YOUR SOURCE ON FOOD LITIGATION AND REGULATION

In almost any area where an emerging technology intersects with a highly regulated industry, there is a dynamic of entrepreneurial spirit facing the realities of existing regulatory frameworks. One novel product facing this dilemma is “cell-cultured meat” (CCM)—meat grown in a cell culture instead of culled from an animal.

CCM is part of a new and emerging area of biotechnology known as “cellular agriculture” through which agricultural products are produced from the cellular level rather than taken from the whole plant or animal. Proponents of cellular agriculture highlight the process as creating a more sustainable, efficient, and predictable food supply, and the National Academy of Sciences estimates products of cellular agriculture will be in the marketplace within the next five years.

On February 6, the Agriculture Marketing Service (AMS) posted a notice in the Federal Register announcing it will delay further rulemaking on a Federal Milk Marketing Order (FMMO) in California[1] while it awaits the US Supreme Court’s decision in Lucia v. Securities & Exchange Commission.[2] On January 12, 2018, the Supreme Court granted certiorari to resolve a circuit split between the US Court of Appeals for the Tenth Circuit and for the DC Circuit.[3]

Lucia calls into question whether administrative law judges (ALJs) working for the SEC are “inferior officers” under the Constitution and therefore fall under its Appointments Clause, which arguably mandates that ALJs be appointed by the president, a court, or a department head. While the immediate impact on the US Department of Agriculture’s (USDA’s) announcement will frustrate California dairy farmers, the broader impact is that a wide range of administrative proceedings within the USDA have been placed in abeyance pending Supreme Court action.

ALJs at USDA, like many other agencies, are not appointed but are chosen through a somewhat independent merit-based hiring system. If the Supreme Court in Lucia determines that such ALJs still function as government employees, the current selection process would be constitutional. But if it determines that ALJs have the power and responsibilities of “inferior officers,” they must be appointed by the president or an agency head to be constitutional.

As referenced earlier in this space, the Food Safety and Inspection Service (FSIS) hosted a public meeting on Whole Genome Sequencing (WGS) issues late in October (see meeting agenda). It provided a range of helpful information on the implications of the rapid and ongoing adoption of such technology by FSIS and other actors in the public health community at both federal and state levels. Also, in the nature of such events, it generated questions, particularly with regard to some of the core legal issues that surround WGS adoption.

On September 22, 2017, the Food Safety and Inspection Service (FSIS) announced its intention to host a public meeting in October to discuss overall federal food safety agency practices as well as plans for collecting and analyzing whole genome sequence (WGS) data of bacteria isolated from official samples, including the state of the science and other issues surrounding use of this technology. Additionally, at the October public meeting, FSIS intends to discuss the agency’s recent experience in using WGS as well as its intention to expand its use in the future.

What is currently unfolding in Texas and Florida is both tragic and unprecedented. Early reports have estimated the reconstruction costs in Texas alone to be around $40 billion dollars. As Texas continues to grapple with the effects of Hurricane Harvey and Florida begins the recovery process, we thought it would be helpful to supply our clients and friends in the food and agricultural sectors with some relevant regulatory information and potential sources of assistance.

Food Safety

Producers and Manufacturers

As a result of the unprecedented rainfall, storm surges, and wind gusts, food production and manufacturing facilities may have been flooded or lost power. In some areas crops as well as processed food may have been submerged in floodwater. Such flooding potentially exposes food products to certain harmful contaminants (e.g., sewage, chemicals, heavy metals, pathogenic microorganisms). As a result, the Food and Drug Administration (FDA) advises that foods exposed to floodwater and perishable foods that are not adequately refrigerated are generally considered adulterated within the meaning of Section 402(a) of the Federal Food, Drug and Cosmetic Act (FDCA) and thus should not enter the human food supply. Individual/case-by-case evaluations are suggested for foods that may not have been completely submerged (e.g., crops as well as grains or similar products stored in bulk containers). Many of you have likely provided a certain level of assurances concerning the regulatory status of your products (i.e., not adulterated) in your contracts. Thus, we take this opportunity to encourage you to be mindful of the impact this aforementioned presumption of adulteration may have on your contracts. We encourage you to conduct additional due diligence and review your standard operating procedures as well as follow current good manufacturing practices for guidance. However, when in doubt, throw it out. The premise behind such an assumption is that both exposure to floodwater and inadequate refrigeration compromise food safety—thus the introduction of an adulterated product into commerce constitutes a violative offense under the FDCA. However, we also note that not all potentially exposed foods are presumed adulterated. FDA has indicated that hermetically sealed (top and bottom double-seam) cans may be reconditioned and relabeled under certain conditions.[1]

For additional FDA information on food safety, please visit FDA’s emergencies website. In a similar vein, owners of meat and poultry producing businesses who have questions or concerns should contact the Food Safety and Inspection Service (FSIS) Small Plant Help Desk by phone at +1.877.FSIS.HELP (+1.877.374.7435) or by email at infosource@fsis.usda.gov. In addition, the US Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) is providing information on its website for farmers, ranchers, and businesses that have been affected by the recent hurricanes.

If you have any specific questions concerning Hurricane Harvey’s impact on your business (e.g., regulatory compliance, cGMP issues), please do not hesitate to contact Kathleen Sanzo or Bob Hibbert from Morgan Lewis’s FDA practice.

Restaurants and Food Retail Establishments

Similarly, FDA advises that restaurants and food retail establishments that have resumed activities do the following:

  • Ensure that any rodents/pests that may have entered the facility are no longer present.
  • Discard all food and packaging materials that have been submerged in floodwater, unless the food is sealed in a hermetically sealed can that has not been damaged and has its label intact.
  • Inspect physical facilities for possible water damage and consult professional service technicians, as needed.
  • Verify that all equipment used for food preparation (e.g., cooking, cooling, and reheating) is clearly functioning and properly calibrated prior to use.
  • All foods, including raw, fresh, frozen, prepackaged, shelf-stable, and ready-to-eat foods, should only be received from licensed and approved food sources. This includes food distributors and vendors licensed by local or state regulatory food authorities.

It is important to understand that your food supply chain will likely be disrupted. As a result, additional due diligence is necessary to identify existing new sources and these efforts should be documented.

For a complete listing of FDA’s advice for restaurants and food retail establishments and retail food protection, please see FDA’s publication on this topic.

Livestock

Reports have indicated that more than 1.2 million beef cows may have been affected by Hurricane Harvey. APHIS, working alongside the Texas Animal Health Commission (TAHC), is providing emergency assistance in caring for animals. The TAHC has advised the public to call 211 or to contact the area emergency management department for assistance in finding large or small animal shelter/holding facilities in your area or evacuation area.

If cattle have strayed onto your property, property owners are encouraged to contact the Texas Southwestern Cattle Raisers Association (TSCRA) at +1.817.332.7064 or the TAHC at +1.512.719.0733 or +1.806.354.9335. Under Texas law[2] you may be eligible for reasonable payment for maintenance of or damages caused by the stray livestock. For additional information, contact your local Sheriff’s department.

Disaster Assistance Programs

To assist businesses in their recovery efforts, please find a few federal disaster assistance programs below.

Small Business Administration

The US Small Business Administration (SBA) offers low-interest, long-term loans for losses not fully covered by insurance or other means. Additional information can be found on the SBA website.

USDA

The USDA Farm Service Agency (FSA) administers many disaster assistance programs to help producers recover from eligible losses, including the following:

USDA encourages farmers and ranchers to contact their local FSA office to learn what documents they can produce to help the local office expedite assistance, such as farm records, receipts, and pictures of damages or losses.

We hope these materials are helpful, and we will continue to monitor ongoing government response to these events.


[1] See FDA, Investigations Operations Manual 2017, Ch. 8, § 8.5.7.9, p. 431, c (2017).

[2] Tex. Agri. Code Ch. 142. 

Last week FSIS’s Revised Nutrition Facts Panel proposed rule was placed on the list of “inactive” regulations, indicating that the rule is no longer a priority and will be reconsidered at an unspecified time in the future.[1] This notice comes after FDA announced last month that it would be postponing the compliance date for its Nutrition and Supplement Facts Label rule and Serving Size rule from July 2018 to an undetermined implementation date.[2]

USDA’s Agricultural Marketing Service (AMS) posted 30 questions for stakeholder input regarding the establishment of a national disclosure requirement for identifying bioengineered foods and food ingredients. The legislation requiring the disclosure of bioengineered foods was enacted on July 29, 2016, and gave AMS two years to establish a national standard and the procedures necessary for implementation (see our LawFlash, New GMO Legislation Signed Into Law, for more information on the legislation). AMS is now seeking input from stakeholders in order to issue a proposed rule this fall, such that it may promulgate a final rule by the mandated July 2018 deadline.

Recent public controversy surrounding an issue many readers would probably rather not hear about—whether it is acceptable to use heart meat in products labeled as “ground beef”—has raised a series of questions involving not simply what might wind up on your grill this summer, but also how USDA’s Food Safety and Inspection Service (FSIS) goes about developing, changing, and publicly announcing policy developments and changes in the labelling of the meat and poultry products it regulates.

A bit of personal history is in order: This author, formerly in government service, signed off on the FSIS policy memo in 1981,[1] which unequivocally stated that “heart meats were not to be allowed as a constituent of [a ground beef] product so labeled.”

As our Canadian neighbors gaze south across the border, their minds are no doubt filled with countless questions over what can safely be described as the unusual political circumstances that currently prevail within the United States.

Read the Canadian Meat Business article >>

On December 1, the US Department of Agriculture's (USDA’s) Food Safety and Inspection Service (FSIS) issued a proposed rule to amend the nutrition labeling regulations for meat and poultry products (Proposed Rule). The revisions in the Proposed Rule are meant to parallel, to the extent possible, the US Food and Drug Administration’s (FDA’s) two similar final rules concerning nutrition fact labels (Nutrition Labeling Rules).1

Some notable similarities between provisions in the Proposed Rule and FDA’s Nutrition Labeling Rules include, but are not limited to, the following:

  • Updating the list of nutrients required or permitted to be declared (e.g., no longer requiring declaration of Vitamins A and C but requiring declarations for Vitamins D and Potassium) and updating Dietary Reference Values (DRVs) and Reference Daily Intakes (RDIs) that are based on current dietary recommendations2
  • Requiring the declaration of trans fat in the Nutrition Facts label
  • Requiring the declaration of added sugars
  • Establishing a new definition of “dietary fiber”
  • Modifying the nutritional labeling format for certain nutrition information (e.g., calories, serving size, and servings per container) prominence, and changing the order of the “Serving Size” and “Servings Per Container” declarations
  • Requiring mandatory dual-column labeling on certain packages of meat and poultry products (i.e., products that contain 200–300% of the applicable reference amounts customarily consumed (RACC))
  • Amending the requirements for foods represented or purported to be specifically for children under the age of four years, and pregnant and lactating women