Tag: FINRA

On November 23, 2021, Senator Cory Booker (D-NJ) announced his intention to reintroduce the Protect America’s Children from Toxic Pesticides Act of 2021, that would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) “to [protect fully] the safety of children and the environment, to remove dangerous pesticides from use, and for other purposes.” Similar legislation was introduced in the House (H.R. 7940) and Senate (S. 4406) in 2020, but the bills did not move out of committee.

Ending Indefinite Delays on Review of Dangerous Pesticides

The bill would amend FIFRA Section 2 to add a provision regarding registration review determination, defined as “the final decision to renew the registration of a pesticide product or active ingredient to authorize the use of the pesticide product or active ingredient” for an additional 15-year period from the date of the previous registration, reregistration, or registration review determination and in compliance with all applicable laws and regulations. Registration review determinations would not include any intermediate determination regarding the continued use of pesticide product or active ingredient.

The bill would allow an interested person to petition the U.S. Environmental Protection Agency (EPA) to designate an active ingredient or pesticide product as a dangerous pesticide, which would be defined as an active ingredient or pesticide product that may:

• Be carcinogenic;
• Be acutely toxic;
• Be an endocrine disruptor;
• Cause harm to a pregnant woman or a fetus; or
• Cause neurological or developmental harm.

EPA would have 90 days after receiving the petition to make a finding as to whether the petition presents substantial scientific information indicating that the designation of the petitioned active ingredient or pesticide product as a dangerous pesticide may be warranted. If EPA fails to make a finding, the active ingredient or pesticide product would be deemed to be a dangerous pesticide. In making its finding, EPA “shall fully consider all relevant evidence,” including epidemiological studies or data; peer-reviewed literature; and data generated by a federal or state agency or an agency of a foreign government.

If EPA issues a finding that an active ingredient or pesticide product may warrant designation as a dangerous pesticide, the registration would be suspended immediately and remain suspended until EPA makes a registration review determination. The continued sale and use of existing stocks of a suspended active ingredient or pesticide product would be prohibited. If EPA fails to suspend the registration of an active ingredient or pesticide product that may warrant designation as a dangerous pesticide by no later than 60 days after any deadline described in this subsection, the registration of the active ingredient or pesticide product would be “immediately and permanently canceled” and the sale of existing stocks would be prohibited.

Emergency Review of Other Pesticides Banned in Other Nations

The bill would amend FIFRA Section 6 to require EPA to suspend immediately the registration of any active ingredient or pesticide product that is banned or otherwise prohibited from entering the market by the European Union (EU), one or more EU member states, or Canada. EPA would then complete an expedited review of the justification and rationale for the ban. Unless EPA determines that the decision was “clearly erroneous,” the suspended registration would be canceled not later than two years after the date of completion of the review. EPA “shall fully consider all relevant evidence,” including epidemiological studies or data; peer-reviewed literature; and data generated by a federal or state agency or an agency of a foreign government. In determining whether the ban was “clearly erroneous,” EPA would be prohibited from considering “any economic analysis of the benefits or costs of continuing to register the pesticide.” Before making a final determination, EPA would provide the draft determination for a comment period of not less than 90 days.

Ensuring Accountability in Conditional Registrations

The bill would amend FIFRA Section 3(c)(7) to provide registrants only two years to meet the terms and requirements of conditional registration. If a registrant fails to comply with the conditions by the earlier of the deadlines established by EPA or two years after the effective date of the conditional registration, EPA would cancel the conditional registration. Conditional registrations outstanding at the time the bill is enacted for which the registrant has not met the conditions would be canceled. The continued sale and use of existing stocks of a pesticide for which the conditional registration has been canceled would be prohibited.

Prohibition on the Sale or Use of Existing Stocks of Suspended or Canceled Pesticides

The bill would amend FIFRA Section 6(a) to prohibit the sale or use of existing stocks of a pesticide for which the registration is suspended or canceled, or vacated or set aside by judicial decree.

Amending Emergency Exemption Provisions

The bill would amend FIFRA Section 18 to limit emergency exemptions for the same active ingredient or pesticide product in the same location to two years in any ten-year period. EPA would no longer grant emergency exemptions to use an active ingredient or pesticide product that is not registered for any use or that is registered conditionally.

Adding Transparency for Inert Ingredients

The bill would amend FIFRA Section 2(n) to require that the ingredient statement include:

• The name and percentage of each active ingredient in the pesticide product;
• The name and percentage of each inert ingredient in the pesticide product;
• If applicable, a statement that the pesticide product contains an inert ingredient determined by a state or federal agency, or the Administrator based on epidemiological data or peer-reviewed literature, to be likely:
  • To be carcinogenic;
  • To be an endocrine disruptor;
  • To be acutely toxic;
  • To cause harm to pregnant women or fetuses; or
  • To cause neurological or developmental harm.

The bill would amend FIFRA Section 3(c)(9) so that any required label or labeling must provide a complete list of inert ingredients.

Cancellation of Registration of Organophosphates

On the date of enactment, the bill would deem all organophosphate pesticides “to generally cause unreasonable adverse effects to humans,” and the registration of all uses of organophosphate pesticides would be “immediately and permanently canceled by operation of law and without further proceedings.” Tolerances and exemptions that allow the presence of an organophosphate or any pesticide chemical residue that results from organophosphate use in or on food would be revoked within six months of the date of enactment. The continued sale or use of existing stocks of organophosphate pesticides would be prohibited on the date of enactment. The bill would not allow any future organophosphate registrations and organophosphate pesticides would be ineligible for emergency use.

Cancellation of Registration of Neonicotinoids

On the date of enactment, the bill would deem all active ingredients and pesticide products containing one or more of the active ingredients imidacloprid, clothianidin, thiamethoxam, dinotefuran, acetamiprid, sulfoxaflor, and flupyradifurone (neonicotinoid pesticides) “to generally cause unreasonable adverse effects to the environment,” and the registration of all uses of neonicotinoid pesticides would be “immediately and permanently canceled by operation of law and without further proceedings.” Tolerances and exemptions that allow the presence of a neonicotinoid pesticide or any pesticide chemical residue that results from neonicotinoid pesticide use in or on food would be revoked within six months of the date of enactment. The continued sale or use of existing stocks of neonicotinoid pesticides would be prohibited on the date of enactment. The bill would not allow any future neonicotinoid registrations and neonicotinoid pesticides would be ineligible for emergency use.

Cancellation of Registration of Paraquat

On the date of enactment, the bill would deem paraquat “to generally cause unreasonable adverse effects to humans,” and the registration of all uses of paraquat would be “immediately and permanently canceled by operation of law and without further proceedings.” Tolerances and exemptions that allow the presence of paraquat or any pesticide chemical residue that results from paraquat use in or on food would be revoked within six months of the date of enactment. The continued sale or use of existing stocks of paraquat would be prohibited on the date of enactment. The bill would not allow any future paraquat registrations and paraquat would be ineligible for emergency use.

Empowering Communities to Protect Themselves from Pesticides

The bill would amend FIFRA Section 24 to extend the authority of a state to regulate the sale or use of any federally registered pesticide or device to “any political subdivision of a State.”

Protecting Farmworkers from Dangerous Pesticides

The bill would amend FIFRA Section 3(c)(9) to require that labels be printed in both English and Spanish. If a pesticide product is known to be used in agriculture by more than 500 individual persons or applicators who speak the same language other than English or Spanish, EPA will provide a translation of the label in that language on its website. The bill would amend FIFRA to include a section concerning farmworker safety. Employers of farmworkers would be required to report to EPA farmworker incidents, defined as exposure of a farmworker to an active ingredient, a pesticide product, a tank mixture of multiple pesticides, a metabolite, or a degradate that results in:

• An illness or injury:
  • Requiring medical attention or hospitalization of the farmworker; or
  • That requires the farmworker to stop working temporarily or permanently;
• A permanent disability or loss in function of the farmworker; or
• Death of the farmworker.

The bill would require EPA to implement an online system to facilitate the reporting of farmworker incidents within 60 days of the bill’s enactment. The online system must allow for anonymous reporting to protect farmworkers from retaliation. Employers that fail to report a farmworker incident would be fined $1,000 per day beginning on the eighth day after the farmworker incident occurs. Employers that knowingly fail to report or that pressure or coerce a farmworker not to report would be liable for a criminal penalty of up to $100,000, six months in prison, or both. The bill calls for EPA to implement a reward system that provides a monetary award of not less than $25,000 per person per farmworker incident that leads to the identification of one or more employers that have failed to report a farmworker incident.

Within 15 days of receiving a report of a farmworker incident, EPA would transmit a report of the incident to the manufacturer of each involved pesticide product and the manufacturer of each involved active ingredient or ingredients. If a farmworker incident results in the death of a farmworker, the pesticide product or active ingredient that caused the death would be immediately suspended, pending a review. Pesticide product manufacturers who receive a farmworker incident report would have 60 days to provide EPA an assessment of the incident, including whether any changes to the label of the pesticide product or active ingredient are warranted at the time of the assessment to avoid future farmworker incidents. Active ingredient manufacturers who receive a report of a farmworker incident would have 60 days to provide to EPA an assessment of the farmworker incident, including whether any changes to the pesticide product or active ingredient are warranted at the time of the assessment to avoid future farmworker incidents.

No later than the earlier of 90 days after receiving an assessment from a pesticide product or active ingredient manufacturer or 180 days after the occurrence of the farmworker incident, EPA will make a draft determination as to whether a change in the label of an involved pesticide product is warranted. EPA will publish its draft determination in the Federal Register for a 30-day comment period. No later than 30 days after the close of the public comment period, EPA will make a final determination as to whether the label should be changed and publish its decision in the Federal Register.

If EPA makes a final determination that the label of the applicable product must be changed and the manufacturer of the pesticide product or active ingredient fails to do so, the pesticide product or active ingredient “shall be immediately and permanently canceled by operation of law and without further proceedings.” If a pesticide product or active ingredient is responsible for ten or more farmworker incidents of any type, or three or more incidents resulting in death, and the pesticide product or active ingredient has not received a final determination regarding a registration review during the preceding 15-year period, EPA will “immediately suspend the pesticide product or active ingredient until a final determination is made regarding the registration review of the pesticide.”

Authority to Bring Civil Action

The bill would amend FIFRA Section 16 to allow any person to bring a civil action where there is an alleged failure of EPA to comply with any of its provisions. The U.S. District Courts would have exclusive jurisdiction over such actions.

Employee Protection

The bill would amend FIFRA to add a section regarding employee protection. Employers would be prohibited from discharging or discriminating against an employee because the employee has commenced or is about to commence a proceeding under the Act, has testified in a proceeding, or has assisted or participated in a proceeding. Employees would have 30 days from the date of the alleged violation to file a complaint with the Secretary of Labor and the Secretary would have 30 days to conduct an investigation.

Commentary

This bill is unlikely to become law any time soon. This legislation, or anything like it in terms of its presumption that pesticides approved by EPA under current law are fundamentally flawed, would present a radical change to current EPA authority and procedures. Advocates of such change believe otherwise, and point to the fact that FIFRA has not been amended for 25 years. Whether this is sufficient to garner broad support of national environmental and consumer advocacy groups is unclear. Assuming it gains the support of at least a handful of Democrats in the Senate, along with a likely House companion bill, this legislation lays the groundwork for advocating eventual changes to FIFRA. This approach takes a page from the Toxic Substances Control Act (TSCA) reform playbook. Certain Members of Congress and TSCA stakeholders established policy positions for reform five or more years before reauthorization occurred. Similar to TSCA, the legislation is premised on the view that FIFRA is fundamentally flawed, a widely held view with TSCA reform. This view is not widely shared with regard to FIFRA, however. Critics of this proposed legislation will argue that EPA has been effective at implementing FIFRA driven by the requirements of the 1996 Food Quality Protection Act amendments, following a rigorous scientific process with various required safety factors to determine that pesticides used on food meet a “reasonable certainty of no harm” standard. In that view, this bill may be a solution in search of a problem. If this legislation is indeed used as a starting point for reform, there will be many more years before any common ground is found — and common ground likely will be essential for any kind of meaningful FIFRA “modernization.”

---

Article by Bergeson & Campbell, P.C.‘s Government Regulation practice group.

For more articles about toxic substance legislation, visit the NLR Biotech, Food & Drug section.