The FDA Modernization Act , which has been pending in the U.S. House of Representatives since April 2021 (H.R. 2565), has now been introduced in the Senate. The bill would amend the federal Food, Drug, & Cosmetic Act by allowing alternatives to animal testing during the development of new drugs. Since 1962, the FDA has required that experimental drugs first be tested on animals before being used on humans in clinical trials. The Senate bill has been introduced by Senators Cory Booker and Rand Paul and currently is co-sponsored by Senators Mike Braun, John Kennedy, and Ben Ray Lujan.
Issue 107: October 11, 2021
This Week's Spotlights
Legislative Updates - Pending Federal Actions
Case Law Updates - Federal Case Law Updates
Lawsuit Challenges Allowing Arizona Cattle Ranchers to Use Protected Habitat
The Center for Biological Diversity and Maricopa Audubon Society have sued the Bureau of Land Management and U.S. Fish & Wildlife Service for allowing cattle ranching in the Gila Box Riparian National Conservation Area (“Gila Box RNCA”) in southeastern Arizona. Plaintiffs argue that cattle grazing and accumulations of manure are harmful to the Gila Box RNCA and allege that the federal agencies are violating their obligations under the Endangered Species Act to protect a designated critical habitat and at least six listed species who live there. Plaintiffs seek declaratory and injunctive relief.
Agency Updates
FWS Restores Migratory Bird Treaty Act Provisions
The U.S. Fish & Wildlife Service has announced it is revoking the rule it published on January 7, 2021, that “reversed several decades of past agency practice and interpreted the scope of the [Migratory Bird Treaty Act] MBTA to exclude any prohibition on the incidental take of migratory birds.” The revocation of the January 7, 2021 rule, effective December 3, 2021, restores FWS’ prior interpretation of the MBTA to prohibit incidental takes as well as the longstanding agency enforcement practices that existed prior to 2017. In conjunction with the scheduled revocation of the January 7, 2021 rule, in a separate notice, FWS also is soliciting public comments to aid the agency in crafting regulations to prescribe narrow circumstances under which incidental takes may be permitted. FWS will accept written comments through December 3, 2021, and will be hosting a series of public meetings for Native American Tribes as well as the general public.
FWS Seeks Comments on Polar Bear Status
The U.S. Fish & Wildlife Service has announced its required 5-year status review for polar bears under the Endangered Species Act. The polar bear was listed as threatened in 2008. The agency is seeking any new scientific or commercial data since the last 5-year review was conducted in 2017 to help evaluate the status of the species. The comment period is open through December 6, 2021.
FSIS Announces Approval of Poultry Imports from Poland
The USDA’s Food Safety and Inspection Service has announced that the Republic of Poland is eligible to export poultry products to the United States. The agency stated that it “has reviewed Poland's poultry laws, regulations, and inspection system, as implemented, and has determined that they are equivalent to the Poultry Products Inspection Act (PPIA), the regulations implementing this statute, and the United States food safety inspection system for poultry products.” Poland's poultry products eligible for import to the United States will be added to the FSIS Import Library on October 7, 2021, and will be subject to reinspection by FSIS.
Legislative Updates
Pending Federal Actions
Congress Considers Streamlining Disaster Aid for Fishers
H.R. 5453, the “Fishery Resource Disaster Improvement Act” has been reintroduced in the U.S. House of Representatives and seeks to provide fishers with disaster relief more quickly following natural disasters or “anthropogenic” catastrophes (e.g., oil spills). U.S. Rep. Jared Huffman introduced the bill, which has been referred to the House Committee on Natural resources.
Congress Considers Ending Mandatory Animal Testing for New Drugs
The FDA Modernization Act , which has been pending in the U.S. House of Representatives since April 2021 (H.R. 2565), has now been introduced in the Senate. The bill would amend the federal Food, Drug, & Cosmetic Act by allowing alternatives to animal testing during the development of new drugs. Since 1962, the FDA has required that experimental drugs first be tested on animals before being used on humans in clinical trials. The Senate bill has been introduced by Senators Cory Booker and Rand Paul and currently is co-sponsored by Senators Mike Braun, John Kennedy, and Ben Ray Lujan.
Pending State Actions
Florida Considers Establishing Valuation Process for Aquaculture Facilities
Florida SB 404 would establish the methodology for valuation of structures and equipment on property used for aquaculture. A companion bill, HB 149, already is pending in the Florida House of Representatives.
Wisconsin Considers Broad Exemptions for Hunting Certain Captive Animals
Wisconsin AB 598 is the companion to Wisconsin SB 563, which was introduced on September 15, 2021. The bills would establish the same criteria for hunting farm-raised bovids as currently exist for hunting farm-raised deer; namely, allowing hunting of farm-raised bovids without a hunting license. The assembly bill has been referred to the Wisconsin Assembly Committee on Sporting Heritage.
Florida Considers Regulation of Companion Animal Cremation Industry
Florida SB 416, “Sevilla’s Law,” is a consumer protection bill that seeks to establish mandatory professional standards and accountability for the companion animal cremation industry. The bill would require providers of companion animal cremation services to provide several written disclosures and include a certification with the returned animal’s cremated remains. It also would allow for agency fines and for civil penalties under a private right of action. The bill has been reintroduced after not passing during the previous legislative session.
Case Law Updates
Federal Case Law Updates
Lawsuit Challenges Allowing Arizona Cattle Ranchers to Use Protected Habitat
The Center for Biological Diversity and Maricopa Audubon Society have sued the Bureau of Land Management and U.S. Fish & Wildlife Service for allowing cattle ranching in the Gila Box Riparian National Conservation Area (“Gila Box RNCA”) in southeastern Arizona. Plaintiffs argue that cattle grazing and accumulations of manure are harmful to the Gila Box RNCA and allege that the federal agencies are violating their obligations under the Endangered Species Act to protect a designated critical habitat and at least six listed species who live there. Plaintiffs seek declaratory and injunctive relief.
Agency Updates
NMFS Announces Increase in Fishing Quota for Tuna and Swordfish
The National Marine Fisheries Service has announced it is rolling over unused 2020 quotas for Northern albacore tuna, South Atlantic Swordfish, and Atlantic bluefin tuna due to and “underharvest” during the 2020 fishing season. The rollover will increase the available 2021 quotas between October 4, 2021, and December 31, 2021.
NMFS Announces Early Closure of the Lane Snapper Fishing Season
The National Marine Fisheries Service announced that it is closing the 2021 commercial and recreational fishing season for lane snapper in the Gulf of Mexico because it projects the annual catch limit will been reached by October 18, 2021. The closure will be effective from October 18, 2021 to December 31, 2021.
FWS Restores Migratory Bird Treaty Act Provisions
The U.S. Fish & Wildlife Service has announced it is revoking the rule it published on January 7, 2021, that “reversed several decades of past agency practice and interpreted the scope of the [Migratory Bird Treaty Act] MBTA to exclude any prohibition on the incidental take of migratory birds.” The revocation of the January 7, 2021 rule, effective December 3, 2021, restores FWS’ prior interpretation of the MBTA to prohibit incidental takes as well as the longstanding agency enforcement practices that existed prior to 2017. In conjunction with the scheduled revocation of the January 7, 2021 rule, in a separate notice, FWS also is soliciting public comments to aid the agency in crafting regulations to prescribe narrow circumstances under which incidental takes may be permitted. FWS will accept written comments through December 3, 2021, and will be hosting a series of public meetings for Native American Tribes as well as the general public.
FWS Seeks Comments on Polar Bear Status
The U.S. Fish & Wildlife Service has announced its required 5-year status review for polar bears under the Endangered Species Act. The polar bear was listed as threatened in 2008. The agency is seeking any new scientific or commercial data since the last 5-year review was conducted in 2017 to help evaluate the status of the species. The comment period is open through December 6, 2021.
NMFS Announces Recovery-Planning Workshops for Rice’s Whale
The National Marine Fisheries Service has announced the dates of five virtual workshops between October 18, 2021, and November 18, 2021, for experts to weigh in on recovery planning for Rice’s whale, a protected species of baleen whale in the Gulf of Mexico that NFMS recognized as its own species on August 23, 2021. The Endangered Species Act directs NMFS to develop and implement recovery plans for the conservation and survival of federally listed species, recovery being defined as effective conservation that brings a species back to the point that it no longer needs or qualifies for ESA listing status. Each of the five workshops will focus on a different aspect of the recovery plan and all are open to the public.
NMFS Announces Temporary Increase in Tuna Fishing Quota
The National Marine Fisheries Service has announced it is exercising its authority to transfer 140 metric tons of Atlantic bluefin tuna from the “Reserve” category to the “General” category in order to allow uninterrupted fishing between October 4, 2021, and November 30, 2021 (or whenever the adjusted quota is met). Because unused seasonal fishing quotas may be “rolled over” into the next season, NMFS is tapping into the Reserve category in order to avoid closing the fishing season. The agency is waiving public comment and the usual 30-day waiting period for new regulations to become effective based on its determination that the move will not affect the overall US Atlantic bluefin tuna quota.
NMFS Authorizes Harassment of Marine Mammals by U.S. Navy
The National Marine Fisheries Service has issued an incidental harassment authorization (IHA) under the Marine Mammal Protection Act to the U.S. Navy’s Office of Naval Research for the harassment (not harm) of marine mammals during oceanographic research activities in the Arctic Ocean. The IHA is effective for activities in the Beaufort and Chukchi Seas between October 5, 2021, and October 4, 2022. The NMFS considers the Navy's activities to be military readiness activities pursuant to the MMPA.
NMFS Reduces Annual Catch Limit for King Mackerel
The National Marine Fisheries service has announced a temporary rule reducing the annual catch limit for king mackerel in the Gulf of Mexico for the 2021-2022 season because the 2020-2021 annual catch limit was exceeded by 11,920 pounds. The 2020-2021 season was closed on January 28, 2021, when the catch limit was reached. Accordingly, NMFS has determined that reducing the annual catch limit for the 2021-2022 season from 575,400 pounds to 563,480 pounds is necessary to protect the supply of Gulf king mackerel.
NMFS Temporarily Reopens Recreational Fishing Season for Snapper
The National Marine Fisheries Service has announced a temporary rule reopening the recreational fishing season for red snapper in the Gulf of Mexico because the annual catch target has not yet been reached. The season will be reopened effective October 15, 2021, through November 6, 2021.
NMFS Approves Interstate Bluefish Quota Transfers
The National Marine Fisheries Service has approved the transfer of 20,000 pounds of bluefish from Virginia’s 2021 state quota to Rhode Island and has approved the transfer of 50,000 pounds of bluefish from New Jersey’s annual quota to Massachusetts to prevent recipient states from exceeding their respective 2021 quotas. NMFS has determined that these transfers are necessary to maintain compliance with the Atlantic Bluefish Fishery Management Plan and will be effective between September 30, 2021, and December 31, 2021.
NMFS Announces Issuance of Permit for Abalone Research
The National Marine Fisheries Service has announced approval of a scientific research permit for the NMFS Southwest Fisheries Science Center in La Jolla, California, to take anadromous fish under the Endangered Species Act during the course of research on the management, conservation, and recovery of black abalone. Anadromous fish are defined as fish born in freshwater who spend most of their lives in saltwater and return to freshwater to spawn, such as salmon and some species of sturgeon.
NMFS Approves Harassment of Marine Mammals During Cruise Ship Terminal Expansion
The National Marine Fisheries Service has approved an application under the Marine Mammal Protection Act for the incidental harassment and harm to five species of marine mammals by the Carnival Cruise line during the expansion of the company’s Port of Long Beach cruise terminal in California. The effective dates of the incidental harassment authorization have been adjusted due to a delay in construction and are now applicable for the incidental take of short-beaked common dolphin, long-beaked common dolphin, bottlenose dolphin, California sea lions, and harbor seals between December 10, 2021, and December 9, 2022.
NMFS Considers Permit Application for Import and Export of Seal Parts
The National Marine Fisheries Service is considering an application under the Marine Mammal Protection Act for the import of grey seal specimens from Canada for research at Texas Tech University. The applicant in the university’s biology department seeks to import and possibly re-export blood, milk, whiskers, nails, fur, blubber, muscle, scat, spew, saliva, and urine opportunistically salvaged from at least 120 dead seals for purposes of scientific research over the next five years studying the role of maternal iron transfer in the development of heme stores and aerobic diving capacity in gray seal pups. The public comment period is open through November 4, 2021.
FSIS Announces Approval of Poultry Imports from Poland
The USDA’s Food Safety and Inspection Service has announced that the Republic of Poland is eligible to export poultry products to the United States. The agency stated that it “has reviewed Poland's poultry laws, regulations, and inspection system, as implemented, and has determined that they are equivalent to the Poultry Products Inspection Act (PPIA), the regulations implementing this statute, and the United States food safety inspection system for poultry products.” Poland's poultry products eligible for import to the United States will be added to the FSIS Import Library on October 7, 2021, and will be subject to reinspection by FSIS.
NMFS Seeks Comments on New Rule to Protect Sharks and Rays
The National Marine Fisheries Service has announced its intention to promulgate rules related to the use of purse seine nets to ensure the sustainability of Bigeye, Yellowfin, and Skipjack Tunafish stocks, and to reduce bycatch of sharks, rays, and sea turtles. The agency has determined these rules are necessary to fulfill its obligations under the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean. In pertinent part, the new rules would mandate the release of any oceanic whitetip sharks, silky sharks, and mobulid rays (which include manta rays and devil rays) from bycatch by U.S. fishers in the areas covered by the Convention. The agency is accepting comments through November 8, 2021.
NMFS Will Allow Oil Company to Harass 18 Cetacean Species
The National Marine Fisheries Service has issued three Letters of Authorization (LOA) under the Marine Mammal Protection Act to BP Exploration & Production that allow the oil company to harass killer whales, spinner dolphins, and sixteen other cetacean species during geophysical survey activity in the Gulf of Mexico. The LOAs are effective between January 1, 2022, and December 31, 2022.
FSIS Announces Pork Product Recall
USDA’s Food Safety Inspection Service has announced a recall of 3,140 pounds of “Nick’s FAMOUS Hickory Smoked Pork Bar-B-Q” ready-to-eat smoked pork products due to possible listeria contamination. The products originated from Nick’s Famous Bar-B-Q, a Nashville, Tennessee establishment and were distributed to several institutions, including school locations in North Carolina. FSIS discovered the problem during an inspection of the producer’s records.
NMFS Seeks Comments on Exempted Fishing Permit
The National Marine Fisheries Service is considering an application for an exempted fishing permit under the Magnuson-Stevens Fishery Conservation and Management Act which would allow fishers off of the eastern coast of Florida to collect a limited number of snapper-grouper, coastal migratory pelagic, dolphin, and wahoo species with evidence of shark depredation for transfer to researchers at Florida Atlantic University. Researchers seek the permit to quantify the impacts of shark depredation on the specified species in relation to recreational fisheries. The public comment period is open through November 8, 2021.
Academic Updates
Articles
Article Explores Sustainable Meat Consumption Intentions in Muslim Market Segment
Zahra, S., McCarthy, B., and Chaiechi, T. "Sustainable meat consumption intentions: conceptualisation, scale development and validation,” British Food Journal (October 4, 2021).
Article Explores the Impact of Tobacco-Like Warnings on Meat Products
Koch, JA., Bolderdijk, JW., van Ittersum, K. “Can Graphic Warning Labels Reduce Consumption of Meat?” Appetite, Vol. 168 (Jan. 1, 2022).
The US Edition of the Animal Law Digest is published weekly with the support of the Brooks McCormick Jr. Animal Law & Policy Program at Harvard Law School.