What Do FSMA’s PC Rules Say About:

Features - Industry & Regulatory Issues

GFSI, Pest Management, Training, Environmental Monitoring, Product Testing

December 11, 2015

FDA began issuing the final rules of the Food Safety Modernization Act in August—complex rules, each extending to hundreds of pages. To bring our readers in-depth insights to these rules, QA asked subject experts to delve into specific aspects of the rules to present their analysis of the topic and its impact on industry. In this issue, we focus on the Preventive Controls rules. In the next issue of QA, we will bring similar insights on the new produce safety and import rules.

PM = PC + PP

by Deni Naumann, president, and Jim Sargent, director of technical support and regulatory compliance, Copesan

The word “pest,” including pest infestation, pest harborage, pest exclusion, and pest control, are mentioned more than 100 times in the Preventive Controls for Human Food rule. However, FDA did not add any new regulations pertaining to pest control in the final rule—it just reaffirmed current Good Manufacturing Practices (cGMPs), adding that it now considers cGMPs to be requirements—not guidance.

Pest control, listed under “Sanitary Operations” (21 CFR 117.35(c)) in the cGMPs states, “Pests must not be allowed in any area of a food plant.” Later, the cGMPs also state, “Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests.”

It is important to understand that the food facility manager is responsible for complying with these requirements, not the PMP or the sanitarian or the QC manager or anyone else. So, when a deer mouse is caught indoors after the PMP recommended keeping doors closed, replacing damaged/missing door strips, and increasing outdoor rodent devices as freezing temperatures approach, it’s the responsibility of the plant manager to make sure that “effective measures” are taken to exclude pests from his or her facility. This means documenting the measures taken, including who took action and when, on the pest prevention recommendations, and the corrective actions.

Thus, pest management as a preventive control can be broken down into two key equations:

  1. PC = PC
    Pest Control is a Preventive Control if pests are a known or reasonably foreseeable food safety hazard at the facility. (And, yes, they are.)
  2. PM = PC + PP
    Pest Management equals Preventive Control and Pest Prevention.

Remember that rodents, birds, flies, cockroaches, and other pests are a documented critical risk to food safety in food/feed establishments. All carry foodborne pathogen bacteria that could be left behind on food products, food contact surfaces, and anywhere they go. Stored product insects aren’t as significant a risk, but an infestation of warehouse beetles, flour beetles, Indianmeal moths, or other stored product insects also mean trouble when you read the cGMPs. (Your customers don’t like pests in your products or your facility either!)

Besides documentation of what’s been done to exclude pests, the new requirements include training of all employees on preventive controls as well as cGMPs. Therefore, required annual employee training should include the importance of pest sightings and what to do, potential problems with pest exclusion (e.g., doors not closing), supporting pest management efforts (as opposed to negating them), and, most importantly, pest control and food safety require everyone’s cooperation.

The greatest challenge to reducing the risk to food or feed safety is personnel blaming someone else for not preventing a pest problem. It’s everyone’s responsibility to do his or her job well and reduce the risk of food contamination. Effective communication from the PMP to the food plant, from food plant employees to their supervisors and to the PMP, and from the plant manager to all food plant employees is needed to reduce the risk of food contamination.

Does GFSI Certified = FSMA Ready?

by Robert L. Garfield, senior vice president, SQFI, Food Marketing Institute

GFSI-certified facilities are well prepared for FSMA compliance. Of course, each facility should look at the provisions of the applicable final FSMA rule and compare that to the GFSI program they have or are planning to engage. As such, a comparison of the proposed preventive controls and produce safety rules with the corresponding modules of the SQF Code, conducted for SQFI by former FDA Associate Commissioner for Foods Dr. David Acheson, found that food and beverage facilities certified to Level 2 have a very strong start toward compliance with the new requirements.

The two greatest challenges facing the food industry are developing a robust food safety management program and maintaining that program over the long term. Many smaller facilities that have two to three years to develop their program believe they have plenty of time to get it right. Let’s assume that implementing a GFSI program meets 95% of the FSMA PC requirements. We know from experience that it takes from six months to a year and a half to be audit ready. It also has been well documented that while the first audit goes smoothly, it is often the second-year audit at which facilities run into problems.

The importance of timing is twofold; prepare now, it takes some time to get your management program right. The second-year audit letdown is an indicator that more work needs to be done on management commitment, culture, and continuous improvement (MCCI). These are the building blocks of a vibrant food safety management program. Start with and reinforce management’s commitment to the program, expand that commitment to all levels of the organization from marketing to maintenance and continue to find ways to improve your program. That is a formula for FSMA compliance success.

Environmental Monitoring and Product Testing

by Stan Bailey, senior director, scientific affairs, bioMerieux

Environmental monitoring and product testing are two important components of a comprehensive food safety plan and should be accounted for when implementing an effective preventive controls program. There is now a requirement for a written food safety plan comprised of hazard analysis, identification of preventive controls to address each of the hazards identified, a written supply-chain program, a written recall plan, and maintaining records associated with each of the above. Emphasis will be on preventive controls which will almost always start with an effective environmental control program, but which will be verified by end-product testing.

The rule requires a designated preventive controls qualified individual in each facility to oversee the development/administration of the food safety plan which is to cover all hazards from the environment/plant through final product, and include process, food allergen, and sanitation controls as well as supply-chain controls and a recall plan.

Additionally, human foods that go into the animal food stream (and may be subject to the Animal Foods Preventive Controls rule) are subject to new requirements including product testing.

To meet both the spirit and letter of the rule, companies need to adopt a real food safety culture. This must involve buy-in from management for a robust monitoring, corrective action, and verification plan which is documented by a robust recordkeeping system. But the most challenging issues for the industry (particularly for small- and mid-size entities) will be conducting a valid hazard analysis and developing better supply chain management—which will require firms to truly know their suppliers.

Required Training

by Jeff Chilton, vice president of professional services, Alchemy Systems

For the first time, there are regulatory requirements for employee training. According to the definitions of required training clarified in the final Preventive Controls rule, only FDA-approved training consistent with the standardized curriculum is accepted. While the rule includes the fact that alternative job experience is acceptable, definitions remain ambiguous.

The good news for food companies is that the FDA recognizes that food-industry training will be an important component in the successful implementation of FSMA, and it acknowledges its role in facilitating the industry’s understanding of the training requirement. As such, it published a strategy for training, which includes strategic alliances composed of federal, state, industry, and academia representation. It also awarded the International Food Protection Training Institute a grant to establish the National Coordination Center (NCC) to lead coordination of curriculum development and delivery; is partnering with USDA’s National Institute of Food and Agriculture to provide grants that fund NCC and four regional training centers (RCs); and with the Food Safety Preventative Controls Alliance to develop a standardized training and education program. A series of “train the trainer” courses are planned to help companies understand the standardized curriculum requirements.

Companies should use care in addressing the FSMA requirement for the preventive controls qualified individual (PCQI)—the only one eligible to prepare the food safety plan, conduct validation activities, complete record review, and carry out reanalysis. This person should have specialized training in the development of risk-based preventive controls under a standardized curriculum recognized by the FDA. Prior HACCP training without a focus on a risk-based approach is not considered adequate. It is critical for each company to develop a training strategy of their own. First, understand what it means to be a PCQI, then establish him or her as your food safety champion. The qualified individual can lead the food safety plan implementation and oversee necessary training throughout the organization.

When developing a training strategy, companies should define learning plan requirements for each target audience at each level of the organization. Other qualified individual training will also be required for each person to understand the importance of hygiene and food safety principles as appropriate to their assigned duties.

It is important to note that the standardized training developed by the alliances and the FDA’s cooperative agreements are the only training programs that will be officially recognized by FDA. Food companies should work with the NCC and RCs to ensure compliance, and adopt good recordkeeping practices for training activities. These records will be necessary to demonstrate compliance once the FDA enforcement dates are reached.

In Summary

by Stephanie K. Barnes, Regulatory Counsel, Food Marketing Institute

Overall, the final rules are substantially the same as FDA’s supplemental proposal, and where revisions were made they provide additional flexibility for facilities to manage their food safety plan. The two most notable changes in the final rule are the requirement for a supply-chain program and new mandatory training requirements. The supply-chain program requirements for manufacturing/processing facility are incredibly detailed and impose substantial new documentation requirements for affected facilities.

There is certainly going to be a significant learning curve as companies begin implementing the new requirements. The rules are dense, complex and over 900 pages so there are important details that need to be considered. The devil is always in the details and implementation will be a learning process for the regulated community and FDA. For most establishments, compliance will be required by September 19, 2016, and given the flexibility imbedded in the rules, it will be essential to have uniform training for industry and FDA inspectors to ensure there is proper education and consistency in inspections.

The agency is also in the process of developing a number of guidance documents that will be essential to flesh out some of the nuances in the rule. Overall, there will be a tremendous need for FSMA education and training up and down the supply chain.


The author is editor of QA magazine. She can be reached at llupo@gie.net.