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CIEL Report Claims Regulation Stimulates Chemical Innovation

Chemical Regulation/Innovation:

Earlier this month, the Center for International Environmental Law (CIEL) released its report, Driving Innovation: How stronger laws help bring safer chemicals to market.  In the report, CIEL offers research showing that stronger laws foster innovation by large and small companies alike.  Among other things,CIEL cites the number of patents for alternative chemicals filed every time there’s new chemical regulation. CIEL is located in Washington, D.C. and Geneva, Switzerland.  More information about CIEL is available here.

Forbes magazine recently published an article on this same topic, citing the CIEL report among other sources.  That article is available here.

What do others think of this conclusion?

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.

EPA Announces FIFRA/TSCA Settlements with Finland-Based Kemira Group

TSCA/FIFRA Enforcement:

EPA continues to steadily increase its enforcement of U.S. chemical control laws.  Last Thursday, the EPA announced settlements with two subsidiaries of the Finland-based Kemira Group to resolve alleged violations of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substance Control Act (TSCA). Kemira Chemicals agreed to pay a civil penalty of over $300,000 to settle claims that the company sold and distributed unregistered and misbranded pesticides, and violated pesticide production reporting requirements. Kemira Chemicals also agreed to correct the alleged violations.

In addition, Kemira Water Solutions agreed to pay a civil penalty of over $500,000 regarding violations of TSCA’s Inventory Update Reporting (IUR) rule during the 2006 reporting period. Under the IUR rule, manufacturers and importers of substances included on the TSCA Chemical Substances Inventory must report the production volume and location of each facility processing such chemicals; this information is used to develop risk-screening and assessment. EPA discovered Kemira Water Solutions’ reporting violations following a January 2012 inspection and the company has since submitted the required information.

International Negotiations on Mercury Treaty

UN/Mercury:

International negotiators in Geneva for the fifth and final Intergovernmental Negotiation Committee (“INC 5”) hope to complete a mercury reduction treaty by the end of this week, although officials warn that difficult issues remain to be resolved. Delegates from over 130 countries are expected to establish the first international legal instrument with enforceable limits on mercury emissions.

The negotiators must still determine issues including: the selection of products and processes containing mercury to be phased out; the deadline for such phase-outs; whether to adopt a complete ban on primary mercury mining; and programs for financial assistance, technology transfer, and capacity-building.

A draft text of the treaty provides for regulation of the supply and trade in mercury, as well as its use in products and processes. The draft also addresses how to: reduce mercury emissions from power plants and metal production facilities; safely store and treat waste containing mercury; and identify and evaluate contaminated sites.

A joint proposal submitted by the EU, Japan, and Jamaica would phase out mercury in products like fluorescent lamps, pesticides, and cosmetics by 2018, with a later phase-out of 2020 for batteries and measuring devices. The joint proposal also calls for phasing out mercury in the production of chlor-alkali, polyurethane, and acetaldehyde by 2018 to 2025.

Negotiators are still considering a ban on the export and sale of mercury from countries with primary mercury mining. Delegates have already reached a compromise on the use of mercury in artisanal and small-scale gold mining (“ASGM”), which recently surpassed coal burning as the major source of global mercury emissions. Under the deal, countries could continue to import mercury for ASGM if they develop national action plans to reduce mercury emissions. In addition, the draft treaty permits the continued use of mercury in producing vinyl chloride monomer (“VCM”), an intermediary chemical used in manufacturing PVC plastic.

In the run-up to the conference, UNEP released two reports warning of the growing environmental and health risks of mercury exposure. The reports present estimates and trends of mercury contamination; for example, in the past century, mercury levels have doubled in the top 100 meters of the world’s oceans. UNEP argues that a global reduction treaty would reduce health problems linked to mercury, including neurological and behavioral disorders.

EPA Removes 16 Chemicals from HPV 'Orphan' List

TSCA:

On December 19, 2012, the Interagency Testing Committee (ITC) recommended to EPA that 16 High Production Volume (HPV) Challenge Program orphan chemicals be removed from the TSCA Section 4(e) Priority Testing List.  (Federal Register notice available here.)   The chemicals are listed below. The ITC determined that appropriate actions have been taken to evaluate the hazardous potential of these chemicals.  Public comments are due January 18, 2013.

CAS No.

Chemical Name

ITC Report

Removal Rationale

62-56-6

Thiourea

55

EPA NPRM

81-16-3

1-Naphthalenesulfonic acid, 2-amino-

55

55 OECD SIDS

84-69-5

1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester

55

EPA NPRM

91-68-9

Phenol, 3-(diethylamino)-

55

Sponsored chemical

110-18-9

1,2-Ethanediamine, N1,N1,N2,N2-tetramethyl-

55

Sponsored chemical

119-33-5

Phenol, 4-methyl-2-nitro-

55

OECD SIDS program

121-69-7

Benzenamine, N,N-dimethyl-

55

Sponsored chemical

131-57-7

Methanone, (2-hydroxy-4-methoxyphenyl)phenyl-

55

EPA NPRM

870-72-4

Methanesulfonic acid, 1-hydroxy-, sodium salt (1:1)

55

EPA NPRM

6473-13-8

2-Naphthalenesulfonicacid, 6-[2-(2,4-diaminophenyl)diazenyl]-3- [2-[4-[[4-[2-[7-[2-(2,4-diaminophenyl)diazenyl]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]phe nyl]amino]-3-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:3)

55

EPA NPRM

28188-24-1

Octadecanoic acid, 1,1′-2- (hydroxymethyl)-2-[[(1- oxooctadecyl)oxy]methyl]- 1,3-propanediyl ester

55

EPA NPRM

61788-44-1

Phenol, styrenated

56

Sponsored chemical

68334-01-0

Disulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products

55

Sponsored chemical

68457-74-9

Phenol, isobutylenated methylstyrenated

56

Sponsored chemical

68915-39-9

Cyclohexane, oxidized, aq. ext., sodium salt

55

Analog to CAS No. 68915-38-8

90640-80-5

Anthracene oil

55

OECD SIDS program

EPA Releases First Set of Draft Risk Assessments Under Existing Chemicals Work Plan Effort

On January 4, EPA  released for public comment draft risk assessments, for particular uses, on five chemicals found in common household products. The draft risk assessments were developed as part of the agency’s Toxic Substances Control Act (TSCA) Work Plan, which identified common chemicals for review over the coming years to assess any impacts on people’s health and the environment. Following public comment, the agency will seek an independent, scientific peer review of the assessments before beginning to finalize them in the fall of 2013.

“The draft risk assessments released today for public review and comment highlight the agency’s ongoing commitment to ensure the safety of chemicals we encounter in our daily lives,” said James J. Jones, acting assistant administrator of EPA’s Office of Chemical Safety and Pollution Prevention. “The public and scientific peer review will ensure use of the best science to evaluate any impacts of these substances on people’s health and the environment.”

The five assessments address the following chemical uses: methylene chloride or dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint stripper products; trichloroethylene (TCE) as a degreaser and a spray-on protective coating; antimony trioxide (ATO) as a synergist in halogenated flame retardants; and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products. The draft assessments focus either on human health or ecological hazards for specific uses which are subject to regulation under TSCA. Three of the draft risk assessments— DCM, NMP, and TCE— indicate a potential concern for human health under specific exposure scenarios for particular uses. The preliminary assessments for ATO and HHCB indicate a low concern for ecological health.

EPA recommends the public follow product label directions and take precautions that can reduce exposures, such as using the product outside or in an extremely well ventilated area and wearing protective equipment to reduce exposure. If EPA concludes in finalizing the risk assessments that there is a potential for concern, the agency will take action as appropriate to address possible risks.

The draft assessments were undertaken as part of EPA’s efforts to identify chemicals for review under the TSCA Work Plan, which EPA released in March 2012. At that time, EPA identified 83 chemicals as candidates for review over the coming years and outlined the data sources and other information the agency would use in the reviews. This initiative is part of EPA’s comprehensive approach to enhance the current chemicals management program within the limits of existing TSCA authorities. EPA continues to support updating TSCA to strengthen and modernize the law.

Additional information on the TSCA Work Plan effort and the specific draft risk assessments can be found at: http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html

 

EPA Announces Proposed Revisions to FIFRA Minimum Risk Exemption

FIFRA:

In a December 31, 2012 Federal Register notice, (77 Fed. Reg. 76,979) EPA announced a new proposed rule that would revise the labeling requirements for minimum risk pesticide products. The proposed rule affects section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by changing how minimum risk pesticides are identified on product labels as well as the way ingredient lists are organized in the implementing regulations. In addition, producer contact information will be required on product labels.

Under FIFRA’s § 25(b) minimum risk exemption, pesticides with active and inert ingredients which are demonstrably safe do not need to be registered with EPA. These permitted ingredients are listed in 40 CFR 152.25(f), but because of ambiguities across the various ingredient lists, confusion remains as to which ingredients are covered and how they should be labeled, leading to increased regulatory burden and inefficiencies for state regulators. Many chemicals may be known by producers, regulators, and consumers by different names; for example, soybean oil may be described on a product label as “Glycine Soja Oil.”

EPA’s new proposed rule is intended to make clear which active ingredients are permitted in exempted pesticide products, and does not add or remove any ingredients from the list. Instead, EPA will identify permitted active ingredients by re-organizing them in tables including the chemical’s “Label Display Name” (e.g., “Citric Acid”), “Chemical Name” as determined by the Chemical Abstract Services (“CAS”) (e.g., “2-Hydroxypropane-1,2,3-tricarboxylic acid”) and “CAS Registry Number,” a unique identifier which is easy to use for consumers and widely accepted by industry and regulators alike. In addition, the table will include a “Specifications” column which will be empty for most ingredients, but will indicate the United States Pharmacopeia (“USP”) standard for “approximately 20 of the active ingredients.”

Inactive ingredients will also be re-organized into a table similar to the one proposed for active ingredients. This table will codify “List 4A,” the list of chemicals currently maintained on EPA’s website. In addition, EPA proposes to incorporate references to other CFR sections which describe which chemicals may be used as inert ingredients for the purpose of the minimum risk exemption. In the case of pesticides that may come in contact with foods, for which there are no federal tolerance levels or tolerance exemptions, EPA proposes to amend the text of the exemption to direct users to an EPA website for more information on which of the listed chemicals may be used in food-use pesticide products.

Finally, EPA proposes that exempted product labels must use the “label display name” in the product’s ingredient listing. The proposed rule also requires that producers of minimum risk pesticide products must include their company’s contact information (address and telephone number) on the product label. In the case of a product label which includes the name of a company that is not the producer, EPA proposes that the label text should clarify that the product was “packed for,” “distributed by,” or “sold by” the non-producer company.

EPA is requesting comments on various topics related to this proposal, including: the format and information to be included in the new tables; whether reference to an online resource with more information on food-use pesticide tolerance requirements would provide clarity for stakeholders; impacts on state and local agencies; and whether products would need to be reformulated as a result of the changes. The comment period for this proposed rule ends on April 1, 2013.

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.  

EPA Withdraws Immediate Final TSCA 8(d) Rule for Cadmium

TSCA:

On Friday, December 14, Wendy Cleland-Hamnett, Director of the Office of Pollution Prevention and Toxics (OPPT), announced the U.S. Environmental Protection Agency’s (EPA) decision to withdraw the Toxic Substances Control Act (TSCA) section 8(d) immediate final rule published on December 3, 2012.  In its announcment the agency said: “Based on several letters asking questions and raising concerns about the scope and extent of the immediate final rule that indicate that there is significant confusion and uncertainty within certain industrial sectors concerning the rule, EPA has decided to withdraw the immediate final rule.” EPA will announce the withdrawal in the Federal Register, no later than January 2, 2013, the original effective date of the final rule. 

EPA  also said that it “will be considering the questions and concerns raised in response to the immediate final rule and next steps with regard to this rule. EPA will also continue to work with the Consumer Product Safety Commission (CPSC) to reduce exposure to cadmium in consumer products generally, and especially those consumer products used by or around children, such as children’s metal jewelry.”

More information about this development is available at the agency’s website here.  Information about section 8(d) is available here.