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

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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

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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

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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

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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

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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

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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

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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

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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.

California Releases Informal Draft of the Revised Green Chemistry Regulations

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Green Chemistry Regulations:

On Monday, October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of its revised green chemistry regulations, the so-called “Safer Consumer Product Alternatives (SCPA) Regulations.”  DTSC spent the last year further revising the regulations after some stakeholders decried the proposed final version released for public comment over the Thanksgiving holiday in 2010.  Public comments on the lastest informal draft are due by December 30, 2011.  The formal rulemaking process will begin in 2012.

On Monday DTSC also released a document setting out the most significant changes from the November 2010 version of the regulations. (For purposes of comparison, a summary of the November 2010 version is available here.)  It is clear that DTSC is envisioning a more robust program with shorter timelines and fewer exemptions, ultimately requiring more agency and private resources to implement without a clear benefit from doing so. In light of the poor state of California’s economy, and the relative weakness of the U.S. economy as a whole, one has to wonder why DTSC has chosen its proposed path. According to DTSC, the following are the most significant changes found in the current informal draft. 

Timeframes

(1) Many timeframes have been shortened and/or made more specific.

(2) Timing of initial Chemicals of Concern (COC) list — effective date of the regulations.

(3) Timing of initial Priority Products list — 6 months for the proposed list.

(4) Both the chemicals and products lists will be reviewed at least once every 3 years.

Chemical / Product Prioritization

(1) The regulations will establish an immediate robust (~3,000) list of COCs (which DTSC can add onto later), based on work already done by numerous authoritative bodies.

 (2) The list of hazard traits has been expanded to include all hazard traits and environmental and toxicological endpoints specified by OEHHA. Additionally, the universe of chemicals considered to be carcinogens and reproductive toxins is no longer limited to only those chemicals listed on a short list of lists.

(3) The regulations no longer limit the product categories that DTSC can consider when listing Priority Products during the first 5 years.

(4) Worker exposure has been added as a prioritization factor.

(5) The requirement for responsible entities to provide chemical and product information during the prioritization process has been eliminated. (DTSC will request this information and list anyone who does not provide the information on a Failure to Respond list.)

Alternatives Assessments

(1) The regulations expand the primary responsibility for compliance beyond the product producer to also include: (i) the person who controls the product design; and (ii) the U.S. importer.

(2) The alternatives assessment (AA) process is more specific and structured, but allows for flexibility.

(3) There is no requirement to fill information gaps during the AA — instead DTSC has the option to require this as a regulatory response.

(4) The third-party verification requirement for AAs has been eliminated — instead AAs are required to be conducted by a certified assessor. Also, DTSC will play a greater role in auditing AAs.

Exemptions

(1) The default de minimis level is 0.01% for chemicals with one of 9 specified hazard traits, and 0.1% for all other chemicals — DTSC can set a lower or higher de minimis level.

(2) The exemption for unintentionally-added chemicals has been eliminated. However, these chemicals are a consideration for setting a higher de minimis level.

(3) The “no exposure pathway” exemption has been eliminated. However, exposure potential will still be considered during the chemical/product prioritization process.

Readers wanting more information should check back for future posts on this development, as well as visit the DTSC website. In addition, there will be a public workshop on the draft proposal on December 5, 2011 from 9:30 am to 3:30 pm in Sacramento. The Green Ribbon Science Panel also will dicuss the proposal at the Panel’s meeting on November 14 – 15, also in Sacramento.        

Department of Interior to Issue Rules Requiring Disclosure of Chemicals Used in Fracking

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Right-to-Know/Transparency:

According to Reuters, on Monday, October 31, 2011, Deputy Secretary of the Department of the Interior (DOI), David Hayes, told the Department of Energy’s shale-gas advisory panel that DOI will issue rules “in a couple of months” requiring the disclosure of the chemicals used in hydraulic fracturing or “fracking” on federal lands.  Fracking is the controversial technique that involves injecting a mixture of water, sand, and chemicals into shale formations at high pressures to extract oil and gas.  Recent technological advances have facilitated greater use of the technique leading to concerns about potential water contamination and air pollution.  The well-known documentary, “Gasland,” purported to document some of the environmental harm resulting from improper use of the technique.  DOI hopes that greater transparency will increase accountability while fostering public confidence.  The Department’s decision is consistent with other initiatives the Obama Administration, particularly through EPA, has undertaken to increase public access to information on chemicals, placing confidential business information at risk.

Reuters reports that about 14 percent of all U.S. natural gas production occurred on federal land during the last fiscal year. DOI supposedly estimates that fracking is used for about 90 percent of gas wells drilled on public lands.  Accordingly, only a fraction of wells in the U.S. would be affected by the rules.   Implicit in the Department’s decision to require disclosure is the reasonable assumption that the same chemicals will be used on both public and private lands subsequent to the rule’s implementation.  By disclosing those used on federal lands, stakeholders will have insight into those used on private lands thereby gaining confidence in the fracking process.  Moreover, several states have disclosure rules in effect or under development.

According to Reuters, DOI’s announcement is part of a larger effort by the Obama Administration to regulate hydraulic fracturing in a way that instills confidence without over-burdening the industry.  Last week, EPA announced that it will promulgate rules for disposing of wastewater from shale gas wells.  Additional information about the Administration’s initiatives is available here and here.  Information from the American Petroleum Institute and others is available here.