• Clean Water Act
• Pesticides
• Environmental

EPA Proposes New Data Requirements for Antimicrobial Pesticide Products

Beveridge & Diamond, P.C. - Client Alert, November 10, 2008

On October 8, 2008, the U.S. Environmental Protection Agency (EPA) proposed revisions to its data requirements for antimicrobial pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), in conjunction with its wider effort to update and streamline its data requirements for all pesticides.  A full copy of the proposed requirements for antimicrobial products is available in the Federal Register at 73 Fed. Reg. 59382 (Oct. 8, 2008).

While the proposal largely retains the Agency’s current data requirements for antimicrobials, it establishes 12 new use patterns specific to antimicrobial pesticides intended to make it easier for applicants to determine which data requirements apply to particular types of antimicrobial products.  The proposal also incorporates nine new data requirements for antimicrobial pesticides, including four new requirements intended for use in a screening-level assessment on the fate of antimicrobials with the potential to reach a wastewater treatment plant.  These products would include “down-the-drain” products as well as microbiocides used in industrial process and water systems. 

EPA is accepting comments on its proposal until January 6, 2009.  Affected parties, including pesticide product manufacturers, antimicrobial pesticide and microbiocide registrants, and wastewater treatment plant operators seeking more information about the Agency’s regulation of antimicrobial pesticide products or the implications of EPA’s proposed changes should contact Kathy Szmuszkovicz at (202) 789-6037 (kszmuszkovicz@bdlaw.com), Karen Hansen at (202) 789-6056 (khansen@bdlaw.com), or Alan Sachs at (410) 230-1345 (asachs@bdlaw.com). 

A.        Background

Pursuant to FIFRA, every pesticide product must be registered by EPA before it may be sold or distributed in the United States.  An application for a pesticide registration must demonstrate that the product will not cause “unreasonable adverse effects” to humans or the environment.  To evaluate proposed product registrations or new uses of existing pesticides pursuant to this standard, FIFRA provides EPA with broad authority to require from pesticide applicants and registrants scientific data concerning each product, including its composition, toxicity, potential human exposure, environmental properties, and ecological effects. 

EPA first promulgated general data requirements for pesticides in 1984, at 40 C.F.R. Part 158.  Although Part 158 specifies the types of data and information generally required by EPA for conventional, biochemical and microbial pesticides, there both have been significant changes to the underlying laws and advances in science since that time and EPA and pesticide registrants have long recognized that it would be helpful for the Agency’s data requirements to address with more specificity the range of  applications, use patterns and other factors particularly relevant to antimicrobial pesticides. 

Antimicrobial pesticide applicants have frequently found it difficult to determine which of the Agency’s pesticide data requirements apply to their products, resulting in the need for unusually extensive consultation with EPA before registration  and throughout the registration lifecycle.  One of the Agency’s primary goals in promulgating its new antimicrobial data requirements is to provide clarity to antimicrobial pesticide registrants and reduce the extensiveness of EPA consultations.

B.        Applicability

EPA’s proposed requirements for antimicrobial products will apply to:

• “antimicrobial pesticides” as defined by FIFRA (generally, any pesticide intended to (1) disinfect, sanitize, reduce or mitigate growth or development of microbiological organisms, or (2) protect inanimate objects, industrial processes or systems, surfaces, water or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae or slime);

• pesticide products intended for antimicrobial uses in or on food or feed;

• antifoulant paints and coatings;

• wood preservatives; and

• pesticide products intended to be manufactured into any of the above. 

The proposed requirements, once final, are intended to apply to all new applications for registration of antimicrobial pesticides submitted after the effective date of the rule.  EPA also anticipates that the new requirements will apply to applications for antimicrobial pesticides that are undergoing Agency review when the new regulation goes into effect.  EPA is also considering a limited transition “window” for certain pending antimicrobial registration applications. 

While EPA does not intend to apply the new requirements automatically to all existing pesticide registrations, the Agency notes that it may be necessary to call-in data on certain existing registrations, as warranted by emerging risks of concern for particular pesticides or as a result of possible future programmatic changes and priorities on existing pesticides, or during the registration reviews required by the Food Quality Protection Act of 1996 (FQPA).  EPA also points out that it may be useful for all applicants, potential applicants and registrants of existing products to evaluate their products in light of the proposed requirements.  The Agency continues to expressly encourage consultation with EPA during the application process. 

C.        Use Patterns for Antimicrobial Pesticides

Previously, in order to determine applicable data requirements for antimicrobial pesticide products, applicants relied on 12 “use categories” developed by EPA for consideration  with antimicrobials.  By identifying the relevant use category for a specific product, the applicant would be referred to a corresponding Part 158 pesticide “use pattern,” through which the applicant could identify associated data requirements.  In its proposal, EPA now seeks to promulgate the 12 existing antimicrobial use categories as independent use patterns for antimicrobial pesticides.  These use patterns are:

• Agricultural premises and equipment (including many indirect food uses with mostly indoor use sites);

• Food-handling/storage establishments, premises, and equipment (including many indirect food uses due to the treatment of food contact surfaces and the resultant human exposures);

• Commercial, institutional and industrial premises and equipment (including nonfood contact areas of commercial sites);

• Residential and public access premises (including mostly nonfood areas, as well as food-handling areas in homes);

• Medical premises and equipment (including uses with the potential for repeated exposure);

• Human drinking water systems (including any methods used to provide potable water from raw water supplies, such as public water systems, water purifier units, and private water systems);

• Material preservatives (including antimicrobial chemicals added to paints, coatings, adhesives, textiles, and paper);

• Industrial processes and water systems (including microbiocides used to control the growth of bacteria, fungi, and algae in circulating water systems);¹

• Antifoulant paints and coatings (including coatings and paints applied to control the growth of freshwater or marine fouling organisms, as well as ballast water);

• Wood preservatives (including products which claim to control wood degradation problems due to fungal rot or decay, sapstain, molds, or wood-destroying insects);

• Swimming pools (including products used to prevent or control the growth of bacteria or algae in swimming pools, Jacuzzis and hot tubs); and

• Aquatic areas (including products designed to control or kill slime-forming bacteria, fungi or algae in lakes, ponds, streams, drainage ditches, or other bodies of water). 

D.        Summary of EPA’s Proposed Data Requirements for Antimicrobial Pesticides

Under the proposal, EPA’s data requirements for antimicrobial pesticides will be incorporated into Part 158 as a new subpart W. 

1.        New Data Requirements

The proposal includes nine new data requirements for antimicrobial products, including four new requirements that are not generally required for conventional pesticides:

• Activated sludge sorption isotherm study;

• Ready biodegradability study;

• Porous pot study; and

• Modified activated sludge, respiration inhibition test. 

These four new studies are being required because of the “many down-the-drain uses” of antimicrobial pesticides, and their discharge to public treatment systems.  73 Fed. Reg. at 59,387.  In its proposal, EPA explains that because many antimicrobial pesticides are typically rinsed down the drain, it is proposing these four new requirements for use in a screening-level assessment on the fate of antimicrobials that reach a wastewater treatment plant.  In addition, seven higher-tiered environmental fate studies could be triggered based on a weight-of evidence evaluation of the results of the screening-level studies. 

2.        Product Performance Data

Consistent with its existing data requirements, EPA requires the applicant to develop product performance data for all products; however, EPA will only require the submission of product performance data from applicants that make a public health claim regarding their product. 

3.        Product Chemistry Data

EPA has proposed application of its existing product chemistry data requirements for conventional pesticides to antimicrobial pesticides.  These chemistry data requirements include data identifying the basic identity and chemical and physical characteristics of a pesticide chemical. 

4.        Toxicology Data

EPA proposes modifying the application of its toxicology data requirements to reflect the differing risks of levels of exposure to antimicrobials by establishing two new groupings for antimicrobial products: “low human exposure” and “high human exposure.”  73 Fed. Reg. at 59,392.  For purposes of determining data requirements, EPA considers high human exposure to include:

those uses which are likely to result in human exposure over a considerable portion of the human lifespan, and which are significant in terms of frequency, duration, or magnitude of exposure (i.e., uses for which there is an expectation of high, prolonged, or repeated exposure). 

40 C.F.R. § 158.2230(b)(1) (proposed).  Examples of high human exposure uses of antimicrobials include uses requiring a tolerance or tolerance exemption, indirect food uses with residues equal to or greater than 200 parts per billion, use in human or animal drinking water, outdoor aquatic uses which have the potential to contaminate potable water, and wood preservatives. 

Low human exposure uses are defined as those not meeting the criteria for high exposure uses.  Under this approach, an application for registration of an antimicrobial with low human exposure might be required to generate fewer studies in total than would be required for high human exposure uses.  

5.        Handler and Post-Application Exposure Data

EPA’s proposal would codify its current practice of requiring handler exposure studies for all antimicrobial products whenever the Agency’s toxicity criteria (i.e., evidence of potentially significant adverse effects have been observed in any applicable toxicity studies, or scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from handling of the pesticide) and exposure criteria (i.e., dermal or respiratory exposure may occur during use) are triggered.  

Similarly, post-application exposure data would be required if a product meets one of the Agency’s toxicity criteria and one of EPA’s exposure criteria for outdoor uses (i.e., occupational human post-application exposure to residues could occur as the result of work-related activity or residential human post-application exposure to residues could occur following application of the pesticide to outdoor areas and spaces at residential sites) or indoor uses (i.e., occupational human post-application exposure could occur following application of the pesticide to indoor spaces or surfaces, or residential human post-application exposure could occur following application of the pesticide to indoor spaces or surfaces at residential sites). 

6.        Residue Chemistry Data

In its proposal, EPA seeks to modify the applicability of its existing residue chemistry data requirements to reflect the differing risks and levels of exposure of antimicrobials.  For example, to determine antimicrobial residue chemistry data requirements, most antimicrobial pesticides will be classified as either direct or indirect food uses. 

7.        Environmental Fate Data

EPA has proposed dividing antimicrobial pesticides into two groups for the purpose of determining environmental fate and ecotoxicity data requirements: a “low environmental exposure” grouping and a “high environmental exposure” grouping.  73 Fed. Reg. at 59,405. 

According to the Agency, the potential for environmental exposure is “high” for three of the antimicrobial pesticide use patterns (antifoulant paints and coatings, wood preservatives, and aquatic areas), because these uses either occur outdoors and thus discharge directly to the environment, or result in materials treated with antimicrobials being placed in the environment.  In addition, EPA includes use in once-through industrial processes and water systems (a subgroup of the industrial processes and water systems use pattern in which the water is not re-used and is released after a single cycle through the system) in its high environmental exposure grouping. 

By contrast, the low environmental exposure grouping includes products with use patterns in agricultural premises, food-handling establishments, medical premises, human drinking water systems, and recirculating industrial processes and water systems. 

As noted above, based on EPA’s concerns about the potential effects of antimicrobials on the biological treatment processes used in wastewater treatment plants -- as well as its concerns about potential bioconcentration of antimicrobials after release and possible effects on nontarget species -- the Agency is also proposing four new environmental fate data requirements to assess all products with “down-the-drain” antimicrobial uses (represented in the proposed rule by the low environmental exposure grouping, as well as once-through industrial processes and water systems).  These data will allow EPA to conduct screening-level environmental fate assessments, which can then indicate the need for higher-tiered data.  

8.        Nontarget Organisms Data

EPA is proposing to use a tiered system of ecological effects testing to assess the potential risks of pesticide uses to nontarget animals for antimicrobial pesticides. 

9.        Plant Protection Data

EPA is proposing to modify the applicability of its existing nontarget plant protection data requirements to reflect the differing risks and levels of exposure of antimicrobial products. 

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¹  As described below, for purposes of determining potential environmental exposure, EPA recognizes two distinct subgroups within this use pattern – (1) once-through industrial processes and water systems and (2) recirculating industrial processes and water systems.