FDA

FDA Issues Guidance on FSMA Enforcement Discretions

By Food Safety Tech Staff
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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
Scott Gottlieb, M.D., FDA

FDA’s Gottlieb Says Some Food Recall Practices Raise Significant Concerns

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

Following the Office of Inspector General’s (OIG) final issuance of its report on FDA food recall practices, FDA Commissioner Scott Gottlieb, M.D., is voicing concern. The OIG report looked at FDA food recall practices from October 1, 2012 to May 4, 2015. Its findings are obvious in the report’s title: The Food And Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply.

“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.

Food Safety Tech first reported on the draft findings in June 2016 when the OIG said the FDA recall initiation process was not efficient or effective. Although Gottlieb noted that the agency took action after the draft was released, “we still have more work to do,” he said in an FDA statement.

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.

Alert

FDA Inspections: Top Five Violations for FY2017

By Food Safety Tech Staff
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Alert

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.
Aaron Biros, Melanie Neumann, Food Safety Consortium

In Today’s Risky World, Verifying Suppliers a Must

By Food Safety Tech Staff
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Aaron Biros, Melanie Neumann, Food Safety Consortium

In today’s risk-based world, companies can’t just trust a third-party auditor based on a handshake, according to Melanie Neumann of Neumann Risk Services and Matrix Sciences. It is also a manufacturer’s responsibility to verify the auditor. Watch the following video, shot at this year’s Food Safety Consortium, to hear Neumann’s take on “trust but verify” and the importance of inspection and audit readiness both today and in the future.

Listeria

Four Pathogens Cause Nearly 2 Million Foodborne Illness Cases a Year

By Food Safety Tech Staff
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Listeria

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).

A copy of the report, “Foodborne illness source attribution estimates for 2013 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, is available on the CDC’s website.

Steven Sklare, USP, Aaron Biros, Food Safety Tech

A Watershed in Food Safety

By Food Safety Tech Staff
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Steven Sklare, USP, Aaron Biros, Food Safety Tech

David Theno was scheduled to speak at this year’s Food Safety Consortium during a special session recognizing the 1993 Jack in the Box E.coli outbreak as a breakthrough moment in food safety. His untimely passing changed the course of discussion at the event to a reflection on Theno’s legacy and the significant changes that the industry has gone through over the past 25 years.

In the following video, Steven Sklare, director of customer engagement, foods program at USP, shares his thoughts on the importance of having an appreciation for what the industry went through in 1993 and the significant impact it had on the how the industry has changed since then.

What events in food safety do you think have had the most impact over the last 25 years? Share in the comments below the video.

 

Paradigm Diagnostics Announces AOAC Approval of Diagnostic Method for Ground Beef

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Paradigm Diagnostics develops and markets novel diagnostic screening tests for bacterial pathogens causing foodborne illness. The company currently markets two environmental screening tests for detection of Listeria and Salmonella in the food-processing environment. The new method for analysis of ground beef offers analysts greater ease of use, lower cost, and fewer steps to simultaneously detect and isolate bacterial pathogens, E.coli and Salmonella, than the current USDA method.

The new method is significant since the USDA mandates that all ground beef and beef trim produced in the United States be continuously screened for the presence of pathogenic E.coli and Salmonella in an effort to enhance the food safety of meat produced domestically. This method is compatible with modern genetic methods used in large laboratories. Significantly, the method allows smaller laboratories to conduct these analyses since the method conforms to traditional cultural methods used in microbiology. The company is investigating the applicability of the new analytical method to monitoring the food safety of produce, fruit and grains.

FDA

FDA Issues Draft Guidance on Inspection Refusal for Foreign Food Facilities

By Food Safety Tech Staff
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FDA

Today FDA released a draft guidance to provide information about what actions by a foreign food establishment or government are considered a refusal of inspection. “FSMA gives the U.S. Food and Drug Administration the authority to refuse imported food admission into the United States if the agency is not permitted to inspect the foreign establishment that produced the food,” FDA stated in a release.

The 12-page draft guidance, Refusal of Inspection by a Foreign Food Establishment or Foreign Government, outlines how the agency goes about scheduling inspections of foreign establishments (despite the fact that FDA is not required to pre-announce inspections), the inspection activities themselves, and very detailed examples of what it considers an inspection refusal from a facility (from a lack of communication with FDA that delays the agency’s request to schedule an inspection, to preventing an FDA investigator from entering a facility, when a facility sends staff home and tells FDA that it is not producing product).

The draft also details what it considers to be refusal of inspection by a foreign government. Some of the actions include preventing FDA investigators from entering the country or asks them to leave the country before an inspection is scheduled; and limiting access to areas of the facility that manufacturing, processing and packaging occurs; and limiting investigators from collecting samples for analysis.

If either a foreign food establishment or a foreign government refuses an inspection, they will stay on the agency’s Red List of Import Alert 99-32 until FDA is able to schedule and conduct an inspection.

Matrix Sciences

Matrix Sciences Acquires Neumann Risk Services

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Matrix Sciences

Matrix Sciences recently announced the acquisition of Neumann Risk Services, LLC (NRS), led by Melanie Neumann, J.D., M.S., according to a press release. Neumann’s venture, NRS, combines a consulting business with a legal practice, focusing in the areas of food safety, food science, food defense, recall & crisis management.

Adding NRS to the Matrix Sciences portfolio allows them to further grow their consulting capabilities, working with Neumann to expand their set of services. She will be building a suite of services targeted at helping companies reap the benefits of their investments in food safety risk management, according to the press release.

In addition to taking the role of Executive Vice President and General Counsel for Matrix, Melanie Neumann will also maintain Neumann Legal Services, a separate but allied legal practice. “I made the decision to join Matrix Sciences because our vision for meeting the changing and unmet needs of the food industry align very well,” says Neumann. “But more than that, our value in how we need to meet those needs make for a great fit.”

Neumann received her law degree from Mitchell Hamline Law School and a Master of Science in Food Science from Michigan State University. Neumann has worked as an attorney in a number of capacities at major food companies throughout the world, building herself a reputation as a prominent consultant, thought leader and adviser in the world of food safety.

Robert Wiebe, chief executive officer of Matrix Sciences, says this acquisition is an important step in their growth strategy. “Melanie and NRS are critical to building a true full-service solution provider,” says Wiebe. “Building on the capabilities and capacity from our acquisitions of Richter International and Northland Laboratories, our portfolio of companies represents a growing and unique partner for our customers in addressing the challenges and opportunities in bringing safe food to market.”