Animal Drugs and Feeds

^1/ Reflects the enacted levels adjusted for the 0.22 percent rescission, which accounts for $141,000 in the Animal Drugs & Feed program.
^2/ Reflects a decrease in base funding from FY 2001 of $73,000, for Human Subject Protection & Bioterrorism.
^3/ Pay increases shown on separate line, and not reflected in individual increase areas.

Historical Funding and FTE Levels

MISSION

• Protect the health and safety of all animals that serve either as companions or food sources for mankind.
• 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.
• Surveillance of marketed products for all animal drugs and feeds to minimize harm to humans or animals, which might arise from the use of these products. This is accomplished through science-based review of drug experience reports, nationwide monitoring systems, and compliance programs implemented by the FDA field offices through inspections, sample collections and analysis, and investigations.  

REQUESTED INCREASES

Pay Increase  + $2,354,000

FDA’s request for funds to cover pay cost increases is vital to the Agency because personnel are so essential to accomplishing its mission.  Pay increases have a major impact on FDA because the Agency is more people-intensive than many other government agencies.  Payroll accounts for over 60 percent of the total FDA budget.  This has a significant impact on all activities in FDA, particularly the field.  In order to maintain the level of activities carried out in FY 2001, FDA is requesting $40,000,000 to cover the cost of the FY 2002 pay raise, annualization of the FY 2001 pay raise, anticipated within grade increases, and one extra day of pay.   The Animal Drugs and Feeds Program portion of this increase is $2,354,000.

Funding of the pay increase is necessary to ensure the integrity of the Agency's work in the field labor force for inspections, compliance, and for the Center for Veterinary Medicine (CVM) to sustain recent progress made toward meeting the core statutory requirements of the program. Specifically, this increase will position the program to maintain the FY 2001 levels of 75 percent of new animal drug applications (NADAs) and Abbreviated New Animal Drug Applications (ANADAs) reviewed and acted on within 180 days, conduct biennial inspections of 50 percent of animal drug and feed manufacturers, and continue to provide, through NARMS an early warning system for identifying emerging resistance in food borne pathogens.

Bovine Spongiform Encephalopathy (BSE)   + $13,100,000 and 105 FTE

Bovine Spongiform Encephalopathy (BSE), widely known as “Mad cow disease”  is a deadly chronic, degenerative disorder affecting the central nervous system of cattle.   The first case was diagnosed in 1986 in Great Britain, and is spread via meat-and-bone meal fed to cattle.  Some of the feed given to cattle includes remnants of the slaughtering process, such as the brain and spinal cord, which may harbor the agent that causes BSE.  BSE belongs to a group of progressive degenerative neurological diseases known as transmissible spongiform encephalopathies (TSEs).  There is strong epidemiologic and laboratory evidence suggesting that the human disease of new variant Creutzfeldt-Jakob disease (vCJD) and BSE are caused by the same infectious agent.  The goal of FDA is to prevent the introduction of BSE in U.S. cattle.

On August 4, 1997, FDA’s Regulation, entitled “Animal Proteins Prohibited From use in Animal Feed” was finalized.  The purpose of the rule is to prevent the establishment and amplification of BSE through animal feed.   The regulation prohibits the use of certain proteins derived from mammalian tissue in feeding ruminant animals.   Active surveillance efforts have yet to detect BSE in the U.S.  If BSE were to enter the U.S., it would pose a serious health risk to humans, and be financially devastating to the U.S. beef industry.  FDA’s goal is to assure 100 percent compliance with the BSE feed regulation through inspections and compliance actions.  With this increase, FDA will:

• Modernize the existing information technology infrastructure to facilitate electronic inspection reporting and information collection and distribution;
• Develop and validate detection methods for BSE collaborating with experts and foreign scientists to assist in developing BSE methods;
• Educate industry and the general public on BSE through public meetings, publications, and FDA’s website;
• Review and evaluate field inspection data and take enforcement action when necessary;
• Train Federal and state inspectors on the BSE feed regulation, update them on the current European Union situation, Animal Plant and Health Inspection Service (APHIS) authority and approach, and what to look for and how and when to sample;
• Develop a domestic sampling plan, collecting and analyzing 600 domestic feed, and feed component samples for BSE related contaminants.  In addition, the Animal Drugs and Feeds Program will increase the number of import samples by 600.  This sampling plan will ensure proper labeling of animal feeds and feed components;
• Conduct targeted BSE inspections of all renderers and licensed and non-FDA licensed feed mills handling prohibited material, such as meat and bone meal on a yearly basis;
• Leverage with State agencies by funding approximately 4,000 contract inspections of feed mills and renderers, and conduct compliance, follow-up, and audit inspections to state contracts; and,
• Provide intensive line entry and label review of an anticipated 175,000 import line entries for use in domestic commerce for the Animal Drugs and Feeds Program by expanding import staff by 17 FTE.

Imports and Inspections  + $1,000,000 and 4 FTE (Budget Authority +$300,000 and 2 FTE; User Fees +$700,000 and 2 FTE)
Budget Authority

Surveillance of the animal drug industry and the marketplace for imports is necessary to assure that animal drugs are available and that they are manufactured according to Good Manufacturing Practices (GMPs).  This is necessary to ensure that companion and other non-food animals are treated with safe imported products.  The importation of food and animal feed from other countries with facilities that lack proper food safety process controls is growing.  For imports the Animal Drugs and Feeds Program collects samples and conducts a laboratory analysis on about 0.3 percent of animal drug and feed products.  The ability to protect consumers will be compromised without additional inspectors and updated review criteria to examine imports.  With this increase FDA will:  

• Increase domestic inspection and take appropriate regulatory action when necessary;
• Ensure current information is available to import examiners to ensure well founded regulatory decisions; and,
• Conduct 30 inspections for illegal residue and contaminants in domestic animal feed.

Proposed User Fees

FDA proposes to collect $700,000 in additive import user fees to fund the Operational and Administrative System for Import Support (OASIS), and other import operations.  The OASIS system enables FDA to substantially reduce the risk of potentially harmful foods and other imported products reaching the American market place.  The importer/broker community benefits through faster turn-around times, elimination of large volumes of paperwork, and reduced costs of doing business.   OASIS will give FDA staff access to historical information to better target products and firms at high risk, the ability to plan inspections more effectively, and the ability to share findings from inspection and lab analyses with other offices.   With this increase FDA will:

• Modernize the Operational and Administrative System for Import Support (OASIS) to allow import reviewers to have rapid and direct access to information necessary for entry decisions; and,
• Increase data audits, import filer training, and liaison activities to ensure the integrity of import data submitted by import filers.

Food Safety  + $1,500,000 and 6 FTE

The Animal Drugs and Feeds Program is requesting food safety increases in four areas: Antimicrobial Resistance, Hazard Analysis and Critical Control Point (HACCP), aquaculture, and animal biotechnology.   The first area, antimicrobial resistance is a top priority for the Center and is important because several bacterial species have developed strains that are resistant to multiple antimicrobial drugs.  We need to take steps to minimize food borne disease outbreaks and identify emerging health problems from non-human use of antibiotics. The next increase, HACCP is a systematic approach for assuring food safety, and is employed by segments of the food industry and federal regulatory agencies to control and prevent hazards, most notably those of microbiological origin.  The third increase, aquaculture, is a rapidly growing industry abroad, and discussions with foreign governments reveal that there are many animal drugs used in the production of imported aquaculture products which are not approved, and are even banned in the U.S.  Ingestion of animal drug residues and contaminants that may be contained in imported food products could potentially cause unsafe conditions for humans, ranging from drug allergies to cancer.  The fourth area is Biotechnology, or genetically engineered animals.  This industry is characterized by entrepreneurs and small companies due to the relatively low startup costs for production.  Since the science is only now emerging we must conduct research, develop testing methods and build the regulatory system for these products.  With this increase, FDA will:

• Conduct research to identify food animal species causing human drug resistance;
• Develop educational devices, such as interactive CD-ROMS, to describe the issue of antimicrobial resistance and government and industry efforts taken to reduce or eliminate risks to consumers from the use of antimicrobials in food-producing animals;
• Propose HACCP regulations for the animal and vegetable rendering (processing) industry by September, 2002, and organize a pilot program with one or two manufacturing plants. FDA regulation 21 CFR 500.35 declares certain feed ingredients to be adulterated under 402(a) of the Federal Food Drug and Cosmetic Act if they contain Salmonella;
• Develop training programs for federal and state inspectors to conduct HACCP audit inspections and co-sponsor workshops with the field to gather information and support from the feed industry;
• Compile a list of animal drugs that are used in foreign aquaculture and develop risk assessment priorities by importance to human health, through literature searches and equivalence discussions with other nations;
• Prepare guidance’s to the industry explaining that animal biotechnology products are subject to premarket approval as new animal drugs and the information required to show safety and effectiveness for this class of products; and,
• Develop an inventory of firms that are developing products derived from bioengineered animals.  If animals are milked or they produce offspring, the planning should address their safe disposition because they may not be suitable for use as a human food source or to be rendered and processed into an animal feed component.

JUSTIFICATION OF BASE

Activities Related to Increases for FY 2002
Payroll

• FDA’s Animal Drugs and Feeds program protects the health and safety of all animals that serve either as companions or food sources for mankind.   This is accomplished through processing premarket applications 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 through the surveillance of marketed products for all animal drugs and feeds to minimize harm to humans or animals which might arise from the use of these products. 
• The field component of Animal Drugs and Feeds inspects regulated industry, and collects and analyzes samples.  Other activities that often arise are review and management of enforcement actions, and consumer complaints, trace back efforts, and review of import entries for admissibility decisions.  These functions are inherently governmental and highly personnel intensive.

Bovine Spongiform Encephalopathy (BSE)

• Enforce the rule “Animal Proteins Prohibited From Use in Animal Feed”.  Prevent the establishment and amplification of BSE through animal feed.  The regulation prohibits the use of certain proteins derived from mammalian tissue in feeding ruminant animals.  In addition update compliance guidance regulations, when necessary, and work with state counterparts on the coordination and inspection of all renderers, protein blenders, and feed mills, as well as some of the ruminant feeders.
• Maintain relationship with industry using telecommunication and conferences to provide information on regulation compliance and share inspection data.

Food Safety

• Leverage with the USDA Agriculture Residue Violation Information System and the FDA Tissue Residue Information Management System.
• Participate on a Joint Subcommittee on Aquaculture of the National Science and Technology Council of the Office of Science and Technology Policy in the Office of the Science Advisor to the President to encourage the development of safe and effective aquaculture in the United States. Assist in the development of approved aquaculture drugs through participation in the National Research Support Project #7 (NRSP #7).
• Identify emerging resistance in food borne pathogens through an early warning system, the National Antimicrobial Resistance Monitoring System (NARMS).   This has improved our ability to detect emerging resistance among food borne pathogens.
• Reduce the transfer of resistant animal pathogens to humans by conducting research studies and risk assessments that will yield future benefits, and begin to reverse the trend of food borne pathogen antibiotic resistance development.
• Deliver the food safety message to livestock producers and veterinarians at trade shows to educate them on the risk of antimicrobial resistance of bacteria following the use of antimicrobial drugs in food animals.
• Work with the public on the education of biotechnology products and assist developers through the regulatory process, while continuing research on challenging biotechnology issues.

Imports and Inspections

• Inspect 50 percent of statutory biennial inspections, which include registered animal drug and feed establishments and FDA licensed feed mills, and provide postmarket inspectional coverage and investigations for domestic establishments.  In addition continue sampling program for animal feeds detained at U.S. ports of entry in the U.S. that contained ingredients possibly derived from contaminated animals.
• Develop laboratory analytical methods to permit the analyses of products for chemical and microbiological hazards, and performed laboratory validation of analytical methods submitted to support pre-market product applications.

Activities Related to Other Priority Areas
Premarket Activities

• Increase 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.
• Continue pre-submission conferences, meeting, and workshops with   industry, and support electronic submission of applications.
• Conduct method validation studies required before applications for new drugs for food producing animals can be approved.
• Continue to expand inspectional expertise emerging technologies and increase quality assurance to monitor the inspection process to improve the quality and timeliness of product reviews.

Bioterrorism

• Collaborate with state diagnostic laboratories to ensure they are aware of the potential for a terrorist attack against food-producing animals, and begin to develop a secure communication network in order to share intelligence information, and continue to participate in the planning for and coordination of exercises simulating responses to bioterrorist attacks.
• Develop an internet feed contaminants web site to share information with federal and state governments, academia and industry.

Postmarket Activities

• Maintain early warning systems by collecting information from Drug Experience Reports and Adverse Event Reports.

Selected FY 2000 Accomplishments

Premarket Review

New Product Applications – During FY 2000, the Office of New Animal Drug Evaluation (ONADE) processed 5,497 submissions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), investigational new animal drug files (INADs), generic investigational new animal drug (JINADs) files and master files.       

• Approximately 74 percent of the submissions for NADAs, ANADAs and supplements were processed within the applicable statutory time frame of 180 days;
• 72 submissions were for original NADAs and ANADAs, and 977 were for supplements to previously approved NADAs and ANADAs;
• FDA reviewed 367 phased data submissions under INADs and JINADs to support approvals; and,
• FDA published 53 documents in the Federal Register relating significant NADA and ANADA approvals.  Significant approvals included:  3 new chemical entities, 8 products for use in new animal species, 1 new dosage form of a previously approved product and 4 products available in new dosages.

Antibiotic Resistance

Augmentations of NARMS during FY 2000 included:

• Testing non-typhoid Salmonella, Campylobacter, Enterococcus and E.coli isolates collected from animal sources; and, non-typhoid Salmonella, Campylobacter, Enterococcus, Shigella, Salmonella typhi and E. coli isolates from human clinical samples;
• Incorporated isolate collection from two additional state veterinary diagnostic laboratories;
• Began limited retail food testing in conjunction with the CDC; and,
• Continued studies with the University of California (Davis) and Michigan State University examining antimicrobial use on the farm.

International Expansion of NARMS:

• Conducted a pilot study with medical microbiologists from Mexican hospitals in close proximity to significant animal agriculture;
• Provided initial training for Mexican investigators in standardized laboratory methodologies for the isolation, identification, and antimicrobial susceptibility testing of food borne Salmonella; and,
• Sample collection and isolation of Salmonella from clinically ill humans in Mexican hospitals and from healthy children in community daycare centers.

Continued finalizing framework document describing FDA’s regulatory approach:

• Obtained input through avenues such as public meetings, workshops, and federal register notices;
• Examined the objectives of pre-approvals studies and their role in making microbial safety determinations;
• Prepared and released a discussion paper for public comment, outlining a proposed approach for applying the threshold concept;
• Conducted and finalized risk assessment study on Campylobacter;
• Initiated risk assessment feasibility study on Enterococcus; and,
• Developed Antibiotics Sensitivity Screening of Salmonella, to detect Salmonella with resistant genes to multiple antibiotics.

Bovine Spongiform Encephalopathy (BSE)

• Continued work to prevent the introduction and spread of BSE in the United States.
• Issued an interactive CD-ROM that provides training on the BSE feed regulation for use by FDA, state regulatory authorities, and the regulated industry.
• Continued enforcement strategy to conduct inspections of 100 percent of renderers, protein blenders and feed mills, and a sampling of ruminant feeders to assure compliance with BSE regulation.
• Began an evaluation of the inspectional information on the BSE feed regulation to begin developing a strategy for the future.
• FDA provided technical expertise and assistance to the Department of Agriculture (USDA) in identifying entry criteria for import examination.   FDA provided early information to its field offices in the identification of products susceptible to BSE contamination, and instructions regarding forwarding of this information to local USDA, Animal Plant Health Inspection Service (APHIS) offices.
• USDA/APHIS enacted an immediate prohibition on the importation of all meat and bone meal (MBM), bone/meat/blood meals, tankage, offal or any product containing such, which originates directly from Europe or was rendered/processed in European plants processing animal materials, regardless of the species of origin, including poultry and fish meal FDA issued an import bulletin to disseminate information to field import offices and to provide guidance to districts when they encounter any of these products.

Dioxin Contamination

FDA continued to follow through on earlier findings of animal feed contaminated with dioxins:

• Issued revised guidance to industry and the general public cautioning users of anti-caking products to check for dioxin;
• Coordinated an overall government response to the Environmental Protection Agency’s (EPA) dioxin risk assessment report as a member of the Inter-Agency Working Group, and developed an extensive question and answer document made available to the public through agency web-sites; and,
• Issued a sampling assignment to determine dioxin-like compounds in animal fats, animal meals, oilseed meal, deodorizer distillates, and molasses.

Animal Drug Availability Act (ADAA)

The primary effect of the ADAA, enacted in 1996, was to modify the effectiveness standard for new animal drugs. The following steps have been taken to implement the ADAA:

• The final rule on Medicated Feed Mill Licensing was published in the Federal Register;
• Issued a proposed regulation to implement the Veterinary Feed Directive Drugs provision of the ADAA and, a proposed regulation describing the procedures for requesting, conducting, and documenting a pre-submission conference published; and,
• Provided technical assistance on legislation to implement FDA’s proposal, the “Minor Animal Species Health and Welfare Act” (HR 4780), which was introduced in Congress.

Food and Drug Administration Modernization Act (FDAMA)

During FY 2000, Section 116 of FDAMA (section 506A of the act) has been implemented as follows:

• A proposed rule amending 21 CFR 514.8 supplemental new animal drug applications was published; and,
• A notice of availability of the draft companion guidance document to the above proposed rule entitled #83 Guidance for Industry:   Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA was announced.

Generic Animal Drug and Patent Term Restoration Act (GADPTA)

Generic animal drugs are approved under the Abbreviated New Animal Drug Application (ANADA) review process.  FDA publishes a bimonthly listing of all approved new animal drug applications in the FDA Veterinarian.  In FY 2000, the Office of New Animal Drug Evaluation (ONADE): approved ten ANADAs; received approximately a two-fold increase in JINADs (compared to FY 1999); and received 12 Suitability Petitions--six were approved, three were denied, one was not required, and two are currently under review.

Minor Use and Minor Species

Published a final rule to reclassify sheep as a minor species for all data collection purposes.  This reclassification allows sponsors of new animal drug applications to extrapolate human food safety data from a major species such as cattle.  This rule will allow the extrapolation of the tolerances for residues of new animal drugs in cattle to sheep.

Biotechnology

• CVM is working on a case study on genetically engineered salmon in an Office of Science and Technology Policy/Council on Environmental Quality (OST/CEQ) Interagency Working Group examining the regulatory framework for products of animal and plant biotechnology.
• CVM is contracting with the National Academy of Sciences/National Research Council (NAS/NRC) to examine risks and risk assessment methods for animal biotechnology products.  An ad hoc steering committee of the National Research Council’s Standing Committee on Biotechnology, Food and Fiber Production and the Environment will prepare a brief consensus report identifying risk issues concerning products of animal biotechnology.

Aquaculture

In support of Congressionally mandated aquaculture drug review in FY 2000:

• Hired two aquaculture drug reviewers and created the Aquaculture Drugs Team to perform review of aquaculture investigational new animal drug (INAD) files;
• Eliminated the backlog of aquaculture submissions awaiting review; and,
• Upgraded the aquaculture INAD database, and worked with INAD sponsors to generate the data necessary for aquaculture drug approvals.

Inspections and Recalls

• Provided audits of 1,000 feed mills, of which 350 were tissue residue domestic inspections completed by the states under contract to FDA.
• Awarded 19 state contracts for inspection of medicated feeds, 453 Good Manufacturing Practices (GMP)/BSE inspections and 96 BSE-only inspections for a total of $330,000 and 15 state tissue residue contracts for 548 inspections for a total of $260,000.
• In October 1999, Pet Valu International Inc. of Wayne, Pennsylvania recalled certain dog chew products manufactured by Farm Meats Canada Ltd. because of possible Salmonella contamination. Following notification from the Canadian Food Inspection Agency, FDA initiated inspections and sample collections that resulted in several nation-wide recalls and a seizure action.
• Non-pathogen related  incidents were investigated by FDA, including: adverse reactions; chemical contaminants; recalls; and drug residues.

Animal Drugs and Feeds
Program Activity Data

^1/ The Center has experienced an increase in the receipt of applications from FY 1999 to FY 2001. Companion animal drug applications received have increased by three-fold.
^2/ Includes originals and reactivations.  If application is not approvable, the sponsor may submit additional information until the Agency is able to approve the application.
^3/ All applications received during a fiscal year are not reviewed during the same fiscal year.  Pending applications indicates the number of applications in our backlog.
^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).

Animal Drugs and Feeds
Program Activity Data

^5/ Applications for non-drug substances added to animal feed are considered Food Additive Petitions, which require review and approval.

Animal Drugs and Feeds
Program Activity Data

⁶ /DERs contain AERs.  Due to an increased number of AERs within the submitted DERs, the number of DERs completed is not as great as in the past (4,400 in FY 1998).

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