FIFRA Minimum Risk
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 25b products under FIFRA) with public
health benefits to consumers without the additional complexities
of a federal registration. In the intervening 20 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:
a. Commonly consumed food commodities, animal feed items and
edible fats and oils as described in 40 CFR 180.950(a), (b), and (c);
b. Listed in 40 CFR 152.25(f)(2);
c. 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 Association1
(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 survey2 of
minimum risk pesticides and found that 40 States require registration,
while 10 States do not currently require registration of minimum
risk pesticides. Of the 40 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 firstname.lastname@example.org.
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
10 Spray September 2018
Director, Scientific Affairs, HCPA
Continuing Innovation with Increased Oversight
1 Formerly the Consumer Specialty Products Association (CSPA)
2AAPCO State survey results can be found at https://aapco.org/2015/07/02/fifra-25b-workgroup/