"Microbiological standards are not a new concept, as they have been applied for decades in the processed-food areas," said Dane Bernard, NFPA's Vice President of Food Safety Programs. "These criteria have been a regular part of our food safety system, and they work. Further, microbiological criteria focused mainly on indicator organisms have been used routinely by the food industry, on a voluntary basis, for both raw and processed products as guideposts to indicate that there may be operational or production problems deserving investigation."

Bernard made his comments in testimony delivered at a Senate Agriculture Committee hearing titled, 'How Should Our Food Safety System Address Microbial Contamination?' held recently in Washington, D.C.

Addressing USDA's 1996 Pathogen Reduction HACCP Rule, which established mandatory microbiological standards for Salmonella for raw meat, Bernard noted that "these standards are the first time a bright-line, pass/fail standard based on frequency of finding Salmonella were broadly applied to products that are not ready-to-eat. While NFPA believes that the goal of providing more focus on microbiological quality is laudable, such standards simply are not appropriate when used as a pass/fail regulatory tool. Such standards do not measure whether a product is safe, or whether the operation that produced the product is sanitary. Such microbiological measurements are useful tools as operational or production quality-control indicators, but are not reliable as a definitive regulatory measure."

Bernard stated that "NFPA feels that there are opportunities to utilize results of microbiological testing of raw products to achieve the desired result of improvement in the food supply with a HACCP system. The approach we suggest is one where results of microbiological testing are used to indicate when an in-depth investigation is warranted, rather than as a determination that a product or an establishment is non-conforming solely on the basis of test results."

Is the Cry9C protein an allergen?
Scientists are still investigating whether the Cry9C protein is an allergen, but no definitive evidence has indicated that it is. Based on the limited available evidence, the EPA Scientific Advisory Panel said there was a 'medium' risk that the protein was a potential allergen. Because the amino acid sequence of the Cry9C protein is not similar to known allergens, the protein does not have a high likelihood of allergenicity. However, the protein met 'to some degree' the additional six risk factors for allergenicity established by a previous panel:

1. The protein is relatively resistant to acid treatment.
2. The protein is relatively resistant to breakdown by digestive enzymes.
3. The protein size is in the general molecular weight range for an allergen (10-70 kD).
4. The native protein is probably a glycoprotein.
5. The protein (isolated or in corn) induces an immunologic response in Brown Norway rats.
6. The protein may be found intact in the bloodstream after oral feeding in the rat model.

The EPA panel called for additional data to better assess whether these risk factors were applicable to the Cry9C protein.

Is it safe to eat food that may contain Starlink ® corn?
Many scientists believe that for people to become allergic to a protein, they must be exposed to it multiple times over an extended period until they become sensitized. Also, allergenic proteins are usually present at a relatively high percentage of the total protein content. According to an analysis conducted by the corn's manufacturer, the Cry9C protein represents only a small fraction of the corn protein. After considering all the available evidence, the EPA SAP concluded that at the very small amounts of the Cry9C protein present in today's food supply, the probability that the protein would sensitize some individuals is low.

If it is safe, why are products being recalled?
The products are subject to recall requirements simply because they contain a substance that has not been approved for human food. FDA has created a tiered system of food recalls, based on the severity and likelihood of potential adverse medical consequences as a result of the recalled product.

The recall that initiated the removal from the market foods that are contaminated with Starlink ® corn was a Class II recall. This type of recall is initiated when a product may cause temporary or medically-reversible adverse health consequences, and the probability of serious adverse health consequences is remote. This recall classification was assigned based on the evidence that the extremely small amount of Starlink ® corn present in the recalled foods does not pose a serious health risk to consumers.

Foods that have a reasonable probability of causing serious adverse health consequences or death would fall under the Class I recall procedures. A Class III recall is initiated for products that are not likely to cause adverse health consequences.

Has consuming Starlink ® corn made anyone ill?
Although FDA has received approximately 34 reports of adverse reactions, 20 of those reports have already been classed as very unlikely to be the result of an allergic reaction.

U.S. Center for Disease Control and Prevention is researching a group of 7 people who experienced symptoms consistent with an allergic reaction after eating a meal that contained corn. However, it is not known if the Cry9C protein was present in the corn products that were consumed. In addition, the presence of other allergens within the meal has not been ruled out. Another 7 individuals experienced reactions that were less likely to be allergic reactions, but data were insufficient to rule out an allergic reaction. CDC continues to investigate those cases.

We Didn't Have Time To Do
What We Were Supposed To Do

This article by Henry Carsberg appeared in
the March/April 2000 issue of "Food Safety" magazine.

If I were a shareholder of a large food processing company -- say, Sara Lee, for example -- I would expect the company to do three fundamental things: make a profit; produce safe, high-quality products; and carry on the good name of the company. A product recall can negatively affect all three of these areas, so it befuddles me that so many companies do not have the necessary safeguards in place to prevent product recalls from occurring.

There have been several major recalls during the past two years. Let's take a look at Sara Lee, and specifically its Bil Mar Foods subsidiary which, in December 1998, recalled $76 million (15 million pounds) of hot dogs and packaged meat products. The recall, traced to Listeria contamination in some of the product, has been linked to six deaths and 73 million illnesses (see FQ June/July 1999, p. 40). If I were a shareholder of Sara Lee, I would be smoking mad over the fact that my company lost this much money, not to mention the damage to its reputation, especially when I feel the recall could have been prevented.

The Detroit Free Press ran a series of articles on the recall in its August 23-27, 1999 editions. (The entire story is available at <http://www.freep.com/outbreak>.) As a food safety/sanitation professional, what is truly disturbing to me is the remark that, quoting from the August 23 article, "to sanitation employees, it seemed that there was hardly enough time to get the work done. [Sanitation manager] Shawn Maguire couldn't believe the pressure. Most nights were a race against dawn, as her cleaning crew and others tried to scrape, spray, and cleanse away the greasy residue left each day throughout the huge plant near Zeeland [MI]."

New on the Job.
The Free Press reported that Maguire was hired through a temporary agency in April 1998 to work at Bil Mar. She had never worked in a meat plant before. Maguire told the paper she was quickly put in charge of a sanitation team. The team worked the night shift, cleaning the hot-dog production area. The work was brutal, with dirty floors, counters, mixers, vats, conveyors, and other equipment spread throughout the expansive facility. "The sanitation crew I was working with was horrible," Maguire told the Free Press. "We were all brand new. And we learned together, and we did the best job we could do."

Workers were supposed to clean the entire processing area. They had to scrub meat residue from hard-to-reach places, then sanitize the surfaces to combat bacteria, a wily foe that Maguire knew next to nothing about. According to the Free Press, "They were expected to get the work done in time for the morning start up, but it was a struggle . . . The crew often got started late because workers who made hot dogs during earlier shifts got behind. That put sanitation crews in a squeeze to finish by morning."

Maguire told the Free Press, "We didn't have time to do what we were supposed to do." How often have regular readers of this column heard that lament?

Not Clean Enough.
Eventually, the source of the contaminating Listeria at Bil Mar was traced to dirt stirred up (and then tracked throughout the facility by workers) when a refrigeration unit was replaced. There is evidence that sanitary conditions in the processing area -- the cold, damp type of environment in which Listeria thrives -- were conducive to the growth of any stray pathogens that might have been released in the process. The old refrigeration unit itself was a major contributor to a condensation problem in the plant. An intensive clean-up ensued after the unit was replaced, but high bacterial counts began to show up on environmental swabs, and they didn't go away.

FSIS inspectors expressed concerns about inadequate cleaning and sanitation efforts at the plant, and the Free Press located USDA reports that show on July 26 and 27, well before the recall, inspectors forced cleaning crews to re-clean dirty areas along the hot-dog lines. The paper also obtained a memo from John Stephenson, a senior USDA official assigned to the plant, in which he expressed "major concern" to Bil Mar Vice President Mary Delrue. Stephenson noted that the problems weren't confined to the hot-dog lines, and that other areas of the plant "appeared to have been neglected for a significant period of time."

Delrue wrote in response on July 28 that the concerns raised "are in the process of being addressed," and pointed out several measures being taken, including moving the sanitation manager to the third shift to focus on training and awareness for both supervisory and hourly personnel. Further, manufacturing and quality-assurance managers were adjusting their work times to be present at each day's pre-op inspection, to assure compliance.

Good Reading.
I encourage you to obtain and read the full Detroit Free Press article because it presents a vivid account of the types of situations food-safety and sanitation people face every day.

What occurred at the Bil Mar plant is not an isolated incident. Processing equipment in all manner of plants is full of organics. Yes, it can be ugly after a day of production. Yes, cleaning and sanitizing is hard work. Which is why it's critically important that upper management support the sanitation effort.

I am curious as to just how much training the Bil Mar crew ever received. Of course, the standard line from management (not necessarily Bil Mar's) is, "We have such high turnover that it's hard to train people. It's a lot of effort and expenditure that is wasted if they're just going to walk out the door." When someone from the sanitation crew quits -- as Maguire did in August 1998, roughly four months after starting -- that person is really firing the management. Could it be that this 'who cares?' attitude from management is precisely why people quit the job? Sanitation is a hard and, at times, unpleasant task as it is, made doubly so when someone feels like they are just cast out there, with no support, and then given highly demanding deadlines to meet.

Many companies opt to use contract cleaning firms, but using a contract cleaner does not abdicate your responsibility. What you are really doing is turning over control of your sanitation program to someone else. You still must monitor and manage the system, but now you're doing so without adequate control. You're dealing with a written contract instead of your own food safety/sanitation manager.

If you want a food safety/sanitation program that is 'above the best', one that will protect you from recalls and the considerable losses, both tangible and intangible, they can wreak, then you must be willing to do two basic things: commit to and make an investment in eliminating high turnover on the sanitation crew, and bring your entire food-safety and sanitation program up to meet (and preferably exceed) your customers' demands. Positive attitude on managements' part, not to mention wages and benefits, plays a major role in empowering people. The more they know and understand the importance of what they are doing, the better they will do their jobs. They will respond when management cares enough to show support for them, and they, in turn, will support the company.

Henry Carsberg is a food safety/sanitation consultant with nearly 30 years of experience in food-plant sanitation. Contact him at 1-800-729-2426, ext. 260 or at <henrycat@gte.net>.

This article appeared as "Food Safety Report," Volume 3, Number 4, January 24, 2001, published by BNA, Inc.

uice processors must put in place measures to prevent contamination of fruit and vegetable juices by pathogens under a final Food and Drug Administration rule, published January 19 (66 Fed. Reg. 6138).

The rule requires all juice manufacturers to develop and implement a Hazard Analysis and Critical Control Points plan (HACCP), Robert Buchanan, senior science adviser at FDA, told BNA. Under the HACCP rules, juice processors must develop an analysis of potential hazards, identify those points in processing where hazards can occur, and implement control measures to prevent, reduce, or eliminate these hazards, Buchanan said. Manufacturers must provide appropriate verification of these plans, and maintain appropriate records, he said. The HACCP rule pertains not only to microbiological hazards but to chemical and physical ones, he said. In addition, processors are required to treat juice as a "5-log," or 100,000-fold reduction in pathogens, according to Buchanan. With the exception of citrus fruit, this treatment, which could include heat, pressure, or ultraviolet irradiation, must be done after the juice is produced, he said.

Citrus Exempt.
FDA exempted the citrus industry because that industry successfully demonstrated it is extremely unusual for bacteria to get inside the fruit, according to Buchanan. The rule allows citrus processors to apply the 5-log pathogen reduction on the surface of the fruit, in combination with microbial testing, to assure the process is effective. Processors who make shelf-stable juices -- those that do not require refrigeration -- are exempt from the microbial hazard requirements of the HACCP rule, Buchanan said. "The amount of treatment they do is so overwhelming, that microbiological concerns associated with pathogens are nil," he said. Since almost all producers will have to treat to 5-log reduction, "warning labels on most products will disappear," he said. An exception is retail firms that make a juice product for direct consumption by their customers, he said.

Effective in 2003, 2004.
FDA estimates the rule will cost industry about $50 million the first year of implementation and about $23 million annually thereafter, agency spokesman Sebastian Cianci told BNA. Currently, there are about 48,000 cases of juice-related illnesses each year, according to FDA. The new rule will prevent about 6,000 illnesses per year, including two deaths, Cianci said. The value of prevention is estimated at about $150 million per year, he said. The rule will take effect January 19, 2002. Small systems will have until January 19, 2003 to comply, and very small businesses until January 19, 2004.

Industry Emphasizes Pasteurization.
The National Food Processors Association is "happy that FDA did not exempt small processors from pasteurization or equivalent treatment," Allen Matthys, vice president of regulatory affairs for the group told BNA. "That's where the problem is -- in the unpasteurized juices," he said. NFPA also lauds FDA for exempting shelf-stable products from part of the HACCP rule, Matthys said. In these products "instead of a 5-log reduction, you're getting about a 50,000-log or greater reduction in pathogens," he said. However, the HACCP rule will impose an additional burden on those companies already operating under good manufacturing regulations and "doing a good job," Matthys said. The regulation requires all manufacturers to have a HACCP program and have it evaluated, he said. NFPA also is pleased that FDA's rule reflects recent research showing that some pathogens can 'internalize', so cleaning the outside of the fruit is not always adequate, Matthys said.

The HACCP rule comes after a number of illness outbreaks associated with juice products in recent years, FDA said. In 1996, an outbreak linked to apple juice products contaminated with E. coli sickened about 70 people in the western United States and Canada, and caused one death, the agency said. In 2000, about 88 people in six western states became ill from unpasteurized orange juice contaminated with Salmonella, the agency said.

A crisis management workshop will be held on the campus of Texas A&M University, College Station, Texas, on February 27, 2001 at Rudder Tower, Room 501 (see schedule below). Register via the web at <http://ifse.tamu.edu/resources/industry> or by the attached form. All registration is due by February 18, 2001. Questions? Check out our web site at <http://ifse.tamu.edu> or contact Audrey Thomas <audreyt@tamu.edu>, or call (979) 862-2036 for more information. We look forward to seeing you there!

MORNING

7:30-8 - Registration/Continental Breakfast

8-9 - Introduction -- Crisis Management 101: "What you can get into and what you might plan for . . . ". Dr. Mark McLellan, Director, Institute of Food Science and Engineering.

9-10 - Basics of Food Safety, HACCP, and Emerging Challenges, an Introduction. Dr. Gary Acuff, Professor, Food Sciences, TAMU.

10-10:30 - Break

10:30-11 - "We're Here to Help," -- How to Work with TDH and Federal Regulators. Mr. Frank Borden, Texas Department of Health.

11-12:30 - Lunch

AFTERNOON

12:30-1:30 - Surviving a Recall/Outbreak: A case Study. Marc Isaacs, CEO. Sun Orchards.

1:30-2:30 - "How to Tell Your Side of the Story" -- Public Relations. Tom Bennit, Ketchum, Inc.

2:30-3 - Break

3-4 - Insurance, "Product Recall and Liabilities." Speaker TBA.

4-4:30 - Question and Answer Session. All speakers.

A short course on "Nutraceuticals and Functional Foods" will be held February 18-22, 2001 in College Station, Texas. For more information, contact Dr. Sefa Koseoglu at (979) 845-2749 or e-mail at <s-koseoglu@tamu.edu>.

A "Practical Membrane Technology" short course will be held March 25-29, 2001 in College Station. Contact Dr. Koseoglu for information (see above).

The Texas Food Processors Annual Meeting will be held April 18-20, 2001 at the Doubletree Hotel in Austin, Texas. For meeting information, contact Cindy Wise at (979) 846-3285.

A "Quality and Safety of Juice Processing" workshop will be held at the University of California at Davis March 13-14, 2001. For general information, contact University Extension at 1-800-752-0881. For specific program information call (530) 757-8899.

A symposium on the 2001 Employment Law will be held in San Antonio, Texas on February 22 and in Austin on February 23, 2001. For information, call (210) 978-7700, ext. 5815, or (512) 236-2000, ext. 5815, or e-mail <IKuykendall@jw.com>.

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