What Types of FSMA Training Do Your Employees Need?

By Claudio Gallottini, DVM PhD, Ita Corporation

All seven core rules of FSMA require general training of individuals or employees. The FDA has made specific training mandatory. In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety.

Additionally, individuals who are responsible for a specific critical control point will still need to be trained in Hazard Analysis Critical Control Points (HACCP). However, this will probably not be sufficient for an employee responsible for a preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls). For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA).

Produce Safety Rule

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically, they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, are clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs. This course will be available through the Produce Safety Alliance. Training for sprouts is being developed by the Sprout Safety Alliance and include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

FSVP

The new Importer introduced by FDA, the Foreign Supplier Verification Program Importer (FSVP), needs to be trained (21 CFR 1.503), to become aware about the new requirements. Unfortunately, this training is suggested from FDA and not mandatory. The course is available from FSPCA LI. In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities.

Sanitary Transportation of Human
and Animal Food

With regard to the Sanitary Transportation of Human and Animal Foods (21 CFR 1.910), the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems, and the responsibilities of the carriers in the regulation. The course is offered online directly by FDA. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Food Defense

With the Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training. For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense page. All personnel should be trained at least annually in food hygiene, food safety and food defense.

ITA Corporation is a company specializing in food safety, inspection and auditing worldwide. Its main focus is to offer support, awareness and guidance about Food and Drug Administration (FDA) regulatory matters. ITA thoroughly assists both domestic and foreign food facilities in meeting the requirements of the Food Safety Modernization Act (FMSA) with consulting, auditing and training programs. Services cover all FSMA rules, HACCP, labeling and U.S. regulations. To contact ITA, e-mail: cgallottini@itacorporation.org or call + 347-964-0171 in the U.S.