September 2018

FIFRA Minimum Risk Pesticides; Continuing Innovation with Increased Oversight

Aerosols are often the convenient package of choice for pesticides, and whether it is their ability to spray more than 20 feet, or dispense product continuously, as with bug bombs, consumers and commercial workers depend on aerosol pesticides for everyday needs and in tricky situations. When facing off with a wasp’s nest, I’m always grateful for the aerosol pesticide in my hand.

Manufacturers and marketers of aerosol pesticides are constantly innovating to meet increasing consumer demand for new products and are acutely aware of the complex regulations that govern aerosol products. However, sometimes regulations are devised to reduce the regulatory burden in an effort to foster innovation. One such example was the formation of the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) Minimum Risk Pesticides.

Established in 1996, the minimum risk pesticide exemption relies on the premise that it is unnecessary to require submission of data that proves the safety of a chemical already known to pose little or no risk to human health or the environment. These exemptions benefit consumers and businesses by reducing the costs and regulatory burdens associated with pesticide registration.

This allows companies to provide minimum risk pesticide products (often referred to as 25[b] products under FIFRA) with public health benefits to consumers without the additional complexities of a federal registration. In the intervening twenty years, these products have taken off in the marketplace. However, these products may be a victim of their own success as there appears to be an increased need for federal oversight.

A minimum risk pesticide product must meet the following six conditions to be exempted from federal registration under FIFRA, i.e., the pesticide does not need to be registered with the U.S. Environmental Protection Agency (EPA):

  1. The product’s active ingredients must only be those that are listed in 40 CFR 152.25(f)(1).
  2. The product’s inert ingredients may only be those that have been classified by EPA as:
    1. Commonly consumed food commodities, animal feed items and edible fats and oils as described in 40 CFR 180.950(a), (b), and (c);
    2. Listed in 40 CFR 152.25(f)(2);
    3. Certain chemical substances listed under 40 CFR 180.950(e).
  3. All ingredients (active and inert) must be listed on the label. The active ingredient(s) must be listed to display the name and percentage by weight while inert ingredient(s) need to be listed only by name.
  4. The product must not have claims that either control or mitigate organisms, insects or rodents that pose a threat to human health.
  5. The company’s name and contact information displayed prominently on the product label.
  6. The label cannot include any false or misleading statements.

While 25(b) products meeting these six criteria do not require formal EPA registration, these products are still considered pesticides; hence states may—and most do—require registration of the products where sold or distributed.

In 2006, the Household & Commercial Products Association[1] (HCPA) petitioned EPA to exclude from the minimum risk pesticide exemption pesticides that claim to control “pests of significant public health importance” and require an abbreviated registration for minimum risk products that are to be used for the control of public health pests. These pests would include mosquitoes that can carry a host of diseases (such as Malaria, the West Nile Virus or Zika Virus) or ticks that can carry Lyme disease. In 2011, EPA addressed the petition by adjusting the label claims to only allow general public health claims while keeping the door open to potential future regulation.

Additionally, while EPA does not register these products, each state has its own statutes and regulations concerning pesticide sales and distribution. This has led to a variety of state requirements and a cornucopia of compliance requirements that are challenging for product manufacturers and other states to navigate. In light of these challenges, the Association of American Pesticide Control Officials (AAPCO) formed a workgroup in the spring of 2017 to facilitate the collaboration of states and industry in order to share information, provide guidance, foster label consistency and reduce the duplication of efforts in the review and registration of minimum risk pesticide products. To illustrate the complexity, they conducted a survey[2] of minimum risk pesticides and found that forty states require registration, while ten states do not currently require registration of minimum risk pesticides. Of the forty states and the District of Columbia that currently require state registration of minimum risk pesticides, there is a wide variance of their requirements that vary from a review of the label to submission of a Confidential Statement of Formula (CSF), Safety Data Sheet (SDS) and efficacy data.

With this in mind, HCPA, representatives from the states and member companies recently visited with EPA to discuss minimum risk pesticides and explore ways to improve federal oversight. From that meeting, we requested improved federal guidance and guidelines to refine definitions and clarification of the exemption to improve certainty around these products. These conversations continue within EPA, the states and industry.

The work being done here represents the efforts of HCPA’s Pest Management Products Division, but these issues also emphasize the importance of working with regulators to ensure innovative products have opportunities to thrive in the marketplace. If your company is interested in this division’s activities, please contact [email protected]

To expand your knowledge of pesticide regulations, please join us in Washington, D.C. on October 9–10, 2018, for HCPA’s annual Overview of Pesticide Regulation in the U.S. The course focuses on the practical: what you need to know to get your pesticide products on the market, keep them on the market and avoid penalties. HCPA also has a number of webinars and workshops coming up in September and October on topics such as VOC limits, ingredient disclosure, the NYSDEC and more. SPRAY

[1] Formerly the Consumer Specialty Products Association (CSPA)

[2] AAPCO State Survey Results can be found here