Tag Archive for: New & Events

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.

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.

Phil Moffat Will Speak About Green Marketing at the 2011 ASC Fall Conference and Expo

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Green Marketing:

Verdant is pleased to announce that Philip Moffat will speak at the 2011 ASC Fall Conference and Expo in Indianapolis, Indiana on October 16 – 18.  Phil will discuss marketing and enforcement trends, the tools available to regulate green marketing in the U.S. and elsewhere, and the legal risks attending the marketing of “sustainable” packaging or other “green” products for which universally accepted metrics and definitions are lacking.  

More information about the Fall Conference and Expo is available here.  A copy of the presentation is available here.

EPA Awards Contracts to U.S. Companies to Screen Chemicals for Human Health Impacts

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Chemical Screening:

EPA continues in its laudable quest to screen thousands of chemicals.  See press release below.

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EPA Awards Contracts to U.S. Companies to Screen Chemicals for Human Health Impacts

WASHINGTON— The U.S. Environmental Protection Agency’s (EPA) ToxCast chemical screening program has awarded contracts to four United States-based companies to test up to 10,000 chemicals for potential toxicity to people and the environment. ToxCast is designed to determine how chemical exposures affect human health.  When fully implemented, ToxCast will be able to screen thousands of chemicals in fast, cost-effective tests.

The four companies will initially screen up to 1,000 chemicals currently in the ToxCast program using innovative technologies such as stem cell toxicity tests. These new technologies can quickly determine the potential for a chemical to cause harm to the human body.  Screening results from the new technologies will be combined with data already being generated by the other 500 rapid chemical tests used by EPA’s ToxCast program.

The chemicals ToxCast is now screening are found in industrial and consumer products, food additives and drugs. ToxCast’s goal is to reduce EPA’s reliance on slow and expensive animal toxicity tests, enabling the agency to screen chemicals more quickly and to predict and identify potential risks to Americans.

EPA scientific studies using ToxCast have already been published in peer-reviewed science journals, and demonstrate the ability of ToxCast to predict a chemical’s potential to cause several diseases.

The four companies awarded the contracts have offices throughout the country and plan to hire new scientific staff to help with the project. The companies are Vala Sciences, Cee Tox, CellzDirect and BioReliance.  Two of the companies, Vala Sciences and BioReliance are small businesses based in San Diego, Calif. and Kalamazoo, Mich. All four companies plan to hire new employees as a result of these contracts.

More information on ToxCast:  http://epa.gov/ncct/toxcast/

More information on ToxCast database:  http://actor.epa.gov/actor/faces/ToxCastDB/Home.jsp

 

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.

Upcoming Event: Chemical Regulation in Canada – Lessons for U.S. Reforms

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TSCA/CEPA:

Readers attending the ABA’s meeting in Toronto in August may be interested in the following event concerning the Canadian system for regulating industrial chemicals and lessons that system may offer the United States as it debates TSCA Reform.  A short description is embedded below, and more information about the annual meeting is available here.  The list of speakers is impressive, so the event should prove worth the time investment. 

3:45 p.m. to 5:15 p.m.

Chemical Regulation in Canada—Lessons for U.S. Reforms

Room 801A, 800 Level, MTCC, South Building

Everyone agrees that chemical regulation in the US needs to be updated. Industry, NGOs and the EPA all find fault with TSCA, the 1976 law that still governs the process. The EU and Canada are both implementing new, ambitious programs that provide models and cautionary experiences for US reforms. The EU’s REACH program has been widely criticized for needless expense and complexity and for producing slow results. The Canadian Environmental Protection Act, by contrast, is frequently cited by stakeholders as a better approach. This program will focus on features of CEPA that make it apparently more efficient and productive, and explore how compatible those processes would be with US law and expectations regarding transparency, participation and due process.

Moderator:

James Conrad, Washington, D.C.

Panelists:

Joseph Castrilli, Toronto, Ontario, Canada

Mark Duvall, Washington, D.C.

Robert Fishlock, Toronto, Ontario, Canada

Karen Levins, Mississauga, Ontario, Canada

Additional Sponsor:

Section of Environment, Energy, and Resources

 

Pesticides, Nanoscale Materials, and FIFRA

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FIFRA/Nanotechnology:

Guest Column: 
Kathryn Brausch & Irene Hantman
Law Clerk & University of Maryland Law Fellow
US EPA Office of Civil Enforcement
 

Readers interested in EPA’s regulation of nanoscale materials may want to know about recently proposed policies under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that would affect the use of nanoscale materials in pesticide products.   

On June 17, 2011, EPA published a Federal Register notice (76 FR 35383), requesting comments on two alternative approaches for obtaining information on nanoscale materials, both active and inert ingredients, used in currently registered pesticide products.  The Agency also requested comments on a proposal that would affect the classification of registration applications for pesticide products containing nanoscale materials.  An overview of these proposals, and a summary of their scientific basis, is set out below.

The Scientific Basis

In the Federal Register notice, the Agency reviews the growing body of scientific evidence concerning the human health and environmental hazards of certain nanoscale materials, some of which are used in pesticide products.  After reviewing the evidence, EPA concludes that it indicates that significant differences exist between many nanoscale materials and their non-nanoscale counterparts.  Although some of the differences have beneficial applications, some of them pose new or increased hazards.  EPA reasons that these potential “new” hazards warrant further regulatory scrutiny.

The Alternatives for Collecting Information

The scientific evidence has led EPA to conclude that collecting information from registrants of existing pesticide products is relevant to the Agency’s statutory obligation.  Under FIFRA, EPA has a statutory obligation to determine whether the registration and use of a pesticide may cause unreasonable adverse effects on the environment or human health.  This finding is required for “each and every pesticide product, regardless of whether another pesticide product with the same or similar composition and use patterns is already registered.”  Thus, according to EPA, the presence of a nanoscale material in a pesticide formulation provides a sufficient basis for the Agency to request additional information that may be used to characterize potential risks that may not have been considered when the pesticide was originally registered.  Although the presence of nanoscale materials is sufficient to justify the proposed requests for information, the Federal Register notice stresses that the presence of a nanoscale material is not, by itself, an indicator of potential adverse effects.  However, EPA will use the information it receives from registrants to assess whether additional data are necessary to support continuing the registration and whether amending a registration is necessary to prevent such adverse effects.    

According to the proposed policy, EPA would use one of the two alternative processes summarized in the bullet-points below to collect the data and other information needed.  The process would apply to both active and inert nanoscale ingredients.  

— Under one alternative, EPA would formally announce that ‘reportable’ information required under FIFRA §6(a)(2) includes information on the presence of nanoscale materials. Following the formal policy announcement, any registrant with such information would have 30 days to submit it to EPA.  Specifically, each registrant that knew it had a registered product containing a nanoscale material would provide existing information concerning:  (1) the identity of the affected product; (2) the identity of the nanoscale materials in the product; (3) the size or size distribution of the nanoscale materials; (4) the manufacturing process used to produce them; (5) the size and size distribution of the composite matrix, if any, containing the materials; and (6) the data showing adverse effects at any level of exposure, and the nature and levels of human and environmental exposure.  This alternative has proven controversial because section (6)(a)(2) concerns “adverse effects” reporting – members of the nanotechnology community therefore worry that use of this section would create a stigma for all nanoscale materials used in pesticide products.

— Under a second alternative, EPA would issue data call-ins under FIFRA §3(c)(2)(B) to specific groups of registrants. The scope of information collected would potentially be the same under this alternative as it would be under the other one, but registrants would be given 90 days to respond.  EPA could also request the generation of new data and information, which it cannot request under the other alternative.  Moreover, the burden on industry and EPA would increase.  Typically, registrants that receive such data call-in requests are required to respond even when they don’t have the requested information. And EPA would have to track its requests to identify non-responders warranting enforcement. 

Under either alternative, EPA would use the information it received to determine whether additional data needs to be generated or whether a registration should be cancelled or amended to prevent unreasonable adverse effects. 

The New Classification of Applications

EPA also announced a policy affecting the classification of applications seeking to register pesticide products containing nanoscale materials.  Under the new approach, EPA would presume that active or inert nanoscale ingredients are potentially different from non-nanoscale versions of those ingredients that were previously registered.  EPA also would presume that one nanoscale version of an ingredient is potentially different from another, already-registered nanoscale version of the same ingredient.  Based on these presumptions, EPA would initially classify all such applications as applications for “new” ingredients, increasing the application fee, the time EPA has to review the application, and the amount of information it may require.  An applicant could overcome the presumption by proving that the nanoscale version to be registered is sufficiently similar to the registered version or differs only in ways that do not significantly increase the risk of unreasonable adverse effects or require different registration terms or conditions.  If successful, EPA would review the application in a shorter timeframe and allow the applicant to rely on the data from the previous registrant, subject to appropriate compensation where required.

This proposed policy also has significant compliance implications.  Specifically, a company would potentially violate the registration requirements by substituting nanoscale ingredients for non-nanoscale ingredients without first notifying EPA and receiving Agency approval.  Assuming the policy is finalized, it is clear that substitutions occurring after the policy announcement would face a significantly increased risk of having violated the registration requirements.  However, the Federal Register notice is less clear with respect to the legal implications of substitutions that occurred before announcement of the new policy — such substitutions might be considered potential violations of the registration requirements or the section 6(a)(2) reporting requirements.

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Once adopted, the policies announced in the above-cited Federal Register notice are likely to be the first of many policies EPA develops to address the use of nanoscale materials in consumer products and other product types.  Accordingly, those using such materials should be prepared for additional inquiries about their use of such materials and their potential effects.

 DISCLAIMER: This work is not a product of the United States Government or the United States Environmental Protection Agency. The views expressed are those of the authors only and do not necessarily represent those of the United States or the US EPA.

 

Reminder: Upcoming Meeting of the California Green Ribbon Science Panel

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Green Chemistry Regulations:

For readers interested in learning more about the development of California’s Green Chemistry Regulations – the “Safer Consumer Product Alternative Regulations” – the upcoming meeting of the Green Ribbon Science Panel may be of interest.  Details are set out below in the embedded announcement from the Department of Toxic Substances Control (DTSC).  Enjoy!

DTSC: Green Chemistry Initiative

 The Department of Toxic Substances Control (DTSC) will convene the Green Ribbon Science Panel (GRSP) on Thursday, July 14, 2011, from 9:30 a.m. to 5:00 p.m. (PDT), and on Friday, July 15, 2011, from 8:30 a.m. to 12 noon (PDT) in Sacramento, California and via webcast. The public is invited to attend, and comments to the GRSP on agenda items are welcome.

 Meeting notice:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/GRSP_7-14_PN.pdf

Meeting agenda:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/GRSP_7-14_Agenda.pdf

 

EPA Announces Winners of 2011 Presidential Green Chemistry Challenge Award

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Readers curious about notable innovations in the green chemistry space may be interested in the following announcement from EPA regarding the 2011 winners of the Presidential Challenge Awards.

CONTACT:
Dale Kemery (News media only)
kemery.dale@epa.gov
202-564-7839
202-564-4355

FOR IMMEDIATE RELEASE
June 20, 2011

 

EPA Honors Winners of 2011 Presidential Green Chemistry Challenge Awards

WASHINGTON – For the 16th year, the U.S. Environmental Protection Agency is recognizing pioneering chemical technologies developed by leading researchers and industrial innovators who are making significant contributions to pollution prevention in the United States. These prestigious awards recognize the design of safer and more sustainable chemicals, processes, and products that will protect Americans, particularly children, from exposure to harmful chemicals.

The awards will be made this evening, June 20, at the Green Chemistry Challenge Awards ceremony in Washington, D.C. This year’s awards are significant because 2011 has been named the International Year of Chemistry and marks the 20th anniversary of EPA’s efforts in what would become the creation of green chemistry. 

“EPA congratulates this year’s winners for designing and developing innovative green chemistry technologies that will result in safer chemicals for use in products, homes, schools, and workplaces that also have significant environmental and economic benefits,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention.

The Presidential Green Chemistry Challenge Awards are bestowed in five categories. The 2011 award winners are:

  •  Academic: Bruce H. Lipshutz, PhD, University of California, Santa Barbara
  •  Small business: BioAmber, Inc., Plymouth, Minn.
  • Greener synthetic pathways: Genomatica, San Diego, Calif.
  • Greener reaction conditions: Kraton Performance Polymers, LLC, Houston, Texas
  • Designing greener chemicals: The Sherwin-Williams Company, Cleveland, Ohio

By recognizing groundbreaking scientific solutions to real-world environmental problems, EPA’s Presidential Green Chemistry Challenge Program has significantly reduced the hazards associated with designing, manufacturing and using chemicals. The program promotes research and development of less-hazardous alternatives to existing technologies that reduce or eliminate waste, particularly hazardous waste, in industrial production.

An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute selected the 2011 winners from among scores of nominated technologies. During the program’s life, EPA has received more than 1,400 nominations and presented awards to 82 winners. Winning technologies alone are responsible for reducing the use or generation of more than 199 million pounds of hazardous chemicals, saving 21 billion gallons of water, and eliminating 57 million pounds of carbon dioxide releases to the air. These benefits are in addition to significant energy and cost savings by the winners and their customers. 

More information: http://www.epa.gov/opptintr/greenchemistry/pubs/pgcc/past.html

Listen to podcasts about this year’s winners: http://www.epa.gov/greenchemistry/pubs/2011_podcasts/index.html

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.