Thursday, August 25, 2016

Agricultural Law Weekly Review—August 25, 2016

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

GMO Labeling: USDA Issues New Guidance on Labeling of “Negative Claims” for Meat, Poultry, and Egg Products
On August 24, 2015, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) published notice in the Federal Register of the availability and comment period regarding the agency’s “compliance guide for companies that seek to make label or labeling claims concerning the fact that bioengineered or GM ingredients were not used in a meat, poultry or egg product” (81 FR 57879).  Previously, as a matter of policy, FSIS only permitted the use of the terms “genetically modified organism” or “GMO” in “negative claims” on labels if the terms were part of the name of the third-party certifying organization (such as “Non-GMO Project”).  Due to language in the recently enacted National BioengineeredFood Disclosure Standard, “FSIS has reconsidered its position and will [now] allow the use of the terms ‘genetically modified organism’ or ‘GMO’ in negative claims provided that the label or labeling is otherwise truthful and not misleading.” The comment period is scheduled to close October 24, 2016.

FSMA: FDA Extends Compliance Date for Four Final Rules
On August 24, 2016, the Food and Drug Administration (FDA) published notice in the Federal Register of a final rule extending and clarifying compliance dates for certain provisions in four of the seven foundational FDA Food Safety Modernization Act (FSMA) final rules (81 FR 57784).  The four affected final rules are: (1) “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”; (2) “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals”; (3) “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals”; and (4) “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”

FSMA: FDA Announces Availability of Draft Guidance for “Hazard Analysis and Risk-Based Preventive Controls for Human Food”
On August 24, 2016, the Food and Drug Administration (FDA) published notice in the Federal Register of “the availability of several chapters of a multi-chapter draft guidance for industry entitled ‘Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry’” (81 FR 57816).  According to FDA, though the draft guidance document “does not establish any rights for any person and is not binding on FDA or the public,” the document explains FDA’s “current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.’”  

FSMA: FDA Announces Availability of Draft Guidance for “Current Good Manufacturing Practice Requirements for Food for Animals”
On August 25, 2016, the Food and Drug Administration (FDA) published notice in the Federal Register of the availability of draft guidance for industry #235 entitled: “Current Good Manufacturing Practice Requirements for Food for Animals” (81 FR 58519).  According to FDA, “[t]his draft guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule.”

FSMA: FDA Announces Availability of Draft Guidance for “Human Food By-Products for Use as Animal Food”
On August 25, 2016, the Food and Drug Administration (FDA) published notice in the Federal Register of the availability of draft guidance for industry #239 entitled: “Human Food By-Products for Use as Animal Food” (81 FR 58521).  According to FDA, “[t]his draft guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), because they manufacture, process, pack, or hold human food for consumption in the United States, determine what requirements to follow for their human food by-products for use as animal food and provides examples and recommendations for how to meet those requirements.”

FSMA: FDA Announces Availability of Draft Guidance for “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities”
On August 25, 2016, the Food and Drug Administration (FDA) published notice in the Federal Register of the availability of draft guidance for industry entitled: “Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities; Draft Guidance for Industry” (81 FR 58421).  According to FDA, “[t]he draft guidance, when finalized, will help food establishments determine whether the activities that they perform are within the ‘farm’ definition established [under FDA’s] regulation for Registration of Food Facilities.”

EPA Inspector General: EPA has not met Renewable Fuel Standard Requirements
On August 18, 2016, the Environmental Protection Agency (EPA) Office of Inspector General issued a report entitled: “EPA Has NotMet Certain Statutory Requirements to Identify Environmental Impacts ofRenewable Fuel Standard.” The report stated that under the statutory reporting requirements of the Renewable Fuel Standard, every three years, EPA’s Office of Research and Development is required to provide Congress with a report regarding the impacts of biofuels.  The report stated that “EPA provided a report to Congress in 2011, but has not provided subsequent reports as required.”

NRCS: Proposed Changes to National Handbook of Conservation Practices
On August 22, 2016, the United States Department of Agriculture (USDA) Natural Resources Conservation Service (NRCS) published notice in the Federal Register “of the intention of NRCS to issue a series of revised conservation practice standards in the National Handbook of Conservation Practices” (81 FR 56579).  Public comment on the proposed changes closes September 21, 2016.

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