FDA Proposes Model Food Code
Be Amended:
Leafy Greens To Be Held At 41 Degrees
Or Less — Retail And Foodservice Operators Affected

There are two important food safety events going on this week. The Pundit is participating in a sold-out program at Seattle University School of Law entitled, Who’s Minding the Store? The Current State of Food Safety and How It Can Be Improved — with a group of high-powered lecturers:

SPEAKERS

Special Guest Speaker

• Governor Christine Gregoire, Washington State

Keynote Speakers

• Robert Brackett, PhD, Senior Vice President and Chief Science and Regulatory Officer, Grocery Manufacturers Association
• Dr. Patricia Griffin, CDC, Chief, Enteric Diseases Epidemiology Branch, Centers for Disease Control & Prevention
• John Kobayashi, MD, MPH, Clinical Assistant Professor, University of Washington School of Health
• Barbara Kowalcyk, Director of Food Safety, Center for Foodborne Illness Research & Prevention
• Richard Raymond, MD, Under Secretary for Food Safety, USDA FSIS

Panelists

• Andrew K. Benson, PhD, Associate Professor, Dept. of Food Science and Technology, University of Nebraska
• Tom Billy, President, International Food Safety Consulting
• Phil Brasher, Washington Correspondent, Des Moines Register
• Sarah Brew, JD, Attorney, Greene Espel PLLP
• Christine Bruhn, Director, Center for Consumer Research
• Caroline Smith DeWaal, Food Safety Director, Center for Science in the Public Interest
• Neal Fortin, JD, Director, Institute for Food Laws and Regulations at Michigan State University
• David Goldman, MD, MPH, Assistant Administrator, Food Safety and Inspection Service (FSIS), Office of Public Health USDA
• Chris Griffith, Director of Food Research and Consultancy, University of Wales Institute, Cardiff, Wales
• Stephen Hedges, Reporter, Chicago Tribune
• William Keene, PhD, MPH, Senior Epidemiologist, Oregon Public Health Services, Acute & Communicable Disease Program
• Liu Zhouhui, Deputy Director General, Certification and Accreditation Administration, People’s Republic of China
• Deon Mahoney, Principal Microbiologist, Food Standards, Australia and New Zealand Canberra, BC, Australia
• Andy Martin, Reporter, New York Times
• Al Maxwell, JD, Attorney, Weinberg Wheeler Hudgins Gunn & Dial
• Sandra McCurdy, Extension Food Safety Specialist, School of Family and Consumer Sciences, University of Idaho
• Carlota Medus, PhD, MPH, Epidemiologist, Acute Disease Investigation and control section, MN Dept of Health Minneapolis, MN
• John Munsell, President, Montana Quality Foods & Processing; Manager, Foundation for Accountability in Regulatory Enforcement. Mile City, MT
• Canice Nolan, First Counselor, Head of Food Safety, Health, and Consumer Affairs, Delegation of the European Commission
• Douglas Powell, PhD, Associate Professor, Department of Diagnostic Medicine/Pathobiology, Kansas State University. Scientific Director, International Food Safety Network
• Jim Prevor, Editor-in-Chief, Perishable Pundit
• Scott Rickman, Associate General Counsel, Del Monte Foods
• Mansour Samadapour, PhD, President & CEO, IEH Laboratories
• Jørgen Schlundt, Director, Dept of Food Safety, Zoonoses, and Foodborne Illness, World Health Organization — Geneva, Switzerland
• Richard Seigler, MD, Pediatric Nephrologist, University of Utah
• Denis Stearns, JD, Attorney, Marler Clark LLP, PS
• Brad Sullivan, JD, Attorney, Lombardo & Gilles
• Bala Swaminathan, PhD, Vice President, Technical and Business Development IHRC, Inc.
• Craig Wilson, Vice President, Food Safety and Quality Assurance, Costco Wholesale Corporation
• Devon Zagory, PhD, Senior Vice President, Food Safety & Quality Programs, NSF Davis Fresh

Simultaneously, the Conference for Food Protection is having its biennial meeting in San Antonio, Texas. This organization is rich in history, and the conference is focused on “Promoting Food Safety through Collaboration”. The conference is unusual because the organization makes decisions that may wind up being incorporated into the FDA model food code:

The Conference for Food Protection has a place for you in its representative and equitable partnership of regulators, industry members, academics and consumers. You have ideas to bring to the table to help identify problems, formulate recommendations, and develop practices that promote food safety and consumer protection. Our Committees can benefit from your knowledge and experience as they tackle the many food safety and security concerns that face us all.

You can be part of our next Conference meeting in San Antonio, Texas, April 11-16, 2008. First, you can submit an Issue about improving food safety using our online Issue Form by the deadline in January 2008. Then you can present your Issue at the meeting to one of three Councils that will provide a unique balanced consideration of yours and the other Issues before it. Approved Conference recommendations may be incorporated into the FDA Model Food Code and offered for adoption by regulatory agencies to help establish nationwide uniformity.

In between the Biennial Conferences, much work continues in the various Conference committees that are tasked with charges by the Conference. You can review the work of many committees and find the areas where you can be a part of the solutions they develop. Our future in food safety and food security can be enhanced with your involvement, so we encourage you to get into the front line in this national forum, the Conference for Food Protection.

We owe a tip of the hat to a food safety consultant who alerted us to an issue affecting leafy greens that Glenda R. Lewis, a Team Leader for FDA/CFSAN/Retail Food Protection Team, has submitted for acceptance:

Not sure if you’ve seen Issue 08-III-022 going before the Conference for Food Protection (CFP) next week here in San Antonio.

Note that FDA has used their Reference B, CDC surveillance outbreak for 5 specific leafy greens as justification for making a broad scope of LG fall under time/temperature control for safety at retail operations (grocery and restaurant operations).

It also uses a definition out of their “FDA Guide to Minimize Microbial Food Safety hazards of Fresh cut Fruits and Vegetables” that essentially ties in a guidance document to FDA Food Code mandates.

What’s your take on this? It forces compliance from the retailer back to processor in my view.

— Fred Reimers
Food Safety Consultant
Creative FoodSafe Solutions
Schertz, Texas

Here is the basic proposal:

Title: Time/Temperature Control for Safety for Cut Leafy Greens

Issue you would like the Conference to consider:

Research shows that cut lettuces and other cut leafy greens support the growth of pathogens commonly associated with foodborne illness outbreaks when stored outside of temperature control. Requiring that these foods be stored under refrigeration in retail and foodservice establishments should significantly limit the growth of pathogens that may be present on the product and therefore represents an important step in preventing foodborne illness in the U.S.

Public Health Significance:

Since 1996, at least 21 confirmed foodborne illness outbreaks have been attributed to consumption of various types of leafy greens (11) that were contaminated prior to the point of service, most likely on the farm. Additional outbreaks are likely to have occurred due to contamination at the point of service. These illnesses can produce severe gastrointestinal distress long-term chronic sequelae, and death.

Cut leafy greens with a pH of 5.8 or more (1, 4) and aw of 0.99 or more (3) have been shown to support pathogenic growth (1, 2, 3, 7, 8, 9, 12) once the product is cut and internal liquid and nutrients are made available to pathogens that may be present.

Laboratory studies have shown that storage of cut leafy greens at 41ºF or less effectively limits the growth of pathogens such as E. coli O157:H7, Salmonella spp. and Listeria monocytogenes. Refrigeration of cut leafy greens at 5ºC/41ºF or less has been shown to limit the growth of E. coli O157:H7 as well as promote a general die-off of the pathogens over time (1, 2, 3, 8, 9).

It is common industry practice to refrigerate cut produce to preserve the crispness and to prevent browning, decomposition and sliminess from spoilage organisms. Changing state and local retail food codes and ordinances to mandate that cut leafy greens be stored and displayed at a temperature of 41ºF or less in retail and foodservice establishments will help to ensure that these products are not held for extended periods within the lower temperature limit of growth for E. coli O157:H7 (8ºC/46.4ºF), Salmonella spp. (7ºC/44.6ºF) and other pathogens identified in illness outbreaks associated with lettuce and other leafy greens. Storage at temperatures above 41ºF can negate pathogen reductions achieved from prior washing in cold or warm chlorinated water and allow surviving pathogens to multiply.

In the FDA Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables, subparagraph VII ©(3) and paragraph VIII (D), FDA recommends that finished, fresh-cut produce be held, stored, transported, and displayed at 40ºF or lower. (5) Once the pathogens have been in contact with the leaves, they are able to attach to the leaves, especially at cut surfaces and openings such as stomatal pores. Under adverse conditions, E. coli O157:H7, Salmonella and Listeria monocytogenes can also form biofilms for additional protection. Contamination, which may occur anywhere from the field to the kitchen (6), cannot be effectively removed from the leaves once the pathogen has attached or internalized through cut surfaces. For example, studies have shown that once E. coli O157:H7 becomes internalized in cuts in the plant tissue, it becomes inaccessible to chlorinated or other chemical washes and can survive the disinfection or sanitizing process (13). Other controls such as different atmospheres (anaerobic or other gases) or competing microflora (Standard Plate Count (SPC) of 5-8 million are normal) have not been proven effective at preventing pathogenic growth on cut leafy greens (7).

Recommended Solution: The Conference recommends…:

1. The FDA Food Code and state and local regulations applicable to retail and foodservice establishments be amended to include cut leafy greens among the foods that require time/temperature control for safety, including cold holding at 41ºF or less; and
2. The intended meaning of the term “cut leafy greens” should be made clear by including appropriate definitions in Chapter 1 of the FDA Food Code. For the purposes of this recommendation, the term “cut leafy greens” refers to 1) leafy greens that are considered “fresh-cut produce” as defined in FDA Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (5), and 2) fresh leafy greens whose leaves have been cut, shredded, sliced, chopped or torn at the point of sale or service. For the purposes of this recommendation the term “leafy greens” refers only to iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula and chard. The term “leafy greens” does not include herbs such as cilantro or parsley.

Submitter Information:

Name: Glenda R. Lewis, Team Leader
Organization: FDA/CFSAN/Retail Food Protection Team

You can read the whole proposal with attachments and get contact info for Glenda R. Lewis here.

Fred astutely notes that tying in a guidance document to the FDA Model Food Code is no small deal. What happens is that most states and localities use the FDA Model Food Code as the basis for their own laws and regulations, so putting something in the FDA Model Food Code is a way of taking a “guidance” document and giving it the force of law in most places without having to have Congress pass a law.

We became focused on this issue in part through our coverage of the spinach crisis but especially during our work when Bolthouse had its struggles with the issue of botulism on improperly refrigerated juice.

In our pieces, Bolthouse And Juice Refrigeration and Botulism III, we reviewed the cold chain and study results — a bit old but the best we’ve got, indicating retailers are not maintaining the cold chain — and pointed out the dangers inherent in this.

With this move, the FDA is defacto saying that industry efforts focused on the grower are fine, but insufficient, that just as we have to be dedicated to preventing microbial contamination, we also have to be dedicated to creating conditions that make it less likely any contamination will grow to the point that it becomes dangerous.

We have always felt there is disequilibrium in the auditing related to food safety. Growers, packers, even processors, are put under countless audits, but retailers are almost never subjected to independent audits of their food safety practices. This is despite their refrigerated cases routinely failing to deliver required temperatures during defrost phases and in certain locations in the cases themselves.

When we have raised this issue, some good retailers have objected that they do hire auditors to self-check. We ran a piece on one of these companies entitled, A Closer Look At Retail Safety Audits.

Of course, it is great that some retailers do this but, first, the one’s that do it voluntarily are rarely the ones that need it. Second, a self-audit, where one doesn’t have to be publically accountable for the results, is different in kind, not degree from an audit one has to mail to all one’s customers.

Of course, having standards in the local food codes creates an inspection metric for local inspectors, and violations are typically matters of public record, so it seems that the FDA thinks the retailers should have accountable inspections just like growers.

Many thanks to Fred for pointing this out.