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.

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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.

 

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.