Due to scheduling conflicts, this program is being re-scheduled for sometime between mid-March and mid-April. When a new date is set, program details will be available here.
Due to scheduling conflicts, this program is being re-scheduled for sometime between mid-March and mid-April. When a new date is set, program details will be available here.
For readers interested in the current state of play regarding governance of nanotechnology, the ABA Pesticides, Chemical Regulation and Right-To-Know Committee, along with other committees listed below, is organizing the following half-day event.
SAVE THE DATE
January 27, 2011
NANO GOVERNANCE: THE CURRENT STATE OF
FEDERAL, STATE, AND INTERNATIONAL REGULATION
Please mark January 27, 2011, on your calendar for an exciting program under development by the Pesticides, Chemical Regulation, and Right-to-Know Committee and the Science and Technology Section, Nanotechnology Committee. Program co-sponsors include the Young Lawyers Division Administrative Law and Environment Energy and Resources Law Committees and the Section on the Environment and Energy Resources, Environmental Disclosure Committee.
Program: Nano Governance: The Current State of Federal, State, and International Regulation
Date: Thursday, January 27, 2011
Time: 1:00 – 5:30 p.m. (EST). Networking reception immediately following.
Tentative Program Overview:
More details to follow shortly, but for questions on this tentative program, please contact Irene A. Hantman at firstname.lastname@example.org.
Also remember that the PCRRTK Committee web page provides you with access to valuable resource materials and analysis from past programs, newsletters, reports, and Practitioners E-reference documents covering a wide range of pesticide, chemical regulation, and right-to-know legal issues. Please visit us at http://www.abanet.org/environ/committees/pesticides.
On January 7, 2011, EPA published a final rule under section 4(a)(1)(B) of theToxic Substances Control Act (TSCA), (15U.S.C. 2603(a)(1)(B)), requiring manufacturers, importers, and processors to test 19 high production volume (HPV) chemicals. The rule, which takes effect on February 7, 2011, requires these persons to obtain screening level data for health and environmental effects and chemical fate, and then provide that data to the Agency. The rule is one of a series of actions that EPA is taking to ensure that it has the data necessary to adequately review priority chemicals. In addition, now that the Agency has issued a final test rule, any person (including those required to test) who exports, or intends to export, any of the 19 chemicals will be subject to the export notification requirements in 40 CFR part 707, subpart D. The chemicals are listed below:
1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)
2,4-Hexadienoic acid, (E,E)-
Methanesulfinic acid, hydroxy-, monosodium salt
Phosphorochloridothioic acid, O,O-diethyl ester
D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt
D-gluco-Heptonic acid, monosodium salt, (2.xi.)-
C.I. Leuco Sulphur Black 1
Castor oil, sulfated, sodium salt
Castor oil, oxidized
Alkenes, C12–24, chloro
Hydrocarbons, C > 4
The 19 chemicals were originally included in the voluntary High Production Volume (HPV) Challenge Program, which “challenged” companies to make health and environmental effects data publicly available on chemicals produced or imported in the United States in the greatest quantities. HPV chemicals are classified as those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year. EPA has determined that HPV chemicals account for approximately 95% of total chemical production in the United States. As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts. However, no data were provided for the 19 chemicals, making a mandatory test rule necessary.
More information on EPA’s HPV Challenge Program is available here.
On December 30, 2010, EPA announced a settlement under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with Crocs, Inc., the company famous for its ubiquitous, colorful foam clogs. EPA alleged that Crocs violated FIFRA by making unsubstantiated antimicrobial health claims on its website, in advertising, and on packaging for several styles of the Company’s shoes. Pursuant to the settlement agreement, Crocs will remove the offending language and pay a $230,000 penalty. The Company will undoubtedly incur significant additional expense to revise its advertising materials, field questions from distributors and worried customers, and take other steps necessary to ensure future compliance and help protect the Crocs brand. A copy of the settlement agreement is available here.
This case is another unfortunate example of the relative ignorance of many consumer products companies about the application of FIFRA to consumer products treated with antimicrobials or other pesticides. One would not normally consider shoes to be a pesticide product, but under FIFRA, they can be. Making an antimicrobial public health claim about a product (usually because of a chemical applied to the product) is one of the easiest ways to make a cutting board, computer keyboard, etc., subject to FIFRA. Many companies simply don’t understand this, or they mistakenly think their products qualify for the “treated articles” exemption and therefore they don’t need to worry about FIFRA. (More on the “treated articles” exemption in a minute.) EPA’s enforcement docket is littered with past examples of such mistakes.
Simply stated, products that claim to kill or repel bacteria or germs are considered pesticides under FIFRA. FIFRA requires companies to register pesticide products with EPA before selling, distributing, or making public claims about their ability to control germs or pathogens. The registration process can be time-consuming and expensive because EPA will not register a pesticide until it has been shown, through testing, not to pose an unreasonable risk when used according to the label’s directions.
Companies often aren’t aware of the scope of the registration requirement. Others are aware of it, but believe (mistakenly) that their products qualify for the “treated articles” exemption in 40 CFR 152.25(a). Eligibility for this exemption is not as straightforward as it might seem. In a nutshell, the exemption requires: (1) the incorporated pesticide to be registered for use in or on the article and (2) the sole purpose of the treatment to be protection of the article itself. Implied or explicit public health claims for protection against bacteria, fungi, viruses, or other pathogens (e.g., “antibacterial”) are prohibited since they show that treatment was not solely for protection of the article itself. Companies commonly make claims broader than those allowed or they fail to confirm that the registration covers treatment of their specific type of product. The result is a violation of FIFRA with all the pain and expense that entails.
Where does this leave a consumer products company wanting to capitalize on society’s germ phobia? Well, before succumbing to the sirens’ song from Marketing or Sales about the new marketing opportunities, usually an in-house counsel, product steward, or other EH&S professional inquires about FIFRA compliance. If shrugs or blank stares are returned, that person will arrest the momentum and probe the issue further. (Disclaimer: This is a practical observation and not legal advice.) EPA has helpful guidance , and other information is available on its website, here and here.
Green Chemistry Regulations:
After nearly two years of multi-stakeholder collaborative efforts, the California Department of Toxic Substances Control (DTSC) failed to timely adopt its Safer Consumer Product Alternatives Regulations (SCPA Regulations), a key component of California’s Green Chemistry Initiative. The regulations would have represented a new paradigm in chemicals and products regulation, providing a strong incentive for manufacturers to market products that are “benign by design” through the use of “safer” chemicals and other techniques. The enabling legislation, AB 1879, required DTSC to complete the rulemaking by January 1, 2011, but that did not happen. The Department’s parent agency, the California Environmental Protection Agency (Cal-EPA), decided to have DTSC delay adoption in the face of substantial criticism of last-minute changes the Department proposed in November. No deadline for completing the rulemaking has been announced publicly.
After receiving comments on its first regulatory proposal, released in September, DTSC made substantial changes in November and released them for a 15-day comment period extending over the Thanksgiving holiday. The changes largely streamlined and clarified the requirements and removed potential impediments to innovation. However, critics accused DTSC of employing “bait-and-switch” tactics, caving to industry pressure, and violating the California Administrative Procedures Act. In the face of such criticism, Cal-EPA’s Secretary for Environmental Proection, Linda S. Adams, decided — in consultation with key legislators and the Governor’s Office — to violate the statutory deadline. She announced her decision in a December 23, 2010 letter to Assembly Member Mike Feuer, the primary author of AB 1879. The letter states that DTSC will reconvene its Green Ribbon Science Panel — a multidisciplinary advisory body — and revisit the issues raised in the last round of comments.
The two most controversial changes concern (1) a five-year limitation on the categories of products subject to regulation and (2) the removal of a provision that would have affected manufacturers’ ability to redesign products. Readers will recall that both the September and November proposals set out a three-step process – (1) identification of chemicals of concern and the priority products containing them, (2) assessment of alternatives to determine whether a viable, safer alternative is available, and (3) imposition of a regulatory response to protect health and the environment from the alternative selected. In recognition of the challenges of implementing an entirely new regulatory scheme, the Department’s November proposal would have limited (until January 1, 2016) the categories of products from which priority products could be identified. Only children’s products, personal care products, and household cleaning products would be eligible. To avoid stifling innovation, the November proposal also would have removed the so-called “Tier I” notification, a streamlined alternatives assessment for a product voluntarily redesigned or reformulated to reduce or remove chemicals of concern prior to the product being identified as a priority product. Avoidance of “regrettable substitutions” was the goal of the Tier I notification, but the potential cost to innovation convinced DTSC to remove the requirement.
These eleventh-hour developments create considerable uncertainty for the regulated community and others, which have been struggling to understand the full import of the regulations and prepare for their implementation. The impending debate over November’s changes is certain to be contentious. Although the changes seem meritorious, they were proposed in a manner that appears to have eroded trust and damaged the spirit of cooperation. Whether the various stakeholders can reach consensus on the most controversial issues remains to be seen.
California Green Chemistry Regulations:
Verdant is pleased to announce that Philip Moffat will participate on a “quick teleconference” program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources entitled “California Dreaming or Reality? California’s New Paradigm in Chemicals and Products Management Could be Coming to a Store Near You.” The November 15, 2010, teleconference will discuss the regulations recently proposed by the California Department of Toxic Substances Control (DTSC) to implement AB 1879, a new California Green Chemistry Initiative law designed to “accelerate the quest for safer products” in the state. In addition to discussing the law’s requirements and its implementation, the teleconference will provide both industry and public health perspectives.
Other speakers include:
There are two ways to participate in this program, either attending a host site location or individual dial-in. Participation at a host site location is free of charge for ABA members, and $110 for non-members. Registration with the host site contact is required, however:
Yesterday, the California Department of Toxic Substances Control (DTSC) circulated the following announcement regarding an upcoming symposium on Green Chemistry and public health. The event will be held on October 18. DTSC and the Department of Public Health are co-sponsoring the event. More details, including a copy of the agenda, are provided in the excerpt below.
“DTSC and the California Department of Public Health will host a brown-bag symposium on October 18 to explore impacts of Green Chemistry on public health. Keynote Speaker is Margaret L. Kripke, Ph.D., a member of the President’s Cancer Panel which recently advocated expanded research into Green Chemistry. Kripke is a professor of immunology at the University of Texas, MD Anderson Cancer Center. Our afternoon keynote speaker is Steve Owens, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention at the U.S. Environmental Protection Agency. Owens oversees regulatory and scientific programs on pesticides and industrial chemicals along with numerous collaborative pollution prevention programs.
The symposium will be held on October 18, 2010 from 10 a.m. to 3 p.m. at the California Department of Public Health East End Complex, 1500 Capitol Ave., Sacramento, CA. It is free, open to the public and to all interested stakeholders in Green Chemistry and Public Health.
For more information or to register for in person or live webcast attendance, please visit: http://www.dtsc.ca.gov/upload/GreenChemPublicHealthBrownBagFlyer.pdf
To view the agenda, visit: http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/PHAgenda.pdf
Instructions on how to view the webcast will be provided a few days before the event.
To subscribe to or unsubscribe from the DTSC Green Chemistry Initiative Listserv or other Listservs, please go to http://www.calepa.ca.gov/listservs/dtsc. For information on DTSC`s Green Chemistry Initiative, go to http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/index.cfm“
Green Chemistry Regulations:
After nearly two years of public meetings, informal comment periods and other multi-stakeholder collaborative efforts, the California Department of Toxic Substances Control (DTSC) released on September 15, 2010 its proposed Safer Consumer Product Alternatives regulations, a key component of California’s Green Chemistry Initiative. The proposed regulations would require DTSC to create a list of chemicals identified as posing the greatest threats to human health or the environment, the so-called “Priority Chemicals.” Using a number of factors such as volume in commerce and extent of public exposure, DTSC would then prioritize products containing those chemicals. Entities responsible for commercial introduction of the highest priority products, the so-called “Priority Products,” would be required to perform an alternatives assessment to determine whether a viable safer alternative is available. The alternative ultimately selected would inform DTSC’s regulatory response, which could range from no action to sales prohibitions.
The proposed regulations represent a paradigm shift in the regulation of chemicals and products, having significant implications for all members of a product’s value chain. The process for identifying Priority Chemicals and Priority Products is complicated and information-intensive. Products undergoing an alternatives assessment will require a substantial resource commitment. To help ensure compliance, reduce the risk of reputational harm, maintain market presence, and potentially identify new opportunities, companies will need to understand the process, closely monitor future DTSC pronouncements and be prepared to respond appropriately.
Companies placing products into the stream of commerce in California that have not yet reviewed the proposed regulations are probably doing so now. Although many industry representatives actively participated in the collaborative drafting process, many more did not, mistakenly believing that their products were not “consumer products” and therefore would not be affected. The reality is that only a limited universe of products is excluded from the definition of consumer product or otherwise eligible for some type of exemption.
Public comments on the proposed regulations are due on November 1, 2010, the same date as the public hearing on them. DTSC intends to complete the formal rulemaking process by the end of 2010, as required by statute. A copy of the proposed regulations, a set of Frequently Asked Questions, a conceptual flowchart, and other information is available here.
Readers that are familiar with the previous draft of the regulations may be interested in the type of changes that DTSC incorporated into the current proposal. DTSC claims that the changes:
The proposed regulations include the following deadlines:
Future postings may delve further into various aspects of the proposed regulations, as well as review public comments that are submitted to DTSC.
On August 13, 2010, the Environmental Protection Agency (EPA) published a notice in the Federal Register, proposing to modify the Inventory Update Reporting (IUR) rule. For readers less familiar with the IUR, this is a rule established under section 8(a) of the Toxic Substances Control Act (TSCA). It enables EPA to collect, and then make public, critical information on the manufacture (including import), processing, and use of certain chemicals listed on the TSCA Chemical Substances Inventory. This includes current information on volumes of chemical production, manufacturing facility data, and how the chemicals are used. EPA uses this information to help identify and, when necessary, manage potential risks that some chemicals may pose to human health or the environment.
The proposed rule includes a number of important changes that will impact industry. Among these include: requiring electronic reporting; increasing the reporting frequency; requiring process and use information for substances over 25,000 pounds; changing the method for determining whether the reporting threshold has been exceeded; replacing the “readily obtainable” reporting threshold with “reasonably ascertainable” for processing and use information; and requiring submission of production volume information for all years in between reporting periods.
EPA intends to issue the final rule in advance of, and have it apply to, the 2011 submissions. That submission period runs from June 1, 2011 through September 30, 2011. Reporting companies are closely monitoring this development to ensure compliance with the requirements EPA ultimately adopts. Comments must be received on or before October 12, 2010.
EPA states that it is modifying the rule to meet four primary goals:
The changes the Agency is proposing to meet these goals are discussed in further detail below.
I. General Reporting Changes
II. Reporting of Manufacturing Information
III. Reporting of Processing and Use Information
IV. Other Proposed Changes
V. Concluding Thoughts
EPA’s proposed changes move the Agency closer to meeting its stated goals. They should help resolve many of the difficulties it encountered using the information received in the last IUR reporting cycle. The limitations and requirements on the protection of CBI are not surprising given the Agency’s stated interest in expanding public access to information on chemicals. Nonetheless, it is clear that the proposed changes will increase industry’s reporting burden and place more confidential business information at greater risk of public disclosure.
This evening the California Department of Toxic Substances Control (DTSC) circulated the following announcement, reminding interested persons about the upcoming symposium on life cycle analysis.
“DTSC invites you to the Life Cycle Analysis: 101 Brown-Bag Symposium, taking place on Thursday, Sept. 23, 2010. This session looks at real-world examples of life cycle analysis (LCA) and how it affects product formulation, decision analysis and business practices. Presenters from HP, P&G, PE Americas and UCLA will share their front-line experiences of developing protocol and collaboration to successfully complete LCAs.
The symposium takes place in the Elihu M. Harris Building in Oakland, from 10:30 a.m. to 3 p.m. Bring a lunch and plenty of questions for our presenters. Register (http://www.dtsc.ca.gov/LCA_symposium.cfm) to attend in person or participate via webcast.”
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