The Food Defense Rule is in effect — are you in compliance? Or, to address it from a more pragmatic angle — are you prepared to defend against the potential intentional adulteration of your food products?

As of July 26, 2019, larger businesses were to be in compliance with FSMA’s Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (generally referred to as the IA Rule or the Food Defense Rule). Small businesses, of fewer than 500 full-time employees, have another year to comply (July 26, 2020). Very small businesses, averaging less than $10 million per year, are exempt from the rule, except that by July 26, 2021, they must be able to show documentation verifying that they meet the exemption.

However, neither the extended time frames nor the exemptions mean that you should take food defense lightly and put off, or completely dismiss, ensuring facility and employee preparedness and development of a food defense plan.

The IA Rule is primarily designed to prevent acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. But it also includes provisions for measures to help prevent or minimize insider attack, such as that by a disgruntled employee — to which even the smallest of food facilities can be subject. In fact, according to a 2018 survey of food industry representatives conducted through a collaboration by The Acheson Group (TAG) and the Food Protection and Defense Institute (FPDI), 62% of the food processors, manufacturers, and distributors surveyed rated employees as their top food defense concern.

Unfortunately, according to the TAG and FPDI analysis of the survey results, Intentional Adulteration & Food Defense — Industry Preparedness Report (https://bit.ly/2YbHPu9), at the time of the survey, 78% of those covered by the IA Rule were unaware of the draft guidance published by FDA, and only 62% of those had reviewed or commented on the guidance. Since that time, FDA has published the second of three parts of the intended guidance, but as of the effective date of the rule, the third part had not yet been released.

Despite the lack of the third part and the conversion of the guidance from draft to final, food processors — large and small — are well advised to review and apply all guidance as applicable to their operations. It is particularly important to review the guidance released in its draft form, as this provides the opportunity to make comments and recommendations prior to the final being developed. Although guidance is non-binding, it represents the current thinking of FDA and, essentially, provides free advice and recommendations on how to best comply with the related rule.

This can be especially helpful in the writing of the Food Defense Plan (FDP) required by the IA Rule. Although a very high percentage (91%) of those surveyed had an existing plan, only 50% had developed or updated it after publication of the IA Rule. So, while you may have a plan in place, it may not be fully compliant with the provisions of the rule. FDA has stated that it does not intend to begin IA Rule-focused inspections until a year after its effective date, however it will tack on a few focused questions to its regular inspections, primarily asking about (and likely wanting to see) the FDP. And the agency will expect you to have one.

A second essential requirement of the IA Rule is that of training. The rule requires (and guidance further explains) different levels of training for different facility roles. This ranges from awareness training for front-line workers to more comprehensive training for qualified individuals responsible for the Food Defense Plan and related activities. Front-line worker awareness training can be completed through in-house training, online resources, or external trainers. However, qualified individuals are required to complete a training that is at least equivalent to the standardized curriculum recognized as adequate by FDA, which includes identifying and explaining mitigation strategies at actionable process steps identified by a vulnerability assessment, or be otherwise qualified through job experience to conduct the specified activities.

Interestingly, while it may be expected that smaller companies would be more likely to use outside resources, more of the surveyed large (63%) than small (46%) companies used FDA online tools such as the mitigation strategies database or the FDP Builder software. FDA also has updated these tools to reflect the IA Rule, so — like the guidance — they provide a valuable resource for understanding and compliance.

As is recommended in the conclusion of the Industry Preparedness Report, whether or not you are specifically covered by the IA Rule, and no matter when your company must comply, a Food Defense Plan will help protect your product against acts of intentional adulteration or outright terrorism — and help protect your business and brand as well.

If you have not completed any of the report’s seven recommended steps (assess, plan, conduct vulnerability assessments, determine actionable process steps, identify mitigation strategies, evaluate, and educate and train), you are well-advised to complete these now. It can only benefit you.

For more information on the survey and seven steps, download the Industry Preparedness Report.

Consumers are having greater influence over the composition of food products as a function of their desire for natural, non-artificial and additive-free formulations. This so-called “clean label” is moving from a trend to a rule. Major food and beverage companies always have and will respond to consumer wants and needs to maintain brand relevance. Providing such differentiation offers a way for companies and brands to communicate benefits to consumers and provide a critical competitive advantage by setting themselves apart from competitors. Additionally, claims and certifications such as non-gmo, gluten-free, and Rainforest Alliance Certified have increasing importance for products.

The flip side of the coin is that this transformation to simpler, non-chemical sounding ingredient lists is creating a significant challenge for the food industry to respond to the shift in consumer trends and meet their evolving wants and needs. The quest to remove these perceived “undesirable” functional ingredients falls on product developers and food-scientist support teams of both consumer product companies and ingredient suppliers. And that can result in real or potential trade-offs of which consumers may not be fully aware. Whether or not one believes consumers are being unduly influenced to view so-called artificial colors, flavors, and additives as “not good for them,” and even when the science does not support this, the reality is that consumers should and do have free choice to avoid them regardless of the reason. Consequently, food and beverage companies must respond to their consumer base to stay relevant in the marketplace.

Over the course of history, the food industry has invested a great deal of time, money, and other resources to research, develop, and commercialize technological ingredient advancements aimed at providing consumers what they desire in the way of better tasting, safer, longer shelf life, more universally available, and less costly products. The developments of food science and technological advancements have always been driven by consumer pull; not by food manufacturer push. Through a collaborative network of university, government, and industry, a base of safe functional ingredients has been made available that protect foods from spoilage, extend shelf life, improve color and texture, deliver superior taste, lengthen freshness, and cost less. Food science and technology enable foods to be distributed over greater distances and provide greater variety to more consumers worldwide. The functional benefits of these ingredients contribute to a more sustainable food supply for the masses now and as the population of the world increases, thus contributing to global food security.

As with all choices we make, removing these functional ingredients and additives from foods can have drawbacks. There are trade-offs. The food industry is doing the best job feasible to find suitable substitutes or alternate formulations that maintain the organoleptic properties, safety, shelf life, and cost of clean-label alternatives. The fact is that there is a practical limit as to what can be achieved, and the consumer will need to accept some trade-offs. Of course, food safety and regulatory compliance cannot be sacrificed in the process. Take the example of preservatives traditionally used in some sauces and condiments. These are FDA-approved safe substances added to a food to inhibit microbial growth or retard deterioration. A possible clean label goal would be to remove preservatives where technically feasible without compromising food safety or product quality. The most apparent solutions would be a requirement to keep the product refrigerated or to replace the artificial preservatives with natural materials. The former would result in an inconvenience and both would result in increased product cost.

Unquestionably, a large portion of consumers have a negative view of functional ingredients. I would argue that a major contributing factor is that they do not have ready access and, therefore, an understanding of their benefits and unique values. Without such information it is difficult for them to have a balanced viewpoint to guide their decision making. This can be a source of frustration to food scientists and product developers who wish for the perfect world to be guided by science-based rational thinking. From a positive perspective, a number of food trade associations have recognized that the industry must do a better job of providing and communicating balanced information to consumers. Speaking as a consumer, I believe industry has an obligation to pursue this goal rather than tacitly acquiescing to one side of the story to dominate the dialogue.

Therein lies the premise of “A Chain of Linked Nuances,” the chapter I authored for Food Traceability (Springer, 2019). Just as all food ends with the person who intends to consume it, so too do the demands and expectations of food begin with that same consumer. So, to understand, and develop solutions for, the nuances and challenges of each link, we must consider consumers to be an integral link; understand their expectations and perceptions (right or wrong); and realize the impact of these on the demands of traceability.

That backward flow is the very essence of traceability or “traceback,” such as that which has always been necessitated by recalls. And that which is now being driven by consumer demand for transparency and accountability, with the use of their virtual voices and purchasing power impacting the entire chain of food production.

This proposition is widely evidenced by a number of today’s trends to which the food industry is acceding, such as that discussed by Roger Lawrence in “Clean Label Trade-Offs.” Noting the increased influence consumers have over the composition of food products, Lawrence states that whether or not a food producer feels consumer perceptions are being unduly influenced; regardless of whether science supports their thinking on additives, etc., “the reality is that consumers should and do have free choice to avoid them regardless of the reason.” An interesting take on consumer perception also is proposed by Darin Detwiler in “Turning Headlines into Public Health Messages.”

Another rapidly emerging trend which is impacting all links of the chain is consumer pursuit of protein-alternative products, such as plant-based and cell-cultured “meats.” Spurring innovation by both established and newly founded food businesses, the overall goal is to reduce the world’s dependency on animals for food. (Be sure to get your copy of the upcoming September/October issue of QA, in which we will profile the meatless meats of Impossible Foods.) With this trend’s focus on both the increased use of plants and the decreased use of animals, the impact will be felt in one way or another by every segment of the industry and every link of the chain.

As all of this shows, each link of the food chain has its unique stressors and strains, but each has an integral charge to keep the chain intact, each must hold itself interconnected with the next, and a pull on any one link will impact every other, forward and back.

Food Traceability is available from Springer or Amazon in hard cover or electronic format; chapters also can be purchased individually in electronic format.

The new rules for bioengineered (BE) foods labeling are out there to be enforced by USDA. Here is a summary of what you should know and be working toward.

In January 2016, Congress enacted the National Bioengineered Food Disclosure Standard Act requiring USDA to provide a standard. The president signed it into law (Public Law No. 114-216)) in July 2016. The law does many things: It defines “bioengineered’’; requires a disclosure on a label or by other means for any foods that are bioengineered; states that the law applies to USDA- and FDA-regulated foods (with exceptions); preempts any state bioengineered labeling laws; defines that animals that consumed bioengineered feeds are not considered bioengineered; considers that BE crops are just as safe as non-BE crops; allows certified organic products to make the non-BE claim; and provides that foods that do not meet the labeling requirement cannot be recalled because of non-compliance to the BE labeling disclosure.

In December 2018, USDA published the final rule (7CFR Part 66) with an implementation date of January 1, 2020, except for small food manufacturers, whose implementation date is January 1, 2021. The mandatory compliance date is January 1, 2022, however regulated entities may voluntarily comply with the standard until December 31, 2021.

In March 2019, FDA published guidance on labeling of BE foods to help manufacturers and processors understand the requirements under the new law which also created a list of all BE crops that must be labeled as BE. The list includes: alfalfa, Arctic varieties of apples, canola, corn, cotton, eggplant (only BARI Bt Begun varieties), papaya (only ringspot virus-resistant varieties, pineapple, (pink flesh varieties) potatoes, salmon (only the AquAdvantage), soybeans, (summer squash), and sugar beet.

If you have not looked into this new requirement, it would be a good idea to review the regulations and the guidance so that you can assure your products are labeled as required.

I personally thank Congress, USDA, and FDA for their work on this. Many of us recall when Vermont passed a law requiring the labeling of BE ingredients in all products sold in Vermont. Many other states had followed suit with similar laws. However, each had unique requirements meaning that product sold in Vermont would need to be labeled differently than product sold in, say, New York. This would have led manufacturers to package products differently for each state’s market, and then be able to control which of their products were moved into which states. Many states had fines for not labeling correctly even though a manufacturer may not control how its product is distributed. It would have been chaos (the opposite of control!) for manufacturers. Now, with this single, nationwide labeling law, it will be much easier.

I’m also pleased that the USDA has defined which products are BE. I’ve asked non-food scientist (or food quality managing) friends how many GMO (or BE) foods they believe there are, with responses varying from a simple “too many” to “most foods are GMO now.” So it’s good to know we now have a place to refer these folks so that they can see definitively that there are only 11 approved for food use (alfalfa is not a food, it is more of a feed item). And we can now note for these folks that many of these 11 have restrictions (e.g., it related to only the Arctic-brand apples).

In addition, the law passed by Congress and signed by the president includes a statement regarding the safety of GMOs, helping to ensure that the public knows this. Here’s the excerpt: “SAFETY. — For the purpose of regulations promulgated and food disclosures made…a bioengineered food that has successfully completed the pre-market federal regulatory review process shall not be treated as safer than, or not as safe as, a non-bioengineered counterpart of the food solely because the food is bioengineered or produced or developed with the use of bioengineering.” NICE! And a thank you to the congressional rule writers.

Finally, there’s a new logo we can expect to see on packages very soon (shown above). There are definitions of the logo and how it can be used in the regulations. Be sure to read the law and the guidance to know how to use it.

I know it’s a pain to have yet another law and more rules to follow. But I do appreciate that there is only one rule now instead of the 50-plus we were headed for only five years ago.