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.

ECHA Publishes the 2011- 2013 Work Program of the REACH and CLP Enforcement Forum

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REACH/CLP Enforcement:

On July 6, 2011, the European Chemicals Agency (ECHA) published the 2011 -2013 work program for the Forum on Exchange of Information on Enforcement of the REACH and CLP Regulations.  The program lists the Forum’s current and upcoming activities, a description of the activities, the expected time frame for each, and its priority.  Readers less familar with the REACH and CLP Regulations should know that the Forum coordinates a network of authorities responsible for enforcement of the regulations in each country or “Member State.”

Very high priority activities for the work period include the follwing: 

  • EU-wide coordinated REACH Enforcement Projects (REFs) such as the coordinated project concerning downstream user obligations of formulators of mixtures;
  • clarification of the links between ECHA, Member State competent authorities and Member State enforcement authorities;
  • access to REACH-IT by Member State enforcement authorities;
  • cooperation with customs authorities, including execution of a coordinated enforcement initiative; and
  • preparation of advice concerning the enforceability of REACH restriction proposals.

In addition, new rules of procedure for the Forum adopted at the recent ECHA Management Board meeting are published, along with minutes of the Forum meeting held in March of this year. 

Copies of the documents are avaialble here.

Pesticides, Nanoscale Materials, and FIFRA

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FIFRA/Nanotechnology:

Guest Column: 
Kathryn Brausch & Irene Hantman
Law Clerk & University of Maryland Law Fellow
US EPA Office of Civil Enforcement
 

Readers interested in EPA’s regulation of nanoscale materials may want to know about recently proposed policies under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that would affect the use of nanoscale materials in pesticide products.   

On June 17, 2011, EPA published a Federal Register notice (76 FR 35383), requesting comments on two alternative approaches for obtaining information on nanoscale materials, both active and inert ingredients, used in currently registered pesticide products.  The Agency also requested comments on a proposal that would affect the classification of registration applications for pesticide products containing nanoscale materials.  An overview of these proposals, and a summary of their scientific basis, is set out below.

The Scientific Basis

In the Federal Register notice, the Agency reviews the growing body of scientific evidence concerning the human health and environmental hazards of certain nanoscale materials, some of which are used in pesticide products.  After reviewing the evidence, EPA concludes that it indicates that significant differences exist between many nanoscale materials and their non-nanoscale counterparts.  Although some of the differences have beneficial applications, some of them pose new or increased hazards.  EPA reasons that these potential “new” hazards warrant further regulatory scrutiny.

The Alternatives for Collecting Information

The scientific evidence has led EPA to conclude that collecting information from registrants of existing pesticide products is relevant to the Agency’s statutory obligation.  Under FIFRA, EPA has a statutory obligation to determine whether the registration and use of a pesticide may cause unreasonable adverse effects on the environment or human health.  This finding is required for “each and every pesticide product, regardless of whether another pesticide product with the same or similar composition and use patterns is already registered.”  Thus, according to EPA, the presence of a nanoscale material in a pesticide formulation provides a sufficient basis for the Agency to request additional information that may be used to characterize potential risks that may not have been considered when the pesticide was originally registered.  Although the presence of nanoscale materials is sufficient to justify the proposed requests for information, the Federal Register notice stresses that the presence of a nanoscale material is not, by itself, an indicator of potential adverse effects.  However, EPA will use the information it receives from registrants to assess whether additional data are necessary to support continuing the registration and whether amending a registration is necessary to prevent such adverse effects.    

According to the proposed policy, EPA would use one of the two alternative processes summarized in the bullet-points below to collect the data and other information needed.  The process would apply to both active and inert nanoscale ingredients.  

— Under one alternative, EPA would formally announce that ‘reportable’ information required under FIFRA §6(a)(2) includes information on the presence of nanoscale materials. Following the formal policy announcement, any registrant with such information would have 30 days to submit it to EPA.  Specifically, each registrant that knew it had a registered product containing a nanoscale material would provide existing information concerning:  (1) the identity of the affected product; (2) the identity of the nanoscale materials in the product; (3) the size or size distribution of the nanoscale materials; (4) the manufacturing process used to produce them; (5) the size and size distribution of the composite matrix, if any, containing the materials; and (6) the data showing adverse effects at any level of exposure, and the nature and levels of human and environmental exposure.  This alternative has proven controversial because section (6)(a)(2) concerns “adverse effects” reporting – members of the nanotechnology community therefore worry that use of this section would create a stigma for all nanoscale materials used in pesticide products.

— Under a second alternative, EPA would issue data call-ins under FIFRA §3(c)(2)(B) to specific groups of registrants. The scope of information collected would potentially be the same under this alternative as it would be under the other one, but registrants would be given 90 days to respond.  EPA could also request the generation of new data and information, which it cannot request under the other alternative.  Moreover, the burden on industry and EPA would increase.  Typically, registrants that receive such data call-in requests are required to respond even when they don’t have the requested information. And EPA would have to track its requests to identify non-responders warranting enforcement. 

Under either alternative, EPA would use the information it received to determine whether additional data needs to be generated or whether a registration should be cancelled or amended to prevent unreasonable adverse effects. 

The New Classification of Applications

EPA also announced a policy affecting the classification of applications seeking to register pesticide products containing nanoscale materials.  Under the new approach, EPA would presume that active or inert nanoscale ingredients are potentially different from non-nanoscale versions of those ingredients that were previously registered.  EPA also would presume that one nanoscale version of an ingredient is potentially different from another, already-registered nanoscale version of the same ingredient.  Based on these presumptions, EPA would initially classify all such applications as applications for “new” ingredients, increasing the application fee, the time EPA has to review the application, and the amount of information it may require.  An applicant could overcome the presumption by proving that the nanoscale version to be registered is sufficiently similar to the registered version or differs only in ways that do not significantly increase the risk of unreasonable adverse effects or require different registration terms or conditions.  If successful, EPA would review the application in a shorter timeframe and allow the applicant to rely on the data from the previous registrant, subject to appropriate compensation where required.

This proposed policy also has significant compliance implications.  Specifically, a company would potentially violate the registration requirements by substituting nanoscale ingredients for non-nanoscale ingredients without first notifying EPA and receiving Agency approval.  Assuming the policy is finalized, it is clear that substitutions occurring after the policy announcement would face a significantly increased risk of having violated the registration requirements.  However, the Federal Register notice is less clear with respect to the legal implications of substitutions that occurred before announcement of the new policy — such substitutions might be considered potential violations of the registration requirements or the section 6(a)(2) reporting requirements.

 * * * *

Once adopted, the policies announced in the above-cited Federal Register notice are likely to be the first of many policies EPA develops to address the use of nanoscale materials in consumer products and other product types.  Accordingly, those using such materials should be prepared for additional inquiries about their use of such materials and their potential effects.

 DISCLAIMER: This work is not a product of the United States Government or the United States Environmental Protection Agency. The views expressed are those of the authors only and do not necessarily represent those of the United States or the US EPA.

 

EU Environmental Law Group Releases Reports on Member State Implementation and Enforcement of REACh

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REACh:

The EU public interest environmental law group, ClientEarth, recently released a series of progress reports summarizing Member State activities under the European Union (EU) regulation: Registration, Evaluation, and Authorisation of Chemicals (REACh).  Each report reviews a different Member State’s efforts to implement and enforce REACh.  Reports also are available for three non-Member State countries that have enacted REACh – Lichtenstein, Norway, and Iceland.

The reports are essentially responses to a lengthy questionnaire from the European Commission.  Activities reviewed include communications between Member State authorities and EU authorities, such as the European Chemicals Agency (ECHA); operation of the national helpdesks; development and promotion of alternative test methods; participation on REACH committees; evaluation of substances; preparation of Annex XV dossiers; and details concerning enforcement-related activities, such as inspections and the imposition of sanctions.  The reports may prove useful to companies wanting insight into the level and types of enforcement activity occurring within the countries regulating their operations.

ClientEarth received the reports through a public records request, insisting that their broad dissemination was necessary “so that [the public] can know if REACH is really working.” (Critics probably think they know the answer already.)  The reports are available here.