Tag Archive for: Enforcement

EPA Announces FIFRA/TSCA Settlements with Finland-Based Kemira Group

TSCA/FIFRA Enforcement:

EPA continues to steadily increase its enforcement of U.S. chemical control laws.  Last Thursday, the EPA announced settlements with two subsidiaries of the Finland-based Kemira Group to resolve alleged violations of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substance Control Act (TSCA). Kemira Chemicals agreed to pay a civil penalty of over $300,000 to settle claims that the company sold and distributed unregistered and misbranded pesticides, and violated pesticide production reporting requirements. Kemira Chemicals also agreed to correct the alleged violations.

In addition, Kemira Water Solutions agreed to pay a civil penalty of over $500,000 regarding violations of TSCA’s Inventory Update Reporting (IUR) rule during the 2006 reporting period. Under the IUR rule, manufacturers and importers of substances included on the TSCA Chemical Substances Inventory must report the production volume and location of each facility processing such chemicals; this information is used to develop risk-screening and assessment. EPA discovered Kemira Water Solutions’ reporting violations following a January 2012 inspection and the company has since submitted the required information.

Verdant Settles EPCRA Enforcement Matter for New Cingular Wireless

EPCRA:

Verdant is pleased to announce that it helped its client, New Cingular Wireless, reach a favorable settlement with EPA over a longstanding EPCRA enforecement matter involving legacy facilities owned by a predecessor company.  A copy of EPA’s press release is embedded below. 

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WASHINGTON – The U.S. Environmental Protection Agency (EPA) and New Cingular Wireless (NCW) have reached an administrative settlement requiring the company to pay a civil penalty of $750,000 and spend $625,000 on environmental projects to resolve alleged reporting, planning and permitting violations at 332 legacy AT&T Wireless (AWS) sites now owned by NCW.

The violations, which occurred at AWS sites in 43 states, such as cellular towers, transmitter sites, switching stations and warehouses, included failure to comply with Emergency Planning and Community Right-to-Know Act (EPCRA) reporting requirements related to the presence of sulfuric acid and diesel fuel at sites, inadequate or no Clean Water Act (CWA) Spill Prevention, Control, and Countermeasure (SPCC) Plans, and Clean Air Act (CAA) minor source permitting requirements.

The EPCRA requirements help communities plan for emergencies involving hazardous substances, the CWA’s SPCC rule requires facilities to have oil spill prevention, preparedness, and response plans to help prevent oil discharges to navigable waters and adjoining shorelines, and the minor source permitting requirements under the CAA ensure that air emissions limits are met.

Under the settlement, NCW will provide a certification of EPCRA compliance at 1,356 sites and conduct comprehensive compliance audits of CAA and CWA/SPCC requirements at 1,361 and 41 legacy-AWS facilities, respectively. NCW has also agreed to pay stipulated penalties for all disclosed and corrected violations discovered through these audits.

NCW has also agreed to conduct environmental projects, which will provide hazardous materials awareness and health/safety training to building inspectors and fire fighters. The projects will also support the procurement of emergency response equipment such as fire-fighting equipment, gas meters, hazmat identification equipment, satellite phones and other emergency communications equipment. The seven entities, located in four states that will benefit from the projects are: Palm Beach County Fire Rescue and Georges Lake Volunteer Fire Department, Putnam County, Fla., New York City Fire Department, N.Y., Yancey, Texas Volunteer Fire Department, Texas, and San Diego, County California Office of Emergency Services, Bodega Bay, California Fire Protection District, and Los Angeles, California Police Department Calif.

Since 1998, nearly 6,000 telecommunications facilities have been brought into compliance through more than 30 settlements as part of EPA’s effort to improve compliance in the telecommunications sector.

More information on the New Cingular Wireless settlement: http://www.epa.gov/enforcement/waste/cases/att.html

EPA Undertakes FIFRA Enforcement Initiative Against Companies Selling Alleged Plant Growth Regulators

FIFRA Enforcement:

On September 13, 2012, EPA issued a press release announcing three enforcement actions the agency recently settled against Missouri pesticide distributors under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  EPA alleged the distributors violated FIFRA by selling and distributing unregistered and misbranded pesticides. All three cases involved the sale and distribution of “plant growth regulators,” which are regulated as “pesticides” under FIFRA.  (Readers are forgiven for not knowing that plant growth regulators, several of which are natural and found in seaweed, are pesticides under FIFRA.)  Although the agency’s press release doesn’t mention it, the enforcement actions appear to be part of a broader, “under-the-radar” initiative against companies producing growth regulators, many of which are marketed as “biostimulants” or “fertilizers,” and not “pesticides.”

FIFRA defines plant growth regulators as substances intended to accelerate or retard the growth of plants.  Among other things, substances considered to be plant regulators may include hormone additives intended to stimulate plant root growth or fruiting, such as gibberellins, auxins, and cytokinins derived from seaweed. Products containing these additives are often marketed as fertilizers or biostimulants, but EPA says such claims do not exempt the products from regulation as pesticides.

The three settlements are summarized below, but others are pending within EPA and we suspect the agency is pursuing investigation of still more.

  • On June 14, 2012, FIFRA-07-2012-0015, Mayberry Seed Company of Essex, Missouri, agreed to pay a $17,160 penalty to resolve violations of FIFRA. EPA alleged that Mayberry distributed or sold an unregistered plant growth regulator and fungicide on at least 14 occasions between April 1, 2010, and August 25, 2011.

  • On July 5, 2012, Southeast Cooperative Service Company, Inc., of Advance, Missouri, agreed to pay a $12,000 civil penalty to resolve multiple sales of an unregistered plant growth regulator and fungicide to at least four individuals between April 1, 2010, and August 21, 2010.

  • On Sept. 4, 2012, FIFRA-07-2012-0029, AgXplore International, LLC, of Parma, Missouri, agreed to pay a $237,573 civil penalty to resolve violations of FIFRA, including 212 counts for the sale or distribution between May 7, 2009, and March 25, 2012, of 19 different unregistered pesticide products, including plant regulators, insecticides, and fungicides. AgXplore International, LLC has informed its customers and distributors of its violative products.

Under FIFRA, distributors of pesticides must ensure that pesticides intended for distribution within the U.S. are registered both if the distributor claims the substance can be used as a pesticide or if the product is intended to be used for a pesticidal purpose, including as a plant regulator.

Many plant growth regulator products are properly registered with EPA. Companies which comply with pesticide registration requirements must pay registration fees and may also incur significant costs in ensuring their products are correctly formulated, perform as intended, and are properly labeled. Accordingly, entities which produce, sell or distribute unregistered pesticides place themselves at an economic advantage relative to their competitors who comply with the law.

EPA registration requirements also protect consumers by ensuring that products are formulated in accordance with the product label. Without proper registration and labeling on pesticides (including required safety information), users may unintentionally misapply pesticides and cause damage to crops or non-target areas and may lack adequate first aid information in the event of an accident.

As part of their respective settlements with EPA, each of the three companies has certified that it is presently in compliance with FIFRA and its regulations. 

Stay tuned for future postings regarding this development.

EPA Levies Record-Setting Penalties under FIFRA

FIFRA Enforcement:

On September 7, 2012, EPA and the Department of Justice announced criminal and civil settlements with the Scotts Miracle-Gro Company for alleged violations of  the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the federal law governing manufacture, distribution, and sale of pesticides.  Scotts produces pesticides for commercial and consumer lawn and garden uses.  The case levied the largest criminal penalty, and the largest civil settlement, ever sought under FIFRA.  According to the EPA’s press release, Scotts had sold more than 70 million units of bird food illegally treated with pesticide that is toxic to birds.   The settlement leaves one asking:  “How did this happen at such a well-known and respected company?”

Criminal 

Scotts was sentenced in federal district court in Columbus, Ohio.   Scotts must pay a $4 million fine and perform community service for eleven criminal violations of FIFRA.   In addition to the $4 million criminal fine, Scotts will contribute $500,000 to organizations that protect bird habitat, including $100,000 each to the Ohio Audubon’s Important Bird Area Program, the Ohio Department of Natural Resources’ Urban Forestry Program, the Columbus Metro-Parks Bird Habitat Enhancement Program, the Cornell University Ornithology Laboratory, and The Nature Conservancy of Ohio to support the protection of bird populations and habitats through conservation, research, and education.

Scotts pleaded guilty in February 2012 to illegally applying insecticides to its wild bird food products that are toxic to birds, falsifying pesticide registration documents, distributing pesticides with misleading and unapproved labels, and distributing unregistered pesticides. 

In the plea agreement, Scotts admitted that it applied the pesticides Actellic 5E and Storcide II to its bird food products even though EPA had prohibited this use.  Scotts purportedly had done so to protect its bird foods from insect infestation during storage.  The company admitted that it used these pesticides contrary to EPA directives and in spite of the warning label appearing on all Storicide II containers stating, “Storcide II is extremely toxic to fish and toxic to birds and other wildlife.” Scotts sold this illegally treated bird food for two years after it began marketing its bird food line and for six months after employees specifically warned Scotts management of the dangers of these pesticides.

Scotts also pleaded guilty to submitting false documents to EPA and to state regulatory agencies in an effort to deceive them into believing that numerous pesticides were registered with EPA when in fact they were not. The company also pleaded guilty to having illegally sold the unregistered pesticides and to marketing pesticides bearing labels containing false and misleading claims not approved by EPA. The falsified documents submitted to EPA and states were attributed to a federal product manager at Scotts.

The criminal case was investigated by EPA’s Criminal Investigation Division and the Environmental Enforcement Unit of the Ohio Attorney General’s Office, Bureau of Criminal Identification & Investigation. It was prosecuted by Senior Trial Attorney Jeremy F. Korzenik of the Justice Department’s Environmental Crimes Section of the Environment and Natural Resources Division, by Michael J. McClary, EPA Criminal Enforcement Counsel and Special Assistant U.S. Attorney and by Assistant U.S. Attorney J. Michael Marous.

Civil 

In a separate civil agreement with EPA, Scotts agreed to pay more than $6 million in penalties and spend $2 million on environmental projects to resolves additional civil pesticide violations. The violations include distributing or selling unregistered, canceled, or misbranded pesticides, including products with inadequate warnings or cautions.

At the time the criminal violations were discovered, EPA also began a civil investigation that uncovered numerous civil violations spanning five years. Scotts’ FIFRA civil violations included the nationwide distribution or sale of unregistered, canceled, or misbranded pesticides, including products with inadequate warnings or cautions. As a result, EPA issued more than 40 Stop Sale, Use or Removal Orders to Scotts to address more than 100 pesticide products.

In addition to the $6 million civil penalty, Scotts will complete environmental projects, valued at $2 million, to acquire, restore and protect 300 acres of land to prevent runoff of agricultural chemicals into nearby waterways.

The civil case was investigated by U.S. EPA Region 5’s Land and Chemicals Division and Office of Regional Counsel, and the U.S. EPA Headquarters Office of Civil Enforcement, assisted by the Office of Pesticides Program.

Agency Press Statements

According to EPA’s press release: “The misuse or mislabeling of pesticide products can cause serious illness in humans and be toxic to wildlife,” said Cynthia Giles, assistant administrator for EPA’s Office of Enforcement and Compliance Assurance. “Today’s sentence and unprecedented civil settlement hold Scotts accountable for widespread company noncompliance with pesticide laws, which put products into the hands of consumers without the proper authorization or warning labels.”

“As the world’s largest marketer of residential use pesticides, Scotts has a special obligation to make certain that it observes the laws governing the sale and use of its products. For having failed to do so, Scotts has been sentenced to pay the largest fine in the history of FIFRA enforcement,” said Ignacia S. Moreno, assistant attorney general for the Environment and Natural Resources Division of the Department of Justice. “The Department of Justice will continue to work with EPA to assure that pesticides applied in homes and on lawns and food are sold and used in compliance with the laws intended to assure their safety.”

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More information about the civil settlement and recalled products: http://www.epa.gov/compliance/resources/cases/civil/fifra/scottsmiraclegro.html  

 

TSCA Fines Announced

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/

 

Irene Hantman to Moderate ABA Panel on Federal Suspension and Debarment Authority

Enforcement:

Verdant Law is pleased to announce that Irene Hantman will be moderating a panel on the federal government’s suspension and debarment authority.  The program, “Suspension and Debarment an Administrative Tool for Addressing NonCompliance: Perspective from EPA,” is sponsored by the ABA Sections on Administrative Law and Environment, Energy, and Resources.  It will be hosted at EPA Headquarters Tuesday, May 15, 2012 from 12:00 – 1:30 EST.  Additional details are set out below, and available here.

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Tuesday, May 15

Suspension and Debarment:   An Administrative Tool for Addressing NonCompliance: Perspective from EPA

The Section of Administrative Law, Environmental Law Committee and the Section of Environment, Energy and Resources In-House Counsel Committee invite you to attend a Brown Bag program 12:00-1:30 EST Tuesday, May 15, on the federal government’s suspension and debarment authority. Companies subject to these actions are unable to participate in government contracts, subcontracts, loans, grants, and other assistance programs. Being subject to such an action, or even the threat thereof, can have an immeasurable impact on a company, and can serve as a powerful incentive for a company to improve its compliance program. The effect of suspension and debarment by a Federal agency is government wide and can be extended to include subsidiaries and parent companies. Join SEER’s In-House Counsel Committee and EPA officials to learn how the Agency uses suspension and debarment as a tool for deterrence, what constitutes an actionable offense, and the regulatory framework. The program will also present industry perspectives and address control systems and remediation efforts.

Panelists are:

  • Stacey Dey-Foy, EPA
  • Irene Hantman, Verdant Law PLLC (Moderator)
  • Richard Pelletier, EPA
  • Steve Solow, Katten Muchin Rosenman LLP, Washington, DC
  • Mike Walker, EPA

To Register:

To attend this brown bag on-site free of charge at EPA or for remote participation contact Alice Mims: (202) 564-6069 or mims.alice@epa.gov.

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.

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

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

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.

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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

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.