EPA finalizes withdrawal of TSCA § 8(d) reporting rule for cadmium

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TSCA:

As we previously reported, EPA announced that it would withdraw its TSCA § 8(d) final rule requiring manufacturers of cadmium or cadmium compounds to report certain unpublished health and safety studies. Today, EPA released the pre-publication version of the final rule withdrawing the December 3, 2012 reporting rule. The reporting rule for cadmium was withdrawn due to “significant confusion…in certain industrial sectors subject to the final rule,” including uncertainty about which industries were subject to the rule.

EPA’s action today is based on the agency’s conclusion that the commenters’ concerns constitute good cause to withdraw the reporting rule without prior notice and comment per the Administrative Procedures Act. Likewise, because the withdrawal does not impose any new requirements, EPA found that the action is not subject to any Executive Orders (such as E.O. 12866, “Regulatory Planning and Review”), nor is it subject to the requirements of the Regulatory Flexibility Act or Title II of the Unfunded Mandates Reform Act. Per the Congressional Review Act (“CRA”), EPA will submit the withdrawal document along with other required information to Congress and the Comptroller General. Following section 808 of the CRA, the withdrawal rule will take effect early, on January 2, 2013.   A draft copy of the Federal Register notice is available here:  Prepublication_Cadmium-FRM-Withdrawal_2012-12-20[1].

EPA Withdraws Immediate Final TSCA 8(d) Rule for Cadmium

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TSCA:

On Friday, December 14, Wendy Cleland-Hamnett, Director of the Office of Pollution Prevention and Toxics (OPPT), announced the U.S. Environmental Protection Agency’s (EPA) decision to withdraw the Toxic Substances Control Act (TSCA) section 8(d) immediate final rule published on December 3, 2012.  In its announcment the agency said: “Based on several letters asking questions and raising concerns about the scope and extent of the immediate final rule that indicate that there is significant confusion and uncertainty within certain industrial sectors concerning the rule, EPA has decided to withdraw the immediate final rule.” EPA will announce the withdrawal in the Federal Register, no later than January 2, 2013, the original effective date of the final rule. 

EPA  also said that it “will be considering the questions and concerns raised in response to the immediate final rule and next steps with regard to this rule. EPA will also continue to work with the Consumer Product Safety Commission (CPSC) to reduce exposure to cadmium in consumer products generally, and especially those consumer products used by or around children, such as children’s metal jewelry.”

More information about this development is available at the agency’s website here.  Information about section 8(d) is available here.

CBO Estimates Senator Lautenberg's TSCA Reform Bill Would Cost $128 Million over the Next Five Years

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TSCA Reform:

On Tuesday, October 2, the Congressional Budget Office published its evaluation of the costs of implementing the amended version of S.847, The Safe Chemicals Act of 2011, which is Senator Lautenberg’s latest attempt to amend the federal Toxic Substances Control Act (TSCA).  Readers will recall that the Senate Committee on Environment & Public Works passed the amended bill on July 25, sending it to the full Senate for a vote.  Our blog post on that version of the bill is available here.

The CBO press release says the following:

“S. 847 would modify the Toxic Substances Control Act (TSCA), the law that regulates the manufacture, importation, and processing of chemicals, with the aim of shifting the burden from the Environmental Protection Agency (EPA) to chemical manufacturers to prove that substances are safe before they enter the marketplace. This new responsibility for chemical manufacturers would be accomplished primarily by increasing the amount of information about chemical toxicity and usage that they would be required to submit to EPA. Enacting this legislation also would require EPA to undertake other activities that would encourage and support the development of safer alternatives to existing hazardous chemical substances.

CBO estimates that implementing this legislation would cost $128 million over the next five years, assuming appropriation of the necessary amounts, as EPA would incur additional administrative costs to meet the new requirements imposed by S. 847.

Enacting S. 847 could affect direct spending and revenues because the bill would increase some existing civil and criminal penalties for violations of TSCA, establish some new civil and criminal penalties for violations related to that act, and authorize EPA to charge fees to chemical manufacturers. Therefore, pay-as-you-go procedures apply to S. 847. CBO estimates that any changes in revenues and direct spending would not be significant.

A copy of the CBO report is available here.

EPA Publishes the Peer Review Plans for the Risk Assessments on the Seven 2012 Work Plan Chemicals

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TSCA:

Today, August 17, 2012, EPA published the Peer Review Plans for the risk assessments on the seven 2012 work plan chemicals. The plans, which form part of the Agency’s Peer Review Agenda, describe the focus of the risk assessment being conducted on each chemical, indicate how peer reviewers will be selected and how the peer review will be conducted, and provide the time line for the reviews. As indicated in the plans, EPA will publish a notice in the Federal Register when the External Review Drafts of the assessments become available, and will provide a 60-day period for public comment on the drafts before the peer review begins. The public will also be able to present comments at the teleconference panel review meetings. You can access and submit comments on the individual peer review plans for each chemical by using the following links:

EPA to Post List of Chemicals Acceptable for DfE-labeled Products

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Design for the Environment (DfE) / Green Chemistry:

EPA’s Design for the Environment (DfE) team announced today that, in September, it will post on the agency’s website a list of chemicals that are acceptable for use in DfE-labeled products.   Questions or comments about the proposal should be submitted to EPA by August 24, 2012.  The contact at DfE is Bridget Williams (williams.bridget@epa.gov).

As readers know, over the years many DfE stakeholders have requested that EPA issue a list of safer chemicals.  According to the agency’s press release, EPA’s intent is for the list to serve as a resource for product formulators and consumers, to increase understanding of the DfE Safer Product Labeling Program and the types of chemicals in DfE-labeled products.  The list is also intended to enhance the dialogue on safer chemicals and products.  

EPA is compiling its list from the ingredients in DfE-labeled products, as well as from chemicals eligible for use in labeled products – i.e., chemicals that meet the DfE criteria. The chemicals will be identified by their specific chemical name and Chemical Abstract Service (CAS) number and grouped by functional class—surfactants, solvents, etc. (chemicals with more than one common functionality may be listed in multiple classes).

A color code will appear next to each chemical to indicate its safer chemical status.  A green circle will appear next to chemicals that have met the DfE component-class criteria; a green/yellow square next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but are missing some experimental data on potential hazards; and a yellow triangle next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but have unresolved hazard profile issues.

No other information about the chemical—not its source, manufacturer, or use; association with a trade name product, percentages in formulation, etc.—will appear in the listing. EPA intends to include on this list the ingredients in third-party formulations sold by manufacturers to DfE participants, and will likewise not associate those ingredients with specific products. Also, no chemicals on the confidential portion of the Toxic Substances Control Act Inventory will be included in the listing.

According to the agency’s press release, the DfE list will complement the Green-Blue Institute’s CleanGredients database (www.cleangredients.org), which will continue to serve as a marketplace for chemicals that are acceptable for use in DfE-labeled products and provide trade name chemicals, physical-chemical and functional properties, hazard information, vendor contacts, and other information.

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.