012-compliant SDSs from upstream suppliers but have not received them, they will be allowed limited continued use of HCS 1994-compliant MSDSs and labels.”

Canada imposes new reporting requirements for nanoscale substances.

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Canada’s Minister of the Environment is requiring manufacturers and importers of certain nanoscale substances to report information for “the development of a list of nanomaterials in commerce in Canada and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities.”

A notice published in the Canada Gazette on July 25 lists 206 substances by CAS number. A listed substance is reportable if it “has a size of between 1 and 100 nanometres in at least one external dimension, or internal or surface structure.” The Minister of Environment intends to use the reported data to assess whether the listed substances “are toxic or are capable of becoming toxic,” or to assess whether and how to control the substances.

The reporting requirements apply to any person who manufactured or imported more than 100 kg of a listed nanoscale substance in calendar year 2014, including imports of substances in mixtures and products, at any concentration. However, the notice does not apply to listed nanoscale substances that are in transit through Canada, are naturally occurring, were incidentally produced, or are covered by various other laws, such as the Fertilizers Act or Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations.

Reportable information includes total quantities manufactured or imported, end uses (commercial, consumer, or use by children under 14 years of age) and studies or data on physical-chemical properties, bioaccumulation, persistence, toxicity, metabolism, degradation, and release or disposal from the final mixture or product. The reporting deadline is February 23, 2016.

EPA issues new electronic reporting rule for TSCA section 5.

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Today, EPA released a pre-publication version of a new rule for electronic reporting under section 5 of the Toxic Substances Control Act (TSCA). The action, which comes in the form of a Direct Final Rule, amends the regulations governing the electronic submission of premanufacture notices (PMNs), other TSCA § 5 notices, and related documents to EPA. The rule provides for various new procedures and requirements for registration, reporting and submission, including new ways to access and complete the electronic-PMNs (e-PMNs), changes to the registration process for the Central Data Exchange (CDX), and requiring all “bona fide intents to manufacture” notices to be submitted electronically. The Agency’s intention in passing this rule is “to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and the EPA.”

The Agency previously issued a Final Rule in January 2010 requiring the use of e-PMN reporting software for the submission of PMNs, other TSCA § 5 notices, and related documents through CDX. The new rule mandates the use of a new version of the e-PMN software, which is cloud-based. Firewall and file submission size limitations from the old version of the software have been eliminated.

Other minor changes to the regulations include:

  • Corrections of regulatory cross- references in 40 CFR parts 720 and 721;
  • Standardizes use of “manufacture” and similar language in parts 720, 721, and 725; and
  • Specifies electronic reporting procedures for the notification of new manufacturing sites pursuant to 40 CFR 723.50(j)(6)(ii).

After this rule, the only submissions related to TSCA § 5 that cannot be handled via e-PMN are:

  • Certain notices, like polymer exemption annual reports;
  • Certain support documents, including § 5(e) consent orders;
  • Certain communications, such as pre-notice communications and TSCA Inventory correspondence.

The Agency “may consider offering electronic reporting of these and other submissions in the future.”

The rule is scheduled to be published on Monday, July 20, and will become effective 180 days thereafter, unless EPA receives adverse comment within 30 days of the rule’s publication date. EPA will begin accepting submissions via the new e-PMN system beginning 45 days after the rule’s publication.

Senate leaders urged to consider competing TSCA reform bills.

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Since our last update, U.S. lawmakers and other stakeholders have kept busy with competing legislation to reform the Toxic Substance Control Act (TSCA), with the hope of bringing the issue to the Senate floor for debate before the August Congressional recess. The TSCA Modernization Act of 2015 (H.R. 2567) passed the House by a vote of 398-1 on June 23, while the Udall-Vitter bill (S. 697), which was approved by the Senate Environment and Public Works Committee in April, continues to await scheduling for a floor vote.

Last week, Democratic supporters of the bipartisan Udall-Vitter bill urged Senate leaders to bring the bill to a floor vote “as soon as possible.” In a letter addressed to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Harry Reid (D-NV), thirteen senators lauded S. 697 as “stronger and more comprehensive” than the House bill. The lawmakers criticized the House bill for creating a “virtually unlimited pathway for chemicals favored for review by industry.” The Democrats also took issue with the House bill for failing to overhaul the new chemical review program, provide for an independent funding mechanism, limit animal testing, or mandate EPA to review Confidential Business Information (CBI) claims.

A vocal critic of S. 697, Sen. Barbara Boxer (D-CA) joined a group of environmental and public health organizations in lobbying for adoption of the more limited House bill, which she called “the best approach for meaningful TSCA reform.” Led by the Safer Chemicals, Healthy Families coalition, 57 advocacy groups sent a letter [PDF] advocating the House bill as “more appropriate to use as the vehicle for changes as the process moves forward.” The coalition stressed that if the Senate proceeds with S. 697, then the bill’s “primarily failings” – including provisions regarding state preemption and the “low-priority loophole” – must be addressed.

TSCA Modernization Act approved by House Energy and Commerce Committee, floor vote expected by end of June.

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Today, the House Energy and Commerce Committee approved the TSCA Modernization Act (H.R. 2576), setting up the bill for a floor vote currently scheduled for June 23. The vote was 47-0 with one abstention, by Rep. Anna Eshoo (D-CA), who warned of the legislation’s insufficient protections for state chemical laws. Rep. John Shimkus (R-IL), the initial author of the proposal, also won adoption of a technical amendment [PDF] making minor changes to the bill’s language.

The preemption of state laws has been a major sticking point in this year’s proposals to reform the Toxic Substances Control Act (TSCA) in both the House and Senate. Notwithstanding changes to the TSCA Modernization Act designed to address those concerns, environmental and public health advocacy groups have not dropped their opposition to the bill. In addition, a dozen state Attorneys General representing California, Massachusetts, New York, and Maryland, among other states, sent a letter [PDF] last week to Energy and Commerce Committee leaders Fred Upton (R-MI) and Frank Pallone (D-NJ). In the letter, the Attorneys General expressed concern that the bill “scales back the states’ police powers and inhibits the traditional state-federal partnership that protects the public from toxic chemicals.” Following promises from Rep. Upton to negotiate new state preemption language before the floor vote, Rep. Eshoo agreed to withdraw her own proposed amendment [PDF] meant to clarify ambiguities on state authority. Rep. Pallone suggested that the state authority issues might be addressed later, although Rep. Shimkus suggested that the scope of the proposed changes may be too disruptive to win sufficient support for passage.

While the Environmental Working Group criticized the bill’s approval, saying the legislation “falls short,” industry groups responded favorably and continue to push for action in the Senate. Over 140 trade groups ranging from the Alliance of Automobile Manufacturers to the U.S. Chamber of Commerce, organized as the American Alliance for Innovation sent a letter [PDF] to Senate Majority Leader Mitch McConnell (R-KY) urging the swift passage of S. 697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” which they described as a “balanced compromise.” Yesterday, Bloomberg BNA reported that Sen. McConnell had not scheduled floor time for the bill yet, so it would not reach the floor until July or August.

TSCA reform: NYT calls for more high-priority chemical assessments, House bill formally introduced.

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Even while Congress is in recess this week, the cause of reforming the Toxic Substances Control Act (TSCA) continues to progress. Notably, the New York Times Editorial Board is calling for stronger regulation of chemicals by requiring and empowering EPA to evaluate “at least 20 high-priority chemicals a year of its own choosing.” The editorial describes the current TSCA reform proposals in Congress as “a substantial improvement” while simultaneously decrying the bills’ failure to provide “speedy evaluations of the most worrisome chemicals among tens of thousands that have never been tested for safety.” The Times notes the “remarkable feat” of attracting 20 Republican and 20 Democratic co-sponsors to the Senate bill, but criticizes the legislation’s “slow pace of designating high-priority chemicals that require safety assessments.” The editorial also claims that under the House proposal, EPA would be tied up with conducting industry-initiated assessments instead of “chemicals the agency might regard as posing the highest risk.”

Meanwhile, Rep. John Shimkus (R-IL) formally introduced his bill, the TSCA Modernization Act of 2015 (H.R. 2576), on Tuesday. The legislation’s initial co-sponsors are Representatives Fred Upton (R-MI), Frank Pallone (D-NJ), and Paul Tonko (D-NY). The bill was unanimously approved by the House Subcommittee on Environment and the Economy earlier this month.