• FAQs
  • The Point Person for FSMA Food Safety

    One requirement of the new food safety law is the creations of a new position, the so-called "Qualified Individual." He/she will be the point person to insure food manufacturing and processing plants, as well as shippers and importers, are operating with carefully drawn up preventive control-based food safety plans.

    Who, exactly, is this qualified individual? What is he/she responsible for?

    First, a bit of background. The new food safety law, known by the acronym FSMA, requires all food manufacturers and processors to conduct a detailed analysis of possible food contamination points throughout their facilities. From that analysis, a plant-wide food safety plan must be created in order for the facility to gain compliance with the law (or eventually face penalties). That plan must emphasize concrete, specific steps to prevent contamination at every step in the manufacturing process.

    Someone has to manage all of these details, and that designee is the Qualified Individual (also called a Preventive Controls Qualified Individual, or PCQI). Some companies already have such a person, perhaps a food safety director or specialist. But others companies, especially smaller-sized operations, will have to create this job and fill it with either a current employee, a new hire, or by using an outside consultant.

    Here is the position as described by the FDA:

    A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review.

    What about training? What's required?

    In advance of FSMA implementation, an industry-academic-government consortium called the Food Safety Preventive Controls Alliance (FSPCA) was established to translate the law's many requirements into a comprehensive curriculum for those interested in (or assigned to) becoming a qualified individual. The requirements are set out here in Q and A form. However, the FDA has also enabled training to be much more flexible, as long as the curriculum meets the FSPCA's standards. Food safety training, in fact, has spawned a cottage industry with courses available in many locations as well as online. Google "Preventive Controls Qualified Individual Training courses" and you will see listed numerous training courses available.

    The Preventive Controls Qualified Individual isn't the only person responsible for  a company's food safety. FSMA also incorporates what is known as the "Park Doctrine" that makes a manufacturing company's top executive directly responsible for food safety oversight. Additionally, the law requires that the food safety plan is shared with all employees through meetings, presentations and one-on-one sessions. Moreover, the plan must be revised and updated every three years.

    All of this -- the required food safety plan, preventive controls, qualified individual training and executive oversight -- represents a sea change in government regulation of the food supply (for humans and animals). Food safety has long been a voluntary industry priority, but and the continuing scourage of deadly foodborne illness recalls and microbiological contaminations demonstrated that stronger protections were needed. FSMA is the result.

    The new requirements also bring a new sensibility to food production and distribution. It is the awareness that food safety must be not just a management priority, but also an attitude that becomes ingrained and habitual at all levels of the massive global food supply chain. It heralds a culture of food safety which, if it truly takes hold in the industry, holds the promise of making food fatalities a thing of the past.


  • What Is a “Reasonable Belief?”

    As the new Food Safety Act (FSMA) is being implemented, the food manufacturing industry is confronting an expanded array of compliance regulations, most notably in record-keeping requirements.

    As food manufacturers would undoubtedly agree, federal record-keeping regulations are plentiful and costly. But under the Food & Drug Administration’s intent to prevent as much as possible food illness outbreaks, companies are required to put in place written food safety plans that include food products that are “reasonably likely” to be adulterated. That’s not all. The FDA can also request records of products for which there is a “reasonable probability” that the items could cause serious adverse health consequences or death to humans or animals.

    Once either of these circumstances is met (in the opinion of the agency), the FDA may request “all existing records” needed to help the agency in determining whether (quoting from the FDA’s website): “the circumstances, which gave rise to the records request, exist.”

    If your head hurts after reading that, you are probably not alone. And, regrettably, the FDA hasn’t been able so far to clarify just what this means. It does offer up this explanation: “reasonable belief” is a determination that will be made on a case-by-case basis. That leaves manufacturers with the disagreeable duty of maintaining lots of new records on production just in case the FDA comes calling.

    In FDA’s defense, expanded record keeping is in large part a response to what has long been a significant challenge: tracing a recalled product – one that threatens public health – back along its production and distribution path. Congress directed that traceability be baked into the new food safety act, and one manifestation of that inclusion is the requirement for manufacturers and suppliers to maintain more comprehensive records.

    Not unexpectedly, the record keeping requirements have generated criticism as being either too vague, on the one hand, and too detailed, on the other. The records can be kept electronically or in print, but they must be instantly available within 24 hours notice, for example. Also, the records need to be updated every two years. One law firm that represents manufacturers posed this dystopian possibility: “FSMA expands the conditions under which the FDA has access to company records containing sensitive product-related information, (and it also has the ability) to publicize agency findings, suggesting that particular products and companies may be linked to foodborne disease outbreaks or other public health risks.”

    Others are more sanguine. Former FDA and USDA Medical Officer David Acheson summarized the record-keeping requirements as a precautionary duty for the industry: “My main message on recordkeeping is that it is really important to do it right. I say this because the FDA view is that if you can’t produce the records you didn’t do it. I think this could be an Achilles heel for many facilities in that they do the right thing but don’t keep the records, and that will not be acceptable to the regulators. As noted above, keep in mind that your records will demonstrate to FDA that you know what you are doing, that you are taking a risk-based approach, and that you are compliant with the new rules.”

    As Acheson suggests, the FDA expects that companies will take seriously their obligation to minimize risks inherent in food manufacturing and do all in their power to prevent contaminated product from reaching the market.

    That’s a reasonable belief, certainly, and a welcomed one for consumers.

  • Explain the difference between “food grade” and 3H lubricants.

    Food grade lubricants (H1 NSF) are certified for incidental contact with food during processing. They are made specifically with ingredients that pose no danger to humans and animals even if they were to get into the food product. 3H lubricants are certified for direct use on surfaces that come into contact with food.  A good example is the coating spray allowed on bread pans to prevent dough from sticking.

  • What is meant by the phrase “reasonably foreseeable hazard?”

    It means a manufacturing vulnerability that could create a food safety issue via contamination with a substance or other material that is injurious to human or animal health. An example might be a hard-to-reach gear assembly where microbes could live. Another example of a hazard might be contaminated water used to spray clean a production line.

  • Does NSF certification of lubricants satisfy the compliance standards of FSMA?

    The NSF is an independent body that has created certification standards for a variety of industrial products used in food manufacturing.  However, the body of law that governs all food safety-related matters is the Code of Federal Regulations (CFR).

  • Does the FDA approve compliance plans?

    The Food and Drug Administration does not approve (or reject) any compliance plans. The agency writes and releases new regulations, to which companies in the food industry will be required to follow. Companies all along the food supply chain will be required to maintain comprehensive documentation demonstrating to the FDA that they are managing compliance.

  • How do we find out what to do to be in compliance?

    Fortunately, the food industry had a head start in the area of food grade lubricants, and a number of firms are already on the market with efficient solutions.  One such program is offered by CRC Industries, through its StopLight™ for Food Safety program, which provides clear labels and packaging for food grade lubricants. Information on StopLight is available here.

  • Will we have time to make the changes required under FSMA?

    Regulations covering the use of food grade lubricants were published in 2012, and manufacturers and processors are required to be fully compliant in the third quarter of 2016

  • Industrial lubricants are already classified by their use; will this system change under FSMA?

    No. What has changed is new requirements of plant managers to maintain careful records of the use of food grade lubricants, NSF H1, H2 & 3H, that may come into contact with the product being manufactured. The regulations also cover procedures on how all machine greases are stored, inventoried and separated by usage.

  • Are there penalties for violations or non-compliance?

    FSMA creates tougher criminal liabilities for food companies in the supply chain – including food retailers and wholesalers, as well as suppliers and vendors. Under the so-called “Park Doctrine,” chief executive officers and other corporate officers can be held personally liable for misdemeanor violations of the Federal Food, Drug and Cosmetic (FD&C) Act, regardless of whether they personally were engaged in the violations, or even knew about about them.

    Criminal penalties are harsh. Misdemeanor convictions are punishable by up to a year in prison and fines as much as $100,000 for an individual. If a food contamination incident results in death, the maximum fine becomes $250,000, which doubles for an organization.

  • What is a food grade lubricant?

    Lubricants suitable for food and beverage applications are registered as H1, H2 & 3H by NSF International (NSF), an independent registration body. They comply with food regulations because they are physiologically inert, tasteless, and odorless. They are suitable for incidental, technically unavoidable contact with a food product up to 10ppm.

  • Practically speaking, how will this apply to our business?

    The FDA is addressing a common situation in manufacturing, in which lubricants of all types and uses are stored together in a cabinet or on shelves. As a result, food grade lubricants might be stored alongside cleaners, glue removers, sprays, et. al. Problems may arise if someone reaches for the wrong lubricant at the wrong time. In this scenario, it’s possible that a non-food-grade lubricant might make its way into the grease fitting.

    The new FSMA rules require that NSF food grade lubricants be stored separately from other, non-food MRO chemicals. Plus, stepped up training is required for employees working in food production.

  • Our company stocks “food grade” lubricants, which allows “incidental contact” with food being produced. Can we use these lubricants during manufacturing?

    Although food grade lubricants are used during production, they also are classified as a potential “adulterant” – and therefore prohibited from use -- under the Code of Federal Regulations (CFR), which govern the FDA’s regulations. Therefore, to exercise caution, it is recommended that food grade lubricants (and all MRO chemicals) be used only when product is not present and/or the manufacturing line is stopped.

  • Would NSF certification or some other third party food safety standard help executives avoid prosecution, or at a minimum demonstrate good faith compliance?

    Every potential prosecution would have its own set of facts, so it is impossible to state for certain whether third party certification would mitigate culpability. That said, third party certification can’t hurt companies that are serious about managing food contamination risks.

    Food grade lubricants may be safely used for handling, canning, bottling, blending, chilling, cooking, cutting, slicing, and peeling on machinery components such as pumps, mixers, gearboxes, chain drives, and conveyor belts.