Tag Archive for: FIFRA

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.

EPA Assistant Administrator Steve Owens Resigns

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EPA Administration/Chemical Regulation:

On Tuesday, October 25, 2011, the Environmental Protection Agency (EPA) announced the resignation of Assistant Administrator Steve Owens.  Readers will recall that President Obama appointed Mr. Owens the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), which is the office implementing the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Pollution Prevention Act, and other federal laws concerning chemicals management.  November 30, 2011, will be Mr. Owens’ last day in office before returning home to Arizona where he previously served as the Director of the Arizona Department of Environmental Quality.  It is unclear at this time who will assume Mr. Owen’s responsibilities and what effect his departure will have on EPA’s various chemicals management initiatives.

Mr. Owens served the EPA during a two-year period in which Congress, the courts, and various stakeholders engaged in vigorous debate and litigation over the appropriate regulation of chemicals in the United States.  In a 2010 brown-bag session (available on podcast), sponsored by the American Bar Association’s Pesticides, Chemical Regulation, and Right-to-Know Committee, Mr. Owens discussed many of the initiatives the Agency was undertaking and some of the challenges it faced as it participated and attempted to shape the debate. 

In a letter to EPA staff announcing his resignation, Mr. Owens said:

“I am writing to tell you that, after more than two years of working closely with all of you to protect Americans’ health and environment, I have made the difficult decision to leave EPA. My last day in the office will be November 30, 2011.
 
As many of you know, my family has remained in Arizona while I have been working at EPA headquarters in Washington. Although I have been able to get home to see my family periodically, I have essentially been away from them for more than two years. After a lot of hard thinking, we have decided that it is time for me to come home. My wife needs her husband; my sons need their father; and I need them.
 
While I am very happy that I will be back with my family, I will miss all of you greatly. It has been a true privilege to work with so many incredibly talented and dedicated people who are doing so much to protect the health and safety of the American people and our environment.
 
I am extremely grateful to Lisa Jackson for her wonderful friendship and the remarkable vision and leadership she provides to this Agency. We are truly fortunate that she is EPA’s Administrator.
 
As I said earlier, I will continue working alongside you all through November 30. Administrator Jackson will share additional information about the transition process shortly.
 
In closing, let me thank you so much for the friendship and support you have given me during my time at EPA. Please know how much I appreciate you and all that you are doing for our country.”

 

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.

 

EPA Pesticide Program Dialogue Committee

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FIFRA:

For readers looking for an update on US EPA FIFRA regulatory, policy and program implementation efforts, consider attending the Pesticide Program Dialogue Committee (PPDC) Meeting: Wednesday April 20 & Thursday April 21, 2011.

PPDC meetings provide a forum for a diverse group of stakeholders to provide feedback to the EPA Office of Pesticide Programs on various pesticide regulatory, policy and program implementation issues.

The PPDC meeting is open to the public. Attend in person at EPA’s Potomac Yard Conference Center (2777 Crystal Drive, Arlington, VA) or dial-in to the meeting (Conference Line: 1-866-299-3188; conference Code: 703-308-4775#).

The agenda, information about workgroups and past meetings can be accessed at http://www.epa.gov/pesticides/ppdc/.

Topics to be discussed at this week’s meeting include:

Tuesday April 20, 2011
• Integrated Pest Management (see e.g., http://www.epa.gov/pesticides/factsheets/ipm.htm)
• Spray Drift (see e.g., http://www.epa.gov/pesticides/ppdc/2010/dec2010/session5-drift.pdf )
• Inerts Disclosure (see e.g., http://www.epa.gov/opprd001/inerts/inertdisclosure.html)
• Water Quality/Drinking Water (see e.g., http://water.epa.gov/lawsregs/rulesregs/sdwa/dwstrategy/index.cfm)
• Pollinator Protection (see e.g., http://www.epa.gov/opp00001/ecosystem/pollinator/index.html)
• Children/Worker Risk Protection (see e.g., http://www.epa.gov/pesticides/health/worker-rsk-assmnt.html)
• OPP Strategic Directions (see e.g., http://www.epa.gov/pesticides/science/testing-assessment.html)
• Improving Regulations (see e.g., http://epa.gov/oppfead1/cb/csb_page/updates/2011/ppdc-regreview.html)
• Comparative Safety Statements (see e.g., http://www.epa.gov/pesticides/ppdc/compara-safety/index.html)
• Public Health Issues—Bed Bugs, Lyme Disease Prevention (see e.g., http://www.epa.gov/pesticides/ppdc/public-health/index.html)

Wednesday April 21, 2011
• Endangered Species (see e.g., http://www.epa.gov/espp/, http://www.nmfs.noaa.gov/pr/consultation/pesticides.htm)
• Clean Water Act Pesticide General Permit (see e.g., http://cfpub.epa.gov/npdes/home.cfm?program_id=410) (Also note, the ABA is hosting a program focused solely on this permit April 27–The NPDES Pesticide General Permit: Perspectives from the Hill, EPA, the Regulated Community, and Environmental Advocates. For registration information see http://www2.americanbar.org/calendar/the-npdes-pesticide-general-permit/Documents/Final_Flyer.pdf.)
• 21st Century Science Activities (see e.g., http://www.epa.gov/pesticides/ppdc/testing/index.html) (Also note, the EPA Science Advisory Panel Meeting May 24-26, 2011 will focus on toxicity testing—Integrated Approaches to Testing and Assessment Strategies: Use of New Computational and Molecular Tools. More at http://www.epa.gov/scipoly/sap/meetings/2011/052411meeting.html.)

EPA Reissues FIFRA Guidance on Cleaning Products

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FIFRA:

On January 11, 2011, EPA issued revised guidance regarding the types of claims that would require registration of cleaning products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §136 et seq.  Readers may recall that, in early 2010, the Agency initially issued guidance that could have made claims such as “removes mold, mildew and algae stains” potentially subject to registration, differing from the established interpretation of the “cleaning agents” exemption set out at 40 CFR § 152.10.  EPA reasoned that, in certain contexts, such statements would constitute claims of pest mitigation.  At the same time, EPA Headquarters was also coordinating with the Agency’s regional offices to undertake an enforcement initiative based in part on that 2010 guidance.  However, a large-scale enforcement initiative did not occur.  Industry trade associations and others were successful in convincing EPA that its expanded application of FIFRA was unnecessary and potentially unlawful.  EPA responded by issuing revised guidance essentially reducing the number of scenarios in which pesticidal intent would be inferred.

Under FIFRA a “pesticide” is “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”  FIFRA § 2(u), 7 U.S.C. § 136(u) (emphasis added).  Unless otherwise exempted from registration under 40 CFR §§ 152.20, 152.25 or 152.30, pesticide products that are intended for a pesticidal purpose must be registered.  In general, a product is considered to be intended for a pesticidal purpose when the person who distributes or sells it claims, states, or implies that the product prevents, destroys, repels or mitigates a pest.  Therefore, once a product label (or other statement made in connection with the sale or distribution of the product) includes any claim of pest mitigation, under 40 CFR § 152.15, the product is one that is intended for a pesticidal purpose and becomes subject to registration.  For cleaning products, claims of pest mitigation are frequently what trigger the registration requirement. 

According to EPA, a product need not act directly on a pest in order for it to mitigate the pest and be considered a pesticide.  See IN THE MATTER OF AQUARIUM PRODUCTS, INC. (IF&R Docket No. 1 1 1 – 4-C) (1995).  However, certain products may have effects that mitigate pests without being intended for a pesticidal purpose.  As noted above, the regulation at 40 CFR § 152.10 sets out three groups of products that are not pesticides because they are not intended to prevent, destroy, repel or mitigate a pest.  One of these includes deodorizers, bleaches and cleaning agents.  However, the regulation provides that these products are not pesticides only if no pesticidal claim, express or implied, is made on their labeling or in connection with their sale and distribution (e.g., web sites, advertising, promotional or sales activities and testimonials, or even website links to research demonstrating pesticidal efficacy).  This includes claims about the use of a cleaning product alone or in combination with other substances.

Some cleaning products claim pest mitigation, noting their ability to affect the habitat or food source of a pest, but others merely claim the ability to remove dirt or other debris.  Although such distinctions may appear subtle, they’re important from a regulatory standpoint.  Moreover, many claims are not so easily categorized, so the context in which they occur must be evaluated.  Thus, with the range of claims occurring in the marketplace, EPA guidance distinguishing between claims subject to registration and those not subject is important. 

EPA offers many examples of claims that would require registration because of a linkage to mitigating a pest, its food, food source, or its habitat.  These include the following:

  • Cleans away, washes away or removes any pest, biofilm or scum, allergen or allergen associated with a pest.
  • Removes pests by suffocating or drowning.
  • Cleans or removes pest habitats or breeding sites.
  • Cleans, precipitates or removes contaminants, nutrients or matter that provide food or habitat for pests.
  • Cleans, reduces or removes scum or sludge where pests breed, feed or live.
  • Out-competes or displaces a pest for nutrition or habitat.
  • Cleans or removes the habitat where biofilm, germs, allergens or microorganisms can hide, thrive or grow.
  • Prevents, blocks, removes, neutralizes or controls bacteria or other pests that cause odors.
  • Sanitizes, disinfects or sterilizes.
  • Images of pests or pest habitats (e.g., nest, hive or web) that imply cleaning or removal of pest habitats, or of nutrition or sources of nutrition for pests.
  • A banner, logo, design, header or any claim on a label or labeling, or through other means such as web sites, advertising, etc. that specifically links the cleaning product to pest control, Integrated Pest Management (IPM), pests or a specific kind of pest. 

In contrast, claims lacking a linkage to mitigation would not require registration.  Examples of such claims include:

  • Cleans or removes stains.
  • Cleans or removes stains from algae, mold, mildew or other non-public health organisms.
  • Cleans or removes dirt, soil, dust, debris, inanimate scum, inanimate nutrients, inanimate organic particulates, or inanimate contaminants.
  • Cleans a site (e.g., ponds, aquariums, etc.).
  • Prevents, blocks, neutralizes, reduces, eliminates, encapsulates or removes odors; deodorizes.
  • Cleans, reduces or removes sludge.
  • Cleans or removes inanimate scum such as “soap scum.”
  • Cleans, washes or prepares the surface for application of a registered disinfectant intended to kill biofilm.
  • Combines suspended inanimate particulates for easy removal by a filtration system.
  • Cleans away or removes inanimate dust-mite matter, non-living matter, or  allergens from non-living sources (e.g., pet dander allergens, cockroach matter allergens, dust mite matter allergens) (emphasis added).

Despite the numerous examples, there are scenarios for which EPA cautions companies to undertake a careful evaluation of the entire context.  These include the following types of scenarios:

  • Catalogs or web sites that list both cleaning products and pesticidal products in close proximity since these could imply that the cleaning products are pesticidal.   
  • Use of references to IPM on a cleaning product’s label.  (Although EPA considers IPM an effective and environmentally sensitive approach to pest management that relies on a combination of common-sense practices, references to IPM could imply by association that a clean product may control or mitigate a pest.)

The Agency’s guidance appears generally consistent with the longstanding practice of many companies.  However, FIFRA’s registration requirement has proven to be a source of confusion for others, so there are undoubtedly companies out there currently evaluating the guidance and adjusting their practices accordingly.

Crocs Shoe Company Settles FIFRA Enforcement Action with EPA

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FIFRA:

On December 30, 2010, EPA announced a settlement under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with Crocs, Inc., the company famous for its ubiquitous, colorful foam clogs.   EPA alleged that Crocs violated FIFRA by making unsubstantiated antimicrobial health claims on its website, in advertising, and on packaging for several styles of the Company’s shoes.   Pursuant to the settlement agreement, Crocs will remove the offending language and pay a $230,000 penalty.  The Company will undoubtedly incur significant additional expense to revise its advertising materials, field questions from distributors and worried customers, and take other steps necessary to ensure future compliance and help protect the Crocs brand.  A copy of the settlement agreement is available here.

This case is another unfortunate example of the relative ignorance of many consumer products companies about the application of FIFRA to consumer products treated with antimicrobials or other pesticides.  One would not normally consider shoes to be a pesticide product, but under FIFRA, they can be.  Making an antimicrobial public health claim about a product (usually because of a chemical applied to the product) is one of the easiest ways to make a cutting board, computer keyboard, etc., subject to FIFRA.  Many companies simply don’t understand this, or they mistakenly think their products qualify for the “treated articles” exemption and therefore they don’t need to worry about FIFRA.   (More on the “treated articles” exemption in a minute.)  EPA’s enforcement docket is littered with past examples of such mistakes.

Simply stated, products that claim to kill or repel bacteria or germs are considered pesticides under FIFRA.   FIFRA requires companies to register pesticide products with EPA before selling, distributing, or making public claims about their ability to control germs or pathogens.   The registration process can be time-consuming and expensive because EPA will not register a pesticide until it has been shown, through testing, not to pose an unreasonable risk when used according to the label’s directions. 

Companies often aren’t aware of the scope of the registration requirement.  Others are aware of it, but  believe (mistakenly) that their products qualify for the “treated articles” exemption in 40 CFR 152.25(a).  Eligibility for this exemption is not as straightforward as it might seem.  In a nutshell, the exemption requires: (1) the incorporated pesticide to be registered for use in or on the article and (2) the sole purpose of the treatment to be protection of the article itself.  Implied or explicit public health claims for protection against bacteria, fungi, viruses, or other pathogens (e.g., “antibacterial”) are prohibited since they show that treatment was not solely for protection of the article itself.  Companies commonly make claims broader than those allowed or they fail to confirm that the registration covers treatment of their specific type of product.  The result is a violation of FIFRA with all the pain and expense that entails.

Where does this leave a consumer products company wanting to capitalize on society’s germ phobia?  Well, before succumbing to the sirens’ song from Marketing or Sales about the new marketing opportunities, usually an in-house counsel, product steward, or other EH&S professional inquires about FIFRA compliance.   If shrugs or blank stares are returned, that person will arrest the momentum and probe the issue further.  (Disclaimer:  This is a practical observation and not legal advice.)  EPA has helpful guidance , and other information is available on its website, here and here.