EPA releases interim guidance on data requirements for antimicrobial pesticides and food contact surfaces.

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Last week, EPA released interim guidance on the agency’s toxicology data requirements for antimicrobial pesticides on food contact surfaces. The interim guidance clarifies that the 200 parts per billion (ppb) threshold that triggers different data requirements is based on “total estimated daily dietary intake” for an individual and not the total amount of residue on a food item, which interpretation is in line with the policy of the U.S. Food and Drug Administration (FDA). Generally, if pesticide residues from food contact services are found in food at 200 ppb or less, EPA requires the submission of certain toxicology data, and additional data may be required if residues are greater than 200 ppb.

The interim guidance was issued as part of a March 2, 2015 settlement reached between the EPA and the American Chemistry Council (ACC) resolving the trade group’s challenge of EPA’s 2013 Final Rule on “Data Requirements for Antimicrobial Pesticides.” The settlement also requires that EPA propose, by July 2, 2015, a guidance document called the “Antimicrobial Pesticide Use Site Index,” which will be subject to public comment. In addition, by September 2, 2017, the agency must propose a “correction” to 40 C.F.R. § 158.2230(d) clarifying that the 200 ppb level relates to total estimated daily dietary intake, consistent with the FDA policy.

EPA and FDA announce data sharing agreement for CBI.

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Today, EPA and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to share data on pesticides and toxic substances. According to a notice published last month in the Federal Register, in response to the FDA’s spring 2014 request, EPA will grant FDA access to information collected under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including information claimed by submitters as Confidential Business Information (CBI). This data-sharing initiative “is intended to maximize the utility of data collected under those statutes, and enhance the efficiency of the participants’ regulatory processes and facilitate better risk management activities.” The MOU applies specifically to EPA’s Office of Chemical Safety and Pollution Prevention and FDA’s Foods and Veterinary Medicine Program, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine.

FDA and EPA “have complementary roles” regulating substances incorporated into food (including animal feed), animal drugs, and cosmetics. Antimicrobial food wash products, for example, must meet different standards for safety and non-adulteration of food (FDA), and no adverse environmental effects (EPA).

The MOU covers the sharing of non-public information exempt from public disclosure, including CBI and “confidential commercial information” (CCI). Information will be shared “on a reciprocal and as-needed basis” for substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. The MOU provides that each agency will develop internal procedures and designate liaison officers for the information-sharing exchanges and to protect against unauthorized disclosure of CBI or CCI. Appendices to the MOU establish a framework process for information sharing, including specific language to be used in requesting information or responding to a request.

The MOU does not specify any limits as to programmatic uses for shared information. The disclosure of non-public information remains governed by applicable laws and regulations, and non-public information may not be disclosed further or shared with personnel at the other agency that have not been authorized to access non-public information. If EPA requests information from FDA identified as a trade secret, FDA will assess whether the information is in fact trade secret. TSCA/FIFRA-designated CBI requested by FDA will have to be returned to EPA or destroyed when no longer needed. Either agency may choose not to share requested information, or may choose to limit the scope of information provided in response to a request. The agencies may also protect information “in connection with research that has not been peer reviewed.”

EPA agrees to clarify data requirement rule for antimicrobial pesticides.

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EPA and the American Chemistry Council (ACC) have reached a settlement regarding the ACC’s petition concerning data requirements for antimicrobial pesticides. This settlement addresses a Final Rule published by EPA on May 8, 2013, “Data Requirements for Antimicrobial Pesticides,” for which the ACC, the chemical industry trade group, sought judicial review in the U.S. Court of Appeals for the D.C. Circuit.

Under the settlement, EPA will within the next four months release for public comment a proposed guidance document, “Antimicrobial Pesticide Use Site Index.” This guidance will include “a compilation of existing antimicrobial pesticide use sites and identify how each use site fits within the 12 use patterns established in the regulation.” The Use Site Index will include the following descriptions, as set forth in the settlement:

  • Direct Food Use: a use is generally considered to be a direct food use if an antimicrobial pesticide is intended to be directly applied to food (defined for purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f)) or applied to a material or article for the purpose of treating food.
  • Indirect Food Use: a use is generally considered to be an indirect food use if the use involves application of the antimicrobial pesticide in or on a material or article that comes into contact with food and may result in residues in or on food, but the use is not intended for pesticidal treatment of food.
  • Nonfood Use: a use is generally considered to be a nonfood use when there is a reasonable certainty of no residues in or on food, for example because the antimicrobial pesticide is not expected to come into contact (directly or indirectly) with food as a result of its intended use.

In addition to the Site Index proposed guidance, the settlement agreement provides that EPA shall propose an interim guidance document and then a “correction to the Final Rule” regarding the 200 ppb level for antimicrobial residues in or on a food item, as established at 40 C.F.R. § 158.2230(d). Under the Final Rule, additional toxicology tests are required for indirect food uses with antimicrobial residue levels greater than 200 ppb. Within 60 days, EPA must issue an interim guidance document “explaining EPA’s interpretation of the 200 ppb level established in the Final Rule.” Within two and a half years, EPA must propose a “correction” to make “clear that the 200 ppb level established in the Final Rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity.”

EPA sued over lack of nanosilver regulations.

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On December 16, a group of NGOs sued [PDF] the U.S. EPA over the agency’s failure to regulate nanosilver in consumer products. The plaintiffs, which include the Center for Food Safety, Center for Environmental Health, and Beyond Pesticides, seek to compel EPA to take action in response to their 2008 petition for rulemaking. The groups’ petition requested that EPA regulate nanosilver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), thus requiring product manufacturers to obtain pesticide registrations. The petition also asked EPA to analyze “the potential human health and environmental risks” of nanosilver under FIFRA and other environmental statutes, including the Endangered Species Act (ESA) and National Environmental Policy Act (NEPA).

Since the 2008 petition, EPA has accepted comments on the petition, enforced against companies making antimicrobial claims about nanosilver-containing products, convened a scientific advisory panel, and proposed a policy statement on the subject, but the NGOs maintain that EPA’s actions constitute an “ongoing failure to meaningfully regulate nanotechnology.” The plaintiffs contend that EPA has violated the Administrative Procedure Act by failing to provide a timely response to the 2008 petition.

The case is Center for Food Safety et al v. McCarthy, Case No. 14-cv-2131, in the U.S. District Court for the District of Columbia.

EPA agrees to update enforcement guidance for FIFRA and TSCA.

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The Environmental Protection Agency (EPA) has agreed to update its enforcement guidance for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) following a report [PDF] from the agency’s Office of Inspector General (OIG) released on September 27, 2013. The report contained findings and recommendations related to FIFRA and TSCA good faith reductions and “ability to pay” penalties, based on the OIG’s review of 23 FIFRA cases and 20 TSCA cases (13 lead disclosure and 7 PCB cases).

The OIG found that EPA regions differed in how they assessed FIFRA and TSCA enforcement penalty reductions; some appeared to justify reductions automatically, without considering the good faith compliance efforts of the violators. Because of the lack of adequate guidance and supporting documentation for determining and justifying good faith penalty reductions, there is a risk that EPA might treat violators inequitably and might be losing opportunities to fully collect all penalties due. Based on the OIG’s findings and recommendations, EPA has agreed to reissue the enforcement policy document GM-88, “Documenting Penalty Calculations and Justifications in EPA Enforcement Actions.”

The OIG also found that EPA’s enforcement response and penalty policy for lead-based paint disclosure rule to address violators who are unable to pay penalties is inadequate. Specifically, no guidance exists for applying non-monetary penalty alternatives (such as public service or delayed payment plans) when violators do not have the cash to pay the penalty. EPA has agreed to evaluate whether additional guidance is needed to clarify whether non-monetary alternatives must meet the agency’s existing Supplemental Environmental Projects policy.

In addition, the OIG report found that EPA’s “INDIPAY” economic model may be limited in its ability to help teams evaluate individuals’ claims of inability to afford penalties or clean-up costs. According to the OIG, the INDIPAY model does not assess an individual’s assets and should be updated to improve its accuracy. Furthermore, the report found that EPA does not provide adequate guidance or case development training to help regional teams evaluate ability to pay cases. In order to improve the agency’s consistency in handling the growing number of ability to pay cases, EPA has agreed to provide regional staff with updated training for case development of ability to pay claims. EPA also agreed to update its 1986 document “Guidance on Determining a Violator’s Ability to Pay a Civil Penalty” [PDF] to further improve guidance on evaluating ability to pay cases and address the inadequacies of the INDIPAY model.

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

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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.

EPA Announces Proposed Revisions to FIFRA Minimum Risk Exemption

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FIFRA:

In a December 31, 2012 Federal Register notice, (77 Fed. Reg. 76,979) EPA announced a new proposed rule that would revise the labeling requirements for minimum risk pesticide products. The proposed rule affects section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by changing how minimum risk pesticides are identified on product labels as well as the way ingredient lists are organized in the implementing regulations. In addition, producer contact information will be required on product labels.

Under FIFRA’s § 25(b) minimum risk exemption, pesticides with active and inert ingredients which are demonstrably safe do not need to be registered with EPA. These permitted ingredients are listed in 40 CFR 152.25(f), but because of ambiguities across the various ingredient lists, confusion remains as to which ingredients are covered and how they should be labeled, leading to increased regulatory burden and inefficiencies for state regulators. Many chemicals may be known by producers, regulators, and consumers by different names; for example, soybean oil may be described on a product label as “Glycine Soja Oil.”

EPA’s new proposed rule is intended to make clear which active ingredients are permitted in exempted pesticide products, and does not add or remove any ingredients from the list. Instead, EPA will identify permitted active ingredients by re-organizing them in tables including the chemical’s “Label Display Name” (e.g., “Citric Acid”), “Chemical Name” as determined by the Chemical Abstract Services (“CAS”) (e.g., “2-Hydroxypropane-1,2,3-tricarboxylic acid”) and “CAS Registry Number,” a unique identifier which is easy to use for consumers and widely accepted by industry and regulators alike. In addition, the table will include a “Specifications” column which will be empty for most ingredients, but will indicate the United States Pharmacopeia (“USP”) standard for “approximately 20 of the active ingredients.”

Inactive ingredients will also be re-organized into a table similar to the one proposed for active ingredients. This table will codify “List 4A,” the list of chemicals currently maintained on EPA’s website. In addition, EPA proposes to incorporate references to other CFR sections which describe which chemicals may be used as inert ingredients for the purpose of the minimum risk exemption. In the case of pesticides that may come in contact with foods, for which there are no federal tolerance levels or tolerance exemptions, EPA proposes to amend the text of the exemption to direct users to an EPA website for more information on which of the listed chemicals may be used in food-use pesticide products.

Finally, EPA proposes that exempted product labels must use the “label display name” in the product’s ingredient listing. The proposed rule also requires that producers of minimum risk pesticide products must include their company’s contact information (address and telephone number) on the product label. In the case of a product label which includes the name of a company that is not the producer, EPA proposes that the label text should clarify that the product was “packed for,” “distributed by,” or “sold by” the non-producer company.

EPA is requesting comments on various topics related to this proposal, including: the format and information to be included in the new tables; whether reference to an online resource with more information on food-use pesticide tolerance requirements would provide clarity for stakeholders; impacts on state and local agencies; and whether products would need to be reformulated as a result of the changes. The comment period for this proposed rule ends on April 1, 2013.

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

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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

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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  

 

EPA Conditionally Registers Nanosilver Pesticide and NRDC Files Blocking Lawsuit

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FIFRA/Nanotechnology:

EPA’s Conditional Registration

On December 1, 2011, EPA announced that it was conditionally registering a pesticide product containing nanosilver as a new active ingredient. The antimicrobial pesticide product, HeiQ AGS-20, is a silver-based product for use as a preservative for textiles. As a condition of registration, EPA stated that it would require additional data on the product to confirm EPA’s assessment that the product will not cause unreasonable adverse effects on human health or the environment, the general standard for a registration under the Federal Insecticide, Fungicide, and Rodenticide Act.

By way of background, on August 12, 2010, EPA posted a Proposed Conditional Registration to the docket for public comment. EPA received 45 public comments, and responses to these comments along with the decision document to conditionally register the product can be found at www.regulations.gov in Docket ID # EPA-HQ-OPP-2009-1012. A description of the additional studies and timeline when the data must be submitted is also available in the docket.

NRDC’s Lawsuit

In response to the conditional registration, on January 26, 2012, the Natural Resources Defense Council filed a lawsuit in the 9th U.S. Circuit Court of Appeals, challenging EPA’s decision.  NRDC asserts that there is a lack of data concerning the human health and environmental effects of nanosilver.  The lawsuit seeks to limit public exposure to the nanosilver that EPA registered for use in clothing, baby blankets, and many other textiles.

Verdant will soon post a copy of the NRDC’s legal documents.  Check back soon for these documents and for further commentary on this important development for the nanotechnology community.