Quotable Quotes:

The first batch of specially irradiated mangoes from India reached New York, April 27th, touching the US shores after 18 years, following the Bush administration clearing the way for import of the fruit from the country, PTI reported. About 600 kgs of the choicest Alphonso and Kesari mangoes grown in Gujarat and Maharashtra and irradiated in Lasalgaon, were airlifted by Air India's Flight AI III in its first cargo consignment of the perishable good. (To view video go to following):

Will US President George W Bush get his Indian alphonso mangoes this season after his request during his visit to New Delhi last year? ìMost probably yes. The food irradiation plant at Lasalgaon in Maharashtra has been chosen for preserving mangoes to fulfill quarantine requirements of the US department of agriculture and experts from India and the US are working on necessary protocols. The facility is expected to be approved soon by officials of the American plant health inspection services (APHIS) and their Indian counterparts in the National Plant Protection and Quarantine section as the quarantine requirements, including the radiation dose levels and protection from insects, have been fulfilled.î

AK Kohli, executive chief of the Board of Radiation and Isotope Technology (BRIT), Mumbai, India

"Currently, the single largest source of food-borne disease is produce such as lettuce, spouts, tomatoes, spinach, green onions and parsley. Here are some figures. In the past 10 years, the Food and Drug Administration ñ the FDA ñ reported 21 outbreaks related to fresh leafy products. In 2006, 205 people became sick and five died from eating E. coli contaminated spinach." Bill Marler, Attorney, MarlerClark.

"The nation requires education about the benefits of irradiation of all mass-produced food including produce. Resistance to this practice seems to be rooted in public perception, not science"; Bill Marler, Attorney, MarlerClark.

In This Update:

Indian Mangoes Reach Shores of New York After 18 Years

Attorney Bill Marler's Statement at hearing of the US House Energy and Commerce Committee

FDA May Loosen Labeling Rules for Irradiated Foods

Food irradiation plant in Hyderabad

Irradiation is Safe for Food

FDA Turns Down Hearing Request on Irradiation Levels

Studies Show Irradiation Suitable for Cilantro & Sprouts

Quarantine Requirements for India Mango Exports to US in Place

Settlements reached in spinach-related E. coli deaths

Recalls come at critical time for FSIS

Indian Mangoes Get US Clearance: Shipment April 26th

Texas A & M Teaching Module: Improving Safety of Complex Food Items using Electron Beam Technology

Food Irradiation Research and Technology text book now available from IFT & Blackwell Publishing

Marler's testimony

Here is a link to Bill Marler's written testimony that will be submitted at the May 1, 2007 hearing of the House Energy and Commerce Committee. Marler indicated he won't be a panelist that presents to the committee in person, but he is submitting these written remarks, and some of his clients will testify.
 

It is time that you help government, help business, help consumers and make me unnecessary. I will do that by presenting best practices and other recommendations that can make that possible. Therefore, I thank this committee for inviting me to help with a dialogue about making the food chain safer for consumers.

Marler then makes the connection between the E. coli cases on produce with the early struggles the meat industry.

What have changed since Upton Sinclairís ìJungleî are two things. One, the source of disease has shifted from the meat that Sinclair described to produce. As usually happens, it took a crisis for incidences of E. coli in meat to decline. That crisis occurred in the early 1990s. Undercooked hamburgers containing E. coli from Jack in the Box sickened 650 people, four of them children who died. Shortly, I will discuss how that problem was fixed, perhaps not completely, and the important lessons we as a nation should learn from that. Incidentally, that has been one of the major food safety success stories of our time. According to the CDC, E. coli outbreaks linked to tainted meat have declined by 42 percent. The American Meat Institute puts that figure at 80 percent. Currently, the single largest source of food-borne disease is produce such as lettuce, spouts, tomatoes, spinach, green onions and parsley. Here are some figures. In the past 10 years, the Food and Drug Administration ñ the FDA ñ reported 21 outbreaks related to fresh leafy products. In 2006, 205 people became sick and five died from eating E. coli contaminated spinach.

Marler has eight recommendations for the committee:
From research and experience, here are eight recommendations.

First of all, there exist two ìbest practicesî in meat that should be extended to produce. Following the Jack in the Box crisis, the head of the U.S.D.A.ís Food and Safety Inspection service took a regulatory and systems approach to food safety. That ìheroî was Michael Taylor. Taylor declared that raw ground beef that is contaminated with E. coli would be classified and treated as ìadulteratedî within the meaning of the Federal Meat Inspection Act. Following Taylorís example, we must serve notice to produce and other food processors that E. coli, salmonella, etc. will be classified and treated as adulterants. In addition, the same kind of comprehensive Risk Management System must be established and implemented. Penalties must be criminal and civil.
Two, we need the same kind of food safety champion that Taylor was. This person would be a highly visible symbol of our commitment. Along these lines, it is useful to consider consolidating responsibility in one federal-level agency. That would be the central point for communication about best practices and the point of contact for state and local regulators and health departments.
Three, the track record of business for issuing warnings and recalls rapidly isnít good. Peanut butter has been a classic example. The federal and state governments should have authority to do this. That means increased funding, particularly at the state level. Most outbreaks are regional, not national.
Four, produce an E. coli vaccine for cows. I would say that the lionís share of produce problems result from this contaminant passed on through cow feces.

Five, the nation requires education about the benefits of irradiation of all mass-produced food including produce. Resistance to this practice seems to be rooted in public perception, not science.

Six, attention has to be paid to the vulnerability of our food supply system to acts of terrorism. Denial and lack of common sense seem to dominate thinking at all levels ñ business and federal and state government.
Seven, why havenít we applied our economic and political muscle to imposing more stringent regulations on food imports? This is a central trade issue that has been neglected.
And, eight, thereís an urgent need to improve the resources available to foodborne disease victims. At the top of the list are the out-of-pocket medical costs. Those are usually not immediately or even eventually reimbursed by medical insurance if victims have coverage. By time compensation comes from litigation, the person could be heavily in debt.

Let me wrap this up with one thought. Just as the boldness, courage and relentlessness of Michael Taylor made meat safer, these eight recommendations can ensure the integrity of the rest of the food chain. And better care for victims. Let me say again: ìI ask this committee to put us at Marler Clark out of business.î Thank you.

The US Food and Drug Administration (FDA) recently proposed rules that would relax some labeling restrictions on irradiated foods and invited the public to comment.

The FDA currently requires all irradiated foods to have the international radura symbol and the statement "treated by irradiation" or "treated with radiation" clearly displayed on the packaging.

However, in an Apr 4 notice published in the Federal Register, the FDA proposed that only foods that are "materially changed" by irradiation be required to carry the radura logo and the term "irradiated." The FDA defines a material change as an alteration in a food's characteristics caused by irradiation, such as extended shelf-life in bananas or changes in color, texture, or taste that exceed the normal range of variability for the food.

The proposed rule change would also allow companies to petition the FDA for permission to use alternative terms for irradiation and would permit firms to use the term "pasteurized" instead of "irradiated" if the process they use meets federal criteria for pasteurization. Comments from the public are due by Jul 3, 2007.

The move toward loosening labeling rules for irradiated foods began nearly 5 years ago when Congress passed the 2002 farm bill. Labeling-related provisions intended to promote the acceptance of irradiated foods were included in amendments authored by Sen. Tom Harkin, D-Iowa.

The bill broadened the definition of pasteurization to include any safe process that is at least as protective as pasteurization and is reasonably certain to kill the most resistant pathogens likely to occur in the food. The legislation also directed the FDA to review its regulations on labeling of irradiated foods, receive public comments, and then revise the regulations "as appropriate."

The 2002 farm bill specified that, until the issuance of new rules, anyone could petition the FDA for permission to change the labeling of an irradiated food, provided that the change "is not false or misleading in any material respect." The FDA's Federal Register notice says that the agency has not received any petitions from companies requesting the use of alternative labeling for their irradiated products.

The FDA says in the notice that it was unclear how many products could be marketed without "irradiation" on the label if its proposal is adopted, because labeling requirements cannot be made in advance for all products. Labeling requirements will mostly likely be set case-by-case because the effects of irradiation on different foods vary. "It is more likely that this option would simply allow firms more flexibility in how they label irradiated foods," the notice states.

It also says the labeling changes could allow some consumers to make more informed decisions about their food purchases, but it acknowledges that others may regard substitute terms as misleading.

The FDA says companies are sure to consider their bottom line when deciding to make a labeling change, but the new rules could also increase the use of irradiation as a food safety tool.  "It is possible that some manufacturers not currently using irradiation as a safety tool (because of the current labeling requirement) may opt to start using irradiation in order to enhance the safety of their products," the FDA notice states.

The revised labeling rules, however, could make it more difficult for consumers who want to avoid irradiated foods, because they would need to do more research on which foods are irradiated.  Currently, few foods are irradiated. Though several major health and science organizations, such as the World Health Organization and Infectious Diseases Society of America, have endorsed food irradiation as safe, US consumers have been slow to warm to irradiated foods.

Some consumer groups, such as Public Citizen, strongly oppose food irradiation because they are suspicious about its effects and believe food producers will use it as a substitute for more traditional food safety measures.

However, recent illness outbreaks caused by contaminated produce have sparked new interest in ways to make the US food supply safer. Last October, amid a nationwide Escherichia coli O157:H7 outbreak linked to fresh spinach, the FDA, in an outbreak update on its Web site, said it had a petition under review to permit the irradiation of multi-ingredient foods, including prepackaged fresh produce, to reduce microbial contamination.

See also:

Apr 4 FDA Federal Register notice on proposed change in labeling rules

Jun 17, 2002 CIDRAP News article "New farm bill may promote food irradiation, but changes could be slow"

Oct 2006 FDA statement on E coli outbreak

CIDRAP overview on food irradiation

Regulator turns down hearing request on irradiation levels; FoodUSA (April 12, 2007)

The FDA this week said it would not hold any hearings on the objections to the limit submitted by various parties. Instead the FDA submitted as a final rule an amendment to the food additive regulations that establishes a new maximum permitted energy level of x-rays for treating food at 7.5 million electron volts (MeV).

The FDA is fighting a rearguard action due to the lobbying of consumer groups over the perceived dangers of irradiation when used to rid foods of microbes.

The level is valid for x-rays generated from machine sources that use tantalum or gold as the target material. There is no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations. The level was originally published in a notice in the Federal Register of March 13, 2003 when it announced the filing of food additive petition by Ion Beam Applications. The petition sought to amend the food additive regulations by increasing the maximum permitted energy level of x-rays for treating food to 7.5 MeV from from 5 MeV.

The rights to the petition were subsequently transferred to Sterigenics International. In response to the petition, the FDA issued a final rule on December 23, 2004.  Following publication of the 7.5 MeV x-ray final rule, the FDA said it received about 100 objections within the 30-day objection period.

All but one of the submissions expressed general opposition to increasing the maximum permitted energy level of x-rays used to irradiate food and to food irradiation.  Most of these objections were form letters, the FDA stated.  "While most of these objections requested a hearing, no evidence was submitted in support of these objections that  could be considered in an evidentiary hearing," the FDA stated.

Earlier this month the FDA made a proposals to revise labeling regulations for irradiated foods and supplements, suggesting that some could be labeled as "pasteurized". The proposed rule would provide consumers with "more useful" information than the current regulation, the FDA claimed.

Irradiation works by exposing foods to ionizing radiation that kills insects, moulds and bacterium. The technology, which can kill up to 99 per cent of pathogens, is seen by the industry as a means of ensuring food safety.

However public concerns over the health effects of the technology has meant global food companies have had to deal with a confusing thicket of legislation and restrictions when making and marketing their products. The US currently requires all single-ingredient irradiated foods sold in stores to be labeled as "treated with irradiation" and to carry the 'radura' symbol.

Under the FDA's proposed labeling revisions, only those irradiated foods in which the irradiation causes a material change in the food, would bear the radura logo and the term "irradiated" or a derivative thereof, in conjunction with a description of the change in the food.

The agency said it is using the term 'material change' to refer to a change in the organoleptic, nutritional, or functional properties of a food, caused by irradiation, that the consumer could not identify at the point of purchase in the absence of appropriate labeling.  FDA is also proposing to allow a firm to petition for use of an alternate term to "irradiation" (other than "pasteurized").

In addition, FDA is proposing to permit a firm to use the term "pasteurized" in place of "irradiated", provided it notifies the agency that the irradiation process being used meets the criteria specified for use of the term "pasteurized" in the Federal Food, Drug, and Cosmetic Act.

CDC data show E. coli O157:H7, Salmonella, Listeria Rates Rose in 2006: (April 12, 2007) Compiled from various sources:

FoodNet data released by the Centers for Disease Control show that illnesses associated with three major pathogens increased in 2006 over the preceding year. The rates for food poisoning from E. coli O157:H7, Salmonella and Listeria were higher in 2006 than in 2005. While the increase was not large, it showed that progress against foodborne illness has leveled off.

For the second straight year rates of E. coli and Listeria food poisoning have increased while rates of Salmonella have increased over 2005 rates.

The Listeriosis rate rose for the second straight year and the U.S. again failed to meet the National Health Objective of reducing the rate of illness from this pathogen to 2.5 by 2005. In 2006, the incidence of Listeria infections remained higher than at its lowest point in 2002. While Listeriosis causes few cases of illness each year, 20% of those stricken die. The estimated number of deaths is 499, second only to the total deaths from E. coli O157:H7, a more commonly occurring illness. Most of those made ill from Listeriosis are pregnant women who virtually always suffer miscarriage or stillbirth as a result of the illness.

In 2006, compared with the 1996--1998 baseline period, significant declines occurred in the estimated incidence of Campylobacter, Listeria, Shigella, and Yersinia infections. However, most of these declines occurred before 2006. Most of the decline in Campylobacter incidence occurred by 2001.

After substantial declines in 2003 and 2004, the incidence of E. coli O157 infections increased in 2005 and again in 2006. The earlier decline in incidence was temporally associated with measures by the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS) and the beef-processing industry to reduce the contamination of ground beef. These measures were accompanied by a decline in the frequency of isolation of E. coli O157 from ground beef in 2003 and 2004. In 2005 and 2006, however, the frequency of isolation of E. coli O157 in ground beef remained at the same level as 2004. Reasons for the increases in human E. coli O157 infections in 2005 and 2006 are not known. However, E. coli O157 outbreaks caused by contaminated spinach and lettuce in 2006 highlight the need to more effectively prevent contamination of produce that is consumed raw. In a measure to reduce the risk for illness attributed to fresh produce, the Food and Drug Administration recently published draft guidance advising processors on how to minimize microbial food-safety hazards common to the processing of most fresh-cut fruits and vegetables.

Quarantine requirements for mango exports to US in place; Financial Express (April 20, 2007):

MUMBAI, INDIA:  Will US President George W Bush get his Indian alphonso mangoes this season after his request during his visit to New Delhi last year? ìMost probably yes,î says AK Kohli, executive chief of the Board of Radiation and Isotope Technology (BRIT), a unit of the department of atomic energy that handles the irradiation of the fruits for export.

ìThe food irradiation plant at Lasalgaon in Maharashtra has been chosen for preserving mangoes to fulfill quarantine requirements of the US department of agriculture and experts from India and the US are working on necessary protocols,î Kohli said. ìThe facility is expected to be approved soon by officials of the American plant health inspection services and their Indian counterparts in the National Plant Protection and Quarantine section as the quarantine requirements, including the radiation dose levels and protection from insects, have been fulfilled.î

The family of an 81-year-old Nebraska woman who died after eating spinach grown at a San Benito County ranch has, according to this story, reached an undisclosed settlement ó the first in what could be a long line of cases stemming from last year's E. coli outbreak.

Two other fatal cases linked to the outbreak in August and September also have been settled. Bill Marler, the Seattle-based attorney representing the three families as well as dozens of others sickened in the outbreak, was cited as saying the circumstances surrounding the wrongful death lawsuits of Betty Howard, 83, of Richland, Wash., and June Dunning, 86, of Hagerstown, Md., weren't as "cut and dried" as the death of Ruby Trautz, adding, "They just didn't die immediately after eating it, but they got sick. But there's no question that it came from Dole baby spinach, or else there wouldn't have been a settlement"

Sarah Brew, an attorney for Dole Food Co., was cited as confirming the settlements were reached in late March in San Diego and the mediation took place in front of retired federal court Judge Lawrence Irving. But she would not comment further.
Attorneys for Mission Organics, which grew the spinach, and Natural Selection Foods, which packed it, could not be reached for comment.

According to Marler, all of the parties are "liable under the law from a consumer's perspective," and they and their insurance companies all came to an agreement on the settlements. http://www.santacruzsentinel.com/archive/2007/April/21/local/stories/01local.htm

Mumbai, April. 26 (PTI): After a gap of 18-years, the first consignment of Indian mangoes is ready to be exported to the United States today, after receiving necessary clearance from the US regulators.

The Bhabha Atomic Research Centre (BARC) and Board of Radiation and Isotope Technology (BRIT) got a green signal for the export of the mangoes, last night.

The first and a small consignment of `Alphonso' and `Kesar' varieties of mangoes consisting of 150 boxes has been processed today at the Lasalgaon food irradiation plant in Maharashtra of BARC/BRIT units of the Department of Atomic Energy.

"The consignment is ready after irradiation process to go to Mumbai any moment for export to New York this evening cargo flight," BARC Food Technology Chief A K Sharma, who is stationed at Lasalgaon for the purpose, told PTI.

"We got the certificate of approval from American Plant Health Inspection services of the US Department of Agriculture last night and today we got the first customer," he said.

US stopped import of mangoes 18-years back as they felt that Indian farmers were using too much pesticides, according to Agricultural Products Export Development Authority.

However, the import was revived after a request made by President George W Bush after meeting Prime Minister Manmohan Singh in New Delhi last year.

"The food irradiation plant at Lasalgaon in Maharashtra has been chosen for preservation of mangoes to fulfill the quarantine requirements of the United States Department of Agriculture and experts from India and US worked on the necessary protocols," BRIT Chief Executive A K Kohli said.

Texas A & M University has recently completed a USDA sponsored project was called "Improving Safety of Complex Food Items using Electron Beam Technology." The titles of the four teaching modules are:

Lesson 1 : Microbiological Safety of Fresh Fruits & Vegetables

Lesson 2 : Control of Microbial Growth & Foodborne Disease Pathogens in Fresh Fruits & Vegetables

Lesson 3 : Current Strategies used to Eliminate or Reduce Pathogenic Microorganisms from Fruits and Vegetables

Lesson 4: Science and Applications of Electron Beam Irradiation Technology

The lessons may be accessed by all at http://aggiehorticulture.tamu.edu/foodsafety/foodsafetyissues.html

For more information contact:

Tom A. "Andy" Vestal, Ph.D.

Professor and Extension Specialist

AgNR Emergency Management

Texas Cooperative Extension

Dept of Agric Leadership, Education & Communications

Mail Stop 2116

Texas A&M University

College Station, TX 77843-2116

979.862.3013 http://www.aged.tamu.edu/people/faculty/vestal-a.asp