Are You ‘Qualified’ under the Preventative Controls for Human Food Rule?

Who is “qualified” under FDA’s final rule on preventive controls for human food? Why would someone want to be “qualified?” What is the role of someone who is “qualified?” How much of a role does a “qualified” person play to ensure a safe and wholesome food supply?

The Preventative Controls for Human Foods (PCHS) Rule under the Food Safety Modernization Act has several definitions such as Qualified Auditor, Qualified Individual, and Preventive Controls Qualified Individual. I will discuss the definitions and responsibilities for the Preventive Controls Qualified Individual and the Qualified Individual only. As implementation of the PCHS rule begins for some, these individuals will play a vital role in the safety of our food supply.

The PCHS Rule was adopted on September 15, 2015 and applies to facilities that manufacture, process, pack, or hold human food. In general, facilities required to register with FDA under section 415 of the Food, Drug and Cosmetic Act are regulated. The rule sets standards for most wholesale food establishments and updates Good Manufacturing Practices. Most noteworthy is that it requires a food safety plan that identities known or reasonably foreseeable hazards; initiates, monitors, and verifies preventative controls; takes corrective action when needed; and requires documentation to demonstrate that the plan is working. It excludes farms, retail establishments, and those facilities under juice and seafood HACCP. Several other exemptions and limited exemptions within the Rule exist, but are beyond the discussion of this article.

There is some similarity between the definitions of the Qualified Individual and the Preventive Controls Qualified Individual, and thereby, some confusion. However, very distinct responsibilities and background qualifications separate the roles. The regulatory definitions of these two positions appear in bold type below.

Qualified Individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.

This definition casts a broad net that will include many wholesale food facility employees that have at least some food safety responsibilities. The Qualified Individual is expected to be able to demonstrate competence for their assigned job activities as it relates to food safety. Training in the principles of food hygiene and food safety, as appropriate to the food, the facility, and the individual’s assigned duties, must be provided and documented. There are no defined minimum training requirements within the rule for the Qualified Individual.

Preventive Controls Qualified Individual (PCQI) means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

The “standardized curriculum” is offered through the Food Safety Preventive Controls Alliance (FSPCA). The courses, found on the FSPCA website, are 2.5 days in length. The FSPCA also provides a train-the-trainer course for instructors. Courses are being scheduled throughout the nation by the FSPCA and others including food facilities, academia, consultants, and private food safety trainers. Individuals can also meet the PCQI requirements through job experience in lieu of the training requirement.

The rule is very clear in defining tasks that only a PCQI can do. The responsibilities of a PCQI include preparation of the food safety plan, validation of preventive controls, records review, and reanalysis of the plan. The PCQI may be a facility employee, but they can also use outside assistance in developing the plan and for other tasks that must be performed by the PCQI. In many situations, more than one PCQI may be needed to effectively develop and implement the food safety plan.

The mandates under the PCHF Rule establish set requirements and standards for the two positions that are vital for proper implementation. The rule places great responsibilities on the regulated community, so competent and knowledgeable food safety staff are essential. Food safety continues to become more complex and demanding as new and emerging challenges arise. Competent Qualified Individuals and Preventive Controls Qualified Individuals will go a very long way towards ensuring a safe and wholesome food supply.

FSMA Final Rule on Sanitary Transportation of Food Includes Major Revisions

FDA released the FSMA Final Rule on Sanitary Transportation of Human and Animal Food on April 6, 2016.

The final rule, which is part of the agency’s implementation of the 2005 Sanitary Food Transportation Act, contains some significant revisions of the proposed version, including affirming that the use of current sanitary food sanitation best practices will allow industry to meet the rule’s requirements.

The final rule focuses more narrowly on food safety and not on adulteration as a result of spoilage or quality defects. The agency also simplified the definitions for parties covered by the rule to make them activity based.

The final rule places primary responsibility on the shipper for determinations about appropriate transportation operations – for example, whether food needs temperature control for safety and the relevant operating temperature and mode of temperature monitoring, whether particular cleanout procedures are needed, and whether the previous cargo must be identified.

“We believe the shipper is in the best position of the parties covered by this rule to know the appropriate specifications for transport of its food,” the agency says.

Businesses other than small businesses have one year from the date of publication of the final rule to comply with the rule. Small businesses get two years to comply.

FDA hosted an April 25 webinar in which Consumer Safety Officer Mike Kashtock of the Center for Food Safety and Applied Nutrition reviewed the key requirements of the new rule. The agency plans to post the recorded webinar on its FSMA website.

What Makes a Good Sampling Plan?

You have a question, so you design a study to explore it. You determine that A is better than B and that the average difference is 3 units. It should be obvious that this is not sufficient information, but why not? After all, it is exactly what you wanted to know.

First of all, is a 3-unit difference a large number or a small one? You would likely know this from your experience as a scientist or engineer. And this is certainly important. But it is also important to know whether the difference is well or poorly known. This is more of a statistical question.

The first issue is the variation encountered in the study. If two of the experimental units in the study on different treatments are just as likely to have an 8-unit difference or even a difference of 2 units in the opposite direction, the 3-unit difference is no longer so impressive. So in designing the study a statistician would want to take enough observations to ensure that with high probability the study would recognize an important difference as an important difference (a statistically significant comparison) but would not declare a small difference to be significant.

The procedure for calculating sample sizes for a simple two-treatment comparison study is well known and widely available on the Internet. Unfortunately, this is not the only issue to consider. Recently the National Institutes of Health and the Food and Drug Administration have become concerned that a large number of preclinical studies are not reproducible (Landis, et al 2012). The stakes are very high. NIH spends about $30 billion per year to support scientific research and it has been estimated that half of these studies cannot be reproduced. Studies and clinical trials that would follow up on the results shown could well be looking in the wrong direction.

The NIH has recently been emphasizing the need for reproducible and repeatable studies. First, some definitions. In this context, a repeatable study is one that an independent scientist/statistician can analyze and get the same answers as the original scientists did. It is a matter of clarity in reporting the (statistical) analysis methods and in having the same data available. A reproducible study is one that independent scientists can begin again from scratch and follow the study description to produce very similar results as described in the original reports.

Repeatability is a rather minimal requirement, but one that is easily failed in a study of any complexity. There will likely be several scientists involved and each will be evaluating the data. Someone may modify the data after someone else has finished their analysis. It will then be impossible to get the same result as the first scientist did. Early in my career with the FDA, I ran into this problem frequently. When we did, we had to stop our review and send the application back to the sponsor. Sponsors soon learned to lock the database before anyone proceeded to an analysis and to be sure that FDA statisticians received only that database.

There is more flexibility in the requirement for reproducibility because variation in the responses of a second study are anticipated. This variation should be largely overcome by the sample size. Difficulties in reproducibility may be subtle and therefore more difficult to correct. Scientists may not even recognize the cause of a problem. For example, it might not even be known that there are important differences in the subspecies of animals used in the study. Or a reagent used in the study might have run out midway and have been replaced by a fresh batch, corresponding to the changeover to laboratory evaluation of animals on Treatment B from that of those on Treatment A.

Scientists may well have a good idea about how the study “should” come out. It would be unreasonable to expect that they run randomly or haphazardly chosen studies. In some cases, animals that did not respond as expected were eliminated from the study and not included in the analysis. There may have been a good reason for this, such as a determination that the animal failed to eat enough to receive a proper dose of its assigned treatment. The problem was that neither this evaluation nor the course of action was preplanned and the evaluation was not conducted for every animal in the study. The resulting bias prevents reproduction of the study.

Neither of the above definitions of repeatable or reproducible insist that the statistical analyses be appropriate for the study. In many cases in the literature, they have not been. It should be taken for granted that the appropriateness of statistical methods is as important as the appropriateness of laboratory methods.

A good sampling plan is one that will reliably produce a repeatable, reproducible study. It should start with a protocol that describes both the laboratory and statistical procedures to be employed. It should cover all anticipated events of the study in detail, and it should make provision for unexpected events.

In this short article I have not covered many of the potential statistical issues that occur in a study. These include interim looks at the data, specification of primary and secondary hypotheses, treatment of missing data, etc., all of which can affect the analytical methods to be used and the interpretation of the results.