Tag Archives: Clean Rooms

By George Miller

Military software has been retrained for deployment in protecting the United States’ food supply against terrorist attack, helping those in the food business how to think like terrorists might. According to Jon Woody, policy analyst with the U.S. Food and Drug Administration’s (FDA’s) Office of Food Defense, Communication, and Response, a software program with the unwieldy moniker of CARVER + Shock provides the food industry with an offensive targeting-prioritization tool. Woody described the program in a presentation hosted by Ross Enterprise of CDC Software in Atlanta that was webcast on March 12, exactly 19 years after the Chilean grape scare of 1989.

On that day, the U.S. embassy in Santiago received two phone calls warning that fruit shipped to the U.S. and elsewhere had been poisoned. Cyanide was identified in two grapes seized at the port of Philadelphia after lab testing, but investigators found no cyanide in proximate grapes tested at another lab. FDA officials temporarily banned all fruit shipments from Chile and urged that such fruit be removed from grocers’ shelves.

Some 2 million crates of grapes were impounded by the FDA. Without the income from those grapes, and from fruit shipped elsewhere in the world that was banned by other governments, tens of thousands of Chileans lost their jobs.

Later, some believed the cyanide-positive findings were the result of a botched test, leading to an overreaction by the FDA. Others believed the entire incident was a hoax, while still others saw it as a miraculously avoided tragedy.

Acceptable level of risk

A raft of editorial and op-ed pieces came down to a basic question: What is a tolerable level of risk in our food supply? Zero risk is unachievable, experts say, and promoting zero risk creates a false sense of assurance and reduces overall food protection.

By conducting a CARVER + Shock assessment, says Woody, the user can determine facility vulnerabilities and then focus resources on protecting those areas. The software helps the user think like an attacker in order to identify the most attractive targets for an attack.

The acronym “CARVER” stands for the six attributes used to evaluate targets for attack: criticality, accessibility, recuperability, vulnerability, effect, and recognizability. “Shock” refers to the psychological impact of an attack, which increases with the number of deaths involved or the historical significance of the target.

Food, from all its varied sources, is big business, representing $1.24 trillion per year–13 percent of the nation’s gross domestic product, according to Woody and government sources. Some 2.2 million U.S. farms feed more than 57,000 food processors, 6,500 of which process meat, poultry, and egg products. These products represent not just what we eat, but also $60 billion of U.S exports.

The U.S. Centers for Disease Control and Prevention reports more than 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths annually from unintentional food-borne disease contamination alone.

Collaborative effort

CARVER + Shock, announced in mid-2007, was developed by the FDA Center for Food Safety and Applied Nutrition in collaboration with Sandia National Laboratories, the Institute of Food Technologists, U.S. Department of Agriculture Food Safety and Inspection Service, National Center for Food Protection and Defense, and state and industry representatives.


Sandia National Labs researcher Susan Carson tests CARVER + Shock, a computerized program that helps protect America’s food supply against terrorist attacks. Sandia worked with the FDA to prepare the program for distribution throughout the food industry. Photo by Randy Montoya/courtesy of Sandia National Labs.
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CARVER + Shock is the latest in a series of food defense efforts by FDA following the terrorist attacks of September 2001. Since then, FDA has worked with federal, state, and local governments, and with the food industry to assess and improve food defense measures.

One such effort, the Strategic Partnership Program Agroterrorism Initiative, helps identify sector-specific vulnerabilities, determine research gaps, and increase coordination between the federal government and industry stakeholders.

In 2006, FDA launched the ALERT Initiative to raise industry awareness of food defense and preparedness issues. The ALERT acronym reminds industries and businesses of the five key program elements: assure, look, employees, reports, and threat. The elements collectively help food handlers decrease the risk of intentional contamination at their facilities. CARVER + Shock builds on ALERT.

By Hank Hogan

In one sense, the recent purchase by Entegris (Chaska, MN) of a stake in privately held Integrated Materials, Inc. (Sunnyvale, CA) is just the latest example of a tradition among semiconductor cleanroom equipment manufacturers: When there’s a downturn, merger and acquisition activity often picks up. Such activity is one way for companies to find somebody–or some technology–that can help them weather the economic storm.

For Entegris, the deal offers technology that extends the company’s product line into the processing chamber. Integrated Materials builds high-quality, high-temperature operation wafer processing boats out of polysilicon instead of the more traditional quartz or silicon carbide. That difference pays off, says Entegris vice president of corporate relations Steve Cantor. “The breakthrough advantage to the end customer is substantially higher yield and lower contamination.”


The addition of IMI’s unique, consumable solution, which uses a polysilicon material to significantly reduce particle contamination and improve yields, is expected to considerably extend Entegris’s wafer handling business and material science expertise. Photo courtesy of Entegris.
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This improvement happens, he explains, because the boat is made of the same material as the wafer. While the actual yield bump is proprietary, one measure of the benefit is the mean time between preventative maintenance in a processing chamber. There, the savings can be close to 50 hours a month, says Cantor.

As for the deal itself, he notes that the initial phase is an investment by the larger company in the smaller one. The first phase will be followed by a second if certain closing conditions are met by the private firm. “The intention of Entegris is to buy the remaining equity within a relatively short period of time,” explains Cantor.

This deal isn’t the only recent merger and acquisition activity related to semiconductor cleanrooms. Within the last few months, Lam combined forces with SEZ in a seemingly friendly deal (See “Lam Hopes to Clean Up with SEZ,” CleanRooms, February 2008, p. 8). More combative was an unsolicited bid by Sumitomo Heavy Industries (Tokyo) with regard to Axcelis Technologies (Beverley, MA) and a similar offer from Aquest Systems (Sunnyvale, CA) and others for Asyst Technologies (Fremont, CA).

Although these deals involve companies of different sizes pursuing various strategies and technologies, they all revolve around the same economic realities, says Gartner research vice president Dean Freeman. “Smaller firms are struggling with trying to make margins, trying to be profitable. You really need a critical mass of a certain extent.” He estimates that a semiconductor cleanroom tool company needs to be in the $200 million annual revenue range.

In looking around for a solution to the problem of size, firms can come up with a friendly and mutual merger or attempt one that’s decidedly less congenial, but the drive to find some synergism and make a situation more profitable is always there and can be especially strong during a downturn.

The current tight credit environment, however, may limit the amount of such activity during this business cycle because funds may not be as readily available. Another brake on current mergers and acquisitions, notes Freeman, is that photovoltaics, light-emitting diodes, and other high-tech areas may be more attractive investment opportunities than semiconductor manufacturing equipment.

The issue isn’t the tools but rather the market they serve. “The biggest problem in the semiconductor space right now is growth overall is only going to be on a 5 to 8 percent CAGR,” says Dean.

FDA has received approval from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government. This is an important step forward in FDA’s plans to hire and place FDA staff in China over the next 18 months, the agency says. In addition, FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

So I got a press announcement from FDA this week announcing it was embarking on a “major hiring initiative” to fill more than 1,300 positions within the next several months as part of a multi-year hiring effort. The new employees will be medical officers, consumer safety officers, health care and regulatory scientists, and other such professionals involved in protecting the public from unsafe food and drug products. And I said, “Great! FDA is finally stepping up to its charter and working to provide the manpower demanded for a truly effective safety monitoring and inspection program.”

I read on. It turns out that many of these positions will be located in the Washington metropolitan area, specifically Rockville, Silver Spring, and College Park, MD. That’s logical since that’s where FDA is largely based. And there will also be new hirings across the country in FDA’s five regions, 20 districts, more than 179 resident posts, and the newly created FDA offices overseas.

And I stopped. What was that? “

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Tissue banks and researchers rely on frequent testing and strict cleanroom controls to keep human cell- and tissue-based products alive and free from contamination.

By Sarah Fister Gale

Every year, more than 1.5 million units of allograft tissues harvested from deceased donors are distributed annually for transplant in the U.S. While the risk of bacterial infection from an allograft tissue transplant is extremely low, in an industry where the lives of human patients are at stake, any contamination risk is a serious concern. Fortunately, the industry has established strict protocols for the screening and handling of tissue in the manufacturing environment to effectively manage that risk.

“The current risk of an allograft infection to the average patient appears to be much less than the risk of infections surrounding the operation itself,” notes Joel Osborne, vice president of quality assurance for the Musculoskeletal Transplant Foundation (MTF), an American Association of Tissue Banks (AATB) accredited tissue bank in Edison, NJ. Still, the allograft industry and the FDA are making constant strides to more strictly control contamination in the handling and processing of human tissue-based products.

Patients receiving allograft tissues put their lives in the hands of the companies supplying those products, relying on them to enforce strict tissue reviews, cleaning and disinfecting processes, and monitoring strategies to ensure donor tissue is healthy and free from infection, and that it does not encounter contaminants during processing.

Human tissues intended for transplantation have been regulated by the U.S. Food and Drug Administration (FDA) since 1993 under 21 CFR 1271. All human cells, tissues and cellular, and tissue-based products (HCT/Ps) used for transplant fall into this category, including bone, ligament, skin, and other soft tissues. These requirements were designed to prevent the introduction, transmission, and spread of communicable diseases via HCT/Ps by ensuring that the HCT/Ps do not contain communicable disease agents, are not contaminated, and do not become contaminated during manufacturing.

As part of the ongoing effort to enforce rigorous safety methods, in May 2005, FDA put three new, comprehensive regulations into effect that address manufacturing activities associated with HCT/Ps. The first requires companies that produce and distribute HCT/Ps to register with FDA. The second provides criteria that must be met for donors to be eligible to donate tissues (the “Donor Eligibility” rule). The third rule defines current Good Tissue Practices (cGTPs), which govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program.

Many tissue banks also receive accreditation from the AATB, a voluntary accreditation organization that sets standards for tissue banking.

Every step of the way

“HCT/Ps are unlike pharmaceutical products because they are composed of living functional cells,” notes Dr. Scott Burger, principal of Advanced Cell and Gene Therapy, a consulting firm in Chapel Hill, NC. “They can respond to the microenvironment of the patient, taking advantage of their intrinsic biological functions and capabilities, but they are very complex and challenging materials to handle.”

The success of a tissue-based product relies on its ability to stay alive and functional, which dramatically limits sterilization options and requires strictly controlled transportation and handling conditions to maintain that viability. Those limits in larger part define the processing environment.

“A tissue manufacturing facility cannot be a sterile operation because you are working with biomass,” notes Mark Hallworth, pharmaceutical business manager for Particle Measuring Systems in Boulder, CO. “Human tissue is a living organism that can’t be sterilized, so you’ve got to be able to prove you are in control of your processes at all times.”


Figure 1. A CryoLife technician dissects a human heart, retrieving valve and vascular tissue for preservation and eventual implantation. Photo courtesy of CryoLife.
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Proving that drives a lot of the environmental controls used by the HCT/P industry, and it begins with evaluating the donor tissue before it ever comes through the door.

The Donor Eligibility rule requires comprehensive screening of the donor’s medical and social histories, and testing of the donor for risk factors and/or clinical evidence of infection due to communicable disease agents and diseases, such as HIV, Hepatitis, or Strep A. The rule also includes requirements for recordkeeping, quarantine, storage, and labeling of the HCT/Ps.

If a donor meets the eligibility requirements, the tissue is removed in a hospital setting using aseptic surgical techniques. At the time of recovery, cultures of the tissue are taken to look for the presence of bacteria, mold, and fungi, with those test results later determining whether the tissue can and will be processed, says MTF’s Osborne. While every processing facility is different, at MTF the donor tissue is frozen at

Pre-planning and coordinated response to disaster helps garment manufacturer speed return to productivity

The experience of White Knight Engineered Products (WKEP) in dealing with disaster is a textbook example of how proper upfront planning and an immediate and well-coordinated response can make the difference between an insurmountable situation and an orderly and rapid recovery. Just three weeks after a devastating fire destroyed the cleanroom garment company’s Childersburg, AL, manufacturing and distribution center, WKEP was back in production at a temporary facility. And, just a little more than 7 months later, the company’s employees were able to move back into their fully rebuilt, refurbished, and dramatically improved plant.

It was the afternoon of June 4, 2007, when an electrical short circuit spawned the fire between the roof of the building and the ceiling panels over the manufacturing floor. Jane Collier, WKEP Childersburg manufacturing manager, recalls, “Safety was our first concern, and thank goodness no one was injured. We had just practiced an evacuation drill the previous month, and it paid off, because it was a close call.”

Meanwhile, WKEP president Scott Banks was meeting with his management team at the company’s Charlotte, NC, offices when the call came in. “We received a call from Alabama saying that there had been a fire, but the scope and extent of the damage wasn’t immediately clear to our people on site.” By 5:00 p.m. that same day, however, Banks and his team were on site in Childersburg, and whatever early uncertainty existed quickly disappeared as it became clear that a major disaster had occurred, with most of the damage caused not by the fire itself but by the associated smoke and water. “In addition to the extensive heat damage to the building, we lost every bit of our inventory, both raw materials and finished product,” says Banks.

Not surprisingly, one of the first calls made on the day was to the company’s insurance carrier, Factory Mutual/FM Global Insurance (Johnston, RI). Banks was pleased with their responsiveness. “This is why you have insurance and the importance of a good carrier,” says Banks. “FM is used to dealing with big issues, and certainly, in our eyes, this was the biggest issue. Their number one concern was the same as ours: Get us back up and running as quickly as possible.”


Figure 1. Smoke and water damage after the fire at WKEP’s Childersburg facility prompted the company to redesign the entire building, not only considering further fire safety measures but other improvements for lean manufacturing. Photo courtesy of White Knight Engineered Products.
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The first thing FM recommended was to immediately get a disaster-recovery company on scene to prevent and/or minimize any additional damage. Servpro Industries (Gallatin, TN) filled that bill, with a team immediately beginning the initial clean-up process–for example, getting the water out of the facility to prevent further damage. After that, the priority turned to getting the machinery out, cleaning it, and putting it into temporary storage trailers until a temporary facility could be located. A second company, Disaster Services, Inc. (Atlanta, GA), was also brought in to assist with the process.

Overall, Banks says that FM Global connected WKEP management with the people and expertise they needed to put together a roadmap to recovery and rebuilding. “They always proposed two to three options and were instrumental in helping us find the best solution.” For example, Banks points to the redesign of WKEP’s sprinkler system, which now includes sprinkler heads both between the roof and ceiling panels as well as below the ceiling. “As the previous fire started above the drop ceiling, we wanted to ensure that this type of disaster cannot occur again,” says Banks.

FM Global also connected the company with Gilbane Building Co. (Providence, RI) for initial advice on the rebuilding plan. But again, Banks points out that FM Global allowed them to decide themselves how to best meet their needs, and they eventually brought in their own primary contractor–BE&K of Birmingham, AL. Says Banks, “Yes, we relied on and benefited from Gilbane’s expertise, but at the same time, we also needed to stand on our own two feet, which is why we got BE&K involved. We focused on what we wanted the plant to do and turned to them for the best way to get there.”


Figure 2. WKEP’s managers and employees participated in the redesign with feedback on features from the lighting and layout on the manufacturing floor to areas such as the cafeteria. Photos courtesy of White Knight Engineered Products.
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The end result was a complete renovation of the facility from floor to roof. As explained by Banks, the only thing that remains of the original building is its aluminum shell, some cinderblock walls, and the concrete floor. “We pulled out everything–all wood, insulation, every pipe and wire. We didn’t want to take any chance that there would be any residue of the fire. No odor or any kind of potential contaminant.”

As WKEP general manager Greg Winn notes, it was also at this stage that the company began to take advantage of this opportunity to rethink the entire layout of the building and optimize it for current environmental concerns, manufacturing requirements, and operating costs. “We had a clean slate and almost too many options, but ultimately, we were able to rebuild to better meet our customers’ demands as well as the realities of the global economy.”

One major accomplishment was the complete separation of the manufacturing floor from the distribution areas. In fact, this move was part of an overall focus on implementing modern lean manufacturing principles. Says Winn, “We took a hard look at our raw material and workflows, emphasizing our need for a highly flexible yet tightly controlled production environment.” WKEP’s Childersburg plant focuses on the manufacture of quick turnaround, short production runs of specialty, highly custom cleanroom and protective garments. These include special design, flame retardant, and ESD protective garments as well as more esoteric products such as wheelchair and equipment covers.

Winn says the focus on lean manufacturing principles led the team to many basic improvements in the plant’s layout that seem simple, like placing their laser cutter in close proximity to their plotter and having their QC department open directly onto the manufacturing floor. “The result is that we’ve reduced a lot of walking around, improved the efficiency of people, and provided a better working environment overall.”

In truth, however, WKEP was already well along in embracing lean manufacturing principles even before the fire. The company had applied for and received a grant from the State of Alabama for training on lean manufacturing concepts, and everyone in the building was taken through the 8 to 10 week training program. As noted by Collier, “This training provided us with a good streamlined framework from which to advance.” Wireless routers were connected through a new high-tech network, allowing warehouse data transfer throughout the facility for easy location of product and raw materials. Traditional phones were replaced with voice over IP (VoIP) technology, allowing for easy connections between WKEP’s other facilities.

A number of new physical improvements were also made to the facility. For example, a new sealant and floor finish was put over the raw concrete floor to help control particulate and other potential contaminants. And more efficient, brighter, and cost-effective lighting was installed throughout the manufacturing area. Winn notes that in addition to improving the working environment of personnel, this change also dramatically aids their overall quality control and inspection process.

Another extremely important factor in WKEP’s successful and rapid recovery operation can be traced directly to its early business history in the manufacture of medical devices. Now, although the company no longer manufactures these products and is therefore no longer audited by the FDA, it nevertheless still works to adhere to FDA GMP guidelines. As noted by Banks, adherence to the FDA’s GMP requirements offers many practical benefits to the cleanroom industry and contributed significantly to their being back on line quickly. “We maintain data to trace a garment back to its date and location of manufacture. Equally important, we back up and store quality, manufacturing, and specification data off site in the event of a situation like this, and it’s this infrastructure that allowed us to get back into production quickly.”

Finally, as observed by Banks, the only way they could approach a project and challenge of this scope with any hope of success was to subdivide tasks and responsibilities and to count on the dedication of their employees. Most of WKEP’s employees and managers have been with them for many of the 40 years that its Controlled Environments division has been supplying protective apparel for cleanrooms in the pharmaceutical, microelectronics, and automotive industries. “All of our people stepped up to participate in their own areas of responsibility, whether it was the warehouse, manufacturing, IT, and even how to best decorate our offices and cafeteria for our employees. Our vendors also met our needs as quickly as possible and our customers stuck with us through this crisis. In an economy where the trend is to close domestic textile plants, we’re proud that we were able to rebuild and re-establish this facility.”

April 29, 2008 — /PRNewswire/ — ST. LOUIS, MO — SAFC Hitech(TM), a focus area within SAFC(R), a member of the Sigma-Aldrich Group, today underlined its commitment to the electronic materials markets with the opening of a $9 million state-of-the-art cleanroom located on the company’s Sheboygan Falls, WI campus. The 5,000-sq.-ft. facility consists of an ISO 4 cleanroom, a distillation suite, and office space.

The new facility, which became fully operational in late April, provides in-house trace metals analysis and the capability to clean and fill containers in a tightly controlled environment. The Sheboygan campus was selected as the site for the new cleanroom as it already provides large-scale manufacturing of products for the material science industry for SAFC, which supports the silicon semiconductor, compound semiconductor, and performance materials markets.

The extension of the Sheboygan campus enables SAFC Hitech to produce, package, and analyze its products in one location, completing the total supply chain, eliminating the need to use outside facilities, and ensuring customers an uninterrupted supply of the highest quality materials required for advanced semiconductor manufacturing.

“One of SAFC’s primary business objectives is to continue to build the SAFC Hitech segment into a global leader in the supply of ultra-pure, high-quality materials and technical solutions to the electronics industries we serve,” says SAFC president Frank Wicks. “As the demand for new and increasingly efficient materials continues to grow, so does the need to attain higher and higher levels of quality and dependability from our products.

“This cleanroom investment complements existing manufacturing and extensive research and development sites at Sheboygan and will help us to achieve our objectives, essentially providing a ‘one stop shop’ for manufacturing, analysis, and packaging. As a result, SAFC Hitech customers will benefit from high-quality products that meet or exceed specifications, feature significantly reduced quality variations and are delivered on time.”

Looking ahead, Geoff Irvine, director, commercial development & marketing, SAFC Hitech, believes the Sheboygan facility can act as a blueprint for future expansion in overseas markets. “In 2007 we announced long-term plans for the expansion of our manufacturing footprint in both China and South Korea,” Irvine says. “We expect to be able to use the construction and operational experiences gained from Sheboygan and apply it to future, similar developments serving other markets, thereby expanding our global presence using tried and tested methodologies.”

About SAFC Hitech
SAFC Hitech provides a unique chemistry service translating application understanding into performance materials worldwide. Through collaborative partnerships and an integrated approach from research and development, process development, and scale-up to commercial manufacturing, SAFC Hitech invests in innovation and manufacturing enabling current and future technology needs.

Visit www.safchitech.com

About SAFC
SAFC(R) is the custom manufacturing and services group within Sigma-Aldrich that focuses on products and services for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four focus areas — SAFC Pharma(TM), SAFC Supply Solutions(R), SAFC Biosciences(TM), and SAFC Hitech(TM) — and had annual sales of nearly $600 million in 2007. SAFC is one of the world’s 10 largest fine chemical businesses.

Visit www.safcglobal.com

About Sigma-Aldrich
Sigma-Aldrich is a leading life science and high technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease, and as key components in pharmaceutical and other high technology manufacturing. The company has customers in life science companies, university and government institutions, hospitals, and industry. More than one million scientists and technologists use its products. Sigma-Aldrich operates in 36 countries and has 7,900 employees providing excellent service worldwide. The company is committed to accelerating customers’ success through leadership in life science, high technology, and service.

Visit www.sigma-aldrich.com

April 29, 2008 — /FDA NEWS/ — On April 24, the U.S. Food and Drug Administration (FDA) issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as “mad cow disease”).

“This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE,” said Dr. Bernadette Dunham, Director of FDA’s Center for Veterinary Medicine. “The new rule strengthens existing safeguards.” The new measure builds on FDA’s 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed.

The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE. These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older. The entire carcass of cattle not inspected and passed for human consumption is also prohibited, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed. The risk of BSE in cattle less than 30 months of age is considered to be exceedingly low.

The removal of high-risk materials from all animal feed will further protect against inadvertent transmission of the agent thought to cause BSE, which could occur through cross-contamination of ruminant feed (intended for animals with four-chambered stomachs, such as cattle) with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm. The added measure of excluding high-risk materials from all animal feeds prevents any accidental feeding of such ingredients to cattle.

Today’s regulation finalizes a proposed rule that the FDA issued for public comment in October 2005. The final rule is effective 12 months from today to allow the livestock, meat, rendering, and feed industries time to adapt their practices to comply with the new regulation. Under the new requirements of the final rule, renderers that process cattle not inspected and passed for human consumption must make available for FDA inspection their written protocols for determining the age of cattle and demonstrating that the brain and spinal cords of cattle have been effectively removed.

Scientific studies have linked BSE to cases of variant Creutzfeldt-Jakob Disease (vCJD) in humans, an invariably fatal disease that most likely results from human consumption of infectious material from cattle with BSE. Rules issued in 2004 prohibited specified risk materials from use in the human food supply. There have been no vCJD cases linked to consumption of U.S. beef and the risk of BSE among U.S. cattle is low.

FDA regulates animal feed and drugs. The U.S. Department of Agriculture (USDA) and FDA promulgate and enforce the regulations that ensure the exclusion of specific risk materials from the human food supply.

For more information about the FDA’s work on BSE, go to
www.fda.gov/oc/opacom/hottopics/bse.html.

April 29, 2008 — /FDA NEWS/ — On April 24, the U.S. Food and Drug Administration (FDA) issued an order requiring that Evanger’s Dog & Cat Food Co., Inc., in Wheeling, IL, obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce. A recent inspection revealed significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company’s thermally processed low acid canned food (LACF) products. These problems could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.

“As outlined in the Food Protection Plan, the FDA uses a risk-based approach to locate the areas of greatest risk for foods, and targets preventive controls and inspections to those areas,” said Dr. Stephen Sundlof, director, Center for Food Safety and Applied Nutrition. “The FDA’s authority to issue an order requiring an emergency permit is an enforcement tool designed to prevent unsafe foods from reaching consumers.”

The FDA issues an “Order of Need for Emergency Permit” if the agency determines that a company fails to meet the regulatory requirements to process a product that does not present a health risk. For Evanger’s to resume business, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.

Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.

In light of human botulism illnesses and recalls that occurred due to under-processed hot dog chili sauce, and potentially under-processed canned green beans, FDA has urged all LACF processors to review their operations and to apply scientific principles and regulations that have been established to provide a safe product.

While FDA’s Center for Veterinary Medicine has authority over animal feed and foods, CFSAN is responsible for regulating all human and animal LACF processing. The two centers are collaborating on this enforcement action.

Visit www.fda.gov

April 29, 2008 — /PRNewswire/ — CORONA, CA — Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has completed the inspection of the company’s Florida manufacturing facilities and has informed the company that it has removed the Official Action Indicated (OAI) status at Watson’s Davie, FL site. As a result of this action, and subject to satisfying other FDA approval criteria, Abbreviated New Drug Applications (ANDAs) for products at this site are now eligible for FDA approval.

The FDA completed the on-site portion of its inspection on April 10, 2008, at which time it issued a Form 483 List of Inspectional Observations. The company responded to the Form 483 Inspectional Observations on April 17, 2008.

Since 2005, the Davie, FL manufacturing facility has been under OAI status. During that time, Watson has continued to file ANDAs for product candidates to be manufactured at this site. However, FDA approval of pending ANDAs has been withheld pending positive resolution of the OAI status. Watson is working closely with FDA to obtain approval of pending ANDAs eligible for final approval.

About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells, and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations, and synergistic acquisitions of products and businesses.

Visit www.watson.com