Agriculture
Federal Insecticide, Fungicide, and Rodenticide Act (FIRFA) (7 U.S.C. § 136 et seq.)
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulates the registration, labeling, and use of pesticides to protect human health and the environment. While the law establishes national standards, its implementation has raised concerns about unequal exposure risks, particularly in agricultural and low-income communities.
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7 U.S.C. § 136a(c)(5) of FIFRA specifically outlines the requirements for the EPA to unconditionally register a new pesticide. It states that the EPA shall register a pesticide if: (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials comply with the requirements of FIFRA; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practices, it will not generally cause unreasonable adverse effects on the environment. This provision essentially requires the EPA to determine, based on the available data and evidence, that the pesticide will not cause "unreasonable adverse effects on the environment" when used as intended and according to its labeling. This means that "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide" is an unreasonable adverse effect.
References
ARTICLE: ENVIRONMENTAL CRIMES, 58 Am. Crim. L. Rev. 821
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), under EPA has the authority to deny the registration of pesticides that might cause "unreasonable adverse effects" on the environment. This article states that "Pollinator Stewardship Council v. EPA, 806 F.3d 520, 523 (9th Cir. 2015)," affirms FIFRA allows the EPA to reject or restrict the use of pesticides to prevent unreasonable environmental damage. This law review also emphasizes the agency's mandate to ensure that the products it approves do not pose significant risks which shows the importance of its role in environmental protection and the enforcement of regulations that safeguard ecological and public health.
ARTICLE: ENVIRONMENTAL CRIMES, 57 Am. Crim. L. Rev. 657
The EPA has the authority to deny or cancel the registration of a pesticide if it is determined that the pesticide would cause "unreasonable adverse effects" on the environment. This aligns with the court's findings in Pollinator Stewardship Council v. EPA, where the court noted that FIFRA enables the EPA to deny registration to prevent such adverse effects. The case is used as an example to show the EPA's regulatory authority and the judicial backing for decisions to protect environmental health.
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Link to the case: https://casetext.com/case/pollinator-stewardship-council-v-united-states-epa-3
Link to the United States Code (2023 Edition): https://www.govinfo.gov/app/details/USCODE-2023-title7/USCODE-2023-title7-chap6-subchapII
Please note that the following brief was prepared by a student.
Plaintiff: Pollinator Stewardship Council; American Honey Producers Association; National Honey Bee Advisory Board; American Beekeeping Federation; Thomas R. Smith; Bret L. Adee; Jeffery S. Anderson
Defendant: U.S. Environmental Protection Agency; Bob Perciasepe (in his official capacity as acting administrator of the USEPA); Dow AgroSciences LLC (Respondent-Intervenor)
Procedural History: This case originated from a petition for review filed by the plaintiffs challenging the EPA's approval of insecticides containing sulfoxaflor, a new insecticide that initial studies showed to be highly toxic to honey bees. The case was heard before the United States Court of Appeals for the Ninth Circuit.
Background: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) prohibits the sale of pesticides that lack approval and registration by the EPA. The EPA may deny an application for registration when necessary to prevent unreasonable adverse effects on the environment. In 2010, Dow Agrosciences LLC applied for approval of sulfoxaflor under FIFRA. As part of the registration process, the EPA analyzed studies submitted by Dow using a tiered risk assessment framework to evaluate the potential risk to bees. The EPA's Tier 1 analysis showed that sulfoxaflor exceeded the level of concern for acute toxicity to bees, triggering the need for further testing. The EPA then proceeded to Tier 2, which involved semi-field studies evaluating the effects of sulfoxaflor on bee colonies. However, the EPA found that the Tier 2 studies submitted by Dow had significant limitations and did not conclusively demonstrate the effects of sulfoxaflor on brood development and long-term colony health, particularly at the maximum proposed application rate. Initially, the EPA proposed to conditionally register sulfoxaflor at a reduced application rate and requested additional studies to address the data gaps. However, a few months later, the EPA unconditionally registered sulfoxaflor with certain mitigation measures and a lowered maximum application rate, without obtaining any further studies.
Legal Issue: Did the EPA’s decision to unconditionally register sulfoxaflor reference the statute 7 U.S.C. § 136a(c)(5) to find the pesticide "unreasonable adverse effects.”
Holding: The Ninth Circuit Court of Appeals vacated the EPA's unconditional registration of sulfoxaflor and remanded the case to the EPA because the EPA's decision to unconditionally register sulfoxaflor was not in accordance with the statutory requirements of 7 U.S.C. § 136a(c)(5), as the EPA failed to determine, based on substantial evidence, that sulfoxaflor "will not generally cause unreasonable adverse effects on the environment."
Reasoning: Under 7 U.S.C. § 136a(c)(5), the EPA can register a new pesticide only if it determines that the pesticide "will not generally cause unreasonable adverse effects on the environment." The EPA's decision to unconditionally register sulfoxaflor was based on flawed and limited data that did not adequately address the effects of sulfoxaflor on brood development and long-term colony strength of bees. The Tier 2 semi-field studies submitted by Dow had significant limitations, which included use of application rates lower than the maximum proposed rate, short observation periods, and inconclusive data on the effects on brood development and long-term colony strength. As a result, the EPA acknowledged the insufficiency of the data and initially proposed conditional registration pending additional studies but later granted unconditional registration without obtaining any new data to determine whether sulfoxaflor would cause unreasonable adverse effects on bees. The court rejected the EPA's argument that the inconclusive studies could be used as affirmative proof that sulfoxaflor would not cause unreasonable adverse effects on bees, as required by 7 U.S.C. § 136a(c)(5). Without sufficient data to determine whether sulfoxaflor would cause unreasonable adverse effects on bees, the EPA's decision to unconditionally register sulfoxaflor was not in accordance with the statutory requirements of 7 U.S.C. § 136a(c)(5).
Plant Protection Act (PPA) (7 U.S.C. §§ 7701–7786)
The Plant Protection Act of 2000 supersedes a patchwork of prior acts such as the Farmland Protection Policy Act (FPPA), the Plant Quarantine Act (PQA), and the Federal Noxious Weed Act (FNWA) to create a unified law that defends the agriculture, parks, and overall ecosystem of the United States from plant pests and noxious weeds. It defines plant pests and noxious weeds as two separate categories and requires the Secretary of Agriculture to regulate their introduction and dissemination within the United States. The Animal and Plant Inspection Service (APHIS) undertakes that authority. There is a petition and approval process in place to verify newly imported species or newly bred or genetically engineered species of plants or potential plant pests before they may be imported, grown, and/or sold.
The Secretary further has the authority to add or remove plants from the list of permit-requiring species at their discretion. The Secretary must quarantine any imported plant or plant-related article until it is inspected and approved, and can destroy unauthorized and dangerous plant material. The Secretary may acquire land, coordinate with other agencies, give grants, and issue regulations and orders in order to intercept the spread of plant pests and noxious weeds. They may also stop and inspect people or cargo without a warrant and may enter any premises within the US with a warrant, and bring suits in a court of law with a maximum penalty of 1 year in prison for one violation, and up to 10 years in prison for multiple violations. Mail carriers are not responsible for plants or plant pests illegally sent in the mail. The Act establishes the National Clean Plant Network, which provides clean, pest-free plant propagative material for nurseries for agricultural purposes. Money may be allocated for the removal of noxious weeds from an area.
There are also sections of the PPA detailing how the government must control specific pests like Sudden Oak Death, grasshoppers, and Mormon crickets, as well as the use of the pesticide methyl bromide.
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7 U.S.C. § 7701, part of the Plant Protection Act of 2000, outlines Congressional findings that emphasize the need to detect, control, and eradicate plant pests and noxious weeds to protect U.S. agriculture, the environment, and the economy. It highlights the importance of safe interstate and/or foreign commerce and supports using biological controls to manage risks
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Please note that the following brief was prepared by a student.
Link to the United States Code (2024 edition): https://www.govinfo.gov/app/details/USCODE-2024-title7/USCODE-2024-title7-chap104-sec7701/summary
Link to the case: https://advance.lexis.com/search/?pdmfid=1519360&crid=4ccf48b0-f976-
1. Heading.National Family Farm Coalition et al., v. Vilsack et al., 758 F. Supp. 3d 1060, 2024 U.S. Dist. (N.D. Cal, 2024).
a. Plaintiff: National Family Farm Coalition et al.
b. Defendant: Vilsack et al.
c. Court: U.S. District Court for the Northern District of California
2. Procedural History. None, this seems to be the first trial of this case
3. Facts. The PPA (Plant Protection Act) delegates authority to APHIS (Animal and Plant Health Inspection Service) to regulate plant pests and noxious weeds. The initial definition of a GE (genetically engineered) organism that is a plant pest is one that is produced using the DNA of plant pests. “Under the part 340 regulations, plant pests could not be moved interstate or introduced into the environment without notification and a permit, and permitting conditions included record-keeping and labeling requirements.” Noxious weeds are regulated under 7 C.F.R. § 360, which “prohibits the unauthorized movement of any plant designated as a noxious weed by the Secretary of Agriculture.” Part 360 regulates noxious weeds by taxon, meaning that a plant's GE and non-GE counterparts are treated identically for noxious weed purposes. However, The PPA defines "noxious weed" as "any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment." There were many proposed versions of new litigation, and the final version proposed in 2019 was much less restrictive than the prior proposals and effectively did not integrate any new noxious weed regulation into the part 340 regulations, stating that part 360 regulations were sufficient.
4. Legal Issue. In view of the expanded definition of noxious weeds in the PPA (7 U.S.C. § 7701), does APHIS have to integrate noxious weed regulation into its rule 340 regulations?
5. Holding or Decision. Yes, in light of 7 USC 7701, APHIS must either add noxious weed regulations into its rule 340 or provide sound scientific reasoning for why it will not do so in a manner that addresses concerns raised in prior notices of proposed rulemaking (NPRMs) or reports by the OIG; not addressing them is considered arbitrary and capricious.
6. Reasoning.
Based on Transportation Division of the International Association of Sheet Metal, Air, Rail, & Transportation Workers v. Federal Railroad Administration (Transp. Workers), 988 F.3d 1170 (9th Cir. 2021), APHIS has to address concerns raised in prior rule proposals (NPRMs) and Office of the Inspector General reports when making a new rule. Prior NPRMs in 2008 and 2017 and prior OIGs in 2005 and 2015 all raise the issue of expanding the regulation of noxious weeds due to advances in GE technology wherein a species may not originally be a noxious weed, and may be modified via a mechanism that does not include a plant pest or the genes of a plant pest such that it becomes a noxious weed. Due to these advances, defining a noxious weed by taxon significantly limits the scope of regulation such that it is likely to miss potentially noxious GE plants.
“APHIS's errors are significant. For over a decade it believed it should incorporate its noxious-weed authority into its part 340 regulations due to specific concerns APHIS itself identified. The final rule does the opposite without so much as a mention of the concerns identified in the prior NPRMs. This is not an error of a "technical nature." Nat'l Fam. Farm Coalition, 966 F.3d at 929. The error undergirding the conventional-breeding exemption is also substantial, for the rule ignores scientific evidence suggesting that its premise is without scientific basis. Consequently, it is unclear that APHIS would "adopt the same rule on remand." Pollinator Stewardship Council, 806 F.3d at 532.”
7. Dissenting Opinions. None.