OSHA to Adopt Final GHS Rule by August 2011

Globally Harmonized System of Classification and Labeling of Chemicals (GHS):

On December 20, 2010, the Occupational Safety and Health Administration (OSHA) released its Fall 2010 Unified Agenda.  75 Fed. Reg. 79604.  The Agenda sets August 2011 as the date for publishing a final rule that will modify the current hazard communication standard (HCS) at 29 CFR 1910.1200 to incorporate elements of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  Readers will recall that GHS is a system the United Nations (UN) developed for standardizing and harmonizing the classification and labeling of chemicals to help ensure their safe use, transport and disposal.  Publication of the final rule is the culmination of a five-year process that has left the United States behind many countries in its implementation of GHS. 

The UN first published the GHS in 2003 in response to the diverse and sometimes inconsistent hazard classification and communication systems in use around the world.  Governments, industry, and labor, working through the UN, hoped that a harmonized system would increase safety and reduce the regulatory burden associated with the global trade in chemicals.  Under the GHS, labels would include signal words, pictograms, and hazard and precautionary statements and safety data sheets would have a standardized format.  

When the GHS system was first adopted, the goal was implementation in each country by 2008.  However, that has not happened.  Some countries met the deadline while others did not.  Japan required compliance in 2006, and New Zealand and Korea required at least partial compliance in 2008.   The European Union’s GHS regulation entered into force in January 2009.   (Information on other countries’ adoption is available here.)

Adoption in the US has been slower, possibly because several agencies are involved, including the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), and the Department of Transportation (DOT).  Each agency is evaluating its existing regulations and guidance, and making the necessary changes.  OSHA’s adoption of GHS has been particularly slow.  The Agency first published an advanced notice of proposed rulemaking in September 2006, 71 Fed. Reg. 53617, and then waited almost three years before proposing a rule, 74 FR 50279, and finally initiated several public hearings thereafter.   Some question whether US industry, particularly smaller businesses, have been hurt by the delay since smaller companies sometimes cannot afford to comply with multiple countries’ hazard communication systems and therefore avoid significant international trade.

Multiple aspects of OSHA’s current HCS will be affected by the impending rule.  According to OSHA’s website, the following major areas are subject to significant changes.

  • Hazard classification: Specific criteria for classification of health and physical hazards, as well as classification of mixtures will be adopted.
  • Labels: Chemical manufacturers and importers will be required to provide a label that includes a harmonized signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided.
  • Safety Data Sheets: A prescribed 16-section format will be required for all safety data sheets.
  • Information and training: The GHS does not address training. However, the proposed rule will require workers to be trained on GHS within two years of the publication of the final rule to facilitate recognition and understanding of the new labels and safety data sheets.

Additional details about the proposed changes are available in the Federal Register notices cited above.  For those interested in learning more, OSHA has published a lengthy comparison of the GHS and HCS, and a comprehensive discussion of the GHS also is avaialble on OSHA’s website.

 

Reminder: February 4 Meeting of the Green Ribbon Science Panel for CA DTSC

Green Chemistry:

The Green Ribbon Science Panel (GRSP) of the California Department of Toxic Substances Control (DTSC) is holding its first meeting of 2011 later this week.  The meeting will be held this Friday, February 4.  Details and links to additional information are set out in the DTSC notice below. 

From the agenda, this meeting does not appear to include discussion of the draft Safer Consumer Product Alternatives (SCPA) regulations.  Readers will recall that Cal-EPA decided on December 23 to delay adoption of those regulations, and reconvene the GRSP to discuss further revisions to the regulations despite a December 31, 2010 statutory deadline for completing the rulemaking process.  A new date for completing the process has not yet been announced publicly.

________________________

DTSC: Green Chemistry Initiative

DTSC will convene a teleconference meeting of the Green Ribbon Science Panel (GRSP) to discuss future process considerations for the GRSP. 

The meeting will be held on February 4, 2011, from 9 a.m. to 10:30 a.m. Pacific Time.

To find out how to participate in person or via teleconference go to:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/GRSP-Feb-4-2011-PN.pdf

To view meeting materials and an agenda go to:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/GreenRibbon.cfm#grspmeetings

To subscribe to or unsubscribe from the DTSC Green Chemistry Initiative Listserv or other Listservs, please go to http://www.calepa.ca.gov/listservs/dtsc.  For information on DTSC`s Green Chemistry Initiative, go to http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/index.cfm

 

Reminder: Upcoming DTSC Symposium on Green Chemistry and Public Health

Green Chemistry:

Yesterday, the California Department of Toxic Substances Control (DTSC) circulated the following announcement regarding an upcoming symposium on Green Chemistry and public health.  The event will be held on October 18.  DTSC and the Department of Public Health are co-sponsoring the event.  More details, including a copy of the agenda, are provided in the excerpt below.

“DTSC and the California Department of Public Health will host a brown-bag symposium on October 18 to explore impacts of Green Chemistry on public health. Keynote Speaker is Margaret L. Kripke, Ph.D., a member of the President’s Cancer Panel which recently advocated expanded research into Green Chemistry.  Kripke is a professor of immunology at the University of Texas, MD Anderson Cancer Center. Our afternoon keynote speaker is Steve Owens, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention at the U.S. Environmental Protection Agency.  Owens oversees regulatory and scientific programs on pesticides and industrial chemicals along with numerous collaborative pollution prevention programs.

The symposium will be held on October 18, 2010 from 10 a.m. to 3 p.m. at the California Department of Public Health East End Complex, 1500 Capitol Ave., Sacramento, CA. It is free, open to the public and to all interested stakeholders in Green Chemistry and Public Health.

For more information or to register for in person or live webcast attendance, please visit: http://www.dtsc.ca.gov/upload/GreenChemPublicHealthBrownBagFlyer.pdf

To view the agenda, visit: http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/PHAgenda.pdf

Instructions on how to view the webcast will be provided a few days before the event.

To subscribe to or unsubscribe from the DTSC Green Chemistry Initiative Listserv or other Listservs, please go to http://www.calepa.ca.gov/listservs/dtsc.  For information on DTSC`s Green Chemistry Initiative, go to http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/index.cfm

California DTSC Requests Comment on Proposed Green Chemistry Regulations for Safer Consumer Product Alternatives

Green Chemistry Regulations:

After nearly two years of public meetings, informal comment periods and other multi-stakeholder collaborative efforts, the California Department of Toxic Substances Control (DTSC) released on September 15, 2010 its proposed Safer Consumer Product Alternatives regulations, a key component of California’s Green Chemistry Initiative.  The proposed regulations would require DTSC to create a list of chemicals identified as posing the greatest threats to human health or the environment, the so-called “Priority Chemicals.”  Using a number of factors such as volume in commerce and extent of public exposure, DTSC would then prioritize products containing those chemicals.  Entities responsible for commercial introduction of the highest priority products, the so-called “Priority Products,” would be required to perform an alternatives assessment to determine whether a viable safer alternative is available.  The alternative ultimately selected would inform DTSC’s regulatory response, which could range from no action to sales prohibitions.

The proposed regulations represent a paradigm shift in the regulation of chemicals and products, having significant implications for all members of a product’s value chain.  The process for identifying Priority Chemicals and Priority Products is complicated and information-intensive.  Products undergoing an alternatives assessment will require a substantial resource commitment.  To help ensure compliance, reduce the risk of reputational harm, maintain market presence, and potentially identify new opportunities, companies will need to understand the process, closely monitor future DTSC pronouncements and be prepared to respond appropriately.

Companies placing products into the stream of commerce in California that have not yet reviewed the proposed regulations are probably doing so now.  Although many industry representatives actively participated in the collaborative drafting process, many more did not, mistakenly believing that their products were not “consumer products” and therefore would not be affected.  The reality is that only a limited universe of products is excluded from the definition of consumer product or otherwise eligible for some type of exemption.

Public comments on the proposed regulations are due on November 1, 2010, the same date as the public hearing on them.  DTSC intends to complete the formal rulemaking process by the end of 2010, as required by statute.  A copy of the proposed regulations, a set of Frequently Asked Questions, a conceptual flowchart, and other information is available here.

Readers that are familiar with the previous draft of the regulations may be interested in the type of changes that DTSC incorporated into the current proposal.  DTSC claims that the changes:

  • Address criticism that the initial scope of chemicals list was too narrow.  DTSC has significantly broadened the proposed scope by expanding the lists of authoritative bodies that could be consulted for establishing the Priority Chemicals list.
  • Respond to concerns that the previous draft regulation’s lack of deadlines could cause unintended delays.  Proposed deadlines are now included for both chemicals and products lists along with specific timelines for various regulatory steps.  (These are set out in more detail below.)
  • Additionally, DTSC has added a tiered process for alternative assessments intended to reduce the time for identifying safer alternatives and provide more specific performance targets to move manufacturers through the regulatory process.
  • Address comments regarding the complexity of the process.  DTSC has simplified the process somewhat and clarified what information would be required and how it would be submitted.
  • Respond to requests to have public comments on regulatory actions.  DTSC now proposes to allow public comment on any regulatory responses that are triggered by a DTSC ruling or determination.

The proposed regulations include the following deadlines:

  • The proposed initial list of Chemicals under Consideration must be issued for public review and comment no later than June 1, 2011;
  • The final initial list of Chemicals under Consideration must be issued no later than March 1, 2012;
  • The proposed initial list of Priority Chemicals must be issued for public review and comment no later than July 1, 2012;
  • The proposed initial list of Products under Consideration must be issued for public review and comment no later than March 1, 2013;
  • The proposed initial list of Priority Products must be issued for public review and comment no later than September 1, 2013;
  • The final initial list of Priority Products must be issued no later than December 1, 2013.

Future postings may delve further into various aspects of the proposed regulations, as well as review public comments that are submitted to DTSC.

Reminder: Upcoming California DTSC Symposium on Life Cycle Analysis

Green Chemistry:

This evening the California Department of Toxic Substances Control (DTSC) circulated the following announcement, reminding interested persons about the upcoming symposium on life cycle analysis.

“DTSC invites you to the Life Cycle Analysis: 101 Brown-Bag Symposium, taking place on Thursday, Sept. 23, 2010. This session looks at real-world examples of life cycle analysis (LCA) and how it affects product formulation, decision analysis and business practices. Presenters from HP, P&G, PE Americas and UCLA will share their front-line experiences of developing protocol and collaboration to successfully complete LCAs.

The symposium takes place in the Elihu M. Harris Building in Oakland, from 10:30 a.m. to 3 p.m. Bring a lunch and plenty of questions for our presenters. Register (http://www.dtsc.ca.gov/LCA_symposium.cfm) to attend in person or participate via webcast.”

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

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

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.”

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

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

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

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)