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From: Food Quality & Safety magazine, February/March 2014

The Food Safety Preventive Controls Alliance

by Tim Donald

Alliance Gears Up to Develop Preventive Controls Curriculum

A public-private alliance of industry, academic, and regulatory leaders is working to establish a standardized curriculum to help food companies comply with the preventive controls rules for human and for animal food required by the Food Safety Modernization Act (FSMA). Although the final regulations on preventive controls for human food are not expected to be published until mid-2015, the work of the Food Safety Preventive Controls Alliance (FSPCA) is already well underway, according to members of the steering committee. The aim is to have the curriculum in place at the time the final rule is published.

“We’re very excited about this alliance,” says Jenny Scott, senior advisor in the Office of Food Safety of the FDA’s Center for Food Safety and Applied Nutrition. “We think the FSPCA is developing a good curriculum, and it’s going to be very important as we go forward in moving the industry toward producing safer food products.”

The FSPCA was funded as a part of an existing grant to the Illinois Institute of Technology (IIT) that helps to fund the Institute for Food Safety and Health (IFSH), the entity that hosts the FSPCA. The FDA will also offer ongoing input as the curriculum is developed and will review the final product, Scott says, “so that it can become an FDA-recognized curriculum.”

The core curriculum and corresponding technical materials will be designed to help small- and mid-sized firms design food safety risk-reduction preventive controls that comply with federal regulations, says Purnendu Vasavada, PhD, outreach project manager for the FSPCA.

“Our mission is to support the FSMA requirements and help companies comply with those requirements to ensure a safe food supply. We will also provide additional technical information and serve as a go-to entity for industry to approach for help with FSMA compliance,” Dr. Vasavada says.

Available to All

The FSPCA was conceived soon after the FSMA was signed into law in 2011, according to Robert E. Brackett, PhD, vice president of IIT and director of the IFSH.

“At that time there was recognized need for an institute to help small- and mid-sized members of industry to achieve compliance with FSMA, and a decision was made to use the model of the Seafood HACCP [Hazard Analysis and Critical Control Points] Alliance in terms of putting together the best thoughts from industry, academia, and government,” Dr. Brackett says.

Jenny Scott

“We think the FSPCA is developing a good curriculum, and it’s going to be very important as we go forward in moving the industry toward producing safer food products.”

—Jenny Scott, senior advisor, Office of Food Safety of the FDA’s CFSAN

“From that time we have been working toward designing a curriculum that will be available to anybody in the industry, focusing on aspects of the preventive controls rule that will help companies have what they need to fulfill the requirements for the qualified individual,” he adds. “Much of the work is already done, but we have to wait until the proposed rule is finalized so that our curriculum is completely in sync with what the rule says. The “qualified individual,” under the proposed FSMA rule, is to be responsible for preparing a company’s food safety plan, developing a hazard analysis, validating preventive controls, and other functions.

“One way a person gets to be a qualified individual is by successfully completing training in the development and application of preventive controls that is at least equivalent to that received in a standardized curriculum that is recognized as adequate by the FDA,” Scott explains, “That’s the crux of why the FSPCA was established.”

Training the Trainers

The FSPCA steering committee hopes to finish a draft of the curriculum in the third quarter of 2014, Dr. Vasavada says.

Robert E. Brackett, PhD

“At that time there was recognized need for an institute to help small and mid-sized members of industry to achieve compliance with FSMA…""

—Robert E. Brackett, PhD, vice president, IIT, and director, IFSH

“Then we will do a pilot to make sure the content and delivery of the curriculum is as smooth and effective as intended,” he says. “We will issue a call for people who are interested in working as alliance-recognized trainers and offer train-the-trainer courses for them after the final curriculum is available. Anyone doing the alliance-recognized training must be giving out the same message, as it is intended for compliance with the regulation.”

The curriculum will be publicly available, posted on the FDA and FSPCA websites, according to Scott, and anyone can use the curriculum for training.

FSPCA-recognized training courses will have alliance-trained trainers, and only these courses will issue FSPCA certificates, she says.

Once the final rule is published, facilities will have one to three years, depending on size, to comply with the requirements. Until issuance of the final rule, Dr. Brackett says, interested parties can follow the progress of the curriculum development on the FSPCA website (www.iit.edu/ifsh/alliance).

“We are trying to do a really great job of keeping the website as up-to-date as we can,” he says. “People can watch the web page for developments.”

Curriculum ‘Just the Beginning’

The FDA expects more from the FSPCA than just the development of the curriculum, Scott says.

Purnendu Vasavada, PhD

“We will also provide additional ­technical information and serve as a go-to entity for industry to approach for help with FSMA compliance.”

—Purnendu Vasavada, PhD, outreach project manager, FSPCA

“We think the curriculum is just the beginning,” she says. “For training and education to be effective, there will have to be information available about specific foods produced by small businesses, which are the primary targets of this effort. Beyond the basic curriculum, we are expecting the alliance to help develop training modules for specific food types, so that the FSMA requirements can be related to a specific company or group.”

The FDA will also expect the FSPCA to help develop information for food-type-specific guidance documents to help small businesses understand how to do a hazard analysis, the types of hazards that are likely to be associated with their particular types of products, and how to implement controls for those types of hazards, Scott says.

“And we expect the alliance to do outreach to these types of companies, so the people involved in training may also become part of a network of experts that small businesses can call upon to help answer questions,” Scott adds. “So hopefully the alliance can coordinate what we call a National Technical Assistance Network and post information on their website that companies can go to for help with their preventive control or food safety plans.”


Donald is a veteran journalist with extensive experience covering a variety of industries. Reach him at timdonald2020@gmail.com.

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