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Animal Drugs and Feeds

<< Return to FY 2005 Budget Proposal

 

Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005

 

ANIMAL DRUGS AND FEEDS

 

  FY 2003
Actual
FY 2004
Enacted 1/ 2/
FY 2005
Estimate
Increase
or Decrease
Program Level $87,659,000 $88,897,000 $99,299,000 + $10,402,000
Center
$57,115,000
$59,705,000
$63,485,000
+ $3,780,000
FTE
341
355
376
+ 21
Field
$30,544,,000
$29,192,000
$35,814,000
+ $6,622,000
FTE
255
276
296
+ 20
Budget Authority $87,659,000 $84,147,000 $91,905,000 + $7,758,000
Cost of Living--Pay 3/
 
 
$1,134,000 + $1,134,000
Bovine Spongiform
Encephalopathy
$15,811,000 $15,624,000 $23,649,000 + $8,025,000
 Administrative Efficiencies
 
 
- $1,401,000 - $1,401,000
FTE    
- 12
- 12
Budget Authority FTE 596 591 614 + 23
User Fees
 
$4,750,000 $7,394,000 + $2,644,000
 ADUFA 4/
 
$4,750,000 $7,394,000 + $2,644,000
FTE  
40
58
+ 18
User Fee FTE
 
40 58 + 18
1/Contains a Budget Authority rescission of 0.59 percent for a total of $499,000 for Animal Drugs and Feeds.
2/ In FY 2004, a total of 104 Human Resources FTE were transferred from the FDA to the Department as part of the Secretary's One HHS Initiative. The Animal Drugs and Feeds Program's share of this transfer was 5.
3/ Pay increases shown on separate line, and not reflected in individual initiative areas.
4/ For the purposes of the FY 2005 budget, FDA has assumed ADUFA's appropriations have been enacted and is in its second year.

 

Historical Funding and FTE Levels

Fiscal Year Program Level Budget Authority User Fees Program Level FTE
2001 Actual $64,070,000 $64,070,000 $0 442
2002 Actual 5/ $85,643,000 $85,643,000 $0 570
2003 Actual $87,659,000 $87,659,000 $0 596
2004 Enacted $88,897,000 $84,147,000 $4,750,000 631
2005 Estimate $99,299,000 $91,905,000 $7,394,000 672
5/Includes FDA's FY 2002 Appropriation and the Counterterrorism Supplemental.

 

MISSION

 

The Animal Drugs and Feeds Program is responsible for ensuring that animal drugs and medicated feeds are safe and effective for intended uses and that food from treated animals is safe for human consumption. The aim of the program is to:

  • Foster public and animal health by approving safe and effective products for animals and by enforcing applicable provisions of the Federal Food, Drug, and Cosmetic Act, and other authorities;
  • Process premarket applications as quickly as possible to increase the availability and diversity of safe and effective veterinary products that relieve animal pain and suffering while ensuring the resulting products are safe, wholesome, and free of drug residue when they reach the consumer; and,
  • Monitor marketed products for all animal drugs and feeds to minimize harm to humans or animals that might arise from the use of these products. This is accomplished through science-based review of drug experience reports, nationwide monitoring systems, compliance programs conducted by FDA field offices through inspections, sample collections and analysis, investigations, and appropriate regulatory actions to control violative goods and firms.

 

BACKGROUND

 

The Animal Drugs and Feeds Program (Program) is administered by FDA's Center for Veterinary Medicine (CVM) and supported by the Office of Regulatory Affairs' (ORA) field force. The authority to regulate animal drugs and medicated feeds is derived from the Food, Drug, and Cosmetic Act, which in 1968 was amended to include sections specifically addressing animal drugs. These amendments were designed to ensure that animal drugs are safe and effective for their intended uses and that the drugs do not result in unsafe residues in foods.

 

The Animal Drugs and Feeds Program scope is far-reaching. The program's customers include:

  • 115 million dogs and cats
  • 6.9 million horses
  • 7.5 billion chickens
  • 292 million turkeys
  • 109 million cattle
  • 92 million pigs
  • 7 million sheep
  • 280 million humans in the U.S.

The safety of the food supply is a paramount concern for the Program, as the average American consumes nearly 200 pounds of meat and fish, 30 pounds of eggs, and 600 pounds of dairy products each year. While most of these food products are regulated by the Department of Agriculture, FDA plays an important role in ensuring that animal drugs and feeds used in the care of these animals do not result in unsafe residues in food products that are harvested or produced (e.g., eggs) from these animals. The Program's other priorities are animal drug review, antibiotic resistance, prevention of Bovine Spongiform Encephalopathy (BSE) or "mad cow disease", and the safety of food derived from genetically modified animals.

Of these priorities, the Program's BSE efforts have sought to limit the exposure of BSE in the food and feed supply through a program of regulation and enforcement. In 1997, FDA issued a regulation prohibiting the use of most animal proteins in feeds for cattle and other ruminants. In its enforcement strategy, FDA initiated a comprehensive inspectional program using the Field and its State partners covering 100 percent of the affected industry. With its educational emphasis and other outreach efforts, the result has been that more than 99 percent of all renderers and feed mills in the U.S. are in compliance with the 1997 regulation.

The ORA field force supports the Program by conducting inspections of both foreign and domestic establishments and bioresearch monitoring of clinical research; and inspections of manufacturing facilities to determine if the factory is able to manufacture the product to the specifications stated in the application. The Field also conducts risk-based domestic and foreign postmarket inspections of animal drug manufacturers to assess their compliance with Good Manufacturing Practice and biennial inspection requirements, and monitoring and sampling imports to ensure the safety of animal drugs and feed products. In addition to overseeing regulated products on a surveillance or "for cause" basis when a problem is encountered, ORA staff also responds to emergencies and investigates incidents of product tampering and terrorist events or natural disasters that may impact FDA-regulated goods. To complement the regular field force, the Office of Criminal Investigations (OCI) investigates instances of criminal activity in FDA regulated industries.

Animal Drugs and Feeds Program Increases for FY 2005
By FDA Strategic Goal

FDA Strategic Goal FY 2005 Increase What the Increase Buys Related Performance Goal(s)
Strong FDA Cost of Living-Pay -- + $1,134,000
  • Review and act on animal drug applications (new, investigational, and generic) and reactivations; and,
  • Monitor marketed animal drugs and medicated feeds to minimize harm to humans or animals.
  • Complete review and action on 90 percent of original NADAs and reactivations received in FY 2005 within 270 days.
Efficient Risk Management: The Most Public Health Bang for our Regulatory Buck

Bovine Spongiform Encephalopathy (BSE) --

+ $8,025,000

  • Conduct additional risk based BSE inspections and targeted sample collections and analyses of animal feed or feed components;
  • Improve data quality and data management practices to better monitor industry compliance and improve the usefulness of state data; and,
  • Conduct outreach to inform industry of the requirements to prevent BSE from contaminating animal feed.
  • Maintain biennial coverage by inspecting 50 percent of 1,440 registered animal drugs and feed establishments; and,
  • In conjunction with state inspections, conduct targeted BSE inspections of 100 percent of all known renderers and feed mills processing products containing prohibited material.

 

PROGRAM RESOURCES CHANGES

 

Budget Authority
Cost of Living- Pay: + $1,134,000

 

FDA's request for pay cost increases is essential to accomplishing its mission. Without a specially trained national cadre of scientific staff, FDA's ability to adequately carry out the mission of protecting public health and providing consumer safety will be compromised. FDA must maintain staffing levels and scientific capabilities that meet the demands of an increasing workload and new challenges. Payroll costs, which account for over 60 percent of our total budget, significantly impact all FDA activities.

The total Agency request for pay increases is $14,352,000. The Animal Drugs and Feeds portion of this increase is $1,134,000. Without this, the FDA's ability to fulfill its mission to protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use will be significantly reduced.

Bovine Spongiform Encephalopathy (BSE): + $8,025,000 and + 35 FTE

In responding to the discovery of a cow infected with BSE in Washington State, the USDA implemented additional safeguards to protect the nation's food supply from further outbreaks. In supporting these USDA safeguards, FDA announced that it would increase its efforts to meet its expanded responsibilities for protecting the safety of the food and feed supply. With the increase funding in FY 2005, FDA will fund the following activities:

  • Educate industry on requirements of new/updated regulations and the impact to their practices;
  • Increase funding of state BSE inspections, on-farm BSE inspections, and BSE monitoring and control infrastructure grants so that the states can perform an additional 2,500 inspections, improve state and federal information on the inventory of animal feed firms and firms handling prohibited materials, and strengthen state infrastructure to monitor, and respond to potential feed contamination with prohibited materials;
  • Increase funding for field BSE inspections, sample collections and analyses so that FDA can perform an additional 920 risk-based BSE inspections and an additional 600 targeted sample collections and analyses of animal feed or feed components;
  • Increase the funding of field investigator training, state coordination, and industry outreach to expand investigational efforts to industry sectors vulnerable to cross contamination, such as truckers, on-farm mixers and distressed or salvaged food; improve data quality and data management practices so that FDA can better monitor industry compliance and improve the usefulness of state data; and conduct industry outreach to better inform industry of responsibilities and opportunities to prevent BSE from contaminating animal feed;
  • Improve inventory of firms by keeping it updated based on information in mandatory feed registration system;
  • Analyze and audit BSE reported inspectional information which will determine where additional inspection and education is needed;
  • Enhance the ability to respond efficiently to for-cause follow-up actions; and,
  • Evaluate the effectiveness of commercial tests to detect ruminant proteins in animal feeds, and initiation migration of current polymerase chain reaction methods into new technologies to allow for more rapid analyses of samples.

 

Administrative Efficiencies: - $1,401,000 and - 12 FTE

 

To fully embrace the President's Management Agenda, FDA is delayering its organizational structure, performing competitive sourcing reviews, modernizing its financial management system, and consolidating its information technology infrastructure. The Animal Drugs and Feeds program portion of these management improvements consists of - $1,401,000 and - 12 FTE.

 

User Fee

 

Animal Drug User Fee Act (ADUFA): + $2,644,000 and + 18 FTE

The Animal Drug User Fee Act, enacted into law on November 18, 2003 (P.L. 108-130), will ensure the availability of safe and effective animal drugs benefiting both food producing and companion, service animals. These safe and effective animal drugs will allow food animal producers to maintain healthy animals with the assurance that resulting food products will be safe, wholesome, and free of harmful drug residue. Ingestion of animal drug residues in food products could potentially cause unsafe conditions for humans, ranging from drug allergies to cancer. The availability of safe and effective drugs also ensures companion, service animals that assist the disabled, and other animals such as zoo animals will live healthier and longer lives. The Animal Drug User Fee Program which requires new animal drug applicants, sponsors, and manufacturers to incur a fee to expedite their respective applications, will help provide a cost-efficient, high quality animal drug review process that is predictable and performance driven. This fee has strong industry support and provides a complementary set of incentives to all interested parties -- industry, consumers, Congress, and FDA. This fee is modeled after the Prescription Drug User Fee Act, a successful partnership between the Federal government and stakeholders to improve and expedite the review of applications. The net increase of $2,644,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the implementation of ADUFA.

 

PROGRAM ASSESSMENT RATING TOOL (PART)

 

In the FY 2004 review, FDA was assessed as five distinct programs (Foods, Human Drugs, Biologics, Veterinary Medicine, and Medical Devices and Radiological Health) and was rated as "results not demonstrated" due to a lack of long-term outcome goals. To address this concern, long-term outcome goals were developed.

For FY 2005, the Office of Management and Budget conducted a second program review that treated FDA as a single agency program. In this review, FDA received a rating of "moderately effective" and score of 77 percent, up from 59 in FY 2004. This was due to considerable improvements in developing long-term agency-wide outcome goals that will demonstrate its effectiveness and impact on the public health. FDA also reduced the number of performance goals, and made various management improvements that further streamline its infrastructure while supporting core, mission-critical public health activities.

The Animal Drugs and Feeds Program shares in an agency-wide outcome goal of reducing administrative overhead through the reduction of the number of administrative staff. All of the Agency's outcome goals support the Department's priorities and Administration's initiatives with the intent to improve the health and well-being of the American public.

 

JUSTIFICATION OF BASE

 

EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK

Base resources will be used to conduct science-based risk management in all agency regulatory activities; so that the Agency's limited resources can provide the most health promotion and protection at the least cost for the public. These activities include compliance activities related to the BSE regulation; premarket review; and, imports and inspections.

Bovine Spongiform Encephalopathy (BSE)

BSE or "Mad Cow Disease" is a deadly chronic, degenerative disorder affecting the central nervous system. Feed containing remnants of the slaughtering process, such as the brain and spinal cord, may harbor the agent that causes BSE. To ensure such substances are not contained in animal feed, and to prevent the establishment and amplification of BSE through animal feed, the FDA finalized a regulation on August 4, 1997 entitled "Animal Proteins Prohibited from use in Animal Feed". FDA will:

  • Reinspect any firm found to be in violation of the regulation and inspect other potentially affected firms to determine compliance with the regulation;
  • Enforce the feed rule by conducting targeted BSE inspections of all known renderers and feed mills processing products containing prohibited material, such as meat and bone meal, on a yearly basis;
  • Provide Federal and state inspectors with up-to-date information on BSE feed regulations; European Union regulatory issues; Department of Homeland Security and Department of Agriculture's Animal Plant and Health Inspection Service authority; and best sampling practices;
  • Ensure the BSE Feed Regulations are current to prevent the establishment and amplification of BSE through animal feed;
  • Maintain relationships with industry using telecommunication and conferences to provide information on regulatory compliance and share inspection data;
  • Maintain the new database and data entry procedures for BSE inspections, and new BSE inspection checklist to target firms for re-inspections and to collect better data from FDA and state inspectors;
  • Leverage with state agencies by funding contract inspections of feed mills and renderers, and conduct compliance, follow-up, and audit inspections to state contracts;
  • Collect and analyze domestic and import feed and feed component samples for BSE related contaminants to ensure proper labeling of animal feeds and feed components;
  • Minimize and detect inadvertent problems associated with animal feed through a risk-based control system in order to avoid adverse health consequences in animals or humans;
  • Develop and validate detection methods to for prohibited mammalian protein in ruminant feed; and,
  • Provide intensive line entry and label review of Animal Drug and Feed product import line entries for use in domestic commerce.

 

Premarket Review

 

The availability of safe and effective animal drugs allows food animal producers to maintain healthy animals with assurance that products will be safe, wholesome, and free of harmful drug residues when they reach the consumer. Over time, animal drug use has moved from therapeutic treatment to save animals intended for human consumption, to the routine use of production drugs, which helps the producers maintain a profit margin while keeping safe and wholesome animal products available at a reasonable cost to the American consumer. FDA needs to improve product review by keeping pace with the increased volume and complexity of review workload. Keeping pace with technological advances will also improve the efficiency of agency reviews, and decrease review time. FDA will:

  • Increase the availability of safe and effective animal products, by reviewing animal drug applications in a timely manner for safety and effectiveness, and continue to work with regulated industry to minimize drug development time;
  • Reduce the backlog of pending submissions by developing new more meaningful metrics to measure performance and distribute workload, and the design of a "Back to Basics" strategy, including the development of a five-year business plan and a project management tracking system;
  • Continue pre-submission conferences, meetings, and workshops with industry, and support electronic submission of applications;
  • Improve the quality and timeliness of product reviews by monitoring pre-approval inspections and expanding inspectional expertise in emerging technologies;
  • Review previously approved new animal antimicrobial drug submissions with respect to antimicrobial resistance and human food safety; and,
  • Participate in the development of policy and practical guidance to industry.
  • Conduct inspections of registered animal drug and feed establishments;
  • Maintain biennial inspection coverage of animal drug and feed establishments;
  • Develop additional laboratory analytical methods to permit analyses of products for chemical and microbiological hazards, and perform laboratory validation of analytical methods submitted to support pre-market product applications;
  • Provide emergency operation, investigation and response for incidents involving regulated domestic products;
  • Conduct criminal investigations of reported product tampering, counterfeit products and other fraudulent criminal activities involving regulated products; and,
  • Conduct bioresearch-monitoring inspections, which assure that product sponsors are in compliance with regulations and good laboratory practices.

 

EMPOWERING CONSUMERS: IMPROVING HEALTH THROUGH BETTER INFORMATION

 

Base resources will be used to better enable consumers to make informed decisions weighing benefits and risks of FDA-regulated products. These activities include:

  • Deliver the food safety message to livestock producers, veterinarians, industry and consumers via trade shows, videotapes, and pamphlets to educate them on the risk of antimicrobial resistance of bacteria following the use of antibiotics in food animals; and,
  • Enhance the transparency of the National Antimicrobial Warning System (NARMS) program to stakeholders, the public and other interested parties by increased reporting and communications of NARMS results and program information by: publishing Annual Reports of NARMS animal, human and retail meat data; posting NARMS publication references on the web site, and presenting NARMS susceptibility testing results at scientific meetings via poster or oral presentations.

 

IMPROVING PATIENT AND CONSUMER SAFETY

 

Base resources will be used to promote improved patient and consumer safety by reducing risks associated with FDA-regulated products.

 

Food Safety

 

Millions of people get sick each year from food they eat. Some foodborne illness is due to harmful or illegal residues in animal products while other illness is due to microbiological infection. Concerns over chemical residues have grown considerably over the past few years because of change in consumer eating habits, such as eating more meals away from home and demanding seasonal foods year round making transportation and refrigeration of foods increasingly important. In order to safely manage animal drug use at home and abroad, we must have the knowledge to make proactive, sound science based decisions. The Agency will:

  • Identify emerging resistance in foodborne pathogens through the NARMS which contains three arms: human, animal and retail meat;
  • Continue to enhance the transparency of the NARMS program to stakeholders, the public, and other interested parties by increased reporting and communicating of NARMS results and program information;
  • Continue to accomplish the following using NARMS data: assess the human health impact of the use in food-producing animals of antimicrobials that are also used in human medicine; trigger broader research projects of prudent antimicrobial use in animals, and determine the role of the environment in the emergence and spread of antimicrobial resistance;
  • Conduct research to identify food animal species causing human drug resistance;
  • Supply data to Pulse Net on bacterial isolates of animal origin;
  • Leverage FDA's Tissue Residue Information Management System with the USDA's Residue Violation Information System to maintain tissue residue and feed contaminants compliance programs;
  • Detect chemical and microbial contaminants in the animal feed supply with the maintenance of the Feeds Contaminants Compliance Program;
  • Maintain early warning systems by collecting information from Drug Experience Reports and Adverse Event Reports;
  • Use new technologies in the development of multi-residue methods for the detection of drug residues in imported aquaculture products;
  • Conduct method validation studies required before applications for new drugs for food producing animals can be approved;
  • Provide educational information on biotechnology products and assist developers through the regulatory process to the public;
  • Reduce the transfer of resistant animal pathogens to humans by conducting a risk assessment to assess the link between the use of virginiamycin in animals and Synercid resistance in humans; and,
  • Continue to support the World Health Organization's Global Salmonella Surveillance.

 

PROTECTING AMERICA FROM TERRORISM

 

Base resources will be used to strengthen FDA's capability to identify, prepare for, and respond to terrorist threats and incidents.

The goals of the Animal Drugs and Feeds Program are to protect the health and safety of all food producing, companion, and other non-food animals; and assure that food from animals is safe for human consumption.FDA must work to develop profiles of possible or probable food threats and points of attack and must have the capacity to quickly and accurately identify outbreaks that may be happening or about to occur at any point in the food chain, and take prompt action to mitigate their effects. Base funding will enable FDA to:

  • Assist state diagnostic laboratories in acquiring the scientific and analytical expertise and capability to handle a feed contamination incident;
  • Educate state veterinary offices about FDA's technical role in identifying and responding to an intentional or accidental contamination of animal feed;
  • Work with feed trade associations to develop biosecurity awareness guidelines for the feed manufacturing industry;
  • Developing rapid analytical methods for screening imports at the border;
  • Review, assess and take appropriate enforcement action as a result of violations discovered in inspections conducted or samples collected. This includes follow-up actions as a result of intentional contamination;
  • Assure immediate assessment and identification of good manufacturing practices compliant facilities to ensure continued availability of veterinary drug products and increase supply of pivotal drug products to meet emergency needs;
  • Maintain a comprehensive inventory of registered animal drug establishments and listed animal drug products and use the database to assess the availability or anticipated shortage of animal drug products that would be needed to deal with terrorist attacks;
  • Develop analytical methods to detect the presence of prohibited animal substances that could be introduced into U.S. animal feed supplies by bioterrorists. Once developed and optimized, these methods would be used by FDA diagnostic laboratories to test prohibited substances in routine animal feed surveys;
  • Intensify the review of products offered for import and collaborate with the U.S. Custom Service on safety and security issues at ports of entry;
  • Increase the number of import line entries reviewed for admissibility into domestic commerce;
  • Strengthen relationships with state partners and solicit interest in the expansion of contracting efforts with state laboratories to provide surveillance and surge capacity related to counter terrorism activities; and,
  • Sample domestic animal feeds and those detained at U.S. ports of entry that contain ingredients possibly derived from contaminated animals.

 

SELECTED FY 2003 ACCOMPLISHMENTS

 

EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK

 

Bovine Spongiform Encephalopathy (BSE)

  • As of September 23, 2003, inspected over 25,000 renderers, feed mills, and other firms, including on-farm mixers and ruminant feeders, to determine compliance with the BSE feed regulations. Re-inspections of the facilities determined to be out of compliance with the BSE regulation are on going;
  • Published a new Compliance Program entitled "BSE/Ruminant Feed Inspections" to assist investigators in determining compliance with the FDA regulation (21 CFR Part 589.2000) prohibiting the use of most animal proteins in ruminant feeds; conducted five training sessions for investigators on the new compliance program to enhance uniformity and quality of domestic inspections, and provided updates on the science of BSE and animal protein detection methods; and, issued a new import alert that called for the detention without physical examination of animal feed products from BSE-at-risk countries that were analyzed as containing animal protein material;
  • Issued 7 Warning Letters for animal proteins prohibited in ruminant feed, and 14 class II recalls at 12 firms in response to violations of the BSE rule;
  • Created a new BSE web report which provides inspectional information derived from the ORA-FACTS database involving all active FDA-inspected firms. This web report allows for both dynamic, multi-field search and for a spreadsheet download of all firm inspections;
  • Organized the Animal Feed Safety Team comprised of representatives from various FDA offices, as well as with two State Departments of Agriculture. Approved and completed a charter, project definition and concept documents; and,
  • Held a two day meeting in September 2003, with industry, government and public consumers, to discuss the potential development of a comprehensive, risk-based Animal Feed Safety System. In addition, information was obtained how animal feeds (individual ingredients and mixed feeds) should be manufactured and distributed, to minimize risks to animals consuming the feed and humans consuming food products from animals.

 

Premarket Review

 

  • Decreased the backlog of overdue submissions in order to move FDA back on track towards meeting statutory and stakeholder requirements for new animal drug application reviews. FDA reduced its backlog by 101, from 278 to 177, between October 1, 2002 and September 30, 2003. This reflects a 36.3 percent reduction.
CVM Significant Approvals
Type of Approvals FY 01 FY 02 FY 03
Totals 39 59 64
Originals 22 30 44
Supplementals 16 28 19
Food Additive Petitions 1 0 1
Public Master File 0 1 0
Sample of Significant
Approval Types (Non-Add):
   
New Chemical Entity
2
4
4
New Indication
2
8
4
New Species / Class
6
8
8
New Minor Species
1
1
0
ADAA
7
16
2

 

In FY 2003, the Program experienced 8 percent increase in the number of significant approvals of new animal drugs.

The number of approvals is expected to increase in the next several years as FDA implements the newly enacted Animal Drug User Fee Act of 2003 that is intended to improve the efficiency of the review of animal drugs and shorten the time for new or improved therapies.

  • Approved two noteworthy medicines.
    • Neutersol provides a non-surgical (or chemical) castration for young male dogs, which is the first FDA-approved alternative to surgical castration. This will permit better control of pet over-population and give shelter managers a positive way to address that problem by allowing a veterinarian to administer the product to dogs on-site to ensure that adopted dogs are sterilized. Previously, shelters relied on owners to take the adopted dogs to a veterinarian for surgery for sterilization.
    • Optaflexx is used for increasing the weight gain for cattle fed in confinement prior to slaughter. This medicine will also improve feed efficiency.

 

Biotechnology

 

  • The Animal Biotechnology Working Group made progress on developing the science basis for the regulation of animal biotechnology products and issued its first annual report which details its efforts in coordinating reviews within and outside of CVM on the safety of transgenic biopharmaceutical producing animals. Transgenic biopharmaceutical producing animals include those animals that contain heritable genes constructs that allow them to produce products for pharmaceutical or industrial uses;
  • Issued a Draft Executive Summary of "Animal Cloning: A Risk Assessment", discussed publicly at the November meeting of FDA's Veterinary Medicine Advisory Committee. The draft risk assessment, which evaluates the risks to animals involved in the cloning process, is built on the findings of the National Academy of Sciences which indicated that food products derived from animal clones and their offspring are likely to be as safe to eat as food from their non-clone counterparts; and,
  • Conducted several investigational inquiries to researchers who may not be aware of the need to obtain pre-market approval for their genetically engineered products. FDA issued a reminder letter to all land-grant universities involved in research dealing with genetic engineering that animal species commonly used for food in research require an investigational new animal drug exemption or another type of regulatory approval.

 

Imports, Inspections, and Surveillance

 

  • Performed an inter-laboratory evaluation of a commercial chloramphenicol screening test favored by state regulatory agencies. This Ridascreen test was found to be acceptable for regulatory use. Chloramphenicol is an effective, but toxic, antibiotic that is banned for use in all food producing animals. The presence of any detectable level of chloramphenicol in food is forbidden and foods so adulterated may not be imported for sale in the U.S.;
  • Developed and validated sensitive and specific analytical procedures to definitively identify the presence and quantity of nitrofuran metabolites in shrimp. Like chloramphenicol, detectable levels of nitrofurans or their metabolites in food are not allowed;
  • Conducted a training course on the Residue Violation Information System (RVIS), and the Tissue Residue Information Management System (TRIMS) for personnel monitoring illegal drug residues in meat and poultry. RVIS is an interagency database developed to enable the timely sharing of information on residue violations. TRIMS, an FDA database linked to RVIS which contains results from the Department of Agriculture's Food Safety and Inspection Service reported residue violations. The objectives were: enable FDA District Program Monitors to access RVIS; identify patterns of egregious violations; add inspectional information, and provide management with violator reports; and,
  • Created an outreach program to educate producers, veterinarians and students about preventing drug residues in dairy animals; investigated 447 tissue residue violations; and issued 65 tissue residue-related warning letters; 6 injunctions, and 1 criminal action.

 

Emerging Issue -- Monkey-Pox

 

  • Involved in the coordination and enforcement of the FDA/CDC Joint Order on Monkey-Pox, a zoonotic disease that spread from imported African rodents to prairie dogs to humans. The Joint Order was done under the Public Health Service Act; and,
  • Developed an approach to assure affected parties were notified of the Joint Order, and coordinated the follow-up to possible violations of the Order; stationed staff at CDC in Atlanta to work cooperatively on developing guidance for this issue and evaluated requests for permits to allow movement of animals for reasons other than those identified in the Joint Order, and drafted with CDC the Interim Final Rule for Monkey-Pox that went on display November 3, 2003.

 

Interim Rule to Prevent Transmission of Monkeypox

To prevent the transmission of monkeypox, a rare viral disease, today the Food and Drug Administration (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. "Today's actions will minimize the likelihood of additional problems related to monkeypox."

Earlier this year, an outbreak of monkeypox linked to exotic animals caused 37 confirmed, 12 probable, and 22 suspect cases in the United States. Monkeypox is a communicable viral disease that occurs primarily in rain forest regions of central and west Africa. Discovered in 1958 in Africa, monkeypox was first reported in prairie dogs and humans in the United State sin May 2003.

 

IMPROVING PATIENT AND CONSUMER SAFETY
Antimicrobial Resistance

 

  • Finalized and published Guidance for Industry #152 on antimicrobial resistance. This guidance was developed with public input and is significant because it provides a scientific, risk-based approach to preventing antimicrobial resistance that may result from the use of antimicrobial drugs in food-producing animals;
  • Continued to review previously approved new animal antimicrobial drug submissions with respect to antimicrobial resistance and human food safety; and,
  • Completed the Abattoir (slaughterhouse) survey wherein bacterial samples were obtained from abattoir workers handling live chickens and compared them to bacterial samples from a human control group. The purpose of the study was to examine the extent to which human antibiotic resistance may be transferred to humans from the food and animal production environment. The abattoir study results showed that the prevalence of Campylobacter was higher among abattoir (slaughterhouse) poultry workers (48 percent positive) than among the general population (14 percent positive) living in the same general geographical area. The findings would suggest that poultry workers may be at higher risk for exposure to foodborne pathogens, in this case from the poultry production environment, than the general population.

 

Guidance on Evaluating the Safety of Antimicrobial New Animal Drugs

The FDA issued a guidance document (Guidance for Industry #152 ("Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern") that for the first time outlines a comprehensive evidence-based approach to preventing antimicrobial resistance that may result from the use of antimicrobial drugs in animals. Antimicrobial drugs, such as antibiotics, are medicines often used to treat bacterial infections in both humans and animals. Their use has been one of the great advances in modern medicine -- helping to prevent many of the leading causes of death for most of human history.

When bacteria develop resistance, human and animal health is at risk because the medicines that we depend on to treat infections become ineffective. There are several important sources of this problem, including inappropriate use of antibiotics in people, but the new FDA guidance addresses the issue of the use of antimicrobials in food producing animals as a contributing factor to the development of antimicrobial resistance.

The guidance provides a scientific process for assessing the likelihood that an antimicrobial drug used to treat an animal may cause an antimicrobial resistance problem in humans consuming meat or other byproducts from that animal. This process can help prevent antimicrobial drugs with a high risk of causing such problems from being improperly used in food producing animals, and thereby potentially leading to antimicrobial resistance in humans. The guidance is directed at animal drug sponsors who seek FDA approval of an antimicrobial for use in food-producing animals. More information is available online at ww.fda.gov/oc/antimicrobial/questions.html.

 

National Antimicrobial Resistance Monitoring System (NARMS)

 

  • Completed a study as a part of the NARMS to collect data on the prevalence and antimicrobial drug susceptibility of foodborne bacteria in retail meat. The research findings were:
    • Campylobacter was recovered from chicken more often than the other three meat types;
    • Salmonella was recovered from turkey more often than the other three meat types;
    • Enterococci were recovered from all meats at similar contamination rates (all above 96 percent);
    • No Salmonella were isolated from any pork and no Campylobacter were isolated from ground beef; and,
    • The results of this ongoing study demonstrate that Campylobacter and Salmonella are present in a significant percentage of retail poultry, including antibiotic resistant variant.
  • Provided an intensive training course on methods to ensure that the FoodNet sites located in nine states follow standardized protocols to ensure the success of the NARMS retail food program. Nine states currently participate in monthly grocery store sampling of various types of meat to culture for the presence of Salmonella and Campylobacter. In addition, four sites (Georgia, Maryland, Oregon, and Tennessee) culture the rinse for E. coli and enterococci;
  • Added the retail food component of NARMS which provides a more representative picture of the contribution of the food supply to antimicrobial resistance among enteric bacteria of animal origin, and continued sharing information with the other agencies since the three arms of NARMS (human, animal and retail meat) are integral components of the monitoring system. FDA is able to track the changes in susceptibility among isolates from all three sources;
  • Supplied data to PulseNet, a national computer network of DNA fingerprinting database for foodborne pathogens, and worked in conjunction with the NARMS/FoodNet retail food surveillance, in determining the genetic relatedness of all Salmonella and Campylobacter isolated from the FoodNet sites; and,
  • Completed the second year of a three-year cooperative agreement with Mexico to determine the prevalence of Salmonella, Campylobacter, and quinolone-resistance generic E. coli in humans, chicken, cattle, and pigs on farms, and the identification and comparison of the susceptibility profiles of the Salmonella, Campylobacter, and E. coli isolates. The agreement has also:
    • Fostered collaboration among Mexican and U.S. microbiologists and epidemiologists. As a result, the Mexican national capacity in the surveillance of foodborne disease and resistant pathogens has been strengthened; and,
    • Recognized FDA's efforts by being awarded the HHS Secretary's Award for Distinguished Service.

 

FDA Conducts Retail Meat Pilot Study

Retail foods such as raw meat may be contaminated with resistant organisms. FDA conducted a pilot study as a part of the NARMS to collect data on the prevalence and antimicrobial drug susceptibility of foodborne bacteria in retail meat; develop laboratory methods for the testing of retail meat products; and, determine the feasibility of conducting on-going surveillance of retail meats. A random sample of 300 of approximately 500 retail groceries located in Iowa was selected with a total of 981 samples from 263 groceries were collected as part of the Iowa Pilot Study and more than 2,000 bacterial isolates were tested at FDA. The results from this study will generate prevalence and antimicrobial drug susceptibility data on foodborne organisms such as Salmonella, Campylobacter, and Enterococcus spp. The study will also help quantify the role contaminated food plays in spreading antibiotic resistant bacteria.

 

PROTECTING AMERICA FROM TERRORISM
Counterterrorism

 

  • Participated in the May Top Officials 2 (TOPOFF) exercise and assisted the Agency in identifying information and coordinating responses relating to animal drug and feed issues with participants from other government agencies and industries. During the TOPOFF 2 exercise, CVM coordinated an "outside of the box" component leading to the prevention of continued zoonotic spread of the plague involving owners and their pets;
  • Worked with the Department of Energy and Iowa State University on a database to describe test method capabilities of veterinary diagnostic laboratories;
  • Intensified the review of products offered for import, and collaborated with the Department of Homeland Security's Customs and Border Protection at ports on safety and security issues. FDA also played an active role in providing information about how to take, preserve, and ship an appropriate feed or animal sample to laboratory for analysis; and,
  • Drafted preliminary assessment of vulnerabilities in the feed industry, and is working to update its Counterterrorism Plan on emergency preparedness and response, including scenarios where animal feeds may be a vector. Additionally, interagency mock exercises on response to BSE introduction to the U.S. are taking place.

 

STRONG FDA

 

Under this strategic goal, the Animal Drugs and Feeds Program supports the Agency efforts to strengthen its infrastructure, enhance employee performance, and take other steps to build a high functioning organization. Some of the accomplishments achieved in CVM include:

  • Improved financial management -- CVM continues the implementation of activity-based costing (ABC) practices that directly support the FDA Strategic Plan and CVM's "Back to Basics" approach. The ABC process clearly communicates the Program's priorities to the front line staff and emphasizes what is important for staff to spend time on. Included in the "Back to Basics" strategy are the development of a five year business plan and a project management tracking system;
  • Strategic management of human capital -- CVM developed and implemented strategy to integrate its staff college competency model with the recruiting and interviewing process to ensure selection of best candidates by using the Lominger Recruitment Architect, a tool for identifying the best qualified candidates, by providing targeted interview questions that screen for technical skills, leadership, management and team skills, and learning agility. CVM's Staff College was recognized as having the best practice government-wide for its Competency Model and Learning Management System;
  • Competitive sourcing --CVM conducted meetings for all staff to explain the competitive sourcing process and administrative consolidation efforts; and,
  • Integration of Budget and Performance -- CVM developed a Center Strategic Plan that supports and nests within the FDA Strategic Plan. The major theme of the CVM plan is "Getting Back to Basics" that involves re-engineering many of program's business processes and developing new ways to measure and improve program performance on the Program's core mission and functions. Over 140 individual project plans have been developed, approved and are being monitored for progress by the Center's Strategic Plan working group.

 

Animal Drugs and Feeds Program Activity Data
Program Workload and Output FY 2003
Actuals
FY 2004
Estimate
FY 2005
Estimate
New Animal Drug Applications (NADAs):2
 
 
 
Received

28

25

25

Completed

29

25

25

Approved

18

19

19

Pending 3

11

11

11

NADAs - review & act on 90% w/in 1
 

295 days

270 days

New Animal Drug Application Supplements:2 4
 
 
 
Received

568

596

626

Completed

570

598

628

Approved

439

457

475

Pending 3

225

223

221

;Safety & Efficacy -- review & act on 90% w/in 1
 

320 days

285 days

Manufacturing -- review & act on 90% w/in 1
 

225 days

190 days

Abbreviated New Animal Drug Applications: 2
 
 
 
Received

49

49

49

Completed

54

54

54

Approved

26

26

26

Pending 3

41

36

31

Abbreviated New Animal Drug Application Supplements::2 4
 
 
 
Received

143

150

158

Completed

128

135

142

Approved

87

92

97

Pending 3

61

76

92

Investigational New Animal Drug (INAD) Files:5
 
 
 
Received

2,175

2,200

2,200

Completed

2,521

2,200

2,200

Pending 3

293

293

293

Protocols -- review & act on 90% w/in 1
 

125 days

100 days

1 CVM is transitioning to user fee goals (reference CVM budget justification and performance plan). A sample of the enhanced performance under the ADUFA program is reflected by the improved timeliness (number of days). At this time, it is not possible to anticipate a large increase in submissions from industry. Also, FY 2003-2005 figures do not include invited labeling change supplemental applications because it is not possible to accurately project sponsor or CVM requests for this type of application.
2 Includes originals and reactivations. If the application is not approvable, the sponsor may submit additional information until the Agency is able to approve the application.
3 Reflects submissions (received during the fiscal year) which still require review.
4 A supplemental application is a sponsor request to change the conditions of the existing approval. They can be significant (a new species or indication), or routine (product manufacturing changes).
5 An INAD or JINAD file is established at the request of the sponsor to archive all sponsor submissions for a phased drug review including: request for interstate shipment of an unapproved drug for study, protocols, technical sections, data sets, meeting requests, memos of conference and other information.

 

Animal Drugs and Feeds Program Activity Data

 

Program Workload and Output FY 2003
Actuals
FY 2004
Estimate
FY 2005
Estimate
Investigational New Animal Drug (INAD) Files: (contd)
 
 
 
Data --review & act on 90% w/in 1
 
320 days 285 days
Generic Investigational New Animal Drug (JINAD) Files:
 
 
 
Received 132 100 100
Completed 235 108 108
Pending 26 18 10
Investigational Food Additive Petitions 42 40 40
Food (Animal) Additive Petitions 6 2 28 30 30

Production & Manufacturing Defect Reports - Received

- Reviewed

2,075

1,775

2,000

1,900

2,000

1,900

Adverse Experience Reports (AERs) - Received

- Reviewed

23,079

19,483

25,000

23,600

25,000

23,600

Animal/Medicated Feed Partnership Agreements 25 30 30
NARMS Salmonella Isolates Tested - 03 data not available yet* * 12,000 12,000
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS7
 
 
 
Preapproval/Bioresearch Monitoring Programs Inspections 102 190 190
Drug Process and New ADF Programs Inspections 255 260 260
BSE Inspections 2,598 2,800 3,720
Feed Contaminant Inspections 57 100 100
Illegal Tissue Residue Program Inspections 324 364 364
Feed Manufacturing Program Inspections 457 300 300
State Contract Inspections: BSE 3,119 3,100 5,600
State Contract Inspections: Feed Manufacturers 412 360 360
State Contract Inspections: Illegal Tissue Residue 407 670 670
State Partnership Inspections: BSE & Other 700 700 700
Total FDA & State Contract Inspections 8,431 8,844 12,264
State Contract Animal Drugs/Feeds Funding $1,650,000 $1,980,000 $5,000,000
Domestic Laboratory Samples Analyzed 8 1,374 2,400 2,400
PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS
 
 
 
Foreign Preapproval/Bio Monitoring Programs Inspections 30 50 50
Foreign Drug Process and New ADF Program Inspections 16 10 10
Total FDA Foreign Inspections 46 60 60
6 Non-drug substances added to animal feed are considered Food Additive Petitions and require review and approval.
7 An Inspection is any visit to a firm during which all or part of one or more phases of that establishment's operation is evaluated against appropriate Agency requirements.

 

Animal Drugs and Feeds Program Activity Data

 

Program Workload and Output FY 2003
Actuals
FY 2004
Estimate
FY 2005
Estimate
Import Field Exams/Tests9

3,261

500

500

Import Laboratory Samples Analyzed8

388

775

775

Import Physical Exam (Subtotal)

3,649

1,275

1,275

Import Lines

146,360

173,000

204,000

Percent --Physical Exams of Import Lines

2.5%

0.74%

0.63%

8 Laboratory Samples Analyzed are product samples physically analyzed in the laboratory to determine whether or not the product is in compliance with Agency requirements.
9 A Field Exam is the on-site examination of a product that is sufficient in itself to determine whether the product is in compliance with Agency requirements.

 

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