bioengineered food

By: Ellen Essman, Friday, July 17th, 2020

Written by Ellen Essman and Peggy Hall

 

This edition of the Ag Law Harvest has a little bit of everything—Ohio and federal legislation responding to COVID issues, new USDA guidance on bioengineered foods, and a judicial review of Bayer’s Roundup settlement.  Read on to learn about the legal issues currently affecting agriculture.  

Ohio COVID-19 immunity bill stalls.  While the Ohio House and Senate agree with the concept of immunity for COVID-19 transmissions, the two chambers don’t yet see eye-to-eye on the parameters for COVID-19 liability protection.  H.B. 606, which we reported on here, has passed both the House and Senate, but the Senate added several amendments to the legislation.  The House won’t be addressing those amendments soon because it’s in recess, and doesn’t plan to return for business until at least September 15.   The primary point of disagreement between the two bills concerns whether there should be a rebuttable presumption for Bureau of Workers’ Compensation coverage that certain employees who contract COVID-19 contracted it while in the workplace.  The Senate amendment change by the Senate concerns exemption from immunity for "intentional conduct," changed to "intentional misconduct.”  Currently, there is not a plan for the House to consider the Senate’s amendments before September 15.

Lawmakers propose bill to avoid more backlogs at processing plants.

Most people are aware that the COVID-19 pandemic created a huge backlog and supply chain problem in U.S. meatpacking plants.  A group of bipartisan representatives in the House recently proposed the

Requiring Assistance to Meat Processors for Upgrading Plants Act, or RAMP-UP Act.  The bill would provide grants up to $100,000 to meat and poultry processing plants so the plants could make improvements in order to avoid the kind of problems caused by the pandemic in the future.  The plants would have to provide their own matching funds for the improvements.  You can find the bill here

Revisiting the Paycheck Protection Program, again.  In a refreshing display of non-partisanship, Congress passed legislation in late June to extend the Paycheck Protection Program (PPP).  Employers who haven’t taken advantage of PPP now have until August 8, 2020 to apply for PPP funds to cover payroll and certain other expenses.  Several senators also introduced the Paycheck Protection Program Small Business Forgiveness Act, a proposal to streamline an automatic approval process for forgiveness of PPP loans under $150,000, but there’s been little action on the bill to date.  Meanwhile, the American Farm Bureau Federation is in discussion with the Senate on its proposal for other changes to PPP that would expand access to PPP for agriculture.

More clarification for bioengineered food disclosure. You may recall that the National Bioengineered Food Law was passed by Congress in 2016.  The legislation tasked USDA with creating a national mandatory standard for disclosing bioengineered foods. The standard was implemented at the beginning of 2020, but USDA still needed to publish guidance on validating a refining process and selecting an acceptable testing method.  On July 8, 2020, that guidance was published. The guidance provides steps for industry to take when validating a food refining process under the rule.  A lot of food refining processes remove traces of modified genetic material. So, if a refining process is validated, there is no further need to test for bioengineered material to disclose.  The guidance also contains instructions on testing methods. Basically, “any regulated entity that is using a food on the AMS List of Bioengineered Foods and does not want to include a bioengineered food disclosure because the food or ingredient is highly refined and does not include detectable modified genetic material” should follow these testing instructions. Therefore, any entity with highly refined foods that do “not include detectable modified genetic material” should follow the recently published guidance. 

Bayer settlement proposal under scrutiny.  Last month, Bayer, the owner of Roundup, announced that it would settle around 9,500 lawsuits related to alleged injuries caused by using the product.  Not only was the proposal supposed to settle previous lawsuits, but it was also meant to address any future lawsuits stemming from purported injuries caused by Roundup.  A judge from the United States District Court for the Northern District of California recently pumped the breaks on this plan, stating that any settlement that would resolve “all future claims” against Roundup must first be approved by the court.  A hearing will be held on July 24, where the court will decide whether or not to “grant preliminary approval of the settlement.”

By: Peggy Kirk Hall, Monday, July 10th, 2017

Written by Ellen Essman, Law Fellow, OSU Agricultural & Resource Law Program

Last summer, federal legislation requiring a National Bioengineered Food Disclosure Standard (“the Standard”) was signed into law by President Obama. The law requires the establishment of standard for labeling foods that contain bioengineered substances such as GMOs (genetically modified organisms). It was meant to preempt state GMO labeling laws and instead create a standard that would be applicable nationwide. This summer, the United States Department of Agriculture’s Agricultural Marketing Service (AMS) is moving a step closer toward implementing the law. To this end, AMS released a list on June 28, 2017 of thirty questions for parties interested in the Standard, such as food producers, retailers and manufacturers. The answers will be taken into consideration when USDA begins writing its agency rules to fully implement the Bioengineered Food Disclosure Standard.

Many of the questions concern how certain terms, such as “very small” and “small” packages, “very small” and “small” food manufacturers should be defined under the law. Similarly, the agency asks what terms should be considered synonymous with “bioengineering.” AMS also presents technical questions, such as what kinds of breeding techniques should be thought of as conventional, what genetic modifications should be seen as natural, and what amounts of bioengineered substance in a food should require a disclosure and a number of questions relating to how bioengineering should be disclosed on food products and their packages. Finally, AMS asks quite a few questions involving compliance with the Standard, such as what types of records should be maintained by regulated parties and how AMS will go about investigating noncompliance.

The full list of questions, including an explanation of each, is available here. Producers, retailers, manufacturers, biotechnology companies, consumers and others interested in the rule are encouraged to submit their answers and feedback to GMOlabeling@ams.usda.gov by July 17, 2017.

For more information on the National Bioengineered Food Disclosure Standard legislation, see our previous blog post from July 2016 here.

By: Peggy Kirk Hall, Friday, July 15th, 2016

After several years of debate over voluntary versus mandatory GMO (genetically modified organism) labeling, Congress passed legislation yesterday to create a unified national standard requiring disclosure of information for bioengineered foods.  Predictions are that President Obama will sign the legislation soon.  Once effective, the new law will preempt state laws that require labeling of foods containing GMOs, such as the Vermont labeling law that recently became effective on July 1.  The bill's passage through Congress represented a bi-partisan compromise led by senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI).  "This is the most important food and agriculture policy debate of the last 20 years," said Sen. Roberts.

What’s in the bill?

The legislation amends the Agricultural Marketing Act of 1946 to include the following:

  • Definition of “bioengineered” food, which is food intended for human consumption that contains genetic material that has been modified through in vitro recombinant DNA techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.
    • The Secretary of Agriculture shall determine the amount of bioengineered substance necessary to deem the food as bioengineered.
    • A food that is derived from an animal that consumed feed containing bioengineered substances shall not be considered bioengineered.  Thus, meat, poultry, dairy and eggs from animals that have consumed GMO feed will not be subject to the labeling requirements because they cannot be defined as bioengineered.
  • Preemption of state food labeling standards.  No state or political subdivision may establish requirements for labeling whether a food or seed is bioengineered or contains ingredients that are bioengineered.  A food may bear disclosure of bioengineering only in accordance with federal regulations arising from this law.
  • Creation of federal mandatory disclosure standard.  Within two years of the bill’s enactment, the Secretary of Agriculture must establish a mandatory national bioengineered food disclosure standard and the procedures necessary to implement the national standard.  
  • Choice of labeling.  The federal standard must give a manufacturer the option of disclosing information with on-package text, a symbol or an electronic or digital link, such as a QR code.  An electronic or digital link must contain access to an internet website or other type of electronic source.
    • The USDA must conduct a study to identify potential technological challenges of disclosure through electronic or digital means, and must provide additional options if determined that the proposed technological options do not provide sufficient access to bioengineered food disclosure information.  
    • The USDA must also develop alternative disclosure options for foods contained in small packages.
  • Exclusions.  The following are excluded from the national disclosure standard:
    • Food served in a restaurant or similar retail food establishment.
    • “Very small” food manufacturers, to be defined through rulemaking.
    • As explained above, meat, poultry, dairy and eggs from animals that consume GMO feed.
    • A food containing meat, poultry or eggs if the predominant ingredient would not independently be subject to the standard of if the predominant ingredient is broth, stock, water or a similar solution and the second-most predominant ingredient would not independently be subject to the national standard.
  • “Small” food manufacturers.  The USDA must define “small food manufacturers” and provide such manufacturers with a grace period of at least one year for implementation of the new standards and the additional option of providing only a telephone number or internet website on a food label to disclose required information.
  • Food safety implications.  The FDA conducts a pre-market consultation process for foods from genetically engineered plants; foods that successfully complete the process shall not be treated as more or less safe than non-genetically engineered counterparts because of bioengineering.
  • Organically produced foods.  A food certified as “organic” under the national organic program may be labelled as “not bioengineered,” “non-GMO” or with similar language.
  • Enforcement.  Failing to disclose a food as bioengineered is a prohibited act, but the rulemaking process will determine whether there will be penalties for noncompliance.  The USDA Secretary will have authority to request records and conduct audits and hearings in regards to compliance but will not have recall authority for a food that does not comply with disclosure regulations.

What’s next?

The preemption established in the new law will be effective immediately and the State of Vermont is prohibited from enforcing its GMO labeling law.  The USDA, through its Agricultural Marketing Service, will begin the rulemaking process for the national disclosure standard.  A few key issues for agriculture to track though out the rulemaking stage will be the determination of "how much" bioengineered substance is sufficient to deem a food as bioengineered; defining the "very small" food manufacturers that will be exempt from the standard and the "small" manufacturers that will have a grace period and simpler disclosure requirements, whether QR codes and other technology options will remain viable due to expected objections that they discriminate against lower income consumers; and penalties for noncompliance. The two year window for rulemaking, however, leaves open the opportunity for future changes such as amending the legislation or prohibiting funding to be used for its implementation.  Thus, while we have entered a new stage of the GMO labeling debate, the uncertainty of GMO labeling is not yet fully resolved.

To read the legislation, visit this page.

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