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Caliente! Hot Topic!
Have you heard? FDA is going to initiate recalls and announce recalls to consumers. Technically, the FDA initiating a recall is not new, because FDA gained the authority to initiate a recall in 2011 with the signing of the Food Safety Modernization Act (FSMA). FDA has pumped out three new guidance documents on public notification of a recall. The last of the three, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019, was recently published.

What is the Purpose of the February 2019 Guidance?
FDA is communicating to industry and providing recommendations for its own staff for when they will initiate a recall and publish a public warning of a recalled food. FDA has seen, in rare cases, where there is not cooperation from the recall firm or there is slow announcing of a recall. FDA calculated the average time for a firm to announce a recall is four days; it is implied that four days is too long for hazardous food to be in commerce. FDA intends to work cooperatively with the recall firm. The FDA must first provide the responsible party with an opportunity to voluntarily cease distribution and recall the article of food. FDA gives the first opportunity for initiating and announcing a recall to the Owner, Operator, or Agent-in-charge. Infant formula recalls are mandated separately, but all food, ingredients and chewing gum are otherwise covered by the guidance.

It’s not all bad news!
For fiscal year 2018, there were 7420 recalls and 831 classified as a high risk. Since 2012, the 2018 numbers are the lowest number of recalls. What happened after 2012? February 2013 was the start of FDA uploading whole genome sequences to GenomeTrakr and the transition away from PulseNet which uses the method of pulsed field gel electrophoresis. The greater sensitivity of whole genome sequencing has led to more recalls.

Timeline: April 2016
Given a head’s up on a pending report from the Office of the Inspector General (OIG), FDA created a team of senior leaders with oversight of recalls; the team meets at least weekly. Named Strategic Coordinated Oversight of Recall Execution (SCORE), SCORE expediated the process for suspending the registration of two facilities as of December 2017.

This is where the E. coli hit the fan.
The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply, December 2017. The 2017 report published from the OIG found FDA failures in food recall practices. The OIG made a series of recommendations on how the agency might improve its management of recalls.

Timeline: January 2018
FDA draft guidance [the January 2018 draft guidance is no longer available] on FDA’s policy and notification of recalled products and posting recalls to the FDA Enforcement Reports was published to assist the food industry in working with FDA through a recall.

What products are covered?
Food, drug, or device intended for human or animal use; cosmetic and biologic intended for human use; tobacco product; and any item subject to quarantine regulation. Radiation emitting electronic products are not covered.

Timeline: April 2018
I wanted to know when and how FDA used its new authority under the Food Safety Modernization Act (FSMA) in 2011. Last year I wrote what I learned in a ConnectFood blog post, which included 3 cases:

    1. Sunland peanut butter sold finished product containing Salmonella.
    2. Kasel dog treats recalled after Salmonella found.
    3. Triangle Pharmanaturals’ kratom dietary supplements contain Salmonella.

One of my favorite sentences from the Kasel recall notification is as follows:

    If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats.

Timeline: September 2018
FDA Draft Guidance, Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff September 2018, was the first of three guidance documents published by the FDA. If known, FDA will notify the public of stores where recalled food was sold. Retail consignees include grocery store, pet food stores, convenience stores, but not restaurants or distributors.

Timeline: November 2018
In this FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market November 2018, two examples were given for when FDA has notified the public of a recall:

    FDA Investigated Multistate Outbreak of Vibrio parahaemolyticus Linked to Fresh Crab Meat Imported from Venezuela, September 2018
    FDA Alerts the Public Regarding Recalled Vegetable Products, October 2018 McCain’s Ready-to-cook and ready-to-eat (RTE)

While I appreciate the explanation, the following sentence stopped me in my tracks:

We’ve already acted on these draft guidances.

I had previously heard that FDA was acting on a different unpublished draft guidance document, but here I saw it in print. It is not clear if the FDA is working from the published draft guidance shared with the food industry or from unpublished, draft guidance documents.

The second guidance document was published: Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff, November 2018. The Q & A addresses three questions.

1. When will the FDA publicize retail consignee lists?
FDA will determine the likelihood of serious adverse health consequences or death of humans or animals (SAHCODHA) resulting in the food being adulterated and in most cases a class I recall. Some class II recalls or unclassified recalls will be publicized. I was very interested to see examples of what FDA considers high risk foods:

    Listeria monocytogenes-smoked salmon, pumpkin seeds
    Salmonella in ready-to-eat food-peanut butter, alfalfa sprouts, deli products
    Certain undeclared allergens in food
    E. coli O157:H7 in leafy greens
    Botulinum toxin- e.g. under processed canned chili
    Choking hazard in baby food, and
    Misbranded food with missing or incorrect food allergen labeling

For notification by FDA and in most cases, the retail packaging will make recalled food difficult to identify, and the food will be likely to still be in homes or stores. For example in the spring 2018 Romaine lettuce recall, much of the Romaine was beyond its shelf life and was not expected to be available in stores or homes by the time the recall was announced. From the Q & A guidance: There may be situations where both criteria are not met and FDA notifies the public. The FDA is not required to contact the firm before issuing a public warning or allow its review of the proposed statement. FDA may supplement or correct [the] warning.

What information will the FDA provide?
When FDA notifies the public of a recall, they wish to have information that help the consumer identify the product. Such information includes name of the food, lot or code dates, product description, photographs, geographic information, retail-related information, e.g. by naming the retail store chain, and potentially store specific information such as city and state. FDA will describe the risks and information about similar food that is not affected by the recall. FDA will state that the information may be under or over inclusive.

How will the FDA publicize this information?
FDA Public Warnings will come as a press release posted on the FDA website, alerts, and public notices by email, web or social media. Public notification of a recall is published in the weekly FDA Enforcement Report.

Timeline: February 2019
The FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls February 2019, and FDA Guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019, detail the FDA’s current thinking on when FDA will notify consumers of a recall. Companies which do not cooperate with the FDA for a recall or communicate a recall slowly to the public may experience the FDA announcing a recall.

ConnectFood can help you meet the requirement of the rule and be prepared for a potential recall. The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.

References

    1. Food Safety Modernization Act (FSMA) January 2011
    2. FDA Rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food September 2015
    3. Office of the Inspector General (OIG) Report, The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply December 2017
    4. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls December 2017
    5. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls January 2018
    6. ConnectFood blog post, FDA Uses New Authority Under FSMA to Order a Mandatory Recall, April 2018
    7. FDA Draft Guidance, Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff September 2018
    8. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market November 2018
    9. FDA Guidance, Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff November 2018
    10. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls February 2019
    11. FDA Guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019
    12. 21 CFR Part 7 FDA Enforcement Policy, Subpart C–Recalls (Including Product Corrections)–Guidance on Policy, Procedures, and Industry Responsibilities

As a high school teacher in Chicago, in a past career, I was on a school bus headed south to the university campus of Champaign-Urbana, riding through the flat cornfields of Illinois. One of my students pointed out the window and asked, “Dr. Knutson, what are those… factories over there?” My reply was, “that is a farm.” In light of the new FDA guidance, the question is valid. Do on-farm processing steps change a location from a traditional farm to a factory? My previous blog post started with the definitions of supplier, receiving facility, and farm mixed-type facility. Farms are not required to implement a food safety plan, and farm mixed-type facilities have been under enforcement discretion while FDA figures this out. FDA took a giant step in sharing their current thinking on the definitions of produce covered by the Produce Safety rule and the Preventive Controls for Human Food rule. FDA recognizes the variety of produce grown on farms and approaches to building in food safety.

Produce Safety Rule Exemptions:

Farms with an annual average revenue under $25,000 are exempt. This makes sense from a public health view. Small farms are not going to cause wide-scale harm, in general. There are other exemptions for farms with an annual average revenue above $25,000 and based on how much is sold directly to customers through a farm stand-like store, local grocery store or restaurant. Another exemption is based on the sale of other products like hay or wine. For farms that don’t know where they fall, my advice is to ask an accountant and attorney to interpret the farm’s sales of commodities regarding the rule. See COVERED FARMS.

Produce is the edible portion of fruits and vegetables for human consumption. Produce grown for animal feed or other uses is exempt from the Produce Safety rule.

Grains are exempt from the Produce Safety rule because grains are always going to be further processed. Produce that is rarely consumed raw (RCR) is exempt from the Produce Safety rule. Examples include potatoes and beans.

Don’t worry about your backyard garden. Produce that is grown for personal use or on-farm consumption is exempt from the Produce Safety rule.

Farm Mixed-type Facilities:

The bottom line is that as soon as produce is processed in any way to make it a new food, the activity is under the Preventive Controls for Human Food rule. Most of us understand that roasting of nuts is a processing step that requires preventive controls to create a safe product. The same is true for making bags of chopped lettuce and sliced apples. These raw agricultural commodities (RAC) have been changed into processed food, and processed food is under the Preventive Controls for Human Food rule.

Until now, FDA has been hands-off on processing of RAC on the farm. If processing is done on a farm in a farm mixed-type facility, the process is under the Preventive Controls for Human Food rule. The facility must have a written hazard analysis, implement a food safety plan, and have a Preventive Controls Qualified Individual (PCQI). The FDA is seeking comments on their published guidance for farm mixed-type facilities. In some ways, the FDA guidance seems like too much. Do we really need this for farms? Then I am reminded of Salmonella outbreaks from cantaloupe. In one outbreak the melons were only washed as a processing step, but in such a way as to not remove or kill pathogens. The outbreak covered 28 states with 143 hospitalizations of 147 documented cases. There were 33 deaths. Yes, we need this.

    “If you’re a farmer or anyone processing food whose company is interested in using ConnectFood to write or compile your food safety plan, check out our Enterprise tier. This Enterprise-level subscription allows you to experience full systems management, including having multi-facility supplier management, multi-facility records management, and direct access to food safety experts.” – Matthew Botos, CEO.

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.