FDA Issues Final Guidance for Voluntary Recalls

Last Thursday, March 3, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk. 

“Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe,” said Associate Commissioner of Regulatory Affairs Judith McMeekin. “It is critical that all companies in the supply chain are 'recall ready' to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”    

The final guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, explains how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions, which the FDA recommends that all companies do. It encourages recalling companies to use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about a voluntary recall.  

This latest action reflects the FDA’s ongoing commitment to working closely with companies so they can quickly act to protect the public from violative products on the market. In recent years, the FDA has made proactive and systemic improvements to recall processes, including issuing guidance on public availability of lists of retail consignees to effectuate certain human and animal food recalls; mandatory recalls for human and animal foods; and public warnings and notifications for all FDA-regulated products, which reiterates a policy to rapidly post new recalls to the FDA’s weekly Enforcement Reports, a public listing of all recalls monitored by the FDA. 

Posted 3/7/22

Registration Now Open
Virtual Training Academy for Regulatory Food Inspectors

AFDO is hosting the first of its kind “Inspector Bootcamp” on Mondays, March 28, April 4 & 11. There will be duplicate morning “East Coast” (8:30 a.m. -12:30 p.m. EDT) and afternoon “West Coast” (1-5 p.m. EDT) editions of the course, with limited seats in both. The live virtual training is planned for both retail and manufactured food inspectors (new and seasoned), with presentations on both soft and technical skills and facilitated breakout discussions. The goal is for all participants to share experiences, hear from other inspectors and jurisdictions, learn from each other and network, while gaining additional tools and knowledge to help be better prepared in the field.

During this training, inspectors will:

• Apply more risk-based approaches to conduct quality inspections
• Learn how to leverage evidence to support the writing of accurate, valid reports
• Understand how to identify special processes and review food safety plans
• Improve operator interviewing skills to drive productive conversations and listen more effectively
• Identify the difference between aggression versus violence, and how to de-escalate potential conflicts to create a calmer environment in the field

Seats Still Available
Root Cause Analysis for Retail Food Safety Session Offered in 2022

• Determine the underlying reasons for how and why an outbreak/violation(s) occurred
• Provide tools for more effective problem solving
• Data collection tools and analyzation
• Interventions or corrective actions to prevent recurrence

Regulatory Input Sought by Purdue

Purdue University is working to develop food safety extension programs for small- and very small- produce dehydrating processors. To better serve small and very small processors, Purdue is investigating the regulatory landscape specific to produce drying operations, by conducting an interview study with health and food safety inspectors to understand regulatory standards for produce drying. One major barrier for small processors is the expectations and interpretation of regulations.

The objectives of the study are:

• Identify food safety concerns of produce drying 
• Identify regulation interpretations for produce drying in different regions and states 
• Identify needs for future extension resources and technical support for small produce drying stakeholders  

To participation in the study requires a 60-minute Zoom call. Purdue is offering $50 as an honorarium in appreciation. Please contact Betty Feng at yhfeng@purdue.edu to participate or get details.

Posted 3/8/22

AFDO Partnership Supports Healthcare Products Learning and Collaboration

Effective today, February 28, 2020, the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s 12-year legacy of delivering the Xavier MedCon Conference.

“The annual MedCon Conference has historically provided outreach and engagement with stakeholders in the medical products industry with government colleagues to discuss trends, innovations, and challenges in an educational setting,” says Steven Mandernach, AFDO Executive Director. “It is our partnership’s desire to fill that need into the future. We are continuing to work with the more than 150 industry and government representatives involved in medical products working groups and committees.”

The MedCon 2022 Conference will be held virtually May 4–6, 2022. This event will bring together medical device regulators and industry experts from around the world for content-rich conference sessions that include uncommon collaboration, deep dialogue, and networking as close as your computer.

The AFDO/RAPS Healthcare Products Collaborative reflects the support of both organizations to continue the important work Xavier Health has done to advance the industry. This new partnership will also produce Xavier Health’s other industry events—including the PharmaLink Conference, Combination Products Summit, and AI Summit.

MedCon Conferences have been credited with providing open, transparent interactions with stakeholders, and the AFDO/RAPS Healthcare Products Collaborative plans to support and enhance these efforts. Registration for MedCon 2022 is now open. For more information and to view the virtual program details, visit www.healthcareproducts.org/MedCon.

Posted 2/28/22

Early Bird Discounts End March 31
2022 AFDO AEC Registration Now Open

This year's AFDO Annual Educational Conference will be co-hosted by the Western Association of Food and Drug Officials in Phoenix, AZ from Saturday through Wednesday, June 11 – 15, 2022.

Get ready for five days of educational sessions focused on five content tracks. Make new connections with peers and find out how they are managing common challenges.

In addition, several training opportunities will be offered the Saturday and Sunday before the conference. Saturday, June 11, will include four workshops to choose from:  The Science and Art of Storytelling, Mutual Reliance in Action - Utilization of State Regulatory Sampling and Lab Analytical Packages, Retail HACCP Validation and Verification, and Retail Active Managerial Controls - Train-the-Trainer. You can view more information on these on the AFDO AEC page.   

Sunday, June 12, will include two committee meetings and the welcome reception for the conference! 

Early Bird registration is open until March 31, so register ASAP to get the discounted rate!  And if you are an AFDO member, your membership includes an additional discount for the annual conference.  Watch your email for your special discount code.

Posted 2/22/22

Come Early. Stay Late.
Experience More Learning at AFDO AEC

They fill up fast so now is the time to book your participation in pre-conference training opportunities and tours.  For an additional $75 each fee beyond the conference registration,   Visit the AFDO Conference Event Page to register for the conference and get your seat in these great opportunities listed below. Learn more by clicking here.

• Saturday, June 11 Mutual Reliance in Action - Utilization of State Regulatory Sampling and Lab Analytical Packages
• Saturday, June 11 The Science and Art of Storytelling 
• Saturday, June 11  Retail Active Managerial Controls - Train-the-Trainer
• Saturday, June 11  Retail HACCP Validation and Verification
• Wednesday, June 15  AFDO Cannabis Offsite Tour  is a unique opportunity to increase your awareness and education by touring a cannabis facility but is limited to 50 people so register now.

Last Chance to Register
Retail HACCP Validation and Verification Course Available

       

Be a Sponsor or Exhibitor at the AFDO AEC 

Become a Sponsor

Sponsorship offers visibility to both the regulatory and industry communities, and positions your organization as a supporter of AFDO.  We offer several levels of sponsorship, and your company name and logo will appear on signage displayed during your sponsored event.  A list of sponsors will also be posted on the AFDO website conference pages, with links to their organizations’ websites. Please visit the AFDO Conference website to learn how to become a sponsor. 
 

Become an Exhibitor 

Posted 2/28/22

Scholarship Applications Due in One Week
2022 Integrated Foodborne Outbreak Response and Management Conference

Scholarship submission is now open! Registration scholarships are available to participants at local, state, or tribal health departments who work in enteric disease surveillance and outbreak response activities. There are many scholarship opportunities available; all are encouraged to apply. Students are eligible for registration scholarships.
 
Visit the 2022 InFORM Conference website to review the eligibility requirements and instructions for submitting a registration scholarship application. Scholarship applications must be submitted no later than Monday, March 14, 2022 to be considered. All applicants will be notified of scholarship status by Friday, March 25, 2022. 
 
ELC funds, if available, should be used to register epidemiologists and PulseNet laboratory scientists for InFORM.

New Population Survey Data Available on FoodNet Fast
 

The CDC has announced that data from the Foodborne Diseases Active Surveillance Network’s (FoodNet) 2018–2019 population survey are now available in FoodNet Fast [wwwn.cdc.gov], CDC’s online toolbox for accessing information reported to FoodNet.
With FoodNet Fast’s Population Survey Tool, you can see how often people in FoodNet’s surveillance area [cdc.gov] eat various foods and have other exposures linked to diarrheal illness.
Data now include responses to questions about:

• Food
• Drinking water
• Raw milk
• Dietary practices
• Food handling practices
• Chicken handling practices

• Food safety behaviors
• Contact with animals
• Contact with recreational water
• International travel
• Vomiting and diarrheal illness symptoms
• Health-seeking behaviors

Who Do You Know?
Nominations for Honorary Membership Now Being Accepted

Please note that for someone who is a member of a Regional Affiliate but not a member of AFDO, their contributions need to be extremely and nationally significant for them to receive serious consideration.

Nominations without a completed nomination form cannot be considered. Please complete the nomination form and send to afdo@afdo.org.  The most recent list of honorary members can be found here so you can review those who have already received this type of membership:

Posted 2/14/22

Save-the-Date
CASA Annual Educational Seminar Set for April

Click Here for a fillable PDF Registration Form

Call Out Your Favorite Food Safety Team
AFDO Grosvenor Food Safety Award Taking Nominations

Established in 2010, the Grosvenor Food Safety Award is given to recognize outstanding achievements made by food safety programs within State Departments of Agriculture, Natural Resource Agencies, Public Health Departments or Environmental Conservation Departments in the United States or Canada. The award will go to the program that best showcases improvement, innovation, or sustained high performance within a food safety program.  Program elements should assess proficiency in strategic planning, managing, and evaluating continuous improvement.  A food safety program could include responsibility for: food safety, food protection, and food defense or food sanitation.

Nominations are due April 1 and will be reviewed by the Elliot O. Grosvenor Food Safety Award Committee.  Self-assessments for program standards may be used to demonstrate progress. This award will be given during the 2022 AFDO Annual Educational Conference scheduled to be held in person this year from June 11 through June 15. 

Updated Deadline April 1
Salute Someone in the Regulatory World with the Corby Award

Do you know a person who has gone above and beyond in their regulatory position during this unusual year? Maybe a field person who has made inspections in person or virtually as a significant portion of their working time.

Nominate them now for the Jacob Joseph Corby Achievement Award. It is the perfect way for you to recognize their performance. The application is easy to fill out and the deadline is April 1, 2022.

The Jacob Joseph Corby Achievement Award is awarded for one or more specific achievements, or for a documented sustained high level of performance. The scope of what counts as an “achievement” is very wide. A few examples of achievements that would be considered are: developing evidence in a difficult case that results in an indictment, conviction, or administrative action; bringing about a measurable improvement in general conditions, e.g., raising test scores on dairy farms or average scores in a group of food establishments; teaching courses that result in more food manager certifications; removing dangerous consumer products from the marketplace; or developing new techniques such as more effective use of computers.

To be eligible for the award, one must be in their first ten years of service as a sanitarian, inspector, investigator, milk specialist, food specialist, radiological health inspector, consumer product safety inspector, laboratory analyst or similar regulatory position. They must be a field person; that is, one who goes out of the office or works virtually to make inspections a significant portion of his or her working time. The winner may not be a supervisor unless the work for which they were nominated was done as a field person and it played a role in the promotion to supervisor. The winner must be employed by a federal, state, county, or municipal regulatory agency, which has at least one employee as a member of AFDO.

The winner will be presented with a framed certificate of achievement and have a choice of receiving a check for $500.00 or a future full conference funding. Conference attendance is not mandatory for receiving the award. 

Posted 2/14/22

Deadline Extended
AFDO Encourages Students Through 
Scholarships

Do you know a college student who is considering a career in food or medical products safety?

The Association of Food and Drug officials offers three $2,500 undergraduate scholarships each spring. To be eligible, students should be a junior with a 3.0 grade average during the first two years of undergraduate study with demonstrated leadership capabilities and a desire to serve in a career of research, regulatory work, quality control, or teaching in an area related to some aspect of foods, drugs, or consumer product safety. 
 

To apply or to encourage someone to apply, in addition to completing an application, an official and complete college transcript must be submitted along with letters of recommendation from two faculty members. Scholarship applications must be submitted by March 31, 2022 to be considered for the current year’s award. 

Application info may be found at: www.afdo.org/grants/afdo-scholarship

Posted 2/14/22

Epidemiologist for FDA Office of Food Policy and Response

OFPR exercises all food safety modernization activities & human food safety-related legal authorities that the Commissioner is empowered to exercise under the Federal Food, Drug, and Cosmetic Act & other applicable laws. This position coordinates the oversight of food related outbreak responses, tracebacks, recalls, and communication to stakeholders involving threats to human health and serves as the primary advisor to the Commissioner on these activities.

Position may be filled in the locations listed and will be determined upon selection.

• White Oak, MD

Post 3/7/22

Rapid Response Team Coordinator - Washington

The Washington State Department of Agriculture has been serving the state for more than 100 years. Through service, regulation and advocacy, we keep agriculture viable and vital in Washington State, while protecting consumers, public health, and the environment. We work extensively with farmers and ranchers, but our responsibilities – from ensuring food safety to environmental protection – touch the lives of millions of people locally, nationally, and abroad.
 
The agency includes 780 employees approximately and grows close to 1,000 employees at the peak of seasonal work. To learn more and view additional openings, please visit our Employment Page. For more information about the Washington State Department of Agriculture (WSDA), visit us at www.agr.wa.gov .

Apply Early! The first review date of applications will be on 03/14/2022. 

Post 3/7/22

Manufactured  Food Specialist - Virginia 

The Virginia Department of Agriculture and Consumer Services is seeking a Manufactured Food Specialist within the agency’s Food Safety Program. This position ensures that food products and dietary supplements in Virginia are safe by providing guidance and technical advice to consumers and the food industry. The successful candidate will assist the Manufactured Food Regulatory Program Standards (MFRPS) Coordinator with conformance and maintenance of all MFRP Standards. Duties include assisting the MFRPS Coordinator to ensure that all of the outcomes and deliverables specified in the MFRPS FDA Cooperative Agreement are adhered to and met; working with home based food manufacturing operations and small food producers to address issues in labeling, processing, and general food safety; gathering information necessary to conduct the facility inspections; and evaluating the condition of food manufacturing facilities relative to food safety. Additional duties include conducting audits of inspection reports and of sample collection forms; preparing various reports and documents; maintaining an assortment of files and records; and coordinating outreach efforts in order to protect public health and educate industry partners. This is a restricted position that has been developed as part of a Cooperative Agreement with the Food and Drug Administration and will last until July 30, 2023; however, the cooperative agreement has the potential for continuation. Re-announcement.

Post 2/28/22

Food Industry Field Scientist 9-P11/Food Safety Inspector - Michigan

The Michigan Department of Agriculture and Rural Development (MDARD) is currently recruiting for a permanent, full-time Food Industry Field Scientist 9-P11/Food Safety Inspector within the Food and Dairy Division. The Food Safety Inspector (Food Industry Field Scientist) is a field-based position that performs food safety regulatory inspections and related work within an assigned work area. This position requires the incumbent to live in Wayne, Oakland, or Macomb Counties or be willing to relocate within 10 months of hire and is open to all applicants. Interested applicants must apply through NEOGOV.  Closing date is 2/27/2022 11:59 PM Eastern.
 
If you are interested in obtaining more information or applying, click on the link below.

Post 2/22/22

Paster Training, Inc. 

• Preventive Controls for Human Food (PCHF), Full and Part 2
• Intentional Adulteration Vulnerability Assessment (IAVA)
• Foreign Supplier Verification Program (FSVP), Full and Part 2
• Current Good Manufacturing Practices (cGMPs)

• Certified Protection Food Manager (CPFM)
• Food Handler/Food Employee
• HACCP Manager
• HACCP Employee
• Food Defense
• SPANISH TRAINING AVAILABLE!!!!!

EAS Consulting Group Training 

The Food Safety Doctor LLC 

ONLINE Preventive Controls for Human Foods (PCQI) Courses

March 1-3, 2022

Click here to access the schedule of PCQI courses

ONLINE Foreign Supplier Verification Courses (FSVP-QI) Courses

March 15-16, 2022

Click here to access the schedule of FSVP-QI courses

Intentional Adulteration Vulnerability Qualified Individuals (IAVA-QI) Course

March 23, 2022

Click here to access the schedule of IAVA-QI courses

Laws and Regulations Committee Update

A collection of current food, drug, device, and consumer product regulatory issues and news