Pesticides/Herbicides: U.S. Supreme Court Declines to Hear Bayer RoundUp Verdict Appeal
On June 21, 2022, the U.S. Supreme Court denied the August 16, 2021 Petition For Certiorari filed by Bayer (purchaser of Monsanto’s glyphosate-containing RoundUp product line and successor to its product liabilities) seeking to appeal the May 14, 2021, decision of the Ninth Circuit U.S. Court of Appeals holding that products liability claims for failure-to-warn of the risk of non-Hodgkin’s lymphoma from the products’ use are not preempted by the federal pesticide/herbicide labeling regulatory scheme set forth in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and administered by the Environmental Protection Agency (FDA). Monsanto Company v. Edwin Hardeman, No. 21-241. As a result, Plaintiff Edwin Hardeman’s $25 million jury verdict against Bayer awarded in the United States District Court for the Northern District of California on December 13, 2019, became final. Previously, in May 2021, Bayer announced its so-called “five point plan” to bring closure to potentially tens of billions of dollars of glyphosate personal injury liabilities contained in an estimated 138,000 claims. In July 2021, upon announcing the intent to appeal the Hardeman case to the U.S. Supreme Court, Bayer updated the plan with two possible outcomes of the case, stating “The first scenario is based on obtaining a favorable decision by the United States Supreme Court on a cross-cutting issue like federal preemption which would effectively and largely end the U.S. Roundup litigation. The second scenario assumes that the Supreme Court either declines to hear the Hardeman case or issues a ruling in favor of plaintiff – in that case the company would activate its own claims administration program.” On June 21, 2022, immediately after the U.S. Supreme Court Hardeman decision was announced, Bayer issued a statement saying, “[T]here are likely to be future cases, including Roundup cases, that present the Supreme Court with preemption questions and could also create a Circuit split.”
Pesticides/Herbicides: U.S. Supreme Court Declines to Hear Second Bayer RoundUp Verdict Appeal
On June 27, 2022, six days after denying a petition for certiorari alleging nearly identical legal issues in Monsanto Company v. Edwin Hardeman, No. 21-241, the U.S. Supreme Court denied Bayer’s March 17 2022, Petition for Certiorari requesting to appeal the November 17, 2021 final decision of the California Supreme Court also rejecting the claim that federal law preempted any failure-to-warn products liability theories arising from RoundUp exposure causing Hodgkin’s lymphoma. Monsanto Company v. Alberta Pilliod, et al., No. 21-1272. As a result, the $87 million California state court jury verdict in Pilliod became final. A previous Bayer statement made on June 21, 2022, upon the adverse ruling in Hardeman referenced the Pilliod case as a remaining possibility of a positive U.S. Supreme Court ruling on preemption significantly reducing Bayer’s potential liability. As a result of the denial of appeals in both Hardeman and Pilliod, there are presently no remaining jury verdicts against Bayer based upon RoundUp exposure through which Bayer could pursue a U.S. Supreme Court ruling that failure-to-warn products liability claims are preempted by FIFRA and federal law.
- However, a case does presently exist in which the issue remains pending on appeal to the Eleventh Circuit U.S. Court of Appeals. In John D. Carson, Jr. v. Monsanto Company, No. 21-10994, Plaintiff Carson’s failure-to-warn products liability claims were dismissed by the federal trial court on December 21, 2020 on federal preemption grounds. The case ultimately settled but an appeal was taken by the Plaintiff on March 26, 2021, from the ruling on preemption as part of a settlement agreement with Bayer. The Carson case, if the preemption ruling is upheld, could create a conflict between the Eleventh and Ninth Circuit Courts which may justify the U.S. Supreme Court agreeing to hear a future appeal of the issue. This process would likely take several years to complete.
Pesticides/Herbicides: EPA’s 2020 Glyphosate (RoundUp) Registration Review Decision Reversed and Remanded
On June 17, 2022, the Ninth Circuit U.S. Court of Appeals issued an opinion granting the Petitions For Review filed by Natural Resources Defense Council and others and reversed and remanded back to the U.S. Environmental Protection Agency (EPA) its January 22, 2020 Interim Registration Review Decision for glyphosate, the active ingredient in RoundUp. The EPA registration review decision was termed interim because EPA had not completed an Endangered Species Act (ESA) assessment. While EPA’s Interim Registration Review found, among other things, that glyphosate does not pose “any unreasonable risk to man or the environment” the Court vacated the human health risk assessment as not sufficiently supported nor consistent with other EPA analysis on the casual relationship between glyphosate and non-Hodgkin’s lymphoma. The decision also found fatal flaws in the ecological assessment as well as ESA violations but did not vacate those two portions before remand. Therefore, the label use provisions contained in the 2020 Interim Registration Review Decision remain in effect. On remand, EPA is to re-perform the entire analysis and produce a Registration Review Decision consistent with the law and the contents of the Court’s decision in due course, with one deadline of October 1, 2022, applicable to the ecological portion due to a statutory requirement. The Interim Registration Review Decision’s assumed validity on human health formed the support for Bayer’s argument in the RoundUp toxic exposure litigation that product liability failure-to-warn claims are preempted by federal law. Any continued validity of Bayer’s argued preemption defense is now likely to be in significant legal jeopardy.
Dairy Policy: Federal Court Affirms Denial of Interstate Raw Butter Sales Petition
On June 10, 2022, the District of Columbia (D.C.) U.S. Circuit Court of Appeals issued an opinion affirming the 2020 decision of the lower federal court and the U.S. Food and Drug Administration (FDA) to deny a 2016 petition for rulemaking filed by California dairy producer Mark McAfee requesting FDA change the federal regulatory scheme to permit the interstate sale of butter manufactured from unpasteurized milk (raw butter). According to the opinion, in 1938 Congress codified the standard of identity for butter as “made exclusively from milk or cream, or both” and that “[n]o [other]. . . standard of identity. . . shall be established for. . . butter. . .“ 21 U.S.C. § 321a and 341. The federal Public Health Service Act authorized the FDA in 1987 to ban the interstate distribution of “any milk or milk product” that has not been pasteurized. 21 C.F.R. § 1240.61. In 1992, FDA confirmed that “milk product” includes butter. 57 F.R. 343. McAfee’s argument on appeal was that by imposing the pasteurization requirement on butter in 1987 it had impermissible altered butter’s 1938 Congressionally established standard of identity. The Circuit Court disagreed and noted that simply because the FDA cannot alter the standard of identity of butter does not mean it cannot regulate butter for other purposes, such as distribution, pursuant to the Public Health Service Act.
Pesticides/Herbicides: Three Neonicotinoid Final Biological Evaluations Released
On June 16, 2022, the U.S. Environment Protection Agency released its final biological evaluations (BEs) for three neonicotinoid insecticides (clothianidin, imidacloprid, and thiamethoxam), to determine under all registered uses and approved product labels whether they affect one or more federally listed endangered or threatened species or other designated critical habitats. Draft BEs were published in August 2021. The findings were: Clothianidin is likely to adversely affect 67 percent of species and 56 percent of critical habitats. Imidacloprid is likely to adversely affect 79 percent of species and 83 percent of critical habitats. Thiamethoxam is likely to adversely affect 77 percent species and 81 percent of critical habitats. Because of the findings, EPA has initiated formal consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) which ultimately publish their biological opinions and recommended risk mitigation measures. The process is expected to take until at least 2024 and is following the new EPA Endangered Species Act (ESA) Workplan adopted in April 2022 to help address and cure EPA long-standing lack of timely and thorough ESA compliance.
Air/Water Quality: EPA Announces $60 Million for Gulf Hypoxia Program
On June 10, 2022, the U.S. Environmental Protection Agency announced funding of $60 million over the next five years of Bipartisan Infrastructure Law funding for nutrient reduction efforts through the EPA’s Gulf Hypoxia Program by the twelve member states of the Mississippi River/Gulf of Mexico Watershed Hypoxia Task Force. Also publicly released was a 26-page Memorandum with cooperative agreement guidance for states on how EPA will award and administer funds, priorities for nutrient reduction, and flexibility for state specific activities.
Avian Influenza: Commercial Poultry HPAI Detection Totals Unchanged
As of June 30, 2022, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS)’s HPAI 2022 Confirmed Detections database confirmed a total of 379 highly pathogenic avian influenza (HPAI) detections in 36 states (186 commercial flocks and 193 backyard flocks), resulting in 40.09 million birds depopulated.
- Nationally, new commercial poultry premise detections have decreased from a high of 45 during the first week of April to 3 detections in the month of June.
- Pennsylvania’s last commercial premise detection was on June 2. According to a Pennsylvania Department of Agriculture, Bureau of Animal Health update on June 27, all Control Zones in Pennsylvania except one are scheduled to be released by July 6, 2022.
- Between April 15 through June 28, 2022, USDA APHIS confirmed17 HPAI infected commercial poultry premise/flocks in Pennsylvania, totaling 4,224,700 birds depopulated. 8 infected premises are in Lancaster County, totaling 3,767,300 layers, 68,400 broilers, and 19,300 ducks. 9 infected premises are in neighboring Berks County, totaling 162,400 layers, and 207,000 ducks.
PROGRAMS & RESOURCES
- SCOTUS Update: Sackett v. EPA (June 28, 2022).
- SCOTUS Update: National Pork Producers Council v. Ross (June 23, 2022).
- New HPAI cases nearly zero and Renewable Fuel Standards volume set (June 15, 2022).
Top #AgLaw HotLinks June 20 – 25, 2022:
USDA Announces Financial Assistance for Food Safety Certification for Specialty Crops Producers, (Food Safety Magazine).
Pa. leads nation, investing $8.2 million to protect 32 farms in 18 counties, (Morning Ag Clips).
APHIS turns attention to swine fever after months of battling avian flu, (Food Safety News).
Webinars: Understanding Agricultural Law. A free monthly webinar series via ZOOM for general practice attorneys and business advisors of all kinds representing agricultural and rural clients. One hour of substantive CLE credit available for Pennsylvania licensed attorneys at no charge. Recordings and materials of prior webinars in the series:
- Understanding the Basics of Agricultural Labor Laws (April 29, 2022)
- Understanding the Basics of Leasing Farmland for Energy Development (May 20, 2022).
- Understanding the Basics of Land Use Regulation of Agriculture (June 24, 2022).
- July 22, 2022, noon ET: Understanding the Basics of Statutory Protections for Agricultural Operations. Register.
Webinars: Legal Planning for Specialty Crop Producers. A free periodic webinar series via ZOOM. Register at any time to watch recordings of past, and attend all future, sessions, as well as receive the webinar materials. Prior webinars in the series:
- Legal Liability Risks from Business Invitees on the Farm (Mar. 9, 2022).
- Legal Liabilities in Selling Raw and Processed Specialty Crop Products (Mar. 23, 2022).
- Business Structures for Operational Resilience and Liability Avoidance (Apr. 6, 2022).
- Nov. 16, 2022, noon ET: Licensing and Regulatory Obligations in Selling Raw and Processed Specialty Crop Products.
- Nov. 30, 2022, noon ET: Municipal Law & Zoning for Agritourism / Agritainment, Specialty Crop Processing & Sales.
- Dec. 14, 2022, noon ET: Statutory Protections/Restrictions: Understanding PA’s Ag Area Security, Right-To-Farm, ACRE, and Clean & Green Laws.
Webinars: Dairy Quarterly Legal Webinar. A free quarterly webinar series via ZOOM covering legal and regulatory developments in the U.S. dairy industry from the preceding quarter, plus an in-depth look at a single focus topic of law, regulation, or government policy of interest to dairy professionals. One hour of substantive CLE credit available for Pennsylvania licensed attorneys at no charge. More info and registration.
- July 26, 2022, noon ET.2nd Quarter of 2022—In addition to a round-up of quarterly legal developments, the focus topic will be labeling of plant-based foods and beverages being manufactured and sold as substitutes for milk and dairy.
- October 25, 2022, noon ET. 3rdQuarter of 2022—In addition to a round-up of quarterly legal developments, the focus topic will be the upcoming 2023 Farm Bill and the potential implications for the dairy industry.
Agricultural Law & Policy Resources of Interest:
Tex. A&M Agric. Law Blog, June 24, 2022, Weekly Round Up, Tiffany Dowell Lashmet (June24, 2022).
Tex. A&M Agric. Law Blog, Second Edition – Five Strands: A Landowner’s Guide to Fence Law in Texas, Tiffany Dowell Lashmet (June 20, 2022).
Ohio St. Univ. Ext. Farm Off. Blog, What Assets are Subject to Divorce?, Robert Moore (June 23, 2022).
Univ. Md. Risk Mgmt. Educ. Blog, Interpreting Conservation Easements and When New Structures are Allowed, Paul Goeringer (June 21, 2022).
Nat’l Agric. Law Ctr., Ninth Circuit Orders EPA to Revisit Conclusion That Glyphosate is “Not Likely” to Cause Cancer, Brigit Rollins (June 23, 2022).
Nat’l Agric. Law Ctr., The Legality of Food Labeling Claims: Eggs and Dairy, Jana Caracciolo (June 21, 2022).
- of Ill.’s FarmdocDaily, Inflation and Commodity Prices, Gary Schnitkey, et al. (June 21, (2022).
- of Ill.’s FarmdocDaily, 1.) Introducing the Gardner Food and Agricultural Policy Survey; 2.) Climate Change & the Food System: Gardner Survey Results, Part 2; 3.) Public Perception of Government Support for Farmers: Gardner Survey Results, Part 3; 4.) Public Perception of USDA Spending: Gardner Survey Results, Part 4 (June 3 – 24, 2022).
Penn State News, Research & Resources:
PSU Ext., 2022 Pennsylvania Vegetable Disease Update for June 22 (June 22, 2022).
PSU Ext., Bringing Grazing Animals Back to Our Croplands by Grazing Cover Crops (June 22, 2022).
PSU Ext., What Can Pennsylvanians Do About Hemlock Woolly Adelgid? (June 20, 2022).
Agriculture-Related Legislative Hearings & Reports:
No upcoming meetings.
Pennsylvania Farm/Food Employers’ Listserv (PFEL) is a human resources networking group exclusively for farm and food employers. Subscribe by email with “subscribe” in the subject line to [email protected].
FEDERAL ACTIONS—EXECUTIVE & LEGISLATIVE
U.S DEPARTMENT OF AGRICULTURE (USDA) PRESS RELEASES
Fact Sheet: Supporting the Wildland Firefighting Workforce (June 21, 2022).
USDA AGENCY PRESS RELEASES:
Agricultural Marketing Service (AMS)
Agricultural Research Service (ARS)
Collecting a Library of Bee Genomes (June 22, 2022).
Winter Honey Bees Show Resistance to a Common Insecticide (June 21, 2022).
Animal and Plant Health Inspection Service (APHIS)
Economic Research Service (ERS)
Low-Income and Low-Foodstore-Access Census Tracts, 2015–19 (June 23, 2022).
Food and Nutrition Service (FNS)
Foreign Agricultural Service (FAS)
STATEMENT: USDA Trade Mission Underway in London (June 21, 2022).
Forest Service (FS)
Statement from Chief Randy Moore on Hermit’s Peak Fire Review (June 21, 2022).
National Institute of Food and Agriculture (NIFA)
SCSU Team Finds Ozone Treatment to Manage Stored-Product Pests (June 21, 2022).
Natural Resource Conservation Service (NRCS)
FEDERAL EXECUTIVE AGENCIES (Federal Register June 20–25, 2022):
Agricultural Marketing Service
87 FR 37495 Notice: “Solicitation of Nominations for Members of the USDA Grain Inspection Advisory Committee” (June 3, 2022).
87 FR 37495 Notice—Comment Period: “National Organic Standards Board; Meeting” (June 23, 2022).
87 FR 37240 Proposed Rule—Comment Period: “Modification of Marketing Order Regulations for Almonds Grown in California” (June 22, 2022).
87 FR 37808 Notice: “Submission for OMB Review; Comment Request [Request for a Medical Exemption to the COVID-19 Vaccination Requirement]” (June 24, 2022).
87 FR 37301 Notice: “Submission for OMB Review; Comment Request [Information Collection Request; Representations Regarding Felony Conviction and Tax Delinquent Status for Corporate Applicants.]” (June 22, 2022).
Animal and Plant Health Inspection Service
Error! Hyperlink reference not valid. Notice: “International Sanitary and Phytosanitary Standard-Setting Activities” (June 24, 2022).
87 FR 37812 Notice: “Concurrence With WOAH Risk Designations for Bovine Spongiform Encephalopathy” (June 24, 2022).
87 FR 37301 Notice—Comment Period: “Notice of Availability of a Pest Risk Analysis for the Importation of Fresh Baby Kiwi Fruit From France Into the Continental United States” (June 22, 2022).
Environmental Protection Agency
87 FR 37287 Notice—Comment Period: “Receipt of Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities May 2022” (June 22, 2022).
87 FR 37332 Notice: “Spirodiclofen; Rescinding Cancellation Order for Certain Pesticide Registrations” (June 22, 2022).
87 FR 36850 Notice—Comment Period: “Pesticide Product Registration; Receipt of Applications for New Active Ingredients-May 2022” (June 21, 2022).
87 FR 36851 Notice—Comment Period: “Pesticide Product Registration; Receipt of Applications for New Uses-May 2022” (June 21, 2022).
Farm Service Agency
87 FR 36816 Notice—Comment Period: “Notice of Funds Availability (NOFA) for the Food Safety Certification for Specialty Crops Program” (June 21, 2022).
Food and Drug Administration
87 FR 36864 Notice: “Food and Drug Administration Oversight of Food Covered by Systems Recognition Arrangements; Guidance for Food and Drug Administration Staff; Availability” (June 21, 2022).
Food and Nutrition Service
87 FR 37813 Notice—Comment Period: “Agency Information Collection Activities: Proposed Collection: Comment Request-EmpowHR/Person Model Non-Employee Data Sheet-FNS-775″ (June 24, 2022).
87 FR 37814 Notice—Comment Period: “Agency Information Collection Activities: Proposed Collection; Comment Request-FNS Generic Clearance for the FNS Fast Track Clearance for the Collection of Routine Customer Feedback” (June 24, 2022).
Land Management Bureau
87 FR 36877 Notice: “Filing of Plats of Survey: Oregon/Washington” (June 21, 2022).
National Institute of Food and Agriculture
87 FR 37302 Notice: “Solicitation of Veterinary Shortage Situation Nominations for the Veterinary Medicine Loan Repayment Program” (June 22, 2022).
Rural Business-Cooperative Service
87 FR 37819 Notice—Comment Period: “60-Day Notice of Proposed Information Collection: Intermediary Relending Program” (June 24, 2022).
U.S. HOUSE AGRICULTURE COMMITTEE:
H.R.8169 “To establish a Rural Telehealth Access Task Force to determine how to address barriers to the adoption of telehealth technology and access to broadband internet access service in rural areas, and for other purposes.” Referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. (June 22, 2022).
H.R.8168 “To improve the health and resiliency of giant sequoias, and for other purposes.” Referred to the Committee on Natural Resources, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. (June 22, 2022).
H.R.8162 “To direct the Secretary of Agriculture to fill vacancies and increase the number of positions available in the Forest Service Law Enforcement and Investigations organization, and for other purposes.” Referred to the House Committee on Agriculture. (June 21, 2022).
H.R.8150 “To amend the Families First Coronavirus Response Act to extend child nutrition waiver authority, and for other purposes.” Referred to the Committee on Education and Labor, and in addition to the Committees on Appropriations, Small Business, and Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. (June 21, 2022).
H.R.7606 “Meat and Poultry Special Investigator Act of 2022” Received in the Senate and Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (June 21, 2022).
U.S. SENATE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY:
S.4030 “Cattle Price Discovery and Transparency Act of 2022” Committee on Agriculture, Nutrition, and Forestry. Ordered to be reported with an amendment favorably. (June 22, 2022).
S.3870 “Meat and Poultry Special Investigator Act of 2022” Committee on Agriculture, Nutrition, and Forestry. Ordered to be reported with an amendment favorably. (June 22, 2022).
S.4438 “A bill to amend the Food and Nutrition Act of 2008 to modify work requirements under the supplemental nutrition assistance program, and for other purposes.” Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (June 21, 2022).
STATE ACTIONS—EXECUTIVE & LEGISLATIVE
PENNSYLVANIA DEPARTMENT OF AGRICULTURE PRESS RELEASES:
PENNSYLVANIA EXECUTIVE AGENCIES (Pa. Bulletin Vol. 52, No. 26—June 25, 2022):
State Conservation Commission
52 Pa.B. 3666 “Action on Odor Management Plans for Concentrated Animal Operations and Concentrated Animal Feeding Operations and Volunteers Complying with the Commonwealth’s Facility Odor Management Program”
Dillon Lightfoot—Research Assistant
Brook Duer—Staff Attorney