EPA Denies TSCA Petition for Banning Lead Fishing Tackle

TSCA:

On February 14, 2012, EPA formally announced that it was denying the Center for Biological Diversity’s petition to ban or restrict lead (Pb) in fishing tackle  – fishing weights, sinkers, lures,jigs, etc. – pursuant to section 6 of the Toxic Substances Control Act (TSCA).  The agency stated succinctly:  “After careful review, EPA has determined that, while the petition does provide evidence ofexposure and a risk to waterfowl in some areas ofthe United States, it does not provide a basis for finding that the risk presented is an unreasonable risk for which federal action under section 6(a) of TSCA is necessary to adequately protect against such risks.”  In other words, CBD failed to show that (a) an unreasonable risk of injury was present, and (b) that risk required federal action to correct.   A copy of EPA’s letter is available here, and the Federal Register notice, setting out the complete supporting analysis, is available here.  CBD’s petition is avaialble here.

EPA reasoned that existing federal and state regulatory and educational efforts were sufficiently protective.   “Your petition does not demonstrate why federal action is necessary given the mix of regulatory and education actions state agencies and the Federal Government already are taking to address the impact of lead fishing tackle on local environments. The risk described in the petition does appear to be more prevalent in some geographic areas than others, and the trend over the past decade has been for increasing state and localized federal activity regarding lead in fishing tackle. The petition does not demonstrate that these state and local efforts are ineffective or have failed to reduce the exposure and risks presented to waterfowl in particular.”  In other words, the data simply weren’t there to support the petitioners’ request.

EPA Budget Would Increase Spending on Chemical Assessment and Control

EPA Budget/Chemical Control

According to an EPA press release, today the Obama Administration proposed a FY 2013 budget of $8.344 billion for the agency. The budget is $105 million below the EPA’s enacted level for FY 2012, but it increases spending by $11 million, or approximately 16%, to “protect … Americans from harmful chemicals.”  This increase for chemical assessment and control signals a clear intention to promote regulatory TSCA reform and related efforts in the absence of legislative reform. 

The press release states – “EPA is proposing $68 million, an increase of $11 million from FY 2012, to reduce chemical risks, increase the pace of chemical hazard assessments, and provide the public with greater access to toxic chemical information. Funding will sustain the agency’s successes in managing the potential risks of new chemicals coming into the market and accelerating the progress to help ensure the safety of chemicals on the market that have not been tested for adverse human health and environmental impacts.”

A complete copy of the agency’s budget proposal is available here.

EPA Fines Dover Chemical $1.4 Million for TSCA Violations – But Was EPA Really Looking for an Easy Way to Ban SCCPs?

TSCA Enforcement:

On February 7, 2012, the federal Environmental Protection Agency (EPA) and the Department of Justice (DOJ) announced a settlement with the Dover Chemical Company to resolve alleged violations of the premanufacture notice (PMN) requirements in section 5 of the federal Toxic Substances Control Act (TSCA).  Section 5 requires companies to file a PMN and receive EPA approval before manufacturing a “new” chemical – i.e., one not listed on the TSCA Inventory of existing chemical substances.  EPA accused Dover of failing to file PMNs before manufacturing various chlorinated paraffins at the company’s facilities in Ohio and Indiana.  Although the settlement is noteworthy in demonstrating EPA’s willingness to reinterpret the TSCA Inventory and enforce that reinterpretation, it is perhaps more noteworthy because it suggests EPA is willing to use enforcement as a shortcut to banning substances, as described in the last paragraph of this posting.  A copy of the settlement agreement is available here, and the EPA press release is available here

As part of the settlement, Dover will pay $1.4 million in civil penalties, and the company will stop manufacturing short-chain chlorinated paraffins (SCCPs).  Dover is the only domestic producer of those substances.  In addition, Dover will file PMNs for certain medium-chain and long-chain chlorinated paraffins (MCCPs and LCCPs) in hopes of receiving EPA approval.  Whether the company will receive approval – and if so, under what terms – remains to be seen.

Dover appears to have fun afoul of EPA’s nomenclature guidance and ever-evolving interpretation of the TSCA Inventory.  When EPA first established the TSCA Inventory, the agency arguably required less precision with substance identification.  Over time, however, that has changed.  The agency would certainly disagree, arguing it has been consistent over time, but experience suggests otherwise.  In 1995, EPA published nomenclature guidance – available here – – for complex reaction products, UVCB substances, mixtures, and substances containing varying carbon chain lengths (such as some SCCPs have).  In certain cases, that guidance conflicted with earlier agency statements, requiring some companies to seek Inventory corrections, pursue exemptions or file PMNs for substances they had been manufacturing for years.  Since 1995, EPA has reinterpreted the Inventory status of statutory mixtures and activated phosphors, among others.  It’s almost certain that more changes are on the horizon with the current Administration’s aggressive and expansive use of the TSCA statute.

Perhaps of greatest interest to cynics is the agency’s apparent use of the enforcement mechanism to essentially achieve a ban on SCCPs.  In December 2009, EPA published a Chemical Action Plan for SCCPs , proposing to ban or restrict SCCPs under section 6(a) because the chemicals are thought to be persistent, bioaccumulative, and toxic (PBT), a set of hazard traits that regulatory agencies are particularly concerned about.  The Plan also identified Dover as the only known domestic producer.  According to the settlement agreement, December 2009 was the same month that Dover received a NOV for alleged violations of the PMN requirements for SCCPs and other chemicals.  It is doubtful that this timing was coincidental.  While Dover’s agreement to cease production of SCCPs doesn’t apply to other manufacturers/importers, by shutting down the only domestic production and publicly questioning the Inventory status of many SCCPs, EPA effectively achieved a ban.   This is a cynical conclusion perhaps, but the publicly available facts suggest it’s a reasonable one to draw.  Did EPA initiate enforcement to achieve a result that would have been more difficult to achieve under section 6(a)?  You decide.

EPA Conditionally Registers Nanosilver Pesticide and NRDC Files Blocking Lawsuit

FIFRA/Nanotechnology:

EPA’s Conditional Registration

On December 1, 2011, EPA announced that it was conditionally registering a pesticide product containing nanosilver as a new active ingredient. The antimicrobial pesticide product, HeiQ AGS-20, is a silver-based product for use as a preservative for textiles. As a condition of registration, EPA stated that it would require additional data on the product to confirm EPA’s assessment that the product will not cause unreasonable adverse effects on human health or the environment, the general standard for a registration under the Federal Insecticide, Fungicide, and Rodenticide Act.

By way of background, on August 12, 2010, EPA posted a Proposed Conditional Registration to the docket for public comment. EPA received 45 public comments, and responses to these comments along with the decision document to conditionally register the product can be found at www.regulations.gov in Docket ID # EPA-HQ-OPP-2009-1012. A description of the additional studies and timeline when the data must be submitted is also available in the docket.

NRDC’s Lawsuit

In response to the conditional registration, on January 26, 2012, the Natural Resources Defense Council filed a lawsuit in the 9th U.S. Circuit Court of Appeals, challenging EPA’s decision.  NRDC asserts that there is a lack of data concerning the human health and environmental effects of nanosilver.  The lawsuit seeks to limit public exposure to the nanosilver that EPA registered for use in clothing, baby blankets, and many other textiles.

Verdant will soon post a copy of the NRDC’s legal documents.  Check back soon for these documents and for further commentary on this important development for the nanotechnology community.

California DTSC Releases Public Comments on Informal Draft Green Chemistry Regulations

Green Chemistry Regulations:

The public comment for the latest informal draft version of California’s “Safer Consumer Product Regulations” closed on December 30, 2011.   On January 20, 2012, the implementing agency, the California Department of Toxic Substances Control (DTSC), posted the comments on its website.  DTSC received ninety submissions from a range of stakeholder interests.  More information about the regulations is available here.

US EPA and California DTSC Form Green Chemistry Partnership

Sustainable Products/Green Chemistry:

On January 12, 2012, the US Environmental Protection Agency (EPA) and the California Department of Toxic Substances Control (DTSC) announced their Green Chemistry Partnership.  The agencies’ agreement is memorialized in a Memorandum of Understanding (MOU) that outlines principles by which the agencies will cooperate to reduce toxic chemicals in consumer products, create new business opportunities in the emerging safer consumer products economy, and reduce the burden on consumers and businesses struggling to identify what’s in the products they buy for their families and customers.

The agrement supposedly will allow DTSC and EPA to minimize duplication of effort and promote consistency in their assessment methodologies, potentially providing increased environmental protection. The agreement sets up a framework for the agencies to collaborate on Green Chemistry issues so that California’s innovative “Green Chemistry” program can grow.

Jim Jones, EPA’s acting assistant administrator for the Office of Chemical Safety and Pollution Prevention said:  “This partnership will build and harmonize common tools and practices used to conduct alternative assessments to promote safer products ….  These alternative assessments inform and speed the adoption of safer chemicals for use in products, homes, schools, and workplaces, which produce significant environmental and economic benefits.”

In its press release, EPA said:  “The agreement represents a major advance for Californians looking to buy safer children’s toys, personal care products, household cleaners and other products. By shifting the question of an ingredient’s toxicity to the product development stage, concerns raised by … consumers can be addressed early on. The approach results in safer ingredients, and provides an opportunity for California industry to once again demonstrate its innovative spirit by making products that meet consumer demand throughout the world.”

EPA and DTSC signed the agreement in a ceremony at California’s Kaiser Permanente Sidney R. Garfield Health Care Innovation Center in San Leandro. Kaiser Permanente is nationally recognized as an industry leader in safer products, using its purchasing power and a sustainability scorecard to press suppliers for safer chemicals in medical products. 

FDA Regulation of Nanotechnology

Nanotechnology:

Readers interested in learning about FDA’s regulation of nanotechnology might want to download the free book available here:  FDA REGULATION OF NANOTECHNOLOGY .  Verdant attorney, Philip Moffat, and many others authored the book over the course of the past several years.  This book is a valuable resource to those wanting to learn about regulation in the United States of foods, cosmetics, drugs, medical devices and many other products that have been enhanced with nanotechnology.  Further information about FDA’s role in the regulation of nanotechnology may be found on the agency’s website, here.  Enjoy!

Reminder: Upcoming Workshop on California's Green Chemistry Regulations

Green Chemistry Regulations:

For readers interested in learning more about California’s latest revision of the so-called Green Chemistry Regulations, the Department of Toxic Substances Control (DTSC) is convening a public workshop on December 5, 2011, to discuss the latest proposal.  Details of the workshop are set out below.

________________________________________________________

DTSC: Green Chemistry Initiative

Please join us for the Workshop on Safer Consumer Product Regulations:

December 5, 2011

9:30 a.m. to 3:30 p.m.

Cal/EPA Headquarters Building

Byron Sher Auditorium

1001 “I” Street, 2nd Floor

Sacramento, CA 95814

As a reminder, if you have questions about the informal draft Safer Consumer Product regulations that you would like to have addressed at the workshop, please submit them via e-mail to gcregs@dtsc.ca.gov by November 28, 2011.  You may submit comments or questions in real time during the workshop and, as time allows, DTSC staff will read and respond to them aloud.  Submitting your questions in advance will ensure your questions will be addressed at the workshop.

Additionally, if you plan to speak at the workshop, please let us know by December 1, 2011, via e-mail at gcregs@dtsc.ca.gov.  Include in the e-mail: (1) affiliation, (2) subject of your comments/questions, and (3) the amount of time you are requesting.  This information will assist DTSC staff in planning the workshop and will place you in the speaker?s queue.  Please note, however, that DTSC cannot guarantee that each speaker will get the full amount of time requested. 

The December 5, 2011, Workshop Notice may be found at:

http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Workshop-Notice-10312011.pdf

The regulations and other related documents may be found at:

http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/SCPA.cfm  and http://www.dtsc.ca.gov/SCPRegulations.cfm

Phil Moffat Will Participate on ABA Panel Concerning California's Green Chemistry Regulations

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, titled California Dreaming, Reality, or Nightmare?  California’s New Paradigm in Chemicals and Products Regulation Is Coming to a Store Near You.”  The December 13, 2011, teleconference will discuss the substantially revised 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:

  • Philip Crowley, Assistant General Counsel, Johnson & Johnson, New Brunswick, NJ
  • Dr. Joseph Guth, UC Berkeley Center for Green Chemistry; and the Science and Environmental Health Network, Berkeley, CA
  • Dr. Jeff Wong, Chief Scientist, DTSC, Sacramento, CA
  • Ann Grimaldi, McKenna Long & Aldridge LLP, San Francisco, 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.  The host sites are:

  • 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: Debbie Leitner, (202) 496-7372, dleitner@mckennalong.com

The teleconference will begin promptly at 1:00 pm EasternTime, Tuesday, December 13, 2011, and last for 105 minutes.

  • 1:00 p.m. – 2:45 p.m. Eastern Time / 12:00 p.m. – 1:45 p.m. Central Time
  • 11:00 a.m. – 12:45 p.m. Mountain Time / 10:00 a.m. – 11:45 a.m. Pacific Time

Additional information about the teleconference is available here.

Reminder: Upcoming Meeting of California's Green Ribbon Science Panel

Green Chemistry Regulations:

California’s Green Ribbon Science Panel (GRSP), the expert body established to advise the Department of Toxic Substances Control (DTSC) on green chemistry and the regulation of consumer products, will convene in Sacramento on November 14 (all day) and 15 (morning only) to discuss the latest informal draft of the so-called Safer Consumer Product Alternatives (SCPA) Regulations.  No agenda or other meeting materials have been publicly released at this time, but a copy of the informal draft regulations and related information is available here.