Reminder: Upcoming Meeting of California's Green Ribbon Science Panel

Green Chemistry Regulations:

California’s Green Ribbon Science Panel (GRSP), the expert body established to advise the Department of Toxic Substances Control (DTSC) on green chemistry and the regulation of consumer products, will convene in Sacramento on November 14 (all day) and 15 (morning only) to discuss the latest informal draft of the so-called Safer Consumer Product Alternatives (SCPA) Regulations.  No agenda or other meeting materials have been publicly released at this time, but a copy of the informal draft regulations and related information is available here.

California Releases Informal Draft of the Revised Green Chemistry Regulations

Green Chemistry Regulations:

On Monday, October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of its revised green chemistry regulations, the so-called “Safer Consumer Product Alternatives (SCPA) Regulations.”  DTSC spent the last year further revising the regulations after some stakeholders decried the proposed final version released for public comment over the Thanksgiving holiday in 2010.  Public comments on the lastest informal draft are due by December 30, 2011.  The formal rulemaking process will begin in 2012.

On Monday DTSC also released a document setting out the most significant changes from the November 2010 version of the regulations. (For purposes of comparison, a summary of the November 2010 version is available here.)  It is clear that DTSC is envisioning a more robust program with shorter timelines and fewer exemptions, ultimately requiring more agency and private resources to implement without a clear benefit from doing so. In light of the poor state of California’s economy, and the relative weakness of the U.S. economy as a whole, one has to wonder why DTSC has chosen its proposed path. According to DTSC, the following are the most significant changes found in the current informal draft. 

Timeframes

(1) Many timeframes have been shortened and/or made more specific.

(2) Timing of initial Chemicals of Concern (COC) list — effective date of the regulations.

(3) Timing of initial Priority Products list — 6 months for the proposed list.

(4) Both the chemicals and products lists will be reviewed at least once every 3 years.

Chemical / Product Prioritization

(1) The regulations will establish an immediate robust (~3,000) list of COCs (which DTSC can add onto later), based on work already done by numerous authoritative bodies.

 (2) The list of hazard traits has been expanded to include all hazard traits and environmental and toxicological endpoints specified by OEHHA. Additionally, the universe of chemicals considered to be carcinogens and reproductive toxins is no longer limited to only those chemicals listed on a short list of lists.

(3) The regulations no longer limit the product categories that DTSC can consider when listing Priority Products during the first 5 years.

(4) Worker exposure has been added as a prioritization factor.

(5) The requirement for responsible entities to provide chemical and product information during the prioritization process has been eliminated. (DTSC will request this information and list anyone who does not provide the information on a Failure to Respond list.)

Alternatives Assessments

(1) The regulations expand the primary responsibility for compliance beyond the product producer to also include: (i) the person who controls the product design; and (ii) the U.S. importer.

(2) The alternatives assessment (AA) process is more specific and structured, but allows for flexibility.

(3) There is no requirement to fill information gaps during the AA — instead DTSC has the option to require this as a regulatory response.

(4) The third-party verification requirement for AAs has been eliminated — instead AAs are required to be conducted by a certified assessor. Also, DTSC will play a greater role in auditing AAs.

Exemptions

(1) The default de minimis level is 0.01% for chemicals with one of 9 specified hazard traits, and 0.1% for all other chemicals — DTSC can set a lower or higher de minimis level.

(2) The exemption for unintentionally-added chemicals has been eliminated. However, these chemicals are a consideration for setting a higher de minimis level.

(3) The “no exposure pathway” exemption has been eliminated. However, exposure potential will still be considered during the chemical/product prioritization process.

Readers wanting more information should check back for future posts on this development, as well as visit the DTSC website. In addition, there will be a public workshop on the draft proposal on December 5, 2011 from 9:30 am to 3:30 pm in Sacramento. The Green Ribbon Science Panel also will dicuss the proposal at the Panel’s meeting on November 14 – 15, also in Sacramento.        

Department of Interior to Issue Rules Requiring Disclosure of Chemicals Used in Fracking

Right-to-Know/Transparency:

According to Reuters, on Monday, October 31, 2011, Deputy Secretary of the Department of the Interior (DOI), David Hayes, told the Department of Energy’s shale-gas advisory panel that DOI will issue rules “in a couple of months” requiring the disclosure of the chemicals used in hydraulic fracturing or “fracking” on federal lands.  Fracking is the controversial technique that involves injecting a mixture of water, sand, and chemicals into shale formations at high pressures to extract oil and gas.  Recent technological advances have facilitated greater use of the technique leading to concerns about potential water contamination and air pollution.  The well-known documentary, “Gasland,” purported to document some of the environmental harm resulting from improper use of the technique.  DOI hopes that greater transparency will increase accountability while fostering public confidence.  The Department’s decision is consistent with other initiatives the Obama Administration, particularly through EPA, has undertaken to increase public access to information on chemicals, placing confidential business information at risk.

Reuters reports that about 14 percent of all U.S. natural gas production occurred on federal land during the last fiscal year. DOI supposedly estimates that fracking is used for about 90 percent of gas wells drilled on public lands.  Accordingly, only a fraction of wells in the U.S. would be affected by the rules.   Implicit in the Department’s decision to require disclosure is the reasonable assumption that the same chemicals will be used on both public and private lands subsequent to the rule’s implementation.  By disclosing those used on federal lands, stakeholders will have insight into those used on private lands thereby gaining confidence in the fracking process.  Moreover, several states have disclosure rules in effect or under development.

According to Reuters, DOI’s announcement is part of a larger effort by the Obama Administration to regulate hydraulic fracturing in a way that instills confidence without over-burdening the industry.  Last week, EPA announced that it will promulgate rules for disposing of wastewater from shale gas wells.  Additional information about the Administration’s initiatives is available here and here.  Information from the American Petroleum Institute and others is available here.

Japan Revises Its Annual Notification Requirements to Provide Greater Protection for Foreign Suppliers’ Confidential Business Information

Japan/Chemical Notification and Reporting:

Early in June 2011, Japan’s Ministry of Economy, Trade, and Industry (METI) announced a revision to the process Japanese companies use to annually notify the agency about the chemical substances that they import.  Under the new process, a foreign supplier can provide certain confidential business information (CBI) directly to METI rather than to the Japanese customer, and the Japanese customer would submit the remainder of the notification.  This joint process is a welcome approach, and although it is not a complete solution, it is an encouraging signal that METI will adopt a practical approach to implementing the 2009 amendments to the Chemical Substances Control Law (CSCL).

The annual notification requirement was adopted as part of a series of amendments to the CSCL that the government enacted in 2009 to move the country toward a more risk-based approach to chemical regulation.  For readers less familiar with the CSCL, the law is Japan’s analogue to the U.S. Toxic Substances Control Act (TSCA).  Several agencies, including METI, administer the law.  The CSCL generally requires Japanese manufacturers and importers to notify the agencies and receive their approval before commencing manufacture or importation of “new” chemical substances that are not otherwise excluded or exempt.  The law also bans certain substances and imposes restrictions and reporting requirements on others.  The annual notification requirement adopted in 2009 is distinct from the new chemical notification requirement.  The annual requirement applies to substances already on the market, and it was designed to provide additional exposure-related information to the agencies so that they can identify those whose risks warrant further management through restrictions or other measures.

The annual notification requirement applies to two classes of chemical substances, “General Chemical Substances (GCS)” and “Priority Assessment Chemical Substances (PACS)” that are manufactured or imported at or above 1 metric ton during the previous fiscal year.  (There is a similar notification process for so-called Monitoring Chemical Substances (MCS) that are manufactured or imported at or above 1 kg per year.)  When a GCS is present in a mixture below 10%, or a PACS is present as an impurity at less than 1%, it is not counted toward the 1-ton threshold.  Japanese companies that manufacture or import a reportable substance above the threshold must submit a notification form to METI between April 1 and June 30 each year.  2011 is the inaugural notification year.  The prescribed form requires information about the quantity of the substance imported or manufactured, as well as information about its chemical identity and uses.  

Prior to the revision METI announced, foreign suppliers, especially of mixtures, faced a tough choice.  Basically, they would either need to disclose to their Japanese customers the identities and percentages of the substances in their mixtures, potentially losing CBI since many of the mixtures are proprietary, or lose the customers by not providing information necessary to fulfilling a compliance obligation.  Preferring neither option, suppliers in the United States and elsewhere began lobbying METI for an alternative.  METI announced the alternative earlier this month, issuing guidance that revises the annual notification process.  However, the revision is not as comprehensive as what was requested since it does not protect from disclosure information concerning PACs.

METI’s revision affects annual notification of General Chemical Substances, but not PACs.  METI issued a three-page guidance document explaining the revised notification process.  A copy of the guidance is available here.  In it, METI explains that a Japanese company could submit a joint notification with its foreign supplier when the foreign supplier claims as CBI the chemical identity or its concentration rate in a mixture.  The Japanese company would initially complete as much of the notification form as possible and submit it to METI along with a cover letter explaining the situation and identifying the foreign supplier.  The incomplete form would function as a placeholder while the supplier completed the final version.  The supplier would then submit the final form to METI and the notification process would be considered complete. 

METI’s revision is an improvement on the annual notification process.  How well it works remains to be seen.  Presumably, the agency will make an evaluation at the end of this first notification cycle.  Readers interested in Japanese chemical regulatory control matters should check back periodically for further updates on this development and others in Japan.

Leading Consumer Products Companies Explain How and Why They Share Chemical Data Along the Supply Chain

Green Chemistry/Sustainable Supply Chain Management:

The Green Chemistry and Commerce Council (GC3) recently published a report titled, Meeting Customers’ Needs for Chemical Data: A Guidance Document for Suppliers.  The Guidance Document is designed to improve supply chain communication between suppliers and their customers concerning chemical identities and health and safety data.  In the report, leading companies such as HP, Johnson & Johnson, Method, Nike, SC Johnson, and Wal-Mart explain why they want such data and how they interact with their suppliers to obtain it. 

Readers unfamiliar with GC3 should know that it is a business-to-business forum for members to discuss and share information and experiences relating to the advancement of green chemistry, design for the environment, and sustainable supply chain management.  GC3, which began in 2005, is a project of Lowell Center for Sustainable Production at the University of Massachusetts Lowell.  GC3 prepared the Guidance Document with two goals in mind: “(1) to advance the efforts of companies trying to obtain the chemical data needed for regulatory and corporate sustainability programs and in response to market demands, and (2) to advance the efforts of suppliers to provide chemical data needed by their customers.”

The Guidance Document is a response to the growing demand for increased transparency concerning chemical-related data. Companies attempting to bring “green” or “safer” products to the market need chemical identity and health and safety data at the product design phase.  Access to this information enables them to evaluate and manage market, regulatory, and tort liability risks, as well as respond to requests from their customers, including consumers, wanting more information.

The Guidance Document should prove helpful to suppliers less familiar with the trend toward greater transparency, the rationale supporting it, and the techniques used to sustain it.  The document explains why fabricators and formulators are requesting chemical data, what chemical data are being sought, how suppliers can benefit from sharing data, why Material Safety Data Sheets (MSDS) often provide inadequate data, how companies are handling confidential business information, how fabricators and formulators collect data from their suppliers and what they are doing with the data, and where suppliers can obtain the data being requested.  In addition to describing the chemical data collection practices of different companies, the Guidance Document also provides customizable letters and forms that companies can use to facilitate their communications. 

More information about GC3 is available here.

EU Environmental Law Group Releases Reports on Member State Implementation and Enforcement of REACh

REACh:

The EU public interest environmental law group, ClientEarth, recently released a series of progress reports summarizing Member State activities under the European Union (EU) regulation: Registration, Evaluation, and Authorisation of Chemicals (REACh).  Each report reviews a different Member State’s efforts to implement and enforce REACh.  Reports also are available for three non-Member State countries that have enacted REACh – Lichtenstein, Norway, and Iceland.

The reports are essentially responses to a lengthy questionnaire from the European Commission.  Activities reviewed include communications between Member State authorities and EU authorities, such as the European Chemicals Agency (ECHA); operation of the national helpdesks; development and promotion of alternative test methods; participation on REACH committees; evaluation of substances; preparation of Annex XV dossiers; and details concerning enforcement-related activities, such as inspections and the imposition of sanctions.  The reports may prove useful to companies wanting insight into the level and types of enforcement activity occurring within the countries regulating their operations.

ClientEarth received the reports through a public records request, insisting that their broad dissemination was necessary “so that [the public] can know if REACH is really working.” (Critics probably think they know the answer already.)  The reports are available here.

EPA Denies Protection for Chemical Identities in TSCA 8(e) Reports

TSCA:

As part of EPA’s initiative to increase transparency under the Toxic Substances Control Act (TSCA), on February 10, 2011, the Agency sent a letter to five companies informing them that the identities of 14 chemicals contained in certain health and safety studies were ineligible for protection from public disclosure.  The studies are “substantial risk” reports that the companies submitted to EPA to fulfill their obligations under section 8(e) of TSCA (15 U.S.C. § 2607(e)).  Readers will recall that substantial risk reports disclose information that reasonably supports the conclusion that a chemical substance or mixture (collectively “chemicals”) presents a substantial risk of injury to health or the environment.  EPA reasons that the public has a right to know the identities of chemicals posing such risks.  In contrast, industry frequently contends that disclosure of identities could reveal commercially valuable information about formulations or manufacturing processes.  To stop the disclosure of the identities of its chemicals, a company would need to initiate a legal challenge within 30 days of receiving the Agency’s February letter.

The letters comprise the Agency’s first serious attempt to implement a new transparency policy announced on January 21, 2010.  (The scope of the policy was subsequently expanded in May 2010.)  As announced in January, EPA will deny Confidential Business Information (CBI) protection for the identities of chemicals included in section 8(e) reports when those chemicals are listed on the public version of the TSCA Inventory.  EPA contends that substantial risk reports are a type of health and safety study, as defined under section 3(6) of TSCA (15 U.S.C. § 2602(6)) and the regulations at 40 C.F.R. § 2.306(a)(3).  The Agency also asserts that a chemical’s identity is either part of a health and safety study or the data included within such study, as explained in various TSCA regulations such as those at 40 C.F.R. § 716.3; § 720.3(k).  And because section 14(b)(1) of TSCA (15 U.S.C. § 2613(b)(1)) “does not prohibit disclosure of” health and safety studies (and their data) concerning chemicals offered for commercial distribution, EPA concludes that a chemical’s identity would be eligible for disclosure when it is listed on the public version of the TSCA Inventory and it is the subject of a substantial risk report.

According to EPA’s letter, the chemicals fit squarely within the Agency’s policy.  Each of the chemicals is currently listed on the public version of the TSCA Inventory of “existing” substances.  (The Inventory is EPA’s official list of chemicals that can be lawfully imported or manufactured for commercial distribution without first submitting a premanufacture notice under section 5 of TSCA – the public version lists those chemicals whose identities are not confidential.)  And each of them supposedly was the subject of a substantial risk report.

However, section 14(b)(1) prohibits disclosure of data from health and safety studies when such disclosure would reveal “processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release [would disclose] the portion of the mixture comprised by any of the chemical substances in the mixture.”  These exceptions are designed to prevent the disclosure of trade secrets and other sensitive business information.  EPA’s letter seems to anticipate this objection from the companies, noting “that the [chemical] identity itself, as well as any information that might be derived from it about processes or portions, has already been disclosed” and therefore neither exception applies.

Whether the companies will seek judicial review remains to be seen.  Many challenged CBI claims are withdrawn, and judicial review is expensive.  If the companies seek judicial review, they may challenge EPA’s statutory interpretion or its conclusion that neither disclosure exception applies.  (If a challenge(s) is brought, look for a future blog post discussing the various arguments.)

Regardless of whether there’s a challenge, the Agency’s decision is somewhat controversial – applauded by some and criticized by others.  Unless there’s a successful legal challenge or some other restraint imposed, look for EPA’s continued release of unredacted substantial risk reports and possibly other health and safety studies.  The Agency has clearly signalled its intention to increase the amount of publicly-available information concerning chemical risks.  When balancing commercial interests against environmental and health interests, EPA’s current administration plans to favor the latter at the expense of the former, raising the question:  “Could a better balance be achieved?”  Perhaps – EPA could release the reports with a descriptive generic name in lieu of the chemical’s specific name, a practice the Agency’s used elsewhere under TSCA. 

EPA Requires Testing of 19 High Production Volume (HPV) Chemicals

TSCA/HPV Chemicals:

On January 7, 2011, EPA published a final rule under section 4(a)(1)(B) of theToxic Substances Control Act (TSCA), (15U.S.C. 2603(a)(1)(B)), requiring manufacturers, importers, and processors to test 19 high production volume (HPV) chemicals.  The rule, which takes effect on February 7, 2011, requires these persons to obtain screening level data for health and environmental effects and chemical fate, and then provide that data to the Agency.  The rule is one of a series of actions that EPA is taking to ensure that it has the data necessary to adequately review priority chemicals.  In addition, now that the Agency has issued a final test rule, any person (including those required to test) who exports, or intends to export, any of the 19 chemicals will be subject to the export notification requirements in 40 CFR part 707, subpart D.  The chemicals are listed below:

CAS No.

Chemical Name

75-07-0

Acetaldehyde

78-11-5

1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)

84-65-1

9,10-Anthracenedione

89-32-7

1H,3H-Benzo[1,2-c:4,5-c’]difuran-1,3,5,7-tetrone

110-44-1

2,4-Hexadienoic acid, (E,E)-

118-82-1

Phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)-

119-61-9

diphenylmethanone

144-62-7

Ethanedioic acid

149-44-0

Methanesulfinic acid, hydroxy-, monosodium salt

2524-04-1

Phosphorochloridothioic acid, O,O-diethyl ester

4719-04-4

1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol

6381-77-7

D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt

31138-65-5

D-gluco-Heptonic acid, monosodium salt, (2.xi.)-

66241-11-0

C.I. Leuco Sulphur Black 1

68187-76-8

Castor oil, sulfated, sodium salt

68187-84-8

Castor oil, oxidized

68479-98-1

Benzenediamine, ar,ar-diethyl-ar-methyl-

68527-02-6

Alkenes, C12–24, chloro

68647-60-9

Hydrocarbons, C > 4

The 19 chemicals were originally included in the voluntary High Production Volume (HPV) Challenge Program, which “challenged” companies to make health and environmental effects data publicly available on chemicals produced or imported in the United States in the greatest quantities.  HPV chemicals are classified as those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year.  EPA has determined that HPV chemicals account for approximately 95% of total chemical production in the United States.  As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts.  However, no data were provided for the 19 chemicals, making a mandatory test rule necessary.

More information on EPA’s HPV Challenge Program is available here.