FDA has given an update on its resources to provide the industry with continued assistance as it struggles through the challenges presented by the ongoing pandemic.
The Food and Agriculture Sector Coordinating Council is a collaboration between FDA, USDA, the U.S. Department of Homeland Security and the Food and Agriculture Government Coordinating Council to discuss critical infrastructure security and resilience activities. Companies that want to get involved with the council or discuss the supply chain disruptions that they have been experiencing, they can contact Clay Detlefsen, Chairman of the council and Senior Vice President, Environmental and Regulatory Affairs & Staff Counsel; National Milk Producers Federation.
The FDA has also issued several temporary policies (guidance documents) to help companies, including:
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit Susanne Kuehne.
Lead chromate, flour, curcuma, Metanil Yellow or Sudan Dye, anyone? These are just some of the possibly hazardous adulterants that may make their appearance in turmeric, a popular and pricey spice and ingredient in dietary supplements. The American Botanical Council published a laboratory guidance document to determine the proper methods for the analysis of a number of adulterants. The document gives lists of the methods with their pros and cons, grouped by type of adulterant.
In mid-August, FDA and OSHA released a checklist to help food companies that were going through operational changes as a result of the COVID-19 pandemic. Specifically, the “Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic” document reviews employee health and social distancing (how to deal with employee exposure and testing, the arrangement of work environments, especially considering work breaks and close operations), and food safety and HACCP plans—including suppliers and incoming ingredients—cGMPs, and other operational alterations due to COVID-19.
Today FDA held an “FDA COVID-19 Update for Food Operations Stakeholders” in collaboration with CDC and OSHA to further discuss the checklist, which targets owners, operators or agents in charge of a food operation. The purpose is to help the user assess operations during the COVID-19 pandemic, particularly operations that have restarted after a facility shutdown. Following the initial remarks, it was clear the FDA wanted to emphasize that the food safety checklist is intended to serve as a resource document, not a new guidance document or a new regulation. What was originally envisioned to be a one- to two-page checklist became a 16-page checklist that should be used in conjunction with additional information provided by FDA, CDC and OSHA, said Jenny Scott, senior advisor, office of food safety at CFSAN.
Scott reviewed the outline of the checklist, touching on employee health practices to help minimize the spread of COVID-19 (from basic handwashing practices to deadline with sick and exposed workers), employee testing and potential changes related to personnel requirements (i.e., if you are putting new people into new roles, you must consider whether more training is required), and the cGMP requirements. Among the key questions related to sanitation that Scott advised one must ask include: Are necessary cleaning, sanitizing and disinfecting supplies available? Are changes needed for cleaning, sanitizing and disinfecting procedures for certain areas or the frequency of conducting the procedures? Do the changes result in the need for updating instructions or training workers?
As the understanding of COVID-19 and how it spreads is evolving, Scott stressed that industry should frequently check FDA, CDC and OSHA websites for updates.
Michael Rogers, assistant commissioner for human and animal food operations, ORA, FDA also stressed the fact that the food safety checklist is not a new regulatory requirement, commenting that there has been “some anxiety associated” with this misperception. “This is simply an educational tool,” Rogers said. “We recognize that every firm is different, and the checklist should be information to consider…This is not an enforcement tool.” He added that the FDA’s approach during inspections will be collaborative and that the agency will not be holding firms to the specifics of the checklist. During the pandemic, the agency has been conducting mission critical inspections. FDA has also started domestic inspections in certain areas and will be preannouncing inspections as it moves forward, and it continues to assess the situation abroad to determine when foreign inspections can resume.
The increase in deaths during the COVID-19 pandemic has pushed funeral homes and morgues beyond capacity, and other measures have been taken to store the bodies of victims. As a result, refrigerated food transport vehicles and food storage units have been temporarily used for this purpose. Now, FDA has released the guidance document, “Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic” because when those additional storage units are no longer needed to store bodies, “industry may wish to return the trailers and storage units to use for food transport and storage”.
Returning these vehicles and storage units to use for food is possible—but only with thorough cleaning and disinfection. The agency recommends the use of EPA-registered disinfectants that are suitable for the material being disinfected. It also recommends these disinfectants be effective against SARS-CoV-2 and foodborne pathogens. When disinfecting, it is important to adhere to the instructions for use for guidance on how many times application is required, the contact time needed, and effectiveness at refrigeration temperatures. For instances in which the interior surfaces have been in direct contact with blood or bodily fluids, the FDA guidance provides the scenarios in which the vehicles and storage units should not be returned to use for transporting or storing food for humans or animals.
OSHA has also stated that compressed air or water sprays should not be used to clean contaminated surfaces due to the risk of aerosolizing infectious material.
Due to the public health emergency, the guidance has been issued without the agency’s usual 60-day comment period.
Honey is defined as “the natural sweet substance produced by honey bees” from the nectar of plants. However, there is not currently an FDA standard of identity for honey in the United States, which would further define and specify the allowed methods of producing, manufacturing and labeling honey (there is, however, a nonbinding guidance document for honey). Some of the details of honey production that a standard of identity might address include allowable timing and levels of supplemental feeding of bees with sugar syrups and the appropriate use of antibiotics for disease treatment.
In circumstances where strict regulatory standards for foods are not available, they may be created by other organizations.
What Is a Food Standard?
A food standard is “a set of criteria that a food must meet if it is to be suitable for human consumption, such as source, composition, appearance, freshness, permissible additives, and maximum bacterial content.”1
To ensure quality, facilitate trade, and reduce fraud, everyone in the supply chain must have a shared expectation of what each food or ingredient should be. Public standards set those expectations and allow them to be shared. They help ensure that stakeholders have a common definition of quality and purity, as well as the test methods and specifications used to demonstrate that quality and purity. Public standards help ensure fair trade, quality and integrity in food supply chains.
How Is a Standard Different from a Method?
A method is generally an analytical technique to assess a particular property of the content or safety of a food or food ingredient. For example, methods for detection of nitrates in meat products or baby food, coliforms in nut products, or high fructose syrups in honey. Methods are an important component of food standards.
A food standard goes a step further and provides an integrated set of components to define a substance and enable verification of that substance. Standards generally include a description of the substance and its function, one or more identification tests and assays (along with acceptance criteria) to appropriately characterize the substance and ensure its quality, a description of possible impurities and limits for those impurities (if applicable), and other information as needed (see Figure 1).
Figure 1. The Anatomy of an FCC Standard (Source: Food Science Program, Food Chemicals Codex, USP)
Figure 1. The Anatomy of an FCC Standard (Source: Food Science Program, Food Chemicals Codex, USP)
A standard defines both what a food or food ingredient should be and documents how to demonstrate compliance with that definition.
Public Standards and Food Fraud Prevention
Many of the foods prone to fraud are those that are not simple food ingredients, but agricultural products that can be more complex to characterize and identify (such as honey, extra virgin olive oil, spices, etc.). Milk products are an example of a commodity that is prone to fraud with a wide range of adulterants (for example, fluid cow’s milk is associated with 155 adulterants in the Food Fraud Database). Ensuring the quality and purity of a product link milk requires implementation of multiple analytical techniques or the development of non-targeted methods.
The creation of effective public standards with input by a range of stakeholders will be particularly important for ensuring the quality, safety and accurate labeling of these high value commodities in the future.
Reference
A Dictionary of Food and Nutrition 2005, Oxford University Press.
Resources
The Food Chemicals Codex is a source of public standards for foods and food ingredients. It was created by the U.S. FDA and the National Institute of Medicine in 1966 and is currently published by the nonprofit organization USP. The FCC contains 1250 standards for food ingredients, which are developed by expert volunteers and posted for public comment before publication.
The Decernis Food Fraud Database is a continuously updated collection of food fraud records curated specifically to support vulnerability assessments. Information is gathered from global sources and is searchable by ingredient, adulterant, country, and hazard classification. Decernis also partners with standards bodies to provide information about fraudulent adulterants to support standards development.
FDA has announced it will exercise enforcement discretion for Produce Safety Rule requirements that apply to entities that grow, harvest, pack and hold wine grapes, hops, pulse crops and almonds. The agency added that it will “consider pursuing rulemaking to address the unique circumstances” that the above-mentioned products present. It also issued the guidance document, “Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds”.
FDA has issued a final guidance that reviews the situations in which a company should warn the public about a voluntary food recall. This includes the appropriate timeframe for issuing the warning and what information a company should include in the warning. The guidance, “Public Warning and Notification of Recalls”, also discusses when the FDA may decide to take action to issue a public warning, should one that a company issues is not sufficient.
In an agency statement, FDA Commissioner Scott Gottlieb, MD., also addresses the buzz around folks feeling that there have been more recalls. “In actuality, for fiscal year 2018, there were a total of 7,420 recalls with 831 that were classified as the highest risk. That figure represents a five-year low in recalls. However, the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent,” said Gottlieb. “We’re routinely providing more information on recalls and other safety issues that have happened.” He added that the ability to detect, track and trace product issues has improved with the help of technology, including whole genome sequencing.
“Our labs are currently testing cutting-edge technology that can screen for multiple allergens simultaneously and even technology that shrinks the genetic testing of pathogens from machines that were once the size of an entire room to a device that’s smaller than many smart phones. We’ll also be working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health.” – Scott Gottlieb, M.D., FDA
In addition, the agency is looking at how new technologies can be used notify consumers about whether a product they purchased has been recalled.
Last week FDA released a guidance document to help facilities understand whether they are subject to the “qualified facility” definition under the FSMA preventive controls rules for human and animal food. Titled “Determination of Status as a Qualified Facility”, the guidance offers frequently asked questions about the requirements for facilities that manufacture, process, pack or hold human as well as animal food (defined separately—Part 117 for human food and Part 507 for animal food).
“Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.” – FDA
Facilities that fall under the PC Human Food rule must submit the first required attestation forms by December 17, 2018, and those subject to the PC Animal Food role must submit the first required attestation forms by December 16, 2019.
This week the FDA issued another guidance document to explain a waiver to the Sanitary Transportation rule and that it applies to retail food establishments that sell food for humans as well as those that sell both human and animal food. It does not apply to establishments that exclusively sell animal food.
“The Sanitary Transportation rule established a process by which FDA may waive any of the rule’s requirements for certain classes of persons, vehicles, or types of food if doing so will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.” – FDA
In April, FDA announced three waivers that apply to businesses with transportation operations subject to State-Federal controls. Since this time, FDA stated that it has received questions regarding whether the term “retail food establishment” also applies to businesses that sell animal food. “The purpose of the guidance document is to clarify that the waiver is intended to apply to establishments that are covered by human food regulations based on the FDA Food Code and administered by state and local authorities,” FDA stated in a news release.
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