American Feed Industry Association (AFIA) - Q&A
Thank you to the American Feed Industry Association (AFIA) for compiling answers to the four most commonly asked questions regarding training requirements for FSMA compliance. By September 2017 the largest feed manufacturers will be required to have a preventive controls qualified individual in place to prepare and monitor an animal food safety plan.
Q. When does the "preventive controls qualified individual" need to be in place at my facility?
A. The preventive controls qualified individual (PCQI) is defined as "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 the U.S. Food and Drug Administration, or is otherwise qualified through job experience to develop and apply a food safety system." According to the regulations, a PCQI would need to be in place when a facility is in compliance with 21 CFR, part 507, Subpart C, as detailed in Table 32 (80 Federal Register at 56329 and below) with the date being the earliest for large firms (with more than 500 employees across the business) on Sept. 18, 2017.
However, the PCQI is responsible for preparation of the facility's animal food safety plan. Therefore, it is very likely that a facility will need to have a PCQI in place well before the facility's compliance date of September 2017 or September 2018 in order to properly prepare the animal food safety plan.
Q. Does the PCQI need to be an employee of the facility? Can it be a team of individuals?
A. Title 21 CFR § 507.53 (c)(1) states the PCQI does not need to be an employee of the facility. Each firm will need to review the requirements for the PCQI and determine if the requirements can be met by PCQI(s) not located at the facility. Section 507.53 details the requirements applicable to the PCQI. In (a), it states "one or more preventive controls qualified individuals must...," therefore implying that it can be more than one individual.
Q. When will I be able to get my preventive controls qualified individual trained?
A. The preamble to the final rule states, "It is the responsibility of the owner, operator or agent in charge of the facility to determine whether any individual who prepares (or oversees the preparation of) the food safety plan has appropriate qualifications to do so, whether by on-the-job experience or by training" (80 FR at 56283). Having the PCQI go through a standardized curriculum (being developed by the Food Safety Preventive Controls Alliance (FSPCA) is one method to determine if the PCQI is qualified).
AFIA believes most plants already have a PCQI among current employees that are quality and/or regulatory team members due to these employees' experience and training. AFIA recommends that eventually one or more employees may take the PCQI training, but it is not essential to initially have all PCQIs trained. The individuals may be appointed immediately and begin preparing the hazard analysis and animal food safety plan. The FSPCA will finalize the training curriculum sometime in 2016 and AFIA will begin holding training sessions later in the year.
Q. So what is a "qualified individual" and when do they need to be trained?
A. The final rule defines a qualified individual as "a person who has the education, training or experience (or a combination thereof) necessary to manufacture, process, pack or hold safe animal 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." Title 21 CFR 507.4 details the applicability and qualifications of all individuals engaged in manufacturing, processing, packing or holding animal food. As mentioned in last week's FSMA update, FDA has responded to AFIA's inquiry and clarified the compliance date of the requirements for the qualified individual in 21 CFR 507.4. The compliance date for this section coincides with the date the facility manufacturing, processing, packing or holding animal food first becomes subject to part 507, Subparts B or C. For most animal food facilities, the first compliance date will correspond to the facility being in compliance with Subpart B (Current Good Manufacturing Practices), which is as early as Sept. 19, for large facilities. Please find Table 32 below for a quick reference.
AFIA will develop materials that can be used for qualified individual training in the near future, but suffice it to say the qualified individual is anyone in the plant involved in the manufacturing, processing, packing or holding animal food. It would be helpful to train everyone in the plant or operation to ensure each understands the importance and commitment to food safety and hygiene.
Federal Policy Background
The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, and provides the U.S. Food and Drug Administration (FDA) with sweeping new authorities and requirements. The law was a bi-partisan supported bill backed by the food and feed industries. It authorizes FDA to promulgate new rules for preventive controls, develop performance standards, create new administrative detention rules, provides authority for mandatory recall of adulterated products and provides authority for hiring more than 4,000 new field staff among other provisions. It is unclear whether Congress will provide sufficient funding authorization to fully implement the law.
Federal Policy Position Statement
The Alliance supports development of technical assistance within state and federal governments, land grant universities, private service provider and the cooperative extension systems, to assist businesses with compliance with Food Safety Modernization Act and Occupational Safety and Health Administration mandates.
Federal Policy Background
Immigration - Access to affordable labor is important for all farms. The Alliance supports immigration reform measures that recognize the vital role of foreign labor in food production. Farmers experience difficulty employing local labor to feed and milk their herds and care for youngstock. These roles have been filled more and more by dependable employees from other countries. Steps are needed to streamline the H-2A visa program’s application process and provide a reasonable mechanism for the most experienced, but unauthorized agricultural workers, to earn legal status are critical as well. The Alliance supports proposed changes to current immigration laws that would provide agricultural employers with a stable, legal labor force while protecting farmworkers from exploitative working conditions.
Federal Policy Position Statement
The Alliance supports thoughtful reform of Federal dairy policy and supports immigration reform measures that recognize the vital role of foreign labor to the US food production system.