EPA Proposes TSCA SNUR for Certain Perfluorinated Chemicals

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TSCA:

On August 8, 2012, EPA signed a proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) to:

  • Require companies to report 90 days in advance of all new uses of long-chain perfluoroalkyl carboxylic (LCPFAC) chemicals as part of carpets or to treat carpets, including the import of new carpet containing LCPFACs;
  • Add seven perfluoroalkyl sulfonate (PFAS) chemicals to the existing PFAS SNUR (40 CFR 721.9582), and amend that SNUR to include “processing” in the definition of significant new use for PFAS chemicals.

The following is a link to the pre-publication copy of the proposed SNUR:

http://www.epa.gov/oppt/pfoa/pubs/PrePublication_LCPFC-SNUR_NPRM_2012-08-07.pdf

Comments on the proposed SNUR are due 60 days after the SNUR is published in the Federal Register. For more information, see EPA’s website

TSCA Reform Bill Headed to Full Senate

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TSCA Reform:

On July 25, the U.S. Senate Committee on Environment & Public Works passed a 174-page, substantially revised version of Senator Lautenberg’s 2011 Safe Chemicals Act (S.847).  The bill was approved along party lines, with all Republicans voting against it.  It will now move to the full U.S. Senate for consideration.  Since the bill moved out of committee, we are aware of no meaningful progress toward passage of the bill on the floor of the full Senate.  Moreover, it is unlikely that a companion bill will be passed in the U.S. House of Representatives prior to the November election.  Therefore, we continue to anticipate meaningful TSCA reform efforts in 2013, but not before then.  We also expect this amended bill to remain a focal point of future negotiations in both houses.

  • Summary of Proposed Changes – Although the bill would make significant revisions to the current TSCA statute, the law’s scope would remain largely unchanged in terms of persons and chemicals subject to regulation, as well as the range of risk management measures available to EPA.  Compared to the existing statute, the bill would increase the regulatory burden of “processors,” making them subject to requirements similar to those imposed on manufacturers (e.g., notifications, risk management).  Compared to the prior version of the bill, this version places greater reliance on existing information before requiring new data and information to be generated in a targeted manner as part of a tiered evaluation process.  It limits the number of substances that must undergo a full safety determination.  It also provides greater protection for confidential business information than the last version.  Below is a short summary of some of the more noteworthy changes.
    • Inventory Reset – Manufacturers and processors would submit declarations of current or potential commercial interest in “existing” chemical substances (i.e., those on the current TSCA Inventory), and EPA would use the declarations to establish an “Active” and an “Inactive” Inventory.  The Active Inventory would list substances for which EPA received declarations of current commercial interest (basically manufacturing/ processing at the time of the new law’s enactment).  The Inactive Inventory would list substances that might be used as a substitute for a substance currently manufactured or processed.  Substances would be eliminated from the Inventory if no declaration was submitted.
    • New Chemicals Notification and Categorization – Pre-manufacturing notices (PMN) would be required for substances not on either the Active or Inactive Inventory.  (Certain exemptions would be available, but it does not appear the “articles” exemption would be based on its absence in the prior version or the current amendment.  Many of the exemptions would require some form of notification to EPA.)  More substantial data and information requirements would apply than under the current statute, even though “existing information” would be used initially.  EPA would “categorize” substances and impose data generation requirements on substances in some of the categories. The five categories are listed below.
      • Substances in the “SVHC category” would be PBTs and those that are “highly hazardous.”  They could not be manufactured or processed except under very limited circumstances requiring an exemption application (e.g., critical uses).  These would not be added to the either Inventory.
      • “Substances to Undergo a Safety Determination” would be set into one of three “Priority Classes” and then undergo a risk assessment to confirm that their manufacturing, processing, use (including in articles), etc., would meet the safety standard discussed below.  Risk management measures could be imposed in order to meet the standard.  These substances would be added to the Active Inventory while awaiting assessment because it’s anticipated that they would satisfy the standard.
      • “Substances of Very Low Concern” are not subject to risk management, and would not undergo further evaluation unless new information arose indicating a change was necessary.  They would be added to the Active Inventory.  They would be considered to have “intrinsic low-hazard properties.”
      • “Substances with Insufficient Information” would need certain data submitted and could not be manufactured or processed until the EPA had re-categorized the substance into one of the other categories.
      • “Substances Unlikely to Meet the Safety Standard” could not be manufactured or processed except under very limited circumstances requiring an exemption application. These would not be added to the either Inventory.
    • Existing Chemicals Notification Requirements – Existing chemicals would be subject to certain advance notification requirements.  Again, the “articles” exemption appears unavailable.
      • Substances on the “Inactive Inventory” would require certain limited data and other information to be submitted before manufacturing or processing could occur. 
      • Substances on the “Active Inventory” that had not undergone a safety determination would require advance notification before (1) engaging in a use not ongoing at the time of the law’s enactment or (2) substantially increasing the volume of a substance.  A submission akin to the current significant new use notification (SNUN) would be required – again certain existing data, etc., would be provided to EPA beforehand. 
      • Substances on the “Active Inventory” that had undergone a safety determination would require advance notification before undertaking a use that was not included in the determination.  The applicant would have to establish with data that the use would also comply with the standard.  EPA would impose any new risk management measures that might be necessary to meet the standard.
    • Existing Chemicals Categorization – Every five years, EPA would select a “batch” of approximately 6,000 existing chemicals.  It would then place them into “categories” very similar to the ones identified above for new chemicals.  Substances identified for safety standard determinations would be placed into one of three different “priority” classes and then reviewed. EPA might require data generation to categorize or a substance or to conduct the safety standard determination.  Risk management measures could result – again, SVHCs would be subject to expedited and highly restrictive risk management, but certain limited exceptions would be available.  Other substances unable to meet the safety standard would be banned except for under limited circumstances (e.g., critical uses).
    • Safety Standard – The safety standard proposed remains very rigorous and controversial.  It’s the same standard found in the Food Quality Protection Act.  Based solely on considering human health and the environment, including vulnerable populations, EPA must determine whether “there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.”  The burden of proof rests on the company, however.  Use in “articles” must meet the standard as well.
    • Confidential Business Information – EPA would place information into one of three categories – (1) always eligible for protection, (2) never eligible, and (3) sometimes eligible.  Most eligible information would be protected for 5 years, with a possible extension for another five years.  Certain sensitive information would receive indefinite protection.  Severe penalties would be imposed for release of protected information or for claiming protections that were unwarranted.
    • Preemption of State Laws – the bill does not include a robust preemption provision. 

A copy of the amendment to the bill is available here Final-Amendment-to-S.-847[1].  The original version is available here BILLS-112s847is.  Senator Lautenberg’s summary is available here.  And a webcast of the committee hearing is available here.

TSCA Fines Announced

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EPA issued a News Release Monday July 23 announcing fines for violations of TSCA’s recordkeeping and reporting requirements.

The announcement details the following settlements:

  • Haldor Topsoe, Inc., paid $202,779 to settle a complaint that it had violated the 2006 IUR rule for 13 chemical substances.
  • Chemtura Corporation paid $55,901 to settle a complaint that its El Dorado, Arizona facility failed to report two chemicals pursuant to the 2006 IUR rule.
  • Bethlehem Apparatus Company paid a $103,433 to settle a complaint that it had failed to comply with import certification and export notification requirements, and that if also failed to meet 2006 IUR requirements for one chemical substance.

See below for the full News Release.

WASHINGTON – The U.S. Environmental Protection Agency (EPA) has issued complaints seeking civil penalties against three companies for alleged violations of the reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA). The alleged violations involved the companies’ failure to comply with EPA’s TSCA section 8 Inventory Update Reporting (IUR) regulations, which require companies to submit accurate data about the production and use of chemical substances manufactured or imported during a calendar year. Under TSCA, penalties can be assessed up to $37,500 per day, per violation.

Formerly known as the IUR, the TSCA Chemical Data Reporting Rule requires the collection of information about existing chemicals on the market by requiring periodic reports about the production and use of chemicals to help understand the risks they may pose to human health and the environment. The data collected by EPA is the most comprehensive source of information for chemicals currently in commerce in the U.S.

The reporting deadline for the 2006 IUR rule ended in March of 2007. EPA’s enforcement efforts have led to 43 civil enforcement actions and approximately $2.3 million dollars in civil penalties against companies that failed to report required chemical data information. The reporting deadline for the 2012 submission period of the Chemical Data Reporting Rule is August 13, 2012.

The three most recent cases are against Chemtura Corporation, Bethlehem Apparatus Company, and Haldor Topsoe, Inc., and resulted in penalties totaling $362,113.

The Chemtura Corporation is headquartered in Philadelphia, Pa. and has a facility located in El Dorado, Arizona. In a May 31, 2012 complaint, EPA alleged that the facility failed to report two chemicals pursuant to the 2006 IUR rule and assessed a penalty of $55,901. The company corrected the violations, paid the penalty and a final order was issued by the Environmental Appeals Board (EAB) on June 25, 2012.

During an inspection of the Bethlehem Apparatus Company, located in Hellertown, Pa., EPA found that the facility was in violation of the 2006 IUR Rule for one chemical substance. EPA also determined during the inspection that the company had failed to comply with the export notification requirements as required under TSCA section 12(b) and the import certification requirements as required under TSCA section 13 on a number of occasions for the same chemical substance. The company corrected the violations and paid a $103,433 penalty proposed in a May 31, 2012 complaint.

Haldor Topsoe, Inc., headquartered in Houston, Texas, is subject to a TSCA complaint that was filed on June 20, 2012. The complaint alleged that that the company had violated the 2006 IUR rule for 13 chemical substances. The complaint assessed a proposed penalty of $202,779, which the company paid on July 2, 2012.

More information about the settlements and EPA’s TSCA enforcement program: http://www.epa.gov/compliance/resources/civil/tsca/tscaiur.html

More information about TSCA reporting requirements: http://www.epa.gov/iur/

 

Update on TSCA "Reform" – The Summer of Bipartisan Consensus?

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TSCA Reform:

Whether you think the Toxic Substances Control Act (TSCA) needs to be “reformed,” “modernized,” “updated” or simply left alone, you’re probably interested in knowing where Congressional efforts to amend the statute currently stand.  Here’s a short update, which is based on our latest understanding.  If others have additional details or insights, please feel free to share them with us here at Verdant Law.

Supposedly Senator Lautenberg (D-NJ) has agreed to set aside his current version of the Safe Chemicals Act (S.847) and attempt to achieve consensus with his Republic colleagues on the Environment and Public Works (EPW) Committee.  Although Senator Lautenberg introduced S.847 in 2011 and has not introduced a similar version in 2012, the bill has remained somewhat of a centerpiece in the negotiations with other EPW Committee members. 

While Senator Lautenberg is the leading Democratic negotiator, Senator David Vitter (R-LA) is leading the Republicans’ efforts.  Senators James Inhofe (R-OK, Ranking Committee Member), Mike Crapo (R-ID, Ranking Subcommittee Member), and Lamar Alexander (R-TN) are also playing key roles. 

Negotiations are supposed to continue over the summer.  Around Labor Day, the parties will decide whether to attempt a bipartisan markup of S.847 in Senator Lautenberg’s Superfund, Toxics, and Environmental Health Subcommittee, whether a markup is premature but negotiations should continue, or whether to terminate further negotiations for the remainder of the year.  Presumably if negotiations terminate, Senator Lautenberg might reintroduce S.847 and attempt passage in the last weeks of the current congress.  Republicans would probably oppose it, but may not be in a position to introduce a viable competing bill.

We at Verdant Law think it’s highly unlikely that consensus will be achieved and a bill passed and signed into law before the November election.  However, perhaps this summer’s efforts will point the parties in a direction that eventually leads to a workable solution.  (One can dream, right?)   Stay tuned.

EPA Announces More Muscular Use of TSCA Section 6

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TSCA/Section 6 restrictions:

June 7, 2012 Jim Jones, Acting Administrator, Office of Chemical Safety and Pollution Prevention, announced that EPA plans to use TSCA §6 to ban or restrict the use of chemicals that pose an unreasonable risk.  This is an extension of the Administrator’s 2009 Comprehensive Approach to Enhance the Agency’s Current Chemical’s Management Program.  At that time, the Agency announced a renewed focus on identifying chemicals of concern and initiating appropriate risk management, including regulatory action to restrict or ban chemicals.  Jones’ Office explained that the agency intends to use its existing authority to the best of its ability until Congress enacts TSCA reform.  It noted that TSCA reform is one of the Administrator’s highest priorities.

Jones statement was made at the Environmental Council of the States’ State Environmental Protection in 2012 forum.  He spoke extemporaneously.  For further information, Jones’ Office recommends reviewing the Comprehensive Approach and the Administrator’s Essential Principles for Reform of Chemicals Management Legislation.  See also the Administrator’s September 2009 remarks announcing both efforts.

New TSCA Work Plan Chemicals

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TSCA/Work Plan for Existing Chemicals/Chemical Risk Assessment

June 1, 2012 EPA announced the addition of 18 chemicals to its work plan for existing chemicals risk assessment. The 18 chemicals include flame retardants, fragrance chemicals, and chlorinated hydrocarbons.  Many of these chemicals are potentially carcinogenic, or pose reproductive or developmental toxicity.  In addition, some of these chemicals present persistent, bioaccumulative, and toxic potential or are found in consumer products.  New and existing work plan chemicals are listed on EPA’s website.

As part of the Agency’s strategy to manage existing chemicals (see EPA’s Existing Chemicals Program Strategy (PDF), EPA has been screening chemicals against risk criteria (see e.g., Identifying Priority Chemicals for Review and Assessment).  Chemicals are likely to be flagged for further review and assessment if screening indicates:

  • children’s health effects (e.g., chemicals with reproductive or developmental effects);
  • persistence, bioaccumulation, and toxicity (PBT);
  • carcinogenic effect ;
  • presence in children’s products;
  • presence in consumer products; and
  • detection by biomonitoring programs. 

In the June 1 announcement, EPA solicited unpublished health and safety studies on these chemicals.  Research should be submitted to docket EPA-HQ-OPPT-20110-516 by August 31, 2012. Health and safety studies comprise “any study of any effect of a chemical substance or mixture on health or the environment or on both,” including but not limited to:

  • Epidemiological or clinical studies;
  • Studies of occupational exposure;
  • In vivo and in vitro toxicological studies; and
  • Ecotoxicological studies;

Risks assessments on the new work plan chemicals will be conducted in 2013 and 2014.

EPA Denies TSCA Petition for Banning Lead Fishing Tackle

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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

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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?

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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.

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.