Agricultural Law Weekly Review - September 13, 2018

Written by:

Jackie Schweichler - Education Programs Coordinator

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

Biotechnology: Proposed Rule on Bioengineered Foods Continues to Move Forward

On August 31, 2018, the U.S. Department of Agriculture (USDA) sent a proposed rule on bioengineered foods to the U.S. Office of Information and Regulatory Affairs (OIRA).  The proposed rule, National Bioengineered Food Disclosure Standard, was published May 4, 2018.  The proposed rule will provide a mandatory uniform national standard of disclosure for bioengineered food products.  The proposed rule suggests three ways in which manufacturers could disclose that their products contain bioengineered ingredients.  On product packaging, manufacturers could use text disclosures, symbols, or an electric/digital link disclosure that could be scanned with a smartphone.  OIRA will have 90 days to review the rule, and if approved, the rule will be published in the Federal Register.

Food Labeling: FDA Announces Preparation of Final Guidance to Nutrition Facts Label

On September 6, 2018, the U.S. Food & Drug Administration (FDA) announced that it is preparing the final guidance for the Nutrition Facts label on packaged foods.  In the initial draft guidance, manufacturers would have been required to categorize maple syrup and honey as “added sugars” on the nutrition label.  Under the draft guidance, manufacturers could use a “†” to lead the reader to a statement with additional information.  FDA received over 3,000 comments in response to the draft guidance. In light of these comments, FDA will not use the “added sugars” declaration for pure, single-ingredient “packaged as such” products.  FDA states, however, that it will still use the required percent daily value for honey and maple syrup.  FDA expects the final guidance to be issued by early 2019.

Food Labeling: USDA and FDA Will Hold Public Meeting on Animal Cell Cultured Food Products

On September 10, 2018, the U.S. Department of Agriculture and the U.S. Food and Drug Administration announced a joint public meeting on the use of cell culture technology to create animal food products.  The meeting will focus on the labeling, oversight, and potential problems with animal cell cultured food products. These products, often referred to as “clean meats,” are created by adding nutrients in vitro to animal cells which grow into animal muscle tissue.  The U.S. Cattlemen’s Association has petitioned USDA to prohibit these products from being labeled or marketed as “beef” or “meat.”  USDA received over 6,000 comments on this petition.  The two-day meeting will be held on October 23-24, 2018.

 Pesticides: Brazilian Judge Overturns Glyphosate Ban

On September 3, 2018, an injunction banning glyphosate from Brazil was overturned, according to a Reuters article.  Last month, on August 6th, a Brazilian judge issued a ruling prohibiting the registration of any new products containing glyphosate, abamectin, and thriam.  That judge also suspended current registrations for those chemicals in order for the government to complete an evaluation.  Monsanto extensively markets Roundup Ready glyphosate-resistant soybeans within Brazil.  According to Reuters, in the most recent court order, the judge stated that the prohibition of these chemicals was unjustified.

National Agricultural Policy: USDA NAD Determines Farm is Entitled to Compensation for Damages from Bald Eagles

On August 21, 2018, the National Appeals Division (NAD) of the Farm Service Administration (FSA) determined that White Oak Pastures is entitled to compensation for damages from bald eagle attacks. White Oak Pastures claimed that 80 bald eagles roosted on their property and destroyed approximately 30 percent of their organic chickens.  The farm sought compensation from FSA under the Livestock Indemnity Program but was denied.  The program provides compensation to producers who experience above average livestock deaths as a result of animals introduced into the wild by the federal government.  White Oak Pastures appealed the decision to NAD which stated in its ruling that FSA acted improperly in denying the farm’s request for compensation.

From National Ag Law Experts:

Kristine Tidgren, What's Up with WOTUS?, Iowa State University (September 12, 2018).

Amie Alexander, Court Rules on Grocery Manufacturer’s Association Actions Regarding GMO Initiative, The National Agricultural Law Center (September 10, 2018).

Josh Wise, Uprooted Episode 44: The Affordable Clean Energy Rule, Institute for Agriculture & Trade Policy (September 12, 2018).

Pennsylvania Regulations

HB 1483 referred to State Government (September 7, 2018) (the bill would establish Forest & Wildlife Advisory Council to implement proven, scientific, wildlife management techniques to increase deer, grouse, & other populations for hunting tourism & recreation)

Pennsylvania Notices

Meeting set: Conservation and Natural Resources Advisory Council on September 18, 2018.

Meeting cancelled: Environmental Quality Board will not meet on September 18, 2018. Next meeting is scheduled for October 16, 2018

Public hearing: Milk Marketing Board to conduct hearing on September 26, 2018 (to solicit comments for changes to Milk Marketing Law)

Public hearing: Senate Agriculture and Rural Affairs meeting on invasive and native species (October 2, 2018)

Follow us on Twitter at PSU Ag & Shale Law (@AgShaleLaw) to receive AgLaw HotLinks

"American Dairy Coalition pushes for worker-vetting program"  - Dairy Reporter

"U.S. dairy exports reach record-high levels during first half" - Feedstuffs

"Ag appropriations on the move" - Politico

"North Carolina pork trials delayed during appeals" - Feedstuffs

"GMOs Are Not Agriculture's Future--Biotech Is" - Scientific America

"Dairy to take $2.7b hit from Mexico, China trade tariffs"  - Feedstuffs

"California agriculture will show the world how to lead on climate change" - Sacramento Bee

"From traditional farms to niche farming, ag evolves" - Morning Ag Clips

"Perdue: USDA will look into immigrants dropping from nutrition program" - Politico

"Bayer officials vague on lawsuit strategy" - Morning Ag Clips

"Cultured meat cos agree to replace term ‘clean meat’ with ‘cell-based meat’ and form trade association" - Food Navigator

"Palmer amaranth: You have questions, we have answers" - Ag Week Magazine

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Agricultural Law in the Spotlight – FSMA Regulatory Update

Written by M. Sean High—Staff Attorney

On January 17, 2017, the Center for Agricultural and Shale Law posted two new Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) guidance documents on the Center’s FSMA Library Guide.

The first document posted is entitled Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.  The resource contains nonbinding recommendations regarding FDA’s “voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.”  According to FDA, “[t]hese requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.”

The second document posted is entitled Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods.  According to FDA, the draft guidance is intended for those subject to regulation 21 CFR part 117, entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and for those “who manufacture, process, pack, or hold ready-to-eat (RTE) foods.” The document is not for implementation and is being distributed for comment purposes only. 

According to FDA the “guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.” FDA stated that “the guidance also is not intended for food establishments that are not subject to part 117, such as farms.” 

The Center for Agricultural and Shale Law's FSMA Library Guide is intended to represent a collection of legal resources relating to FSMA and FDA food and safety regulations.  To view the FSMA Library Guide, please click here. 

FDA Releases New Voluntary Labeling Guidance for GE Food

Written by Tyler R. Etter

On November 19, the Food and Drug Administration (FDA) released two new guidance documents for genetically engineered (GE) plants and animals for use as food. One document is the finalized guidance on labeling food to indicate if food has or has not been derived from GE plants. The other document is draft guidance on voluntary labeling indicating if food has or has not been derived from GE Atlantic salmon.

The first document, pertaining to plant-derived food products, is meant to assist food and feed manufacturers that wish to apply labels to their products. The FDA’s primary concern is that any label is truthful and not misleading. For foods that do not use GE derived foods, labeling such include a statement in a context that clearly refers to bioengineering, such as “Not bioengineered” or “Not genetically engineered”, among other possibilities. Foods that are derived from GE products must have statements such as “Genetically engineered” or similar declarations. The FDA does not encourage the use of “GMO” or “genetic modification” as such claims are very broad, and encompass a wide variety of alterations, including natural breeding methods.

The second document, pertaining to food derived from GE Atlantic salmon, was released in conjunction with the approval of AquAdvantage Salmon, a GE Salmon from AquaBounty Technologies. The guidance recommends labeling standards similar to the GE plant guidance, with clear context for the labeling directly stating an association or lack thereof with bioengineering.

The new guidance documents are merely recommendations, and are not binding on the FDA or the public. The commenting period on both documents opens on November 24, 2015, and closes after 60 days. Comment for the plant guidance can be made here, and comment for the GE Salmon guidance can be made here.

Lawsuit Against USDA Compost Policy Allowed to Continue

Written by Tyler R. Etter

On September 29, 2015, a California federal court denied the USDA’s motion to dismiss the lawsuit
brought by the Center for Food Safety, Center for Environmental Health, and Beyond Pesticides. The
lawsuit is challenging a USDA guidance that recognized the presence of synthetic pesticides in compost
used for organic food productions.

The plaintiffs asserted that the USDA guidance effectively allows certified organic producers to use
compost materials treated with synthetic pesticides, amending existing organic food regulations. They
also argued that the guidance violates the produces for public notice and comment, as the guidance was
issued without an opportunity for public input. The USDA argued the requirement did not apply, as the
guidance was not a legislative rule. Magistrate Judge Jacqueline Scott Corley found merit in the
plaintiffs’ arguments, specifically within the context of the premium paid by consumers and farmers to
ensure that organic produce avoids synthetic pesticides.

Prior to the release of the guidance, synthetic substances were expressly prohibited from compost used
in organic food production. Ralph Bloemers, attorney for the Crag Law Center, stated that the guidance
“radically changes organic requirements...” and that the USDA “made the change without the required
rulemaking process.”

Proponents of the lawsuit are calling the denial of the motion to dismiss a major victory for public input
in the organic policy process, and believe that the USDA must facilitate public input to ensure the
integrity of the process.

FDA Publishes Draft Guidance for Qualified Importer Program

On Thursday June 4, 2015, the Food and Drug Administration (FDA) released draft guidance outlining the implementation of the Voluntary Qualified Importer Program (VQIP). VQIP is a fee-based program, established by the Food Safety Modernization Act, that expedites the importation process for importers with a proven track record of food safety.

                                       

The aim of the program is to incentivize the adoption of practices that will improve importers’ supply chains and allow the FDA to focus resources to higher risk areas of food safety. The program rewards those importers that have maintained a strong record of food safety and benefits public health by allowing the FDA to shift focus to those importers with poorer track records.

The guidance contains the expected benefits of and the criteria for participation in the program. The document also details the instructions for applying to the program, as well as the scenarios that may result in an importer being removed from the program.

The draft guidance, once finalized, will represent the FDA’s current thoughts on the implementation of the program, and will not create any new binding regulations or duties on the part of the FDA or importers. There is no obligation on the part of an importer to take part in the program, as participation is purely voluntary.

The complete draft guidance is available here. Public comments on the draft are open until August 4, 2015, and can be submitted here.

Written by Tyler R. Etter- Research Assistant

June 9, 2015

FDA Releases Draft Guidance for Mandatory Food Recalls

On May 7, 2015, the Food and Drug Administration (FDA) published a draft of planned guidance for the implementation of the mandatory recall authority established with the Food Safety Modernization Act of January 2011.

The guidance serves to highlight the FDA’s current thinking on the recall authority and how industries can comply with the existing regulations, creating no new duties or regulations on the part of the FDA or industry in general.

The draft provides the definition of “food”, “responsible parties”, and “person” within the Food, Drug, and Cosmetics Act. The draft also explains how the FDA determines when a food is considered adulterated or misbranded and what evidence might be considered.

The criteria for a recall are met when there is a reasonable probability of adulteration or misbranding as well as a reasonable probability of serious adverse health consequences or death to humans or animals. The draft then outlines the process for the recall, beginning with the opportunity for a voluntary recall and in the event of non-compliance the FDA may order a recall. To date, this power has only been exercised twice.

Public comment on the draft guidance is open until July 6, 2015, and may be submitted here.

Written by Tyler R. Etter - Research Assistant
June 3, 2015