EPA to Post List of Chemicals Acceptable for DfE-labeled Products

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Design for the Environment (DfE) / Green Chemistry:

EPA’s Design for the Environment (DfE) team announced today that, in September, it will post on the agency’s website a list of chemicals that are acceptable for use in DfE-labeled products.   Questions or comments about the proposal should be submitted to EPA by August 24, 2012.  The contact at DfE is Bridget Williams (williams.bridget@epa.gov).

As readers know, over the years many DfE stakeholders have requested that EPA issue a list of safer chemicals.  According to the agency’s press release, EPA’s intent is for the list to serve as a resource for product formulators and consumers, to increase understanding of the DfE Safer Product Labeling Program and the types of chemicals in DfE-labeled products.  The list is also intended to enhance the dialogue on safer chemicals and products.  

EPA is compiling its list from the ingredients in DfE-labeled products, as well as from chemicals eligible for use in labeled products – i.e., chemicals that meet the DfE criteria. The chemicals will be identified by their specific chemical name and Chemical Abstract Service (CAS) number and grouped by functional class—surfactants, solvents, etc. (chemicals with more than one common functionality may be listed in multiple classes).

A color code will appear next to each chemical to indicate its safer chemical status.  A green circle will appear next to chemicals that have met the DfE component-class criteria; a green/yellow square next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but are missing some experimental data on potential hazards; and a yellow triangle next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but have unresolved hazard profile issues.

No other information about the chemical—not its source, manufacturer, or use; association with a trade name product, percentages in formulation, etc.—will appear in the listing. EPA intends to include on this list the ingredients in third-party formulations sold by manufacturers to DfE participants, and will likewise not associate those ingredients with specific products. Also, no chemicals on the confidential portion of the Toxic Substances Control Act Inventory will be included in the listing.

According to the agency’s press release, the DfE list will complement the Green-Blue Institute’s CleanGredients database (www.cleangredients.org), which will continue to serve as a marketplace for chemicals that are acceptable for use in DfE-labeled products and provide trade name chemicals, physical-chemical and functional properties, hazard information, vendor contacts, and other information.

Environmental Advocates Want Disclosure of Chemicals in Consumer Products

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Chemicals in Consumer Products:

Researchers at the Silent Spring Institute argue that the findings of their consumer product evaluation illustrate the need for full disclosure of ingredient information. The Institute tested consumer products — ranging from toothpaste to laundry detergent — for compounds identified as either endocrine disruptors or asthma-related. Most products evaluated by the Institute included one or more “chemicals of concern.”  In their report, the researchers emphasize that current chemical testing and product labeling requirements do not prevent the use of hormone disruptors or asthma-associated chemicals in products or provide enough information for consumers to avoid them. Silent Springs published its findings in the March 8, 2012 issue of the National Institute of Environmental Health Sciences’ Environmental Health Perspectives.  The report has proven highly controversial and been severely criticized by industry for a flawed methodology and equating the mere presence of a chemical in a product with a lack of product safety.

The Institute, and other environmental and public health advocates, clearly plan to use the report to support their arguments for robust reforming of TSCA, the primary federal statute for regulating chemicals in the United States.  Such advocates argue that many consumer products contain chemicals known to adversely affect human health. They note that for numerous common commercial chemicals, information about their presence in consumer products is limited. In particular, little information is available about hazardous chemical exposures from personal care and cleaning products.

The Institute found 55 chemicals of concern in conventional and “green” consumer products. The evaluation assessed consumer products for the presence of 66 known endocrine disruptors and asthma causing chemicals. Tested consumer products ranged from toothpaste to laundry detergent. The researchers found bis-2-ethylhexyl phthalate, diethanolamine, and glycol ethers in high concentrations. They found phthalates, monoethanolamine, alkylphenols, parabens, and cyclosiloxanes in many of the products.  Sunscreens and scented products such as air fresheners and dryer sheets contained both the largest number of target chemicals and some of the highest chemical concentrations. However, the Institute did not report whether these chemicals were present above limits setting safe levels of exposure.  For example, the National Institute for Occupational Safety and Health recommends diethanolamine exposure be limited to 3 parts per million.

The researchers allege that regulations require only limited product labeling, thereby limiting the information available to consumers.  Personal products such as sunscreens, deodorants, and anti-bacterial hand soaps are largely regulated as over-the-counter drugs by the FDA. FDA regulations mandate only that “active” ingredients be identified on product labels.  The Institute asserts that EPA has primary regulatory oversight of cleaning products, and only when these products are pesticide products (e.g., products that will kill bacteria and viruses) is active ingredient labeling required. Many consumer products call themselves “natural,” “non-toxic,” and “green;” however, the Institute contends that these terms are unregulated and the chemical contents of such products do not necessarily differ from comparable products.

The Institute also argues that gaps in ingredient information are also problematic for regulators.  It argues that EPA, for example, relies on ingredient concentrations in products for exposure modeling. 

And lastly, the researchers conclude that further study of the risks posed by the types of chemical mixtures that are found in personal care products, cleaning products, etc. are needed to understand their effects on human health.

US News, Forbes, Consumer Reports, and many other news outlets have published stories on this report.

France to require mandatory reporting of nanoscale materials in 2013

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Nanotechnology:

France will implement a compulsory declaration scheme for the quantities and uses of nanoparticle substances or nanomaterials produced in, distributed in, or imported to France January 1, 2013. Information about material identity, quantity, uses, and users will be required from all companies producing, distributing and importing nanomaterials, and public and private research laboratories. The declaration scheme will be implemented by the Ministries of Ecology, Sustainable Development, Transport and Housing; Economic, Financial and Industrial Affairs; Labor, Employment and Health; and Agriculture, Food, Fisheries, Rural Affairs and Planning. Detailed information on reporting requirements will be published in the Official Journal of the French Republic.

The reporting mandate was published February 19, 2012 in Decree 2012-232 (available in French only) (the December 2011 draft decree is available in English). The decree explains that the purpose of the scheme is to improve knowledge of nanomaterials and their uses, to monitor the channels of use, to improve knowledge of the market and the volumes sold and to collect available information on toxicological and eco-toxicological properties.  Data on 2012 nanomaterial use must be submitted by May 1, 2013.

Reporting requirements affect materials that are at least 50 percent comprised of particles with one or more external dimension between 1 nm and 100 nm. When any such material is produced, imported or distributed in quantities of 100 grams, the user must declare identity of the producer, importer, or distributor; identity of the nanomaterial; quantity of nanomaterial produced, distributed or imported; intended uses, and identifying information about the professional users to whom the material has been distributed. Specifics of the reporting requirements include:

  • Identity of the producer, importer, or distributor:
    • business name, official address, VAT number; and
    •  apacity (manufacturer, importer or distributor) and field of activity.
  • Identity of the nanomaterial:
    • chemical identification of the substance,
    • potential presence of impurities,
    • average particle diameter and particle size distribution,
    • specific surface,
    • surface coating, and
    • surface charge.

 

California DTSC Releases Public Comments on Informal Draft Green Chemistry Regulations

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Green Chemistry Regulations:

The public comment for the latest informal draft version of California’s “Safer Consumer Product Regulations” closed on December 30, 2011.   On January 20, 2012, the implementing agency, the California Department of Toxic Substances Control (DTSC), posted the comments on its website.  DTSC received ninety submissions from a range of stakeholder interests.  More information about the regulations is available here.

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

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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

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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

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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.

EPA Assistant Administrator Steve Owens Resigns

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EPA Administration/Chemical Regulation:

On Tuesday, October 25, 2011, the Environmental Protection Agency (EPA) announced the resignation of Assistant Administrator Steve Owens.  Readers will recall that President Obama appointed Mr. Owens the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), which is the office implementing the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Pollution Prevention Act, and other federal laws concerning chemicals management.  November 30, 2011, will be Mr. Owens’ last day in office before returning home to Arizona where he previously served as the Director of the Arizona Department of Environmental Quality.  It is unclear at this time who will assume Mr. Owen’s responsibilities and what effect his departure will have on EPA’s various chemicals management initiatives.

Mr. Owens served the EPA during a two-year period in which Congress, the courts, and various stakeholders engaged in vigorous debate and litigation over the appropriate regulation of chemicals in the United States.  In a 2010 brown-bag session (available on podcast), sponsored by the American Bar Association’s Pesticides, Chemical Regulation, and Right-to-Know Committee, Mr. Owens discussed many of the initiatives the Agency was undertaking and some of the challenges it faced as it participated and attempted to shape the debate. 

In a letter to EPA staff announcing his resignation, Mr. Owens said:

“I am writing to tell you that, after more than two years of working closely with all of you to protect Americans’ health and environment, I have made the difficult decision to leave EPA. My last day in the office will be November 30, 2011.
 
As many of you know, my family has remained in Arizona while I have been working at EPA headquarters in Washington. Although I have been able to get home to see my family periodically, I have essentially been away from them for more than two years. After a lot of hard thinking, we have decided that it is time for me to come home. My wife needs her husband; my sons need their father; and I need them.
 
While I am very happy that I will be back with my family, I will miss all of you greatly. It has been a true privilege to work with so many incredibly talented and dedicated people who are doing so much to protect the health and safety of the American people and our environment.
 
I am extremely grateful to Lisa Jackson for her wonderful friendship and the remarkable vision and leadership she provides to this Agency. We are truly fortunate that she is EPA’s Administrator.
 
As I said earlier, I will continue working alongside you all through November 30. Administrator Jackson will share additional information about the transition process shortly.
 
In closing, let me thank you so much for the friendship and support you have given me during my time at EPA. Please know how much I appreciate you and all that you are doing for our country.”

 

EPA Publishes Rule to Improve Reporting of Chemical Information – Chemical Data Reporting Rule, Formerly Inventory Update Rule

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TSCA – Inventory Update Rule:

Readers may recall a post from this time last year concerning EPA’s proposal to revise TSCA’s Inventory Update Rule.  Well, the Agency has now published the final version, which is available here.  Also, here are links to commentary on the rule from Environmental Defense and the National Petrochemical and Refiners’ Assocation, which should give readers a flavor of the contrasting opinions currently circulating.  Embedded below is a copy of EPA’s press release.  Check back soon for a more detailed posting, setting out a short analysis of the rule.

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WASHINGTON – The U.S. Environmental Protection Agency is increasing the type and amount of information it collects on commercial chemicals from chemical manufacturers, allowing the agency to better identify and manage potential risks to Americans’ health and the environment. The improved rule, known as the chemical data reporting rule (CDR), also requires that companies submit the information electronically to EPA, rather than on paper, and limits confidentiality claims by companies. The changes are part of EPA Administrator Lisa Jackson’s commitment to strengthen the agency’s chemical management program and increase the transparency of critical information on chemicals. 

“Collecting this critical information on widely used chemicals will enable EPA to more effectively identify and address potential chemical risks,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “The new electronic reporting requirement and limits on confidentiality claims also will bring EPA’s data collection effort into the 21st Century and give the American people greater access to a wider range of information on chemicals to which their children and families are exposed every day.”

The CDR rule, which falls under the Toxic Substances Control Act inventory update rule (IUR), requires more frequent reporting of critical information on chemicals and requires the submission of new and updated information relating to potential chemical exposures, current production volume, manufacturing site-related data, and processing and use-related data for a larger number of chemicals. The improved information will allow EPA to better identify and manage risks associated with chemicals.

EPA is requiring companies to submit the information through the Internet, using EPA’s electronic reporting tool. On-line reporting will improve both data quality and EPA’s ability to use the data, as well as make it more accessible to the public.

Companies will be required to start following the new reporting requirements in the next data submission period, which will occur February 1, 2012 to June 30, 2012.

More information about the CDR Rule and reporting program is available at www.epa.gov/iur.

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

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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.