Contact us/ Search FoodHACCP.com/ Consulting room/
Internet Journal of Food Safety/ On-Line Courese/ Discussion Room

7/23, 2003
ISSUE:74

Sponsors








IGEN






Sponsorship
Q/A


 

 

New Sponsor
Bio-Rad


Click Logo to Visit Bio-Rad

Guidance for Industry
Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors

Food Security Preventive Measures Guidance
FINAL GUIDANCE
Comments regarding this document may be submitted at any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

For questions regarding this document, contact John Kvenberg, Office of Compliance, HFS-600, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2359, e-mail: jkvenberg@cfsan.fda.gov or Donald W. Kraemer, Office of Seafood (HFS-400), Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2300, e-mail: dkraemer@cfsan.fda.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 2003
-------------------------------------------------------------
Guidance for Industry
Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors
Food Security Preventive Measures Guidance

This guidance represents FDA's current thinking on the kinds of measures that operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations, and fluid milk processing facilities may take to minimize the risk that fluid milk under their control will be subject to tampering or other malicious, criminal, or terrorist actions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

Purpose, Scope and Limitations:

This guidance is designed as an aid to operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities. It identifies the kinds of preventive measures operators of these establishments may take to minimize the risk that fluid milk under their control will be subject to tampering or other malicious, criminal, or terrorist actions. Operators of these establishments are encouraged to review their current procedures and controls in light of the potential for tampering or other malicious, criminal, or terrorist actions and make appropriate improvements.

FDA¡¯s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead guidances describe the Agency¡¯s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Not all of the guidance contained in this document may be appropriate or practical for every dairy farm, bulk milk transportation operation, bulk milk transfer station, or fluid milk processing facility. FDA recommends that operators of these establishments review the guidance in each section that relates to a component of their operation, and assess which preventive measures are suitable. FDA further recommends that operators consider the goal of the preventive measure, assess whether the goal is relevant to their operation, and, if it is, design an approach that is both efficient and effective to accomplish the goal under their conditions of operation.

Additional food security guidance that may also be applicable to operators of these establishments is contained in an FDA guidance document entitled, "Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance." This document is available at: http://www.cfsan.fda.gov/~dms/secguid6.html.

Management

FDA recommends that operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities consider:

Conducting an initial assessment of the adequacy of food security procedures and operations, which we recommend be kept confidential.

Developing a security management strategy to prepare for and respond to tampering and other malicious, criminal or terrorist actions, both threats and actual events, including identifying, segregating and securing affected product.

Developing a product recall strategy

Providing training in food security awareness to encourage all staff to be alert to any signs of tampering or other malicious, criminal or terrorist actions or areas that may be vulnerable to such actions, and report any findings to management. The training may also encourage staff to be alert to the presence of unidentified or unknown individuals or individuals that are in areas to which they are not designated access, and to directly question such individuals or report them to management

Providing appropriate supervision to all staff with access to raw and pasteurized milk storage, vitamin supplement receiving and storage, and milk processing and packaging areas of the facility, including cleaning, maintenance and quality control staff, seasonal, temporary, contract, and volunteer staff, and especially, new staff. The supervision may include watching for unusual or suspicious behavior by staff (e.g., staff who, without an identifiable purpose, stay unusually late after the end of their shift, arrive unusually early, access files/information/areas of the facility outside of the areas of their responsibility; remove documents from the facility; ask questions on sensitive subjects; bring cameras to work)

Conducting routine security checks of the raw and pasteurized milk storage, vitamin supplement receiving and storage, and milk processing and packaging areas of the facility, for signs of tampering or malicious, criminal or terrorist actions or areas that may be vulnerable to such actions.

Alerting appropriate law enforcement and public health authorities about any threats of or suspected tampering or other malicious, criminal or terrorist actions. FDA may be contacted through its 24-hour emergency number, 301-443-1240, or through a local FDA District Office. FDA District Office telephone numbers are listed at: http://www.fda.gov/ora/inspect_ref/iom/iomoradir.html.

Reviewing, at least annually, the effectiveness of the food security plan, using knowledgeable in-house or third party staff, and revising the program accordingly, which we recommend be kept confidential.

Human element

FDA recommends that operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities consider:

Obtaining and verifying work references, addresses and phone numbers of all staff with access to raw and pasteurized milk storage, vitamin supplement receiving and storage, and milk processing and packaging areas of the facility, including cleaning, maintenance and quality control staff, seasonal, temporary, contract, and volunteer staff.

Having a criminal background check performed by local law enforcement or by a contract service provider for the above listed staff, except if such staff are under direct supervision when they access the above listed areas.

Limiting access to raw and pasteurized milk storage, vitamin supplement receiving and storage, and milk processing and packaging areas of the facility to those staff that need to enter because of their job functions and only during appropriate work hours.

Preventing staff from bringing personal items (e.g., lunch containers, purses) into raw and pasteurized milk storage, vitamin supplement receiving and storage, and milk processing and packaging areas of the facility.

Being alert for atypical staff health conditions that staff may voluntarily report and absences that could be an early indicator of tampering or other malicious, criminal or terrorist actions (e.g., an unusual number of staff who work in the same part of the facility reporting similar symptoms within a short time frame), and reporting such conditions to local health authorities

Accompanying all visitors.

Facility

FDA recommends that operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities consider:

Securing doors (including freight loading doors, when not in use and not being monitored, and emergency exits), windows, roof openings/hatches, vent openings, ventilation systems, utility rooms, loft areas, trailer bodies, tanker trucks, and bulk storage tanks, to the extent possible.

Inspecting bulk unloading equipment and pumps in the receiving area before use.

Monitoring the security of the premises.

FDA further recommends that operators of dairy farms consider:

Locking or sealing, with serially numbered seals, all entrances to the milk house or all entry ports on the bulk milk tank from the time the bulk milk tank is washed until the time it is emptied, except when it is under direct, visual supervision (Remember to first make arrangements with the State regulatory agency that will ensure that the regulatory agency, rating agency and FDA continue to have ready access to the milk house and milking operation for routine inspections, Grade "A" IMS ratings and FDA check ratings, when applicable).
Operations

Vitamin supplements and laboratory supplies

FDA recommends that operators of fluid milk processing facilities consider:

Using only known, appropriately licensed or permitted (where applicable) sources for vitamin supplements.

Establishing delivery schedules for vitamin supplements, not accepting unexplained, unscheduled deliveries or drivers, and investigating delayed or missed shipments.

Supervising off-loading of incoming vitamin supplements, laboratory reagents and positive controls, including off-hour deliveries.

Reconciling the product and amount received with the product and amount ordered and the product and amount listed on the invoice and shipping documents.

Investigating shipping documents with suspicious alterations.

Inspecting incoming vitamin supplements for signs of tampering, contamination or damage (e.g., abnormal powders, liquids, stains, or odors, evidence of resealing) or ¡°counterfeiting¡± (e.g., inappropriate or mismatched product identity, labeling, product lot coding or specifications).

Storing vitamin supplements, laboratory reagents, and positive controls in a secure location.

Keep track of vitamin supplements, laboratory reagents and positive controls and investigating any missing or extra stock outside a predetermined normal range of variability.

Labeling

FDA recommends that operators of fluid milk processing facilities consider:

Storing product labels in a secure location and destroying outdated or discarded labels
Raw milk

FDA recommends that operators of bulk milk transfer stations and fluid milk processing facilities consider:

Accepting only those incoming tanker loads of raw milk for which all openings were either locked or sealed, with a serially numbered seal, from the time the tanker was last washed until the load is delivered. Exception may be provided for incoming loads for which a thorough investigation demonstrates that there is a verified, reasonable explanation for a deviation. Seals or locks need not be in place during those times that the tanker was under the direct, visual supervision of the driver.

Using only known, reputable transportation companies

Establishing delivery schedules for raw milk, not accepting unexplained, unscheduled deliveries or drivers, and investigating delayed or missed shipments. We recommend that driver identification include the name of the transportation company.

Supervising off-loading of incoming milk.

Reconciling the amount received with the amount listed on the shipping documents.

Verifying that operators of bulk milk transfer stations that supply raw milk adhere to the preventive measures listed in this guidance.

FDA recommends that operators of bulk milk transportation operations consider:

Locking or sealing, with a serially numbered seals, every tanker from the time it is last washed until the time the load of milk is delivered to the bulk milk transfer station or fluid milk processing facility. Seals or locks need not be in place during those times that the tanker is under the direct, visual supervision of the driver.

Article from
Food Safety Magazine


Guest Editorial: Why Consumers Take Risks with Food Safety
By Robert A. LaBudde, Ph.D.


Ask the Regulators: Prioritizing Food Safety Risk Assessments: A New Approach
By S.B. Dennis, Ph.D. and the CFSAN Risk Analysis Working Group Series Editor: Catherine "Kitty" Bailey, M.Ed.

The Sanitarian's File: Glossary Useful in Defining Industry Terms
By Robert W. Powitz, Ph.D., MPH, RS, CFSP

Inside Microbiology: Seek & Destroy: Identifying and Controlling Listeria monocytogenes Growth Niches
By John Butts, Ph.D.

CHEMICAL COMPOUND Acrylamide: Out of the Frying Pan and into the Fire (of Analytical Chaos)
By Gerald DeMenna, Ph.D., and Dhia Habboush, Ph.D.


Antimicrobial Products Needed to Combat E. Coli Contamination; Nymox Pharmaceutical Corporation Has Novel Proprietary Product to Treat E. Coli O157 Contamination of Meat

Business Editors/Health/Medical Writers
Source: http://www.businesswire.com/
MAYWOOD, N.J.--(BUSINESS WIRE)--July 17, 2003--A recent U.S. government report on strategies for enhancing food safety has outlined the ongoing problems posed by E. coli O157 contamination of meat products and some of the initiatives taken or proposed to deal with these problems. The July 10 report, Enhancing Public Health: Strategies for the Future, from the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA), comes on the heels of news of a massive recall of 739,00 pounds of frozen steak suspected to be contaminated with potentially fatal E. coli O157 bacteria.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) recently announced plans to extend its field trials of NXC-4720, a novel antibacterial product under development for the treatment of E. coli O157:H7 meat contamination. Its NXC-4720 product has continued to make its milestones in product development. Recent studies have shown that treatment with NXC-4720 cleared infected beef of E. coli O157 contamination and helped prevent further E. coli contamination.
In its report, the FSIS outlined new initiatives to encourage the use of new technology such as antimicrobial agents, including new rules to provide food processors with much more flexibility in using antimicrobial agents in their products.
The FSIS report recognized that, despite overall improvements in food safety, the incidence of foodborne illnesses caused by E. coli O157 contamination had not shown a sustained decline (CDC: MMWR 2003; 52: 340-343). As well, recent data indicated that the prevalence of E. coli O157 in cattle was higher than previously believed. In response, the FSIS has targeted specific measures to deal with E. coli O157 contamination and implemented more stringent testing.
"Our NXC-4720 product promises a cost-effective solution to the difficult problem of E. coli O157:H7 contamination of our meat supply," said Dr. Michael Munzar, Medical Director of Nymox. "It is very encouraging to see that the FSIS is looking to antimicrobial agents as an additional safeguard. We do not anticipate that our product will in any way affect the taste of the treated meat."
In 2002 alone, over 23 million pounds of meat was recalled in the U.S. because of possible E. coli contamination, affecting all sectors of the meat industry from large meat processors to local supermarkets and many consumers. On average, Americans consume over 65 pounds of beef per person per year.
E. coli O157 bacterial contamination is a major public health problem throughout the world. The Centers for Disease Control and Prevention estimates that in the United States alone, 73,000 human cases occur every year as a result of E. coli O157 contamination of food and drink products and of water supplies. This type of E. coli infection can cause severe bloody diarrhea and abdominal cramps and can lead to kidney failure, particularly in young children and in the elderly, with often serious long term and sometimes fatal results. One USDA study estimated the direct and indirect costs of foodborne E. coli O157 infections at over $650 million per year.
More information about Nymox is available at www.nymox.com, email: info@nymox.com, or 800-936-9669.

This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
--30--AC/ny*
CONTACT: Nymox Pharmaceutical Corporation
Dr. Michael Munzar, 1-800-93NYMOX
www.nymox.com or
Sitrick & Company
Lew Phelps, 310-788-2850, ext. 4103

MINIATURE BIOLAB EMBEDDED ON SILICON CHIP
July 9, 2003
American Society for Microbiology
NEW YORK ?- Researchers from Cornell University have developed a
miniaturized DNA-based biological testing system that fits on a silicon chip and can be customized to detect a wide variety of microorganisms. They present their research today at the American Society for Microbiology's (ASM) Conference on Bio- Micro- Nano-systems. The chip consists of two areas. The first area captures the DNA from the sample and purifies it. The second is a reaction chamber where a process called polymerase chain reaction is performed to rapidly replicate the selected segment of DNA, which can then be tested. "Other people have developed real-time PCR on silicon chips, but nobody has really done the purification of the DNA sample on the same chip," says
Nathan Cady, one of the researchers on the study. "As near as we can tell, we are one of the first groups to incorporate the purification step into the chip."
Cady and his colleagues are currently working on incorporating a 3rd step to the process that uses fluorescence technology where an added dye would glow
green to, indicate a positive sample. The chip itself is 2 cm x 4 cm in size. Because PCR requires a precise
series of specific temperatures at specific times, it fits into a tiny device (5 cm x 5 cm x 3 cm) that handles the cycling of the temperature. Once they have finally incorporated the fluorescence, Cady expects they will
have a device roughly the size of a shoebox that will be capable of real-time automated detection of biological agents. "Part of the reason we put these functions on a chip is that it simplifies the process," says Cady. "You can hand this to someone in the field, someone
who is not a trained lab technician, and they can do it."
Another advantage of this system is that it has a very broad range in what organisms it can be used to detect. That makes it very useful for a variety of purposes from monitoring food and water supplies to detecting agents of biological warfare. "We can detect pretty much any organism as long as we have the PCR primers
for it," says Cady.

Sanitation Control Procedures for Processing Fish and Fishery Products (from PSU)

Duck Delivery Produce Recalls Cut Honeydew and Cut Cantaloupe Melon for Possible Health Risk
Contact:
Ron Carlston
503-288-9380

FOR IMMEDIATE RELEASE --Portland, OR -- July 16, 2003 -Duck Delivery Produce, Inc. of Portland, Oregon is voluntarily recalling cut honeydew and cut cantaloupe melons because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

The cut honeydew and cut cantaloupe melons are sold as single fruit items or in various combinations with other fruits and packaged in plastic trays, plastic cups or plastic bags and sold in retail stores in Washington, Oregon and Idaho. Products contain a ¡°sell by¡± date on or before 07-21-03. Some of the fruit has the brand ¡°Mary¡¯s Select¡± and other product does not have a brand name. All product is labeled distributed by Duck Delivery Produce.

No illnesses have been reported to date.

The Washington State Department of Agriculture conducted routine sampling of the product held for retail sale. Analysis found samples to be contaminated with Listeria monocytogenes.

Consumers who have purchased the product with ¡°sell by¡± date on or before 07-21-03, should return it to the store where purchased for a refund or exchange. For additional information, call John Rich at Duck Delivery Produce from 8 a.m. to 5 p.m. Monday through Friday at 1-800-452-2481.

HEPATITIS A DISCOVERED AT POPULAR RESTAURANT
July 22, 2003
Fort Murray Today/ Grande Prairie Daily Herald-Tribune
Health officials are, according to this story, sounding a warning after a
part-time employee of the Golden Star restaurant in Grande Prairie tested
positive for hepatitis A.
Val Beynon, community health manager, was quoted as saying during a press
conference Monday afternoon that, "I would certainly have no concerns about
eating or drinking here today.©÷
Anyone who ate at the Golden Star between July 11-14 is potentially at risk
of having contracted hepatitis A, an infection of the liver that can lead to
fever, weakness, abdominal discomfort and yellowing of the skin and eyes.
Anyone who ate at the restaurant on those dates is being urged to attend
another free, walk-in clinic at the public health unit today for an
injection to protect against infection.
Over the two days the clinic has been open, about 550 people have received
shots.
Ken Wong, general manager at the Golden Star, was cited as saying all of his
staff were screened for the disease, and health inspectors went over the
restaurant with "a fine-tooth comb" Saturday and pronounced it a clean
operation, adding, "If we were bad, we would be closed today.©÷