Consultation Periods Open on Proposals to Harmonize Classification and Labeling of Four Substances under the EU's CLP Regulation

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EU CLP Regulation:

Public consultation periods have opened on propoosals to harmonize the classification and labeling of four substances under the EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures (the so-called “CLP Regulation,” (EC) No 1272/2008). The CLP Regulation implements the UN’s Globally Harmonized System of Classification and Labeling of Chemicals (“GHS“). The substances are:  2-Ethoxyethanol (CAS No. 203-804-4); Reaction mass of 2,4,4-Trimethylpent-1-ene and 2,4,4-Trimethylpent-2-ene (CAS No. 246-690-9); Vinyl acetate (CAS No. 203.545-4); and Indoxacarb and Indoxacarb (enantiomeric reaction mass S:R 75:25 (Indoxocarb CAS No. 173584-44-6).   Copies of the proposals, and other details such as the deadlines for submitting comments, are available on the website of the European Chemicals Agency (“ECHA”).

If a proposal is accepted, the substance would be added to the list of harmonised classifications in Annex VI, part 3 of the CLP Regulation.  Thereafter, all manufacturers, importers and users of the substance in the EU would need to abide by the new harmonised classification and labelling.  Persons potentially affected may be interested in submitting comments.

Background on CLP Regulation and Harmonization

The so-called CLP Regulation entered into force on January 20, 2009.   The regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and Dangerous Preparations Directive (1999/45/EC).  Both directives will be repealed by June 1, 2015. 

Under the Regulation, individual EU Member States (“Competent Authorities” or “CAs”) and industry may propose harmonization of the classification and labelling of substances.  The decision on a particular classification for a substance or mixture is usually made by the supplier (“self-classification”).  However, in certain cases the decision on the classification of a substance is made at the Community level, which is then called “harmonized classification.”  A harmonized classification must be applied by default by the suppliers of the respective substance.

Hamonized classification and labeling may be approved:

  • when the substance is either:

    • carcinogenic;

    • mutagenic;

    • toxic for reproduction; and/or

    • a respiratory sensitiser;

  • when the substance is an active substance in a biocidal or plant protection products; or

  • when there is a need to harmonize a classification at EU level, as supported by a justification demonstrating the need for such action.

* * * *

Check back periodically for future postings on CLP developments.

DTSC Announces New Date for the Public Workshop on Nanomaterials

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Nanotechnology:

The California Department of Toxic Substances Control (DTSC) announced a new date for its public workshop on nanomaterials.  State budget constraints forced the agency to reschedule the meeting from its original date of August 13.   The new date is Wednesday, September 22, 2010.  The workshop will be held at the U.S. EPA Region 9 office in San Francisco, California. 

Persons who previously registered are not required to re-register.   However, DTSC has circulated an email to registrants requesting confirmation of their plans to attend on the new date. 

At the workshop, DTSC and EPA will discuss the results of the carbon nanotube (CNT)  information call-in that DTSC recently completed, future activities by DTSC on other nanomaterial call-ins, and U.S. EPA efforts related to CNTs and future regulatory plans for other nanomaterials.

Reminder: DTSC Reschedules Meeting on Results of Information Call-In for Carbon Nanotubes

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Nanotechnology:

Due to state budget constraints, the California Department of Toxic Substances Control (DTSC) has had to reschedule its August 13 meeting on carbon nanotubes (CNTs) and other nanoscale chemicals substances and materials.  No new date has been provided.

DTSC was co-sponsoring the meeting with the US Environmental Protection Agency (EPA) and the University of California, Los Angeles.  The sponsors had planned to discuss the results of the CNT information call-in that DTSC recently completed, future activities by DTSC on nanomaterial call-ins, and U.S. EPA efforts related to carbon nanotubes and future regulatory plans for nanomaterials.

Although readers can register here to attend in-person or via teleconference, no new date for the event has been provided.

DTSC Posts Public Comments on Draft Green Chemistry Regulation for Safer Consumer Products

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Green Chemistry Regulations:

The California Department of Toxic Substances Control (DTSC) circulated the following announcement, informing stakeholders that the agency published all public comments received to date on the draft Green Chemistry Regulation for Safer Consumer Products.  The comments should make interesting reading.  Those of potential importance may be featured in future postings on the Green Chemistry Law Report, so stay tuned!

“DTSC: Green Chemistry Initiative

As part of DTSC’s commitment to transparency and public participation, we have posted, in the order received, all public comments on the Green Chemistry Initiative draft Regulation for Safer Consumer Products  http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm.

The regulation reflects nearly 16 months of collaboration with stakeholders, including numerous formal and informal meetings and workshops; input from the Green Ribbon Science Panel; and comments on the conceptual process flowchart, earlier drafts and the draft regulation outline released in the spring of 2010.

DTSC requested public comments during this informal comment period be received by July 15. This posting includes the comments received to date. Additional comments are expected and will be posted when received.

DTSC will now evaluate all comments and consider changes to the regulation. DTSC expects to move into the formal Administrative Procedure Act (APA) rulemaking process in late summer.”

House of Representatives Introduces Bill to Modernize TSCA

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TSCA Reform:

On July 22, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (“TCSA,” confusingly similar to the acronym of the current statute).  The bill is intended to modernize the current Toxic Substances Control Act (“TSCA”).  The introduced bill is different in many respects from the discussion draft the Representatives circulated back in April.  In some instances the introduced bill is better and in others it is worse.   A short summary of the bill, provided by the House Committee on Energy and Commerce, is set out below.   A more detailed analysis will be available in a future posting on the Green Chemistry Law Report.

According to the House Committee, the bill would:

  • Establish a framework to ensure that all chemical substances to which the American people are exposed will be reviewed for safety and restricted where necessary to protect public health and the environment;
  • Require the chemical industry to develop and provide to the U.S. Environmental Protection Agency (EPA) essential data, and improve EPA’s authority to compel testing where necessary;
  • Ensure that non-confidential information submitted to EPA is shared with the public and that critical confidential information is shared among regulators, with states, and with workers in the chemical industry;
  • Establish an expedited process for EPA to reduce exposure to chemical substances that are known to be persistent, bioaccumulative, and toxic;
  • Create incentives and a review process for safer alternatives to existing chemicals, promoting innovation and investment in green chemistry;
  • Create a workforce education and training program in green chemistry, promoting and ensuring long-term viability of American jobs;
  • Encourage the reduction of the use of animals in chemical testing;
  • Allow EPA to exempt chemicals already known to be safe from requirements of the TCSA;
  • Promote research to advance understanding of children’s vulnerability to the harms of chemicals;
  • Direct EPA to address community exposures to toxic chemicals in certain “hot spot” locations;
  • Require EPA to engage in international efforts to control dangerous chemicals;
  • Ensure that EPA actions are transparent, open to public comment, and subject to judicial review, without unreasonable procedural burdens; and
  • Give EPA the resources needed to carry out the TCSA.

Key documents, including a copy of the bill, are available here.

EPA Promulgates Direct Final SNURs under TSCA for Seventeen Chemicals

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TSCA:

On June 24, 2010, EPA promulgated significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances
Control Act (TSCA) for 17 chemical substances that were the subject of premanufacture notices (PMNs), the type of notice submitted prior to manufacturing or importing a “new chemical” for commercial purposes.  The Federal Register notice announcing the SNURs can be found at 75 Fed. Reg. 35977.

Two of the substances are subject to ‘‘risk-based’’ consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the substances may present unreasonable risks to human health or the environment.  The SNURs for these two substances are based on and consistent with the provisions in the underlying consent orders.  The 5(e) SNURs designate as a ‘‘significant new use’’ the absence of the protective measures required in the corresponding consent orders.

The other 15 substances are not subject to consent orders under section 5(e).  EPA did not find that the use scenarios described in their PMNs triggered the determinations set forth under TSCA section 5(e).  Nonetheless, the Agency concluded that certain changes from the use scenarios could result in increased exposures potentially causing adverse human health or environmental effects, or both, and thereby would constitute ‘‘significant new uses.’’

The Agency used its direct final rulemaking procedure to promulgate the SNURs, which means the rules will become effective on August 23, 2010, if EPA does not receive by July 26, 2010, written adverse or critical comments, or notice of intent to submit such comments.  In that instance, EPA would withdraw the SNUR for the substance(s) for which it received comments or notices, and instead it would issue a proposed SNUR and provide a 30-day public comment period.

A short overview of each substance, and the next steps some companies will likely consider, are set out below.

Overview of the Chemicals Affected

Persons who intend to manufacture, import, or process any of these 17 substances for an activity that is designated as a significant new use are required to notify EPA at least 90 days before commencing that activity. The required notification will give EPA the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

Each substance is listed below – typically with a generic name to protect Confidential Business Information (CBI) – along with the Code of Federal Regulations (CFR) citation to its respective SNUR, the PMN number, and the use(s) identified in its PMN.

  • Aliphatic triamine (generic). CAS number not available.  PMN Number P–02–996.  Will be used as a monomer for polymers with amide or imide links; a crosslinker for epoxy type coatings, adhesives and sealants; a crosslinker for epoxy type composites; a monomer for urea and urethane urea polymers used in coatings; a chemical intermediate for functional chemicals: amides, imides; a chemical intermediate for functional chemicals: isocyanates, salts; and a chemical intermediate for functional chemicals: cyclic amines, etc..  SNUR to be codified at 40 CFR § 721.10184.

  • 1,2-Propanediol, 3-(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts). CAS number: 328389–90–8.  PMN Number P–03–106.  Will be used as a surface treatment agent.  SNUR to be codified at 40 CFR § 721.10185.

  • Ethylhexyl oxetane (generic). CAS number not available.  PMN P–04–132.  Will be used as an additive for industrial applications.  SNUR to be codified at 40 CFR § 721.10186.

  • 4-Morpholinepropanamine, N-(1,3-dimethylbutylidene)-. CAS No. 1003863–30–6.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10187.

  • Fatty acids, tall-oil, reaction products with 4-methyl-2-pentanone and aliphatic polyamine (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10188.

  • Fatty acids, tall-oil, reaction products with (butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine, propylene glycol diamine and aliphatic polyamine, N-(1,3 -dimethylbutylidene) derivs (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10189.

  • Formaldehyde, polymer with aliphatic diamine and phenol, reaction products with 4-methyl-2-pentanone (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10190.

  • Amides, coco, N-[3-(dibutylamino)propyl]. CAS No. 851544–20–2.  PMN P–06–262.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10191.

  • Amides, coco, N-[3-(dibutylamino)propyl], acrylates. CAS No. 851545–09–0.  PMN P–06–263.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10192.

  • 1-Butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-,N-coco acyl derivs., inner salts. CAS No. 851545–17–0.   PMN P–06–263.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10193.

  • Dialkylcocoamidoalkylpropionate (generic). CAS number not available.  PMN P–06–264.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10194.

  • Dialkylcornoilamidoalkylamine (generic). CAS number not available.  PMN P–06–265.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10195.

  • Dialkylcornoilamidoacrylate (generic). CAS number not available.  PMN P–06–266.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10196.

  • Dialkycornoilamidoalkylbetaine (generic). CAS number not available.  PMN P–06–266.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10197.

  • Dialkylcornoilamidopropionate (generic). CAS number not available.  PMN P–06–267.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10198.

  • Substituted aliphatic amine (generic). CAS number not available.  PMN P–06–702.  Will be used as a polymer curative.  SNUR to be codified at 40 CFR § 721.10199.

  • Benzenacetonitrile, cyclohexylidene-alkyl substituted (generic). CAS number not available. PMN P–09–75.  Will be used as a component of odorant compositions for highly dispersive applications..  SNUR to be codified at 40 CFR § 721.10200.

Next Steps

First, many companies are probably determining whether they currently manufacture, import, or process any of these substances, or have plans to do so in the future.   If so, they may be assessing whether and how these rules would affect their business and deciding whether to submit comments to EPA by the deadline noted above.

Second, companies that import any of these substances are likely confirming that they are prepared to make the necessary import certifications.  TSCA section 13 (15 U.S.C. 2612) requires importers to certify that each shipment of a chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemical substances subject to a final SNUR must certify their compliance with the SNUR requirements.  The import certification requirements are set out in the regulations at 19 CFR 12.118 – 12.127, and 127.28 (the corresponding EPA policy is codified at 40 CFR part 707, subpart B).

Lastly, companies may also be confirming that they are prepared to make the necessary export certifications.  In general, any person who exports or intends to export a chemical substance that is the subject of a proposed or final SNUR is subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and the regulations at 40 CFR part 707, subpart D. The export notification requirements apply even when a company does not manufacture, import, or process the substance in a manner restricted by the SNUR.  The notification requirement applies regardless of whether the company is required to take any action under the SNUR.

Reminder: Upcoming DTSC Workshops on Draft Green Chemistry Regulation for Safer Consumer Products

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Green Chemistry:

This evening, the California DTSC circulated the following reminder about its upcoming workshops seeking public comment on the Draft Green Chemistry Regulation for Safer Consumer Products.   These should be interesting events, which I plan to report on in a future post.  Stay tuned!

“DTSC: Green Chemistry Initiative 

Your Input is invited on the Draft Regulation for Safer Consumer Products at 2 workshops scheduled for July 7 and July 8, 2010 in Sacramento and via webcast.  Both workshops will be held in the Cal/EPA Building, 1001 I Street, Sacramento, Byron Sher Auditorium during the following times:

July 7, 2010, 8:30 – 12:00 PDT

July 8, 2010, 1:30 – 5 PDT

Participants are also invited to join via webcast at: http://www.calepa.ca.gov/Broadcast/

The workshop agenda, draft regulation and information on additional opportunities for public input are available at:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm“

California Releases a Draft of the Green Chemistry Regulation for Safer Consumer Products

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Green Chemistry Regulation:

On June 23, the lead agency implementing California’s Green Chemistry Initiative, the Department of Toxic Substances Control (DTSC), published on its website a draft of the Regulation for Safer Consumer Products.  According to the DTSC announcement, the draft will be the subject of two additional informal, half-day public workshops on July 7 from 8:30 a.m. to 11:30 a.m. and July 8 from 1:30 p.m. to 5 p.m.  Both workshops will be held in the Cal/EPA Building, 1001 I Street, Sacramento, Byron Sher Auditorium.  Public comments are due by July 15, 2010.

Under the draft regulation, DTSC would create a list of chemicals that are “toxic” and can harm people or the environment. Products containing those chemicals would be prioritized based upon such factors as the volume in commerce, the extent of public exposure and how the product is eventually disposed. Manufacturers of those products would perform an “alternatives assessment” to determine if a viable safer alternative is available.  The draft currently calls for three phases: (1) the prioritization process, during which DTSC would identify and prioritize chemicals of concern and products that contain them; (2) an alternatives assessment conducted by the product manufacturers to identify safer alternatives for those priority products identified in first phase; and (3) DTSC adoption of regulatory measures to address concerns raised by the alternatives selected by manufacturers for implementation and to encourage manufacturers to design safer products.

DTSC has stated that it may revise the draft based on comments received. It would release the revised draft following the July 15 comment deadline. The formal Administrative Procedures Act (APA) rulemaking process will begin with the release of that draft. The APA process calls for public hearings and a 45-day public comment period. DTSC will release specific information about the APA process when the final draft regulation is available for review.

According to DTSC’s announcement, the draft regulation and related documents can be found at:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm

I plan to review the draft regulation in further detail and provide additional posts on the draft for interested readers.

EPA Recognizes Recipients of 2010 Presidential Green Chemistry Challenge Awards

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Green Chemistry:

This past Monday, June 21, at the Ronald Reagan Center in Washington, DC, EPA held the 2010 Presidential Green Chemistry Challenge Awards ceremony.   This year’s winners include BASF; The Dow Chemical Company; Merck & Co., Inc.; Codexis, Inc.; Clarke; LS9, Inc.; and James C. Liao, Ph.D.  Additional details regarding the Challenge Awards Program and this year’s winners are provided below.

Background on the Presidential Green Chemistry Challenge Awards Program

For those readers that are less familiar with the Challenge Awards Program, EPA offers the following description on its website:

“The Presidential Green Chemistry Challenge Awards Program is an opportunity for individuals, groups, and organizations to compete for annual awards in recognition of innovations in cleaner, cheaper, smarter chemistry. The Presidential Green Chemistry Challenge Awards Program provides national recognition of outstanding chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use, and that have been or can be utilized by industry in achieving their pollution prevention goals.

The Presidential Green Chemistry Challenge Awards Program invites nominations that describe the technical benefits of a green chemistry technology as well as human health and environmental benefits. The Awards Program is open to individuals, groups, and nongovernmental organizations, both nonprofit and for profit. The nominated green chemistry technology must have reached a significant milestone within the past five years in the United States (e.g., been researched, demonstrated, implemented, applied, patented, etc.).

Nominations received for the awards are judged by an independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute. Typically five awards are given annually to industry and government sponsors, an academic investigator, and a small business.”

According to EPA, the awards are typically granted in the following five categories:

  • Small Business: A small business* for a green chemistry technology in any of the three focus areas.
  • Academic: An academic investigator for a technology in any of the three focus areas.
  • Focus Area 1: An industry sponsor for a technology that uses greener synthetic pathways.
  • Focus Area 2: An industry sponsor for a technology that uses greener reaction conditions.
  • Focus Area 3: An industry sponsor for a technology that includes the design of greener chemicals.

* A small business is defined here as one with annual sales of less than $40 million, including all domestic and foreign sales by the company, its subsidiaries, and its parent company.

This Year’s Winners by Category

EPA’s website list this year’s winners, a summary of their innovations and their benefits, as well as a podcast overview of each innovation that is narrated by Dr. Richard Engler of EPA’s Office of Pollution Prevention and Toxics.  The winners include:

  • Greener Synthetic Pathways Award
    The Dow Chemical Company
    BASF
    Innovative, Environmentally Benign Production of Propylene Oxide via Hydrogen Peroxide (summary / podcast)
  • Greener Reaction Conditions Award
    Merck & Co., Inc.
    Codexis, Inc.
    Greener Manufacturing of Sitagliptin Enabled by an Evolved Transaminase (summary / podcast)
  • Designing Greener Chemicals Award
    Clarke
    NatularTM Larvicide: Adapting Spinosad for Next-Generation Mosquito Control (summary / podcast)
  • Small Business Award
    LS9, Inc.
    Microbial Production of Renewable PetroleumTM Fuels and Chemicals (summary / podcast)
  • Academic Award
    James C. Liao, Ph.D.
    Easel Biotechnologies, LLC
    University of California, Los Angeles
    Recycling Carbon Dioxide to Biosynthesize Higher Alcohols (summary / podcast)

Review of the ABA Conference: "Chemicals Regulation: REACHing for TSCA Reform"

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TSCA Reform, Green Chemistry:

Last week, on Friday, June 11, I attended the ABA conference: “Chemicals Regulation:  REACHing for TSCA Reform.”  In my opinion, the conference was a success.  It was well-attended by a range of stakeholders and the speakers’ topics were generally interesting.  Blake Biles did a fantastic job in his opening remarks setting the context in which TSCA was passed in 1976 and the challenges that EPA has faced implementing the statue.  All in all, I think the conference was worth the investment.

The conference provided a brief overview of the Congressional bills to modify TSCA and more detail regarding the role of states in chemicals regulation, the recent green chemistry initiatives, and some of the legal issues that go beyond regulatory compliance.  If anyone would like a copy of the agenda, which includes a biography (of sorts) of supplementary reading material, please let me know.  The suite of conference materials is probably available from the ABA.

I was a little disappointed that the speakers did not cover the mechanics of the new bills in any detail, however.  Presumably this was because they felt that it was premature to do so. In other words, they probably expect the final legislation to differ from what’s currently proposed. Based on what I’m hearing, I would generally agree with that conclusion. However, the recent convergence of chemical industry executives on Capitol Hill suggests that there may be some residual concern about the bills passing this session in something similar to their present form, so more discussion of the mechanics would have been helpful to some attendees, I’m sure.