Tag Archive for: Alternatives Assessment

EU Commission Releases Roadmap on Substances of Very High Concern

EU REACH Substances of Very High Concern:

Last week, the EU Commission released its Roadmap on Substances of Very High Concern (SVHC). The Roadmap outlines a process for identifying and assessing potential SVHCs within the following categories: substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs); substances that are persistent, bioaccumulative or toxic for the environment (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances of equivalent concern, such as endocrine disruptors. The Roadmap estimates that the process will evaluate up to 440 substances, a far lower number than the 1,900 substances originally anticipated, with an initial goal of completing 80 assessments by the end of 2014.

The Roadmap follows the Commission’s commitment to compile a comprehensive REACH candidate list of SVHCs and is designed to help meet the Commission’s plan to include all currently known SVHCs on the candidate list by 2020.

The SVHC Roadmap proposes first screening substances with REACH registration dossiers by applying a minimum quantity threshold and generally exempting substances registered only for intermediate uses. The second step entails conducting a “Risk Management Options” (RMO) analysis. Under this approach, the best regulatory option to manage a particular risk is chosen after considering actions available within REACH (like imposing authorization, restriction or substance evaluation requirements) or under other legislative schemes, such as RoHS. For example, the Roadmap suggests that substances with demonstrated risk should be restricted under REACH.

The roadmap is downloadable as a PDF from the EU website.

DTSC Requests Public Comment on Another Draft of the Green Chemistry Regulations

California Green Chemistry Regulations:

The saga of California’s nascent Green Chemistry program continues. Last week, the Department of Toxic Substances Control (DTSC) released the revised text (PDF) of its proposed Safer Consumer Product Regulations. The comment period for the revisions started on January 29 and closes on February 28, 2013.

Notably, the revised rules significantly pare down the list of potential Chemicals of Concern (COCs), which are now referred to as “Candidate Chemicals,” from over 3,000 to approximately 1,200. The Candidate Chemicals  are drawn from lists of substances which exhibit one or more hazard trait. The revisions also clarify that the list of Priority Products to be regulated will be developed and updated through the Administrative Procedure Act rulemaking process.

In addition, DTSC modified the applicability of upfront exemptions for certain products, providing an exemption for products already regulated by other laws that provide comparable health and environmental protections. However, products which are manufactured, stored, or transported through California solely for use outside of the state, or used in California solely for the manufacture of non-consumer products will no longer be exempted, although these factors will be considered in the product prioritization process.

Requirements for the certification and accreditation of assessors involved in developing Alternatives Analyses (AA) have been relaxed in favor of a public review and comment process for AA reports, a choice that seems likely to increase the administrative burden and place confidential business information at greater risk. The scope of evaluating economic impacts for AA reports has also been limited to “a monetized comparison of public health and environmental costs, and costs to governmental agencies and nonprofit organizations that manage waste, oversee environmental cleanup and restoration efforts, and/or are charged with protecting natural resources, water quality, and wildlife.”

Finally, DTSC’s ability to make regulatory responses has been further refined and clarified. For example, the revised proposal requires DTSC to provide notice (with accompanying public comment period) of its proposed regulatory response determination no later than 90 days after it issues a notice of compliance or disapproval for a submitted AA report. The revised proposal also limits the agency’s ability to impose certain regulatory responses on manufacturers only, and not on retailers or importers.

More details on the revised proposed regulations, including how to submit comments and a comprehensive summary of changes from the agency’s last proposal, are available on the DTSC’s website.

DTSC Reopens Comment Period on Green Chemistry Regulations

California Green Chemistry:

On December 20, DTSC delivered everyone an early Christmas present.  The agency announced that it was re-opening the docket to accept public comments on yet another revised version of the Safer Consumer Product Alternative (SCPA) Regulations.  The agency’s announcement is embedded below.  Merry Christmas – better scratch those holiday plans and get back to work!  Surely some are asking themselves “When will this stop and the litigation begin?”

_____________________________________________________________________________________________________

30 DAY PUBLIC NOTICE AND COMMENT PERIOD

NOTICE OF PUBLIC AVAILABILITY OF POST-HEARING CHANGES

SAFER CONSUMER PRODUCT ALTERNATIVES

Department Reference Number: R-2011-02

Office of Administrative Law Notice File Number: Z-2012-0717-04

Pursuant to Government Code section 11347.1, notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the Initial Statement of Reasons (ISOR) for the Safer Consumer Product Regulations, which establish the criteria for identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and imposition of regulatory responses by adopting chapter 55 to division 4.5 of Title 22, California Code of Regulations, and to amend the Table of Contents. DTSC is revising the ISOR to correct: typographical, spelling, cross-referencing, punctuation and other formatting errors. In addition, DTSC has revised the ISOR to address some substantive drafting issues raised regarding the ISOR. These include, but are not limited to, making more explicit the necessity statement for each provision.

 DTSC mailed the 45-day Public Notice and made it, together with the regulations text and related materials, available for public review and comment on July 27, 2012. A public hearing was held on September 10, 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days and ended October 11, 2012. DTSC has now made post-hearing changes to the ISOR. DTSC is NOT proposing changes to the regulations text as part of this notice and related public comment period.

 A public comment period for the revised ISOR will commence on December 21, 2012, and close at 5 p.m. on January 22, 2013. Interested persons may submit comments regarding the revised ISOR by e-mail to gcregs@dtsc.ca.gov, by fax to (916) 323-5542, or by mail to:

Ms. Krysia Von Burg

Regulations Coordinator

Department of Toxic Substances Control

P.O. Box 806

Sacramento, CA 95812-0806

 Copies of the revised ISOR are posted to DTSC’s Internet site at: http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm and http://www.dtsc.ca.gov/SCPRegulations.cfm and are available for public inspection between 8:00 a.m. and 5:00 p.m. at the Regulations Section located at 1001 I Street, 23rd Floor, Sacramento, California. Requests and inquiries concerning this matter may be directed to Ms. Krysia Von Burg at the address indicated above or by telephone at (916) 324-2810. Additions to the existing text are double-underlined and text deleted from the existing document is shown as strikeout.

 All comments must be received by DTSC by 5:00 P.M. on January 22, 2013, regardless of the form of transmission.

 Technical inquiries regarding the Revised Initial Statement of Reasons should be directed to Ms. Odette Madriago, Chief Deputy Director, at (916) 323-4927. However, it should be noted that oral inquiries are not part of the rulemaking record.   

30 DAY PUBLIC NOTICE AND COMMENT PERIOD 

NOTICE OF PUBLIC AVAILABILITY OF POST-HEARING CHANGES

 

SAFER CONSUMER PRODUCT ALTERNATIVES

 

Department Reference Number: R-2011-02

Office of Administrative Law Notice File Number: Z-2012-0717-04

 

 

Pursuant to Government Code section 11347.1, notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the Initial Statement of Reasons (ISOR) for the Safer Consumer Product Regulations, which establish the criteria for identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and imposition of regulatory responses by adopting chapter 55 to division 4.5 of Title 22, California Code of Regulations, and to amend the Table of Contents. DTSC is revising the ISOR to correct: typographical, spelling, cross-referencing, punctuation and other formatting errors. In addition, DTSC has revised the ISOR to address some substantive drafting issues raised regarding the ISOR. These include, but are not limited to, making more explicit the necessity statement for each provision.

 

DTSC mailed the 45-day Public Notice and made it, together with the regulations text and related materials, available for public review and comment on July 27, 2012. A public hearing was held on September 10, 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days and ended October 11, 2012. DTSC has now made post-hearing changes to the ISOR. DTSC is NOT proposing changes to the regulations text as part of this notice and related public comment period.

 

A public comment period for the revised ISOR will commence on December 21, 2012, and close at 5 p.m. on January 22, 2013. Interested persons may submit comments regarding the revised ISOR by e-mail to gcregs@dtsc.ca.gov, by fax to (916) 323-5542, or by mail to:

Ms. Krysia Von Burg

Regulations Coordinator

Department of Toxic Substances Control

P.O. Box 806

Sacramento, CA 95812-0806

 

Copies of the revised ISOR are posted to DTSC’s Internet site at: http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm and http://www.dtsc.ca.gov/SCPRegulations.cfm and are available for public inspection between 8:00 a.m. and 5:00 p.m. at the Regulations Section located at 1001 I Street, 23rd Floor, Sacramento, California. Requests and inquiries concerning this matter may be directed to Ms. Krysia Von Burg at the address indicated above or by telephone at (916) 324-2810. Additions to the existing text are double-underlined and text deleted from the existing document is shown as strikeout.

 

All comments must be received by DTSC by 5:00 P.M. on January 22, 2013, regardless of the form of transmission.

 

Technical inquiries regarding the Revised Initial Statement of Reasons should be directed to Ms. Odette Madriago, Chief Deputy Director, at (916) 323-4927. However, it should be noted that oral inquiries are not part of the rulemaking record.  

DTSC Requests Public Comment on Scientific Peer Review of Green Chemistry Regulations

California Green Chemistry Regulations:

Yesterday, the Department of Toxic Substances Control (DTSC) notified the public that the agency is adding two external scientific peer review reports to the Safer Consumer Products rulemaking, which was published in the California Regulatory Notice Register (Z-2012-0717-04)on July 27, 2012.  A public comment period for the external scientific peer review reports will commence on November 30, 2012, and close at 5 p.m. on December 30, 2012.

According to the notice, DTSC has complied with Health and Safety Code section 57004 regarding submission of the scientific portions of the proposed safer consumer product regulations to an external scientific peer review. Documents were submitted to scientific peer reviewers through the University of California. Their written reports, which contain an evaluation of the scientific basis of the regulations, have been added to the rulemaking file.  (If truly independent and objective, these comments should make interesting reading, potentially providing ammunition for the legal challenge that seems likely.)

Comments may be submitted by e-mail to gcregs@dtsc.ca.gov, by fax to  (916) 324-1808, or by mail to:

Ms. Krysia Von Burg

Regulations Coordinator

Department of Toxic Substances Control

 P.O. Box 806

 Sacramento, CA 95812-0806

 Tel: (916) 324-2810

 Fax: (916) 324-1808

 The external scientific peer review reports are available at http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/index.cfm or  http://www.dtsc.ca.gov/SCPRegulations.cfm and for public inspection between 8:00 a.m. and 5:00 p.m. at the Regulations Section located at 1001 I Street, 22nd Floor, Sacramento, California. Requests and inquiries concerning this matter may be directed to Ms. Krysia Von Burg at the address indicated above or by telephone at (916) 324-2810. If Ms. Von Burg is unavailable, please call Ms. Jacqueline Arnold at (916) 322-2004.

Inquiries regarding technical aspects of the external scientific peer review report should be directed to Mr. Jeff Wong at (916) 322-2822. If Mr. Wong is unavailable, please call Ms. Odette Madriago at (916) 323-4927. However, such oral inquiries are not part of the rulemaking record.

EU Member State Committee Identifies 5 More SVHCs

REACH/SVHCs/Authorization

During meetings held from June 6 – 8, 2012, the EU’s Member State Committee (MSC) unanimously agreed on the identification of five substances of very high concern (SVHCs).  SVHCs are thought to have serious and often irreversible effects on human health and the environment.  The five substances identified by the MSC are diborontrioxide and the following four dyes:  C.I. Basic Violet 3; C.I.Basic Blue 26; C.I. Solvent Blue 4; and 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol.  The listing for the four dyes will clarify that the substances will only be identified as SVHCs when the concentration of the impurities Michler’s ketone or Michler’s base is equal to or higher than 0.1%.

SVHCs include substances that have one or more of the following hazard characteristics: Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2); Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB); or cause probable serious effects to human health or the environment (e.g. Endocrine Disruptors).  REACH, the primary regulation for industrial chemicals, aims at ensuring that the risks resulting from the use of SVHCs are controlled and that the substances are replaced where possible.

The five substances will be added to the Candidate List and may subsequently become subject to authorization under REACH Title VII.  When an SVHC becomes subject to authorization, persons using or making it available on the EU market must apply for authorization within a prescribed deadline (i.e., the “sunset date”), seeking approval of nonexempt uses while also including an analysis of possible substitutes.  If they can show that the risks from their uses are adequately controlled (except non-threshold CMRs and PBTs/vPvBs), or that the socio-economic benefits outweigh the risks and no suitable alternatives exist, then their uses of the SVHC are “authorized” to continue.

Even without being selected for authorization, inclusion of substances on the Candidate List immediately triggers certain regulatory obligations. 

  • EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
  • EU and EEA producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
  • EU and EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet.
  • EU and EEA suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

More information about the MSC is available here, and information about the process for identifying SVHCs is available here.

California DTSC Announces Two-Day Workshop on Alternatives Assessment

Green Chemistry/Alternatives Assessment:

The California Department of Toxic Substances Control (DTSC) has announced an upcoming two-day workshop on alternatives assessment, a key component of the department’s much-anticipated Safer Consumer Product Alternatives (SCPA) Regulations.  Those regulations are in turn a key component of the state’s vaunted Green Chemistry Initiative.  The timing of this announcement suggests that DTSC will soon release the official draft of the SCPA Regulations.  The workshop will be held in Chatsworth, California from June 4 -5, 2012. Registration information and other details are set out below.

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Alternatives Assessment 101

What: Two-Day Training

When: June 4-5, 2012

Where: Chatsworth, CA

California’s Safer Consumer Products draft regulation requires alternative assessments for certain priority chemicals and products. Would you like to know more about alternatives assessment?

 

 

If you have not performed an alternatives assessment-

 

 

This training is for you! Gain practical, hands-on experience and insights.

 

If you have already conducted alternatives assessments-

 

 

Strengthen your understanding, exchange experiences, and learn from your peers through this two day training from specialists in alternatives assessments.

This two day training from the University of Massachusetts (UM) is in partnership with California’s Department of Toxic Substances Control (DTSC). Participants will be introduced to the process of assessing safer alternatives for chemicals and products through sharing experiences with researchers from UM’s Toxics Use Reduction Institute (TURI) and the Lowell Center for Sustainable Production. DTSC staff will lead a discussion on the role of alternatives assessment in California’s draft Safer Consumer Products Regulation.

 

 

 

Visit for more information and to register:

http://sustainableproduction.org/proj.summerinstitute.overview.php