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Articles from 1999 In April

Understanding prudent use of antimicrobials

Antimicrobial resistance in animal agriculture concerned mainly veterinarians and producers. That changed when the link was made between the resistance in animal and human pathogens.

Before that link, concern was for continued effectiveness of the few antibiotics approved for use in food-producing animals. The potential economic effect also had a direct impact on how veterinarians and producers viewed antimicrobial resistance.

The animal-human antibiotic resistance link, and the potential effect on human health, has created a new, much more emotionally charged issue.

The worldwide emergence of resistance in foodborne and human pathogens has led the World Health Organization to make the issue a top priority.

Defining Prudent Use of Antimicrobials WHO defines prudent use as that which “maximizes therapeutic effect of the antimicrobial agent while minimizing the development of antimicrobial resistance.”

An industry-wide task force altered that definition of “prudent” use to exclude the portion of the WHO definition concerning resistance. The task force cited a lack of data identifying patterns of use which reduce the selection for resistant organisms in a clinical setting.

The task force definition of prudent use is “use that provides the desired therapeutic effect.” The task force uses the term therapeutic as defined by the Food and Drug Administration’s Center for Veterinary Medicine to include treatment, control and prevention of microbial diseases. These definitions, in their strictest sense, might preclude the use of all subtherapeutic or production enhancement antimicrobials unless their use could be considered control or prevention.

WHO and the Centers for Disease Control both have a strong bias toward the human side of this discussion, preferring to see subtherapeutic uses of antibiotics banned. Their logic, “when in doubt, don’t” says: “A risk has been identified. Potential risk has not been quantified. Why not err on the side of caution?”

What is overlooked in this scenario is the risk of removing antibiotics from food production and the resulting degradation of food safety. Is food produced with the benefit of antimicrobials actually safer and more wholesome than food produced without those benefits? The data to support this theory is as lacking as the data that refutes it.

What we do know is that therapeutic and subtherapeutic antibiotics still work. Especially in swine production, there continues to be ample supportive data for the use of antimicrobials for therapeutic as well as subtherapeutic applications. For years, antibiotics have demonstrated their efficacy in terms of welfare, economic and food safety benefits — and they continue to do so.

The definition of prudent use suggested by the task force, follows principles to promote efficacy, while at least theoretically minimizing the chance for resistance to develop. They suggested that therapeutic antimicrobial use be guided by the following simple principles:
► For proven clinical indications — only when indicated — at the appropriate dosage regimen,
► For as long as necessary and
► For as short duration as possible.

Antimicrobial resistance
Antimicrobial resistance is the ability of certain bacteria, normally destroyed by antibiotics, to survive exposure to that antimicrobial. Doctors prescribe antibiotics that are known to kill or inhibit growth of specific bacteria causing a particular disease.

Many bacteria, however, are naturally insensitive to some antibiotics. “Resistance” means that the bacteria no longer respond to the antibiotic therapy. “Susceptibility” is a term used to describe how sensitive bacteria are in responding to antibiotic therapy. What some people call resistant may in fact be just “less susceptible.”

Resistance to antimicrobials usually is a result of antimicrobial use. If you use them, resistance will likely, eventually, develop. Overuse and misuse of antibiotics may speed up the development of resistance. Long-term exposure to antibiotics allows resistant bacteria to be genetically “selected” from large populations which then pass the resistant gene on to future populations.

Some bacteria have natural, inherent resistance to antimicrobials and the genes for this resistance may reside together in small packets of their DNA. Science has discovered ways in which these resistant genes can be passed on from bacteria to bacteria within and even across species. David Reeves has addressed antimicrobial resistance in greater detail.

At issue
Opponents to their use don’t argue the importance of antimicrobials in animal agriculture. They have also acknowledged their importance for sustainable livestock production and for the control of animal infections to protect public and animal health. They further recognize that misuse of antimicrobials in humans by physicians has been a major source of resistance development in human pathogens.

The main concern of these opponents is those antibiotics which have both agricultural and human applications. If resistance develops in animals, which could be transferred to humans, it could result in making the disease more difficult to treat in the human patient.

A relatively new, effective class of antimicrobials referred to as the fluoroquinolones is of special importance to the human medical community. Evidence of resistance in human pathogens is starting to emerge.

Although this class of antimicrobials has only recently received approval for therapeutic use in poultry and cattle in the United States, this new class of antibiotics has been widely used in other parts of the world for human and veterinary purposes. These compounds are banned from extra-label use in all species of food animals in the United States.

Subtherapeutic and growth promotant uses of antimicrobials (especially any antimicrobials which are being used for therapeutics in humans or even animals) are of primary concern to those organizations promoting judicious use. Calls for discontinuing subtherapeutic use of antimicrobials has been made as far back as 1969 and some European countries have adopted this policy.

In the United States, the portion of the resistance issue which is receiving the most attention from the FDA’s CVM surrounds the fluoroquinolones. Since the approval in poultry in 1997, and for bovine in 1998, there have been increased efforts toward monitoring of resistance. The resistance issue is holding up the approval process as FDA officials consider the potential effect on human health. The FDA-CVM must have “reasonable certainty of doing no harm” to human health before an antimicrobial can be approved. This “reasonable certainty” must also be applied to the resistance issue. This issue will make future approvals for any farm animal antibiotics, which are first approved for use in humans, very difficult. 

Implications for livestock
With all the controversy swirling around food safety and antibiotic resistance issues of late, what are the real implications for animal agriculture, especially pork production?

I believe that we can observe what has happened in the European Union to get an idea of what the trend may be in the United States. The major implications I see are:
► The future approval of new therapeutic antimicrobials will certainly be slowed down as the FDA-CVM learns to come to grips with ways to address the resistance issue and its potential affect on human health.
► Subtherapeutic use of any antibiotic, which is currently used therapeutically in humans, will eventually be evaluated and be put “on the table” for restricted use.
► Over-the-counter availability of antimicrobials of all kinds will receive increased scrutiny.
► The extra-label use of antimicrobials will be accompanied with increased scrutiny and regulatory pressure.
► All production enhancement antimicrobial use will be reviewed in light of experiences in other parts of the world and pressures from organizations such as WHO and our own CDC.
► We will continue to develop production technologies which will leave us less dependent on the need for antimicrobials.
► New and improved methods of surveillance and tracking will be developed. The result will be the ability to trace problems back to the farm of origin and eliminate repeat problem herds.
► Use of antibiotics in the U.S. pork industry may become a barrier to free trade and product exports should we be unable to address these issues proactively.
► Educational programs will be developed for veterinarians and producers alike that will promote prudent use of antimicrobials and reduce the likelihood of developing resistance.

Judicious, therapeutic use

The American Veterinary Medical Association has funded a steering committee to develop basic guidelines of judicious antibiotic use. This committee has the charge of planning how to best disseminate this information throughout the various species groups. It will be essential for the various species groups to develop their own specific guidelines for use with producers, and then launch an educational effort to implement these guidelines. Following are the Judicious Use Principles as defined by the committee:

► Preventive strategies, such as appropriate husbandry and hygiene, routine health examinations, and immunizations, should be emphasized.

► Other therapeutic options should be considered before antibiotic therapy.

► Judicious use of antimicrobials, when under the direction of a veterinarian, should meet all requirements of a valid, veterinarian-client-patient relationship.

► Prescription, Veterinary Feed Directive, and extra-label use of antimicrobials must meet all the requirements of a valid, veterinarian-client-patient relationship.

► Extra-label antibiotic therapy must be prescribed only in accordance with the Animal Medicinal Drug Use Clarification Act amendments to the Food, Drug and Cosmetic Act and its regulations.

► Veterinarians should work with those responsible for the care of animals to use antimicrobials judiciously, regardless of the distribution system through which the antimicrobial was obtained.

► Regimens for therapeutic, antimicrobial use should be optimized using current pharmacological information and principles.

► Antimicrobials considered important in treating refractory infections in human or veterinary medicine should be used in animals only after careful review and reasonable justification. Consider using other antimicrobials for initial therapy.

In this context, this principle takes into account development of resistance or cross-resistance to important antimicrobials.

Use narrow-spectrum antimicrobials whenever appropriate.

Utilize culture and susceptibility results to aid in the selection of antimicrobials when clinically relevant.

Therapeutic antimicrobial use should be confined to proper clinical indications. Improper uses such as for uncomplicated viral infections should be avoided.

Therapeutic exposure to antimicrobials should be limited to treatments lasting only as long as needed to achieve the desired clinical response.

Limit therapeutic antimicrobial treatment to ill or at-risk animals, treating the fewest animals indicated.

Minimize environmental contamination with antimicrobials whenever possible.

Consult records of treatment and outcome to evaluate therapeutic regimens.

What should we do?

The development of Judicious Use Guidelines for pork production is in the works. Certainly, the continued development of a fundamental understanding of resistance by everyone involved with pork production is important, as is continued research and study of antimicrobial resistance. We must strive to assess the risks involved with continued use of antimicrobials.

Pork producers and veterinarians must work to assure that we are using antimicrobials properly and within the context of the judicious-use principles. We must understand that new approvals of antimicrobials may come with strings attached. That will force us to be more aware of the resistance issue and public health.

For instance, the VFD for the use of tilmicosin (Pulmotil) was an example of the types of increased controls that the regulators will require for new approvals. The VFD is just one case where regulations can be employed which encourage judicious use of antimicrobials.

There is no doubt that antibiotics and their use in animal agriculture have made a tremendous, positive impact on the quality and quantity of pork and the other meat protein products in the U.S. and around the world. We cannot let the emotionalism and sensationalism replace good science and judgment as we enter the next millennium. Antimicrobials have been a tremendous tool in the past and they promise to be even more important in the future as we attempt to meet the needs of a growing world population.

Antibiotic — a chemical substance produced by a microorganism which has the capacity, in dilute solutions, to inhibit the growth of or to kill other antimicrobials. Antimicrobial — an agent that kills bacteria or suppresses their multiplication or growth. This includes antibiotics and synthetic agents. This excludes ionophores and arsenicals.

Narrow-Spectrum Antimicrobial — an antimicrobial effective against a limited number of bacteria often applied to an antimicrobial active against either gram-positive or gram-negative bacteria.

Broad-Spectrum Antimicrobial — an antimicrobial effective against a large number of bacteria; generally describes antibiotics effective against both gram-positive and gram-negative bacteria.

Antibiotic Resistance — a property of bacteria that confers the capacity to inactivate or exclude antibiotics or a mechanism that blocks the inhibitory or killing effects of antibiotics.

Extra-label — Extra-label use means actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.

Immunization — the process of rendering a subject immune or of becoming immune, either by conventional vaccination or exposure.

Monitoring — monitoring includes periodic health surveillance of the population or individual animal examination.

Therapeutic — treatment, control and prevention of bacterial disease.

Veterinarian-Client-Patient Relationship — A VCPR exists when all of the following conditions have been met:

1. The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client had agreed to follow the veterinarian's instructions.

2. The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept.

3. The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regimen.

Veterinary Feed Directive drug — The VFD category of medicated feeds was created by the Animal Drug Availability Act of 1996 to provide an alternative to prescription status for certain therapeutic animal pharmaceuticals for use in feed. Any animal feed bearing or containing a VFD drug shall be fed to animals only by or upon a lawful VFD issued by a licensed veterinarian in the course of the veterinarian’s professional practice.

Viral Disease Control In Sows

The influence of viruses on sow herds has always been a challenge. Viruses that have caused major disease problems on sow farms in the past 5-10 years include swine influenza virus (SIV), porcine reproductive and respiratory syndrome (PRRS) and pseudorabies (PRV). These viruses cause similar disease signs and must be weighed as we discuss the impact of viral diseases in pork production units.

Some common signs include off-feed sows with elevated temperatures, increase in depression and lethargy, increase in coughing and other respiratory problems. All viruses that cause higher fevers may result in abortions. PRRS virus and PRV can cause abortions due to the impact of the virus on the unborn piglet. The effects of these viruses on piglets in the farrowing barn include a low-grade cough, off- feed piglets and gaunt, feverish piglets with an increase in depression.

PRV can also cause central nervous signs or paddling symptoms in piglets. These nervous signs are not common with either SIV or PRRS.

A typical SIV outbreak occurs in finishing pigs or sow herd and moves rapidly through the rest of the pigs on the farm. There is a high incidence of barking cough due to the effect of the influenza virus by irritating the bronchioles of the lungs. SIV is typically highly infectious, meaning the majority of the pigs are clinically affected, but low death loss.

In the past, there has primarily been one strain of SIV called H1N1. Recently, however, various diagnostic labs have identified a new strain referred to as H3N2. This different strain has resulted in significant number of respiratory outbreaks in sow herds and finishers. The traditional vaccines have not been effective for this new strain of SIV. Signs have also varied with this new strain, coughing and an increase in abortions.

The PRRS virus has created lots of problems in the last five years. This virus has been linked to abortion syndromes and off-feed sows. In addition, it causes a severe respiratory problem in nurseries and finishers. There appears to be large strain variations within the PRRS virus. These strain variations dictate how pathogenic a specific PRRS strain is.

Primary control methods for PRRS revolve around the isolation and acclimation (I/A) policies on specific farms and the status of the source herds. It is important to have replacement stock brought to the farm early enough to allow a minimum of 60 days I/A. Some producers have brought in feeder gilts or weaner pigs as replacements, which gives a longer time for acclimation.

PRV causes off-feed sows, a chronic cough, increased fever and depression. In vaccinated herds for PRV, there is usually no disease signs identified.

Case Study No. 1 I was called to a 1,500-sow, farrow-to-wean facility. This unit had been in operation for two years. Start up was excellent with farrowing rates over 85% and average wean weights over 11 lb. at 14-16 days.

In early December, a number of sows were off feed and feverish. Within the next 3-5 days, 60-70% of the herd had similar symptoms. About 50 sows aborted and replacement gilts seemed to be the hardest hit with respiratory distress, lethargy and off feed. Piglets in the farrowing barn exhibited a cough and were rough-haired and poor doing. Pigs were born weak and an increase in diarrhea was noted. Preweaning death loss went from under 8% to excess of 20%. The number of stillborns and mummies increased over the next month and the incidence of poor-doing pigs increased significantly.

Tissues were collected from sows and gilts that died and sent to a diagnostic laboratory. In addition, serum samples were retrieved to do serology.

These sows were PRRS positive with titers ranging from 1-2 on ELISA. SIV titers were also fairly high and the diagnostic lab reported sows positive for SIV. Piglets in the farrowing barn had interstitial pneumonia indicating PRRS virus. Pigs in downstream nurseries and finishers were positive for PRRS. The sows had been vaccinated for SIV as replacement gilts, but received no booster shots.

For control, the entire herd was vaccinated with SIV vaccine and a killed, autogenous PRRS vaccine. Some sows were given antibiotic injections to help control secondary bacterial problems. Over the next 6-8 weeks, production continued to improve with sows coming back on feed and piglet quality reverting to previous levels.

Case Study No. 2 I was called to a 350-sow farm that had a sudden onset of off-feed sows and an acute barking cough. Temperatures of the sows ranged from 104.5 to 106 F. There had been no abortions and most sows recovered within 3-4 days. Penicillin injections were given to sows with respiratory distress. One sow was euthanized and sent to a diagnostic lab. SIV was isolated from this sow. By the time the farm received the positive SIV diagnosis, sows were back on feed without disease problems. PRRS titers were fairly high but no disease or diagnostic evidence was found.

The viruses of SIV, PRRS and PRV can create big problems. Producers and their veterinarians should attempt to make a definitive diagnosis of which viruses may be present. Once a diagnosis is made, producers can mull various control measures. Contact your local veterinarian to assist you if you have any of the described disease problems.

Understanding Antimicrobial Resistance

While man and animals have shared the benefits of antimicrobials for more than 50 years, this may not be the case in the future. Recent identification of human pathogens which are resistant to multiple antimicrobials has been a source of alarm for public health officials.

These findings have raised concerns about the improper use of antimicrobials both in human and animal medicine. New discoveries about the mechanisms of antimicrobial resistance transfer between bacteria have further fueled this concern.

As a result, there has been a call for more judicious use of antimicrobials in human medicine and greater regulatory restriction on the use of antimicrobials cleared for use in all animals, including hogs. If proposed regulatory changes are fully implemented, they will greatly alter pork producer and veterinary access to antimicrobials.

It is clear the use of antimicrobials in animals can no longer be taken for granted and must be carefully guarded by judicious use. It is also becoming increasingly apparent that public officials will require producers and veterinarians to partner to assure proper application and administration of antimicrobials. This includes creditable consideration of the risk of resistance development and resistance transfer whenever antimicrobials are used.

The Principle Of Selective Pressure Bacteria compete with each other for nutrients and space. Because vital resources are inherently limited, survival and growth of bacteria depends on each individual bacteria's ability to exclude other bacteria. Whenever antimicrobials are used, sensitive bacteria are either killed or their replication is slowed.

However, resistant bacteria are not affected and are given a competitive edge not only for survival, but also for growth. If surviving bacteria also happen to be either human or animal pathogens, then the significance of this event becomes critical.

It should be noted that selective pressure is not limited to pharmaceuticals. Disinfectants and even heavy metals may also result in selection based on resistance.

How Antimicrobial Agents Work Antimicrobials work in conjunction with the animal's immune system to eliminate pathogenic bacteria. Antimicrobials either kill bacteria by altering essential cellular functions or by slowing bacterial growth and replication. Antimicrobials which kill bacteria are classified as bactericidal agents. Those which hinder normal bacterial cellular functions are classified as bacteriostatic agents.

By altering cellular functions such as cell wall (cytoplasmic membrane) synthesis, protein synthesis, DNA replication or inhibition of vital metabolic processes, antimicrobials negatively impact bacteria.

For example, beta-lactam antibiotics such as penicillin or penicillin derivatives affect the enzymatic controls which keep cell wall (peptidoglycan) degradation and synthesis in balance. By adversely altering the ratio of peptidoglycan synthesis and degradation, beta-lactam antimicrobials cause cell wall breakdown. Veterinarians use pharmacokinetic (how drugs effect bacteria) information such as this, along witha working knowledge of pharmacodynamics (how drugs act in the body) and microbiology, when deciding which antimicrobial to use. Obviously, the age and number of pigs in the group must also be considered with each decision.

How Bacteria Resist Antimicrobials To survive an antimicrobial challenge, bacteria adapt so as to avoid the harmful effects of the antimicrobial. It is this adaptation which results in resistance. In a broad sense, resistance occurs either by alteration of cell structure or cell metabolism. The mechanism of resistance is generally distinctive based on the type of bacteria and the antimicrobial.

Specifically, bacteria block antimicrobial effects by:

Altering cell wall integrity,

Use of enzymes to inactivate the antimicrobial,

Using enzymes to stop the antimicrobial from moving across the cell wall,

Active removal (efflux) of the antimicrobial from the cell,

Altering the site in the bacteria destined for the antimicrobial,

Altering the affinity of the site in the bacteria for the antimicrobial, or

Creating metabolic processes which bypass the effect of the antimicrobial.

In some cases, bacteria develop resistance to one antimicrobial and, at the same time, become resistant to another antimicrobial. This "cross-resistance" occurs in select cases, particularly when two antimicrobials are in the same class of compounds or the antimicrobials have a similar mode of action.

Resistance Memory The information necessary to avoid the effect of antimicrobial treatment is embedded in the genetic material of the bacteria. This genetic material is the resident memory of the cell which drives all cell functions.

Early work on resistance suggested that resistance is primarily encoded on plasmids. More recent work has demonstrated that resistance may also be encoded on the chromosome. Within the chromosome, there are specific islands of genes which direct resistance expression. Within these islands are operons, promoters and repressors. It is the operon which codes for resistance. The operon, when acted upon by the promoter, activates resistance genes. In the case of tetracycline exposure, a repressor is present which stops transcription of the gene, thus preventing its resistance expression.

As these mechanisms of control are better understood, it is hoped they can be managed to prolong antimicrobial effectiveness.

Bacteria may be encoded with genes which make them resistant to more than one antimicrobial. Bacteria eliciting resistance to multiple antimicrobials are of great concern, particularly in human medicine, because they limit the therapeutic options for physicians.

The Origin Of Resistance Even though bacterial resistance was recognized shortly after the discovery of antimicrobials, its origin and evolution are still poorly understood.

It is generally accepted, however, that resistance is a natural phenomena and that it originated with a point mutation within the bacteria. Point mutations are thought to be rare, however, the odds of mutation increase when selective pressure is applied. Even when mutations do occur, survival of the mutated organism is generally not good.

However, whenever a viable, mutated bacteria does survive, it can have a major impact, particularly in light of recent discoveries about resistance transfer.

The Transfer Of Resistance Since the late 1980s, there have been several new discoveries which have revolutionized scientific thinking about resistance transfer. It is now recognized that genetic material can be mobilized and transferred between bacteria by conjugation.

Further, it is generally accepted that resistance is mainly acquired from other bacteria. There is considerable debate within the scientific community about the frequency of this passive occurrence. It has been suggested that the odds of resistance transfer increase the more closely related the bacteria.

In short, it is the chance of resistance transfer which is particularly alarming to public health officials. They are concerned that genes encoded for resistance may be transferred to multiple species of bacteria and result in a significant risk to human health.

Characterization Of Resistance Most farm managers at one time or another have received laboratory reports indicating the degree to which animal pathogens are sensitive or resistant to specific antimicrobial agents. These measures are an assessment of a particular bacteria's ability to grow in the presence of specific antimicrobials on artificial media in a laboratory. Sensitivity tests have been valuable in selecting proper antimicrobials for treatment of disease.

However, caution must used in interpreting this data as it may not necessarily reflect what happens in the animal in every instance.

Molecular scientists characterize resistance using sophisticated methods which map gene sequences common to resistant bacteria. Mapping specific gene sequences allows for the grouping of bacteria based upon not only their actual expression of resistance but also on their potential for resistance expression. Further, it gives scientists a tool to trace these bacterial clones throughout animal populations.

Most of the epidemiologic studies of resistance prevalence consists of measures of phenotypic resistance. Little is currently known about the dynamics of resistance transfer between animals, the environment and human populations.

More importantly for the food animal industries, little is known about the relative risk of resistance transfer by bacteria which are able to survive meat processing and cooking. This information is critical for the pork industry to justify its continued access to antimicrobials.

Proactive Prevalence Monitoring To get a handle on the prevalence of resistance that exists within important bacterial pathogens, resistance monitoring systems are being established in many developed countries.

In the U.S., two monitoring systems have recently been established. One, measuring resistance in human pathogens, is at the Centers for Disease Control and Prevention (CDC). The second is a monitoring program which examines resistance in bacterial isolates from animals. This program is NARMS (National Antimicrobial Resistance Monitoring System) and is ongoing at USDA-Agricultural Research Service (see Tables 1 and 2).

NARMS measures resistance in clinical, farm level and slaughter bacterial isolates. These monitoring systems, while limited, are giving us a glimpse at the patterns of resistance that exist throughout the U.S.

Further, they will be able to demonstrate changing trends in resistance. The information gathered from these studies will be important in regulatory decisions that will affect the producer's and veterinarian's access to antimicrobials.

McNutt Elected To Top NPPC Post

A second generation Iowa pork producer, John McNutt, was elected the new president of the National Pork Producers Council (NPPC) during the association's annual meeting in Nashville recently. McNutt's roots run deep into the organization's history. His father, Paul, led the Iowa delegation to what has become widely known as "the Moline meeting." It was at that May 1966 meeting that producer-pledges reinforced the voluntary fundraising concept that served as the precursor to the voluntary pork checkoff program.

"I'm an independent pork producer with a long history of pork production," states the new NPPC president proudly. "I still have pigs in a barn my great grandfather built."

McNutt produces 5,000 hogs annually from his farrow-to-finish operation near Iowa City. He also assists his wife, Dr. Ilene Lande, in a biological products company they founded. Elmira Biological produces custom antiserum for use in biomedical research.

McNutt has held leadership positions at all levels of the industry. Since 1994, he has served on the Board of Directors of the Iowa Pork Producers Association. Additionally, he has served on numerous NPPC committees and task forces, including the Research Committee, Long-Range Strategic Planning Committee and the Networking Committee. Currently, McNutt chairs the NPPC's Science Committee and Budget Committee.

He is a graduate of Iowa State University in agriculture business and received his masters of business administration from the University of Iowa. McNutt is an Iowa Master Pork Producer and also received the first Brian Y. Davidson Fellowship from the Harvard Business School in 1995.

In an effort to prioritize the work of his coming term, McNutt says he will focus on opportunities that will allow pork producers to "thrive, not just survive."

To thrive, he believes, pork producers must first have an opportunity to compete on a level playing field. Next, the supply of pigs and pork must be in line with the demand. To accomplish these goals, he says, "Timely and accurate hogs and pigs inventories are just part of what we need to do to capture more information. We have to have more accurate market information that results in meaningful price discovery. We have to know what the marketing options are and have access to those options. We have to find a way to manage our packer capacity problems."

The new NPPC president-elect is Craig Jarolimek of Forest River, ND. He and his wife, Dawn, own and manage a 5,000-head finishing operation, and raise wheat, barley and sugar beats. A member of the NPPC Board of Directors since 1995, Jarolimek has served his state pork producer group in several elected positions, is a state Master Pork Producer and Pork All-American. He also serves on the NPPC Environment and Budget Committees and chairs the NPPC State and National Relations Committee.

The Jarolimeks have also been recognized as Jaycee Family of the Year and North Dakota's Outstanding Young Farmers.

And, newly elected NPPC vice president is Barb Campbell Determan of Early, IA. Determan and her husband, Steve, operate a 120-sow, farrow-to-finish operation that includes corn and soybean production. She has served on the NPPC Federation Council, the Demand Enhancement and Budget Committees, and the Long-Range Strategic Planning and Producer Communication Task Forces. A member of the NPPC Board of Directors since 1997, Determan chairs the Pork Safety Committee and the Diet/Health & Food Safety Policy Committee. She attended the University of Illinois, majoring in ag communications.

Other Election Results Five producers elected to three-year terms on the NPPC Board of Directors include: Steve Schmeichel, Hurley, SD; Don Herzog, Rapelje, MT; Jon Caspers, Swaledale, IA; Tom Pitstick, Fairborn, OH; and Whitley Stephenson, Smithfield, NC.

Rich Gallant, vice president of procurement and trading for Excel Corp., Wichita, KS; was elected to fill the Packer/Processor Industry Council's associate member seat on the Board, a two-year term.

Producers elected to the Pork Industry Nominating Committee responsible for selecting, interviewing and recommending candidates for national leadership positions, include: Rick Rehmeier, Augusta, MO, (producer-at-large seat); John Adams, Snow Hill, NC, (Federation Council seat); and Jim Quackenbush, Chokio, MN, (state president seat).

The National Pork Producer (Pork Act) Delegate Body also met during the National Pork Industry Forum in Nashville. The Pork Act Delegate Body serves three primary responsibilities: elect nominees to the National Pork Board for submission to the Secretary of Agriculture for his appointment, to set the checkoff rate, and to determine the amount of checkoff funds returned to the states.

Eight nominees are elected by the delegate body and ranked in priority order for the Secretary's consideration. He appoints five to the 15-member National Pork Board each year. Terms are three years.

The nominees, listed in priority order according to the votes cast by the delegate body, are: John Kellogg, Yorkville, IL, (incumbent); Sharon Oetting, Concordia, MO, (incumbent); Michael Bayes, Orient, OH; Deborah Johnson, Clinton, NC; Hugh Dorminy, Russellville, AR; Brad Thornton, Eagle, ID; Richard Alig, Okarche, OK; and Brett Rutledge, Yuma, CO.

What Does 'Quality-Assured Pork' Really Mean?

Quality and quality assurance have become commonplace words in the pork industry. Producers know they need to produce a quality product.

However, there are many definitions of quality in the pork business. For some, it is simply leanness. For others, it means customer satisfaction with the product.

While this Blueprint concentrates primarily on quality assurance with regard to use of antimicrobials and management alternatives to antimicrobial usage, a brief overview of other quality concerns is included in this overview.

Quality can encompass a combination of factors including taste, appearance, color, leanness, ultimate pH, water-holding capacity, intramuscular fat, nutritional value, wholesomeness and safety.

Every segment of the chain has quality expectations and contributes to the quality of the product. Producers want to know how their pigs fare relative to these pork quality considerations.

Packers want to know how the pigs they buy measure up. They may choose to provide incentives or discounts to reinforce their carcass quality preferences.

Processors prefer pork with a high water-holding capacity to use in the manufacturing of their products because it holds a cure better.

Consumers, in general, want a uniform, reddish-pink, fresh pork product with minimal purge and minimal visible fat, but they want that product to be tender, juicy and full of flavor.

Targeting Pork Quality While there is no one standard definition that meets all of the quality components of the pork chain, the National Pork Producers Council (NPPC) Quality Solutions Committee, composed of producers, packers and researchers has developed a series of pork quality targets. These targets represent minimums or ranges for quality attributes in fresh pork loins measured at 24 hours post-mortem. (See Figure 1 on page 8 for the pork quality targets.)

NPPC has an active program to address pork quality issues such as color, ultimate pH, water-holding capacity and intramuscular fat. The program addresses these through:

Research on technologies which can be utilized to define, quantify or solve quality concerns,

Education and communication of factors affecting pork quality and ways to deal with these factors throughout the pork chain, and

Development of new tools which will involve transfer of the quality technology to those who can implement it.

Examples of current NPPC research efforts are development of new technologies to measure pork quality online, identification of some of the factors contributing to pork quality, development of new color and marbling standards, and defining domestic and international consumer attitudes and preferences.

Education and communication efforts center around development of fact sheets on various pork quality and safety issues. These consist of Pork 101 shortcourses, meat judging programs, conferences and summits, and development of a system for assuring pork quality based upon Quality Control Points (QCP) from farm to fabrication (see list of QCPs in Figure 2). This new quality system will be the basis for a producer checklist which will be developed into a producer education module.

New tools to transfer technology include quality audits and problem-solving teams, and workshops targeted at very specific quality subjects. Quality audits are being conducted in packing plants by a team of meat scientists who spend several days critically evaluating the factors which can affect pork quality. The team offers solutions to the problems they see.

These problem-solving teams target specific pork quality issues in the U.S. or abroad and are available to work with producers, input suppliers, packers, processors, foodservice, retail and export markets. Workshops are being developed to transfer current knowledge and technologies to the companies that need and can use these technologies to improve the quality of their products. A recent workshop was held on hog handling and stunning with primary emphasis of the effects on meat quality.

Food Safety Issues Meat quality is just one component of pork quality in its broadest definition. In recent years, food safety issues have captured increased attention from industry groups, consumers and government agencies in the U.S. and throughout the world.

U.S. pork producers have recognized the importance of producing a product in which their domestic and international customers can have the highest confidence. The most significant way U.S. pork producers have addressed their food safety responsibilities is through the Pork Quality Assurance (PQA) program. Producers developed and implemented the voluntary education program in 1989 to encourage responsible use of animal health products. Producers recognized that residues cannot be "fixed" by someone else further down the food chain.

In 1997, NPPC released a new version of the PQA program, which includes all three levels in one booklet. This revision more clearly emphasizes producers' responsibilities with regard to six Good Production Practices (GPP) related to antimicrobial residue avoidance (food safety) and four GPPs to help minimize the use of animal health products (efficient, quality production).

Considerable discussion has taken place with the Food Safety and Inspection Service (FSIS), Food and Drug Administration (FDA), and packers to ensure this revision meets packer and government expectations of producer responsibilities. See the story below for a breakdown of the 10 points.

Currently, 42,000 producers representing 80% of total U.S. pork production have completed the PQA program. The long-range goal is to reach 100% producer enrollment by 2000.

Because of the mandatory implementation of packer Hazard Analysis and Critical Control Point (HACCP) programs, several packing plants recently announced plans to buy only hogs from PQA Level III producers. Those plants include: Farmland Industries, Hormel Foods, Rochelle Foods, Swift & Co. and Hatfield Quality Meats. In addition, the following packers are strongly encouraging their producers to be PQA Level III: IBP Inc., John Morrell & Co. and Seaboard.

Involvement by all U.S. producers in this food safety education effort is vital to assure domestic and international consumers alike that U.S. pork is the safest and highest quality meat protein in the world.

Packing Plant Changes FSIS has set new requirements for all meat and poultry plants to reduce the risk of foodborne illness associated with the consumption of meat and poultry products and to modernize USDA's meat and poultry inspection system. Plants are required to develop HACCP plans with a phase-in for implementation period depending on the size of the plant.

HACCP implementation dates are Jan. 26, 1998 for 500-plus employees, Jan. 25, 1999 for 10 to 500 employees and Jan. 25, 2000 for less than 10 employees.

HACCP is part of a food safety management system where plants evaluate each step in their process for areas where potential food safety problems or hazards could exist. Based on these identified hazards and their potential to be controlled, plants may identify Critical Control Points (CCP) in the process. Packers must develop specific procedures to prevent such problems.

Under HACCP, packers focus on three specific types of hazards: physical (i.e., broken needles), chemical (i.e., antimicrobial and pesticides) and microbial. HACCP systems shift the responsibility for potential hazards, such as violative tissue residues and broken needles, from the government to the plant. One area of control that packer HACCP plans must address is incoming animals. This has increased packer interest in on-farm production practices.

With regard to physical hazards, plants want to know that producers have instituted procedures to prevent broken injection needles. NPPC has conducted studies on needle strength and breakage susceptibility. Results indicated that needles and needle/hub assemblies are very resilient to needle breakage except when bent needles are re-straightened.

Currently, NPPC is studying needle designs from Japan that, on initial tests, appear to be more resistant to bending or breaking and may be more detectable with in-plant metal detection equipment.

With regard to chemical hazards, which include antimicrobial residues, several packers are now requiring their producer-suppliers to have completed the PQA program. This trend is expected to continue.

For microbial hazards, packers are required to meet performance standards for generic E. coli and salmonella. Packers are first taking steps within their plants to meet the microbial standards.

But there is increased interest in what can be done at the farm to reduce levels of potentially harmful bacteria. Since 1994, NPPC has had a very aggressive, on-farm food safety research program focused on the feasibility of HACCP-like systems at the farm level for control of potential human pathogens. Potential pathogens of interest include Trichinella spiralis, Toxoplasma gondii, salmonella, Yersinia enterocolitica and campylobacter.

Currently, there is not enough information to provide producers with specific recommendations to address bacteria such as salmonella at the farm level. NPPC is continuing to work with key researchers and the American Association of Swine Practitioners (AASP) to develop Good Production Practices for salmonella control.

Trichinae Certification Historically, trichinae is the first food safety issue that comes to mind with pork. But, trichinae incidence in pork is rare today. The USDA National Animal Health Monitoring System's National Swine Survey in 1995 showed an infection rate of 0.013%.

However, U.S. pork is still stigmatized due to public perception and lack of education, resulting in consumers continuing to overcook pork products.

To overcome these obstacles, NPPC in conjunction with USDA's Agricultural Research Service, Animal and Plant Health Inspection Service, and FSIS has been developing a Trichinae Certification Program. Several pilot projects have been conducted to develop an on-farm audit for the risk factors for trichinae. These risk factors include ingestion of wildlife or rodents, feeding uncooked waste products containing animal products, general sanitation, hygiene, and biosecurity as they influence vermin attraction, and swine carcass removal and disposal methods.

Farm management strategies for eliminating the risk of infection are simple and usually easy to put in place. Most management systems now in use lack trichinae infection risk factors; this can be documented and monitored through the certification process.

Trichinae certification will be based on an on-farm audit conducted by specially trained veterinarians with USDA program oversight. Startup of the next phase of the program is planned to take place sometime this year.

The certification process includes the following elements:

1.Veterinarians, trained in good production practices relative to trichinae, work with their producers to ensure that trichinae infection on-farm risks are minimized. The on-farm audit will document the absence of trichinae infection risks. Audits will be done periodically to ensure that good production practices, relative to trichinae, remain in place.

2. On a regular basis, statistical samples of certified herds will be tested at slaughter using the ELISA test to verify the absence of infection.

3. Government veterinarians will conduct random "spot audits" of certifications to ensure completeness and to build credibility among trade partners regarding the certification process.

Certification will allow the U.S. to better compete in the fresh pork international market, and it will help change the perceptions of pork held by domestic consumers. With the cooperation of producers, veterinarians, packers, and the government, progress will be made in removing the stigma of trichinae from pork.

In addition, a workable model for on-farm food safety certification for other pathogens of public health significance will have been developed.

Antimicrobial Use And Resistance Recently, there has been heightened interest by the public health community, media, consumers, government and industry in the potential for misuse of livestock antimicrobials. The fear is the use in animals will result in the transfer of resistant bacteria to humans. Subsequent articles in this Blueprint address this issue in more detail.

Many activities are taking place to provide information to better understand the scope of this issue. NPPC, in cooperation with AASP, has formed a Pharmaceutical Issues Task Force which is reviewing the current science regarding antimicrobial use in animal agriculture. This task force will recommend a sustainable position for the pork industry. Research projects, educational programs for producers and veterinarians, and policy positions are currently being developed.

NPPC in cooperation with the National Pork Board has invested significant producer checkoff funds to help answer some of the many questions that need to be addressed. In addition, a working group will be looking at alternatives to antimicrobial use. NPPC supports:

Adequate funding for a strong, scientifically defensible surveillance program to detect changes in microbial sensitivity. Programs that provide this type of relevant data are essential to preserving the usefulness of antibiotics.

Research to safeguard the effectiveness of antibiotics on the market now and those that will be available in the future.

Regulatory decisions regarding antimicrobial use in animals that are reviewed and carefully scrutinized by the scientific community and scientifically defensible.

A timely, efficient and scientifically sound process for new product approvals by the FDA.

Broad-based educational programs for everyone who prescribes, administers or uses antimicrobials including veterinarians, producers, physicians and patients.

Future Quality Assurance Needs Many countries have developed or are developing quality assurance programs for their pork production systems. Examples include the Integrated Quality Control Program in the Netherlands, the Salmonella Control and Monitoring Program in Denmark, and the United Kingdom's Farm Assured British Pigs Program.

Enhancements to the current PQA program in the U.S. are under discussion. Considerations include adding an auditable component on the farm for the Good Production Practices. There may be modules added to address specific issues such as trichinae certification, quality certification including genetics, nutrition and animal handling, and Good Production Practices for preharvest control of pathogens.

In the future, the modules producers choose to receive certification in may depend on the quality assurances their market opportunities require. Pork production is no different than any other business - attention must be directed to meeting consumer needs and increasing expectations for a quality product. Participation in these types of programs may be part of the cost of being in the pork business in the future.

There are 10 Good Production Practices (GPP) identified in Level III of the Pork Quality Assurance (PQA) program.

1. Identify and track all treated animals.

2. Maintain medication and treatment records.

3. Properly store, label and account for all drug products and medicated feeds.

4. Obtain and use veterinary prescription drugs only based on a valid veterinarian-client-patient relationship.

5. Educate all employees and family members on proper administration techniques and withdrawal times.

6. Use drug residue tests when appropriate.

7. Establish efficient quality production and an effective herd health management plan.

8. Provide proper swine care.

9. Follow appropriate, on-farm feed processing and commercial feed processor procedures.

10. Complete the quality assurance checklist annually, and re-certify every two years.

The National Pork Producers Council's Pork Quality Solutions Team has developed a series of pork quality targets.

The targets represent minimums or ranges for quality attributes in fresh pork loin measured at 24 hours post-mortem.

These guidelines (see Figure 1 on page 8) are not intended to be specifications, nor are they standards for industry use. Rather, they are intended to be the cutting edge of measures for each parameter. As such, they are intended to be dynamic in nature, evolving as improvements are made over time.

Some targets are not intended to be exact for all technologies available to measure that particular trait. For example, water-holding capacity is generally expressed as drip loss, no matter how that parameter is measured.

Many targets appear as ranges due to the differences in needs of different segments of the industry.

For example, intramuscular fat is expressed as a range with the minimum reflecting consumer retail purchase requirements and minimum product eating satisfaction requirements.

The maximum reflects a compromise between expectations based upon nutritional and health concerns (lightly marbled) and the eating experience based upon maximum eating satisfaction (heavily marbled).

Delegates Call For Cash Infusion, Market Accountability

Market reporting and price discovery rose to the top of pork producer priority lists during the Pork Industry Forum held in Nashville in early March.

Pork Industry Forum encompasses the concurrent annual meetings of the National Pork Producers Council (NPPC) and the National Pork Board.

Keying on the devastatingly low hog market of recent months, a record number 65 resolutions were presented to NPPC delegates for their debate and action. Nearly half of the resolutions dealt with mandatory price reporting, packer involvement in pork production or other marketing issues.

Capsulizing discussions and actions during the two-day event, delegates passed resolutions to reinforce key policy positions:

Delegates called for a one-time, direct cash infusion to help keep otherwise solid, efficient producers in business.

Delegates supported loan guarantee programs for both operating and ownership loans, including debt restructuring and interest rate buy downs.

Broad support endorsed some form of an ag safety net through fairer access to foreign markets, USDA study of an increasingly concentrated ag sector, plus administrative study of lending practices' contribution to ag sector concentration.

Delegates urged support of legislation requiring pork packers to report prices paid on all hogs, to USDA on a daily basis regardless of the purchasing method.

Delegates voted to form an industry task force to study the impact of the current pork industry structure, including hog ownership.

Resolutions brought to the annual meeting are compiled for state delegates in six broad categories to focus debate and foster consensus. Often, similar resolutions are filed by different states. Therefore, affirmative action on one resolution may set NPPC policy, preempting similar resolutions.

NPPC delegates spent the lion's share of their time on "public policy" resolutions aimed at the financial and marketing challenges facing by pork producers.

Public Policy Resolutions Delegates voted to support a direct, one-time-only cash infusion to help pork producers get back on their financial feet. Likened to a disaster payment, the resolution offered by the NPPC Board of Directors set a $50,000 per operation limit. All pork producers would be eligible for program payments, regardless of size. Payments would be based on total pig sales the last quarter of 1998.

Speaking in support of the cash infusion, Iowa producer Max Schmidt stated: "I realize that we have never gone to the federal government to ask for money. I don't relish doing that, but I don't think we should refrain from it either.

"I have been a pork producer for 33 years, and in 1998 I saw half of my equity go down the drain," he continued. "Think of the producers who have been in business half as long - they lost everything last year. If we're serious about keeping the independent pork producer around, we need to put our full support behind what the NPPC (Board of Directors) have designed here."

Illinois' Rich Brauer also lent support to the resolution, saying: "The first time I saw the resolution, I was a little concerned. But, then I realized what was involved here. Retail prices didn't go down. In effect, we created a lot of wealth but we didn't get our fair share of that wealth. A lot of people need this to continue farming. There has been a lot of equity lost."

And, Indiana delegate Keith Berry added: "It's not our nature to go to the government (and ask) to bail us out. But the government is not blameless in this whole situation." His list of government shortfalls included the inability to pass Fast Track Trade authority, a Hog & Pigs report that missed by a wide mark, and slaughter plants closing or operating at less than full capacity.

Ohio delegate Tom Pitstick reminded delegates that in addition to the cash infusion, the resolution supports a loan guarantee program. The rationale being that the loan guarantee concept would allow lenders to more objectively evaluate producers' portfolios, thereby allowing the market time to regain some balance and, hopefully, return to profitable levels. The resolution supports both operating and ownership loan guarantees, including debt restructuring and interest rate buydowns."While I recognize this is a change in approach for us (NPPC), I encourage the delegates to vote for it," he added.

The resolution passed soundly. Another heavily debated resolution outlined action aimed at providing pork producers and their communities with some sort of a safety net to protect their economic viability.

In concept, delegates supported a bill co-sponsored by Senators Kerrey-Daschle-Johnson (the Agriculture Safety Net and Market Competitiveness Act of 1999). However, they stopped short of giving the bill carte blanche endorsement through the resolution.

Kentucky delegate Dennis Liptrap summarized the consensus: "I have some difficulty supporting this specific of a bill with an official resolution. I think there are parts of this bill that we all endorse. I'd rather see us address those individually, rather than a resolution to support this specific piece of legislation. We certainly endorse the support of Senators Kerrey, Daschle and Johnson, and it may very well be a bill we could wholeheartedly support in its final form. But, to me, we tie the hands of our staff in Washington, and of ourselves, by passing the original resolution."

Liptrap then placed his support behind a substitute resolution presented by the Nebraska Pork Producers Association and the NPPC Bylaws & Resolutions Committee. The newly drafted and amended resolution carried these charges from delegates:

NPPC delegates support pursuing aggressive trade remedies that will provide U.S. pork with fair and meaningful access to foreign markets.

For USDA to investigate the effect increasingly concentrated sectors of agriculture have on rural communities and the general public.

NPPC urges Congress and the Administration to study whether public and private lending practices have contributed, or are currently contributing, to concentration in the pork industry.

The substitute resolution passed.

Also in the public policy arena, delegates passed a resolution directing NPPC to pursue a revenue assurance program for pork producers patterned after the crop revenue assurance programs currently available. And, they endorsed NPPC support for access to adequate debt capital for viable producers at fair market interest rates.

Marketing Resolutions Market issues and price reporting at all levels throughout the pork chain drew considerable discussion.

The most encompassing resolution was offered by the NPPC Board of Directors in an effort to represent a compilation of the seven state resolutions that focused on mandatory price reporting. The motion from board of directors' version, amended by delegates, reads: "That NPPC support legislation consistent with our policies on price reporting that requires all pork packers to provide, by plant, actual prices paid for all live hogs, by category, including contracts and formulas, for slaughter, on a daily basis. In addition, an improved retail price reporting system should also be included in the legislation."

This resolution represented a change in positioning by NPPC that has long held that a voluntary price reporting system could provide as good, or better, information than requiring segments of the pork chain to report prices. The board's turnabout was explained in the rationale, noting that a voluntary price reporting system had been designed and implemented, but that only one packer had participated. Consequently, the board altered their stance and began outlining an acceptable mandatory price reporting system.

When asked by delegates to provide an update on a bill drafted and being circulated in Congress, Gary Madsen from the NPPC Washington office responded: "Let's be clear about a couple of things. First, some form of mandatory price reporting will be approved and probably signed into law this year. We intend to be a player in that, based on the action of the board of directors, and if you should approve this resolution. It gives us additional support and strength to go forward and work with the process of developing meaningful legislation."

Iowa's Schmidt cautioned his fellow delegates: "Remember, we're adopting policy now, we're not trying to manage any particular bill. We have to decide what it is that we want, and let the legislative folks take care of delivering that.

"Our producers feel that for a given quality of hogs, there should be an open bid for anybody's hogs at that particular price, meeting that quality. We want this shroud of secrecy lifted, and (for) people (to) feel that they have access to those prices," he concluded.

Montana delegate Don Herzog added: "I think part of the rationale behind this resolution is to help us make better business decisions. I may not get the same price for the same hogs as some people. I just need to know that, so I don't stick a million bucks into something I don't have good information about. We're all professionals. The rationale here is - know where you are, on a competitive basis, so you can make better business decisions."

Keith Berry, a 120-sow, farrow-to-finish operator from Indiana, added: "I believe I can compete with the larger operations on a price per pound of pork produced (basis). My biggest concern is price discovery and market access."

His contemporaries agreed, passing the mandatory price reporting resolution soundly.

Three additional marketing resolutions dealt with the availability and transparency of marketing contracts.

On the transparency issue, producer concerns centered on those contracts that restricted freedom to discuss a contract with neighbors, lenders or legal counsel. The argument was that producers could not make good financial comparisons, therefore, good business decisions, when this information cannot be shared. Delegates passed a resolution favoring federal legislation that allowed production contract terms and conditions to be shared openly.

Availability of contracts was another sensitive issue. Because marketing contracts are becoming more commonplace, the secrecy associated with them and potential for preferential treatment for some raised additional concerns.

In the end, delegates passed a resolution encouraging USDA to require samples of all marketing contracts be filed with the Grain Inspection Packers and Stockyards Administration (GIPSA), and that the monthly filing of those sample contracts be made readily available to all producers for their review.

Another resolution concerned the current structure of the U.S. pork industry, and more precisely, packer ownership of hogs. Introduced by the Iowa Pork Producers Association, the resolution attempted to set limits on packers "owning, operating, managing or financing captive supplies of live hogs."

The resolution raised considerable discussion, amendments and challenges for interpretation and clarification of Section 202 of the Packers & Stockyards Act.

"From the Minnesota delegates' perspective, this is one of the four issues that, as delegates from our state, we have been sent here to discuss," stated Jim Quackenbush. "It looks like a runaway train, in some respects, and it's moving too fast for us to jump on. We want to slow it down a little bit.

"We, as producers, understand that we need coordination between production and packing-processing. But we need some kind of fair and equitable system that ensures that we're all given the opportunity to make a livelihood. That has to go both ways - the packer has to make a living and so do we. The concern I have is that we have several packers that seem to want to take over a large percentage of this industry. That's where I see the danger," he said.

Quackenbush offered an amendment to the resolution that would limit a company's captive supply of slaughter capacity to 5%. He justified the figure noting it would allow packers the opportunity to secure a portion of their slaughter capacity, yet still allow producers to get together and organize packing and processing if they wished. "It would limit the size of that (captive supply) so that everybody has an opportunity to be involved, yet we don't have the danger of one or two packers taking over the entire industry," he added.

More debate ensued, asking for clarification and interpretation of the Packers & Stockyards Act, whether captive supply meant packer ownership or if it included some of the marketing contracts.

In the end, delegates agreed that more information and study were required, therefore they supported a motion to form a task force.

The NPPC Board of Directors will appoint a task force to study the impact of the current hog industry structure and ownership of hogs, including the role of packers. The task force is to file their report with the NPPC Federation Council, which is made up of representatives of all of the state associations. The report is due in June, with a target date set to coincide with '99 World Pork Expo.

Indiana producer Kaye Whitehead encouraged the task force to include a Packers & Stockyards Act review as part of their report. A later resolution, directing NPPC to support a study by the General Accounting Office (GAO) or acceptable entity, to provide an interpretation of the current authorities of the Packers & Stockyards Act, also passed.

Science & Technology Resolutions Delegates took affirmative action in the following areas:

Support a science-based, coordinated, industry response to the issue of antimicrobial resistance from the use of antimicrobials in pork production, including producer education and reflecting measures appropriate for health and safety of the public.

Continue to work with state and federal animal health officials in the National Pseudorabies (PRV) Eradication Program, including long-range PRV surveillance to ensure eradication is complete by the end of the year 2000.

The new database from the Quality Lean Growth Modeling Project be used to update and implement new Fat-Free Lean Equations as the industry standard for estimating lean content in all U.S. grading systems.

Another resolution focused on continued research on stronger needles for everyday use in pork production, and to work with packers in the development of practical metal detection devices able to reliably detect metal in pork products.

Demand Enhancement Action to ensure fair and equitable trade between the U.S. and Canada received delegate approval. They also passed a resolution stating NPPC does not support mandatory "country of origin" labeling, as its value to the pork chain, to consumers, has not been proven.

Education/Environment/Production Delegate action encouraged leaders at all levels of state and national pork producer activities to participate in the On-Farm Odor/Environmental Assistance Program.

Delegates also passed a resolution directing NPPC to oppose new EPA regulations for propane storage. This was in response to a June 1996 published rule that requires producers storing various chemicals, including propane, to file a risk management plan by June 21, 1999. The rules affect any site with more than 10,000 lb. of propane (about 2,400 gallons).

Understanding The Drug Approval Process

The drug approval process for food-producing animals has evolved gradually, with sporadic bursts of new regulations. Now it appears the pork industry is on the verge of a major change in the way food animal antimicrobials are approved.

An understanding of the drug approval process today involves the laws and regulations that apply, the general data and information requirements for approval, and expected changes in these requirements.

Early in this century, it became apparent that the manufacture and sale of drugs for use in humans and hogs required regulatory oversight. The term "snake oil" still lingers from the days of exaggerated or false efficacy claims for sometimes toxic products.

As we approach the 21st century, we have become confident in the safety and efficacy of the drugs we use and in the safety of the food supply. How did we get from "snake oil" to the drugs we have today?

Regulations For Drug Approval The Federal Food, Drug and Cosmetic Act was passed in 1938. This law is still in force today, although with many amendments. The original act provided only for safety of drugs in a specific species.

In 1951, the Durham-Humphrey Amendment separated drugs into two categories, prescription and "over-the-counter" (OTC). Prescription drugs are evident in veterinary medicine by the inscription: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

The Durham-Humphrey Amendment is actually worded so that if adequate directions for safe and effective use by a lay person can be put on the product label, then the product must be classified as OTC.

In 1958, the Delaney Clause addressed the regulation of chemical substances added to food for human consumption. It stated that no additive shall be deemed to be safe if it can induce cancer in man or animals when ingested. For consumption of food animal products, this meant a zero tolerance for residues.

The Kefauver-Harris Amendment of 1962 provided for the authority of the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) we have today. It established the current method of drug approval and the following drug manufacturing and sales practices under FDA-CVM control:

Drug manufacturing, including inspection of plants and manufacturing practices;

Labeling of drugs (The FDA-CVM actually approves the label, not the drug.); Generic names;

Product promotion;

Reporting of adverse effects; and

The authority to withdraw a previously approved drug from the market.

It is important to note that the "label" encompasses much more than what is attached directly to the bottle. The package insert (which sometimes is also affixed to the bottle) contains key information about product use. A label must include indications, directions for use, precautions/warnings/adverse reactions (the withdrawal time is included here), storage requirements and expiration date.

Recent laws affecting the drug approval process include the Generic Animal Drug and Patent Term Restoration Act (1988), which provides for approval of generic copies of approved animal drugs once the patent or period of marketing rights has expired.

The Animal Drug Availability Act (1996) added more flexibility to the way FDA regulates animal drugs and medicated feeds.

Marketing A New Animal Drug A "new animal drug" is a drug approved since the Food, Drug and Cosmetic Act of 1938. First comes discovery. In the past, many new drugs were discovered by collecting soil or other environmental samples from around the world and testing them.

For example, the fungus that produces a widely used anthelmintic was isolated from a golf course in Japan. Now the discovery process uses efforts based on synthesis of specific molecules for testing.

Once a promising compound is discovered, it is run through a set of screening tests.

If a product makes it to the development stage, the first step is to develop preliminary pig efficacy and safety data, environmental and food safety data. This data is required to apply to the FDA-CVM for listing as an Investigational New Animal Drug (INAD).

Then, the drug may be subjected to large-scale testing for efficacy and safety in hogs. Drug metabolism and slaughter withdrawal time are also evaluated.

"Radiolabeled" (to label with a radioactive atom or substance) compounds are often used to accurately determine the time it takes the drug to leave the body. These studies often start in lab animals with a final study in hogs to set the final withdrawal time. An assay to detect residues in edible pork products is also developed by the company.

Safety tests include a study in the hog and determination of the potential carcinogenicity of the drug and reproductive safety.

These tests are carried out in both hogs and lab animals as required. The required carcinogenicity studies in rats and mice may cost up to $1 million each and take up to three years to complete. They can't be started early in product development because they require other data to set doses used.

Setting the correct therapeutic dose takes a lot of time and money. For an antibiotic, the pharmacokinetics (how it moves in and out of the body) of the drug and the concentration required to retard growth of the disease organism are used to derive a range of reasonable dose regimens. Dose titration studies will give the most effective dose.

Clinical efficacy testing confirms that the drug is safe and effective for the intended use in the field, to be indicated on the label. The FDA recently published an amended definition of "adequate and well controlled studies" (21 CFR Part 514) in the Federal Register (Vol. 63, No. 43, March 5, 1998). This amendment was intended to allow more flexibility in the conduct of adequate and well-controlled studies in food-producing animals in the field.

The FDA-CVM encourages sponsors to submit investigational protocols for review and to attend a joint meeting prior to doing the studies so that the type of studies required, their design and their analysis may be established.

Development Process Good laboratory practices (GLPs) must be followed for laboratory studies, while good clinical practices (GCPs: Good Target Animal Study Practices: Clinical Investigators and Monitors, May 1997) must be followed during clinical trials (i.e., a respiratory disease trial in nursery pigs). Pharmaceutical companies maintain extensive quality assurance (QA) departments to audit studies to assure compliance with GLPs and GCPs. The development process is made even more complex by use of laboratory and clinical trial facilities that are under company control and private facilities used on a contract basis.

While the development process is ongoing, the company is also setting up a manufacturing process, which may involve construction of new facilities.

Manufacturing of pharmaceuticals is subject to good manufacturing processes. The manufacturing process must be approved before the drug is marketed. This means considerable money is invested in parallel development programs, both dependent on drug approval for a return on investment.

Big Changes Ahead In November 1998, the FDA released a draft guidance document which begins: "This draft guidance document announces that FDA now believes it is necessary to evaluate the human health impact of the microbial effects associated with all uses of all classes of antimicrobial new animal drugs intended for use in food-producing animals. To assess this impact, the following two, separate but related aspects, should be evaluated:

1. The quantity of drug-resistant, enteric bacteria formed in the animal's intestinal tract after exposure to the antimicrobial new animal drug; and

2. Changes in the number of enteric bacteria in the animal's intestinal tract that cause human illness (pathogen load).

In the past, the agency evaluated the human health impact of the microbial effects of only certain uses of antimicrobial new animal drugs in animal feeds. Based on scientific data, the agency now believes sponsors of all antimicrobial new animal drugs intended for use in food-producing animals should provide information on resistance and pathogen load. This information would allow the agency to determine that such products are safe under the Federal Food, Drug and Cosmetic Act."

The Proposed FDA Framework The new document to judge the "microbial safety" of antimicrobials used in food animals is entitled, "A Proposed Framework For Evaluating And Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals."

The document clearly states proposed procedures apply to both future approvals and existing antimicrobials as resources permit.

Drugs would be listed based on two criteria: importance in human medicine and "exposure" of the animal microbial flora to the antimicrobial.

Figure 1 (on page 44) summarizes the framework. It represents the author's interpretation and condensation of the actual document, which should be consulted for a clearer understanding of the framework. It is well recognized by all parties involved that the methods for many of these requirements have not been established. In fact, this has been one of the major criticisms of the proposed framework.

The public comment period on the proposed framework document ended April 6.

The future of antimicrobial drug approvals in food animals is best summarized by the comments of Steve Sundlof, director, FDA-CVM. He spoke in March at the annual meeting of the American Association of Swine Practitioners.

"FDA is concerned that the use of antimicrobial drugs in food animals will create antimicrobial drug resistance that could contribute to drug-resistant human pathogen bacteria. This is a unique issue since unlike drug residues, resistance can't be accurately predicted. Also, this problem crosses over into human medicine.

"FDA is in the process of developing a new regulatory approach for antimicrobial products intended for use in food animals. This new system will stress monitoring and surveillance. FDA believes that those individuals involved in developing this regulatory approach must include experts in human as well as veterinary medicine."

Drug approvals in the near future will wrestle with microbial safety. Subtherapeutic and over-the-counter use of antimicrobials in food animals will come to the forefront as major issues. Involving all parties in this process is vital to keeping antimicrobials effective for pork producers.

Viable, Production-Based, Management Alternatives

While rational antibiotic use remains an important part of pork production, and is likely to remain so, there are a number of management alternatives that can reduce the need for their use. These management practices also minimize the introduction and spread of disease organisms, including potential food contaminants.

Biosecurity Practices The best alternative to treating disease is to prevent it. Biosecurity systems are put in place to prevent introduction of disease organisms onto a farm and reduce the spread of disease organisms that are already present.

Biosecurity programs should address the potential for introducing disease-causing organisms onto the farm from pigs, trucks, equipment, wildlife and people. A perimeter fence will help with all these areas of concern.

In addition, animal load out areas deserve special consideration. They should be covered and designed so as to prevent the return of loaded animals from the truck back into the premises. Only those trucks that have been properly cleaned and dried should be allowed to approach the load out area. Likewise, passages between buildings should be covered, bird-screened and any curtain-sided buildings should have bird screening in place.

Moreover, the most important aspect of biosecurity is to understand the health status of the source herd providing new breeding stock. The recipient herd and the source herd veterinarians should openly consult with each other to best accomplish this understanding. Breeding stock suppliers must be open with health status information. Their veterinarian should provide the results of diagnostic workups, slaughter checks, recent clinical observations and serological surveillance to your veterinarian.

When you and your veterinarian are satisfied with the health status of the supplier's herd, then set up an isolation/acclimation (I/A) program for the new breeding stock. Standard practices vary widely within the industry. Still, some general measures should be considered. It doesn't take long distances to separate the isolation facility from the farm. But the isolation area should provide for separation of air space and personnel. Animals in isolation can be cared for at the end of the work day by employees who won't re-enter the production facilities that day.

There are two reasons for the initial isolation period. First is to protect the farm from any pathogens the isolated animals may be carrying. Second is to observe the isolated animals for a certain period of time in case any outbreaks occur on the source farm after the animals have been delivered. A common isolation period is 30 days.

The next step in the I/A program is acclimation of the new animals. This involves exposing new stock to pathogens common to the home farm. This allows new animals time to develop an immune response to those pathogens. This exposure may include the use of vaccines, exposure to cull sows or "spent" gilts (females that have been added to the herd but have not conceived), or the feedback of manure.

When animals are delivered from two different source farms, as may be the case when both boars and gilts are delivered, the acclimation period allows them to become acclimated to each other as well. A normal acclimation period runs from 21-30 days. A combined isolation-acclimation period will take 60 days or more.

Movement Technology The biggest breakthrough in disease prevention and control didn't come from biotechnology or the development of new antibiotics - but from the widespread use of some common hog movement practices.

Herd Repopulations: In the past, "depopulation/repopulation" was the most reliable method of eliminating disease organisms from a herd. Other movement methods, discussed later in this paper, have largely replaced herd repopulations due to their relative lack of downtime and less dramatic disruption of cash flow. Herd repopulations are still useful in some situations and if planned correctly, can minimize downtime.

Herd repopulations used to be a popular solution when an unmanageable level of disease organisms had built up in a herd over time. My general advice was to consider repopulation when an operation was not competitive, and when problems exceeded solutions. In other words, repopulation was the method of choice if your herd had excessive, multiple disease problems.

Today, I see herd repopulations in a different light. Repopulation is a tool used in more specific situations, such as a herd wishing to get rid of one or more major pathogens, particularly in breeding stock herds. By using an off-site breeding project, actual nonproductive downtime can be two weeks or less. Downtime will likely be more in a one-site farm.

Partial Depopulation or Phase Depopulation: This is a form of depopulation that is tried in only one phase of production in order to clean up or cut down on the effects of a specific disease, such as endemic transmissible gastroenteritis (TGE) or porcine reproductive and respiratory syndrome (PRRS). It's most common to depopulate the nursery phase, but this technology may be applied to the finishing phase as well.

Before partial or phase depopulation is tried, however, some background work needs to be done. Diagnostic testing should be performed in the breeding herd, the nursery and the finisher to determine level of infection and how and when disease transmission is occurring.

The next step is phase depopulation. Sell feeder pigs or move them to another facility. It may be necessary to wean pigs into another facility for a designated period, depending on the organism being targeted. During the downtime, the phase that is being depopulated is cleaned thoroughly and disinfected. The objective is to break the cycle of transmission of an organism from older to younger pigs.

All-Out Production Systems: Commonly referred to as all-in, all-out production (AIAO), the key element of this technology is complete emptying of a room, building or site, and thorough cleaning before a new group of pigs enters the area. It is a planned, scheduled depopulation on a regular basis. An integral part of the process is washing and disinfecting.

Multi-Site, Isowean Production Systems: In this system of production, pigs are weaned into isolated nurseries or nursery-finishing buildings, thus the term "Isowean" as coined by D.L. "Hank" Harris, DVM, in the late 1980s. The purpose of Isowean production systems is to eliminate infectious agents and to enhance growth and lean tissue deposition. Specifics of the system, including recommended weaning age, may vary on the organisms targeted for elimination or reduction.

But the general principles are the same - move young pigs away from the sow herd so that diseases that affect grow-finish performance are not transferred within the same facilities to susceptible pigs by older pigs or by people. If disease organisms are introduced onto a site, multi-site production offers more flexibility than traditional systems for dealing with the problem. Sites can be depopulated as described earlier, using partial or phase depopulation, without the need to depopulate the sow herd.

Reproductive Technology There is currently one, production-based reproductive technology, artificial insemination (AI), that is being successfully applied to improve pig health and potentially decrease the need for antibiotics. The use of AI as a health strategy was discussed in detail in the April 15, 1997 Blueprint Series, "The Art of AI."

In brief, AI provides these pluses:

It reduces the number of animals brought onto the farm, and

Females aren't exposed to the natural mating process, allowing a more hygienic process if AI is carried out correctly. In some farms, vaginal discharges have declined when AI replaced natural mating.

A second reproductive method that's not readily available, but will allow movement of genetic material with greatly reduced disease risk, is embryo transfer. It is possible to wash embryos after collection, potentially improving health status above that attainable by AI. This technology will be widely used when practical, non-surgical collection and transfer methods become available.

Environmental Modifications Several environmental changes will reduce the need for antibiotics. Start with a good cleaning and sanitation program, together with AIAO production. The keys are removal of manure and all other biological residues with hot water power washing. Follow cleaning with one of many available disinfectants. Scheduled washing in facilities that are not usually run AIAO may be useful as well.

The best medicine for vaginal discharge complex is power washing the breeding/gestation building every 2-4 weeks or washing the area as groups move to farrowing.

A second environmental modification could be to alter stocking density. My observations are that 8 sq. ft./pig is a good starting point, but should be altered to account for the type of flooring, the waste removal system and the disease organism.

For high-health pigs in an environment with good waste removal, good air quality and little disease challenge, something less than 8 sq. ft./pig may be the best stocking density. With a heavy disease challenge or the presence of certain serious organisms, for example Actinobacillus pleuropneumonia, a lower stocking density is advisable.

A third environmental modification related to stocking density is adjustment in group size. As with stocking density, the optimum group size isn't known and likely varies with the type of facility. However, when faced with serious disease threats, decreasing group size may help. Some farms are having good results with large pen/large group systems, but there is little controlled data available.

Finally, providing the proper environment for the pigs will decrease the need for antibiotic use. Major considerations are effective environmental temperature (EET) and lower critical temperature (LCT).

EET is the temperature the pig feels. LCT is the temperature at which the pig must increase its heat production rate, usually by increasing feed intake, to maintain body temperature. LCT varies with pig age and with group vs. individual housing. Pigs maintained at an EET lower than the LCT will be more susceptible to the effects of endemic pathogens and, therefore, more likely to show clinical signs of respiratory or enteric diseases. Additionally, air quality must be maintained in order to reduce pig exposure to airborne bacteria, dust particles and gases.

Diet & Health Interactions The interaction of diet and health is much broader and more complex than deficiencies or excesses of specific nutrients. Nutritionists now recommend specific, daily nutrient intakes based on age, sex, season and genotype. These suggestions must be considered when evaluating disease treatment and prevention measures.

Poor diets can increase susceptibility to disease. But the converse is also true. Diseases alter feed intake (respiratory diseases) and nutrient utilization (enteric diseases), thereby predisposing pigs to other metabolic or infectious diseases.

An example is the pneumonia/ulcer complex. Ulcers are often found in conjunction with pneumonia, probably stimulated by the decrease in feed intake often seen with respiratory disease. In addition to the factors mentioned above (age, sex, season and genotype) it may become more common to consider disease load and immune status when formulating diets. These types of diets may decrease the need for antibiotic use.

Stimulating Immunity The most common ways to stimulate the immune system are to inject vaccines, to expose naive animals to sick or carrier animals and to provide feedback of manure or other biological material (mummies or placenta for parvovirus exposure or intestinal contents for TGE exposure). The goal is to boost immune response to specific diseases prior to exposure. Vaccines and other types of exposure have been used for many years with variable results.

Keep in mind these vaccination tips when attempting to provide immunity for disease prevention:

Vaccination does not always equal immunization. Vaccines and other types of controlled exposure fail for a number of reasons: the animal may have been incubating the disease at the time of vaccination; the animal may already be sick or stressed and unable to respond to the vaccine; or exposure may overwhelm the animal's defenses.

Also, the vaccine may be unable to stimulate immunity against the disease in question. Some vaccination tips:

Vaccines stimulate the immune system; they do not eliminate disease organisms.

Proper vaccination timing is critical to success. The vaccine should be given soon enough before exposure to a disease challenge to allow the animals' immune system to respond. Usually this should be done at least two weeks prior to exposure. Also, many vaccines require two injections, 2-3 weeks apart, in order to stimulate protective immunity.

Genetic Resistance In the future, genetic resistance to hog diseases may be an option to conventional disease control strategies. There have been reports of genetic differences in susceptibility to atrophic rhinitis, respiratory diseases, porcine reproductive and respiratory syndrome, and colibacillosis.

Progress in selection for genetic disease resistance has been slow due to the necessity of selecting for other performance traits (growth, leanness) that may be counterproductive to selecting for disease resistance.

In addition, selection under field conditions introduces many confounders (environment, management systems) to the process. The use of molecular genetic techniques to find genetic markers or the actual genes linked to disease resistance will potentially allow greater progress in this area in the future.

Strategic Medication Strategic medication involves the use of antibiotics at precisely defined times for a well-defined purpose. Often, injectable, water or feed medication will be used just before the anticipated exposure. If the exposure times or stress periods can be defined well enough, this approach can be useful.

Examples of strategic medication include the use of water medication prior to nursery pig exposure to strep organisms, specific injections in a medicated early weaning (MEW) program, the use of antibiotics in an isolation diet for prevention of ileitis, or spot treatment with an antibiotic for chronic urinary tract disease in gestating sows.

Often, the problem with strategic medication programs is that what starts out as strategic becomes routine. The challenge is to use medications wisely and as needed. The economics of production and quality assurance considerations dictate as much.

Summary There are many viable, production-based, management alternatives to the use of antibiotics in pork production. Most of them are available for your use today. Some would require production system changes (i.e., the movement technologies). Some will be applied in the future (i.e., embryo transfer, genetic resistance). None are likely to replace the need for rational use of antibiotics. But, by using the available alternatives when possible, antibiotics can be used less frequently and more effectively.

Spring And Summer Farrowings Pegged 7% Lower

The USDA's Hogs and Pigs Report came in close to trade estimates. The breeding herd at 94% of a year earlier was some below the average of the trade estimates but above our estimate based on gilt and sow slaughter. We still believe there is a realistic possibility that the breeding herd is below the USDA estimate.

The market inventory at year-earlier levels was at our expectation. Slaughter for the first four weeks ending in March was up about 2.4% - a little less than the 180 lb. and heavier market weight inventory indicated, but well within the potential sample error.

The heavier weight market inventories indicate a second quarter 1999 slaughter about 1% larger than a year earlier. With this slaughter level, prices are expected to be in the mid-$30s for the April, May and June average. The lighter weight market inventories point to a slaughter level in the third quarter about 2% less than 12 months earlier. This slaughter level is still quite large and will likely hold prices in the mid- to upper-$30s for July, August and September.

Cold storage pork stocks at 117% of a year earlier at the end of February will continue to be a negative for stronger prices at least through spring.

Average weights of hogs continue to run at record high levels (carcass weights at 191 lb. in February) and are contributing to the large supplies of pork.

January pork exports were up a short 4% in product weight. Our sales to the Russia Federation were down 87% from a year earlier and to Canada down 43%. The good news is that exports to South Korea were up over 800% and to Taiwan were up over 1,800%. Our largest customer, Japan, showed a 7% increase from a year earlier during January. The second largest customer for U.S. pork, Mexico, showed an 11% gain in purchases from 12 months earlier.

In recent hog cycles, reduction in hog slaughter is yielding a bigger price jump than in the past. For example, for the three productivity cycles between 1974 and 1986, the average production decline in the big year of reduction for each cycle was 10.6% and the average deflated price increase was 19.7%. For the last three production cycles ending in 1996, the average decline in production was 2.7% for the big year of reduction in each cycle and the average price increase was 15.8% in deflated prices.

If the price flexibility of the last three production cycles holds for the current cycle, hog prices in the year 2000 are likely to be higher than most people forecast if production is down as much as now seems likely.

Has the change in the structure of the production segment of the industry contributed to the smaller reduction in production for the big reduction year in the cycle? Our opinion is yes. But, the decrease was also, probably, moderated by the substantial increases in pork exports during this period.

During the 10-year period ending in 1996, the U.S. domestic supply of pork was reduced about 1% each year by larger exports and smaller imports. With this happening along with population growth in the U.S., the supply-demand conditions at the live hog level improved rapidly. During the first three production cycles discussed above, the demand for pork was declining rapidly for much of the period.

Farrowing intentions for both the second and third quarters are for a 7% decline from the same period last year. If these intentions are carried out, the odds are high for prices in both the fourth quarter of 1999 and the first quarter of 2000 to be well above year-earlier levels but still in the $30s with some possibility of $40 or a little better. The bottom line is that pork producers will lose a lot more equity this year.