Downstream User Reports-ECHA Webinar Tue May 31

Readers interested in learning more about downstream user reporting may login to the webinar Tuesday May 31 or download a recorded version of the program from the ECHA website.

The webinar will be addressed to all downstream users of registered substances interested in learning more about downstream user reports and how to submit them to ECHA successfully.

Webinar
Date: 31 May 2011
Time: 11:00 AM Eastern European Time
(4:00 AM Eastern U.S. Time)
Register at: https://echa-events.webex.com/echa-events/onstage/g.php?t=a&d=701184789

Participants will receive practical information on how to complete a downstream user report using IUCLID5 and successfully submit it to ECHA via REACH-IT. Participants wishing to benefit from this training should have elementary knowledge of IUCLID5.

Downstream users may need to report their uses if these are not covered by the exposure scenarios provided by their suppliers. Exposure scenarios are part of the extended safety data sheets under REACH.

Producers, formulators, industrial users, other professional users, re-importers, and other downstream users can learn more about obligations under REACH from ECHA. Downstream user obligations include informing customers of hazards, providing risk management advice to formulators and suppliers, and, for chemicals of very high concern, warning customers and users about the parameters of and protocols for 

Philip Moffat Will Speak About Sustainable Packaging at the 2011 ASC Sustainability Summit

Sustainable Products/Green Marketing:

Verdant is pleased to announce that Philip Moffat will speak at the 2011 ASC Sustainability Summit in Rosemont, Illinois (O’Hare) on July 26 – 27.  Mr.  Moffat will discuss green 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 in the absence of universally accepted metrics and definitions.

The Adhesive and Sealant Council (ASC) and ASTM International (formerly known as the American Society of Testing and Materials) are co-sponsoring the event.  Representatives from well-known organizations such as Dow Corning, John Deere, HP Fuller, the America Chemical Society’s Green Chemistry Initiative, USEPA, and many others will be presenting on timely topics ranging from Green Chemistry to Green Marketing.  A copy of the preliminary agenda is set out below.  The conference brochure is available here.


Tuesday, July 26

Keynote Speaker………………………………………………………………….8:00 – 8:45 am
Dr. Bob Peoples, ACS

Adhesive Panel Discussion (focused on transportation)…………….8:45 – 10:15 am
Moderator: Sandra Niks, ASTM

Sealant Panel Discussion (focused on building construction)…….10:30 am – Noon
Moderator: Ken Yarosh, Dow Corning

Lunch Keynote Speaker……………………………………………………….Noon – 1:00 pm
FEICA – The EU’s perspective on sustainability
in the adhesive and sealant space

Adhesive Panel Discussion (focused on packaging)……………………1:15 – 2:45 pm
Moderator: John Kalkowski, Packaging Digest Magazine

Break Out Session – Adhesives………………………………………………3:30 – 4:30 pm

Break Out Session – Sealants…………………………………………………3:30 – 4:30 pm

Tour of a LEED Silver Building………………………………………………..4:30 – 5:45 pm

Reception…………………………………………………………………………..6:00 – 7:00 pm

Wednesday, July 27

Adhesives Group Key Findings……………………………………………….8:00 – 8:45 am
Presented by Adhesives Group Leader

Sealants Group Key Findings………………………………………………….8:45 – 9:30 am
Presented by Sealants Group Leader

ASTM Future Initiatives & Roadmap………………………………………9:45 – 10:00 am

ASC Future Educational Initiatives ………………………………………10:00 – 10:15 am

Closing Keynote Session……………………………………………………10:30 – 11:30 am
Rik Master, USG Corp.

New EPA Rule for Carbon-Nanotubes

Readers engaged in nanomaterial applications may be interested in EPA’s new Significant New Use Rule (SNUR) for multi-walled carbon nanotubes (MWCNTs). Enterprises wishing to manufacture, import, or process MWCNTS are now potentially subject to Significant New Use Notice (SNUN) regulatory procedures which include the submission of ‘appropriate’ health and safety data. This rule is incorporated into the Code of Federal Regulations at 40 CFR § 721.10183.

EPA evaluation of MWCNTs, and carbon nanotubes generally, has established that exposure may cause lung effects (pulmonary toxicity, fibrosis, carcinogenicity), immunotoxicity, and mutagenicity. More information on toxicological effects is reported in the Summary of EPA’s Current Assessments of Health and Environmental Effects of Carbon Nanotubes (available in the MWCNT SNUR Docket).

EPA recommends SNUNs provide detailed information on the following:

  • Human exposure and environmental release that may result from the significant new use of the chemical substance.
  • Potential benefits of the chemical substance.
  • Information on risks posed by the chemical substance compared to risks posed by potential substitutes.

EPA notes that upon review of a SNUN, the Agency has the authority to require additional testing. Any manufacturers, importers, or processors who intend to conduct testing or submit a SNUN are encouraged to contact EPA to determine ‘appropriate’ testing methods. Substantial detail about this and other governing TSCA provisions is provided in the FR notice (76 FR 26186 (available in the MWCNT SNUR Docket)). More information on SNUN requirements generally is available here and information on requirements for test data is available from EPA and the ACC.

This SNUR is specific to MWCNTs of a specific structure. However, confidentiality claims preclude a more detailed description of the identity of this MWCNT. To determine whether a specific CNT, MWCNT, or single-wall carbon nanotube is on the TSCA Inventory, manufacturers should submit a bona fide intent to manufacture or import to EPA.

Exempt from the rule are MWCNTs that are completely reacted (cured), incorporated or embedded into a polymer matrix that itself has been reacted (cured), or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.

Reminder: Upcoming ABA Conference on the Governance of Nanotechnology

Nanotechnology:

For readers interested in the environmental regulation of nanotechnology, you ought to seriously consider this program. The speakers are top-notch and the topics are timely and interesting.  Enjoy!

___________________________

ABA Webinar Thursday May 19

Nano Governance: The Current State of Federal, State, and International Regulation

Program: 1-5:30 p.m.

Networking Reception Immediately Following (DC site only)

No cost for in-person attendance

Washington, DC (register)

San Francisco, CA (register)

Durham, NC (register)

Webinar (register)

Overview:

The program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Speakers will discuss the approaches various government agencies are pursuing to accommodate evolving nanotechnologies and address potential public health and environmental impacts.

 Panelists:

Jim Alwood, Program Manager, Chemical Control Division, Office of Pollution Prevention and Toxics, U.S.

Raj Bawa, M.S., Ph.D., President of Bawa Biotechnology Consulting LLC, Ashburn, VA

Richard A. Denison, Ph.D., Senior Scientist, Environmental Defense Fund, Inc., Washington,

Steffi Friedrichs, Ph.D., Nanotechnology Industries Association, Brussels, Belgium

Steve Froggett, Ph.D., Froggett & Associates, Seattle, WA

Thomas R. Jacob, Coordinator, California Nanotechnology Initiative

William Jordan, Senior Policy Advisor, Office of Pesticide Programs, U.S. Environmental Protection Agency,

Neena Sahasrabudhe, Ph.D., Office of Pollution Prevention and Green Technology, California

Treye A. Thomas, Ph.D., Toxicologist, Directorate for Health Sciences, U.S. Consumer Product Safety Commission,

Rosalind Volpe, Ph.D., Executive Director, Silver Nanotechnology Working Group A Program of Silver Research

Impacts of Silver Nanoparticles on Wastewater Treatment

Readers involved with industrial and commercial uses of nanomaterials may be interested in the Water Environment Research Foundation’s new report, Impacts of Silver Nanoparticles on Wastewater Treatment.

According to the report, silver nanoparticles from manufacturing and consumer products enter sewers and wastewater treatment plants in unknown quantities. For example, because silver nanoparticles are water soluble, as much as 100 percent of these particles might be able to leach out of clothing in just a few washes. In areas where industrial processes use these materials, concentrations of 0.1mg/L have been observed in municipal wastewater treatment plants.

Wastewater treatment processes generally reduce effluent levels to 10 percent or less of influent concentrations. This means that very low concentrations of silver may be reaching the receiving waters. However, because nanoparticles are more reactive than other forms of silver, many scientists and environmentalists are concerned about toxicity and environmental impacts. (See e.g., Silver Nanoparticles and Silver Nitrate Cause Respiratory Stress in Eurasian Perch, Aquatic Toxicology, January 2010; Nanometals Induce Stress and Alter Thyroid Hormone Action in Amphibia at or below North American Water Quality Guidelines, Environ. Sci. Technol., October 2010; Silver Nanotechnologies and the Environment: Old Problems or New Challenges, Project on Emerging Nanotechnologies, 2008)

WERF investigated the effects of these particles on activated sludge and anaerobic digestion. The research found that the nitrifying bacteria essential to removing ammonia from wastewater treatment systems were especially susceptible to inhibition by silver nanoparticles. Silver ions and silver nanoparticles concentrations as low as 0.4 mg/L inhibited the growth of nitrifying bacteria. In addition, anaerobic microbial activity in biomass (i.e., sewage sludge) was inhibited at silver nanoparticles concentrations of 19 mg/L.

WERF notes that the presence of nanoparticles during sludge treatment can have beneficial results. Recent WERF research has found that nanomaterials reduce the potential for odors in wastewater treatment and improve solids processing. (See Use of Nanomaterials for Biosolids Odor Reduction and Improved Dewaterability.)

Design for the Environment–EPA’s Safer Product Labeling Program

Green Chemistry/Design for the Environment:

Readers interested in EPA’s Safer Product Labeling Program may want to look through the list of products now authorized to carry EPA’s Design for the Environment (DfE) label.  The list is available here.

On April 20, in anticipation of Earth Day, EPA announced that 2,500 products are now approved to carry the DfE label, including all-purpose cleaners, laundry and dishwasher detergents, drain line maintainers, and car and boat care products. DfE-labeled products do not contain known chemicals of potential concern, like carcinogens, reproductive or developmental toxicants. Even minor product components, like dyes and fragrances, are screened for safety.  In fact, according to EPA, before allowing the DfE logo to be used on a product label, the Agency conducts a scientific evaluation to ensure that candidate products are formulated from the safest possible ingredients.  The Agency’s press release explains that “[t]he DfE label means that EPA has screened each ingredient for potential human health and environmental effects and that the product contains only ingredients that, in EPA’s scientific opinion, pose the least concern among chemicals in their class.”

EPA also announced that DfE labeled products will soon be required to disclose their ingredients (other than trade secrets) to consumers. In addition, new DfE-approved products will need to meet additional life-cycle requirements such as sustainable packaging and limits on volatile organic compounds.  The new disclosure and life-cycle requirements will be phased in for existing DfE products, but some companies are already moving to comply with those standards.

Instructions on the application process for DfE labeling are available here.

Click here for the DfE home page.

Green Chemistry Law Report Selected as a LexisNexis Top 50 Environmental Law & Climate Change Community Blog for 2011

Today LexisNexis announced its selection of the Top 50 Environmental Law & Climate Change Community Blogs for 2011.  Verdant Law, PLLC was pleased to learn that the Green Chemistry Law Report was chosen from among a large, diverse, and competitive field of candidates.  According to LexisNexis, the award “recognizes preeminent thought leaders in the blogosphere…. Most good blogs provide frequent posts on timely topics, but the authors in this year’s collective take their blogs to a different level by providing insightful commentary that demonstrates how blogs can—and do—impact the practice of environmental and climate change law.”

Philip Moffat, the Firm’s founder, said “The Firm owes a debt of gratitude to its readers.  Without their support, the Green Chemistry Law Report may not have received the recognition it deserves.  Verdant is a boutique law firm specializing in product risk management with a particular emphasis on sustainability and other environmental challenges.  As such, I feel the Firm has a unique perspective to offer on the evolving debate over chemical regulatory reform and the green chemistry movement in the United States and elsewhere.” 

A complete list of the 2011 winners is available here

EPA Pesticide Program Dialogue Committee

FIFRA:

For readers looking for an update on US EPA FIFRA regulatory, policy and program implementation efforts, consider attending the Pesticide Program Dialogue Committee (PPDC) Meeting: Wednesday April 20 & Thursday April 21, 2011.

PPDC meetings provide a forum for a diverse group of stakeholders to provide feedback to the EPA Office of Pesticide Programs on various pesticide regulatory, policy and program implementation issues.

The PPDC meeting is open to the public. Attend in person at EPA’s Potomac Yard Conference Center (2777 Crystal Drive, Arlington, VA) or dial-in to the meeting (Conference Line: 1-866-299-3188; conference Code: 703-308-4775#).

The agenda, information about workgroups and past meetings can be accessed at http://www.epa.gov/pesticides/ppdc/.

Topics to be discussed at this week’s meeting include:

Tuesday April 20, 2011
• Integrated Pest Management (see e.g., http://www.epa.gov/pesticides/factsheets/ipm.htm)
• Spray Drift (see e.g., http://www.epa.gov/pesticides/ppdc/2010/dec2010/session5-drift.pdf )
• Inerts Disclosure (see e.g., http://www.epa.gov/opprd001/inerts/inertdisclosure.html)
• Water Quality/Drinking Water (see e.g., http://water.epa.gov/lawsregs/rulesregs/sdwa/dwstrategy/index.cfm)
• Pollinator Protection (see e.g., http://www.epa.gov/opp00001/ecosystem/pollinator/index.html)
• Children/Worker Risk Protection (see e.g., http://www.epa.gov/pesticides/health/worker-rsk-assmnt.html)
• OPP Strategic Directions (see e.g., http://www.epa.gov/pesticides/science/testing-assessment.html)
• Improving Regulations (see e.g., http://epa.gov/oppfead1/cb/csb_page/updates/2011/ppdc-regreview.html)
• Comparative Safety Statements (see e.g., http://www.epa.gov/pesticides/ppdc/compara-safety/index.html)
• Public Health Issues—Bed Bugs, Lyme Disease Prevention (see e.g., http://www.epa.gov/pesticides/ppdc/public-health/index.html)

Wednesday April 21, 2011
• Endangered Species (see e.g., http://www.epa.gov/espp/, http://www.nmfs.noaa.gov/pr/consultation/pesticides.htm)
• Clean Water Act Pesticide General Permit (see e.g., http://cfpub.epa.gov/npdes/home.cfm?program_id=410) (Also note, the ABA is hosting a program focused solely on this permit April 27–The NPDES Pesticide General Permit: Perspectives from the Hill, EPA, the Regulated Community, and Environmental Advocates. For registration information see http://www2.americanbar.org/calendar/the-npdes-pesticide-general-permit/Documents/Final_Flyer.pdf.)
• 21st Century Science Activities (see e.g., http://www.epa.gov/pesticides/ppdc/testing/index.html) (Also note, the EPA Science Advisory Panel Meeting May 24-26, 2011 will focus on toxicity testing—Integrated Approaches to Testing and Assessment Strategies: Use of New Computational and Molecular Tools. More at http://www.epa.gov/scipoly/sap/meetings/2011/052411meeting.html.)

EPA Publishes Chemical Action Plans For Diisocyanate Compounds

TSCA:

On April 13, 2011, EPA published chemical action plans for methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI) and related compounds.  According to EPA, diisocyanates are well known dermal and inhalation sensitizers in the workplace and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions. Worker exposures are already subject to protective controls in occupational settings, but EPA is concerned about potential health effects that may result from exposures to the consumer or self-employed worker while using products containing uncured (unreacted) MDI, TDI, and their related polyisocyanates (e.g., spray-applied foam sealants, adhesives, and coatings) or incidental exposures to the general population while such products are used in or around buildings including homes or schools. 

The Agency is proposing a number of regulatory actions under the Toxic Substances Control Act.  These include promulgation of significant new use rules (SNURs) under Section 5(a)(2) for TDI and its related polyisocyanates in consumer products; Section 4 test rules requesting certain exposure monitoring; reporting and data call-ins under Section 8(c) and 8(d); and certain restrictions adopted pursuant to Section 6.  The chemical action plan for MDI and related compounds is available here.  The plan for TDI and related compounds is available here

Senator Lautenberg Continues in His Quest to Reform TSCA

TSCA Reform:

Guest Columnist: 
Irene Hantman
University of Maryland Law Fellow
US EPA Office of Civil Enforcement
Waste and Chemical Enforcement Division

On April 14, 2011, Senator Lautenberg of New Jersey introduced the 2011 Safe Chemicals Act (2011 SCA), almost a year after he introduced a similar bill (S. 3209) that failed to garner sufficient Congressional support.  Senator Barbara Boxer of California, Senators Amy Klobuchar and Al Franken of Minnesota, and Senator Charles Schumer of New York co-sponsored the bill.  The 2011SCA is intended “to modernize the ‘Toxic Substances Control Act of 1976’ (TSCA) and protect Americans from exposure to dangerous toxins.”  Readers familiar with the bill introduced in 2010, S. 3209, will find many of the same concepts and requirements in the 2011 SCA.  Whether this latest bill will progress further than its predecessor is unknown, but there are many reasons to believe that it will not, despite support from the high-ranking Democratic Senators Boxer and Schumer.

According to Senator Lautenberg, the 2011 SCA addresses many of TSCA’s weaknesses identified by the US Government Accountability Office in its 2005 Report to Congress, Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage Its Chemical Review Program.  It also adopts many of the recommendations for US Chemicals Management Policy advocated by the American Academy of Pediatrics, former EPA Associate Administrators for the Office of Prevention, Pesticides, and Toxic Substances, and National Institutes of Health officials.  Readers unfamiliar with those recommendations should know that they stressed that efforts to modernize TSCA must: (1) ensure that chemicals in commerce demonstrate reasonable certainty of no harm, at all stages of human development, and through all possible exposure routes; (2) provide EPA practical tools to assess the safety of chemicals currently in use; and (3) establish public access to chemical safety information.  Senator Lautenberg also emphasized that the 2011 SCA would require safety testing of all industrial chemicals, and put the burden on industry to prove that chemicals are safe in order to get on, or remain on, the market.  In contrast, current TSCA parameters generally do not require chemical companies to test new chemicals for toxicity or to gauge exposure levels before they are submitted for EPA’s review.

Again, the 2011 SCA has many conceptual similarities to legislation the Senator sponsored in 2010 (S. 3209), but there are differences in some of the details of implementation.   The 2011 SCA would:

  • require manufacturers to submit minimum data sets to allow the EPA to conduct screening-level risk assessments for new and existing chemical substances (see amended §4(a));
  • facilitate data sharing across federal agencies (see amended §4(f));
  • require manufacturers and processors to submit new chemical notifications for chemical substances (and mixtures upon certain EPA findings) that EPA could approve upon a finding that the substance meets the Section 6 safety standard or that the substance does not meet other criteria concerning production volume, release, toxicity, etc. (see amended §5);
  • require manufacturers to submit reports describing current manufacturing or processing (see amended §8(a)), including
    • chemical identity,
    • manufacturing and processing facility location,
    • known uses of, exposure to, and fate information, and
    • health and safety studies not previously filed with the Administrator;
  • allow the Administrator to order manufacturers to make supplemental information submissions (see amended §8(b)) to assist
    • in making safety determinations, and
    • any aspect of administering TSCA; and
  • establish an Internet-accessible database to provide public access to significant chemical safety information (see amended §§5(b)(2), 8(d)), including
    • premanufacture notices (PMNs),
    • safety testing, and
    • Agency decisions.

In addition to maintaining a number of the conceptual changes to TSCA proposed in 2010, the 2011SCA includes new authorities regarding safety standard determinations and confidential information.   For example, the amended Section 6 would establish a risk classification scheme for chemical substances currently in use.

  • Priority Class 1 would comprise chemical substances that are assessed by the Administrator as requiring immediate risk management.  Substances in Class 1 would be those that are degraded and metabolized into persistent, bioaccumulative, and toxic substances with the potential for widespread exposure to humans or other organisms. Within 18 months of assignment to this priority class, the Administrator would be required to impose conditions on the manufacturing, processing, use, distribution in commerce, and disposal of the substance to achieve the greatest practicable reductions in human and environmental exposure.  
  • Priority Class 2 would include chemical substances, presently in commerce, for which the Administrator found a more-than-theoretical concern of uncertainty that they could meet the safety standard required for new chemicals.  Assignment to Class 2 would be conducted in order of risk presented to human health and the environment.  
  • Priority Class 3 would include only those chemical substances for which the Administrator determined no immediate action was required because the substance did not and would not, at any stage of the lifecycle, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance.

No judicial review would be available for assignment to any priority class.

The 2011 SCA also specifies minimum considerations for safety standard determinations of both new and existing chemicals (see amended §6(b)).  The legislation would require the Administrator’s risk assessment to include consideration of scientific literature relating to the effect of cumulative exposure to chemical substances.  The Administrator would be permitted to find that a substance meets the safety standard only when there is a reasonable certainty that neither human health nor the environment would be harmed from aggregate exposure.  Judicial review would not available for determinations that manufacturers have not established that chemical substances meet applicable safety standards.

The 2011 SCA would limit protections for confidential business information.  Section 14 would also allow the Administrator to determine that particular information previously considered eligible for confidential treatment is no longer entitled to such treatment.

Lastly, 2011 SCA would have limited preemptive effect.  States and their subdivisions would remain free to adopt or enforce any regulation, requirement, or standard of performance that was different from, or in addition to, a regulation, requirement, liability, or standard of performance established under TSCA, unless it was impossible to comply with both, in which case the TSCA requirement would control.  Although the preemption provision was revised from the 2010 bill, Senator Lautenberg continues to prefer robust state involvement in chemicals management.

The website for Senator Lautenberg’s office provides summaries of and the text of the Safe Chemicals Act of 2010 and 2011 (2010 bill, 2010 summary, 2011 bill, 2011 summary).

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DISCLAIMER:  This work is not a product of the United States Government or the United States Environmental Protection Agency, and the author is not doing this work in any governmental capacity.  The views expressed are those of the author only and do not necessarily represent those of the United States or the US EPA.