USDA Launches BioPreferred Product Certification and Labeling Program

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Sustainable Products:

On January 20, 2010, the US Department of Agriculture (USDA) published a final rule announcing its BioPreferred Program, a voluntary product certification and labeling program established under the authority of section 9002 of the Farm Security and Rural Investment Act of 2002 (FSRIA), as amended by the Food, Conservation, and Energy Act of 2008 (FCEA), 7 U.S.C. 8102.  According to the USDA press release, “this new label will clearly identify biobased products made from renewable resources, and will promote the increased sale and use of these products in the commercial market and for consumers.” The rule is effective February 22, 2011.

Under the program, a biobased product, after being certified by USDA, can be marketed using the “USDA Certified Biobased Product’’ label.  Biobased products are those composed wholly or significantly of biological ingredients – renewable plant, animal, marine or forestry materials. The presence of the label will mean that the product meets USDA standards for the amount of biobased content and that the manufacturer or vendor has provided relevant information on the product for the USDA BioPreferred Program web site. The rule applies to manufacturers and vendors who wish to participate in the voluntary labeling component of the BioPreferred Program.  It also applies to other entities, such as trade associations, that want to use the label to promote biobased products. 

With the launch of the USDA biobased product label, the BioPreferred program is now comprised of two parts: a biobased product procurement preference program for Federal agencies, established in 2005, and a voluntary labeling initiative for the broad-scale marketing of biobased products.  According to the USDA’s website, the Agency has already designated approximately 5,100 biobased products for preferred purchasing by Federal agencies. The new label will make identification of these products easier for Federal buyers, and will increase awareness of these high-value products in other markets. USDA estimates that there are 20,000 biobased products currently being manufactured in the United States and that the growing industry as a whole is responsible for over 100,000 jobs.

Lastly, readers will recall that the Federal Trade Commission (FTC) recently proposed revisions to its guidance concerning compliance with section 5 of the FTC Act when making environmental marketing claims – the so-called “Green Guides.”  In that proposal, the FTC elected to defer to the USDA’s BioPreferred labeling program for guidance on marketing products covered by the program.  So, companies making “biobased” marketing claims in compliance with the USDA’s requirements presumably would have a limited safe-harbor from FTC enforcement.  However,  the FTC has reminded marketers that its proposal contains guidance concerning “made with renewable materials” claims, which can be similar to “biobased” claims, so marketers would need to remain mindful of that guidance when making such claims.

TSCA Reform Likely to Be a Lower Priority in 2011

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TSCA Reform:

Chemical and Engineering News reports that representatives from several major US trade associations have stated publicly that they don’t expect modernization of the federal Toxic Substances Control Act (TSCA) to be a high priority for Congress in early 2011. Their statements are not surprising.  With fears of a double-dip recession still lingering, passage of a substantially revised TSCA seems unlikely in 2011, but with continued industry support, an improved economy, and a little bipartisan cooperation, it might occur in 2012.  (Assuming, of course, that the election doesn’t get in the way.  A big “if.”)

The Republican party controls the House of Representatives and it’s clearly stated its intentions.  Among other things, Republicans are determined to reduce the impacts on the deficit, national debt, and jobs that are associated with government regulation, including some forms of environmental regulation.  Adopting a more robust chemical control statute would likely require a substantial increase in EPA’s budget and it could have a significant ripple effect throughout the economy as downstream companies that don’t manufacture, but “process,” chemicals faced new requirements.  Also, at least some chemical manufacturers would need to generate expensive new health and environmental data.  And finally, there’s the risk that a new program could stifle innovation and affect the global competitiveness of the United States.

Notwithstanding support for reform coming from the American Chemistry Council (ACC), a trade association comprised primarily of chemical manufacturers, economic concerns – real or stated – could prove dissuasive in 2011 to a majority of Republicans in the House.  The Democratically-controlled Senate may be more inclined towards major near-term reform, but in the absence of sufficient support in the House, and with any Senate proposal likely less palatable to the chemical industry, such a goal seems unattainable.  At a minimum, the delay will give key members of the 112th Congress time to try to reach consensus on important points in the reform debate.

So, what will 2011 look like?  Unless there’s another crisis, such as tainted imported consumer products or an oil spill requiring the use of chemicals for which little safety information is publicly available, readers will probably see limited progress through 2011.  Closed-door meetings are certain to occur, a few hearings will take place and a bill may be introduced in the Senate – a bill may even be introduced in the House – but proposals are unlikely to advance significantly in the near-term.  Economic considerations will affect both the resources committed to the TSCA reform debate, as well as the details of any legislative proposals.  Efforts occurring in 2011 will be undertaken in the name of trying to adopt “sensible” reform that protects the environment and health without damaging the economy. 

With the Administration already taking steps to reconcile past differences with business leaders in preparation for the 2012 election, it seems unlikely that the White House will push for robust new legislation either.  So, don’t look for major legislative proposals coming from EPA anytime soon.  However, expect the ACC and others to try to persuade the Administration that TSCA Reform is a potential opportunity for bipartisanship. 

But what about the public’s and the states’ outcry for a more robust federal chemical regulatory program?  And what about the consensus among the chemicals industry, EPA, and environmental groups on the need for reform?  The outcry and the consensus are important and should not be dismissed for ultimately they will help ensure passage of a revised TSCA.  However, for the next year (and possibly longer), jobs creation, debt reduction, election politics, and efforts to reach consensus, are likely to delay reform.  In the interim, EPA will probably continue with its attempts to use existing authority to address chemical risks, despite promises of increasing Congressional oversight.  

Rescheduled: ABA Program on Nano Governance

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Nanotechnology:

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.

 

Save the Date: Exciting Upcoming ABA Program on Nano Governance

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Nanotechnology:

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:

  1. The Federal Regulatory Outlook
  2. Beyond The Feds:  International/State Regulatory Programs and Strategies for Addressing Nanoscale Materials
  3. Perspectives from the Field

Questions:

More details to follow shortly, but for questions on this tentative program, please contact Irene A. Hantman at ihant001@umaryland.edu.

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.

 

EPA Requires Testing of 19 High Production Volume (HPV) Chemicals

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TSCA/HPV Chemicals:

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:

CAS No.

Chemical Name

75-07-0

Acetaldehyde

78-11-5

1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)

84-65-1

9,10-Anthracenedione

89-32-7

1H,3H-Benzo[1,2-c:4,5-c’]difuran-1,3,5,7-tetrone

110-44-1

2,4-Hexadienoic acid, (E,E)-

118-82-1

Phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)-

119-61-9

diphenylmethanone

144-62-7

Ethanedioic acid

149-44-0

Methanesulfinic acid, hydroxy-, monosodium salt

2524-04-1

Phosphorochloridothioic acid, O,O-diethyl ester

4719-04-4

1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol

6381-77-7

D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt

31138-65-5

D-gluco-Heptonic acid, monosodium salt, (2.xi.)-

66241-11-0

C.I. Leuco Sulphur Black 1

68187-76-8

Castor oil, sulfated, sodium salt

68187-84-8

Castor oil, oxidized

68479-98-1

Benzenediamine, ar,ar-diethyl-ar-methyl-

68527-02-6

Alkenes, C12–24, chloro

68647-60-9

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.

Crocs Shoe Company Settles FIFRA Enforcement Action with EPA

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FIFRA:

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.     

DTSC Delays Adoption of its Green Chemistry Regulations for Safer Consumer Product Alternatives

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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.   

 

Philip Moffat Will Participate on ABA Quick Teleconference on California's Green Chemistry Regulations

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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:

  • Ann Grimaldi, McKenna Long & Aldridge LLP, San Francisco, CA
  • Doug Fratz, Vice President, Scientific & Technical Affairs, Consumer Specialty Products Association, Washington, DC
  • Dr. Joseph Guth, UC Berkeley Center for Green Chemistry; and the Science and Environmental Health Network, Berkeley, CA
  • Maziar Movassaghi, Acting Director, DTSC, Sacramento, CA

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:

  • Austin, TX
    Brown McCarroll, L.L.P., 111 Congress Ave., Ste. 1400
    RSVP: Keith Hopson, (512) 479-9735 or khopson@brownmccarroll.com
  • Bloomfield Hills, MI
    Butzel Long, Stoneridge West, 41000 Woodward Ave
    RSVP: Beth S. Gotthelf, (248) 258-1303 or gotthelf@butzel.com
  • San Francisco, CA
    McKenna Long & Aldridge LLP, 101 California St., # 41
    RSVP: Cynthia Kelly, (415) 267-4051 or ckelly@mckennalong.com
  • Washington, DC
    McKenna Long & Aldridge LLP, 1900 K Street, NW
    RSVP: Michael Boucher, (202) 496-7729, mboucher@mckennalong.com or Debbie Leitner, (202) 496-7372, dleitner@mckennalong.com

Additional information about the teleconference is available here.  And a copy of the presentation is available here:  Moffat_CAGreenChem

Reminder: Upcoming DTSC Symposium on Green Chemistry and Public Health

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Green Chemistry:

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“

California DTSC Requests Comment on Proposed Green Chemistry Regulations for Safer Consumer Product Alternatives

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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:

  • Address criticism that the initial scope of chemicals list was too narrow.  DTSC has significantly broadened the proposed scope by expanding the lists of authoritative bodies that could be consulted for establishing the Priority Chemicals list.
  • Respond to concerns that the previous draft regulation’s lack of deadlines could cause unintended delays.  Proposed deadlines are now included for both chemicals and products lists along with specific timelines for various regulatory steps.  (These are set out in more detail below.)
  • Additionally, DTSC has added a tiered process for alternative assessments intended to reduce the time for identifying safer alternatives and provide more specific performance targets to move manufacturers through the regulatory process.
  • Address comments regarding the complexity of the process.  DTSC has simplified the process somewhat and clarified what information would be required and how it would be submitted.
  • Respond to requests to have public comments on regulatory actions.  DTSC now proposes to allow public comment on any regulatory responses that are triggered by a DTSC ruling or determination.

The proposed regulations include the following deadlines:

  • The proposed initial list of Chemicals under Consideration must be issued for public review and comment no later than June 1, 2011;
  • The final initial list of Chemicals under Consideration must be issued no later than March 1, 2012;
  • The proposed initial list of Priority Chemicals must be issued for public review and comment no later than July 1, 2012;
  • The proposed initial list of Products under Consideration must be issued for public review and comment no later than March 1, 2013;
  • The proposed initial list of Priority Products must be issued for public review and comment no later than September 1, 2013;
  • The final initial list of Priority Products must be issued no later than December 1, 2013.

Future postings may delve further into various aspects of the proposed regulations, as well as review public comments that are submitted to DTSC.