Canada begins phase-in of GHS with Hazardous Products Regulation.

Earlier this month, Canada published final regulations implementing the Globally Harmonized System (GHS) for Classification and Labeling of Chemicals. The Hazardous Products Regulation (HPR) aligns closely with the United States’ Hazard Communication Standard and the United Nations’ fifth revision of the GHS. The HPR harmonizes criteria for hazard classification, labels, and safety data sheets, but will not otherwise change the roles and responsibilities for suppliers, employers and workers. A goal of GHS is to allow chemical suppliers to use “a single label and SDS for each hazardous product.”

Adoption of the HPR marks the beginning of Canada’s three-phase transition to GHS, similar to the U.S. approach to implementing GHS. Canada’s transition is scheduled to be completed by December 1, 2018.

California may add BPA to Prop. 65 list.

On Friday, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that bisphenol A (BPA), a chemical found in common consumer products like food packaging and paper receipts, will be considered for possible listing under the state’s Proposition 65 program, which requires businesses to provide warnings for exposures to listed chemicals. The Developmental and Reproductive Toxicant Identification Committee (DARTIC), an advisory panel that helps OEHHA compile the list of chemicals known to cause reproductive toxicity, will meet on May 7, 2015 to “consider whether BPA has been clearly shown by scientifically valid testing according to generally accepted principles to cause female reproductive toxicity.”

In April 2013, BPA was added to the Prop. 65 list as a reproductive toxicant for development endpoints via the Prop. 65 “authoritative bodies” mechanism, based on the National Toxicology Project’s findings that BPA caused reproductive toxicity at high doses. However, California delisted BPA the next week, in response to a lawsuit brought by the American Chemistry Council, and simultaneously withdrew that attempt to list the chemical.

DARTIC will now be revisiting BPA per a 2009 request from the committee to reconsider the chemical “if additional epidemiological or other specific types of data on reproductive and developmental toxicity became available.” Substantial relevant data has become available since 2009, including a significant 2014 review of studies published from 2007-2013 concluding that BPA is a reproductive toxicant.

OEHHA has compiled hazard identification materials on BPA and female reproductive toxicity for the consideration of both DARTIC and the public. The agency is accepting comments on the hazard identification materials through April 6, 2015. These comments will be forwarded to DARTIC members before the May 7 meeting, and also posted online. Instructions for submitting comments are in the meeting notice.

The May 7 meeting will begin at 10:00am in the Coastal Hearing Room of the Cal/EPA Headquarters building, 1001 I Street, Sacramento, and will also be webcast. If DARTIC require more time for deliberations, the meeting will be continued on May 21 at the same location.

EPA’s chemicals outlook for 2015.

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.

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.

EPA proposes updates to Chemical Data Reporting rule.

This week’s Federal Register includes notices from the EPA of two changes to the Chemical Data Reporting (CDR) rule, part of the Toxic Substances Control Act (TSCA). On Tuesday, EPA published a Direct Final Rule that adds six biobased chemicals to the list of chemicals that are partially exempt from certain reporting requirements. Today, EPA published a Notice that the agency has submitted an information collection request to the Office of Management and Budget (OMB).

EPA’s submission to OMB proposes a revision to a previously approved information collection request, which implemented the 2011 updates to the CDR. Information collection requests are reviewed and approved by OMB under the Paperwork Reduction Act. The new request reflects the reporting requirements for the 2016 submission period. The update is estimated to affect almost 5,000 entities once every five years.

The new partial exemptions stem from a petition filed by a group representing the biobased chemicals industry. The Direct Final Rule adds a “biodiesel” category to the list of partially exempt chemicals which are not subject to reporting requirements for processing and use information. Responding to the group’s petition, EPA determined that processing and use information for the six biobased chemicals were of “low current interest.” The chemicals affected are:

  • Fatty acids, tallow, Me esters.
  • Fatty acids, C14-18 and C16-18-unsatd., Me esters.
  • Fatty acids, C16-18 and C-18-unsatd., Me esters.
  • Soybean oil, Me esters.
  • Fatty acids, canola oil, Me esters.
  • Fatty acids, corn oil, Me esters.

The partial exemption puts the biodiesel industry on more equal footing with petroleum-based diesel manufacturers, whose “petroleum process streams” chemicals are already partially exempt.

The partial exemption Direct Final Rule goes into effect on March 30, 2015, unless adverse comments are received by February 26. Comments on the information collection request will be accepted through March 2, 2015.

Industry opposes proposed rule on nonylphenols and nonylphenol ethoxylates.

Companies and trade groups representing industries ranging from automakers to cleaning products have pushed back against an EPA proposal that would restrict certain chemicals widely used in industrial applications and consumer products such as detergents, cosmetics, paints, and sealants. As Bloomberg BNA reports, industry commenters argue that their ongoing uses of the chemicals preclude EPA from issuing the proposed rule. The commenters also criticize EPA’s nomenclature convention, which they contend is not generally used or understood, as well as EPA’s reliance on Chemical Data Reporting Rule (CDR) results as a basis for the rulemaking.

In late September, we wrote that EPA released its proposed Significant New Use Rule (SNUR), under the Toxic Substances Control Act (TSCA), for nonylphenols (NPs) and nonyphenol ethoxylates (NPEs). EPA later extended the comments period for the proposed rule by 45 days, to January 15, 2015.

The proposed SNUR identifies by CAS number 13 “linear NPs and NPEs” for which any use is a significant new use, as well as two branched NPs, for which any use besides “as an intermediate or use as an epoxy cure catalyst” is a significant new use. However, commenters argue that “the global industry practice is to use CAS names” without distinguishing between “branched” or “linear” forms. The American Chemistry Council contends that EPA has not provided sufficient explanation and guidance on its “poorly-understood” naming convention regarding whether an alkyl chain is linear or branched.

Many commenters were highly critical of EPA’s method of evaluating whether the CAS numbers listed in the proposed SNUR were in commerce, stating that many were identified in ongoing uses and included in a variety of public databases. Various commenters also criticized EPA for using the proposed SNUR as a method of collecting use information.

Other comments reported specific ongoing uses of certain chemical substances by Chemical Abstract Service (CAS) Number.

The San Francisco Bay Regional Water Quality Control Board also weighed in to request that EPA not exempt articles from this SNUR, particularly toilet paper, which “has the potential to be a major source of pollution for aquatic resources receiving treated or untreated wastewater discharges.”

House Republicans planning “more limited” TSCA reform proposal.

Chemical Watch reports that Rep. John Shimkus (R-IL), head of the House Subcommittee on Environment and the Economy, is planning “a more limited reform measure” to modernize the Toxic Substances Control Act (TSCA) compared to the Chemicals in Commerce Act (CICA) draft that he first introduced last year. Attempts to negotiate a compromise on that legislation stalled when Republicans and Democrats could not agree on revisions and counter-proposals from either side.

Rep. Shimkus’ strategy is to offer Democrats the chance to add amendments in exchange for committing to support the legislation. However, Rep. Shimkus would not reveal what the limited scope of his proposal would target. He did cite Rep. Frank Pallone’s (D-NJ) expression of interest in working on TSCA reform as “a pretty positive sign.”

In terms of timing, Rep. Shimkus said he would like to move the bill “sooner than later, and have it off the floor before the August break.”

Rep. Shimkus also expressed hope that the more limited House proposal, if approved, could be resolved in conference committee with the more expansive TSCA reform legislation expected from the Senate side.

EPA proposes new SNUR for perfluorinated chemicals, again eliminates articles exemption.

EPA has proposed another Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, including perfluorooctanoic acid (PFOA) and its salts. Under the proposal, significant new uses that would require filing a 90-day notice with EPA include: manufacturing, importing, or processing “an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemicals substances for which there are currently no ongoing uses.” In addition, EPA is continuing its trend in making the articles exemption inapplicable for these substances when imported as part of an article.

In the same proposed rule, EPA also proposes amending a SNUR for perfluorylalkyl sulfonate (PFAS) substances to make the articles exemption inapplicable for importing PFAS substances as part of carpets.

The affected chemicals are used in a variety of industrial applications and consumer goods, including cleaners, textiles, paper and paints, fire-fighting foams, and wire insulation. Their risks to human health and the environment include toxicity, persistence in the environment, and bioaccumulation in humans and animals. The chemicals are found in the blood of the general U.S. population and studies indicate that they may cause reproductive, developmental and systemic effects.

EPA’s proposal targets LCPFAC chemicals containing PFOA and its higher homologues, including the salts and precursors of these substances. Based on data from the 2012 Chemical Data Reporting (CDR) rule, the LCPFAC substances identified in the proposed SNUR are known to have current or recent ongoing uses. Noting that it is not the agency’s intention to regulate fluoropolymers in this rule, the proposed SNUR’s definition of the LCPFAC category includes a perfluorinated carbon chain length upper limit of 20. However, certain LCPFAC substances intentionally used in fluoropolymer formulation would be subject to reporting for the designated significant new uses.

The proposal defines PFAS substances to mean “a category of perfluorinated sulfonate chemical substances of any chain length.” For PFAS substances, EPA proposes modifying an existing SNUR for the chemical substances listed at 40 CFR 721.9582(a)(1).

The proposed rule is just the latest step in the agency’s ongoing work to regulate perfluorinated chemicals. The SNUR supports EPA’s 2010/2015 PFOA Stewardship Program, a voluntary initiative launched in 2006 with the major global manufacturers of LCPFAC substances. The Stewardship Program aims for a complete emissions and product content phaseout of these chemicals by 2015, and the most recent progress reports on the Program for the years 2014 and 2013, released last week, finds that the participating companies are on track to meet this goal. EPA notes that the SNUR for LCPFACs is proposed “in part in anticipation of this 2015 phase-out deadline.” In addition, the SNUR is consistent with EPA’s 2009 LCPFAC Action Plan. In October 2013, EPA finalized another SNUR on LCPFACs in carpets and PFAS, and earlier SNURs regulated PFAS and perfluorooctane sulfonate (PFOS).

Comments on the proposed rule will be accepted through March 23, 2015. In particular, EPA seeks to confirm through comments on this action whether use (including in articles) of the affected chemicals – or related ones – is still ongoing and will cease by the 2015 deadline. The agency notes that the proposed SNUR would not affect any ongoing uses of the chemicals except those that will be phased out by the end of 2015, although “uses not already ongoing as of the publication date of this proposed rule, and ongoing uses that will be phased out by the end of 2015, would not be considered ongoing uses if they later arise, even if they are in existence upon the issuance of a final rule. Furthermore, uses that are ongoing as of the publication date of this proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule (see Units IV. and VI. for further discussion of what constitutes an ongoing use).” EPA also requests comment on whether PFAS substances are currently imported as part of carpets.

CPSC proposes new ban on phthalates in children's products.

Regular readers know that in terms of domestic, national regulation, we usually focus on developments coming out of the Environmental Protection Agency (EPA). In the U.S., the EPA is the principal federal agency that regulates chemicals in products, but it’s not the only one. Last month, the U.S. Consumer Product Safety Commission (CPSC) approved for publication a proposed rule prohibiting the use in children’s toys and child care articles of certain phthalates, a type of plasticizer used in teethers, plastic toys, home furnishings, and cosmetics.

The rule expands the existing “permanent ban” on phthalates at levels greater than 0.1% in accessible plasticized components of toys and child care products. Diisononyl phthalate (DINP) is shifted from the “interim ban” list and di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and butyl benzyl phthalate (BBP) remain on the “permanent ban” list. The rule also adds to the “permanent ban list” the following: diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) in concentrations greater than 0.1%. Two other phthalates, diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DnOP), were removed from the “interim ban” list.

The Commission proposed the rule under § 108 the Consumer Product Safety Improvement Act (CPSIA), which requires promulgation of regulations in response to the Chronic Hazard Advisory Panel’s report and recommendations on the health effects of phthalates in children’s toys and child care articles. Under the CPSIA, a “child care article” is “a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.”

The Commission is accepting public comment on the proposed rule through March 16, 2015.

An early look at TSCA reform's prospects in the 114th Congress.

As the 114th Congress begins, legislators in both houses are expected to continue trying to reform the outdated Toxic Substances Control Act (TSCA), although which specific proposals and policies will be pursued remains to be seen.

According to E&E Daily, Sen. Tom Udall (D-NM) says he’s already rallying support for a new version of the Chemical Safety Improvement Act (CSIA), a bipartisan bill originally developed and introduced by Sen. David Vitter (R-LA) and the late Sen. Frank Lautenberg (D-NJ) in May 2013. Although Sen. Udall lost his seat in the Senate Environment and Public Works Committee, he is still seen by some advocates as “uniquely positioned to garner the support of more lawmakers.” Moreover, efforts at bipartisan collaboration may fare better under new Committee Chair Sen. James Inhofe (R-OK), who is known to have a collegial relationship with Sen. Barbara Boxer (D-CA), the former Chair and current Ranking Member of the Committee. Last year’s TSCA negotiations in the Senate ended with acrimonious disagreements between Sens. Boxer and Vitter. In discussing his agenda for the new Congress, Sen. Inhofe described the CSIA as a “good starting point” and “a high priority” for the Committee. Among the Democrats, a Committee aide said that Sen. Boxer’s support is predicated on the bill being “stronger than current law.” Sen. Udall said he is still trying to resolve Sen. Boxer’s concerns

On the House side, Rep. John Shimkus (R-IL) said in a statement that he is “hopeful” about attracting the bipartisan support needed to pass chemical reform. Rep. Shimkus, returning as head of the House Energy and Commerce Committee’s Subcommittee on Environment and the Economy, tabled his Chemicals in Commerce Act (CICA) draft bill after failing to win buy-in among Democrats. Rep. Frank Pallone (D-NJ), the new Ranking Member of the Energy and Commerce Committee, has expressed “serious concerns” about CICA, a sentiment echoed by other key Democrats. In addition, at a committee hearing last year, Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention, said that “some in the administration would have some problems” with the draft bill if it advanced, which has been interpreted as an implied veto threat. Nevertheless, whether Rep. Shimkus pursues a similar approach as last year or a more targeted one, at least some in the chemical industry are hopeful that this Congress can pass TSCA reform. Bill Allmond, vice president of government affairs at Society of Chemical Manufacturers and Affiliates (SOCMA), said he is optimistic that Rep. Pallone can encourage his Democrats “to be more open-minded than in the last Congress, on TSCA reform, specifically.”