Inspections, Compliance, Enforcement, and Criminal Investigations
Center for Veterinary Medicine 2003
Center for Veterinary Medicine
Dioxin Found in Animal Feeds
FDA Urges Recall of Animal Feed Due to Dioxin Contamination
On February 28, 2003, the FDA announced that its dioxin-monitoring program had found elevated levels of dioxin in some mineral components used in animal feeds. On March 12, 2003, FDA alerted firms manufacturing mineral mixes and mineral premixes for use in animal feed that minerals that are by-products or co-products of industrial metal production may contain dioxin. FDA found that some of these by-products or co-products contained high levels of dioxin, and requested that the specific products be recalled.
FDA advised industry to contact their customers and urged that they immediately stop further distribution of their products made with this mineral component. The implicated zinc oxide premixes were used in livestock, aquaculture, and poultry feed and feed products. Because mineral premixes are diluted greatly in the finished animal feed, it is unlikely that human health effects would occur from this limited exposure.
The recalled products were distributed to feed manufacturers and suppliers in eleven states (California, Iowa, Illinois, Minnesota, Missouri, Mississippi, New England, New York, Pennsylvania, Utah, and Washington) and Canada.
One of FDA's public health objectives is to reduce the level of exposure to dioxin in the animal and human foods it regulates. Finding and stopping sources of added dioxin, such as the mineral components, from entering the food supply is one of the primary goals of FDA's dioxin monitoring program.
Dioxins are ubiquitous, low level environmental contaminants. With cumulative exposure, they are potential carcinogens and may cause reproductive or developmental health problems. Presently, the primary source of human exposure to dioxins is through food.
To further reduce public exposure to dioxins, the FDA established food and feed surveillance programs. It was through these surveillance programs that FDA identified the mineral components as the primary source of dioxins in the affected animal feed.
Class I Recall of Feed Supplement
On March 2003, FDA classified a recall of Dr. Evans’ Alpaca Supplement, as a Class I recall. The Toxicology indicated possible salinomycin contamination of the feed supplement. Land O Lakes Farmland Feeds, LLC, Massillon, Ohio, issued the recall on March 19, 2003, by telephone, fax and letter. The recall involved 238/50 pound bags distributed in the state of Ohio.
Warning Letter Issued to Medicated Feed Company
FDA Issues Warning Letter to Firm for Distribution of Super-Potent Medicated Feed
On April 28, 2003, the FDA’s Cincinnati District Office issued a Warning Letter to the corporate headquarters of Land O’ Lakes Farmland Feed LLC for their failure to establish adequate controls to prevent illegal distribution of Category II Type A Medicated Articles. An FDA inspection of the Land O’ Lakes, Washington Court House, Ohiofacility, dated January 28 - 29, 2003, revealed the firm had illegally distributed twenty bags of roxarsone 20%, which requires a license, instead of the 0.5% roxarsone Type B feed normally purchased, to an unlicensed feed mill, Auglaize Farmers Co-op.
The unlicensed mill subsequently manufactured nine tons of super potent medicated feed containing 27-40 times the legal limit for this drug. Three tons of the super potent feed was delivered to a hog grower on January 15, 2003, who mixed the feed into their bulk delivery system.
The mix-up was not discovered until six days later. The farm mixed the super potent feed with existing feed in their bulk feed system which fed a group of 131 hogs. Five of the 131 pigs that potentially consumed super-potent feed experienced distress during the period that they were fed, and one pig died the day after the super-potent feed was received. Auglaize Farmers Co-op recalled the super-potent feed and destroyed that and remaining stock of the feed by burial in an EPA approved land fill. Land O’ Lakes collected tissue samples from 6 of the 130 animals, for testing by a U.S. Department of Agriculture certified lab. The sampling was witnessed by FDA personnel. The samples all tested negative and the animals were subsequently marketed.
Bovine Spongiform Encephalopathy
Bovine Spongiform Encephalopathy (BSE), commonly called “Mad Cow Disease” is the name for a slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. Since 1990, the U.S. Department of Agriculture (USDA) has conducted aggressive surveillance of the highest risk cattle going to slaughter in the United States, in which 10,000- 20,000 animals per year have been tested. To date, the only cow that has been found to be affected with BSE was the one diagnosed with BSE in December 2003.
The exact cause of BSE is not known but it is generally accepted by the scientific community that infectious forms of a type of protein, prions, normally found in animals cause BSE. In cattle with BSE, these abnormal prions initially occur in the small intestines and tonsils, and are found in central nervous tissues, such as the brain and spinal cord, and other tissues of infected animals experiencing later stages of the disease.
CVM and Ruminant Feed (BSE) Inspections
To prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE) through animal feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, 21 CFR Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997(here called the BSE/Ruminant Feed regulation.) Inspections of renderers, feed mills, ruminant feeders, protein blenders, pet food manufacturers, pet food salvagers, animal feed distributors and transporters, ruminant feeders, and others have been conducted to determine compliance with the BSE/Ruminant Feed regulations.
UPDATE: BSE Found in Washington State
USDA Reports Cow Tested Positive for BSE – FDA Sends Investigators
On December 23, 2003, the U.S. Department of Agriculture (USDA) announced that a Holsteincow in the State of Washingtonhad tested presumptively positive for bovine spongiform encephalopathy (BSE or “mad cow disease”). Following this announcement, FDA dispatched several teams of investigators to trace back and trace forward the potential involvement of any FDA-regulated commodities. USDA, which is responsible for the safety of certain meat and poultry products as well as animal health, led the investigation of this BSE case.
FDA’s primary responsibility related to this investigation involved animal feed, which most experts believe is the main way in which BSE is amplified throughout cattle herds. BSE does not spread naturally from adult cow to adult cow. FDA worked closely with USDA and state officials in this intense investigation.
FDA’s “animal feed” rule, in place since 1997, is designed to prevent the spread of BSE further throughout cattle herds. This regulation prohibits the feeding of most mammalian protein to ruminant animals such as cows, sheep and goats - the route of disease transmission that led to the epidemic of BSE in the United Kingdom, beginning in the 1980’s.
A study published in 2001 by the HarvardCenterfor Risk Analysis identified FDA’s animal feed rule as one of the primary safeguards against the amplification of BSE in the U.S.cattle herd if a case were ever to occur in the U.S.
FDA has vigorously enforced this rule. More than 99 percent of these facilities are currently in compliance with the provisions of this rule to protect the U.S.food supply and its cattle from the agent that causes BSE.
This one case of BSE does not mean that the U.S.food supply is any less safe today than it was yesterday. Concerning the safety of milk, the scientific data indicate that milk from BSE cows does not transmit BSE. National and international public health organizations have consistently stated that milk and milk products are safe regardless of whether the country producing them has had cases of BSE.
On December 27, 2003, FDA announced that its investigators and inspectors from the states of Washington and Oregon had located all of the potentially-infectious product rendered from the one cow that tested positive for BSE in Washington State. The rendering plants that processed all the non-edible material from the BSE cow placed a voluntary hold on all of the potentially-infectious product, none of which left the control of the companies and entered commercial distribution. The firms, located in Washington State and Oregon, assisted and cooperated fully with FDA’s investigation.
FDA Emergency Operations Center
The FDA Emergency Operations Center (EOC), a branch of the OCM, is the single point of coordination for the FDA's response to any BSE emergency. The FDA EOC is the physical facility that serves as the central point for the Agency's response activity. During a BSE emergency, the FDA EOC will coordinate and report on all response activity and interagency communication. The FDA EOC monitors BSE emergencies; triages complaints and alerts; issues assignments to the field; coordinates responses; and communicates with other federal, state, and local agencies as they request technical and material support from the FDA.
The FDA EOC maintains contact with the Department of Health and Human Services (HHS) Secretary's Command Center (SCC), CDC EOC, USDA/FSIS Office of Food Security and Emergency Preparedness, and other EOCs, as appropriate. The FDA EOC will continue to direct and monitor all FDA response activities throughout the life cycle of an emergency.
New Measures to Prevent BSE
Several new public health measures will be implemented by FDA to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S.cattle.
The existing multiple firewalls, developed by both the U.S.Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S.cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle.
The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.
The new safeguards are science-based and further bolster these already effective safeguards.
Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.
FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.
To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication.
The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:
- Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)
- Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);
- Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and
- The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdomcattle in the 1980's and 1990's.
This interim final rule will implement four specific changes in FDA's present animal feed rule. The rule:
- Will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.
- Will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
- Will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
- Will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA plans to step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.
UPDATE: The FDA also notes that in response to finding a BSE positive cow in Washington state on December 23, it inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.
FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of the USpublic health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.
Warning Letters Issued for Violations of BSE Regulations
- On May 6, 2003, the FDA’s Minneapolis District Office issued a Warning Letter to the President of Barr Animal Foods, Greenwood, Wisconsin. The FDA conducted an inspection of the firm on April 8, 2003. The inspection disclosed that the firm was not labeling their 50 pound blocks of frozen beef and bulk loads of beef bone chips and rendering waste, intended for animal feed with the required cautionary statement.
- On August 25, 2003, the FDA’s Chicago District Office issued a Warning Letter to the president of Lincoln Land Livestock Co., Inc., Mascoutah, Illinois. On April 14 - 15, 2003, FDA conducted inspection of the animal feed handling facility. The investigator found that products that contained or may contain prohibited material failed to bear the caution statement, “Do not feed to cattle or other ruminants.” The inspection also disclosed that the firm did not maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants.
- On November 7, 2002, the FDA’s Dallas District Office issued a Warning Letter to the President and Manager of Sunnymead Ranch, Inc., Idalou, Texas. An FDA inspection of this feed mill found significant deviations from 21 CFR 589.2000. FDA’s inspection revealed that the firm manufactures feed for sheep, that may contain residues of prohibited material. The sheep feed is mixed in the same equipment that is used for mixing chicken feed containing bovine meat and bone meal. In addition, the firm failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissue to animal protein or feeds that may be used for ruminants. The Warning Letter cautioned, “As a feed manufacturer and ruminant feeder of sheep intended for slaughter as food, you are responsible for ensuring that your operations are in full compliance with the law.”
- On May 22, 2003, the FDA’s New Orleans District Office issued a Warning Letter to the Manager and Owner of Millstone Agri Distributors, Maryville, Tennessee. An FDA inspection of the firm on February 13, 2003, found significant deviations from the requirements of Title 21, Code of Federal Regulations (21 CFR), Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed.
FDA’s investigation found the following violations of 21 CFR 589.2000:
- Failure to separate the receipt, processing, and storage of products containing prohibited material from products not containing prohibited material;
- Failure to establish written procedures, including clean-out and flushing procedures, to avoid commingling and cross-contamination of common equipment;
- Failure to maintain records sufficient to track prohibited materials throughout the receipt, processing, and distribution of products;
- Failure to provide for measures to avoid commingling or cross-contamination of feeds intended for ruminants and feeds intended for non-ruminants that may contain prohibited materials;
- Failure to label non-ruminant products with the required cautionary statement “Do not Feed to Cattle or Other Ruminants.” The investigation specifically found that dog food containing prohibited material was added as an ingredient to the product “Premium Rooster Kicker.” The failure of these feeds to bear the required BSE warning statement causes them to be misbranded.
Consent Decree of Permanent Injunction Against X-Cel Feeds, Inc.
Feed Manufacturer Enjoined for Violations of the 1997 Animal Feed Rule
On July 11, 2003, FDA announced the filing of a Consent Decree of Permanent Injunction against X-Cel, Feeds Inc., and individual officers based on violations of the Federal Food, Drug, and Cosmetic Act.
X-Cel, a feed manufacturer headquartered in Tacoma, Washington, failed to comply with FDA regulations (the 1997 Animal Feed Rule) designed to prevent the establishment and spread of Bovine Spongiform Encephalopathy (BSE, also known as "Mad Cow Disease") should it ever be found in the United States and FDA regulations concerning the manufacture of medicated feeds.
The Department of Justice, Civil Division, Office of Consumer Litigation and the United States Attorney's Office of the Western District of Washington filed the Consent Decree in the United States District Court of the Western District in Tacoma, Washington. It permanently enjoins X-Cel from manufacturing animal feeds in violation of the Federal Food, Drug, and Cosmetic Act and requires the firm, its officers, and employees to take specific steps to avoid future violations including, implementing clean-out procedures, obtaining protein supplier certifications and implementing standard operating procedures for compliance until it satisfies FDA that it has corrected its problems.
Warning Letters Issued for Illegal Drug Residues
- On April 3, 2003, the FDA’s Minneapolis District Office issued a Warning Letter to O'Hearn Irish Dairy of Reedsville, Wisconsin. The Warning Letter was issued for tissue residue violations involving a dairy cow sold for slaughter for food. The U.S. Department of Agriculture (USDA) analysis of tissue samples from the animal found Gentamicin at 5.27 ppm in the kidney. No tolerance has been established for residues of gentamicin in the edible tissues of cattle. The Warning Letter cited adulteration of food because the farm lacked an adequate system for assuring that animals bearing potentially harmful drug residues do not enter the food supply - e.g., they were not maintaining drug treatment records. The Warning Letter also cited adulteration of the gentamicin due to illegal extra-label use.
On April 12, 2003, the FDA’s Minneapolis District Office issued a Warning Letter to Randy Stewart of Cottonwood Cattle Company, Sioux Falls, South Dakota, for seven tissue residue violations involving cattle sold for slaughter for food. FDA inspected the firm on December 16, 2003. That FDA investigation confirmed that several animals sold by Cottonwood Cattle Company, for slaughter for human food, were in violation of the Federal Food, Drug and Cosmetic Act (the Act).
USDA analysis of tissue samples from these animals found illegal residues of gentamicin, sulfadimethoxine, oxytetracycline, penicillin, Tilmicosin, and sulfamethazine. The Warning Letter cited adulteration of food because the firm lacked adequate controls to prevent medicated animals from being purchased and sold for human food, and did not keep records to permit animal trace back.
On July 29, 2003, the FDA’s Minneapolis District Office issued a Warning Letter to L-J Farms, Inc., of West Bend, Wisconsin. On May 20 and 21, 2003, FDA conducted an inspection at L-J Farms’ dairy farm located in West Bend, Wisconsin. That inspection revealed that the firm used an animal drug in a manner that did not conform with its approved use or the regulations for Extralabel Drug Use in Animals (21 CFR Part 530)]. This caused the animal drug to be unsafe and adulterated.
On or about December 18, 2002, the firm offered a dairy cow (back tag #35GD6-369) for slaughter as human food. U.S. Department of Agriculture (USDA) analysis of tissue samples collected from this cow identified the presence of flunixin at 0.145 ppm in the liver. A tolerance of 0.125 ppm has been established for residues in cattle liver. The Warning Letter cited the producer for administering flunixin in an extralabel manner without the supervision of a licensed veterinarian and failing to follow the specified withhold time. These deviations caused the drug to be adulterated.
Consent Decree of Permanent Injunction for California Dairy
Court Enjoins Firm for Illegal Drug Residues
On March 19, 2003, the U.S. District Court for the Central District of California entered a Consent Decree of Permanent Injunction against the defendant James Bootsma Jr., an individual, doing business as Jim Bootsma, Jr. The Consent Decree was based on the numerous illegal drug residues caused by the firm and the failure of Mr. Bootsma to maintain controls to prevent illegal residues in animals delivered for slaughter.
Jim Bootsma, Jr., is dairy livestock business located in Lakeview, California. The business maintains a herd of approximately 2,000 animals, including a milking herd of about 1,500 cows. Since 1987, Jim Bootsma, Jr., has engaged in the sale and consignment of cattle that were slaughtered for use as human food. Bootsma’s poor management practices were the primary source of these illegal drug residues in spite of the relentless efforts by federal government agencies. The FDA, the U.S. Department of Agriculture (USDA), and the California Department of Food and Agriculture made numerous attempts to gain compliance at this firm through inspections and written warnings.
Under the terms of the Consent Decree, Bootsma agreed to be permanently restrained and enjoined from: (1) introducing or delivering for introduction into interstate commerce any livestock or their edible tissues; (2) administering to cattle any articles of new animal drug while held for sale after shipment in interstate commerce, except in a manner that conforms to such drug’s approved conditions for use or to the specific written instructions of a licensed veterinarian, until the corrective actions enumerated in the decree are established and implemented.
The FDA’s Los Angeles District Office conducted the investigation that led to this Consent Decree. The Center for Veterinary Medicine, Division of Compliance, the FDA’s Office of the Chief Counsel, and the United States Department of Justice Office of Consumer Litigation were responsible for the case processing and legal procedures.
Outbreak of Monkeypox Virus
54 Cases of Monkeypox Reported in New Jersey, Wisconsin, Illinois, and Indiana
Reports of infections associated with the Monkeypox virus in the United States began in early May 2003. As of June 11, 2003, a total of 54 persons with suspected monkeypox had been reported from Wisconsin, Illinois, Indiana, and New Jersey. Monkeypox had been confirmed by laboratory tests in four persons. Seven of the people with suspected monkeypox had been hospitalized for their illness; there have been no deaths related to the outbreak. The number of cases and States involved in the outbreak will likely change as the investigation continues.
All patients reported direct or close contact with Prairie dogs, most of which were sick. In May, the Prairie dogs were sold by a Milwaukee animal distributor to two pet shops in the Milwaukee area and during a pet “swap meet” (pets for sale or exchange) in northern Wisconsin. The Milwaukee animal distributor had obtained Prairie dogs and a Gambian giant rat that was ill at the time from a northern Illinois animal distributor. On the basis of preliminary findings from the trace-back investigation of the Prairie dogs and the Gambian giant rat, it appears that the source of the infection was a shipment of rodents from Africa, which included six distinct species of rodents. It appears that the primary route of transmission may be from infected rodents from Africato native Prairie dogs and then to humans as a result of close contact.
Monkeypox is a rare viral disease that occurs mainly in the rain forest countries of central and west Africa. The disease was first discovered in laboratory monkeys in 1958. Blood tests of animals in Africa later found evidence of monkeypox infection in a number of African rodents. The virus that causes monkeypox was recovered from an African squirrel. Laboratory studies showed that the virus also could infect mice, rats, and rabbits. In 1970, monkeypox was reported in humans for the first time. In June 2003, monkeypox was reported in prairie dogs and humans in the United States.
The outbreak of monkeypox linked to exotic animals caused 37 confirmed, 12 probable, and 22 suspect cases in the United States.
HHS determined, under its authority in the Public Health Service Act, that the current monkeypox outbreak was an interstate problem that requires the use of this Federal authority. Pursuant to the Public Health Service Act, the Centers for Disease Control and Prevention (CDC) has the authority to implement and enforce the foreign importation embargo. Also under the Public Health Service Act, both CDC and FDA have shared authority for implementing and enforcing the ban on distribution, sale and transport of these animals within the United States. FDA and CDC will work jointly, along with other Federal agencies, to enforce these public health measures.
FDA and CDC Issue Embargo
Joint FDA/CDC Embargo Prohibits Importation of African Rodents Into U.S.
On June 11, 2003, FDA and the Centers for Disease Control and Prevention (CDC) issued a joint order prohibiting the importation of all African rodents into the United States. The joint order also bans within the United States any sale, offering for distribution, transport, or release into the environment, of prairie dogs and six genera of African rodents. The joint order was enacted as part of the public health response to the first reported outbreak of monkeypox in the United States.
The order prohibits the importation of all rodents from Africa. In addition, it prohibits within the United States the distribution, sale, transportation and intentional release into the environment of prairie dogs and the following rodent species: Tree squirrels (Sciurus); Rope squirrels (Funisciurus); Dormices (Graphiurus); Gambian Giant Pouched Rats (Cricetomys gambianus); Brush-tailed porcupines (Atherurus africanus); Striped mice (Typomys).
In addition to implementing this embargo, HHS also advised individuals who acquired an animal named in the order since April 15, 2003, to carefully monitor their own health as well as the health of the animal. Should an individual exhibit symptoms, such as a rash accompanied by a fever, cough or aches, or become ill, they should immediately contact a physician. Should an animal become ill, individuals should immediately contact a veterinarian, contain the animal in an appropriate carrier and then transport it to the veterinarian without other people or pets in the vehicle. Under no circumstances should such animals be intentionally released into the wild.
The ban which was implemented on June 11, 2003, does not apply to individuals who transport listed animals to veterinarians, animal control officials, or other entities recommended by Federal, state, or local government authorities.
FDA and CDC Issue Interim Final Rule
On November 4, 2003, to prevent the transmission of monkeypox, a rare viral disease, the FDA and the Centers for Disease Control and Prevention (CDC) issued an interim final rule to establish new restrictions and modify existing restrictions on the import, capture, transport, sale, barter, exchange, distribution and release of African rodents, North American prairie dogs and certain other animals in the United States.
“This interim measure further enhances HHS’s efforts to protect the public health by preventing the spread of communicable diseases,” said FDA Commissioner, Mark B. McClellan, M.D., PhD.
"Emerging infectious diseases which originate in animals – such as monkeypox, plague and West Nile virus -- continue to pose a significant threat to public health here in the United States,” said CDC Director Dr. Julie Gerberding. “Sound public health calls for us to take action to protect the public from diseases that can be spread by exotic animals.”
This interim rule is an increased measure by both agencies to prevent the possible transmission of monkeypox from imported animals and from those currently in the U.S.that may have become infected. As outlined in the interim rule the CDC will restrict the importation of these animals, and the FDA will restrict domestic interstate and intrastate movement of these animals, with exemption procedures to accommodate special circumstances.
Recall of Pet Food from Canadian Manufacturer
Pet Food Recalled Because “BSE” Cow May Have Been Used in Dry Dog Food
On May 26, 2003, the FDA learned from the government of Canada that rendered material from a Canadian cow that tested positive for bovine spongiform encephalopathy (BSE) also known as “mad cow disease” may have been used to manufacture pet food, specifically dry dog food, some of which was reported to have been shipped to the United States. The Canadian government prevented the BSE positive cow from being processed for human food. Therefore, consumers can be assured that their food does not contain any remnants of the BSE positive cow. There is no scientific evidence to date that dogs can contract BSE or any similar disease. In addition, there is no evidence that dogs can transmit the disease to humans.
FDA notified the U.S.pet food firm, The Pet Pantry International, of Carson City, Nevada, when FDA learned that the pet food that the firm received may have included rendered material from the BSE positive cow. The manufacturer of the pet food was Champion Pet Food, Morinville, Alberta. Even though there is no known risk to dogs from eating this dog food, as a prudent measure to help assure that the U.S. stays BSE free, The Pet Pantry International asked its customers who may have purchased the suspect product to hold it for pickup by the distributor so that the dog food would not mistakenly be mixed into cattle or other feeds if any of the dog food was discarded or otherwise not used to feed dogs.
The suspect dog food was produced by Champion Pet Food between February 4, 2003, and March 12, 2003. The Pet Pantry products were packaged in 50 pound bags, distributed to franchises around the country, and sold by home delivery only. There was no retail distribution of the product. Consumers purchase Pet Pantry products by phone or email orders. The product is then delivered by the nearest franchisee directly to the consumer’s home.
The product subject to this notification included “Maintenance Diet” labeled with a use by date of “17FEB04” and “Beef with Barley” with a use by date of “05MAR04”. Consumers who had purchased dog food from The Pet Pantry since February of this year were asked to check their present supplies and see if any match the description of the product being removed.
If so, consumers were asked to contact The Pet Pantry at 1-800-381-7387 for further information on how to return the product to The Pet Pantry for proper disposal. Consumers were asked not to destroy or discard the product themselves. The Pet Pantry also used its sales records to contact consumers who purchased the affected product. FDA worked closely with the Pet Pantry International to assure for proper disposal of the recovered product.
Warning Letter Issued to Veterinarian for Extra-Label Use of Drug
Records Show that Cow Was Administered Twice the Recommended Dose of Penicillin
On April 9, 2003, FDA issued a Warning Letter to Keith A. Scudder, D.V.M., Rio Vista Veterinary Hospital following an inspection by FDA. Investigators visited the veterinary hospital January 24 and 31, 2003. The investigation revealed that Keith A. Scudder, D.V.M. prescribed drug products for extra-label use and that this resulted in illegal tissue residues in two animals offered for slaughter for human food. These included a flunixin residue of 2.47 PPM found in liver tissue for a cow slaughtered on July 19, 2002, and a penicillin residue of 0.65 PPM found in kidney tissue from a cow slaughtered on May 7, 2002.
The presence of these drugs, at the reported levels, in edible tissues of these animals, causes the food to be adulterated under Federal Food, Drug, and Cosmetic Act (the Act). Causing the use of an approved drug in a manner other than the approved, labeled conditions of use without meeting the requirements for exemption outlined in Title 21, Code of Federal Regulations, Part 530, causes the drugs to be adulterated.
The drug residue resulted from the extra-label use of [redacted] injectable solution in a lactating dairy cow. The cow was administered 15 cc intramuscular injection on July 12, 2002, for treatment of pneumonia, prior to being offered for sale for human food on July 18, 2002. FDA’s investigation determined that Dr. Scudder routinely prescribed and dispensed [redacted] to this farm for treating a lactating dairy cattle. This [redacted] is not approved for use in lactating or dry dairy cattle.
The penicillin residue resulted from the extra-label use of penicillin G procaine in the treatment of a dairy cow. The cow was administered two 20 cc injections of injectable suspension per day for three days, as a treatment of pneumonia prior to being sold for human food on May 6, 2002. The dosage administered is more than double the highest daily dosage (3000 units per pound of body weight) recommended on the product label, and exceeds the 10 ml recommended dosage limit per injection site. FDA’s investigation determined that although the drug may have been purchased elsewhere, Dr. Scudder prescribed the extra-label usage of penicillin G procaine for treatment of dairy cows.
The extra label use of approved veterinary or human drugs by veterinarians is allowed under the Animal Medicinal Drug Use Clarification Act (AMDUCA), provided that the regulations contained in Title 21 Code of Federal Regulations (21 CFR) Part 530 are followed. Title 21 CFR 530.20(a)(2) requires a veterinarian to take certain steps prior to prescribing or dispensing an approved new animal or human drug for an extra-label use. One requirement mandates that the veterinarian take appropriate measures to assure that assigned time frames for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment. The fact that illegal residues occurred from extralabel use prescribed indicates a failure to comply with FDA regulations.
Seizure of Veterinary Drug
On June 12, 2003, FDA investigators from the Minneapolis District Office accompanied the U.S.Marshals Service in a seizure of over-the-counter veterinary drugs at New Decade Laboratories, Inc., Farmington, Minnesota. Previously, in March 2001, FDA issued a Warning Letter to New Decade Laboratories identifying significant violations of current good manufacturing practice (CGMP) regulations. In an April 2001 response, the firm promised corrections. However, FDA follow-up inspections in September 2001 and January 2002 found continuing CGMP deficiencies.
In May 2002, FDA met with representatives of the firm in an attempt to correct the CGMP violations. A follow-up inspection in January 16 – 17, 30, and February 11, 2003, revealed that despite prior warnings, the firm continued to operate in violation of FDA’s CGMP regulations.