A comprehensive summary of today’s judicial, legislative, and regulatory developments in agriculture and food. Email important additions to: camarigg at uark.edu
JUDICIAL: Includes FDA, crop insurance, and bankruptcy issues.
Philip Morris USA Inc. v. United States Food & Drug Admin., No. 15-CV-1590 (APM), 2016 WL 4378970 (D.D.C. Aug. 16, 2016) concerned what constitutes a “new tobacco product” under the Tobacco Control Act (TCA). In September 2015, FDA issued a Guidance declaring “a distinct labeling change or a quantity change to an existing product results in a ‘new tobacco product,’ which triggers the need for a showing of substantial equivalence before the product can be commercially marketed.” Plaintiffs (tobacco companies) argued, “neither a label modification nor a quantity change creates a ‘new tobacco product’ and therefore neither type of alteration triggers the substantial equivalence review process.” Plaintiffs also argued the Guidance must be vacated because the FDA did not adopt it through a “public notice-and-comment process.” Court concluded the Guidance “is not a legislative rule and was issued to inform the public of the FDA’s interpretation of the TCA.” Court determined no notice-and-comment was required and the Guidance should not be vacated. Case remanded to FDA.
Pardue v. Humble Ins. Agency, No. CIV-14-1049-D, 2016 WL 4385027 (W.D. Okla. Aug. 16, 2016) involved a number of issues involving a crop insurance claim. Defendant wanted to preclude evidence of a claim for breach of contract for failure to procure insurance. Court observed that, “In order to prevail on a claim for breach of contract to procure insurance, a plaintiff must show that the insurance agent agreed to procure insurance coverage effective as of a certain date and time, or of a certain breadth, and then failed to do so.” Court found plaintiff’s petition put defendant on “reasonable and fair notice that he had asserted a claim for “breach of contract for failure to procure insurance.” Defendant’s motion denied.
In In Re Nagel, No. 15-32135, 2016 WL 4384821 (Bankr. N.D. Ohio Aug. 12, 2016), a plaintiff trustee sought to have two tractors declared property of defendant’s Chapter 7 bankruptcy estate. The court observed that property of an estate includes “all legal or equitable interests of the debtor in property at the commencement of the case,” and that, “In determining whether something is property of the bankruptcy estate, a court must look to both state and federal law.” Trustee had burden of proof to show the two tractors were actually transferred from one defendant to the other. Trustee’s evidence failed to meet burden of proof that the two tractors were “actually transferred at some point prior to the filing of Debtor’s Chapter 7 bankruptcy case.” Judgement for defendant.
REGULATORY: Includes AMS, FDA, FSIS, FAS, FS, GIPSA, and NOAA rules and notices.
AGRICULTURAL MARKETING SERVICE:
Notice AMS seeks public comments on a petition requesting revision to the United States Standards for Grades of Carcass Beef. Info here.
FOOD AND DRUG ADMINISTRATION:
Rule FDA is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. Info here.
Rule FDA is extending the dates for compliance with certain provisions in four final rules. FDA also clarifies compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. Info here.
Notice FDA announces availability of a draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.” Info here.
FOOD SAFETY AND INSPECTION SERVICE: Notice FSIS announced availability of the Agency’s compliance guidance on how companies can make label or labeling claims considering that bioengineered or genetically modified ingredients or animal feed were not used in the production of meat, poultry, or egg products. Info here.
FOREIGN AGRICULTURAL SERVICE: Notice announcing a fee of $250 for the 2017 tariff-rate quota year for each license issued to a person or firm by USDA authorizing importation of certain dairy articles, which are subject to tariff-rate quotas set forth in the Harmonized Tariff Schedule of the United States. Info here.
FOREST SERVICE:
Notice the Lyon-Mineral Resource Advisory Committee will meet in Yerington, Nevada. Details here.
Notice the Yavapai Resource Advisory Committee will meet in Prescott, Arizona. Details here.
GRAIN INSPECTION, PACKARDS AND STOCKYARDS ADMINISTRATION:
Notice the designation of the Amarillo Grain Exchange, Inc., will end on September 30, 2016. Details here.
Notice the designation of the Cairo Grain Inspection Agency, Inc., will end on September 30, 2016. Info here.
Notice GIPSA announces the designations of Mid-Iowa Grain Inspection, Inc.; Fremont Grain Inspection Department, Inc.; Maryland Department of Agriculture; and Titus Grain Inspection, Inc., to provide official services under USGSA. Details here.
Notice GIPSA announces designations of North Dakota Grain Inspection, Inc.; Champaign Danville Grain Inspection Departments, Inc.; Detroit Grain Inspection Service, Inc.; Eastern Iowa Grain Inspection and Weighing Service, Inc.; Enid Grain Inspection Company, Inc.; Keokuk Grain Inspection Service; Michigan Grain Inspection Services, Inc.; and Omaha Grain Inspection Service, Inc., to provide official services under USGSA. Info here.
Notice the designation of the Louisiana Department of Agriculture and Forestry will end on September 30, 2016. Details here.
Notice the designation of the North Carolina Department of Agriculture will end on September 30, 2016. Info here.
Notice GIPSA seeks comments on the quality of services provided by the Wisconsin Department of Agriculture, Trade and Consumer Protection. Details here.
NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION:
Rule implementing the International Commission for the Conservation of Atlantic Tunas Recommendation 15-06 regarding porbeagle sharks caught in association with ICCAT fisheries. Info here.
Rule NMFS prohibits directed fishing for Atka mackerel in the Central Aleutian district of the Bering Sea and Aleutian Islands management area by vessels participating in the BSAI trawl limited access fishery. Details here.
Rule NMFS prohibits directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska. Info here.
Rule NMFS prohibits directed fishing for Pacific ocean perch in the Central Aleutian district of the Bering Sea and Aleutian Islands management area by vessels participating in the BSAI trawl limited access fishery. Details here.