Agricultural Law Weekly Review—May 26, 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:

Labeling: FDA Revises Nutritional Labels

On May 20, 2016, the Food and Drug Administration (FDA) issued an unpublished notice in the Federal Register regarding revisions to the regulations governing nutritional and supplemental facts labels (2016-11867).  According to the pre-publication final rule, the amendment “updates the list of nutrients that are required or permitted to be declared; provides updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amends requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups; and revises the format and appearance of the Nutrition Facts label.” The final rule is scheduled for publication on May 27, 2016, and becomes effective on July 26, 2016.

Labor: DOL Finalizes “White Collar” Overtime Regulations

On May 23, 2016, the Department of Labor (DOL) Wage and Hour Division published notice in the Federal Register of a final rule revising “regulations under the FLSA [Federal Labor Standards Act] implementing the exemption from minimum wage and overtime pay for executive, administrative, professional, outside sales, and computer employees” (81 FR 32391).  Commonly known as the “EAP” or “white collar” exemptions, DOL’s final rule increases the current annual salary threshold for the exemption from $23,660 ($455/week) to $47,476 ($913/week).  The new regulations become effective December 1, 2016.

GE Food: Canada Approves AquaAdvantage Salmon for Livestock Feed

On May 19, 2016, the Canadian Food Inspection Agency (CFIA) issued Decision Document DD2016-117 regarding the approval of the genetically engineered AquaAdvantage Salmon for use as livestock feed.  According to CIFA, the “feed ingredients derived from this animal with a novel trait does not present livestock feed safety or nutrition concerns when compared to feeds derived from salmon currently permitted to be used as livestock feed in Canada.” As a result, as of May 19, 20016, feed ingredients derived from AquaAdvantage Salmon are authorized for use in livestock feeds in Canada.

Transportation: Proposed PA Legislation Assigns Gross Weight for Milk Hauling

On May 23, 2016, Pennsylvania governor Tom Wolf was presented with legislation that would amend Title 75 (Vehicles) of the Pennsylvania Consolidated Statutes (SB 1108).  Under the proposed legislation, vehicles “hauling milk to or from a manufacturer…may be permitted by the department and local authorities to move upon highways within their respective jurisdictions 24 hours a day, seven days a week, except during inclement weather as defined in department regulations, if the gross weight does not exceed 95,000 pounds and the weight of any nonsteering axle does not exceed 21,000 pounds.”

Equine: Clarifying Legislation Introduced for PA Breeding Fund

On May 23, 2016, Pennsylvania House Representative John A. Lawrence introduced House Bill 923 which is “legislation to clarify language in the recently passed Administrative Code regarding the eligibility of thoroughbreds receiving payments from the Pennsylvania Breeding Fund, a restricted account within the State Racing Fund that provides incentive awards for winning Pennsylvania born/bred thoroughbred race horses.” Accordingly, the proposed legislation was referred to the House Agricultural and Rural Affairs Committee.

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.

FDA Approves Genetically Engineered Salmon

Written by Stephen Kenney

On Thursday November 19^th, U.S. health regulators decided that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon.  This approval was the first such approval for an animal whose DNA had been scientifically modified.  The FDA also will not require companies to label the genetically modified food.

AquAdvantage Salmon is a product of AquaBountyTechnologies.  The AquAdvantage Salmon are Atlantic salmon that reach market size more quickly than non-GE farm-raised Atlantic Salmon.  AquaBounty claims that the salmon can grow to market size in half the time required for conventional salmon.  The genetically modified fish is an Atlantic salmon with a Pacific salmon gene for faster growth and a gene from the eel-like ocean pout that promotes year round growth.

Five years ago, the U.S. Food and Drug Administration (FDA) first began the evaluation of GE salmon.  The Salmon can only be raised in land-based hatchery tanks in two specific facilities that are located in Canada and Panama.  The FDA ultimately approved the safety of the fish because the data demonstrated that the “inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s (AquaBounty) claim about faster growth.”  The FDA also assessed the environmental impacts of the fish and found that there would not be a significant impact on the environment because of the containment measures that will be put into place at the hatcheries.  The agency also found that there is not a risk of the fish reproducing with wild fish because the GE fish are sterile.

Activist groups and grocers are not convinced that the GE fish is a safe alternative.  Activist groups are concerned that the genetically modified food may pose a risk to the environment or public health.  Kroger, a national grocery chain, said that it has “no intention of sourcing or selling genetically engineered salmon.”  Trader Joe's and Whole Foods Market Inc. also do not intend to carry the modified fish.

Senate Committee on Appropriations Approves GE Salmon Labeling

On July 16, 2015, the Senate Committee on Appropriations approved the Fiscal Year 2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill. The bill received bipartisan support, which would appropriate $148.3 billion for agricultural and rural development, as well as food safety, public health, and nutrition programs.

The bill covers a wide variety of issues, but one amendment to the bill may prove to be very controversial. Senator Lisa Murkowski (R-AK) introduced an amendment to the bill that would require the FDA to spend “not less than $150,000…to implement a requirement that the labeling of genetically engineered salmon offered for sale to consumers indicate that such salmon is genetically engineered…” Sen. Murkowski assured her colleagues that the labeling would not set precedent for the labeling of bioengineered crops, claiming “[c]orn doesn’t swim from one field to the next…Fish move. Fish escape.”

Although the bill passed with a vote of 28-2, it is important to note that Sen. Murkowski’s amendment was unanimously accepted. A press release summarizing the highlights of the bill can be read here. The full text of the bill can be found here.

Written by Tyler R. Etter- Research Assistant
July 17, 2015

Canadian Department of Environment Will Allow for Sale of GE Salmon Eggs

On November 23, 2013, the Canadian Department of the Environment released a Significant New Activity Notice that, as long as the specified requirements under the Notice are met, companies can sell genetically engineered (GE) salmon eggs to hatcheries and other buyers. The Significant New Activity Notice is not an endorsement of the product, however, and the U.S. Food and Drug Administration and Health Canada still need to approve the GE eggs before they can be sold. According to press releases, the FDA is expected to give its approval based on previous statements concerning the lack of environmental impact of AquaBounty’s GE fish. AquaBounty is the producer of AquAdvantage GE salmon eggs and fish in Canada. AquaBounty also owns the only GE salmon growing facility in the world so far.

For more information on AquaBounty and their product, AquAdvantage, please see their website.

Written by Sarah L. Doyle - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

December 2, 2013