EPA Publicly Discloses More Chemical Identities Claimed Confidential under TSCA


On June 8, 2011, EPA announced the public disclosure of the identities of more than 150 chemicals contained in 104 health and safety studies that had been claimed confidential under the Toxic Substances Control Act (TSCA).  For those 104 studies, the chemical identity will no longer be redacted, or kept from public view.  According to EPA, the chemicals at issue are used in dispersant formulations and consumer products such as air fresheners, non-stick and stain resistant materials, fire resistant materials, nonylphenol compounds, perfluorinated compounds, and lead.  This latest development is another demonstration of EPA’s commitment to increasing transparency under the Toxic Substances Control Act (TSCA) by making publicly available more information about chemical hazards.

Readers will recall that, in 2010, EPA challenged industry to declassify voluntarily unwarranted claims of confidential business information (CBI).  EPA also issued new guidance outlining plans to deny CBI claims for chemical identity in health and safety studies under TSCA.  Based on this guidance, EPA notified a number of companies in February 2011 that it had determined that their CBI claims were not eligible for confidential treatment under TSCA and that EPA intended to make the information public.  (See related posts here and here.)   The health and safety studies included in the lastest disclosure  include some declassified by EPA and other voluntary declassifications by companies in response to EPA’s challenge.

In addition to these actions, EPA over the past several months has taken a number of other steps to make chemical information more readily available.  EPA provided the public, for the first time ever, with free access to the consolidated TSCA Inventory on the EPA and Data.Gov websites.  EPA also launched a new chemical data access tool that gives the public the ability electronically to search EPA’s database of more than 10,000 health and safety documents on a wide range of chemicals that they may come in contact with every day. (See related post here.)  More information about EPA’s transparency initiative under TSCA is avaialble here.

Reminder: Upcoming Teleconferences for Subcommittees of the DTSC Green Ribbon Science Panel

Green Chemistry Regulations:

Each of the three subcommittees of the California Department of Toxic Substance Control (DTSC) Green Ribbon Science Panel will hold two teleconferences in June in preparation for the meeting of the entire Panel scheduled for July 14 and 15 in Sacramento.  Each teleconference will focus on an aspect of the alternatives assessment process required under the Safer Consumer Product Alternatives (SCPA) Regulations still under development.

Members of the public and representatives of organizations are invited to attend and participate in the GRSP subcommittee meeting. The time allotted for individual public comments may be limited, depending on the number of individuals wishing to speak. Speakers are not required to identify themselves publicly.

Additional details are set out below.

#1: Alternative Assessment (as described in AB 1879)

This subcommittee will meet:

Subcommittee #1 members are:

  • Ken Geiser, Ph.D. (subcommittee chair)
  • Art Fong
  • Roger McFadden
  • Julia Quint
  • George Daston
  • Timothy Malloy
  • Ann Blake
  • Mike Wilson
  • Julie Zimmerman
  • Oladele Ogunseitan

#2: Tiered Alternatives Assessments

This subcommittee will meet:

Subcommittee #2 members are:

  • Jeff Wong DTSC Chief Scientist (subcommittee chair)
  • Kelly Moran
  • Richard Denison
  • Mike Kirschner
  • Richard Liroff
  • Meg Schwarzman
  • Anne Wallin
  • Bruce Cords

#3: Quality Assurance for Alternatives Assessments

This subcommittee will meet:

Subcommittee #3 members are:

  • Bill Carroll, Ph.D. (subcommittee chair)
  • Jae Choi
  • Dale Johnson
  • Joe Guth
  • Lauren Heine
  • Tod Delaney
  • Robert Peoples


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.

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.

ChemSec Adds 22 Chemicals to "SIN List"


On May 3, 2011, the EU environmental group, the International Chemical Secretariat (ChemSec), announced the addition of 22 chemicals to its so-called “Substitute It Now!” list or “SIN List.”  ChemSec supposedly selected the chemicals based “solely” on their endocrine disrupting properties.  Although there is no established EU definition for what constitutes an endocrine disrupting chemical (EDC), according to the USEPA and the NRDC, an endocrine disruptor is a synthetic chemical that, upon absorption into the body, either mimics or blocks hormones and disrupts the body’s normal functions.  According to ChemSec’s press release, EDCs “interfere with our hormone system and have been increasingly linked to a range of health problems including cancer, diabetes, behavioural and attention deficit disorders, as well as impaired fertility.” The group added the chemicals in part to force EU regulators to begin selecting EDCs for the authorization process set out in the EU’s primary chemical control law, titled “Registration, Evaluation, Authorisation, and Restriction of Chemicals” (REACh).

The SIN List is an inventory of chemicals that ChemSec developed.  Chemicals on the list purportedly meet the Substance of Very High Concern (SVHC) criteria established under REACh.  SVHCs are those chemicals that may be especially harmful to human health or the environment and thus may be considered for the REACH authorization process, which contemplates substitution of such chemicals for those that are “safer.”  ChemSec developed the list to encourage early substitution and to suggest “candidates” for authorization.

According to ChemSec, many of the 22 chemicals are “commonly found in toys, food packaging, and cosmetics….”  The chemicals that ChemSec selected are:

  • 3-benzylidene camphor
  • 4-methylbenzylidene camphor
  • 4-nitrophenol
  • 4,4´-dihydroxybenzophenone
  • Benzophenone-1
  • Benzophenone-2
  • Benzophenone-3
  • Butylparaben
  • Dicyclohexyl phthalate (DCHP)
  • Diethyl phthalate (DEP)
  • Dihexyl phthalate (DHP)
  • Ethylhexyl methoxycinnamate
  • Metam natrium
  • Methyl tertiary butyl ether (MTBE)
  • Pentachlorophenol
  • Perchloroethylene
  • Propylparaben
  • Quadrosilan
  • Resorcinol
  • Tert-butylhydroxyanisole
  • Thiram
  • Zineb

Thus far, the European Commission has embraced the SIN List and its recent additions. On May 19, 2011, in his opening speech at the annual Helsinki Chemicals Forum, Janez Potocnik, European Commissioner for Environment, said “The recently published second edition of the SIN list, which also includes substances with endocrine disrupting properties, should indicate to you the substances the European Commission will take into consideration for placement on the candidate list.” Potocnik also referred to the European Commission’s goal that another 90 substances should be added to the Candidate List for Authorization by the end of next year: “Now that we are working at full speed getting 136 substances of very high concern on the REACh candidate list by 2012, and even more by 2020, the dream of green chemistry is becoming a reality.”

Companies manufacturing, importing, or using chemicals in the EU will undoubtedly take seriously Mr. Potocnik’s remarks.  Moreover, they are certain to continue monitoring the SIN List and consider its potential implications when making product and raw material selections.

Health Canada Publishes FAQs on Canada Consumer Product Safety Act

Consumer Products:

On May 17, 2011, Health Canada published a Frequently Asked Questions (FAQ) document concerning the Canada Consumer Product Safety Act (CCPSA).  The CCPSA enters into force on June 20, 2011, and many questions remain unanswered.  Industry and other stakeholders have been waiting for more detailed instructions from the agency.  A copy of the CCPSA is available here, and the FAQ is available here.

A broad range of products and associated packaging are covered by the CCPSA.  Under the Act, a “consumer product” is defined as a product, including its components, parts or accessories that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging. Section 4 of the Act outlines the consumer products to which the CCPSA does not apply, including those listed in Schedule I. These include products that are covered under other legislation such as food, cosmetics, medical devices, drugs, natural health products, pest control products, fertilizers and vehicles.

The FAQ includes a fairly comprehensive set of questions.  The following examples are provided for the reader’s convenience:

Q. Does my product fall under the Canada Consumer Product Safety Act (CCPSA)?

Q. Is Health Canada considering adding certain products to the list of products to which the Canada Consumer Product Safety Act (CCPSA) does not apply?

Q. The definition of “consumer product” contains terms such as “obtained” and “non-commercial purposes” which are not defined in the Act. Is Health Canada going to provide definitions or guidance on these terms?

Q. Will there be a transition period for the implementation of the Canada Consumer Product Safety Act (CCPSA) and regulations, and if so, how long will it be?

Q. What does it mean in practice for the Minister to have the authority to order a recall?

Q. What is Mandatory Reporting?

Q. How do I determine what is considered as a reportable incident?

Q. Will the Canada Consumer Product Safety Act (CCPSA) Mandatory Reporting requirements be retroactive? For example, at the time that the Act comes into force on June 20th, 2011, will manufacturers, importers and retailers be required to report incidents that happened prior to that date?

Q. If a product falls under the purview of both the Canada Consumer Product Safety Act (CCPSA) and another statute, such as a provincial one, will Health Canada be the primary reporting body that will distribute the incident report information to the other regulatory body?

Q. Does a recall undertaken in another country need to be reported in Canada as well?

Q. Is Health Canada planning to require traceability of components of consumer products?

Q. When can we expect to see new regulations under the Canada Consumer Product Safety Act (CCPSA)?

Q. When will the regulations for Administrative Monetary Penalties be developed?

Q. Will certain organizations be exempt from the Canada Consumer Product Safety Act (CCPSA)?

Q. What safeguards are in place to protect Confidential Business Information submitted to Health Canada?

Readers interested in consumer product safety should continue to follow Canada’s implementation of this important new law.

EU Environmental Groups Sue ECHA to Force the Disclosure of Companies Manufacturing or Importing Chemicals on the “SIN List”


On May 9, 2011, two EU environmental groups, the International Chemical Secretariat (ChemSec) and ClientEarth, announced that they had initiated a lawsuit against the European Chemicals Agency (ECHA).  The groups filed the lawsuit in the General Court of the EU with the goal of forcing ECHA to publicly disclose the names of companies manufacturing or importing chemicals currently listed on ChemSec’s so-called “Substitute It Now!” list or “SIN List.”  The groups also seek volume information.  ChemSec and ClientEarth want the names and volume information so that they can pressure ECHA and the companies to substitute the chemicals for ones that supposedly are “safer.”  The groups submitted their initial request on December 1, 2010, and after a series of escalating and more formal requests, ECHA issued its final denial on March 7, 2011.  Now, in response to the lawsuit, ECHA has announced that it will release some of the information.  A spokesperson for the groups says that they intend to pursue the case in light of ECHA’s inadequate response.  Additional details are set out below.

ECHA received the names and volume information when the companies submitted their registration dossiers in partial fulfillment of their obligations under the regulation, “Registration, Evaluation, Authorisation, and Restriction of Chemicals” (REACh).  For readers less familiar with the regulation of chemicals, REACh is the primary EU chemical control law.  It applies to most chemicals, except for those used in pharmaceuticals, pesticides, or other products regulated under different EU laws.  Companies that manufacture or import nonexempt chemicals in the EU above 1 metric ton per year are required to submit a registration dossier to ECHA.  The dossier includes certain data and other information about the chemical, its uses, as well as the manufacturer or importer.  ECHA and the EU countries (called Member States) review the dossier to decide whether a chemical should be banned or its use limited through the so-called restriction or authorization processes established under REACh.  Additional testing or other information may also be requested.

The SIN List is an inventory of chemicals that ChemSec developed.  Chemicals on the list purportedly meet the criteria established under REACh for identifying Substances of Very High Concern (SVHC).  SVHCs are those chemicals that may be especially harmful to human health or the environment and thus may be considered for the REACH authorization process, which expressly contemplates substitution of such chemicals for those that are “safer.”

The lawsuit is currently pending before the General Court of the European Union.  The General Court handles cases filed by private individuals, companies and some organizations, and cases relating to competition law (antitrust for American readers).  The General Court provides the first level of judicial review.  Afterwards, a case can be appealed to the European Court of Justice.  The Court of Justice interprets EU law to ensure the law is applied consistently in all EU countries.  The Court of Justice also settles legal disputes between EU governments and EU institutions.  Individuals, companies, or organizations can also bring cases before the Court if they feel their rights have been infringed by an EU institution.  The Court of Justice has one judge per EU country.

A copy of the legal compliant, called an Application for Annulment, is available here.  In it, ChemSec and ClientEarth include numerous allegations challenging the substantive basis and procedures ECHA used in delaying its response and ultimately denying the groups’ request.  A discussion of the legal principles set out in the complaint and an evaluation of the merits of the allegations are beyond the scope of this post.  However, they may be reviewed more closely in a subsequent post.

In response to the lawsuit, ECHA announced on May 11, 2011, that it will begin to publish certain information from the registration dossier contained in the safety data sheet (SDS), including company names.  In addition to the company’s name, ECHA said that it will also make further elements contained in the SDS publicly available such as the REACH registration number and whether the substance meets some of the SVHC criteria.  However, ECHA noted that companies will be able to keep the information confidential, provided that a valid justification is given and accepted by ECHA.   According to the agency, providing this information will require significant revisions to ECHA’s databases so it is currently unable to commit to releasing the information in the immediate future.  ChemSec and ClientEarth have stated publicly that they find ECHA’s response inadequate and plan to proceed with their lawsuit.

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


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)


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.


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.)