A comprehensive summary of today’s judicial, legislative, and regulatory developments in agriculture and food. Email important additions HERE.

Judicial: ESA, water law, Navigable Waters Protection Rule, vacatur

In WILDEARTH GUARDIANS v. DEB HAALAND, Sec’y, U.S. Dep’t of the Interior, et al., No. CV 20-1035 (CKK), 2021 WL 4502054 (D.D.C. Sept. 30, 2021), the court considered the appropriate remedy for the U.S. Fish and Wildlife Service’s (“Service”) failure to comply with a 12-month statutory deadline. WildEarth Guardians brought this suit after it petitioned the Service to list four freshwater aquatic species as threatened or endangered under the Endangered Species Act. When requested by a petition a 12-month statutory deadline for determining the status of the species is warranted. However, the 12-month finding for the Rio Grande chub is 7 years overdue, the Rio Grande sucker is 6 years overdue, and the sturgeon chub and the sicklefin chub are 4 years overdue. The court ultimately held that the Service must complete the 12-month findings for the Sicklefin Chub and Sturgeon Chub by September 30, 2023, and for the Rio Grande Chub and Rio Grande Sucker by June 14, 2024.

In Navajo Nation v. Regan, No. 20-CV-602-MV/GJF, 2021 WL 4430466 (D.N.M. Sept. 27, 2021), the court considered whether to include vacatur when remanding the Navigable Waters Protection Rule (“NWPR”). The Agencies sought voluntary remand of the NWPR to replace the rule, in doing so the Agencies were not requesting vacatur of the NWPR. The Navajo Nation argued that vacatur was proper because leaving the NWPR in place would result in significant, actual environmental harms to the Navajo Nation.

The court considered two factors to determine whether the NWPR should be vacated. One, “the seriousness of the rule’s deficiencies,” and two, “the disruptive consequences of an interim change that may itself be changed.” The court concluded that allowing the NWPR to remain in place upon remand would present a possibility of serious environmental harm. Additionally, the court found that any potential for disruptive consequences was outweighed in favor of vacatur. The court held that voluntary remand of the NWPR was appropriate and that the remand should include vacatur of the NWPR.

REGULATORY: APHIS, EPA, FS

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

Notice announcing APHIS’s intention to request a revision to and extension of approval of an information collection associated with the regulations to prevent the spread of citrus canker, citrus greening, and citrus greening’s vector, the Asian citrus psyllid, to non-infested areas of United States. Info here.

FOOD AND DRUG ADMINISTRATION

Notice announcing the availability of a final guidance for industry #265 entitled “Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.” Info here.

Notice announcing the availability of a final guidance for industry #268 entitled “Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.” Info here.

Notice announcing the availability of a final guidance for industry #266 entitled “Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs.” Info here.

Notice announcing the availability of a final guidance for industry #267 entitled “Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs.” Info here.

FOREST SERVICE

Notice announcing new fee sites for the White River and Grand Mesa Uncompahgre Gunnison National Forests. Info here.