By Loren Israelsen, President, United Natural Products Alliance
If I were to ask, “Who is your PCQI?” (Preventive Controls Qualified Individual), there would be three typical responses:
1. What is PCQI?
2. I don’t know; I’ll ask around and get back to you.
3. Yes, we do have a PCQI (BTW: PCQI is a person, not a thing!).
If an FDA investigator or a major customer were to ask this question of you or your staff, then what? I confess, it took me a while to get the acronym and the concept of PCQI straight in my head, so if that is your situation, you are not alone.
What’s a PCQI?
So, what (remember, it is a “who”) is PCQI?
Preventive Controls for Human Foods is one of seven provisions of the Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, which was signed into law by President Obama on January 4, 2011. According to the Food and Drug Administration (FDA), FSMA aims to “ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”
FSMA is also the key to a new generation of food good manufacturing practices (GMPs) based on the Hazard Analysis Critical Control Point (HACCP) principles of “anticipate, prevent, and validate.” The old system was “problem, investigate, fix and then repeat.”
Within the Preventive Controls for Human Food rule, a PCQI is required for all companies that manufacture foods and dietary supplements, outside of a couple of specific exemptions.
After the melamine protein disaster of 2008 and lots of food safety problems with peanut butter, tomatoes, lettuce, cantaloupe, flour with E.Coli, sprouts, spinach and ice cream, both the public and Congress wanted change. That change was FSMA. FSMA is based on HACCP.
The origins of HACCP go back to World War II as a solution to a big problem: defective artillery-shell firing pins that were blowing up our own soldiers or just not exploding. This problem was solved by carefully examining each possible failure (also known as the “critical point” or CP) and fixing it, until system integrity was confirmed. NASA adopted HACCP to make sure astronauts’ food in space was absolutely safe. Salmonella in a space suit = “Houston, we have a problem.”
The Preventive Controls (PC) is the process, and the PCQI is the person or persons trained to devise, implement and execute the preventive controls developed through a food safety plan.
SEE PCQI: FREQUENTLY ASKED QUESTIONS
Who needs to have a PCQI?
Who or what falls under the PCQI requirement? All food and supplement products, wherever they are from, that are consumed in the United States. Some companies are exempt, including those that manufacture or sell seafood, juice, low-acid canned food, and Code of Federal Regulations Title 21 Part 111-compliant dietary supplements.
Here is our advice: If you produce, transport, distribute, warehouse or sell any products that require a Nutrition Facts or Supplement Facts label, you are strongly advised to complete PCQI training.
This is how it works:
- Companies designate an individual(s) responsible for the preventive control food safety plan and its implementation.
- A PCQI is required to have 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 FDA or as otherwise qualified.
- The standardized, curriculum-based course is 2.5 days with active student participation.
- Class size is capped at 15 people per instructor. The coursework is standardized and approved by an independent body, the Food Safety Preventive Controls Alliance (FSPCA), a non-profit organization recognized by FDA to oversee PCQI training. See FSPCA background and copy of the participant manual here.
- PCQI graduates receive a certificate of training, which is specific to the PCQI, not the company. Thus, if your PCQI leaves your company or is on leave for any reason, you need to designate and train another PCQI.
- The PCQI is now responsible to create, implement, and maintain compliance through the food safety plan that begins with PCQI training.
- Each facility (not company) must have at least one PCQI.
- A food safety plan is specific to each product type, and it is not uncommon for one facility to have multiple food safety plans.
- The compliance date for PCQI implementation is dependent on the company size, and large companies were required to have a PCQI on staff as of September of last year.
- Large companies (>500 employees): September 2016
- Small companies (<500 employees): September 2017
- Very small companies (<$1 million in annual sales, but this includes the value of your inventory): September 2018
In the near future, if not already, customers will be asking about your PCQI status—and so will FDA during your next facilities inspection.
UNPA to offer PCQI trainings
Clearly, thousands of conventional food and dietary supplement/dietary ingredient companies require training to be in compliance with these federal regulations—a huge task. In response, UNPA is offering PCQI trainings through the rest of the year in several locations.
About the UNPA PCQI trainings:
- UNPA’s Larisa Pavlick, our VP of Global Regulatory & Compliance, is a lead instructor for FSPCA Preventive Controls for Human Food and can train your staff to be a PCQI.
- We have contracted with other highly qualified PCQI trainers to work with us to increase class size as needed and as venue size allows.
- The courses include food/dietary supplement/dietary ingredient case studies, which are an integral part of the training.
- All coursework materials are included.
Please refer to the UNPA Events page for information on upcoming PCQI trainings.
There are other parts of FSMA that require a qualified individual with separate training, such as the Foreign Supplier Verification Program (FSVP). We will be offering FSVP training in the future, as well. If you’d like to be added to our seminars list to be notified about future UNPA education and trainings click here and provide your name and email address.
UNPA has set FSMA compliance as a high priority. We are doing all we can to provide the tools, the training and the resources for industry companies to be FSMA compliant. Our goal is to have a 100-percent FSMA-compliant membership within the next 12 months. We hope we can help you become FSMA compliant, too.
About Loren Israelsen
Loren Israelsen has been deeply involved in the commercial, political and regulatory issues facing the global dietary supplement industry since 1980. On the commercial side, he served as general counsel and president of Nature’s Way Products Inc. Much of his career has involved creating and supporting efforts to allow broad access to dietary supplements, together with the systems to assure product quality, safety and benefit. He has authored more than 150 articles and/or book chapters and has lectured in over 30 countries on dietary supplement and functional food issues. Currently, his greatest areas of interest are the growing presence of synthetic biology in the natural products industry, personalized nutrition and the preservation of the cultural knowledge on which the natural products industry is founded.
About the United Natural Products Alliance
The United Natural Products Alliance (UNPA) is an international trade association representing more than 100 leading natural products, dietary supplement, functional food, and scientific and technology and related service companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability. Founded in Utah in 1992, UNPA was instrumental in the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and continues to take a leadership position in legislative and regulatory issues and industry best practices. Visit www.unpa.com.
About the Food Safety Preventive Controls Alliance
FSPCA is a broad-based, public-private alliance, consisting of key industry, academic and government stakeholders, whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that are part of FSMA. Visit www.ifsh.iit.edu/fspca.