12/27
2004

ISSUE:
145

Sponsors




Sponsorship Q/A

Comprehensive News List

General Food Safety News, OUtbreak News
Recall News, New Methods News, USDA/FDA News
On-Line Slides, Job Information

Four States Petition EPA For Food Safety
The states of New York, California, Connecticut and Massachusetts have petitioned the U.S. Environmental Protection Agency for stricter limits on pesticide residues in food products under the pretext of protecting children.

The states¡¯ attorney generals are agreeing with similar contentions that environmental groups have claimed in filing lawsuits. The petition says the EPA does not have data necessary to reassess the safety factors for pesticide residues of at least nine products and their active ingredients. They are requesting major reductions in allowable residues.

A district judge earlier ruled that all administrative remedies with the EPA had not been exhausted prior to bringing a lawsuit and that the lawsuit will ultimately need to be heard in federal appeals court.

Food Safety Network Encourages Consumers to Think 'Food Safety'

Farm-Scape, Episode 1675
The Head of the Food Safety Network is reminding consumers to keep in mind a few simple basics to get the most enjoyment from food during the holidays.

The University of Guelph's Food Safety Network provides research, commentary, policy evaluation and public information on food safety issues.

Scientific Director Dr. Doug Powell says there's been enough media coverage that food safety is more of a top of mind issue but the challenge is whether that information is being taken to heart and impacting behavior.

"When we talk about food safety we talk about a farm-to-fork system. It's important for consumers to practices things like cooking properly, chilling, not cross contaminating, using a meat thermometer but it's also important to recognize that everyone in that farm to fork system beginning on the farm, right through to the consumer has a responsibility to reduce risk. In most cases they are.

There's an awful lot of activity going on on the farm, in the processing plants, at retail and consumers are showing enhanced behavior as well. There are a number of risks.

The basics again, if you're cooking a turkey, use a meat thermometer. Things like fresh fruits and vegetables are certainly a growing source of food borne illness and we have to be careful.

We have to source food from safe sources. The large retail chains have good programs in place, so do some of the small ones. Just make sure that you know where your food's coming from and what they do to protect it and then carry that through in your own kitchen."

Dr. Powell says it's the holidays and we're not thinking about how we can make our guests sick, we're thinking about how we can enjoy food and have a good time.

He says, with a few basic steps all along the chain, we can do that. The Food Safety Network can be accessed at 1 866 503-7638 or at www.foodsafetynetwork.ca

For Farmscape.Ca, I'm Bruce Cochrane.

Mad cow case focused public attention on food safety

By ROXANA HEGEMAN
ASSOCIATED PRESS WRITER

WICHITA, Kan. -- After the nation's first case of mad cow disease was discovered, government regulators and industry officials worked quickly to reassure consumers it was safe to eat a steak. A year later, you'd never guess there was any concern at all - the nation's appetite for beef has remained strong.

But consumer advocates say there's a problem with that lack of reaction from the public - it might have diminished the impact of the mad cow case on improving food safety. Aside from several steps taken shortly after a single cow in Washington state was found infected with the disease, reforms that were promised remain unfulfilled.

Federal regulators, trying to reassure U.S. consumers, promised to strengthen the country's food safety rules. For the most part, it didn't happen, said Caroline Smith DeWaal, director of food safety for the Center of Science in the Public Interest.

"Consumers didn't react very much, so they don't feel the need to take action, and I think that is unfortunate," Smith DeWaal said.

Certainly, significant changes were made to strengthen existing safeguards already in place.

Some consumer groups say the most important was the banning of so-called downer cattle - animals too sick to stand - from slaughter for human consumption. Regulators at the U.S. Department of Agriculture believe new rules that forbid potentially infectious material, such as spinal cords, from being incorporated into food are the most significant reform.

The government's testing program for mad cow - formally known as bovine spongiform encephalopathy, or BSE - was expanded to include more than 221,000 animals, 10 times the number tested in 2003, by the time it is done. The surveillance program went into effect June 1 and is to be completed in a year to 18 months. As of Monday, the agency had tested 152,984 animals.

But animal feed rules designed to prevent future cases of mad cow have not been strengthened. And a national animal identification system designed to track individual cattle - in the works before the BSE discovery, but supposedly expedited after its discovery - has yet to be fully implemented.

Other proposed changes, food safety advocates said, were made not to benefit U.S. consumers, but rather those overseas, whose countries quickly closed their borders to American beef imports after the mad cow discovery.

For example, Smith DeWaal said, during recent trade talks with Japan, U.S. negotiators seemed willing to apply stricter regulations to cattle 20 months or older that would be marketed to Japanese consumers. The regulations would start at 30 months for cattle aimed at the domestic market.

"The pressure put on USDA by foreign governments is far more effective in effecting change than the pressure put on USDA by U.S. consumers," Smith DeWaal said. "They are much more worried about losing markets."

Agriculture Department officials discount that criticism.

"It is our goal to make sure that we are providing a safe and wholesome product to consumers - whether it is in America or elsewhere globally," said Beth Johnson, a specialist assistant to U.S. Agriculture Secretary Ann Veneman.

Johnson said the continuing strong demand for beef is due to the confidence consumers have in the U.S. beef supply and the steps the agency has taken to protect the U.S. cattle herd. She credited safeguards - such as a ban on high-risk cattle parts in cattle feed since 1997 - the agency put in place years before the first mad cow case.

Such safeguards have kept the United States from having widespread incidents of mad cow disease such as those in other nations, she said.

Johnson acknowledged it may be early 2006 before a national animal identification system that can trace an animal back to its source in 48 hours is fully in place. But the agency said it has made headway in putting the system together, and it can now track the majority of cattle under existing state and industry systems.

Through it all, no deaths or illnesses have been attributed to the sole confirmed U.S. mad cow case; other diseases such as E. coli or listeria are far more common. Food-borne diseases account for 5,000 deaths, 75 million cases of illness and 325,000 hospitalizations annually in the United States, the Centers for Disease Control and Prevention estimates.

"Mad cow disease has had a greater visibility than a number of other meat-related diseases," said Greg Watchman, executive director of the Government Accountability Project, a government watchdog group. "In the end, it serves to underscore the systematic problems at USDA in dealing with these diseases as a whole."

That problem, he said, is the conflicting missions of the Agriculture Department: protect the nation's food supply while also promoting the nation's agriculture industry.

"We remain concerned USDA continues to suffer from 'agency capture' - meaning that it too often does the bidding of large (meat) packers rather than advancing the mission of protecting America's families," Watchman said. "Obviously, the bottom line here is America's families remain at risk of food-borne illnesses such as mad cow."

As an example, he cited the Agriculture Department's refusal to allow Creekstone Farms Premium Beef to test all cattle processed at its Arkansas City, Kan., slaughterhouse for mad cow. Such testing was opposed by major meatpackers, who contend it costs too much and is scientifically unnecessary.

"When a small packer offers to test every animal for mad cow - and USDA refuses to allow that practice - something is wrong with the government's fulfillment of its mission to protect our U.S. food supply," Watchman said.

Again, it's an argument rejected by the Agriculture Department. Johnson said the department's decision on Creekstone was based strictly on science. The cattle slaughtered by Creekstone are too young to test reliably, she said.

"The last thing in the world we want to do is promote information and promote assurances on something that scientifically we know is not effective when you are talking about young animals," Johnson said.

New law boosts food safety rules

By Denise Freitag, Staff Reporter
When Madeleine Weaver, Moores Hill, started her job as cafeteria manager for St. John¡¯s Lutheran School, Aurora, in August, she had to act quickly in order to comply with a new state certified food handler law.
As of Saturday, Jan. 1, most Indiana food establishments must have a certified food handler on staff.
She took a two-day course in November before taking the test for certification. The class has helped her lot, said Weaver.
¡°A lot of the information is common knowledge, but you need to bring things to the surface and remind yourself,¡± she said
The new law brings everyone up to a certain level of food safety, said chief food specialist Mary Wesemann, Dearborn County Health Department Food Protection Division.
¡°I think the new regulation is a good idea for public health, to bring us up to the minimum level,¡± she said.
The course gives people more confidence, she said.
¡°I have seen such an improvement,¡± said Wesemann.
Weaver said she learned about the extra steps she can take to keep her working space clean.
¡°Especially working with kids. You have to keep the germs down,¡± said Weaver.
She found the information on storing foods interesting. After the course she rearranged how foods were placed in the cafeteria and her home refrigerator, she said.
¡°It was a real learning experience. I¡¯m glad I went and would recommend it,¡± said Weaver.

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Taking the test
Though the new law will initially include nonprofit organizations excluded from food codes, a bill is expected to be introduced to make exclusions for events such as church chicken dinners.
School cafeterias would not be exempt, however, because it is a nonprofit organization that serves food more than 30 days during a year.
The certification test took her a little over an hour to complete. There were 90 multiple choice questions, said Weaver.
She studied for the test and some of the questions took extra time to figure out, but overall it was not too bad, she said.
¡°If nothing else it reminds you to do certain things,¡± said Weaver.
Though the food handler deadline is Jan. 1, anyone still seeking certification can attend a ServSafe Food Training class scheduled for Wednesday, Jan. 12, and Wednesday, Jan. 19, at Tyson Apartments, 100 S. High St., Versailles.
Participants attend both days. The food handler exam will be give the second day.
Registration begins at 8 a.m. The class is from 9 a.m. to 4 p.m. both days. The cost is $120 which includes instruction, textbook and exam. Exam only is $40.
Pre-registration one week in advance is requested. A $20 late fee will be assessed on walk-in registration.
For more information or to register call the Restaurant & Hospitality Association of America at 1-317-673-4211 or 1-800-678-1957 or visit the Web site www.indianarestaurants.org.

Kicking it up a notch
Dearborn County Health Department Food Protection Division also wants to improve safety by increasing the number of times food establishments are inspected annually.
The county commissioners signed an ordinance in February to increase inspections to four times a year for each establishment, said Wesemann.
The previous average was around once or twice a year, she said.
An attempt was made to increase the number to four this year, but the department was unable to make it happen, she said.
The county has two food inspectors, Wesemann and Robert Skidmore.
The department tries to keep up with the inspections as much as possible, said department food advisor Dr. Frank Frable.
The increased food inspections are in line with state and federal recommendations, he said.
More recommendations keep coming from the state, there is continuing education and a lot of paperwork to fill out, he said.
¡°In the meantime the county has grown. We have new food establishments,¡± said Frable.
Inspections of the past consisted of looking at the floor, walls and ceilings, not where the food is held, prepared, served and mixed, said Wesemann.
Now inspectors conduct risk-based inspections which include tasks such as checking if employees are washing their hands and making sure food establishments know their suppliers, especially as terrorism becomes a bigger concern, she said.
The county has about 350 food establishments in the computer system with the number expected to grow to more than 400 when everything is added, she said.
The number includes restaurants, seasonal food establishments, nonprofit organizations operating more than 30 days a year and temporary food establishments, such as the Aurora Farmers Fair, she said.
The food protection division staff also handles phone calls, complaints, conduct follow-up inspections, investigate foodborne illness and keep track of statistics, said Wesemann.
Another full-time food inspector is needed, said Frable.
A letter asking for another inspector is being sent to the county commissioners, he said.

North Carolina E coli outbreak traced to petting zoo

Dec 23, 2004 (CIDRAP News) ? A recent outbreak of E coli O157:H7 infections was traced mostly to a petting zoo at the North Carolina State Fair, even though the zoo had posted signs and provided facilities to promote hand hygiene.

The outbreak in October and November involved 108 likely and confirmed cases, many of them in children younger than 6 years, according to the North Carolina Department of Health and Human Services (NCHHS). The outbreak led to 15 cases of hemolytic uremic syndrome, a life-threatening kidney complication of E coli O157:H7 infection in children.

After recognizing that most of the people with symptoms had attended the fair, investigators compared case-patients with healthy fair visitors to identify possible causes of the outbreak, the NCHHS said in a news release. The patients and controls were asked about exposure to the fair's two petting zoos, other animal exhibits, food and drinks sold at the fair, and possible household sources of E coli.

The comparison pointed to the Crossroads Farm Petting Zoo as the likeliest source of infection for most of the patients, officials said. Contact with manure at the petting zoo stood out as a risk factor: among children under age 3 who had visited the zoo, case-patients were more than seven times more likely to have had contact with manure than controls were.

In an effort to prevent illness, the zoo had followed guidelines from an organization of public health veterinarians, which included posting signs and providing hand sanitizing stations, the NCHHS said. But information from interviews indicated that hand hygiene failed to protect people from infection.

"Exposures from direct contact between petting zoo visitors and animals or manure might have already led to infection before hand-sanitizer use," or patients might have picked up contamination on skin areas where subsequent hand cleansing failed to remove it, the department said.

Laboratory tests supported the results of the case-control study. In 33 of the 43 confirmed cases, the E coli strain had the same DNA fingerprint (pulsed-field gel electrophoresis pattern) as E coli samples from the petting zoo. Testing of environmental samples from the petting zoo showed that most of the samples containing E coli O157:H7 came from areas where people could pet sheep and goats.

The NCHHS concluded that most patients fell ill as a result of visiting the petting zoo, though some probably picked up the infection elsewhere at the fair.

"In light of the investigation, we recommend restricting direct contact with animals, reducing fecal contamination, and reducing crowding in petting zoos in addition to existing recommendations to prevent future E. coli O157:H7 infections," the NCHHS said, citing recommendations from the National Association of State Public Health Veterinarians (NASPHV). "These recommendations are particularly pertinent for young children and others with reduced immunity to infection."

The North Carolina outbreak is one of several E coli O157:H7 outbreaks linked to petting zoos or farms in recent years. A petting zoo in Ontario was found to be the source of 159 cases in 1999, and 51 cases were traced to a Pennsylvania dairy farm in the fall of 2000, according to the US Centers for Disease Control and Prevention (CDC).

See also:

NCHHS report on the outbreak
http://www.dhhs.state.nc.us/docs/ecoli.htm

NCHHS news release
http://www.dhhs.state.nc.us/pressrel/12-16-04.htm

CDC recommendations to prevent infection in settings where the public has contact with farm animals
http://www.cdc.gov/foodborneoutbreaks/pulication/recomm_farm_animal.htm

April 20, 2001, CDC report on E coli cases associated with farm visits in Pennsylvania and Washington state
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5015a5.htm

A New Vaccine Against Enteritidis Salmonella

The project developed by Javier Ochoa centred on the investigation of a new vaccine based on the encapsulation of the components of the Salmonella enteritidis cell sheath. The vaccine has shown itself to be efficacious in mice infected with this illness and is currently being employed on experimental farms of Hipra laboratories in Gerona, a compnay involved in the control of pathogens in birds.

Low efficacy of vaccines applied

Farmyard fowl and their derivatives are recognised as the most important source of infection of Salmonella enteritidis in humans. Both the World Health organisation (WHO) and the European Union have laid down guidelines in order to erradicate the infection in fowl, the benefits of this for humans being evident. It is generally accepted that the most practical measure is vaccination, as the easiest to apply and the most economic but, to date, all thos applied have proved to have low efficacy.

In Spain, Salmonella enteritidis is the bacteria that causes 85% of food-provoked gastroenteritis. In the concrete case of Navarre, there were 343 food poisoning cases in 2003, of which 79 were grouped together in 14 outbreaks, 12 due to Salmonella.

Lack of beef over mad cow hurts food safety

Promised changes remain unfulfilled

By ROXANA HEGEMAN
Associated Press

WICHITA, Kan. - After the nation's first case of mad cow disease was discovered, government regulators and industry officials worked quickly to reassure consumers it was safe to eat a steak. A year later, you'd never guess there was any concern at all - the nation's appetite for beef has remained strong.
But consumer advocates say there's a problem with that lack of reaction from the public - it might have diminished the impact of the mad cow case on improving food safety. Aside from several steps taken shortly after a single cow in Washington state was found infected with the disease, reforms that were promised remain unfulfilled.

Federal regulators, trying to reassure U.S. consumers, promised to strengthen the country's food safety rules. For the most part, it didn't happen, said Caroline Smith DeWaal, director of food safety for the Center of Science in the Public Interest.

"Consumers didn't react very much, so they don't feel the need to take action, and I think that is unfortunate," Smith DeWaal said.

Certainly, significant changes were made to strengthen existing safeguards already in place.

Some consumer groups say the most important was the banning of so-called downer cattle - animals too sick to stand - from slaughter for human consumption. Regulators at the U.S. Department of Agriculture believe new rules that forbid potentially infectious material, such as spinal cords, from being incorporated into food are the most significant reform.

The government's testing program for mad cow - formally known as bovine spongiform encephalopathy, or BSE - was expanded to include more than 221,000 animals, 10 times the number tested in 2003, by the time it is done. The surveillance program went into effect June 1 and is to be completed in a year to 18 months. As of Monday, the agency had tested 152,984 animals.

But animal feed rules designed to prevent future cases of mad cow have not been strengthened. And a national animal identification system designed to track individual cattle - in the works before the BSE discovery, but supposedly expedited after its discovery - has yet to be fully implemented.

Other proposed changes, food safety advocates said, were made not to benefit U.S. consumers, but rather those overseas, whose countries quickly closed their borders to American beef imports after the mad cow discovery.

For example, Smith DeWaal said, during recent trade talks with Japan, U.S. negotiators seemed willing to apply stricter regulations to cattle 20 months or older that would be marketed to Japanese consumers. The regulations would start at 30 months for cattle aimed at the domestic market.

"The pressure put on USDA by foreign governments is far more effective in effecting change than the pressure put on USDA by U.S. consumers," Smith DeWaal said. "They are much more worried about losing markets."

Agriculture Department officials discount that criticism.

"It is our goal to make sure that we are providing a safe and wholesome product to consumers - whether it is in America or elsewhere globally," said Beth Johnson, a specialist assistant to U.S. Agriculture Secretary Ann Veneman.

Johnson said the continuing strong demand for beef is due to the confidence consumers have in the U.S. beef supply and the steps the agency has taken to protect the U.S. cattle herd. She credited safeguards - such as a ban on high-risk cattle parts in cattle feed since 1997 - the agency put in place years before the first mad cow case.

Such safeguards have kept the United States from having widespread incidents of mad cow disease such as those in other nations, she said.

Johnson acknowledged it may be early 2006 before a national animal identification system that can trace an animal back to its source in 48 hours is fully in place. But the agency said it has made headway in putting the system together, and it can now track the majority of cattle under existing state and industry systems.

Through it all, no deaths or illnesses have been attributed to the sole confirmed U.S. mad cow case; other diseases such as E. coli or listeria are far more common. Food-borne diseases account for 5,000 deaths, 75 million cases of illness and 325,000 hospitalizations annually in the United States, the Centers for Disease Control and Prevention estimates.

"Mad cow disease has had a greater visibility than a number of other meat-related diseases," said Greg Watchman, executive director of the Government Accountability Project, a government watchdog group. "In the end, it serves to underscore the systematic problems at USDA in dealing with these diseases as a whole."

That problem, he said, is the conflicting missions of the Agriculture Department: protect the nation's food supply while also promoting the nation's agriculture industry.

"We remain concerned USDA continues to suffer from "agency capture' - meaning that it too often does the bidding of large (meat) packers rather than advancing the mission of protecting America's families," Watchman said. "Obviously, the bottom line here is America's families remain at risk of food-borne illnesses such as mad cow."

As an example, he cited the Agriculture Department's refusal to allow Creekstone Farms Premium Beef to test all cattle processed at its Arkansas City, Kan., slaughterhouse for mad cow. Such testing was opposed by major meatpackers, who contend it costs too much and is scientifically unnecessary.

"When a small packer offers to test every animal for mad cow - and USDA refuses to allow that practice - something is wrong with the government's fulfillment of its mission to protect our U.S. food supply," Watchman said.

Again, it's an argument rejected by the Agriculture Department. Johnson said the department's decision on Creekstone was based strictly on science. The cattle slaughtered by Creekstone are too young to test reliably, she said.

"The last thing in the world we want to do is promote information and promote assurances on something that scientifically we know is not effective when you are talking about young animals," Johnson said.

Rapid Alert System for Food and Feed (RASFF)
December 22, 2004
European Commission
Week 51 available in pdf format at http://europa.eu.int/comm/food/food/rapidalert/reports/week51-2004_en.pdf

Central Boeki Ltd. receives 4,000 fine for illegally selling fish
December 20, 2004
Canadian Food Inspection Agency
http://www.inspection.gc.ca/english/corpaffr/projud/2004/20041220e.shtml
On December 2, 2004, Central Boeki (Canada) Ltd. entered a guilty plea in Vancouver Provincial Court to one count of violating the Fish Inspection Regulations resulting in a $4,000 fine.
On February 18, 2003, Central Boeki (Canada) Ltd. imported a quantity of fish into Canada from Japan. The company violated the Fish Inspection Regulations by selling the imported fish before it was released by the Canadian Food Inspection Agency (CFIA).
Also during the course of their inspection, the CFIA found 22 cases of dried fugu (puffer fish) imported from Japan. Under section 6(4)(b) of the Fish Inspection Regulations, puffer fish of the family Tetraodontidae are not allowed into Canada. The product was subsequently forfeited to the CFIA.
One of the CFIA¡¯s primary concerns is food safety. The Agency¡¯s priority in the area of inspection helps to continue Canada¡¯s excellent reputation domestically and internationally as having a safe and high quality food supply.

New Simple Method for Detection of Enterobacter sakazakii

The monitoring of E. sakazakii contamination has become essential for all baby food manufacturers.

AES Laboratoire has developed a very simple but reliable method to detect this microorganism in food stuff and environmental samples. The method combines a chromogenic culture medium (24h at 37¡ÆC - ESIATM E. Sakazakii Isolation Agar) with a specific enrichment broth (24h at 37¡ÆC - ESSBTM E. Sakazakii Selective Broth).

The high performance level of the method has led international bodies to include ESIATM in their testing programs for the development of official methods.

Writing a Comparability Protocol for a Rapid Microbiology Method
This article will initiate a discussion on the types of actual information to be considered in writing a comparability protocol for a rapid microbiology method.

The Regulations
The current regulations for comparability protocols are included in the Code of Federal Regulations, Title 21, ¡×314.70(e) and 601.12(e). They state (i): Protocols. An applicant may submit one or more protocols describing the specific tests and studies and acceptance criteria to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, and potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. Any such protocols, if not included in the approved application, or changes to an approved protocol must be submitted as a supplement requiring approval from FDA prior to distribution of a drug product produced with the manufacturing c hange. The supplement, if approved, may subsequently justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect.

Technical Contents of a Comparability Protocol

The FDA Guidance Documents on Comparability Protocols (ii), (iii) provide information on the exact format and information to include in the supplement. Within this format, one must provide specific information regarding the following:
Type of Proposed Change
Tests and Studies to be Performed
Analytical Procedures to be Utilized
Acceptance Criteria to be achieved to demonstrate the lack of an adverse effect on the product quality as it may relate to the safety and effectiveness of the drug product.

Type of Proposed Change

When submitting a protocol for a rapid microbiological methodology, the following types of information should be included in describing the proposed change:
The actual methods/equipment being changed
Whether the method is a compendial method, and if so, which method is being modified
The technology being used in the rapid method, including an overview of how the technology works
Additional information
For example, if a new, automated sterility test method will be implemented, this section might state something like the following:
The current sterility test methodology performed per USP <71> will be replaced by an alternative rapid microbiological methodology. The methodology selected is name of methodology/system. This technology is described in Appendix 1 of this document.

The method will be used for both in-process bioburden testing and final product sterility testing.

Tests and Studies to be Performed

The following is an example of the type of tests and studies that might be performed with an automated sterility test methodology:
Feasibility Analysis
Installation Qualification of the System Hardware and Software
Operational Qualification of the System Hardware and Software
Generalized Method Development, e.g., use of a standard solution, different product types, bacterial detection, fungal detection, use of mammalian cells, stressed cell evaluation. This reflects the method to be used in the Performance Validation
Performance Qualification of the Integrated System, utilizing all affected componentry
Method Development for Each Test Product or Product Family
Method Validation for Each Test Product or Product Family
Within each of these sections, details would be provided on the test methods to be used, e.g., outline the various tests to be conducted for each type of protocol. For some of these steps, e.g., generalized method development or product method development, one might want to say that as an R&D function they are or are not required to have pre- d efined acceptance criteria. It may be necessary during these steps to refine the procedures during the development process, e.g., change incubation time periods, incubation temperatures, use of different reagents and so forth.
When multiple pieces of equipment are part of a system, it would be appropriate to identify whether each piece will have different protocols or tests or whether it is included in a single protocol.

Analytical Procedures to be Utilized

This section of the protocol should describe all of the methodologies to be used, e.g., in the case of showing equivalence to a sterility test methodology, one might be using the USP <71> test methodology, the new test methodology, plate count methods, and so forth.
Where new methods are used, it may be useful to provide a basis for the method and a description of how the methodology operates.

Acceptance Criteria

This is probably the most difficult part of the protocol to prepare. In many ways, the consequence of doing a poor job in this part of the protocol preparation may have dire consequences on the ability to use the comparability protocol, as written. The good news is that FDA does allow a company to revise the comparability protocol when there are issues with the acceptance criteria; however, it requires a subsequent supplement to be submitted. One of the companies that used this approach, and needed to generate a second supplement, indicated that approval of their rapid method was a four-year process (including method feasibility and development studies).

Several sources of guidance are available when setting the criteria, e.g., published literature articles, USP <1223> and <1227>, PDA Technical Report No. 33, and so forth.

One way that the acceptance criteria can be stated is in terms of each type of test/study to be performed, e.g., IQ, OQ, PQ, Method Validation, and so forth.

It is useful to have a strong justification for the criteria being established. This may be based upon regulatory requirements, published literature, or your own development data.

A subsequent issue of the newsletter will address some of the unique concerns to rapid microbiological methods that one may wish to address in their comparability protocol.

This article was written by Jeanne Moldenhauer, Vectech Pharmaceutical Consultants, Inc. and first appeared in November-December 2004 RMUG¢â Newsletter

References
(i) FDA, Federal Register, 69FR 18727, April 8, 2004.

(ii) FDA, Guidance for Industry, Comparability Protocols - Chemistry, Manufacturing, and Controls Information (draft issued Feb. 2003) (Applies to chemical entities and synthetic peptides), Government Printing Office.

(iii) FDA, Guidance for Industry, Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information ( draft issued Sept. 2003), Government Printing Office.

VIDAS¢ç Staph Enterotoxin (SET2) Gets AOAC Approval
bioMerieux have announced the AOAC Research Institute method approval for the VIDAS second generation Staphylococcal Enterotoxin assay, SET2. The certificate number is 070404.

The VIDAS Staphylococcal Enterotoxin II (SET2) assay detects staphylococcal enterotoxins A, B, C (C1, C2, C3), D and E in a variety of foods.

The VIDAS SET2 was validated and certified as a Performance Tested Method by the AOAC Research Institute as an effective method for the detection of staphylococcal enterotoxins in a variety of foods, including frozen lasagne, chocolate eclair, canned mushrooms (post-retort), powered eggs, roast beef, cooked chicken, ham, Italian salami, smoked salmon, potato salad, unpasteurized milk, cheddar cheese, yogurt, ice cream and nonfat dry milk (non-instant).

Overall, the data demonstrates that the VIDAS SET2 test is rugged and is highly sensitive, specific and reproducible for the detection of staphylococcal enterotoxins in a variety of foods, with a 100% detection at the lowest concentrations tested, 0.25 ng toxin/g of food.