PREVENTIVE CONTROLS & RECORD KEEPING: COMPLYING WITH FSMA

The Food Safety Modernization Act (FSMA), signed into law by President Barack Obama in January 2011, represents major changes in food safety oversight. It requires the Food and Drug Administration (FDA) to develop science-based preventive controls throughout the food industry. This is a marked change from the FDA’s previous functions that were mostly reactive; e.g. to respond to incidents of contamination and outbreak. Now, the FSMA requires the FDA to be even more proactive—a preventive authority responsible for seeing that the food industry complies with new regulations. The burden is on food processors to maintain extensive supporting documentation that identifies their potential hazards and confirms adequate preventive controls of those hazards. As a result, food companies are focused on obtaining the tools necessary to address compliance challenges.

Introduction

The origins of the FSMA can be traced to the growing alarm over contamination incidents at a number of plants and its impact on the health of the general public. FDA Commissioner Margaret Hamburg noted that “each year, food-borne illness strikes 48 million Americans, hospitalizing 100,000 and killing thousands.” Congress, in an unusual bipartisan mode, was quick to react following several high-profile recalls, two of which were heavily publicized. One was the recall of peanut products in 2009. According to the New York Times, “more than 2,100 processed and packaged foods” were recalled after nearly 700 people became ill. Infection related to the contaminants is suspected of causing several deaths.

The other, a recall of approximately 380 million eggs in August 2010, followed a salmonella outbreak in four states traced to one company. Investigations by the news media indicated significant food safety lapses, which outraged congressional legislators and no doubt accelerated the FSMA’s passage.

What became obvious during this and other recalls is that a number of companies did not conduct enough preventive measures to avoid such contamination hazards even though many assumed health protocols were being followed. “Even the businesses that had thought they complied with food safety practices ended up with potentially tainted products,” reported the Times in February 2009.

The number of food recalls in 2010 is astonishing. In addition to the huge egg recall, cookies, meat, bread, soy, potatoes, cheese and sprouts also joined the list because of either detected or possible contaminants such as listeria, salmonella, and staphylococcus.

The size and scope of these recalls suggested that the food industry, despite its best efforts at food safety, was falling short—a conclusion that more than anything else expedited

passage of the FSMA. Now, food processors and packagers must

contend with the myriad complexities of the new law.

Beyond Hazardous Analysis & Critical Control Point Principles (HACCP)

The FDA hoped that voluntary adoption of the HACCP principles would be widespread—beyond the mandatory implementation required for the meat, juice and seafood industry—to alleviate possible food contamination issues. HACCP, as defined by the FDA, is a food safety management system designed to detect, reduce or eliminate biological, chemical and physical hazards from “raw material production, procurement and handling to manufacturing, distribution and consumption of the finished product.” The FDA in its published HACCP guidelines listed “growing, harvesting, processing, manufacturing, distributing, and merchandising” as the segments of the industry where HACCP would be applied.

The lengthy requirements of HACCP include formation of a team to develop a plan based on several principles; among them:

  • Develop a hazard analysis, a two-stage plan in which potential hazards would be identified and the severity of each would be assessed
  • Establish critical control points, those stages in the process where controls are necessary to prevent, reduce, or eliminate food safety hazards
  • Set critical limits—the minimum to maximum limits of control necessary to avoid a food safety hazard
  • Implement monitoring procedures and corrective actions when problems are detected

 Clearly, as the spike of recalls indicated, there remained obvious issues in assuring food safety throughout the chain. From the viewpoint of Congress, there was a need to grant more authority and oversight to the FDA and to require the food industry to do a better job preventing food safety issues or face severe penalties for non-compliance. Those are the issues addressed in the new act.

FSMA & the Role of FDA

The FSMA, which in essence amends the Federal Food Drug and Cosmetic Act, increases the scope of regulatory powers in these areas:

  • Provides new and enhanced regulatory and enforcement powers to the FDA
  • Places new responsibilities on food companies, particularly in identifying hazards, establishing preventive controls and maintaining supporting records
  • Imposes new fees on food companies and exporters
  • Places new controls over imported food
  • Provides food industry employees with whistle-blower protection

 Regulatory Power & Enforcement

From production and processing to packaging, distributing and exporting, FSMA greatly expands the FDA’s regulatory power over all of those sectors of the food industry. The act also gives the FDA discretion to prescribe standards, testing and monitoring requirements rather than letting individual companies set them.

It is in enforcement, however, where many companies may find themselves at risk. According to an advisory on the act drafted by the Washington law firm of Kelley, Drye and Warren, “The expansion of FDA authority in these areas is expected to increase the odds that regulatory compliance and product safety missteps will be exposed and result in adverse FDA findings, enforcement, publicity, litigation, and related liability.” The advisory’s author, Attorney Sarah Roller, believes that the impact of the penalty provisions will not be limited to those who willfully try to avoid complying with the law’s more stringent requirements.

“The FSMA raises important liability issues for responsible companies with a solid track record concerning FDCA compliance and food safety assurance,” Roller warns in the advisory. It is a warning that must be taken seriously.

That doesn’t mean, however, that the FDA is ready to immediately exercise its expanded power. “FDA is still determining the most effective way to implement the provisions of the new law and has not yet promulgated regulations or guidance documents to support the new law,” said Sebastian Cianci, an agency policy analyst and press officer. Cianci said the FDA plans a series of public meetings for industry input. FSMA places the agency on a timetable for implementation and rule-making. The statute requires final rulemaking on produce safety and foreign supplier verification in one year, 18 months for preventive control rules to be developed through “science-based mitigation strategies” and two years for the traceability rule pertaining to “high risk food.” Companies are required to register with FDA on a biennial basis beginning in 2012.

Preventive Controls & Record Keeping

The FDA, which provides extensive information about the FSMA on its website (http://www.fda.gov/Food/FoodSafety/fsma/default. htm), emphasizes its mandate from the legislation “to require comprehensive, science-based preventive controls across the food supply.” Preventive controls for food facilities, safety standards for produce, and authority to issue regulations to prevent intentional food contamination are included in FSMA—and all are mandatory. Some provisions of the law are self-implementing, and some of the provisions will require FDA regulations to implement.

Preventive controls, as defined by the FSMA, are “risk-based, reasonably appropriate procedures, practices and processes” that would either limit or prevent hazards that should be identified in a hazard analysis plan. Although not mentioned specifically, these requirements mirror the established HACCP plans required of meat, poultry, seafood, juice and low-acid canned foods establishments. Among the controls are:

  • Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment
  • Hygiene training for supervisors, managers and employees
  • Environmental monitoring to determine the effectiveness of pathogen controls in protecting food from exposure to potential contaminants
  • A program for food allergen control
  • A recall plan
  • Verification of supplier activities that relate to food safety
  • Current Good Manufacturing Practices (cGMP)

 These controls must be identified and implemented wherever a critical control point exists. The FDA defines this as “a point, step or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.” It is possible that some facilities may not have any critical control points, but many will.

The FDA requires a hazard analysis for all food safety plans and this examination can help determine if critical control points exist. The analysis applies to all hazards that could occur by natural processes or could be unintentionally introduced. The agency lists a number of potential risks to be evaluated such as biological, chemical, physical, parasites, drug residues, allergens and unapproved additives.

Under the law, the operator is responsible for verifying that preventive controls are adequate to address the identified hazard, maintaining a monitoring system to insure the controls are in place and appropriate decisions are being made for corrective actions. Operators should test the environment and products to assure that their preventive controls are either minimizing or preventing the occurrence of those hazards listed in the analysis. Also, they are required to conduct a periodic reanalysis of the hazard plan to see if it is still relevant if changes have occurred in processes, equipment and ingredients, and then conduct an examination for other previously unidentified potential hazards that may now exist. This re-analysis must be documented for FDA review.

In fact, the FSMA gives the FDA even more sweeping powers in accessing company records. The agency can now order a company to produce its food safety plan and documents related to it, records of environmental and finished product testing, documentation of corrective actions, and monitoring of the supply chain. The FDA has indicated it will insist upon thorough documentation and record keeping in keeping with the rational behind passage of the FSMA—another warning that is likely to have companies examine whether their current record-keeping based on spreadsheets and manual documentation will be effective for compliance.

Future document reviews under FSMA could lead to FDA-ordered inspections unlike the current methods that are based on observations at a facility. Much like a questionable tax form can precipitate an IRS audit, plant documentation deemed inadequate could likely bring a surprise inspection and the disruption that sometimes occurs with it. It is incumbent upon owners, managers and supervisors to maintain comprehensive record-keeping with thorough documentation and to do it in a consistent pattern that explains the rationale behind all decision making that impacts preventive controls.

Technology & Training as a Preventive Control

In addition, there is one other control the FDA will scrutinize, and it is one that may have as much weight as all the others— training. The FDA has included training among its preventive controls, which is understandable considering the importance of effective training programs in preventing contamination. After all, an employee or supervisor who is fully trained and found to comprehend food safety procedures and protocols is less likely to make a mistake in processing or production that could pose a contamination risk.

Training as a preventive control should be specific to each employee’s duties and responsibilities. In some cases, it may need a bilingual presentation since many companies have employees who may lack English comprehension skills. As in the case of the other listed preventive controls, there has to be an evaluation of the effectiveness of training and employee comprehension and a provable method of remediation for those who fail to grasp the concepts and procedures. Of course, record-keeping is essential for satisfying company’s goals and the FDA should the agency ask to see the documentation.

All of this poses a burden for plant owners and operators. In light of the FDA’s expanded powers along with the ongoing efforts at contamination and hazard avoidance, owners may feel overwhelmed, at least from the training aspect. The sheer volume of the manual paperwork that documents that training has been effective, comprehension established, and safety assured is a resource intense operation. A more important issue to be resolved is whether the company has the right tools to determine whether the training has truly been successful in establishing worker comprehension of food safety concepts. Thanks to technological solutions, companies can respond affirmatively. New technology can help them navigate this tricky training terrain and do it with provable results for their peace of mind and to the satisfaction of the FDA.

The technology in this case is interactive, easily adaptable and does not require employees to be computer literate to use it. Each employee receives an intuitive remote control device for use in answering questions designed to confirm understanding of the topics presented insuring their engagement throughout the training event. This electronic platform can be used to train up to 150 employees at the same time. Additionally, for those workers not as fluent in English, the technology can provide multilingual information if needed on all essentials involved in food handling and processing.

Training based on this type of technology is designed to assure complete comprehension, a necessity for food safety along with FMSA compliance. It validates comprehension and will accept nothing less than perfect scores. Remediation through this process is immediate. If any employee either fails to respond to a question or answers incorrectly, the program launches automatically into remediation and confirms that every employee truly understands what is being taught. What makes this technology a powerful tool for FSMA compliance is its record-keeping algorithms. It is an automated documentation process that can be easily accessed by company officials or FDA inspectors. Record-keeping is a driver of this technology. So is food safety as individuals are trained what to do at the point of potential hazards, such as taking temperatures, calibrations of metal detectors and measuring sanitizer concentrations. The platform is capable of being customized to suit a company’s unique training goals while recording every training session— all paperless. Equally important, a record of each individual’s performance is automated and retained giving the company a clear picture of its workers’ current level of knowledge and the FDA an insight into company compliance with FSMA. Documentation issues are completely eliminated through the automation process and meet FDA/FSMA regulations.

A number of companies have turned to technology to help them comply with training and testing along with FSMA’s myriad of requirements and responsibilities. One example comes from the Sara Lee Corporation. “Compliance would certainly be possible but the process would be much more cumbersome as records would have to be tracked by hand or in a spreadsheet versus using the LMS [learning management system] to house training records,” said Holly Mockus, food safety director for the company. “For a facility with less than 100 employees it is difficult enough to manually schedule training, record attendance and file the sign in sheet, but when you have 1,000 or more employees it becomes almost impossible.”

Mockus acknowledged that the database created through the electronic platform is able to handle all record keeping and reporting. She cited the platform’s ability to track training effectiveness through testing, analysis and immediate identification of those employees who need remediation. She said this is especially important with FSMA on the horizon.

“The FSMA has really heightened the awareness around the importance of training by calling it out specifically,” Mockus said. As the Sara Lee example graphically illustrates, it is clear that the food industry must rely on technology for the critical execution of training programs and for automating all data required for FSMA compliance. There is too much at stake to rely on less comprehensive approaches such as spreadsheets and manual data input.

Conclusion

For some progressive companies, compliance to FSMA may be no more than simple vulnerability audits to confirm that the facility meets or exceeds compliance to each known provision over the course of the next several years. For other companies, these new legal obligations will require major investments in order to create the necessary infrastructure to achieve compliance. Management will need to pursue effective technology solutions to lessen the burden of compliance.

The somewhat drawn-out timeline for regulation and implementation can be an opportunity for companies to prepare themselves for FSMA compliance. It’s incumbent upon them to conduct a systematic review of all HACCP regulations, the hazard analysis, food safety plans with emphasis on critical control points, supply chain management and, of course, training and record keeping. Technology can be a valuable tool in adjusting to life under FSMA, an act that is bound to radically change FDA enforcement and company compliance responsibilities for many years.

About Alchemy

Alchemy is dedicated to providing innovative training products that use technology and media to educate the global workforce. Our award-winning training products enable companies to effectively deliver, document, and manage personnel training. Most importantly, we help solve the training challenges most companies face when balancing production demands with increasingly strict regulatory requirements. For more information please email us at contactus@alchemysystems.com or visit www.alchemysystems.com.


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