Over the past five years, the food and beverage industry has seen a big increase in the units recalled—a 92.7% spike in FDA recalls and an 83.4% increase in recalled pounds by USDA since 2012, according to Stericycle’s quarterly recall index. The firm cites technological advances in food testing, factory farming and more automation in food production as the main contributors to the high numbers.
During Q4 2017, bacterial contamination and undeclared allergens led the pack in food recall causes. According to Stericycle, back in 2012, about 28% of FDA food recalls were a result of bacterial contamination, while undeclared allergens accounted for 35% of pounds of food recalled by USDA. During Q4 2017, 44% of food recalls (based on units) were from bacterial contamination, followed by undeclared allergens (31%), mislabeling (13%), and quality (10%). Among the top categories for recalls were prepared foods (20%, nuts and seeds (16%), produce (15%) and baked goods (12%). In addition, nearly 50% of the USDA recalled pounds were a result of lack of inspection.
FDA has created a new position for former FDA member Jim Gorny to serve as the senior science advisor for produce safety at CFSAN. Gorny worked at FDA from 2009 to 2013 as the senior advisor in the agency’s Office of Food Safety at which time he was involved in the development of FSMA. He was previously the vice president of food safety and technology at the Produce Marketing Association.
In his position at CFSAN Gorny will work with a team of produce safety professionals on implementing new science and risk-based requirements that aim to prevent illnesses from contaminated produce. He will serve as the chief advisor to CFSAN Director Susan Mayne on policies and programs associated with produce safety. His responsibilities include stakeholder outreach and engagement, investigations and recalls, research and training.
“I will be working with state regulatory partners and other government agencies at home and abroad to build support for implementation of the produce rule, as well as with industry to help further compliance… I’ll be working to make sure that the people in senior-level management and the field staff, including those conducting foreign inspections, are speaking the same language. – Jim Gorny, FDA
In an interview published on FDA’s website, Gorny discusses his role at FDA, the produce safety rule and how he will be working with industry and key stakeholders, including the farming community.
FDA has launched a FSMA landing page on its website in an effort to provide more information about FSMA and assist in compliance. Links include information about the rules, guidance documents, training and technical assistance, compliance and implementation tools and general background about FSMA.
As the first major compliance date for large farms recently went into effect, the agency also recently updated the Produce Safety page. In an agency news update, it noted that in September 2017, FDA announced that routine inspections would be postponed until Spring 2019 to provide more time for education, outreach and training in 2018.
In an effort to improve oversight of imported food, today FDA announced its recognition of the first accreditation body under FSMA’s voluntary accredited third body certification program. ANSI-ASQ National Accreditation Board (ANAB) has been recognized by FDA after meeting agency requirements, which were validated via an application review and on-site assessment.
“Accreditation bodies recognized by FDA will have the authority to accredit third-party certification bodies, also known as third-party auditors. These certification bodies, once accredited, can conduct food safety audits and issue certifications of foreign food facilities (including farms) and the foods – both human and animal – that they produce.” – FDA
Today FDA also launched the Voluntary Qualified Importer Program (VQIP), which provides expedited review and entry of human and animal food into the United States. Importers that want to participate in the program must meet certain requirements, including making sure that the facilities of their foreign suppliers are certified under the Accredited Third-Party Certification Program.
Today the FDA issued five guidance documents related to FSMA with the goal of assisting food importers and producers meet provisions in the regulation.
The first two documents are related to the Foreign Supplier Verification Program (FSVP) regulation. The FDA issued the draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, along with a small entity compliance guide. The third draft guidance is related to whether a measure provides the same level of public health protection as the corresponding requirement in 21 CFR part 112 or the PC requirements in part 117 or 507 . “This draft guidance aims to provide a framework for determining the adequacy of a process, procedure, or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and for human or animal food,” according to FDA.
The FDA also released a final chapter in the draft guidance related to FSMA requirements for hazard analysis and risk-based PCs for human food. The chapter is intended to assist food facilities in complying with the supply chain program requirements.
The fifth guidance is an announcement of the FDA’s policy to exercise enforcement discretion related to the FSVP rule regarding certain grain importers that bring the product into the United States as raw agricultural commodities. “This enforcement discretion is meant to better align the FSVP rule with the exemption for non-produce RACs under the PC rules,” stated FDA.
FDA will be exercising enforcement discretion for specific provisions in four FSMA rules, which means that the agency doesn’t expect to enforce the provisions as they apply to certain entities or activities. The agency made the announcement yesterday.
“In general, the FDA is exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding the application of these provisions to certain activities or entities. FDA had previously extended the compliance dates for many of the provisions covered by this enforcement discretion guidance but is now exercising enforcement discretion.”
According to an FDA release, the enforcement discretion applies to provisions in: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety). The applications is as follows:
Facilities that would be farms except for certain factors and activities
Written assurances provisions in the four rules related to the control of identified hazards or microorganisms that could be a risk to public health
Animal food PC requirements for certain manufacturing/processing activities performed on human food by-products used as animal food
FSVP requirements for importers of food contact substances
“Specifically, we found that FDA could not always ensure that firms initiated recalls promptly and that FDA did not always (1) evaluate health hazards in a timely manner, (2) issue audit check assignments at the appropriate level, (3) complete audit checks in accordance with its procedures, (4) collect timely and complete status reports from firms that have issued recalls, (5) track key recall data in the RES [Recall Enterprise System], and (6) maintain accurate recall data in the RES,” according to the OIG report.
One of the action steps for 2018 is that FDA will issue guidance on recall communications in the first half of the year. The agency is also looking at situations in which it can assist consumers in getting information about the stores and food service locations that may have sold or distributed recalled food, as well as the company that supplied the product.
“Much work remains to be done if we’re going to provide the highest assurance of safety.” – Scott Gottlieb, FDA
Gottlieb stated that the agency will be revealing more early this year about policy steps it will be taking to improve food safety oversight and how the recall process is implemented. FDA is also examining how it can expedite the timeliness and scope of information provided to consumers about food recalls.
Check out our Q&A with Trish Wester about FSMA auditsGone are the days of auditing only to standards. In the following video clip, Trish Wester of The Association for Food Safety Auditing Professionals talks about the different role that the auditing community must now take. The interview was conducted by Aaron Biros of Innovative Publishing, LLC at the 2017 Food Safety Consortium.
FDA’s Office of Regulatory Affairs has released the most frequently cited inspectional observations for fiscal year 2017. Among the items on the spreadsheet are food safety hazards, failure to clean, sanitation records, corrective action plan, and lack of sanitation.
“These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.” – FDA
The following are the top five (most frequent) observations.
5. Contamination: Cleaning and sanitizing operations for utensils and equipment not conducted in a manner that protects against contamination of food, food contact surfaces and food packaging materials.
4. Failure to implement HACCP plan procedures.
3. Facility not constructed in a way that enables floors, walls and ceilings to be adequately cleaned; buildings, fixtures and other physical facilities not kept in sanitary condition.
2. Sanitation monitoring: Sanitation conditions and practices not monitored with enough frequency to be in conformance with CGMP.
1. Pests: Lack of effective pest exclusion from processing areas and contamination of foods, and failure to provide adequate screen against pests.
The CDC estimates that Salmonella, E. coli O157, Listeria monocytogenes and Campylobacter cause 1.9 million cases of foodborne illness in the United States. A report just released from the Interagency Food Safety Analytics Collaboration (IFSAC) analyzed data from more than 1000 foodborne disease outbreaks involving these pathogens from1998 through 2013.
The report found the following:
Salmonella illnesses came from a wide variety of foods (more than 75% came from the seven food categories of seeded vegetables, eggs, chicken, other produce, pork, beef and fruit.
More than 75% of E.coli O157 illnesses were linked to vegetable row crops, like leaf greens, and beef.
More than 75% of Listeria monocytogenes illnesses came from fruits and dairy products.
More than 80% of non-dairy Campylobacter illnesses were linked to chicken, other seafood (i.e., shellfish), seeded vegetables, vegetable row crops, and other meat and poultry (i.e., lamb or duck).