Think Your Pesticide Deserves An Exemption? EPA Wants To Hear From You

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In seeking public comments and suggestions on how to improve the exemption process for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the US Environmental Protection Agency (EPA or Agency) has provided a unique opportunity for developers to argue for an expedited path to market for their innovative AgTech as well as conventional products.
 

In an Advance Notice of Proposed Rulemaking (Notice or ANPR) published on April 8, 2021, EPA indicates that it is considering streamlining the current petition process for exemptions and revising its evaluation of potential minimum risk active and inert ingredients under 40 CFR 152.25. The Agency is interested in a variety of topics including factors used in classes of exemptions, state implementation of the minimum risk program, the need for future exemptions or modifications to current exemptions, and the need to consider amending existing exemptions or exempting new classes of pesticidal substances. Comments must be received by July 7, 2021. The Notice can be viewed here.

While the range of comments invited by EPA is very broad, the Notice makes clear that it is focused on the exemption process under FIFRA §25(b)(2), which authorizes the exemption of pesticides the Agency determines “to be of a character which is unnecessary to be subject to [FIFRA]”. The Notice expressly does not cover exemptions that “are in general not based on risk analysis of individual pesticides” such as pesticides found to be adequately regulated by another Federal agency under FIFRA §25(b)(1), 40 CFR 152.20, or covered by an emergency exemption under FIFRA §18, 40 CFR 152.30.

Five pesticides and classes of pesticides are currently “exempt from all provisions of FIFRA when intended for use, and used, only in the manner specified” under 40 CFR 152.25.  Exempt active ingredients are listed in 40 CFR 152.25(f)(1) and the inert ingredients permitted for use with those actives are listed in 40 CFR 152.25(f)(2). The existing regulation contains numerous conditions on the use of minimum risk pesticides including those found in 40 CFR 152.25(f)(3). 

Suggestions are welcome on any and all recommendations for improving the exemption process, as well as on the consideration of environmental justice concerns in the context of the issues raised in the Notice. EPA is particularly interested in public feedback on the questions identified with respect to the topics discussed below.

Petition Process and Rulemaking

Under the Administrative Procedure Act the public can petition EPA at any time to revise the exemption regulations in 40 CFR 152.25 (or any other regulation).  If EPA grants the petition, it would typically publish a proposed rule for public comment and, after considering the comments received, issue a final rule. Petitions are considered on a case-by-case basis. EPA specifically requests comments on two questions related to the Minimum Risk Pesticide Program.

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process? Please explain how changes could increase efficiencies.
  2. Given the identified minimum risk characteristics of these products and anticipated low impacts on communities, are current approaches effective for seeking input from the public and stakeholders, including State local, Tribal, and territorial officials, scientists, labor unions, environmental advocates, and environmental justice organizations? Are there particular approaches that are more or less effective?

Evaluation of Minimum Risk Pesticide Ingredients

The Notice identifies a total of thirteen risk assessment factors considered by the Agency in determining whether a substance should be added to the list of active or inert ingredients eligible for inclusion in minimum risk pesticide products under 40 CFR 152.25(f). The first seven factors were originally described in the publication of the March 1996 minimum risk rule and the next six have since been routinely considered as well.

  1. Whether the pesticidal substance is widely available to the general public for other uses;
  2. If it is a common food or constituent of a common food;
  3. If it has a non-toxic mode of action;
  4. If it is recognized by the Food and Drug Administration (FDA) as safe;
  5. If there is no information showing significant adverse effects;
  6. If its use pattern will result in a significant exposure, and
  7. If it is likely to be persistent in the environment.

Whether the substance in question:

  1. Is likely to have carcinogenic or endocrine disruptor properties;
  2. Is likely to cause human health developmental, reproductive, mutagenic, or neurotoxicity issues;
  3. Is a known allergen or a known allergenic source or a potential allergen;
  4. Is associated with developmental toxicity/adverse effects to mammals, birds, aquatic organisms, insects, plants;
  5. Produces or could produce toxic degradates; and
  6. Has the potential to be contaminated with toxic or allergenic impurities.

EPA notes that environmental justice and pollution prevention directives will continue to be a part of the regulatory planning process for the Minimum Risk Pesticide Listing Program.

EPA then poses the following questions concerning all of the above evaluation factors.

  1. Considering the previous discussion, should the factors discussed above be considered in determining whether a substance should be exempted from FIFRA regulation via the minimum risk exemption?
  2. How would these other factors be weighed in a minimum risk determination?
  3. Are there other policies that EPA should consider in determining whether a substance should be exempt from FIFRA regulation via the Minimum Risk Pesticide Listing Program? For example, should EPA consider additional environmental justice and pollution prevention policies?
  4. When considering products that are a “minimum risk” to public health and the environment, should the product also be considered to be of low impact to all communities, including low-income and minority populations? Please explain why or why not.

Exempted Classes of Pesticides

The regulations at 40 CFR 152.25(a)-(e) exempt the following classes of pesticides and pesticides from all provisions of FIFRA due to their unique and specific character: (a) treated articles or substances, (b) pheromones and pheromone traps, (c) preservatives for biological specimens, (d) foods, and (e) natural cedar. These exemptions are contingent on the products being intended for use, and used only in the manner specified under the regulations. The Notice contains an interesting discussion of the relative merits of exemption under these provisions versus the Minimum Risk Pesticide Program.   

In some situations, an exemption like those codified in 40 CFR 152.25(a) through (e) may be preferable to a listing under the Minimum Risk Pesticides Listing Program in 40 CFR 152.25(f). A minimum risk exemption would include all uses of a product consisting of eligible ingredients, provided that the labeling and other generic requirements are met. Other exemptions are more targeted as to the nature of the use, even as they are, in some cases, more general concerning what ingredients are included. EPA believes that exemptions like those codified in 40 CFR 152.25(a) through (e) may be more appropriate for situations where the exemption sought is narrowly tailored to a specific use pattern or where the pesticide functions via complex chemical processes that do not lend themselves to identification and listing of active and inert ingredients.

As these examples show, EPA has exempted some minimum risks products with pesticidal properties and uses from FIFRA regulation separately from the list of minimum risk pesticide ingredients. These include, like cedar, unrefined natural products that lack a specific formulation and products with a particular form or application, such as pheromone traps. One example of an unrefined natural product which currently lacks a specific formulation is peat. Peat is an accumulation of partially decomposed organic material found in peatlands or bogs, and used as fuel in gardening and certain types of septic filtration systems. While the use of peat in septic systems may be intended for a pesticidal (antimicrobial) purpose, it has been suggested that registration of such uses may not be necessary to carry out the purposes of FIFRA. In the context of this ANPR, EPA is interested in comments about whether there may be criteria that could address such circumstances or if EPA should consider proposing the creation of an exemption from FIFRA registration for the specific use of peat in septic filtration systems. In considering such an exemption, because of the public health and environmental interests at stake, should EPA also consider which label and labeling claims might be considered false or misleading for these systems (i.e., they could not be marketed to perform controls that they cannot be shown to achieve), and whether such circumstances warrant the consideration of any other limitations on the exemption from FIFRA registration.

The Notice goes on to ask a number of broad questions, including, but by no means limited to, the current classes of pesticide exemptions and other aspects of the Minimum Risk Pesticides Listing Program.

  1. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 CFR 152.25.
  2. Are there other pesticidal substances or systems, like peat as mentioned above, that EPA should consider adding as a new class at 40 CFR 152.25 for exemption from registration under FIFRA? How do these other pesticidal substances or systems meet the existing factors?
  3. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation? Please explain how these other factors should be weighed in a determination.
  4. When considering whether a category or class of products are a “minimum risk” to public health and the environment, should the category or class of products also be considered as being of low impact to all communities, including low-income and minority populations? Are there other factors that the Agency should consider?

Minimum Risk Pesticide Program Exemption

The Notice then turns to the conditions imposed on specific pesticide products in order to be eligible for a minimum risk exemption.

Condition 1: The product's active ingredients must all be listed in 40 CFR 152.25(f)(1).

Condition 2: The product's inert ingredients may only be those that are either listed in Table 2 of 40 CFR 152.25(f)(2)(iv); or a commonly consumed food commodity, animal feed item, or edible fat and oils as described in 40 CFR 180.950(a) through (c) as given in 40 CFR 152.25(f)(2)(i) through (iii).

Condition 3: All the ingredients (both active and inert) must be listed on the label. The active ingredient(s) must be listed by the label display name in 40 CFR 152.25(f)(1) and their percentage by weight in the product.

Condition 4: The product must not bear claims to control or to mitigate microorganisms that pose a threat to human health or claims to control insects or rodents carrying specific diseases.

Condition 5: The name of the producer or the company for whom the product was produced, and the company's contact information must be displayed prominently on the product label.

Condition 6: The label cannot include any false or misleading statements.

A pesticide product that meets all these conditions is exempt from federal regulation under FIFRA. EPA does not review products that claim to meet the criteria set by 40 CFR 152.25(f), and companies do not report such products to EPA. However, EPA goes on to discuss the authority of states to regulate federally exempt products.

[s]tates may enforce and often have their own requirements regarding minimum risk products. In 2019, most states required products that are exempt from federal regulation under 40 CFR 152.25(f) to adhere to some form of state regulation, varying from a simple fee to complete state registration.

The states have reported that the regulation of federally exempt products has presented some challenges for the states. EPA's previous response to the state concerns prompted the 2015 rule change to the federal program. The 2015 amendment codified the inert ingredients list by adding specific chemical identifiers, where available, for all eligible active and inert ingredients. The 2015 rule also modified the labeling requirements for the exemption to require products to list ingredients on the label with a designated label display name and provide the producer's contact information.

EPA invites the public to comment on the following questions on the Minimum Risk Pesticide Listing Program or the minimum risk exemptions and solicits comments on other aspects of the Minimum Risk Pesticide Listing Program.

  1. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and the labeling changes, made it easier for manufacturers, the public, and Federal, state, and tribal inspectors to identify specific chemicals used in minimum risk pesticide products?
  2. Are there state challenges to implementing the minimum risk program? Can EPA address those challenges with changes to its program? Do states have suggestions for improvements to the program?

Next Steps

EPA intends to review all the comments and information received in response to this ANPR, as well as previously collected and assembled information, to help determine whether to propose any additions or modifications to the class exemptions or other provisions of 40 CFR 152.25(a)-(e), the Minimum Risk Pesticide Listing Program in 40 CFR 152.25(f), or related policies and procedures. In addition to comments received in response to this ANPR, EPA states it may seek additional information from states, industry or other stakeholders. If EPA decides to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment. The Notice states that, during the development of a proposed rule, the Agency may also engage stakeholders or provide other opportunities to comment on EPA's proposal.

Submitting Comments

EPA’s Notice presents a rare opportunity for product developers and researchers in the private and public sectors to offer comments and suggestions at an early stage in the rulemaking process on a wide variety of key issues and topics. Any changes that ultimately result may have far-reaching impacts on bringing valuable new chemical and biological products to market, including innovative AgTech as well as conventional products. Comments must be received on or before July 7, 2021.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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