Antibiotic Resistance
Agencies Have Made Limited Progress Addressing Antibiotic Use in Animals Gao ID: GAO-11-801 September 7, 2011Antibiotics have saved millions of lives, but antibiotic use in food animals contributes to the emergence of resistant bacteria that may affect humans. The Departments of Health and Human Services (HHS) and Agriculture (USDA) are primarily responsible for ensuring food safety. GAO reviewed the issue in 2004 and recommended improved data collection and risk assessment. GAO was asked to examine the (1) extent to which agencies have collected data on antibiotic use and resistance in animals, (2) actions HHS's Food and Drug Administration (FDA) took to mitigate the risk of antibiotic resistance in humans as a result of use in animals, (3) extent to which agencies have researched alternatives to current use practices and educated producers and veterinarians about appropriate use, and (4) actions the European Union (EU) and an EU member country, Denmark, have taken to regulate use in animals and lessons that have been learned. GAO analyzed documents, interviewed officials from national organizations, and visited producers in five states and Denmark.
HHS and USDA have collected some data on antibiotic use in food animals and on resistant bacteria in animals and retail meat. However, these data lack crucial details necessary to examine trends and understand the relationship between use and resistance. For example, since GAO's 2004 report, FDA began collecting data from drug companies on antibiotics sold for use in food animals, but the data do not show what species antibiotics are used in or the purpose of their use, such as for treating disease or improving animals' growth rates. Also, although USDA agencies continue to collect use data through existing surveys of producers, data from these surveys provide only a snapshot of antibiotic use practices. In addition, agencies' data on resistance are not representative of food animals and retail meat across the nation and, in some cases, because of a change in sampling method, have become less representative since GAO's 2004 report. Without detailed use data and representative resistance data, agencies cannot examine trends and understand the relationship between use and resistance. FDA implemented a process to mitigate the risk of new animal antibiotics leading to resistance in humans, which involves the assessment of factors such as the probability that antibiotic use in food animals would give rise to resistant bacteria in the animals, but it faces challenges mitigating risk from antibiotics approved before FDA issued guidance in 2003. FDA officials told GAO that conducting postapproval risk assessments for each of the antibiotics approved prior to 2003 would be prohibitively resource intensive, and that pursuing this approach could further delay progress. Instead, FDA proposed a voluntary strategy in 2010 that involves FDA working with drug companies to limit approved uses of antibiotics and increasing veterinary supervision of use. However, FDA does not collect the antibiotic use data, including the purpose of use, needed to measure the strategy's effectiveness. HHS and USDA have taken some steps to research alternatives to current antibiotic use practices and educate producers and veterinarians on appropriate use of antibiotics. However, the extent of these efforts is unclear because the agencies have not assessed their effectiveness. Without an assessment of past efforts, the agencies may be limited in their ability to identify gaps where additional research is needed. Except for one $70,400 USDA project, all other federal education programs have ended. Since 1995, the EU, including Denmark, banned the use of antibiotics to promote growth in animals, among other actions. Some of their experiences may offer lessons for the United States. For example, in Denmark, antibiotic use in animals initially decreased following a series of policy changes. The prevalence of resistant bacteria declined in food animals and retail meat in many instances, but a decline in humans has only occasionally been documented. Denmark's data on use and resistance helped officials track the effects of its policies and take action to reverse unwanted trends. The EU faces difficulty collecting data that can be compared across countries, but officials there said such data are needed to fully understand how use in animals may lead to resistance in humans. GAO recommends that HHS and USDA (1) identify and evaluate approaches to collecting detailed data on antibiotic use in animals and use these data to evaluate FDA's voluntary strategy, (2) collect more representative data on resistance, and (3) assess previous efforts on alternatives to identify where more research is needed. HHS and USDA agreed with GAO's recommendations.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Lisa R. Shames Team: Government Accountability Office: Natural Resources and Environment Phone: (202) 512-2649GAO-11-801, Antibiotic Resistance: Agencies Have Made Limited Progress Addressing Antibiotic Use in Animals
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United States Government Accountability Office:
GAO:
Report to the Ranking Member, Committee on Rules, House of
Representatives:
September 2011:
Antibiotic Resistance:
Agencies Have Made Limited Progress Addressing Antibiotic Use in
Animals:
GAO-11-801:
GAO Highlights:
Highlights of GAO-11-801, a report to the Ranking Member, Committee on
Rules, House of Representatives.
Why GAO Did This Study:
Antibiotics have saved millions of lives, but antibiotic use in food
animals contributes to the emergence of resistant bacteria that may
affect humans. The Departments of Health and Human Services (HHS) and
Agriculture (USDA) are primarily responsible for ensuring food safety.
GAO reviewed the issue in 2004 and recommended improved data
collection and risk assessment. GAO was asked to examine the (1)
extent to which agencies have collected data on antibiotic use and
resistance in animals, (2) actions HHS‘s Food and Drug Administration
(FDA) took to mitigate the risk of antibiotic resistance in humans as
a result of use in animals, (3) extent to which agencies have
researched alternatives to current use practices and educated
producers and veterinarians about appropriate use, and (4) actions the
European Union (EU) and an EU member country, Denmark, have taken to
regulate use in animals and lessons that have been learned. GAO
analyzed documents, interviewed officials from national organizations,
and visited producers in five states and Denmark.
What GAO Found:
HHS and USDA have collected some data on antibiotic use in food
animals and on resistant bacteria in animals and retail meat. However,
these data lack crucial details necessary to examine trends and
understand the relationship between use and resistance. For example,
since GAO‘s 2004 report, FDA began collecting data from drug companies
on antibiotics sold for use in food animals, but the data do not show
what species antibiotics are used in or the purpose of their use, such
as for treating disease or improving animals‘ growth rates. Also,
although USDA agencies continue to collect use data through existing
surveys of producers, data from these surveys provide only a snapshot
of antibiotic use practices. In addition, agencies‘ data on resistance
are not representative of food animals and retail meat across the
nation and, in some cases, because of a change in sampling method,
have become less representative since GAO‘s 2004 report. Without
detailed use data and representative resistance data, agencies cannot
examine trends and understand the relationship between use and
resistance.
FDA implemented a process to mitigate the risk of new animal
antibiotics leading to resistance in humans, which involves the
assessment of factors such as the probability that antibiotic use in
food animals would give rise to resistant bacteria in the animals, but
it faces challenges mitigating risk from antibiotics approved before
FDA issued guidance in 2003. FDA officials told GAO that conducting
postapproval risk assessments for each of the antibiotics approved
prior to 2003 would be prohibitively resource intensive, and that
pursuing this approach could further delay progress. Instead, FDA
proposed a voluntary strategy in 2010 that involves FDA working with
drug companies to limit approved uses of antibiotics and increasing
veterinary supervision of use. However, FDA does not collect the
antibiotic use data, including the purpose of use, needed to measure
the strategy‘s effectiveness.
HHS and USDA have taken some steps to research alternatives to current
antibiotic use practices and educate producers and veterinarians on
appropriate use of antibiotics. However, the extent of these efforts
is unclear because the agencies have not assessed their effectiveness.
Without an assessment of past efforts, the agencies may be limited in
their ability to identify gaps where additional research is needed.
Except for one $70,400 USDA project, all other federal education
programs have ended.
Since 1995, the EU, including Denmark, banned the use of antibiotics
to promote growth in animals, among other actions. Some of their
experiences may offer lessons for the United States. For example, in
Denmark, antibiotic use in animals initially decreased following a
series of policy changes. The prevalence of resistant bacteria
declined in food animals and retail meat in many instances, but a
decline in humans has only occasionally been documented. Denmark‘s
data on use and resistance helped officials track the effects of its
policies and take action to reverse unwanted trends. The EU faces
difficulty collecting data that can be compared across countries, but
officials there said such data are needed to fully understand how use
in animals may lead to resistance in humans.
What GAO Recommends:
GAO recommends that HHS and USDA (1) identify and evaluate approaches
to collecting detailed data on antibiotic use in animals and use these
data to evaluate FDA‘s voluntary strategy, (2) collect more
representative data on resistance, and (3) assess previous efforts on
alternatives to identify where more research is needed. HHS and USDA
agreed with GAO‘s recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-11-801] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Background:
Agency Data Are Limited and Restrict Efforts to Understand Antibiotic
Resistance:
FDA Implemented a Process to Mitigate Resistance Risk for Newer
Antibiotics but Faces Challenges with Older Antibiotics:
Agencies Took Steps to Research Alternatives and Educate Users, but
Progress Is Unclear:
Regulation of Antibiotics in the EU and Denmark May Offer Lessons for
the United States:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Alternative Modes of Food Animal Production:
Appendix III: The Food and Drug Administration's Antibiotic Sales Data:
Appendix IV: Structure of DANMAP:
Appendix V: ARS and NIFA Research Activities Related to Alternatives
to Current Antibiotic Use Practices:
Appendix VI: CDC and FDA Research Activities Related to Alternatives
to Current Antibiotic Use Practices:
Appendix VII: Comments from the Department of Agriculture:
Appendix VIII: Comments from the Department of Health and Human
Services:
Appendix IX: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Agencies with Responsibilities Related to Antibiotics in Food
Animals:
Table 2: Current Federal Efforts Collecting Data on Antibiotic Use:
Table 3: Components of NARMS:
Table 4: The Overlap between Growth Promotion and Disease Prevention
Uses in Food Animal Antibiotics:
Table 5: HHS Education Activities Related to Appropriate Antibiotic
Use from 2001-2011:
Table 6: USDA Education Activities Related to Appropriate Antibiotic
Use from 2001-2011:
Table 7: 2009 Sales and Distribution Data, by Drug Class, for
Antimicrobial Drugs Approved for Use in Food-Producing Animals in the
United States:
Table 8: 2009 Sales and Distribution Data, by Route of Administration,
for Antimicrobial Drugs Approved for Use in Food-Producing Animals in
the United States:
Table 9: Components of DANMAP:
Figures:
Figure 1: Potential Pathways for Spread of Antibiotic-Resistant
Bacteria from Animals to Humans:
Figure 2: EU and Denmark Actions to Regulate Antibiotic Use in Food
Animals, 1994-2010:
Figure 3: Antibiotic Use in Swine in Denmark 1994-2010:
Figure 4: Grass-Fed Cattle Raised without Antibiotics:
Figure 5: Free-Range Chickens at a Portable Chicken House:
Abbreviations:
ADUFA: Animal Drug User Fee Amendments of 2008:
APHIS: Animal and Plant Health Inspection Service:
ARMS: Agricultural Resource Management Survey:
ARS: Agricultural Research Service:
CAHFSE: Collaboration in Animal Health and Food Safety Epidemiology:
CDC: Centers for Disease Control and Prevention:
CIPARS: Canadian Integrated Program on Antimicrobial Resistance
Surveillance:
DANMAP: Danish Integrated Antimicrobial Resistance Monitoring and
Research Program:
ERS: Economic Research Service:
EU: European Union:
FDA: Food and Drug Administration:
FSIS: Food Safety and Inspection Service:
HACCP: Hazard Analysis and Critical Control Points:
HHS: Department of Health and Human Services:
MRS: Amethicillin-resistant Staphylococcus aureus:
NAHMS: National Animal Health Monitoring System:
NARMS: National Antimicrobial Resistance Monitoring System:
NIFA: National Institutes of Food and Agriculture:
NIH: National Institutes of Health:
NOP: National Organic Program:
USDA: U.S. Department of Agriculture:
VFD: veterinary feed directive:
WHO: World Health Organization:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
September 7, 2011:
The Honorable Louise M. Slaughter:
Ranking Member:
Committee on Rules:
House of Representatives:
Dear Ms. Slaughter:
Antibiotics have saved millions of lives by controlling infectious
diseases, but the continued effectiveness of these drugs is now
jeopardized by the emergence of bacteria resistant to antibiotics,
according to the World Health Organization (WHO). Antibiotic-resistant
infections can result in the use of more expensive drugs for
treatment, longer hospital stays, and even death. In addition, the
speed at which antibiotic resistance is rendering these drugs
ineffective far outpaces the development of new antibiotics, according
to WHO. Potential contributors to antibiotic-resistant infections in
humans include the widespread use of antibiotics in human medicine,
the presence of antibiotics in the environment, and the use of
antibiotics in animals raised for human consumption--often referred to
as food animals--such as cattle, swine, and poultry.
Antibiotics are an integral part of animal production in the United
States and many other countries. According to food animal producers,
antibiotic use reduces the cost of producing animals and, therefore,
the price consumers pay for food. Antibiotics are used to treat animal
diseases; to prevent and control the spread of diseases during phases
of production when animals are at an increased risk of illness, such
as weaning; and to increase animals' growth rate. Public health
officials are particularly concerned about the use of antibiotics to
promote growth because such antibiotics are administered in low doses
over long periods to large groups of healthy animals, which can cause
animals to become reservoirs of antibiotic-resistant bacteria. Once
the resistant bacteria develop in food animals, they may be passed to
humans through the consumption or handling of meat or other animal-
derived food products, contact with animals by farm workers or food
processors, or runoff of animal waste into soil or water.
Two federal departments are primarily responsible for ensuring the
safety of the food supply, including the safe use of antibiotics in
food animals--the Department of Health and Human Services (HHS) and
the U.S. Department of Agriculture (USDA). Within HHS, the Food and
Drug Administration (FDA) approves for sale, and regulates the
manufacture and distribution of, antibiotics used in animals. USDA
collects information about antibiotic use and resistance in food
animals, funds research related to antibiotic resistance, and educates
producers and other users about appropriate antibiotic use.
In April 1999, we reported on federal responsibilities related to
tracking and overseeing antibiotic use in food animals and noted that,
despite more than two decades of discussion, federal agencies had not
reached agreement on the safe use of antibiotics in food animals.
[Footnote 1] We recommended that agencies develop and implement a plan
to evaluate the risks and benefits of the existing and future use of
antibiotics in agriculture. Subsequently, in 1999, HHS created the
Interagency Task Force on Antimicrobial Resistance to coordinate
federal efforts to address antibiotic resistance in humans and
animals. This task force developed A Public Health Action Plan to
Combat Antimicrobial Resistance in January 2001 to serve as a
blueprint for federal coordination to address antibiotic resistance.
In April 2004, we again reviewed the issue of antibiotic use in food
animals and made two recommendations: that FDA expedite its risk
assessments of the extent to which antibiotic use in food animals
poses a risk to human health, and take mitigating action, if
necessary; and that HHS and USDA jointly develop and implement a plan
for collecting data on antibiotic use in animals.[Footnote 2] HHS and
USDA generally agreed with our findings, but neither has implemented
the recommendations, though both departments continued independent
data collection efforts rather than working jointly to develop and
implement a plan. Furthermore, we reported that countries in the
European Union (EU), in particular Denmark, were taking significant
steps to restrict the use of antibiotics in animals and that many
countries, including Denmark and Canada, collect detailed data on
antibiotic use in animals.
In 2007, we added food safety to our list of high-risk areas that
warrant attention by Congress and the executive branch. Our biennial
reviews of high-risk issues in 2009 and 2011 concluded that
fragmentation of federal food safety oversight continues to be a
problem.[Footnote 3] We have made several recommendations on this
issue, including recommending that agencies develop a government-wide
performance plan for food safety that includes results-oriented goals
and performance measures, as well as information about strategies and
resources.[Footnote 4]
In this context, you asked us to evaluate federal efforts to address
risks from antibiotic use in food animals. Our objectives were to
determine (1) the extent to which federal agencies have collected data
on antibiotic use and resistance in food animals, (2) the actions FDA
has taken to mitigate the risk of antibiotic resistance in humans as a
result of antibiotic use in food animals, (3) the extent to which
federal agencies have conducted research on alternatives to current
antibiotic use practices and educated producers and veterinarians
about appropriate antibiotic use, and (4) what actions the EU and an
EU member country, Denmark, have taken to regulate antibiotic use in
food animals and what lessons, if any, have been learned.
In conducting our work, we reviewed documents related to antibiotic
use in food animals, including applicable laws; federal plans,
regulations, and guidance; and federal reports on antibiotic use,
resistance, research, and education. We also interviewed and collected
documentation from officials at HHS and USDA. In addition, we
conducted structured interviews with representatives of a
nonprobability sample of 11 national organizations representing
producers of food animals, pharmaceutical companies, and public health
organizations. Representatives of these organizations, who spoke on
behalf of their members, answered questions about federal efforts to
collect data on antibiotic use and resistance, conduct research on
alternatives to antibiotics, and educate producers and veterinarians.
We selected these organizations because of their expertise in topics
surrounding antibiotic use in animals and resistance. Furthermore, we
conducted a structured interview of a nonprobability sample of five
representatives of national veterinary organizations about federal
efforts to conduct research on alternatives to antibiotics and educate
producers and veterinarians, as well as any efforts they may have
undertaken to address these issues. We sought to include a variety of
organizations with perspectives about antibiotic use and resistance;
however, the views of organizations consulted should not be considered
to represent all perspectives about these issues and are not
generalizable. In addition, we conducted site visits with conventional
and alternative (either organic or antibiotic-free) producers of
poultry, cattle, swine, and dairy products to obtain a better
understanding of production practices; the types of antibiotic use
data available at the farm level; and perspectives on federal efforts
to educate producers about antibiotics. During these site visits, we
also spoke with veterinarians involved with food animal production.
To identify actions the EU and Denmark have taken regarding antibiotic
use in food animals, we met with EU and Danish government officials,
veterinarians, and producer organizations. We selected the EU and
Denmark because they implemented bans on growth promotion uses of
antibiotics in 2006 and 2000, respectively, which allows for a review
of the effects of these policies in the years since. In addition, we
reviewed documents detailing the results of EU and Danish policy
actions and interviewed Danish producers and veterinarians at
conventional poultry and swine farms to learn about their experiences
implementing government regulations on antibiotic use. A more detailed
description of our objectives, scope, and methodology is presented in
appendix I.
We conducted this performance audit from August 2010 to September
2011, in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
Background:
Antibiotics are substances that destroy microorganisms or inhibit
their growth; they have been used for 70 years to treat people who
have bacterial infections. In this report, the term antibiotic is used
to refer to any substance used to kill or inhibit microorganisms, also
sometimes referred to as an antimicrobial. Resistance to penicillin,
the first broadly used antibiotic, started to emerge soon after its
widespread introduction. Since that time, resistance to other
antibiotics has emerged, and antibiotic resistance is becoming an
increasingly serious public health problem worldwide.
Antibiotic-Resistant Bacteria Can Spread through a Number of Pathways:
Bacteria acquire antibiotic resistance through mutation of their
genetic material or by acquiring genetic material that confers
antibiotic resistance from other bacteria. In addition, some bacteria
developed resistance to antibiotics naturally, long before the
development of commercial antibiotics. Once bacteria in an animal or
human host develop resistance, the resistant strain can spread from
person to person, animal to animal, or from animals to humans.
Antibiotic-resistant bacteria can spread from animals and cause
disease in humans through a number of pathways (see figure 1). For
example, unsanitary conditions at slaughter plants and unsafe food
handling practices could allow these bacteria to survive on meat
products and reach a consumer. Resistant bacteria may also spread to
fruits, vegetables, and fish products through soil, well water, and
water runoff contaminated by fecal matter from animals harboring these
bacteria. If the bacteria are disease-causing, the consumer may
develop an infection that is resistant to antibiotics. However, not
all bacteria cause illness in humans. For example, there are hundreds
of unique strains of Escherichia coli (E. coli), the majority of which
are not dangerous. Indeed, while some strains of E. coli are dangerous
to humans, many E. coli bacteria strains are a normal component of
human and animal digestive systems.
Figure 1: Potential Pathways for Spread of Antibiotic-Resistant
Bacteria from Animals to Humans:
[Refer to PDF for image: illustration]
1) Bacterial population (both resistant and susceptible) in farm
animals.
2) Antibiotic is given to animal for disease prevention, disease
control, disease treatment, or growth promotion.
3) Antibiotic kills susceptible bacteria; resistant bacteria survive
in contaminated animals.
4) Resistant bacteria spread to other animals on the farm through
contact with contaminated animals.
5) Resistant bacteria spread to consumers via contaminated meat
products.
6) Resistant bacteria spread to farm workers and food processors
through contact with contaminated animals or meat.
7) Resistant bacteria spread to soil and water from contaminated
animal waste.
8) Resistant bacteria spread to fish, fruits, and vegetables consumed by
humans.
9) Resistant infection may develop in humans.
Sources: GAO; Art Explosion (human figures).
Note: This figure is not intended to represent the full complexity of
resistance transmission. For example, antibiotic-resistant bacteria
can also be transferred from humans to animals.
[End of figure]
Antibiotics Are Currently Used in Food Animal Agriculture:
The use of antibiotics in animals poses a potential human health risk,
but it is also an integral part of intensive animal production in
which large numbers of poultry, swine, and cattle are raised in
confinement facilities. Over time, food animal production has become
more specialized and shifted to larger, denser operations, known as
concentrated animal feeding operations. According to a 2009 USDA
study, The Transformation of U.S. Livestock Agriculture: Scale,
Efficiency, and Risks, this shift has led to greater efficiencies in
agricultural productivity--meaning more meat and dairy production for
a given commitment of land, labor, and capital resources--and lower
wholesale and retail prices for meat and dairy products. However, the
study notes larger farms with higher concentrations of animals may be
more vulnerable to the rapid spread of animal diseases, which
producers may combat by using antibiotics. Some producers elect to
raise food animals without using antibiotics, in what are known as
alternative modes of production (see appendix II for more information
about alternative modes of production).
[Side bar: Dairy Production:
Modern dairy production is diverse, ranging from cows housed indoors
year-round to cows maintained on pasture nearly year-round. In the
United States, milk comes primarily from black and white Holstein cows
genetically selected for milk production. Over the years, the
concentration of more cows on fewer farms has been accompanied by
dramatic increases in production per cow, arising from improved
genetic selection, feeds, health care, and management techniques.
Expansion to larger herd sizes has also allowed producers to increase
the efficiency of production and capitalize on economies of scale.
When a cow is no longer able to breed and produce milk, it is usually
sold to the market as beef. According to the National Milk Producers‘
Federation, dairy producers use antibiotics to treat mastitis, an
inflammation of the udder, and other diseases. Any milk produced
during antibiotic treatment, and for a specific withdrawal period
after treatment has ceased, must be discarded in order to prevent
antibiotic residues in milk. This discarded milk imposes an economic
cost to dairy producers, so producers generally avoid treating dairy
cows with antibiotics when possible. According to the National Milk
Producers‘ Federation, dairy producers do not use antibiotics for growth
promotion that are medically important in human medicine. Source: GAO.
End of side bar]
Antibiotics provide significant benefits to animal production
according to USDA. For food animals, the purposes for which FDA
approves the use of antibiotics can be divided into the following four
categories:
* Disease treatment: administered only to animals exhibiting clinical
signs of disease.
* Disease control: administered to a group of animals when a
proportion of the animals in the group exhibit clinical signs of
disease.
* Disease prevention: administered to a group of animals, none of
which are exhibiting clinical signs of disease, in a situation where
disease is likely to occur if the drug is not administered.
* Growth promotion: sometimes referred to as feed efficiency,
administered to growing, healthy animals to promote increased weight
gain. Such uses are typically administered continuously through the
feed or water on a herd-or flock-wide basis. Although such use is not
directed at any specifically identified disease, many animal producers
believe the use of antibiotics for growth promotion has the additional
benefit of preventing disease, and vice versa.
In recent years, both FDA and WHO have sought to identify antibiotics
that are used in both animals and people and that are important to
treat human infections, also known as medically important antibiotics.
Specifically, according to FDA, a medically important antibiotic is
given the highest ranking--critically important--if it is used to
treat foodborne illness and if it is one of only a few alternatives
for treating serious human disease. For example, the fluoroquinolone
class of antibiotics is critically important to human medicine because
it is used to treat foodborne illnesses caused by the bacteria
Campylobacter (one of the most common causes of diarrheal illness in
the United States), and it is also one of only a few alternatives for
treating serious multidrug resistant infections in humans. Some
fluoroquinolones are also approved to treat respiratory infections in
cattle.
Several Federal Agencies Have Responsibilities and Authorities Related
to Animal Antibiotic Use:
Two federal departments are primarily responsible for ensuring the
safety of the U.S. food supply, including the safe use of antibiotics
in food animals--HHS and USDA. Each department contains multiple
agencies that contribute to the national effort to assess, measure,
and track antibiotic use and resistance (see table 1). Both HHS and
USDA officials have stated that it is likely that the use of
antibiotics in animal agriculture leads to some cases of antibiotic
resistance among humans and that medically important antibiotics
should be used judiciously in animals.
Table 1: Agencies with Responsibilities Related to Antibiotics in Food
Animals:
Department: HHS;
Agency: Centers for Disease Control and Prevention (CDC);
Contribution to antibiotic resistance efforts:
* Conducts surveillance[A] and other research to assess the extent of
antibiotic resistance and contributes data about antibiotic resistance
in humans to the interagency National Antimicrobial Resistance
Monitoring System (NARMS), a national public health surveillance
system to track antibiotic resistance in foodborne bacteria;
* Promotes appropriate use of antibiotics in animals through
educational activities and training.
Department: HHS;
Agency: FDA;
Contribution to antibiotic resistance efforts:
* Approves for sale and regulates the manufacture and distribution of
animal antibiotics;
* Coordinates NARMS (with CDC and ARS) and contributes data about
antibiotic resistance in retail meat;
* Conducts research on antibiotic resistance and educates animal
antibiotic users about appropriate use.
Department: HHS;
Agency: National Institutes of Health (NIH);
Contribution to antibiotic resistance efforts:
* Conducts research on recognizing, responding to, and circumventing
the processes that contribute to antibiotic resistance.
Department: USDA;
Agency: Animal and Plant Health Inspection Service (APHIS);
Contribution to antibiotic resistance efforts:
* Manages the National Animal Health Monitoring System (NAHMS)--a
periodic, national survey of producers that focuses on animal health,
welfare, and production;
* Manages the National Veterinary Accreditation Program, which
certifies private veterinarians to carry out certain federal animal
health programs.
Department: USDA;
Agency: Agricultural Research Service (ARS);
Contribution to antibiotic resistance efforts:
* Conducts research in the food safety and animal health programs on
alternatives to antibiotics, and the development, persistence, and
transmission of antibiotic-resistant organisms or resistance genes;
* Contributes data about antibiotic resistance in bacteria from food
animals at slaughter plants to NARMS.[B].
Department: USDA;
Agency: Economic Research Service (ERS);
Contribution to antibiotic resistance efforts:
* Conducts the Agricultural Resource Management Survey (ARMS), which
principally focuses on farm finances, and their links to farm
production practices and management decisions. The survey is also used
to track and analyze practices, including antibiotic use, as they
relate to food safety and the production and availability of food
animals.
Department: USDA;
Agency: Food Safety and Inspection Service (FSIS);
Contribution to antibiotic resistance efforts:
* Inspects slaughter plants, food processing, and import
establishments in the United States;
* Contributes samples collected from food animals or food animal
products at slaughter plants as a part of NARMS.
Department: USDA;
Agency: National Institute of Food and Agriculture (NIFA)[C];
Contribution to antibiotic resistance efforts:
* Funds research, education, and extension or outreach activities on
antibiotic resistance through grants to universities and other
organizations.
Source: GAO.
[A] According to the interagency task force, public health
surveillance is the ongoing and systematic collection, analysis, and
interpretation of data for use in the planning, implementation, and
evaluation of public health practice.
[B] ARS also tests bacteria gathered through NAHMS for antibiotic
resistance.
[C] NIFA was formerly known as the Cooperative State Research,
Education, and Extension Service.
[End of table]
[Side bar: Pork Production:
The United States is the world‘s third-largest pork producer and
largest pork exporter. Pigs are produced in several types of specialized
operations. Farrow-to-finish operators raise pigs from birth to
slaughter. In multisite pig production, different phases of production
occur at different locations, and breeding pigs are isolated from
other pigs at various stages of production. After weaning, pigs move
into either a ’wean-to-finish“ building, where they stay until sent to
slaughter, or to a ’nursery“ building (pictured above) and, 6-8 weeks
later, to a ’finisher“ building until slaughter. According to USDA,
the U.S. pork industry has shifted rapidly toward fewer large
operations, and operations that specialize in a single phase of
production have replaced many farrow-to-finish operations. According to
the National Pork Producers‘ Council, multisite production is designed
to keep pigs of the same age together and maximize pig health.
Producers minimize disease exposure by keeping pigs in the same groups
and thoroughly cleaning barns between herds. However, moving pigs from
site to site also presents disease challenges as pigs are exposed to
new bacteria from new environments and other animals. Producers may use
antibiotics to prevent diseases during vulnerable periods, as well as
to treat illnesses. Pork producers may also use antibiotics for growth
promotion, particularly when feed costs are high. Source: GAO.
End of side bar]
As mentioned, HHS and USDA agencies participate in the Interagency
Task Force on Antimicrobial Resistance, which developed a plan in 2001
to help federal agencies coordinate efforts related to antibiotic
resistance. The 2001 interagency plan contains 84 action items
organized in four focus areas: surveillance, prevention and control,
research, and product development. According to the 2001 interagency
plan, public health surveillance, which includes monitoring for
antibiotic resistance, is the ongoing and systematic collection,
analysis, and interpretation of data for use in the planning,
implementation, and evaluation of public health practice. Many of the
plan's action items focus on antibiotic use and resistance in humans,
and some action items address the use of antibiotics in agriculture,
including food animal production, and are directly relevant to this
report. For example, one action item in the surveillance focus area
states the agencies' intentions to develop and implement procedures
for monitoring antibiotic use in agriculture, as well as in human
medicine. Another states that agencies will expand surveillance for
antibiotic-resistant bacteria in sick and healthy food animals on
farms and at slaughter plants, as well as in retail meat, such as
chicken, beef, and pork. The action plan also contains action items
related to research on alternatives to antibiotics and providing
education to producers and veterinarians about appropriate antibiotic
use.
Since 2001, HHS and USDA have used the interagency task force to
coordinate their activities on antibiotic resistance. For example,
each year the task force produces an annual report listing activities
completed in that year related to the 2001 interagency plan. The task
force recently released a 2010 version of the interagency plan, which
is still in draft form but is expected to be finalized this year. The
draft 2010 interagency plan contains some new initiatives and also
reformulates many of the action items listed in the 2001 plan to be
more action-oriented.
Agency Data Are Limited and Restrict Efforts to Understand Antibiotic
Resistance:
The 2001 interagency plan discusses two types of data needed to
understand antibiotic resistance--data on the amount of antibiotics
used in food animals ("use data") and data on the level of antibiotic
resistance in bacteria found in food animals and retail meat
("resistance data"). Agencies have collected some data to track
antibiotic use in animals, but these data lack crucial details
identified by the 2001 interagency plan as essential for agencies to
examine trends and understand the relationship between use and
resistance. To collect data on antibiotic resistance, agencies have
leveraged existing programs, but because these programs were designed
for other purposes, their sampling methods do not yield data that are
representative of antibiotic resistance in food animals and retail
meat across the United States. USDA also collected data on both use
and resistance in a pilot program that was discontinued.
Agencies Collect Data on Use That Lack Crucial Details:
The 2001 interagency plan set a "top priority" action item of
monitoring antibiotic use in veterinary medicine, including monitoring
data regarding species and purpose of use. The plan stated this
information is essential for interpreting trends and variations in
rates of resistance, improving the understanding of the relationship
between antibiotic use and resistance, and identifying interventions
to prevent and control resistance. The task force's draft 2010
interagency plan reiterates the importance of monitoring antibiotic
use and sets a goal to better define, characterize, and measure the
impact of antibiotic use in animals.
Three federal efforts collect data about antibiotic use in food
animals (see table 2). One of these efforts, run by FDA, was created
by Congress as a reporting requirement for pharmaceutical companies to
provide sales data. The other two efforts are run by USDA agencies and
collect on-farm data on antibiotic use by incorporating questions into
existing surveys of food animal producers.
Table 2: Current Federal Efforts Collecting Data on Antibiotic Use:
Program: Animal Drug User Fee Amendments of 2008;
Agency: FDA;
Information collected: (1) the amount of each antibiotic sold by
container size, strength, and dosage form; (2) quantities distributed
domestically and quantities exported; and; (3) a listing of the target
animals, and the approved ways each antibiotic can be used;
Source of information: New Animal Drug sponsors (generally
pharmaceutical companies);
Frequency of reporting: Annual.
Program: NAHMS;
Agency: APHIS;
Information collected: Information about how antibiotics are
administered (e.g., in water, feed, or by injection), the number of
animals treated, producers' preferred antibiotics for various
ailments, and situations when producers would use an antibiotic;
Source of information: Producers;
Frequency of reporting: Varies;
every 6-7 years for most animal commodities.
Program: ARMS;
Agency: ERS;
Information collected: Information about antibiotic use as a
production practice, such as how antibiotic use affects livestock
production and farm financial performance;
Source of information: Producers;
Frequency of reporting: Varies;
approximately every 5 years.
Source: GAO.
[End of table]
Sales Data:
Since our 2004 report,[Footnote 5] FDA has begun to collect and
publish data from pharmaceutical companies on antibiotics sold for use
in food animals, as required by the Animal Drug User Fee Amendments of
2008 (ADUFA). Under ADUFA, the sponsor of an animal antibiotic--
generally a pharmaceutical company--must report annually to FDA: (1)
the amount of each antibiotic sold by container size, strength, and
dosage form; (2) quantities distributed domestically and quantities
exported; and (3) a listing of the target animals and the approved
ways each antibiotic can be used (called indications). Section 105 of
ADUFA also directs FDA to publish annual summaries of these data. To
fulfill this requirement, FDA published the first of these reports on
its public Web site in December 2010. (See appendix III for examples
of antibiotic sales data collected by FDA.) However, to protect
confidential business information, as required by statute, FDA's
report summarizes the sales data by antibiotic class, such as
penicillin or tetracycline, rather than by specific drug and also
aggregates sales data for antibiotic classes with fewer than three
distinct sponsors.
In submitting the original ADUFA legislation for the House of
Representatives to consider, the House Committee on Energy and
Commerce stated that it expected these data to further FDA's analysis
of, among other things, antibiotic resistance, but the data do not
include crucial details that would be needed to do so. Specifically,
ADUFA does not require FDA to collect information on the species in
which antibiotics are used and the purpose of their use. According to
representatives of all the producer and public health organizations we
spoke with, because FDA's sales data lack information on the species
in which the antibiotic is used, these data do not allow the federal
government to achieve the antibiotic use monitoring action item in the
2001 interagency plan, including interpreting trends and variations in
rates of resistance, improving the understanding of the relationship
between antibiotic use and resistance, and identifying interventions
to prevent and control resistance. For example, a representative of
one public health organization stated that species-specific data is
needed to link antibiotic use in animals with resistance in animals
and food. Representatives of most of the public health organizations
also stated that the government needs to collect data on the purpose
of antibiotic use--that is if the antibiotic is being given for
disease treatment, disease control, disease prevention, or growth
promotion. Furthermore, representatives of some public health
organizations indicated that data on antibiotic use should be
integrated with information on antibiotic resistance to allow analysis
of how antibiotic use affects resistance. However, a representative of
an animal pharmaceutical organization stated that FDA should not
attempt to collect national-level antibiotic use data and should
instead collect local data to facilitate study of farm management
practices in order to help farmers better use antibiotics.
According to FDA officials, sales data can provide an overall picture
of the volume of antibiotics sold for use in animals. However, FDA
faces several challenges in collecting detailed antibiotic sales data
from drug sponsors. First, if an antibiotic is approved for use in
multiple species, drug sponsors may not be able to determine how much
of their product is used in a specific species. Second, if an
antibiotic is approved for multiple purposes, drug sponsors also may
not be able to determine how much is used for each purpose. Third,
antibiotics may be stored in inventory or expire before they are used,
so the quantity sold and reported to the FDA may not equal the
quantity actually used in animals. FDA officials acknowledged the
limitation of their current sales data and noted that the agency is
exploring potential approaches to gather more detailed sales data or
other information on actual antibiotic use.
On-Farm Data:
Two USDA agencies collect data on antibiotic use from food animal
producers by incorporating questions into existing surveys. One of
these surveys, managed by APHIS, is the National Animal Health
Monitoring System (NAHMS), a periodic, national survey of producers
that focuses on animal health and management practices. APHIS staff
collect information from producers on how antibiotics are administered
(e.g., in water, feed, or injection), what antibiotics they prefer for
various ailments, and in what situations they would use an antibiotic.
To collect this information, APHIS staff visit farms multiple times
over the course of 3 to 6 months and survey producers' practices.
Previous NAHMS surveys have examined management practices for dairy
cows, swine, feedlot cattle, cow-calf operations, small broiler
chicken flocks, and egg-laying chicken flocks, among other species.
APHIS officials told us that one of NAHMS' strengths is its national
scope and that NAHMS can be used to examine changes in animal
management practices, including antibiotic use practices, between
NAHMS surveys. However, as we reported in 2004, NAHMS produces a
snapshot of antibiotic use practices in a particular species, but the
data it collects cannot be used to monitor trends in the amount of
antibiotics used over time. According to APHIS officials, these
limitations remain today. For example, these officials said that NAHMS
is limited by long lag times (approximately 6 years) between surveys
of the same species, changes in methodology and survey populations
between studies, reliance on voluntary participation by food animal
producers, and collection of qualitative, rather than quantitative
information on antibiotic use.
[Side bar: Beef Production:
The United States is the world‘s largest producer of beef. The beef
industry is roughly divided into two production sectors: cow-calf
operations and cattle feeding. Beef cattle are born in a cow-calf
operation, where both cows and calves are fed grass in a pasture year-
round. Once weaned, most cattle are sent to feedlots, where they are
fed grain for about 140 days. The beef industry has become
increasingly concentrated. According to USDA, feedlots with 1,000 or
more head of cattle comprise less than 5 percent of total feedlots in
the United States, but market 80 to 90 percent of fed cattle. Weaning,
shipping, and processing put stress on cattle and compromise their
immune systems. According to the National Cattleman‘s Beef Association,
beef producers use antibiotics to treat common illnesses, including
respiratory disease, eye infections, intestinal disease, anaplasmosis
(a red blood cell parasite), and foot infections. Some cattle
producers also use antibiotics for growth promotion. Source: USDA.
End of side bar]
Since our 2004 report, USDA's ERS has begun to collect information on
antibiotic use through the Agricultural Resource Management Survey
(ARMS)--a survey of farms conducted since 1996--though these data have
limitations similar to those of NAHMS. ERS uses ARMS data to study how
production practices, including antibiotic use, affect financial
performance and whether specific production practices can substitute
for other production practices. For example, a January 2011 ERS study
found that broiler chicken producers who forgo subtherapeutic uses of
antibiotics (i.e., use in chickens that are not ill) tend to use
distinctly different production practices, such as testing flocks and
feed for pathogens, fully cleaning chicken houses between each flock,
and feeding chickens exclusively from vegetable sources. However, like
NAHMS, ARMS cannot be used to examine trends in antibiotic use over
time because ERS does not resurvey the same farms over time or conduct
annual surveys on specific commodities.
According to officials from agencies and some organizations, it is
challenging to collect detailed data on antibiotic use in animals from
producers for a variety of reasons. First, producers may not always
maintain records on antibiotic use. Second, producers who do collect
these data may be reluctant to provide them to the federal government
voluntarily. FDA is exploring its legal options for requiring
producers to report antibiotic use data to FDA. In addition, we
observed during our site visits that the types of use data producers
collected varied widely. For example, one producer used electronic
systems to track all treatments by individual animal, whereas others
maintained paper records, and one maintained no records. Also, some
food animal species, such as broiler chickens, are generally produced
by integrated companies, which own the chickens from birth through
processing and contract with a grower to raise them. These growers
often receive feed as part of a contract and may not know whether that
feed contains antibiotics. For example, one grower we visited did not
know that his animals received antibiotics for growth promotion,
though the veterinarian from his integrated company indicated that
they did. Surveys, such as NAHMS and ARMS, that rely on producers or
growers to provide antibiotic use data may be particularly limited by
this lack of available data. Moreover, collecting data on-farm from
producers is expensive for the federal agencies involved due to the
large amount of personnel and time required.
[Side bar: Poultry Production:
The United States is the world‘s largest poultry producer and second-
largest poultry exporter, with broiler chickens”-those used for meat-”
comprising over four-fifths of U.S. poultry production. The broiler
chicken industry in the United States is vertically integrated,
meaning that the same company-”the integrator-”generally owns the
birds from birth through processing. Integrators contract with local,
independent growers to raise the birds, providing chicks, feed, and
veterinary services to the grower and visiting each facility regularly
to check for health issues. (Above is a picture of broiler chickens
in a grower facility.) According to the National Chicken Council,
broiler producers may use antibiotics to treat diseases, such as
bacterial enteritis (which causes diarrhea in chickens),
as well as for growth promotion. Source: USDA.
End of side bar]
Agencies also face challenges collecting antibiotic use data from
other sources. For example, use data gathered from veterinarians may
be of limited value because, according to FDA officials, many
antibiotics can be purchased without veterinary involvement. In cases
where antibiotics do require a prescription, the usefulness of records
maintained by veterinarians may vary. For example, one veterinary
clinic we visited maintained extensive paper records dating back 2
years, but because they were not electronic, these records would be
difficult to analyze. In addition, a veterinary organization we spoke
with stated that it would be cumbersome for veterinarians to provide
this information to an agency because there is no centralized
reporting mechanism, such as an electronic database, for them to do
so. According to an official from an organization representing the
animal feed industry, feed mills also maintain records on antibiotics
mixed into animal feed, including the amount of antibiotic used and
the type of feed the antibiotic went into. Although feed mills do not
intentionally track antibiotic use by species, the official said that
collectively, this information could be used to track antibiotic use
by species. However, FDA officials told us that collecting use data
from feed mills would require the development of a new reporting
mechanism for these data.
Agencies Are Leveraging Existing Programs to Collect Resistance Data,
but These Data Are Not Representative:
In 2004, we reported that the federal government collects resistance
data through the National Antimicrobial Resistance Monitoring System
(NARMS), established in 1996. NARMS is an interagency effort that
monitors antibiotic resistance in certain bacteria under three
programs: the animal component, led by ARS, samples bacteria from food
animals at slaughter plants; the retail meat component, led by FDA,
samples retail meat purchased from grocery stores; and the human
component, led by CDC, samples bacteria from humans (see table 3). FDA
serves as the funding and coordinating agency. From fiscal years 2006
through 2010, the NARMS budget remained constant at $6.7 million, with
ARS, FDA, and CDC receiving $1.4 million, $3.5 million, and $1.8
million, respectively. NARMS received a funding increase in fiscal
year 2011, to $7.8 million.
Table 3: Components of NARMS:
Agency: ARS and FSIS;
Source of bacteria: Animals at slaughter plants--chicken, turkey,
cattle, swine[A];
Bacteria tested for antibiotic resistance: Salmonella (chicken,
turkey, cattle, swine); Campylobacter (chicken); E. coli (chicken);
Enterococcus (chicken).
Agency: FDA;
Source of bacteria: Retail meat--samples of chicken breasts, pork
chops, ground turkey, ground beef;
Bacteria tested for antibiotic resistance: All 11 participating
states[B] culture four products for Salmonella and two products
(chicken breast and ground turkey) for Campylobacter; 4 of these
states also culture four products for E. coli and Enterococcus.
Agency: CDC;
Source of bacteria: Humans;
Bacteria tested for antibiotic resistance: All 50 states culture for
typhoidal Salmonella, non-typhoidal Salmonella, E. coli O157, Shigella;
10 states culture Campylobacter[C].
Source: GAO.
[A] ARS also tests bacteria gathered through NAHMS for antibiotic
resistance.
[B] FoodNet is a collaborative project between CDC and 10
participating states: California, Colorado, Connecticut, Georgia,
Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee.
[C] In addition, some states culture non-clinical Enterococcus and E.
coli. CDC also previously tested Listeria and generic E. coli, but is
not currently doing so.
[End of table]
The 2001 interagency plan contains an action item stating agencies
will design and implement a national antibiotic resistance
surveillance plan. Among other things, the 2001 interagency plan
states that agencies will expand and enhance coordination of
surveillance for drug-resistant bacteria in sick and healthy animals
on farms, food animals at slaughter plants, and retail meat. The plan
also states that collecting data on antibiotic resistance will help
agencies detect resistance trends and improve their understanding of
the relationship between use and resistance. The draft 2010
interagency plan also reiterates the importance of resistance
surveillance and includes several action items aimed at strengthening,
expanding, and coordinating surveillance systems for antibiotic
resistance. According to WHO's Surveillance Standards for
Antimicrobial Resistance, which provides a framework to review
existing antibiotic resistance surveillance efforts, populations
sampled for surveillance purposes should normally be representative of
the total population--in this case, food animals and retail meat in
the United States. Additionally, WHO's surveillance standards state
that it is important to understand the relationship of the population
surveyed to the wider population, meaning that agencies should
understand how food animals and retail meat surveyed in NARMS are
similar to food animals and retail meat throughout the United States.
The food animal component of NARMS, led by ARS, gathers bacteria from
food animal carcasses at slaughter plants and tests them for
antibiotic resistance, but because of a change in sampling method has
become less representative of food animals across the United States
since we reported in 2004. ARS receives these samples from an FSIS
regulatory program called the Hazard Analysis and Critical Control
Points (HACCP) verification testing program, which is designed to,
among other things, reduce the incidence of foodborne illness. FSIS
inspectors work in slaughter plants around the country, where they
collect samples from carcasses to test for foodborne pathogens, among
other duties. When we last reported on antibiotic resistance in 2004,
HACCP verification testing included two sampling programs--a
nontargeted program, in which inspectors sampled randomly selected
plants, and a targeted program, in which slaughter plants with a
higher prevalence of bacteria causing foodborne illness were more
likely to be selected for additional sampling. In 2006, FSIS
eliminated the random sampling program, which FSIS officials told us
has allowed the agency to use its resources more effectively. FSIS now
conducts only targeted sampling of food animals in its HACCP
verification testing. This nonrandom sampling method means the NARMS
data obtained through HACCP are not representative of food animals
across the country and cannot be used for trend analysis because
bacteria tested by NARMS are now collected at greater rates from
slaughter plants that are not in compliance with food safety
standards. According to FDA officials, due to this sampling method,
the resulting data are skewed for NARMS purposes.
The NARMS retail meat component, led by FDA, collects samples of meat
sold in grocery stores and tests them for antibiotic-resistant
bacteria, but these samples may not be representative of retail meat
throughout the United States. The program began in 2002 and has since
expanded to collect retail meat samples from 11 states: the 10
participant states in CDC's FoodNet program, which conducts
surveillance for foodborne diseases, plus Pennsylvania, which
volunteered to participate in retail meat sampling (See table 3 for
the types of bacteria tested). Due to its nonrandom selection of
states, FDA cannot determine the extent to which NARMS retail meat
samples are representative of the United States. FDA collects bacteria
from those states that volunteer to participate in the program, so
some regions of the country are not represented in the NARMS retail
meat program. According to the FDA Science Advisory Board's 2007
review of NARMS, this lack of a national sampling strategy limits a
broader interpretation of NARMS data.[Footnote 6] According to FDA
officials, FDA has not analyzed how representative these samples are
of the national retail meat supply in the United States but officials
believe that the samples provide useful data that serves as an
indicator for monitoring US retail meat.
FDA is aware of the sampling limitations in NARMS and has articulated
a strategic goal of making NARMS sampling more representative and
applicable to trend analysis in a draft 2011-2015 NARMS Strategic
Plan, which was released for public comment in January 2011. The
comment period closed in May 2011, and FDA is currently making changes
to the plan based on the submitted comments. The plan states that
NARMS will become more representative by, among other things,
modifying its animal sampling to overcome the biases resulting from
the current reliance on HACCP verification testing and improving the
geographic representation of retail meat testing, though FDA has not
yet planned specific actions to achieve this goal.
According to FDA officials, in light of increased funding for NARMS in
2011, they are exploring ways to improve NARMS sampling to make it
more representative. FDA hosted a public meeting in July 2011 to
solicit public comment on NARMS animal and retail meat sampling
improvements. At this meeting, ARS officials discussed two new on-farm
projects--one pilot project, in collaboration with FDA, plans to
collect samples from feedlot cattle, dairy cows, and poultry with the
goal of evaluating potential sampling sites within the food animal
production chain (e.g., on farms or in holding pens at slaughter
plants). The second project is in collaboration with Ohio State
University and plans to use industry personnel to collect samples from
poultry and swine producers. Both projects will test samples for
antibiotic resistance through NARMS. Some of the additional
suggestions discussed during this meeting included changing FSIS
sampling to provide more representative data to NARMS, discontinuing
slaughter plant sampling altogether in favor of an on-farm sampling
program, and increasing the number of state participants in the retail
meat sampling program.
The NARMS human component, led by CDC, collects and tests bacteria
from health departments in all 50 states and the District of Columbia.
We reviewed the issue of antibiotic resistance and antibiotic use in
humans in 2011. This review examined, among other things, the human
component of NARMS and concluded that CDC's data is nationally-
representative for four of the five bacteria included in the program.
[Footnote 7]
In our interviews, representatives of producer and public health
organizations identified several challenges associated with collecting
data on antibiotic resistance. First, according to representatives
from most public health organizations, ARS, FDA, and CDC are limited
by available funding. Sampling and testing bacteria can be expensive,
and agencies have to balance competing priorities when allocating
resources. For example, in the NARMS retail meat program, FDA could
choose to expand retail meat sampling geographically by adding new
states to the program, expand the number of bacteria tested, expand
the number of samples collected, or expand the types of meat sampled.
Second, according to representatives of several producer and public
health organizations, agencies may face challenges cooperating and
reaching consensus with one another. For example, NARMS reports do not
include interpretation of resistance trends across NARMS components.
Specifically, while NARMS issues annual Executive Reports that combine
data from all three components of NARMS (available on FDA's Web site),
these reports do not provide interpretation of NARMS data. According
to FDA officials, it is difficult to develop consensus on
interpretation for these reports because agencies differ in their
interpretations and preferred presentations of NARMS data. Third,
according to the FDA Science Advisory Board's 2007 review of NARMS,
the lag between NARMS data collection and report issuance can
sometimes be excessive. For example, as of August 2011, the latest
NARMS Executive Report covered 2008 data. According to FDA and CDC
officials, the process of testing bacteria, analyzing and compiling
data, and obtaining approval from agencies is time-consuming and
increases the lag time of NARMS reports.
In our interviews, representatives of public health organizations also
suggested that federal agencies collect additional types of resistance
data. First, representatives of several organizations suggested that
agencies expand the types of bacteria tested for antibiotic
resistance. FDA is aware of this suggestion and has considered whether
to add to the types of bacteria it tests. For example, recent studies
have discussed methicillin-resistant Staphylococcus aureus (MRSA) in
retail meat. MRSA is a type of bacteria that is resistant to several
antibiotics, including penicillin, and that can cause skin infections
in humans and more severe infections in health care settings. In
response, FDA is conducting a pilot study to collect data on the
prevalence of MRSA in retail meat. However, according to FDA
officials, FDA is unlikely to include MRSA in its regular NARMS
testing because general consensus in the scientific community is that
food does not transmit community-acquired MRSA infections in humans.
Second, representatives of three public health organizations suggested
that federal agencies link resistance data with data on outbreaks of
foodborne illness in humans, which representatives of one organization
stated could help scientists document the link between animal
antibiotic use and resistant outbreaks of foodborne illness. According
to representatives of this organization, NARMS' resistance data are
not currently linked to information about foodborne disease outbreaks.
According to CDC officials, CDC tests bacteria associated with
foodborne illness outbreaks in humans for antibiotic resistance, but
does not routinely publish these data.
USDA Discontinued a Program That Collected Data on Both Use and
Resistance:
When we last reported on antibiotic resistance in 2004, APHIS, ARS,
and FSIS collected on-farm use and resistance data from 40 swine
producers through the pilot Collaboration in Animal Health and Food
Safety Epidemiology (CAHFSE), but this program faced challenges in
collecting data and was discontinued in 2006 due to lack of funding.
By collecting information from the same facilities over time, agencies
could use CAHFSE data to examine the relationship between antibiotic
use and resistance. However, according to officials at APHIS and ARS,
collecting quarterly on-farm data was burdensome and generated a large
number of bacterial samples, which were costly to test and store.
Although the agencies wanted to use CAHFSE to monitor antibiotic
resistance throughout the food production system, officials from all
three agencies told us that this "farm to fork" monitoring raised
logistical challenges. For example, FSIS officials examined the
feasibility of monitoring resistance data through the slaughter plant
but discovered that slaughter plants were reluctant to participate in
the program due to fear of enforcement actions and confidentiality
concerns. According to APHIS officials, CAHFSE released quarterly and
annual data summaries, but it did not issue an overall capping report
or formal evaluation of the program.
CAHFSE was discontinued, but NAHMS continues to collect three types of
bacteria (Salmonella, Campylobacter, and E. coli) from a subset of
surveyed producers and sends them to ARS for antibiotic resistance
testing. However, as discussed earlier in this report, NAHMS data
provide a snapshot of a particular species but cannot be used to
monitor trends. Additionally, as discussed earlier in this report, ARS
has started two on-farm projects to collect bacteria from food
animals. In one of these projects, which collects samples from poultry
and swine, ARS partners with integrated companies to collect a variety
of samples from producers. According to an ARS official, because
personnel to collect samples were responsible for the majority of
costs in the CAHFSE program, using industry personnel rather than ARS
staff to collect on-farm samples can significantly reduce the costs of
on-farm sampling.
Although data on both use and resistance can be difficult to collect,
other countries have been successful in doing so. For example, the
Canadian government's Canadian Integrated Program on Antimicrobial
Resistance Surveillance (CIPARS), created in 2002, provides an example
of on-farm collection of antibiotic use and resistance data. In
addition to gathering resistance data similar to NARMS, CIPARS also
has an on-farm component, which collects antibiotic use information
annually from about 100 swine producers and integrates it with data
from resistance testing on fecal samples from the same farms. CIPARS
addresses funding limitations by restricting on-farm surveillance to
swine, sampling annually rather than quarterly, and collecting
slaughter plant samples through industry personnel. A CIPARS official
stated that the program's on-farm data could be used to link
antibiotic use and antibiotic resistance at the herd level and help
identify interventions to prevent antibiotic resistance. CIPARS issues
annual reports, which include interpretation of the data such as
discussions of trends over time. For example, the most recent report,
from 2007, noted an increase in the percentage of bacteria resistant
to several antibiotics in samples collected from pigs at slaughter
plants from 2003 to 2007.
Denmark also has a use and resistance data collection system, called
the Danish Integrated Antimicrobial Resistance Monitoring and Research
Program (DANMAP). Data collection covers antibiotic use in food
animals and humans, as well as antibiotic resistance in food animals,
meat in slaughter plants and at retail, and in humans. The objectives
of DANMAP are to monitor antibiotic use in food animals and humans;
monitor antibiotic resistance in bacteria from food animals, food of
animal origin, and humans; study associations between antibiotic use
and resistance; and identify routes of transmission and areas for
further research studies. According to DANMAP officials, Denmark
achieves these goals by gathering data on veterinary prescriptions,
since all antibiotic use in Denmark is via prescription-only. For
veterinary prescriptions, these officials told us Denmark gathers data
on the medicine being prescribed, the intended species and age group
in which the prescription will be used, the prescribed dose of the
antibiotic, the prescribing veterinarian, and the farm on which the
prescription will be used. Further, DANMAP collects information on
antibiotic resistance in food animals, from healthy animals at
slaughter plants and from diagnostic laboratory submissions from sick
animals. Denmark also gathers both domestically produced and imported
retail meat samples from throughout the country to test for antibiotic
resistance. DANMAP officials noted that, in Denmark, the industry is
responsible for collecting and submitting bacterial samples from
slaughter plants for testing, according to a voluntary agreement, and
that the industry spends additional funds to do so. DANMAP issues
annual reports, which include interpretation of data on antibiotic use
in animals and humans, as well as data on antibiotic resistance in
bacteria from food animals, retail meat, and humans. Some DANMAP
reports also include more detailed analysis of particular areas of
interest. For example, the 2009 DANMAP report examined E. coli
resistant to penicillins in pigs, retail meat, and humans and found
that antibiotic use in both animals and humans contributes to the
development of penicillin-resistant E. Coli. See appendix IV for more
information on DANMAP.
FDA Implemented a Process to Mitigate Resistance Risk for Newer
Antibiotics but Faces Challenges with Older Antibiotics:
FDA implemented a risk assessment process for antibiotic sponsors,
generally pharmaceutical companies, to mitigate the risk of resistance
in food animals to antibiotics approved since 2003. However, the
majority of antibiotics used in food animals were approved prior to
2003, and FDA faces significant resource challenges in assessing and
mitigating the risk of older antibiotics. Instead, FDA has proposed a
voluntary strategy to mitigate this risk but has neither developed a
plan nor collected the "purpose of use" data necessary to measure the
effectiveness of its strategy.
FDA Implemented a Risk Assessment Process to Mitigate Resistance Risk
for New Antibiotics:
FDA approves for sale, and regulates the manufacture and distribution
of, drugs used in veterinary medicine, including drugs given to food
animals. Prior to approving a new animal drug application, FDA must
determine that the drug is safe and effective for its intended use in
the animal. It must also determine that the new drug intended for
animals is safe with regard to human health, meaning that there is
reasonable certainty of no harm to human health from the proposed use
of the drug in animals. FDA may also take action to withdraw an animal
drug when new evidence shows that it is not safe with regard to human
health under the approved conditions of use.
In 2003, FDA issued guidance recommending that antibiotic sponsors
include a risk assessment of any new antibiotics for use in food
animals. The guidance is known as Evaluating the Safety of
Antimicrobial New Animal Drugs with Regard to Their Microbiological
Effects on Bacteria of Human Health Concern, Guidance for Industry
#152. Under this framework, an antibiotic sponsor would assess three
factors: the probability that the resistant bacteria are present in
the animal as a consequence of the antibiotic use, the probability
that humans would ingest the bacteria in question, and the probability
that human exposure to resistant bacteria would result in an adverse
health consequence. As part of the third factor, the sponsor considers
the importance of the antibiotic to treating human illness, under the
assumption that the consequences of resistance are more serious for
more important antibiotics. The guidance provides a preliminary
ranking of antibiotics considered medically important to human
medicine, with the highest ranking assigned to antibiotics deemed
"critically important" if it is (1) used to treat foodborne illness
and (2) one of only a few alternatives for treating serious human
disease. An antibiotic is considered highly important if it meets one
of these two criteria. By considering all three factors, the sponsor
estimates the overall risk of the antibiotic's use in food animals
adversely affecting human health. Though this risk assessment process
is recommended by FDA, the antibiotic sponsor is free to prove the
safety of a drug in other ways and to consult with FDA to decide if
the approach is recommended for its animal antibiotic application. FDA
officials said that, in practice, the risk of antibiotic resistance is
considered as part of any new animal antibiotic approval.
According to FDA documents, this risk assessment process has been
effective at mitigating the risk of resistance posed by new
antibiotics because antibiotic sponsors usually consider the risk
assessment process in their product development, so the products
ultimately submitted for approval are intended to minimize resistance
development. Representatives of some producer, public health, and
veterinary organizations, as well as an animal pharmaceutical
organization, told us that they were generally satisfied with the risk
assessment approach. For example, a representative of an animal
pharmaceutical organization commented that the risk assessment process
was helpful in that it provided a clear road map for drug approvals.
Representatives of a veterinary organization said they were pleased
that new antibiotics were examined using a comprehensive, evidence-
based approach to risk assessment.
However, several organizations also raised concerns. For instance, a
representative of an animal pharmaceutical organization said that
FDA's risk assessment process was an overly protective "blunt
instrument," since FDA would likely not approve any antibiotic product
designed for use in feed to prevent or control disease in a herd or
flock if the antibiotic is critically important to human health.
Representatives from this pharmaceutical organization and a veterinary
organization said that FDA's guidance makes it very difficult for
antibiotic sponsors to gain approval for new antibiotics for use in
feed or water.
In addition, representatives of several public health organizations
said that flaws in the criteria FDA used to rank medically important
antibiotics may lead the agency to the inappropriate approval of
animal antibiotics. For example, they identified a class of
antibiotics known as fourth-generation cephalosporins, which are an
important treatment for pneumonia in humans and one of the sole
therapies for cancer patients with certain complications from
chemotherapy. However, since neither of these are also foodborne
diseases, under FDA criteria this antibiotic is not ranked as
critically important in treating human illness, which these
organizations said could lead to the approval of fourth-generation
cephalosporins for use in food animals and, eventually, increased
antibiotic resistance. FDA officials recently said they intend to
revisit the antibiotic rankings to reflect current information.
However, FDA officials noted that they believed the current ranking
appropriately focused on antibiotics used to treat foodborne illnesses
in humans given that the objective of the guidance was to examine the
risk of antibiotic use in food animals.
FDA Faces Resource Challenges in Assessing the Risk of Older
Antibiotics:
According to FDA officials, the majority of antibiotics used in food
animals were approved prior to 2003. FDA faces significant challenges
to withdraw agency approval, either in whole or in part, of these
antibiotics if concerns arise about the safety of an antibiotic. If
FDA initiates a withdrawal action because of safety questions that
have arisen after an antibiotic's approval, the agency has the initial
burden of producing evidence sufficient to raise serious questions
about the safety of the drug. Once FDA meets this initial burden of
proof, the legal burden then shifts to the antibiotic sponsor to
demonstrate the safety of the drug. If, after a hearing, the FDA
Commissioner finds, based on the evidence produced, that the
antibiotic has not been shown to be safe, then the product approval
can be withdrawn.
FDA's 5-year effort to withdraw approval for one antibiotic for use in
poultry illustrates the resource-intensive nature of meeting the legal
burden to withdraw an approved antibiotic. It is the only example of
FDA withdrawing an antibiotic's approval for use in food animals
because of concerns about resistance. Specifically, Enrofloxacin,
approved in October 1996, is in the critically important
fluoroquinolone class of antibiotics, used to treat foodborne
illnesses caused by the bacteria Campylobacter, and it was used in
poultry flocks via the water supply to control mortality associated
with E. coli and other organisms. In October 2000, based on evidence
of increased fluoroquinolone resistance in bacteria from animals and
humans, FDA initiated a proceeding to withdraw its approval for the
use of two types of fluoroquinolones in poultry. One pharmaceutical
company voluntarily discontinued production, but the manufacturer of
enrofloxacin challenged the decision. FDA officials told us that it
took significant time and resources to gather evidence for the case,
even though they had good data showing a correlation between the
drug's approval for use in poultry and increasing resistance rates in
humans. After an administrative law judge found that enrofloxacin was
not shown to be safe for use in poultry as previously approved, the
FDA's Commissioner issued the final order withdrawing approval for its
use effective September 2005.
FDA officials said that from this case they learned that taking a case-
by-case approach to withdrawing antibiotics due to concerns over
resistance was time-consuming and challenging. In our 2004 review of
federal efforts to address antibiotic resistance risk, we reported FDA
was planning to conduct similar risk assessments of other previously
approved antibiotics.[Footnote 8] FDA officials estimated, however,
that the enrofloxacin withdrawal cost FDA approximately $3.3 million,
which they said was significant. FDA officials told us that conducting
individual postapproval risk assessments for all of the antibiotics
approved prior to 2003 would be prohibitively resource intensive, and
that pursuing this approach could further delay progress on the issue.
FDA Proposed a Voluntary Strategy for Older Antibiotics but Has No
Plan to Assess Effectiveness:
Instead of conducting risk assessments for individual antibiotics
approved prior to 2003, FDA in June 2010 proposed a strategy to
promote the "judicious use" of antibiotics in food animals. FDA
proposed the strategy in draft guidance titled The Judicious Use of
Medically Important Antimicrobial Drugs in Food-Producing Animals,
draft Guidance for Industry #209. FDA describes judicious uses as
those appropriate and necessary to maintain the health of the food
animal. The draft guidance includes two principles aimed at ensuring
the judicious use of medically important antibiotics. First, that
antibiotic use is limited to uses necessary for assuring animal
health--such as to prevent, control, and treat diseases. Second, that
animal antibiotic use is undertaken with increased veterinary
oversight or consultation. To implement the first principle, FDA is
working with antibiotic sponsors to voluntarily phase out growth
promotion uses of their antibiotics. FDA officials told us they have
met with four of the approximately nine major antibiotic sponsors to
discuss withdrawing growth promotion uses from their antibiotics'
labels and that they plan to engage with generic antibiotic
manufacturers in the near future. To implement the second principle of
increasing veterinarian oversight of antibiotic use, FDA officials
told us that they would like to work with antibiotic sponsors to
voluntarily change the availability of medically important antibiotics
currently approved for use in feed from over the counter to veterinary
feed directive (VFD) status. The majority of in-feed antibiotics are
currently available over the counter, but VFD status would instead
require these antibiotics to be used with the professional supervision
of a licensed veterinarian. In March 2010, FDA issued an advance
notice of proposed rulemaking announcing its intention to identify
possible changes to improve its current rule on VFDs and seeking
public comments on how to do so. FDA officials told us that they
received approximately 80 comments by the end of the comment period in
August 2010 from interested parties on how to improve the VFD rule,
and were taking them into consideration as they drafted the rule,
which they hope to publish in 2011. In April 2011, the American
Veterinary Medicine Association also formed a new committee to help
FDA develop practical means to increase veterinary oversight of
antibiotic use.
Representatives of several producer organizations, veterinary
organizations, and an animal pharmaceutical organization expressed
concern that FDA's focus on ending growth promotion uses would
adversely affect animal health. In particular, these representatives
said that some animal antibiotics approved for growth promotion may
also prevent disease, though they are not currently approved for that
purpose. FDA officials said that, in cases where pharmaceutical
companies can prove such claims, FDA would be willing to approve these
antibiotics for disease prevention. FDA officials emphasized, however,
that they do not want companies to relabel existing growth promotion
antibiotics with new disease prevention claims with no substantive
change in the way antibiotics are actually used on the farm. FDA
officials told us they plan to issue additional guidance for
antibiotic sponsors to outline a specific process for making changes
in product labels.
Furthermore, representatives of several producer and veterinary
organizations we spoke with expressed concerns about FDA's efforts to
increase veterinary oversight because there is shortage of large
animal veterinarians. As we reported in February 2009, there is a
growing shortage of veterinarians nationwide, particularly of
veterinarians who care for food animals, serve in rural communities,
and have training in public health.[Footnote 9] Additionally,
representatives of veterinary organizations said that the paperwork
requirements under VFDs are onerous. In particular, this is because
VFDs require the veterinarian to deliver a copy of the VFD to the feed
producer directly for each VFD, and there are not yet many systems for
electronic distribution.
In addition, representatives of several public health organizations
expressed concern that FDA's strategy will not change how antibiotics
are used for two reasons. First, because FDA is depending on voluntary
cooperation to remove growth promotion uses from antibiotic labels,
there is no guarantee that pharmaceutical companies will voluntarily
agree to relabel their antibiotics. To underline the seriousness of
their concerns, in May 2011, several public health organizations filed
a suit to force FDA to withdraw its approval for the growth promotion
uses of two antibiotic classes (penicillins and tetracyclines).
Second, representatives of some public health organizations noted that
several medically important antibiotics (six out of eight) currently
approved by FDA for growth promotion or feed efficiency are already
approved for disease prevention uses in some species (see table 4),
which could negate the impact of FDA's strategy. Because disease
prevention dosages often overlap with growth promotion dosages,
representatives of one of these organizations said that food animal
producers might simply alter the purpose for which the antibiotics are
used without altering their behavior on the farm. One veterinarian
told us that if FDA withdrew an antibiotic's approval for growth
promotion, he could continue to give the antibiotic to the animals
under his care at higher doses for prevention of a disease commonly
found in this species. The veterinarian stated that there is an
incentive to do so because using an animal antibiotic can help the
producers he serves use less feed, resulting in cost savings. For
example, the in-feed antibiotic may cost approximately $1 per ton of
feed, but it can save $2 to $3 per ton of feed, making it an effective
choice for the producer.
Table 4: The Overlap between Growth Promotion and Disease Prevention
Uses in Food Animal Antibiotics:
Antibiotic class: Macrolides;
FDA ranking of the importance of antibiotic class to human medicine:
Critically important;
Antibiotic name: Tylosin;
Approved uses by animal:
Cattle: [Empty];
Poultry: [Check] (shaded light gray);
Swine: [Check].
Antibiotic class: Macrolides;
Antibiotic name: Erythromycin;
Approved uses by animal:
Cattle: [Check];
Poultry: [Check] (shaded light gray);
Swine: [Check].
Antibiotic class: Lincosamides;
FDA ranking of the importance of antibiotic class to human medicine:
Highly important;
Antibiotic name: Lincomycin;
Approved uses by animal:
Cattle: [Empty];
Poultry: [Check];
Swine: [Check] (shaded light gray).
Antibiotic class: Penicillin;
FDA ranking of the importance of antibiotic class to human medicine:
Highly important;
Antibiotic name: Penicillin G Procaine;
Approved uses by animal:
Cattle: [Empty];
Poultry: [Check];
Swine: [Check].
Antibiotic class: Streptogramins;
FDA ranking of the importance of antibiotic class to human medicine:
Highly important;
Antibiotic name: Virginiamycin;
Approved uses by animal:
Cattle: [Check] (shaded light gray);
Poultry: [Check] (shaded light gray);
Swine: [Check].
Antibiotic class: Tetracyclines;
FDA ranking of the importance of antibiotic class to human medicine:
Highly important;
Antibiotic name: Chlortetracycline;
Approved uses by animal:
Cattle: [Check] (shaded light gray);
Poultry: [Check] (shaded light gray);
Swine: [Check] (shaded light gray).
Antibiotic class: Tetracyclines;
Antibiotic name: Oxytetracycline;
Approved uses by animal:
Cattle: [Check] (shaded light gray);
Poultry: [Check] (shaded light gray);
Swine: [Check].
Antibiotic class: Pleuromutilins;
FDA ranking of the importance of antibiotic class to human medicine:
Highly important;
Antibiotic name: Tiamulin;
Approved uses by animal:
Cattle: [Empty];
Poultry: [Empty];
Swine: [Check].
[All of the following are shaded dark gray]
Antibiotic class: Glycolipids;
FDA ranking of the importance of antibiotic class to human medicine:
Not ranked;
Antibiotic name: Bambermycins;
Approved uses by animal:
Cattle: [Check];
Poultry: [Check];
Swine: [Check].
Antibiotic class: Polypeptides;
FDA ranking of the importance of antibiotic class to human medicine:
Not ranked;
Antibiotic name: Bacitracin;
Approved uses by animal:
Cattle: [Check];
Poultry: [Check];
Swine: [Check].
Antibiotic class: Quinoxalines;
FDA ranking of the importance of antibiotic class to human medicine:
Not ranked;
Antibiotic name: Carbadox;
Approved uses by animal:
Cattle: [Empty];
Poultry: [Empty];
Swine: [Check].
Antibiotic class: Ionophores;
FDA ranking of the importance of antibiotic class to human medicine:
Not ranked;
Antibiotic name: Monensin;
Approved uses by animal:
Cattle: [Check];
Poultry: [Check];
Swine: [Empty].
Antibiotic class: Ionophores;
Antibiotic name: Lasalocid;
Approved uses by animal:
Cattle: [Check];
Poultry: [Check];
Swine: [Empty].
Antibiotic class: Ionophores;
Antibiotic name: Laidlomycin;
Approved uses by animal:
Cattle: [Check];
Poultry: [Empty];
Swine: [Empty].
Source: GAO analysis of FDA data.
Note: A {Check} indicates FDA approved growth promotion uses,
including weight gain and improving feed efficiency. Light gray
shading denotes the overlap between antibiotics approved for growth
promotion and disease prevention purposes. Boxes in dark gray denote
antibiotics not ranked important to human health by FDA.
[End of table]
Although representatives of some producer and public health
organizations have raised doubts about the effectiveness of FDA's
strategy, FDA does not have a plan to collect the data necessary to
understand the purpose for which antibiotics are being used or have a
plan to measure the effectiveness of its strategy to encourage more
judicious use of antibiotics in animals. FDA officials told us the
agency will consider this strategy to be successful when all the
growth promotion uses of medically important antibiotics are phased
out. FDA officials were unable to provide a timeline for phasing out
growth promotion uses, though they identified several next steps FDA
intends to take, such as finalizing the guidance document describing
their voluntary strategy and issuing additional guidance on its
implementation, as well as proceeding forward with the VFD rulemaking
process. However, FDA officials stated that the agency had no further
plans to measure its progress. In addition, FDA will still allow
medically important antibiotics to be used for disease prevention.
However, because agency data on sales of antibiotics used in food
animals do not include the purpose for which the antibiotics are used,
it will be difficult for FDA to evaluate whether its strategy has
increased the judicious use of antibiotics or simply encouraged a
shift in the purpose of use--for instance, from growth promotion to
disease prevention--without lessening use. FDA officials told us the
agency is exploring approaches for obtaining additional information
related to antimicrobial drug use to enhance the antibiotic sales data
that is currently reported to FDA as required by ADUFA, but did not
provide a timeline for these efforts.
Agencies Took Steps to Research Alternatives and Educate Users, but
Progress Is Unclear:
USDA and HHS agencies have taken some steps to research alternatives
to current antibiotic use practices and educate producers and
veterinarians on appropriate use of antibiotics but the extent of
these steps is unclear because neither USDA nor HHS has assessed the
progress toward fulfilling the related action items in the 2001
interagency plan.
USDA and HHS Have Conducted Research on Alternatives but Have Not
Assessed Progress:
An action item in the 2001 interagency plan states that federal
agencies will promote the development of alternatives to current
antibiotic use, including through research. According to the 2001
interagency plan, such alternatives could include researching vaccines
and management practices that prevent illnesses or reduce the need for
antibiotic use. However, USDA has not tracked its activities in this
area, and neither USDA nor HHS has determined progress made toward
this action item.
Since 2001, USDA agencies have undertaken some research related to
developing alternatives. However, according to agency officials they
are unable to provide a complete list of these activities because
USDA's research database is not set up to track research at this level
of detail. Instead, research is categorized within the larger food
safety research portfolio. In addition, the agencies did not report
any activities under this action item in the annual reports published
by the interagency task force. Based on documents provided by USDA and
research activities that USDA reported to the interagency task force
under other research action items, we identified 22 projects the
department funded since 2001 related to alternatives to current
antibiotic use practices, with total funding of at least $10 million
(see appendix V). In addition, ARS officials emphasized that the
majority of research performed at ARS related to improving
agricultural practices can result in reduced antibiotic needs by
producers. Officials from both NIFA and ARS said that they had not
assessed the extent to which the research conducted helped achieve the
action item in the 2001 interagency plan. Indeed, conducting such an
assessment would be difficult without a complete list of relevant
research activities. NIFA officials told us that additional funding
and resources would be needed to conduct such an assessment, but they
did not provide more specific details on how many additional resources
would be needed to do so. Although an assessment of research
activities on alternatives has not been conducted, ARS officials
nevertheless said the agency plans to conduct more research on
alternatives to antibiotics in the next 5 years.
Similar to USDA agencies, HHS agencies have conducted some research on
alternatives. Specifically, from 2001 through 2005, CDC and FDA
sponsored at least five research grants that included funding to
research alternatives and reduce resistant bacteria in food animals
(see appendix VI). NIH has conducted research related to antibiotic
resistance that may have applications in both humans and in animals,
but agency officials told us that NIH considers human health issues
its research priority. Like USDA agencies, HHS agencies did not report
any research activities under the action item related to antibiotic
alternatives to the interagency task force. No HHS agency has
sponsored any such research activities since 2005. HHS officials told
us this is because USDA may be the most appropriate lead agency for
undertaking alternatives research related to food animals. USDA
officials acknowledged that they have a role in researching
alternatives to antibiotics, although they said that it is also
important for HHS to be involved since FDA would likely be the
regulatory agency to approve any products resulting from such
research. CDC and FDA officials told us that their agencies have not
performed any assessments to determine whether their research
activities have helped the agency to fulfill this action item in the
2001 interagency plan.
Representatives of the national veterinary, producer, public health,
and animal pharmaceutical organizations that we spoke with told us
that greater federal efforts are needed to research alternatives to
current antibiotic use in animals. In addition, representatives from
most of the veterinary and several public health organizations we
spoke with said that the federal government should make greater
efforts to coordinate with the food animal industry about researching
alternatives to current antibiotic use. Specifically, most
representatives from the producer and veterinary organizations
emphasized a need for the federal government to provide funding and
other resources to the food animal industry for research projects
looking at alternatives. For example, representatives from one
veterinary organization told us that several national producer and
veterinary organizations have goals of utilizing prevention as an
alternative to antibiotic use and said that the federal government
could help by conducting research on preventive measures such as
vaccine development.
The draft 2010 interagency plan includes an action item reiterating
that agencies will conduct research on alternatives to current
antibiotic use practices, yet USDA and HHS agencies have not evaluated
their previous research to determine the extent to which the action
item in the 2001 interagency plan was achieved. Without an assessment
of past research efforts, agencies may be limited in their ability to
identify gaps where additional research is needed. In addition, the
draft 2010 interagency plan does not identify steps agencies intend to
take to conduct research on alternatives or time frames for taking
these steps. In contrast, other action items listed in the draft 2010
interagency plan under the surveillance, prevention and control, and
product development focus areas include specific implementation steps
illustrating how agencies plan to achieve them. CDC officials told us
that the interagency task force agreed not to identify implementation
steps until after the final version of the 2010 interagency plan is
published, at which time the task force will publish its plans for
updating the 2010 interagency plan. In addition, ARS officials said
that the interagency task force requested agencies to identify
implementation steps that could be accomplished within the next 2
years, and USDA was unable to determine such steps for alternatives
research. We have previously reported that evaluating performance
allows organizations to track the progress they are making toward
their goals, and it gives managers critical information on which to
base decisions for improving their programs.[Footnote 10] Tracking
progress and making sound decisions is particularly important in light
of the fiscal pressures currently facing the federal government.
HHS and USDA Educated Users on Appropriate Use but Have Not Assessed
Progress:
An action item in the 2001 interagency plan states that federal
agencies will educate producers and veterinarians about appropriate
antibiotic use. Programs at both HHS and USDA have sought to educate
users about appropriate antibiotic use, but the impact of these
efforts has not been assessed. In addition, agricultural extension
agents and national associations also advise producers on appropriate
antibiotic use. The draft 2010 interagency plan no longer has an
explicit action item related to appropriate antibiotic use education.
There is currently one education activity on appropriate antibiotic
use, and after the completion of this effort, there are no plans to
develop new education activities.
HHS:
HHS agencies sponsored six programs to educate producers and
veterinarians about appropriate antibiotic use, the last of which
ended in 2010 (see table 5). For example, from 2001 through 2010 CDC
funded "Get Smart: Know When Antibiotics Work on the Farm"--also
called Get Smart on the Farm--an outreach program that sponsored state-
based producer education activities to promote appropriate antibiotic
use. CDC officials told us that this was one of the first major
education efforts to bring together stakeholders from the public
health, veterinary, and agricultural communities to discuss the issue
of appropriate antibiotic use. Through the Get Smart on the Farm
program, CDC hosted three national animal health conferences designed
to foster partnerships between these stakeholders. These conferences
included discussions of antibiotic use and resistance in animals. Get
Smart on the Farm also funded the development of an online curriculum
for veterinary students on antibiotic resistance and appropriate use,
which became available in December 2010. CDC officials told us that
the agency is planning to take an advisory rather than leadership role
in future appropriate use education efforts because they believe that
FDA and USDA are the appropriate agencies for leading such efforts.
CDC reported that it spent approximately $1.7 million on Get Smart on
the Farm activities from 2003 through 2010. Both CDC and FDA officials
said that the impact of their education activities had not been
assessed. HHS officials also said that they currently do not have
plans to develop new activities in the future.
Table 5: HHS Education Activities Related to Appropriate Antibiotic
Use from 2001-2011:
Agency(s): FDA, CDC, NIH;
Grantee(s): Not applicable;
Project title: Consumer Education and Outreach Program;
Project year(s): 2002-2010;
Description of the project: National Foundation for Infectious
Diseases Annual Conference on Antimicrobial Resistance, which included
a public comment meeting on the 2001 interagency plan each year on the
last day of the conference.
Agency(s): FDA, CDC;
Grantee(s): American Veterinary Medical Association;
Project title: Veterinarian Education and Outreach;
Project year(s): 2002-2006;
Description of the project: Four species-specific booklets that
explain appropriate antibiotic use principles were published and
distributed to veterinarians; two videos on appropriate use were also
produced for veterinary schools.
Agency(s): CDC;
Grantee(s): 11 states: CO, GA, IA, MI, MN, NE, OH, PA, SC, TN, WA;
Project title: Get Smart on the Farm: State and Producer Outreach;
Project year(s): 2001-2010;
Description of the project: Sponsored three national animal health
conferences where antibiotic resistance and use issues were discussed
and funded and developed state-based educational programs to promote
appropriate antibiotic use.
Agency(s): CDC;
Grantee(s): Michigan State University and University of Minnesota;
Project title: Get Smart on the Farm: Antimicrobial Resistance
Learning Site;
Project year(s): A2001-2010;
Description of the project: An online curriculum with pharmacology,
microbiology, public health, and species-specific modules.
Agency(s): CDC, FDA, APHIS, FSIS, NIFA;
Grantee(s): Not applicable;
Project title: American Veterinary Medical Association Steering
Committee on Antimicrobial Resistance;
Project year(s): 2001-2005;
Description of the project: Species-specific antibiotic judicious use
principles were developed and published for veterinarians and
producers.
Agency(s): FDA, USDA;
Grantee(s): University of California-Davis;
Project title: Producer Education Program;
Project year(s): 2002-2005;
Description of the project: Sponsored university-based program that
educated producers on antibiotic resistance issues; education
materials were distributed to producers by Web-based programs and CD-
ROM.
Source: GAO analysis of agency data.
[End of table]
USDA:
USDA agencies also sponsored education programs addressing appropriate
antibiotic use in animals (see table 6). For example, from 2002
through 2005, USDA agencies worked with FDA to fund university-based
programs that sought to educate producers on animal health issues,
including antibiotic resistance. From 2006 through 2010 USDA agencies
did not report any activities under this action item in the annual
reports published by the interagency task force. However, officials
noted that education on appropriate antibiotic use remains a priority
and that during these years USDA gave presentations at scientific
meetings and universities on this topic. USDA officials said the
impact of these education efforts was not assessed.
Table 6: USDA Education Activities Related to Appropriate Antibiotic
Use from 2001-2011:
Agency(s): APHIS;
Grantee(s): Iowa State University;
Project title: Antibiotic Resistance Continuing Education Learning
Module;
Project year(s): 2011-2012;
Description of the project: 1 of 19 modules that veterinarians may
complete in order to maintain their National Veterinary Accreditation
Program accreditation. Expected to be complete and fully integrated
into the accreditation program by June 2012.
Agency(s): CDC, FDA, APHIS, FSIS, NIFA;
Grantee(s): Not applicable;
Project title: American Veterinary Medical Association Steering
Committee on Antimicrobial Resistance;
Project year(s): 2001-2005;
Description of the project: Species-specific antibiotic judicious use
principles were developed and published for veterinarians and
producers.
Agency(s): FDA, USDA;
Grantee(s): University of California-Davis;
Project title: Producer Education Program;
Project year(s): 2002-2005;
Description of the project: Sponsored university-based program that
educated producers on antibiotic resistance issues;
education materials were distributed to producers by web-based
programs and CD-ROM.
Source: GAO analysis of agency data.
[End of table]
The one ongoing USDA appropriate antibiotic use education activity is
an APHIS-funded training module on antibiotic resistance currently
under development at a cost of $70,400. According to agency officials,
the module will be similar to CDC's online curriculum for veterinary
students. It will be 1 of 19 continuing education modules for the
National Veterinary Accreditation Program, which is designed to train
veterinarians to assist the federal government with animal health and
regulatory services. The program requires participating veterinarians
to periodically renew their accreditations by completing continuing
education modules online or at conferences, and participants may elect
which APHIS-approved modules to take in order to fulfill their
requirements. Since the APHIS module will be similar to CDC's online
curriculum for veterinary students, APHIS officials told us that they
will look at CDC's content to determine whether or not to incorporate
it into the APHIS-funded module. APHIS officials also told us that
they sought out representatives from NIFA, FDA, CDC, the American
Veterinary Medical Association, and academic institutions to review
the module's content, and expect the training to be available for
veterinarians by June 2012. APHIS officials told us that the module on
appropriate antibiotic use is not within the National Veterinary
Accreditation Program's traditional scope of work. More specifically,
APHIS officials are unsure how they would measure the impact of the
module because, unlike the other modules in the accreditation program,
it is not based on any APHIS regulatory information that can be
tracked. That said, officials told us providing antibiotic use
education is beneficial and will increase practitioners' awareness in
this area. After the completion of the antibiotic use module, USDA
officials said they have no plans to develop new education activities.
Additional USDA-funded education activities on appropriate antibiotic
use may be conducted through local extension programs. Each U.S. state
and territory has a Cooperative Extension office at its land-grant
university,[Footnote 11] as well as a network of local or regional
extension offices staffed by one or more experts who provide research-
based information to agricultural producers, small business owners,
youth, consumers, and others in local communities. NIFA provides
federal funding to the extension system, though states and counties
also contribute to the program. NIFA provides program leadership and
seeks to help the system identify and address current agriculture-
related issues. Two producers told us that extension programs are a
helpful source of information about animal health issues. For example,
they said that extension agents are very helpful in disseminating
information, though their impact may be difficult to measure. In
addition, they told us that when producers are successful with a
preventative practice suggested by an extension agent, neighboring
producers may notice and also make similar modifications, creating a
multiplier effect. Two current extension agents also told us they have
received inquiries from producers about antibiotic use, although these
questions are not necessarily framed as appropriate use. NIFA
officials told us that federally funded extension institutions submit
an annual plan of work and an annual accomplishment report that
provides a general overview of their yearly planned projects based on
USDA priorities, but these plans are broad in nature and often do not
provide details that allow NIFA to track efforts related to antibiotic
use.
Producer and Veterinary Organizations' Perspectives on Federal
Education Efforts:
Representatives from most of the producer and veterinary organizations
that we spoke with said that industry-led efforts are responsible for
most of the progress made in educating producers and veterinarians in
the last 10 years. For example, the National Cattlemen's Beef
Association, National Milk Producers' Federation, and National Pork
Board have each developed Quality Assurance programs that advise
producers on their views of proper antibiotic use during production.
Representatives from most of the organizations we spoke with said that
the federal government should have some type of role in educating
producers and veterinarians on appropriate antibiotic use, but many--
including representatives from all of the producer organizations--said
that they believe that these activities should be done in
collaboration with industry. Representatives from most of the
veterinary and producer organizations also said the federal government
could improve collaboration with industry members and groups, and
representatives from one veterinary organization pointed to previous
federal education efforts to collect and disseminate information about
avian influenza as collaborative education efforts federal agencies
could model for appropriate use messages.[Footnote 12] Representatives
from this organization noted that such efforts included the federal
government and other industry stakeholders working together and
disseminating education messages to the public. They also suggested
that similar efforts between the federal government, producers, and
researchers could be used to educate the industry about appropriate
use of antibiotics in food animals.
Regulation of Antibiotics in the EU and Denmark May Offer Lessons for
the United States:
Since 1995, the EU and Denmark have taken a variety of actions to
regulate antibiotic use in food animals and mitigate the risk such use
may pose to humans. Denmark is part of the EU and complies with EU
policies but has also taken some additional actions independently.
Some of the experiences in the EU and Denmark may be useful for U.S.
government officials and producers, though U.S. producers face
different animal health challenges and regulatory requirements than
European producers.
EU and Denmark Have Taken Action to Regulate Antibiotic Use in Food
Animals:
From 1995 to 2006, both the EU and Danish governments took a variety
of actions to regulate antibiotic use in food animals (see figure 2).
In 1995, Denmark banned the use of avoparcin for growth promotion in
food animals, and an EU-wide ban followed in 1997. Avoparcin is
similar to the human medicine vancomycin, and some studies suggested
that avoparcin use in food animals could be contributing to vancomycin-
resistant bacteria in humans.[Footnote 13] Both Denmark and the EU
followed up with bans on several additional growth promotion
antibiotics, culminating in a total ban on growth promotion
antibiotics in 2000 and 2006, respectively. Government and industry
officials we spoke with in Denmark emphasized that their bans on
growth promotion antibiotics began as voluntary industry efforts that
were later implemented as regulations by the government.
Figure 2: EU and Denmark Actions to Regulate Antibiotic Use in Food
Animals, 1994-2010:
[Refer to PDF for image: illustrated timeline]
1995:
Denmark actions:
* Limited the amount that veterinarians can profit on sales of
antibiotics;
* Ban on growth promotion uses of avoparcin.
1997:
EU actions, Original EU member states:
* Ban on growth promotion uses of avoparcin.
1998:
Denmark actions:
* Ban on virginiamycin and all growth promotion antibiotics for
cattle, broiler chickens, and finisher swine.
1999:
EU actions, Original EU member states:
* Ban on growth promotion uses of the following antibiotics: tylosin,
spiramycin, bacitracin, virginiamycin, carbadox, and olaquindox.
2000:
Denmark actions:
* Ban on growth promotion antibiotics for pigs at weaning.
2002:
Denmark actions:
* Ban on use of fluoroquinolones in swine except as drug of last
resort for resistant infections.
2005:
Denmark actions:
* Increased oversight of swine veterinarians by regulatory officials
at the Danish Veterinary and Food Administration.
2006:
EU actions, New EU member states 2004:
* Ban on all remaining antibiotics used for growth promotion.
2007:
Denmark actions:
* Veterinarian oversight expanded to all food animal veterinarians.
2010:
Denmark actions:
* Yellow card initiative creates regulatory limits for antibiotic use
on swine farms.
Sources: GAO analysis of EU and Denmark data; Map Resources (maps).
[End of figure]
EU officials and both industry and government officials from Denmark
said the most important factor in the development of their policies
was sustained consumer interest in the issue of antibiotic use in food
animals and concerns that such use could cause resistance affecting
humans. In the face of these concerns, officials explained that EU
policies were developed based in part on the precautionary principle,
which states that where there are threats of serious or irreversible
damage, lack of scientific certainty should not postpone cost-
effective measures to reduce risks to humans. Danish industry
officials added that, as new data and knowledge arise, it is
appropriate to reevaluate the measures taken to reduce risks. We have
previously reported that the EU made other food safety decisions based
on the precautionary principle, including decisions about inspecting
imports of live animal and animal products, such as meat, milk, and
fish.[Footnote 14]
According to Danish government officials, Denmark has implemented two
additional types of regulations regarding antibiotic use in food
animals. First, Denmark has increased government oversight of
veterinarians and producers. For example, in 1995, Denmark limited the
amount that veterinarians could profit on sales of antibiotics. Then,
in 2005, Denmark implemented policies requiring biannual audits of
veterinarians who serve the swine industry, which Danish government
officials said uses about 80 percent of all food animal antibiotics in
Denmark. Government officials said these audits increase
veterinarians' awareness of their antibiotic prescription patterns. In
2007 the audits were expanded to cover all food animal veterinarians.
Most recently, in 2010, Denmark developed a new system--called the
yellow card initiative--which sets regulatory limits on antibiotic use
based on the size of swine farms. Swine farms exceeding their
regulatory limit are subject to increased monitoring by government
officials, which they must pay for. Danish government officials
explained that the yellow card initiative is different from their past
oversight efforts in that it targets producers rather than
veterinarians. Second, according to Danish government officials,
Denmark developed a policy to reduce veterinary use of antibiotics
classified as critically important to human medicine by WHO, which
like FDA, has a ranking of such antibiotics. For example, in 2002
Denmark limited veterinary prescriptions of fluoroquinolones to cases
in which testing showed that no other antibiotic would be effective at
treating the disease. In addition, veterinarians prescribing
fluoroquinolones to food animals would need to notify government
regulatory officials.
EU and Denmark Experiences Suggest Possible Lessons for the United
States:
U.S. producers face different animal health challenges and regulatory
requirements than producers in the EU and Denmark, making it difficult
to determine how effectively similar policies could be implemented in
the United States. Specifically, industry officials in Denmark
explained that several diseases that affect producers in the United
States are no longer active in Denmark. For example, broiler chicken
producers in Denmark spent many years improving their biosecurity and
successfully eradicated Salmonella, which can cause disease both in
broiler chickens and in humans, and Danish cattle producers do not
have to worry about brucellosis, which has not been seen in Denmark in
decades. Similarly, the regulatory environment in the EU differs from
that in the United States. For example, EU countries develop and
implement policies using the precautionary principle. In addition, the
EU and Denmark both require prescriptions for the use of most
antibiotics in animals, but the United States requires them in certain
limited circumstances. Officials from HHS and USDA said they are aware
of other countries' efforts to regulate antibiotic use in food animals
and participate in international conferences and meetings addressing
these issues. Based on the experiences in the EU and Denmark, there
are several lessons that may be useful for U.S. government officials
and producers.
Denmark's Antibiotic Use Data Allowed Officials to Track How Policy
Changes Affected Use in Food Animals and Take Appropriate Response:
According to Danish government officials, Denmark's antibiotic use
data are detailed enough to allow the country to track trends in use
and monitor the effects of their policies. Specifically, data show
that antibiotic use in food animals declined from 1994 to 1999, but
then it increased modestly from 1999 to 2009, while remaining below
1994 levels (see figure 3). The decline coincides with the start of
the changes to government policies on growth promotion and
veterinarian sales profits. Danish industry and government officials
noted some of the increase in antibiotic use over the last decade may
be in response to disease outbreaks on swine farms. Danish government
officials also mentioned, however, that the government instituted the
2010 yellow card initiative to reverse the recent increase in
antibiotic use. According to these officials, antibiotic use in pig
production fell 25 percent from June 2010 to June 2011 in response to
the implementation of the yellow card initiative.
Figure 3: Antibiotic Use in Swine in Denmark 1994-2010:
[Refer to PDF for image: stacked vertical bar graph]
Milligrams of antibiotic consumed per kilogram of pork produced:
Year: 1994;
Therapeutic Use: 40;
Growth Promotion (Estimated): 58.6.
Year: 1995;
Therapeutic Use: 21.3;
Growth Promotion (Estimated): 51.2.
Year: 1996;
Therapeutic Use: 21.7;
Growth Promotion (Estimated): 59.1.
Year: 1997;
Therapeutic Use: 22.4;
Growth Promotion (Estimated): 58.8.
Year: 1998;
Therapeutic Use: 22.3;
Growth Promotion (Estimated): 26.6.
Year: 1999;
Therapeutic Use: 24.8;
Growth Promotion (Estimated): 6.5.
Year: 2000;
Therapeutic Use: 34.4.
Year: 2001;
Therapeutic Use: 38.5.
Year: 2002;
Therapeutic Use: 38.1.
Year: 2003;
Therapeutic Use: 40.3.
Year: 2004;
Therapeutic Use: 45.1.
Year: 2005;
Therapeutic Use: 46.
Year: 2006;
Therapeutic Use: 46.
Year: 2007;
Therapeutic Use: 47.
Year: 2008;
Therapeutic Use: 48.9.
Year: 2009;
Therapeutic Use: 54.6.
Year: 2010;
Therapeutic Use: 50.9.
Source: DANMAP data provided by Danish officials.
Note: Between 1994 and 1999, Denmark collected data on the use of
growth promotion antibiotics in aggregate, rather than by species.
DANMAP officials estimated growth promotion antibiotic use in swine
based on information from feed mills about the amount of feed sold and
the types of growth promotion antibiotics included in the feed for the
different food animal species.
[End of figure]
Denmark Resistance Data Showed Reductions in Food Animals and Retail
Meat in Most Instances:
According to Danish officials, Danish data on antibiotic resistance in
food animals and retail meat show reductions in resistance after
policy changes in most instances. Specifically, Danish government
officials have tracked resistance to antibiotics banned for growth
promotion among Enterococcus bacteria since the mid-1990s.
Enterococcus are commonly found in the intestinal tract of humans and
food animals, making them relatively easy to track over time, though
they rarely cause disease. Officials said that the percentage of
Enterococcus from food animals that are resistant to antibiotics
banned for growth promotion has decreased since the bans were
implemented. Officials also mentioned declines in resistance among
Campylobacter bacteria (which can cause foodborne illness in humans)
from food animals and retail meat. For example, officials said that
resistance to the critically important class of drugs called
macrolides has decreased in Campylobacter bacteria from swine.
However, Danish industry and government officials cautioned that the
association between antibiotic use and resistance is not
straightforward. For example, despite restrictions on veterinary use
of the critically important fluoroquinolone antibiotics since 2002,
Danish resistance data have not shown a decrease in fluoroquinolone-
resistant bacteria from food animals. Danish industry officials
explained that restrictions on fluoroquinolone use in swine were
implemented before fluoroquinolone resistance became pronounced in
Denmark and that current rates of fluoroquinolone-resistant Salmonella
in Danish pork are lower than for pork imported into Denmark.
Denmark Resistance Data Have Not Shown Decrease in Human Resistance,
Except in Certain Instances:
Danish officials told us that Denmark's resistance data have not shown
a decrease in antibiotic resistance in humans after implementation of
the various Danish policies, except for a few limited examples.
Specifically, officials said that the prevalence of vancomycin-
resistant Enterococcus faecium from humans has decreased since
avoparcin was banned for use in animals in 1995. Resistance has been
tracked for other types of bacteria and antibiotics, but similar
declines have not been seen. Danish government officials explained
that, in addition to antibiotic use in food animals, there are other
important contributors to antibiotic resistance in humans, including
human antibiotic use, consumption of imported meat (which may contain
more antibiotic-resistant bacteria than Danish meat), and acquisition
of resistant bacteria while traveling. Danish officials told us their
data collection systems are not designed to gather information about
whether human deaths from antibiotic resistance have fallen after the
implementation of risk management policies. Officials mentioned a
challenge to this type of data collection is that "antibiotic
resistance" is not listed on death certificates as the cause of death;
generally, as in the United States, the cause of death would be listed
as multiple organ failure, making it difficult to identify deaths
caused by antibiotic-resistant infections.
Danish Policies Do Not Appear To Have Led To an Increase in Bacteria
That Cause Foodborne Illness:
Denmark has also tracked the prevalence of bacteria that cause human
foodborne illness on retail meat products, according to Danish
industry officials. Producer organizations in the United States have
expressed concerns that reductions in antibiotic use may lead to an
increase in foodborne pathogens on meat, but industry officials in
Denmark said that their data show no increase in the rates of these
bacteria on meat products. These officials said, however, that several
changes to management practices in slaughter plants may have helped
ensure rates of foodborne pathogens on meat remained low. For example,
these officials said Danish slaughter plants now use a flash-freezing
technique--called blast chilling--that freezes the outer layer of an
animal carcass, reducing the number of bacteria on the meat and even
killing most Campylobacter.
Danish Policies Affected Poultry and Swine Producers Differently:
Danish producers and veterinary officials noted that the policies were
easier for poultry producers to implement than for swine producers.
Poultry producers had made changes to their production practices
throughout the 1990s to eradicate Salmonella from their flocks, and
these practices also helped maintain flock health without routine
antibiotic use. In contrast, swine producers faced difficulties
weaning piglets without antibiotics, reporting both an increase in
mortality and a reduction in daily weight gain shortly after the ban.
However, Danish industry officials explained that swine producers
implemented multiple changes to production practices that enabled them
to comply with the ban. These production practices included improved
genetic selection, later weaning, improved diet, increased space per
piglet, and improved flooring. Industry officials explained that such
changes in production practices did have real costs to the industry.
For example, weaning piglets later increases the time between litters
and reduces the overall number of piglets produced annually. Despite
these additional costs, however, Danish industry officials expressed
pride in their ability to produce high-quality meat products while
ensuring that they do not contribute unduly to the problem of
antibiotic resistance.
The EU Faces Challenges but Is Working To Collect Use and Resistance
Data:
EU officials told us that they rely on member states to collect data
on antibiotic use. As of September 2010, 10 countries in Europe
collected data on sales of antibiotics used in food animals, and 5 of
these countries collected species-specific data.[Footnote 15] In
addition, 12 other countries have recently started or planned to begin
collecting antibiotic sales data.[Footnote 16] Among countries that
currently collect use data, these data are collected using different
methods, which complicates comparing them across countries. EU
officials identified several challenges to collecting information
about antibiotic use throughout the EU. Specifically, identifying
sources of detailed information about antibiotic use is difficult
because EU countries have different distribution systems for
veterinary medicines and therefore collect this information in varying
ways. For example, in Denmark, such data are collected from veterinary
pharmacies, but not all EU countries require animal antibiotics to be
dispensed through pharmacies. In addition, EU countries vary in the
extent to which veterinary prescriptions are monitored electronically,
making it difficult to track prescriptions consistently throughout the
EU.
Despite these challenges, EU officials emphasized the importance of
gathering data on antibiotic use in food animals for two reasons.
First, they noted that tracking antibiotic use data allows governments
to evaluate the effects of their risk management policies. Second,
they mentioned that data on both antibiotic use and antibiotic
resistance are needed in order to fully understand how use in animals
is related to resistance in humans. Given the importance of collecting
data, the EU has begun a pilot project to collect comparable
antibiotic use data throughout the EU. The first phase will use a
standard instrument to collect, harmonize, and analyze data on sales
of veterinary antibiotics from countries that agree to participate. EU
officials said that a report on sales of veterinary medicines,
covering nine European countries, will be available in September 2011.
EU officials said that subsequent phases will include more detailed
data about species and purpose of use. They emphasized the importance
of going beyond bulk sales data, noting that it is necessary to report
antibiotic use in the context of the number of animals being treated
or the pounds of meat produced, since it can allow for comparisons
between EU countries as well as comparisons to human antibiotic use.
EU officials said that the Danish system uses this type of data
collection, and that WHO is working on developing guidance for how to
create such data collection systems.
For resistance data, EU officials told us that the EU has been
collecting information from numerous member countries and working to
improve the comparability of the data between countries. In 2006, the
EU produced its first report for data gathered in 2004, collating
information from 26 individual countries. However, EU officials said
that resistance data cannot currently be compared across countries or
aggregated to provide conclusions about the entire EU, though
officials are in the process of developing a report that will provide
EU-wide information. Instead, officials pointed to trends identified
in particular member countries. For example, officials noted a
decrease in resistance in Enterococcus from broiler chickens after
avoparcin was banned for growth promotion uses in Germany, the
Netherlands, and Italy. Officials also mentioned similar declines in
resistance among Enterococcus from healthy humans in Germany and the
Netherlands.
Moreover, in addition to their data collection efforts on antibiotic
use in food animals and antibiotic resistance in humans, meat, and
food animals, the EU also conducts periodic baseline surveys to
determine the prevalence of particular drug-resistant bacteria
throughout all countries in the EU. EU officials said these baseline
studies provide information that is comparable across countries. EU
officials explained that EU countries are required to participate in
these studies, which usually last 1 year and are used to set reduction
targets for regulatory programs or to develop risk management
measures. For example, in 2008 the EU conducted a prevalence study of
MRSA in swine herds. It determined that the prevalence varied
dramatically between member countries--it was found in more than 50
percent of swine herds in Spain, but in eight other EU countries there
were no detections.
Denmark and EU Officials Emphasized Industry Role in Research:
According to Danish government and industry officials we interviewed,
the Danish government does not conduct research on alternatives to
antibiotic use. Both industry and government officials agreed that it
should be government's role to set regulatory policy and industry's
role to conduct research on how to meet regulatory goals. The Danish
Agriculture and Food Council--an industry organization representing
producers of a variety of meat and agricultural products--has funded
several studies examining alternatives to growth promotion
antibiotics. For example, one such study examined the economics of
five types of products that had the potential to improve feed
efficiency in swine without leading to antibiotic resistance and found
that few products were both economical for farmers and successful in
improving feed efficiency.
EU officials also reported that at the EU-level government does not
conduct a significant amount of research related to alternatives to
antibiotics. They noted, however, that the EU has been trying to
incentivize private industry to develop alternatives in other ways.
For example, EU officials have tried to spur pharmaceutical companies
to develop products to improve feed efficiency and growth by
lengthening patents on such products. EU officials said that this
results in a reduction in competition from generic manufacturers and
has led to more than 300 applications for new feed additive products.
Conclusions:
Antibiotic resistance is a growing public health problem worldwide,
and any use of antibiotics--in humans or animals--can lead to the
development of resistance. In 2001, USDA and HHS agencies took steps
to coordinate their actions on surveillance, prevention and control of
resistance, research, and product development through the 2001
interagency plan. The surveillance focus area of this plan includes
action items related to improving efforts to monitor both antibiotic
use in food animals, as well as antibiotic resistance in food animals
and in retail meat. According to WHO, populations sampled for
surveillance purposes should normally be representative of the total
population--in this case, food animals and retail meat in the United
States.
Since 2001, however, USDA and HHS agencies have made limited progress
in improving data collection on antibiotic use and resistance. For
example, although FDA has a new effort to collect data on antibiotics
sold for use in food animals, these data lack crucial details, such as
the species in which the antibiotics are used and the purpose for
their use. The 2001 interagency plan states such data are essential
for interpreting trends and variations in rates of resistance,
improving the understanding of the relationship between antibiotic use
and resistance, and identifying interventions to prevent and control
resistance. In addition, two USDA agencies collect data on antibiotic
use from food animal producers, but data from these surveys provide
only a snapshot of antibiotic use practices and cannot be used to
examine trends. Collecting data on antibiotic use in food animals can
be challenging and costly, but without an approach to collecting more
detailed data, USDA and HHS cannot track the effectiveness of policies
they undertake to curb resistance. Indeed, FDA currently does not have
a plan to measure the effectiveness of its voluntary strategy to
reduce food animal use of antibiotics that are medically important to
humans. Although there are challenges to collecting detailed data on
antibiotic use, efforts are under way in the EU to begin collecting
such data.
For data on antibiotic resistance, HHS and USDA agencies have
leveraged existing programs to collect samples of bacteria, but the
resulting data are not representative of antibiotic resistance in food
animals and retail meat throughout the United States. According to the
2001 interagency plan, antibiotic resistance data will allow agencies
to detect resistance trends and improve their understanding of the
relationship between use and resistance. FDA is aware of the NARMS
sampling limitations and has included a strategic goal of making NARMS
sampling more representative and applicable to trend analysis in its
draft 2011-2015 NARMS Strategic Plan. FDA officials mentioned several
ways that NARMS sampling could be improved, such as discontinuing
slaughter plant sampling in favor of an on-farm sampling program and
increasing the number of states participating in the retail meat
program.
USDA and HHS have also undertaken some research related to developing
alternatives to current antibiotic use practices. However, the extent
of these research efforts is unclear, as neither USDA nor HHS has
assessed its research efforts to determine the progress made toward
the related action item in the 2001 interagency plan. In addition,
officials from most of the veterinary and several public health
organizations we spoke with said that the federal government should
make greater efforts to coordinate this research with the food animal
industry. Without an assessment of past research efforts and
coordination with industry, USDA and HHS may be limited in their
ability to identify gaps where additional research is needed. In
addition, USDA and HHS managers may not have the critical information
they need to make decisions about future research efforts. Focus on
tracking progress and making sound decisions about future research is
particularly important in light of the fiscal pressures currently
facing the federal government. Nevertheless, the draft 2010
interagency plan includes an action item on researching alternatives,
but it does not identify steps the agencies intend to take to do so.
Similarly, USDA and HHS had sought to educate producers and
veterinarians about appropriate antibiotic use but did not assess
their efforts. The one remaining education activity, however, is a
$70,400 USDA training module on antibiotic resistance for
veterinarians, which will be completed in 2012, after which there are
no plans to develop new education activities.
Recommendations for Executive Action:
We are making the following three recommendations:
* To track the effectiveness of policies to curb antibiotic
resistance, including FDA's voluntary strategy designed to reduce
antibiotic use in food animals and to address action items in the
surveillance focus area of the 2001 interagency plan, we recommend the
Secretaries of Agriculture and Health and Human Services direct
agencies to, consistent with their existing authorities, (1) identify
potential approaches for collecting detailed data on antibiotic use in
food animals, including the species in which antibiotics are used and
the purpose for their use, as well as the costs, time frames, and
potential trade-offs associated with each approach; (2) collaborate
with industry to select the best approach; (3) seek any resources
necessary to implement the approach; and (4) use the data to assess
the effectiveness of policies to curb antibiotic resistance.
* To enhance surveillance of antibiotic-resistant bacteria in food
animals, we recommend that the Secretaries of Agriculture and Health
and Human Services direct agencies to, consistent with their existing
authorities, modify NARMS sampling to make the data more
representative of antibiotic resistance in food animals and retail
meat throughout the United States.
* To better focus future federal research efforts on alternatives to
current antibiotic use practices, we recommend that the Secretaries of
Agriculture and Health and Human Services direct agencies to (1)
assess previous research efforts on alternatives and identify gaps
where additional research is needed, in collaboration with the animal
production industry, and (2) specify steps in the draft 2010
interagency plan that agencies will take to fill those gaps.
Agency Comments and Our Evaluation:
We provided the Departments of Agriculture and Health and Human
Services a draft of this report for review and comment. Both
departments agreed with our recommendations and provided written
comments on the draft, which are summarized below and appear in their
entirety in appendixes VII and VIII, respectively, of this report. The
departments also provided technical comments, which we incorporated as
appropriate.
In its comments, USDA agreed with our recommendations. In response to
our recommendation on collecting antibiotic use data, USDA noted that
the department has devised strategies to collect detailed information
on antibiotic use in food animals, as documented in "A USDA Plan to
Address Antimicrobial Resistance." Our report discusses many of the
ongoing USDA activities described in the document, including NAHMS,
ARMS, and NARMS. In commenting on our recommendation to collect more
representative resistance data, USDA acknowledged that sampling for
antibiotic resistant bacteria in food animals is not currently
conducted on a nationally representative population, but also stated
that NARMS data can still be used to examine general trends. We
continue to believe that the nonrandom sampling method used for food
animals in NARMS results in data that are not representative of food
animals across the country and cannot be used for trend analysis.
Moreover, as our report states, the NARMS program has prioritized
modifying animal sampling to overcome its current biases, and both FDA
and USDA have identified efforts that could be used to improve NARMS
food animal sampling. In its letter, USDA identified several such
efforts; we had included several of these in the draft report, and we
modified the final version to include the remaining effort.
In its comments, HHS also agreed with our recommendations, but stated
that FDA has made substantial progress and taken an active and
deliberative role in addressing the controversial and complex issue of
antibiotic use in food animals. We acknowledge that FDA has taken many
actions, most of which are discussed in the report. However, as our
report states, since the 2001 interagency plan, USDA and HHS agencies
have made limited progress in improving data collection on antibiotic
use and resistance. Specifically, as we noted in our report, FDA's
data on sales of antibiotics for animal use do not include information
on the species in which antibiotics are used or the purpose for their
use, which, for example, prevents agencies from interpreting trends
and variations in rates of resistance. Similarly, as our report
states, data on antibiotic resistance from food animals are not
representative and cannot be used for trend analysis--even though the
2001 interagency plan identified detecting resistance trends as an
important part of monitoring for antibiotic resistance. In commenting
on our recommendation regarding antibiotic use data collection, FDA
recognized that having more detailed antibiotic use data would benefit
its overall effort to assure the judicious use of antibiotics. FDA
also noted that it is exploring potential approaches for obtaining
more detailed information and that it plans to coordinate with USDA in
that effort. We modified our report to include this information. In
addition, regarding our findings on FDA's resistance data from retail
meat, FDA stated that it does not believe samples need to be
statistically representative of the entire United States to serve as
indicators of U.S. retail meat. We modified our report to better
reflect FDA's position, but as our report states, the FDA Science
Advisory Board's 2007 review of data on antibiotic resistance in
retail meat found that the lack of a national sampling strategy limits
a broader interpretation of NARMS data.
As agreed with your office, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to the
appropriate congressional committees, Secretaries of Agriculture and
Health and Human Services, and other interested parties. In addition,
this report will be available at no charge on the GAO Web site at
[hyperlink, http://www.gao.gov].
If you or your staff members have any questions about this report,
please contact me at (202) 512-3841 or shamesl@gao.gov. Contact points
for our Offices of Congressional Relations and Public Affairs may be
found on the last page of this report. GAO staff who made major
contributions to this report are listed in appendix IX.
Sincerely yours,
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
The objectives of our review were to determine (1) the extent to which
federal agencies have collected data on antibiotic use and resistance
in food animals; (2) the actions the Food and Drug Administration
(FDA) has taken to mitigate the risk of antibiotic resistance in
humans as a result of antibiotic use in food animals; (3) the extent
to which federal agencies have conducted research on alternatives to
current antibiotic use practices and educated producers and
veterinarians about appropriate antibiotic use; and (4) what actions
the European Union (EU) and an EU member country, Denmark, have taken
to regulate antibiotic use in food animals and what lessons, if any,
have been learned.
To address the first three objectives of our study, we reviewed
federal laws, regulations, policies, and guidance; federal plans about
antibiotic resistance; agency documents related to data collection
efforts on antibiotic use and resistance; and documents from
international organizations and other countries related to
surveillance of animal antibiotic use and resistance. In particular,
we reviewed the Food, Conservation, and Energy Act of 2008 (2008 Farm
Bill), as well as laws related to FDA's oversight of animal
antibiotics, including the Federal Food, Drug, and Cosmetic Act, the
Animal Drug Availability Act of 1996, the Animal Drug User Fee Act of
2003. We also reviewed regulations and guidance implementing FDA's
authorities, including Evaluating the Safety of Antimicrobial New
Animal Drugs with Regard to Their Microbiological Effects on Bacteria
of Human Health Concern (Guidance for Industry #152), and The
Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals (draft Guidance for Industry #209). In addition, we
reviewed the 2001 Interagency Public Health Action Plan to Combat
Antimicrobial Resistance, the draft 2010 Interagency Public Health
Action Plan to Combat Antimicrobial Resistance, and agencies' annual
updates of activities they completed related to these plans. We also
reviewed agency documents related to FDA's sales data, the National
Animal Health Monitoring System (NAHMS), the Agricultural Resource
Management Survey (ARMS), the National Antimicrobial Resistance
Monitoring System (NARMS), and the now-defunct pilot Collaboration on
Animal Health and Food Safety Epidemiology (CAHFSE). Internationally,
we reviewed documents from surveillance systems in Canada and Denmark,
including reports about the Canadian Integrated Program on
Antimicrobial Resistance Surveillance (CIPARS) and the Danish
Antimicrobial Resistance Monitoring and Research Programme (DANMAP).
In addition, we reviewed the World Health Organization's guidance on
developing surveillance systems for antibiotic resistance related to
food animal antibiotic use.
To discuss topics related to the first three objectives, we also
conducted interviews with officials at the Department of Health and
Human Services' (HHS) Centers for Disease Control and Prevention
(CDC), FDA, and the National Institutes of Health (NIH) and U.S.
Department of Agriculture (USDA) agency officials at the Animal and
Plant Health Inspection Service (APHIS), the Agricultural Research
Service (ARS), the Economic Research Service (ERS), the Food Safety
and Inspection Service (FSIS), and the National Institute of Food and
Agriculture (NIFA). We also interviewed an official representing
CIPARS to discuss the program's efforts to monitor antibiotic use and
resistance in animals across Canada, the challenges it faces, and how
the program may relate to current and future data collection efforts
in the United States.
We also conducted site visits with conventional and alternative
(either organic or antibiotic-free) producers of poultry, cattle,
swine, and dairy products in Delaware, Georgia, Iowa, Kansas,
Minnesota, and Wisconsin to obtain a better understanding of
production practices and the types of antibiotic use data available at
the farm level. During these site visits, we spoke with producers,
veterinarians, academic researchers, and extension agents involved
with food animal production. We selected these commodity groups
because they represent the top four animal products in the United
States. We selected our site visit locations based on the
accessibility of production facilities of different sizes--we visited
both small and large facilities; including states that are among the
largest producers of each commodity in our scope of study; and
proximity to Washington, D.C., and the USDA NARMS laboratory in
Georgia. These sites were selected using a nonprobability sample and
the findings from those visits cannot be generalized to other
producers.
Based on issues identified by reviewing documents and interviewing
federal, state, and local officials, we developed a questionnaire on
the use of antibiotics in animals and resistance. The questionnaire
gathered organizations' perspectives on a range of topics including
the extent to which federal data collection programs support the
action items identified by federal agencies in the 2001 interagency
plan; what actions, if any, FDA or other federal agencies should take
to implement the two principles FDA outlined in draft Guidance for
Industry #209 and how such implementation may affect antibiotic use in
food animals; and what role, if any, the federal government should
have in conducting research on alternatives to current antibiotic use
practices and educating producers and veterinarians. We conducted a
pretest of the questionnaire and made appropriate changes based on the
pretest.
In addition to developing the questionnaire, we identified 11
organizations involved with the issue of antibiotic use in food
animals and antibiotic resistance. We selected these organizations
because of their expertise in topics surrounding antibiotic use in
animals and resistance based on whether they have been actively
involved in this issue within the past 5 years, including through
testimonies to Congress, in-depth public discussions, or published
research; and to provide representation across producer organizations
that represent the major commodities, in addition to pharmaceutical
and public health organizations. The selected organizations are a
nonprobability sample, and their responses are not generalizable. The
selected organizations were: National Cattleman's Beef Association,
National Milk Producers' Federation, National Pork Producers Council,
National Chicken Council, Animal Health Institute, Alliance for the
Prudent Use of Antibiotics, Center for Science in the Public Interest,
Infectious Diseases Society of America, Keep Antibiotics Working, PEW
Campaign on Human Health and Industrial Farming, and Union of
Concerned Scientists.
We administered the questionnaires through structured interviews with
representatives from the 11 national organizations, who spoke on
behalf of their members, either via phone or in-person. All 11
organizations agreed to participate in these structured interviews. To
identify trends in responses, we qualitatively analyzed the open-ended
responses from the interviews to provide insight into organizations'
views on the issues identified in the questionnaire.
We also conducted structured interviews with representatives from five
national veterinary organizations, who spoke on behalf of their
members, to discuss their views on federal research efforts on
alternatives and federal efforts to educate producers and
veterinarians about appropriate use. The questionnaire covered a range
of topics including federal progress in both of these areas since 2001
and actions the federal government can take to improve future efforts
in these areas. We contacted five veterinary organizations to request
their participation, selecting these organizations to include the
largest U.S. veterinary organization--the American Veterinary Medical
Association--as well as a veterinary organization representing each of
the major commodities in our review--American Association of Avian
Pathologists, American Association of Bovine Practitioners, American
Association of Swine Veterinarians, and the Academy of Veterinary
Consultants. We distributed the questionnaire to the five
organizations electronically and administered the questionnaires
through structured interviews with each organization via phone or in
person. All five veterinary organizations agreed to participate in
these structured interviews. To identify trends in responses, we
qualitatively analyzed the open-ended responses from the interviews to
provide insight into organizations' views on the issues identified in
the questionnaire. Although we sought to include a variety of
organizations with perspectives about antibiotic use and resistance,
the views of organizations consulted should not be considered to
represent all perspectives about these issues and are not
generalizable.
To describe actions the EU and Denmark have taken to regulate
antibiotic use in food animals and potential lessons that have been
learned from these actions, we reviewed documents, spoke with EU and
Danish government and industry officials, and visited producers. We
selected the EU and Denmark because they implemented bans on growth
promotion uses of antibiotics in 2006 and 2000, respectively, which
allows for a review of the effects of these policies in the years
since. In addition, Denmark's experience with regulating antibiotic
use has been well-documented in government-collected data that provide
insight into the effects of policy changes.
For the EU, we reviewed documents describing EU Commission directives
and regulations regarding antibiotic use in food animals, risk
assessments related to antibiotic use in food animals, surveillance
reports describing antibiotic resistance in the EU, and proposals for
future data collection efforts on antibiotic use. In addition, we
spoke with officials from the EU Directorates General for Health and
Consumers, Agriculture and Rural Development, and Research and
Innovation. We also spoke with an official from the European Food
Safety Agency regarding their surveillance reports describing
antibiotic resistance in the EU. Finally, we interviewed the following
organizations that interact with the EU on behalf of their members
regarding animal antibiotic use: Federation of Veterinarians of
Europe, which represents veterinarians throughout the EU, and the
International Federation for Animal Health, which represents
pharmaceutical companies who manufacture animal health products. We
did not independently verify statements of EU law.
For Denmark, we reviewed documents describing Danish laws and
regulations regarding animal antibiotic use and government regulation
of veterinarians, surveillance reports describing antibiotic use and
antibiotic resistance in Denmark, and published studies examining
Denmark's experience with regulating antibiotic use. In addition, we
spoke with officials at the Danish Veterinary and Food Administration
and DANMAP. We also spoke with officials at the Danish Agriculture and
Food Council, which represents producers in Denmark, to learn about
how Danish policies have affected producers. Finally, we conducted
site visits and interviewed Danish producers and veterinarians at a
poultry and a swine facility in Denmark to learn about current methods
of production and how these producers have implemented Danish
policies. These sites were selected based on convenience and the
findings from those visits cannot be generalized to other producers.
We did not independently verify statements of Danish law.
We conducted this performance audit from August 2010 to September
2011, in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
[End of section]
Appendix II: Alternative Modes of Food Animal Production:
Some producers raise animals using alternative modes of production.
[Footnote 17] One such alternative is organic production, for which
USDA's National Organic Program (NOP) develops, implements, and
administers national standards. To comply with NOP standards,
organically produced animals cannot be treated with antibiotics.
According to USDA, organic farming has become one of the fastest-
growing segments of U.S. agriculture, and consumer demand for
organically produced goods has shown double-digit growth for well over
a decade, providing market incentives for U.S. farmers across a broad
range of commodities. According to recent industry statistics, organic
sales account for over 3 percent of total U.S. food sales. Fruits and
vegetables account for about 37 percent of U.S. organic food sales,
while dairy and food animals (including meat, fish, and poultry)
account for about 16 and 3 percent, respectively, of U.S. organic food
sales.
According to the Organic Trade Association, transitioning from
conventional to organic production can take several years, because
producers must adopt certain management practices to qualify for
organic certification. The NOP standards apply to animals used for
meat, milk, eggs, and other animal products represented as organically
produced. Some of the NOP livestock standards include the following:
* Animals for slaughter must be raised under organic management from
the last third of gestation, or no later than the second day of life
for poultry.
* Producers generally must provide a total feed ration composed of
agricultural products, but they may also provide allowed vitamin and
mineral supplements.
* Traditional livestock have transition periods for converting to
organic. For example, producers may convert an entire distinct dairy
herd to organic production by providing 80 percent organically
produced feed for 9 months, followed by 3 months of 100 percent
organically produced feed. If the farm did not convert an entire
distinct herd, new animals added must be raised using organic methods
for at least 1 year before the milk can be sold as organic.
* Organically raised animals may not be given hormones to promote
growth, or antibiotics for any reason.
* All organically raised animals must have access to the outdoors,
including access to pasture for ruminants, such as cattle. They may be
temporarily confined only for specified reasons, including reasons of
health, safety, the animal's stage of production, or to protect soil
or water quality.
* A USDA-approved certifier ensures that organic producers are
following all of the rules necessary to meet NOP standards, which
includes maintaining data that preserve the identity of all
organically managed animals and edible and nonedible animal products
produced on the operation.
One producer we visited told us that his farm began the transition
from a conventional farm in 1995 and became a grass-fed beef and
certified organic farm in 2006 (see figure 4). This producer also said
that the transition experience was economically challenging.
Specifically, during this conversion the farm stopped bringing in
outside animals and changed confinement and feed practices. Through
such changes, this producer said that, overall, the animals are
healthier and the farm has increased marketing opportunities, which he
feels outweighs the costs.
Figure 4: Grass-Fed Cattle Raised without Antibiotics:
[Refer to PDF for image: photograph]
Source: GAO.
[End of figure]
In addition to organic, there are other alternative modes of
production. For example, FSIS has a "raised without antibiotics"
production label for red meat and poultry. Before FSIS will approve
such a label, producers must provide the agency with sufficient
documentation that demonstrates animals were raised without
antibiotics. Other commonly approved FSIS poultry and meat production
labels include "natural" and "free range," though these labels do not
limit the use of antibiotics (see figure 5).
Figure 5: Free-Range Chickens at a Portable Chicken House:
[Refer to PDF for image: photograph]
Source: GAO.
[End of figure]
Some conventional and alternative producers we visited told us that
animals produced without antibiotics typically grow at slower rates
and tend to weigh less at market, requiring producers to charge higher
premiums to cover these additional production costs. Producers raising
animals without antibiotics typically have to take greater
preventative measures, such as changes in husbandry practices, in
order to reduce chances of illness. These changes in husbandry
practices may include providing hay bedding for newly birthed calves
and mother cows, selecting and breeding animals with disease
resistance, and allowing greater access outdoors and space per animal.
When animals do become sick, alternative disease treatments depend on
the animal and illness. For example, cows may be treated with sea salt
and a patch for pink eye and splints for broken legs. Still,
antibiotics may need to be used as a last resort and, in such cases,
these animals are sold to the conventional market, creating an
economic loss for the producer.
[End of section]
Appendix III: The Food and Drug Administration's Antibiotic Sales Data:
Tables 7 and 8 provide examples of the data collected by the Food and
Drug Administration as required by the Animal Drug User Fee Amendments
of 2008 (ADUFA).
Table 7: 2009 Sales and Distribution Data, by Drug Class, for
Antimicrobial Drugs Approved for Use in Food-Producing Animals in the
United States:
Antimicrobial class: Aminoglycosides;
Annual totals (kilograms of active ingredient): 339,678.
Antimicrobial class: Cephalosporins;
Annual totals (kilograms of active ingredient): 41,328.
Antimicrobial class: Ionophores;
Annual totals (kilograms of active ingredient): 3,740,627.
Antimicrobial class: Lincosamides;
Annual totals (kilograms of active ingredient): 115,837.
Antimicrobial class: Macrolides;
Annual totals (kilograms of active ingredient): 861,985.
Antimicrobial class: Penicillins;
Annual totals (kilograms of active ingredient): 610,514.
Antimicrobial class: Sulfas;
Annual totals (kilograms of active ingredient): 517,873.
Antimicrobial class: Tetracyclines;
Annual totals (kilograms of active ingredient): 4,611,892.
Antimicrobial class: Fluoroquinolones and Diaminopyrimidines combined;
Annual totals (kilograms of active ingredient): 11,101.
Antimicrobial class: Aminocoumarins, Glycolipids, Quinoxalines
combined;
Annual totals (kilograms of active ingredient): 802,388.
Antimicrobial class: Amphenicols, Pleuromutilins, Polypeptides, and
Streptogramins combined;
Annual totals (kilograms of active ingredient): 1,413,877.
Source: GAO analysis of FDA data.
[End of table]
Table 8: 2009 Sales and Distribution Data, by Route of Administration,
for Antimicrobial Drugs Approved for Use in Food-Producing Animals in
the United States:
Method of administration: In feed;
Amount of antimicrobial (kilograms): 9,701,180.
Method of administration: In water;
Amount of antimicrobial (kilograms): 2,065,433.
Method of administration: By injection;
Amount of antimicrobial (kilograms): 422,818.
Source: FDA.
[End of table]
[End of section]
Appendix IV: Structure of DANMAP:
The objectives of the Danish Integrated Antimicrobial Resistance
Monitoring and Research Program (DANMAP) are to monitor the
consumption of antibiotics for food animals and humans; monitor the
occurrence of antibiotic resistance in bacteria from food animals,
food of animal origin, and humans; study associations between
antibiotic use and resistance; and identify routes of transmission and
areas for further research studies. Table 9 shows the types of data
gathered about antibiotic use and resistance in Denmark and the
sources of these data.
Table 9: Components of DANMAP:
Antibiotic use data:
Program component: Animal antibiotic use (VetStat);
Source of data: Prescription records from veterinary pharmacies, feed
mills, veterinarians, and private companies;
Type of information recorded:
* Farm identification number;
* Prescribing veterinarian identification number;
* Intended species and age group;
* Disease being treated;
* Medicine being prescribed;
* Dose of medicine;
* Date and place prescription was filled (pharmacy, feed mill,
veterinarian).
Antibiotic use data: Program component: Human antibiotic use (Danish
Medicines Agency);
Source of data: Human pharmacies (including hospital pharmacies);
Type of information recorded:
* Identification number of patient;
* Identification number of prescribing physician;
* Date and place prescription was filled (i.e., pharmacy, hospital
pharmacy);
* Payment/reimbursement method;
* Medicine being prescribed;
* Dose of medicine.
Antibiotic resistance data:
Entity under surveillance:
Source of bacteria samples:
Bacteria tested for resistance:
Entity under surveillance: Animals;
Source of bacteria samples: Healthy production animals at slaughter
plants;
Bacteria tested for resistance:
* Escherischia coli;
* Enterococcus faecium;
* Enterococcus faecalis;
* Campylobacter coli;
* Campylobacter jejuni.
Entity under surveillance: Animals;
Source of bacteria samples: Diagnostic laboratory submissions;
Bacteria tested for resistance:
* Antibiotic use data: E. coli O149 and E. coli F5 (K99).
Entity under surveillance: Animals;
Source of bacteria samples: Danish Salmonella surveillance program in
swine and broiler chickens;
Bacteria tested for resistance:
* Salmonella.
Entity under surveillance: Animals;
Source of bacteria samples: Clinical and subclinical infections;
Bacteria tested for resistance:
* Salmonella Typhimurium.
Entity under surveillance: Food;
Source of bacteria samples: Wholesale and retail food samples from
both Danish and imported foods; Danish Salmonella surveillance program
in pork and beef; risk-based Salmonella surveillance program for
Danish poultry and imported meat;
Bacteria tested for resistance:
* Campylobacter;
* indicator E. coli;
* Enterococci;
* Salmonella.
Entity under surveillance: Humans[A];
Source of bacteria samples: A proportion of patients diagnosed with
Salmonella or Campylobacter infections;
Bacteria tested for resistance:
* Salmonella enterica serovars Typhimurium and Enteritidis;
* Campylobacter jejuni.
Entity under surveillance: Humans[A];
Source of bacteria samples: Blood samples of Staphylococcus aureus are
sent to the Statens Serum Institute on a voluntary basis;
it is mandatory to submit samples of all methicillin-resistant
Staphylococcus aureus (MRSA);
Bacteria tested for resistance:
* Staphylococcus aureus.
Entity under surveillance: Humans[A];
Source of bacteria samples: All blood and spinal fluid samples are
sent to the Statens Serum Institute;
Bacteria tested for resistance:
* Invasive Streptococcus pneumoniae, Streptococcus pyogenes (group A
streptococci), group B, C, and G streptococci.
Entity under surveillance: Humans[A];
Source of bacteria samples: All samples from blood, urine, or other
samples were submitted to the Statens Serum Institute;
Bacteria tested for resistance:
* Escherichia coli;
* Klebsiella pneumoniae;
* Pseudomonas aeruginosa;
* noninvasive Streptococcus pneumoniae;
* noninvasive Streptococcus pyogenes;
* invasive E. faecium;
* invasive E. faecalis.
Source: DANMAP.
[A] Some DANMAP reports include analysis of bacterial samples taken
from healthy humans. However, DANMAP 2009 did not.
[End of table]
[End of section]
Appendix V: ARS and NIFA Research Activities Related to Alternatives
to Current Antibiotic Use Practices:
Agency: ARS;
Grantee(s): University of Arkansas;
Project title: Development of Nonantibiotic Alternatives for Foodborne
Pathogen Control in Turkeys;
Project year(s): 2001-2006;
Description: Studied effectiveness of nonantibiotic drug therapies
(specifically bacteriophages) in eliminating certain bacteria in
poultry;
Total funding: Not provided by the agency[A].
Agency: ARS;
Grantee(s): Not applicable;
Project title: Characterization and Enhancement of Immune Responses of
Calves;
Project year(s): 2002-2006; 2006-2011;
Description: Studied the immune systems of calves and sought to
construct an oral vaccine and devise nutrition-based approaches that
promote disease resistance;
Total funding: $443,500 (FY 2010)[A, B].
Agency: ARS;
Grantee(s): Not applicable;
Project title: Development of Alternative Approaches to Antibiotics
for Controlling Bacterial Respiratory Pathogens in Poultry;
Project year(s): 2002-2006; 2007-2012;
Description: Studying the effectiveness of nonantibiotic drug
therapies (specifically bacteriophages) at preventing and treating
specific diseases in poultry;
Total funding: Not provided by the agency[A].
Agency: ARS;
Grantee(s): Not applicable;
Project title: Interventions to Reduce Epizootic Pathogenic Bacteria
in Swine and Cattle;
Project year(s): 2005-2010;
Description: Researched management strategies that may help reduce
foodborne bacteria in swine and cattle;
Total funding: Not provided by the agency [A].
Agency: ARS;
Grantee(s): Not applicable;
Project title: Impact of Diet and Gut Microbial Ecology on Foodborne
Bacterial Pathogens and Antimicrobial Resistance in Farm Animals;
Project year(s): 2005-2010;
Description: Studied genes resistant to certain bacteria in food
animals and dietary strategies to limit certain diseases in food
animals;
Total funding: $373,800; (FY 2010)[A,B].
Agency: ARS;
Grantee(s): Not applicable;
Project title: Interventions and Methodologies to Reduce Human and
Foodborne Bacterial Pathogens in Chickens;
Project year(s): 2005-2010;
Description: Researched the effectiveness of methodologies such as
nonantibiotic drug therapies (specifically peptides and
bacteriophages) and certain management practices in reducing or
eliminating specific bacteria in poultry farms;
Total funding: Not provided by the agency[A].
Agency: NIFA[C];
Grantee(s): Michigan State University;
Project title: Neutrophil Apoptosis Delay at Parturition-Mechanisms
and Inflammatory Consequences During Interaction with Mastitis-Causing
Coliforms;
Project year(s): 2006-2010;
Description: Researched nonantibiotic drug therapies (specifically
novel blood factors and neutrophil behaviors) to prevent or treat
mastitis in calves;
Total funding: $348,000.
Agency: NIFA[C];
Grantee(s): University of California; Washington State University;
Project title: Dissemination of Cephalosporin Resistance Genes;
Project year(s): 2005-2008; 2007-2008;
Description: Studied the relationship between therapeutic antibiotic
use and antibiotic resistance in animals;
Total funding: $980,000; $425,434.
Agency: NIFA[C];
Grantee(s): University of California; Washington State University;
Project title: Reducing the Use of Antibiotics and the Incidence of
Antibiotic Resistance on Calf Ranches;
Project year(s): 2004-2007; 2007-2009;
Description: Evaluated the effectiveness of three management
strategies that may reduce the use of antibiotics and the incidence of
antibiotic resistance in calf rearing facilities;
Total funding: $600,000; $245,204.
Agency: NIFA[C];
Grantee(s): Iowa State University;
Project title: Functional Genomics and Cellular Immunity to Salmonella;
Project year(s): 2007-2011;
Description: Researched nonantibiotic therapeutic strategies to reduce
bacterial burden in poultry, in order to improve production and food
safety;
Total funding: $472,356.
Agency: NIFA[C];
Grantee(s): Oklahoma State University;
Project title: Enhancing Disease Resistance by Boosting Innate
Immunity;
Project year(s): 2008-2011;
Description: Researched the effectiveness of nonantibiotic drug
therapies (specifically peptides) in disease control and prevention
for food animals, while minimizing the use of antibiotics and
emergence of drug-resistant pathogens;
Total funding: $365,500.
Agency: NIFA[C];
Grantee(s): Ohio State University;
Project title: The Relationship Between Poultry Litter and the
Intestinal Microbial Community Profile in Broilers;
Project year(s): 2008-2012;
Description: Studying the presence of bacteria populations over time
under varying management strategies;
Total funding: $308,086.
Agency: NIFA[C];
Grantee(s): ARS;
Project title: Engineering Bacteriophage Endolysins: Antimicrobials
for Mastitis Pathogens That are Refractory to Resistance Development;
Project year(s): 2007-2011;
Description: Explored the development of a new antibiotic that may be
used to treat mastitis without causing resistance development;
Total funding: $348,703.
Agency: NIFA[C];
Grantee(s): Ohio State University;
Project title: Combating the Transmission of Antibiotic Resistance
through the Global Food Chain;
Project year(s): 2008-2011;
Description: Researched methods to minimize antibiotic resistance
transmission through the global food chain, improve safety of global
food supplies, and enhance U.S. leadership in the global market;
Total funding: $99,979.
Agency: NIFA[C];
Grantee(s): North Carolina State University;
Project title: Molecular Epidemiology of Salmonella in Conventional
and Antimicrobial Free Swine Production Systems;
Project year(s): 2008-2011;
Description: Studied the makeup and presence of Salmonella over time
in conventional verses antibiotic-free production systems;
Total funding: $389,383.
Agency: NIFA[C];
Grantee(s): Texas A&M University;
Project title: Novel Pre-Harvest Interventions to Protect
Antimicrobials of Critical Importance in Human and Veterinary Medicine;
Project year(s): 2008-2012;
Description: Evaluating potential interventions that may manage
antibiotic-resistant bacteria in animal agriculture;
Total funding: Agency: $939,999.
Agency: NIFA[C];
Grantee(s): University of Connecticut;
Project title: Investigating the Potential of Natural Antimicrobials
for Controlling Bovine Mastitis;
Project year(s): 2009-2011;
Description: Studied the development of new antibiotics to control
mastitis which could help decrease use of antibiotics in bovine
operations and decrease antibiotic-resistant bacteria in milk;
Total funding: $150,000.
Agency: NIFA[C];
Grantee(s): Ohio State University;
Project title: Effectiveness of Reduced Agricultural Antimicrobial
Usage as a Food Safety Intervention;
Project year(s): 2010-2013;
Description: Studying the effects of antibiotic use on bacteria
emergence and on antibiotic resistance;
Total funding: $399,924.
Agency: NIFA[C];
Grantee(s): Kansas State University;
Project title: Practical Interventions to Effectively Manage
Antibiotic Resistance in Beef and Dairy Cattle Systems: A Fully
Integrated Approach;
Project year(s): 2010-2014;
Description: Identifying, evaluating, and implementing interventions
for managing antibiotic resistance in beef and dairy cattle systems;
Total funding: $2,000,000.
Agency: NIFA[C];
Grantee(s): Washington State University;
Project title: Minimizing Antibiotic Resistance Transmission: The
Dairy Farm as a Model System;
Project year(s): 2010-2014;
Description: Researching methods and strategies to reduce antibiotic
resistance transmission along the food chain;
Total funding: $2,000,000.
Source: GAO analysis of agency documents.
[A] The focus of this project was not specifically on the development
of alternatives to antibiotic use but has provided a framework for
future research efforts focused on the impact of alternatives.
[B] This figure is based on fiscal year 2010 funding levels, and is
similar to funding for each year of the project.
[C] In 2010, NIFA was allocated up to $4 million to award two
competitive grants related to antibiotic resistance and use (awarded
to Kansas State University and Washington State University). NIFA
expects to make decisions about similar grants for fiscal year 2011 in
September, and to release award announcements in fiscal year 2012.
[End of table]
[End of section]
Appendix VI: CDC and FDA Research Activities Related to Alternatives
to Current Antibiotic Use Practices:
Agencies: CDC, FDA;
Grantees: University of Georgia, North Carolina State University,
Colorado State University, Washington State University;
Project title: Reducing Resistant Bacteria in Food Animals;
Project years: 2001-2003;
Description: Two studies in dairy cattle and two in swine to assess
the impact of antibiotic use, develop alternatives to the use of
antibiotics as growth promotants, and to evaluate new practices that
reduce resistant bacteria in food animals;
Total funding: Not provided by the agency.
Grantees: Not provided by the agency;
Project title: Get Smart on the Farm: Reducing Resistant Bacteria in
Food Animals;
Project years: 2004-2005;
Description: Studies to understand and look at ways to reduce
resistance in food animals, and to investigate alternative therapies
to antibiotics;
Total funding: Not provided by the agency[A].
Source: GAO analysis of agency documents.
[A] Funding for this research activity came from the total $1,716,600
used to fund all of the Get Smart on the Farm related activities from
2003-2010. Officials were unable to provide detailed funding amount
for this specific research activity.
[End of table]
[End of section]
Appendix VII: Comments from the Department of Agriculture:
USDA:
United States Department of Agriculture:
Office of tie Secretary:
Washington, D.C. 20250:
August 25, 2011:
Ms. Lisa Shames, Director:
Natural Resources and Environment:
United States Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Ms. Shames:
The United States Department of Agriculture (USDA) has reviewed the
U.S. Government Accountability Office's (GAO) Draft Report,
"Antibiotic Resistance: Agencies Have Made Limited Progress Addressing
Antibiotic Use in Animals" (11-801). While USDA agrees with each
Recommendation, we offer the following perspectives on each
Recommendation.
Overall, USDA believes that actions taken to address antimicrobial
resistance should be based on science. Currently, there is
insufficient scientific information available to make important policy
decisions regarding use of antibiotics for growth promotion purposes.
Such policy decisions may, in some cases as described in the GAO
report, actually lead to increased use of antibiotics with unknown
potential effects on overall antibiotic resistance and public health,
GAO's assessment that the National Antimicrobial Resistance Monitoring
System (NARMS) data cannot be used to assess antibiotic resistance
trends on livestock and poultry operations is not entirely accurate.
While these data do not provide a national estimate of antibiotic
resistance in animal agriculture and are collected on a rotational
basis, the methods used for collection of these data are consistent
across studies and can be used to examine general trends.
GAO Recommendation:
To track the effectiveness of policies to curb antibiotic resistance,
including FDA's voluntary strategy designed to reduce antibiotic use
in food animals and to address action items in the surveillance focus
area of the 2001 interagency plan, GAO recommends the Secretaries of
Agriculture and Health and Human Services direct agencies to,
consistent with their existing authorities, 1) identify potential
approaches for collecting detailed data on antibiotic use in food
animals, including the species in which antibiotics are used and the
purpose for their use, as well as the costs, time frames, and
potential tradeoffs associated with each approach; 2) collaborate with
industry to select the best approach; 3) seek any resources necessary
to implement the approach; and 4) use the data to assess the
effectiveness of policies to curb antibiotic resistance.
USDA Response:
USDA agrees with this Recommendation. USDA has proactively devised
strategies to identify approaches to more effectively collect detailed
information on antibiotic use in food animals, as documented in the
report titled "A USDA Plan to Address Antimicrobial Resistance," dated
September 3, 2010. This report described a portfolio of current and
planned activities with anticipated funding at current levels and
additional recommended activities that would require additional
funding. This portfolio of activities represented a broad USDA-wide
approach incorporating actions in many different agencies, Under ideal
circumstances, USDA would engage the industry in identifying the
optimal mix of activities to garner the data needed to meet part 4 of
this Recommendation. Our Agricultural Research Service (ARS), in
conjunction with the Food and Drug Administration (FDA), is piloting
two different approaches on collecting antibiotic use data in food
animals and potential tradeoffs for each approach. This is being done
in collaboration with experts from industry, government, and academia.
USDA is committed to working collaboratively with stakeholders
including industry and other government entities to use the data to
craft science-based policy to mitigate risks where appropriate.
GAO Recommendation:
To enhance surveillance of antibiotic-resistant bacteria in food
animals, GAO recommends the Secretaries of Agriculture and Health and
Human Services direct agencies to, consistent with their existing
authorities, modify NARMS sampling to make the data more
representative of antibiotic resistance in food animals and retail
meat throughout the United States.
USDA Response:
USDA agrees with this Recommendation. The NARMS sampling is not
currently conducted on a randomly-selected, nationally-representative
population of food animals and retail meat in the U.S. In consultation
with its Federal partners, our Food Safety and Inspection Service
(FSIS) is evaluating options for changing its Salmonella verification
program to provide sampling data to NARMS that will allow for more
representative characterization of antibiotic resistance in food
animals and retail meat and poultry. Budget constraints and FSIS food
safety verification program needs significantly influence this
evaluation. The Animal and Plant Health Inspection Service (APHIS)
continues to evaluate options to determine the prevalence of
resistance and frequency and manner of use of antibiotics in the pre-
harvest animal production environments. ARS is working with FDA to
develop several approaches to enhance the accuracy and monitoring of
the animal sampling collected for NARMS. These strategies will he
evaluated to determine the best approach for future revisions to
NARMS. Changes to the NARMS program will be done in cooperation with
NARMS' collaborating agencies, which include USDA's APIIIS and FSIS,
and HHS' FDA, and Centers for Disease Control and Prevention (CDC).
GAO Recommendation:
To better focus future federal research efforts on alternatives to
current antibiotic use practices, we recommend that the Secretaries of
Agriculture and Health and Human Services direct agencies to 1) assess
previous research efforts on alternatives and identify gaps where
additional research is needed, in collaboration with the animal
production industry; and 2) specify steps in the draft 2010
interagency plan that agencies will take to fill those gaps.
USDA Response:
USDA agrees with this Recommendation. The 2011 interagency plan can be
improved to better outline potential actions for research alternatives
to antibiotics, Assessment in this area has not been done because the
outcome measurements have not been defined. Actual alternative
products must be approved by FDA. Other alternatives such as vaccines
or management practices are evaluated by disease prevention rattier
than as a specific product and as stated earlier are impossible to
measure in the context of reduced antibiotic use. Some milestones that
ARS has used previously are number of peer-reviewed publications,
technology transfers, and patents.
Sincerely,
Signed by:
Edward Avalos:
Under Secretary:
Marketing and Regulatory Programs:
[End of section]
Appendix VIII: Comments from the Department of Health and Human
Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
August 15, 2011:
Lisa Shames:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Shames:
Attached are comments on the U.S. Government Accountability Office's
(GAO) draft report entitled: "Antibiotic Resistance: Agencies Have
Made Limited Progress Addressing Antibiotic Use In Animals" (GAO-11-
801).
The Department appreciates the opportunity to review this report
before its publication.
Sincerely,
Signed by:
Jim R. Esquea:
Assistant Secretary for Legislation:
Attachment:
[End of letter]
General Comments Of The Department Of Health And Human Services (HHS)
On The Government Accountability Office's (GAO) Draft Report Entitled,
"Antibiotic Resistance: Agencies Have Made Limited Progress Addressing
Antibiotic Use In Animals" (GA0-11-801):
The Department appreciates the opportunity to review and comment on
this draft report. While the Food and Drug Administration (FDA)
generally agrees with GAO's recommendations, FDA has made substantial
progress and has taken an active and deliberative role in addressing
the complex and controversial issue of antibiotic use in food-
producing animals. FDA's work in this area is ongoing, and includes a
number of important accomplishments, including several initiatives
that are relevant to GAO's recommendations. Some of the important
steps that have been taken to date include the following:
* In 1996, the National Antimicrobial Resistance Monitoring System
(NARMS) was established. NARMS provides ongoing monitoring data on
antimicrobial resistance patterns in select zoonotic foodborne
bacteria. NARMS surveillance and research activities arc designed to
supply the data needed to inform and prioritize science-based
approaches to assuring food safety, and to reduce uncertainty about
the potential public health risks posed by antimicrobial use in food
animals. FDA's Center for Veterinary Medicine (CVM) is the lead
coordinator of NARMS and collaborates with the Centers for Disease
Control and Prevention (CDC), the U.S. Department of Agriculture's
Agricultural Research Service (ARS), and state public health
laboratories to collect data to monitor antimicrobial resistant
foodborne pathogens in animal carcasses at slaughter, in retail meats,
and in human clinical cases.
* In 1999. FDA published a "Framework Document" and convened public
meetings to gather public input on developing an approach for
evaluating antimicrobial resistance safety concerns as part of the new
animal drug approval process.
* In 2001, a Public Health Action Plan (PHAP) to Combat Antimicrobial
Resistance was released. The PHAP identified actions needed to address
the emerging threat of antibiotic resistance and highlighted the need
to improve federal agencies' ongoing monitoring of antibiotic use and
of antibiotic-resistant infections. Reports on the action plan have
subsequently been published annually.
* In 2003, as a result of the "Framework Document" process, FDA
published a final guidance document for industry (GFI #152),
"Evaluating the Safety of Antimicrobial New Animal Drugs with Regard
to their Microbiological Effects on Bacteria of Human Health Concern."
The guidance outlines a qualitative risk assessment process for
evaluating the safety of antimicrobial drugs intended for use in food-
producing animals. The importance of a drug for human medical therapy
is a key factor considered in the evaluation.
* In 2004, FDA published a draft risk assessment on the use of
streptogramins (Virginiamycin) in animals and the development of
Synercid-resistant Enterocomis faccium infections in humans. Comments
on the draft risk assessment to assess the link between the use of
Virginiarnycin in animals and Synercid resistance in humans were
received from representatives of the general public, public health
professionals, and industry groups.
* In 2004, FDA also conducted a Veterinary Medicine Advisory Committee
(VMAC) meeting on the microbial food safety of tulathromycin indicated
to treat respiratory disease in cattle and swine. Tulathromycin is
related to the rnacrolide class of drugs which are critically
important for treating bacterial infections in humans.
* In 2005, FDA withdrew approval for the use of enrofloxacin in
poultry. This animal drug belongs to a class of drugs known as
fluoroquinolones which are critically important for treating bacterial
infections in humans.
* In 2006, FDA conducted another VMAC meeting on the microbial food
safety of injectable cefquinome sulfate for bovine respiratory disease
in cattle. Cefquinome is a 4th generation cephalosporin, which is a
class of critically important drugs for treating bacterial infections
in humans.
* In 2010, FDA published draft guidance for industry (GFI # 209), "The
Judicious Use of Medically Important Antimicrobial Drugs in Food-
Producing Animals." In that document, FDA provided two guiding
principles for the judicious use of antimicrobials in animal
agriculture. First, medically important antimicrobial drugs should be
limited to uses in food-producing animals that are considered
necessary for assuring animal health, which means that they should not
be used in healthy animals for production purposes (e.g., to promote
growth or improve feed efficiency). Second, the guidance also
recommended that medically important antimicrobial drugs he limited to
uses in food-producing animals that include veterinary oversight or
consultation.
* In 2010, FDA also published the first annual summary report of
antimicrobial drug sales and distribution data in compliance with
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA).
This new provision requires antimicrobial drug sponsors to report to
FDA on an annual basis the amount of antimicrobial active ingredient
in their drugs that have been sold or distributed for use in food-
producing animals. It also requires FDA each year to make summaries of
the sales and distribution information received from drug sponsors
available to the public.
* In March 2011, a draft revised 2010 PHAP was published for public
comment. The draft revised PHAI' provides a valuable framework for FDA
to work with our federal partners on the issue of antimicrobial
resistance.
Currently, a number of relevant initiatives arc ongoing within FDA
including 1) the development of a coordinated strategy for
implementing the recommendations outlined in GFI #209,2) an effort to
examine possible mechanisms for enhancing the collection of data that
can help track antimicrobial drug use, and 3) the development and
implementation of a strategy for enhancing the NARMS program.
One measure of the progress for implementing FDA's strategy for
encouraging judicious use of medically important antimicrobial drugs
in food-producing animals consistent with GFI #209 is the pace at
which medically important antibiotic products are successfully updated
to align with the GFI #209 recommendations. Implementation of this
strategy is a high priority for FDA. Also, as noted below, FDA is
exploring approaches for obtaining additional information related to
antimicrobial drug use to enhance the antimicrobial drug
sales/distribution data that is currently reported to FDA in
compliance with Section 105 of the Animal Drug User Fee Amendments of
2008 (ADUFA). Such additional information will assist in tracking the
progress of steps taken to support the judicious use of these
important drugs.
Addressing antimicrobial resistance is a challenging task that
requires the expertise and collaborative efforts of many entities. FDA
continues to utilize a multi-pronged approach for addressing concerns
about the use of antimicrobial drugs in animal agriculture. The agency
is working diligently to phase in key changes with the cooperation of
the animal health industry and is exploring other regulatory tools to
help support the goal of assuring the judicious use of medically
important antimicrobial drugs in food-producing animals. FDA is
collaborating with other relevant government agencies and is seeking
input from its stakeholders to develop a sound strategy for addressing
this important public health issue.
FDA offers the following additional comments regarding GAO's
recommendations:
GAO Recommendation No. 1:
To track the effectiveness of policies to curb antibiotic resistance,
including FDA 's voluntary strategy designed to reduce antibiotic use
in food animals and to address action items in the surveillance focus
area of the 2001 interagency plan, we recommend the Secretaries of
Agriculture and Health and Human Services direct agencies to,
consistent with their existing authorities, (1) identify potential
approaches for collecting detailed data on antibiotic use in food
animals, including the species in which antibiotics are used and the
purpose for their use, as well as the costs, time frames and potential
tradeoffs associated with each approach; (2) collaborate with industry
to select the best approach; (3) seek any resources necessary to
implement the approach; and (4) use the data to assess the
effectiveness of policies to curb antibiotic resistance.
FDA Response:
FDA generally agrees with this recommendation and recognizes that
having more detailed data to help track trends in antibiotic use in
food-producing animals would benefit the overall effort to assure the
judicious use of these drugs. This information can be helpful when
analyzing trends in antimicrobial resistance observed through the
NARMS program and can provide an indication of changes in antibiotic
use practices in response to the implementation of judicious use
strategies.
Given the limitations of the antimicrobial drug sales and distribution
data currently reported to FDA annually in compliance with Section 105
of the Animal Drug User Fee Amendments of 2008 (ADUFA), the agency is
exploring potential approaches for obtaining more detailed sales and
distribution information or other information on actual drug use. FDA
intends to consult with USDA and seek opportunities where the agencies
could collaborate on strategies for addressing this issue.
GAO Recommendation No. 2:
To enhance surveillance of antibiotic-resistant bacteria in food
animals, we recommend that the Secretaries of Agriculture and Health
and Human Services direct agencies to, consistent with their existing
authorities, modify ATARMS sampling to make the data more
representative of antibiotic resistance in food animals and retail
meat throughout the United States.
FDA Response:
In 2007, the FDA Science Board completed a detailed review of the
NARMS program and provided a number of recommendations. With these
recommendations in mind, FDA developed a draft strategic plan for
pursuing a number of key enhancements to the NARMS program, many of
which have been implemented or are being developed.
Based on the 2007 FDA Science Board review, FDA published the WARMS
Strategic Plan for public comment on January 24, 2011. The key
strategic goals outlined in this plan include, I) to develop,
implement and optimize a shared database, with advanced data
acquisition and reporting tools; 2) to make sampling more
representative and more applicable to trend analysis; 3) to strengthen
collaborative research projects to address high risk food safety
issues; and 4) to support international activities which promote food
safety, and mitigate the spread of antimicrobial resistance.
In July 2011, FDA held a public meeting to discuss this strategic plan
with particular focus on ways to improve the current sampling
approach. Based on this input, FDA intends to work collaboratively
with CDC and USDA on moving forward with enhancements to the NARMS
program.
We note that on page 19 of the draft report, GAO states that, Due to
its nonrandom selection of states, FDA cannot determine the extent to
which NARMS retail meat samples are representative of the United
States. It is true that the participating states are not selected
randomly, but instead volunteer to participate in the program.
Therefore, some regions of the country are not represented in the
NARMS retail meat program. We do not believe that samples need to be
statistically representative of the entire US to serve as indicators
of U.S. retail meat.
GAO Recommendation No. 3:
To better focus future federal research efforts on alternatives to
current antibiotic use practices, we recommend that the Secretaries of
Agriculture and Health and Human Services direct agencies to (1)
assess previous research efforts on alternatives and identify gaps
where additional research is needed, in collaboration with the animal
production industry; and (2) specify .steps in the draft 2010
interagency plan that agencies will take to Jill those gaps.
FDA Response:
FDA agrees that an important component of an overall strategy for
curbing the development of antimicrobial resistance is to encourage
the use, where possible, of alternatives to antibiotics for treating,
controlling, or preventing disease in animals. Although some of these
alternatives, such as the use of vaccines in animals or alternative
management practices, are beyond the scope of FDA's authority, FDA is
committed to working collaboratively with other agencies such as
USDA/ARS on this important issue.
[End of section]
Appendix IX: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames, (202) 512-3841, or shamesl@gao.gov:
Staff Acknowledgments:
In addition to the individual named above, Mary Denigan-Macauley,
Assistant Director; Kevin Bray; Antoine Clark; Julia Coulter; Cindy
Gilbert; Janice Poling; Katherine Raheb; Leigh Ann Sennette; Ben
Shouse; and Ashley Vaughan made key contributions to this report.
[End of section]
Related GAO Products:
Antibiotic Resistance: Data Gaps Will Remain Despite HHS Taking Steps
to Improve Monitoring. [hyperlink,
http://www.gao.gov/products/GAO-11-406]. Washington, D.C.: June 1,
2011.
Federal Food Safety Oversight: Food Safety Working Group Is a Positive
First Step but Governmentwide Planning Is Needed to Address
Fragmentation. [hyperlink, http://www.gao.gov/products/GAO-11-289].
Washington, D.C.: March 18, 2011.
High Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-11-278]. Washington, D.C.: February
2011.
Veterinarian Workforce: Actions are Needed to Ensure Sufficient
Capacity for Protecting Public and Animal Health. [hyperlink,
http://www.gao.gov/products/GAO-09-178]. Washington, D.C.: February 4,
2009.
Food Safety: Selected Countries' Systems Can Offer Insights into
Ensuring Import Safety and Responding to Foodborne Illness.
[hyperlink, http://www.gao.gov/products/GAO-08-794]. Washington, D.C.:
June 10, 2008.
Avian Influenza: USDA Has Taken Steps to Prepare for Outbreaks, but
Better Planning Could Improve Response. [hyperlink,
http://www.gao.gov/products/GAO-07-652]. Washington, D.C.: June 11,
2007.
Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts
to Address Risk to Humans from Antibiotic Use in Animals. [hyperlink,
http://www.gao.gov/products/GAO-04-490]. Washington, D.C.: April 22,
2004.
Food Safety: The Agricultural Use of Antibiotics and Its Implications
for Human Health. [hyperlink,
http://www.gao.gov/products/GAO/RCED-99-74]. Washington, D.C.: April
28, 1999.
Executive Guide: Effectively Implementing the Government Performance
and Results Act. [hyperlink,
http://www.gao.gov/products/GAO/GGD-96-118]. Washington, D.C.: June
1996.
[End of section]
Footnotes:
[1] GAO, Food Safety: The Agricultural Use of Antibiotics and Its
Implications for Human Health, [hyperlink,
http://www.gao.gov/products/GAO/RCED-99-74] (Washington, D.C.: Apr.
28, 1999).
[2] GAO, Antibiotic Resistance: Federal Agencies Need to Better Focus
Efforts to Address Risk to Humans from Antibiotic Use in Animals,
[hyperlink, http://www.gao.gov/products/GAO-04-490] (Washington, D.C.:
Apr. 22, 2004).
[3] See, most recently, GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: February
2011).
[4] See: GAO, Federal Food Safety Oversight: Food Safety Working Group
Is a Positive First Step but Governmentwide Planning Is Needed to
Address Fragmentation, [hyperlink,
http://www.gao.gov/products/GAO-11-289] (Washington, D.C.: Mar. 18,
2011).
[5] [hyperlink, http://www.gao.gov/products/GAO-04-490].
[6] FDA Science Advisory Board, National Antimicrobial Resistance
Monitoring System (NARMS) Program Review (May 25, 2007).
[7] For more information, see GAO, Antibiotic Resistance: Data Gaps
Will Remain Despite HHS Taking Steps to Improve Monitoring,
[hyperlink, http://www.gao.gov/products/GAO-11-406] (Washington, D.C.:
June 1, 2011).
[8] [hyperlink, http://www.gao.gov/products/GAO-04-490].
[9] GAO, Veterinarian Workforce: Actions are Needed to Ensure
Sufficient Capacity for Protecting Public and Animal Health,
[hyperlink, http://www.gao.gov/products/GAO-09-178] (Washington, D.C.:
Feb. 4, 2009).
[10] GAO, Executive Guide: Effectively Implementing the Government
Performance and Results Act, [hyperlink,
http://www.gao.gov/products/GAO/GGD-96-118] (Washington, D.C.: June
1996).
[11] A land-grant university is an institution that has been
designated by its state legislature or Congress to receive unique
federal support, including funds for cooperative extension offices.
Land-grant universities are directed by law to offer public education
programs based on the results of university research, including
research and education related to agriculture issues.
[12] For more information on USDA's efforts to prepare for outbreaks
of highly pathogenic avian influenza, see GAO, Avian Influenza: USDA
Has Taken Steps to Prepare for Outbreaks, but Better Planning Could
Improve Response, [hyperlink, http://www.gao.gov/products/GAO-07-652]
(Washington, D.C.: June 11, 2007).
[13] Avoparcin was never approved for food animal use in the United
States.
[14] GAO, Food Safety: Selected Countries' Systems Can Offer Insights
into Ensuring Import Safety and Responding to Foodborne Illness,
[hyperlink, http://www.gao.gov/products/GAO-08-794] (Washington, D.C.:
June 10, 2008).
[15] Denmark, Sweden, France, the Netherlands and the United Kingdom
collected antibiotic use data by species. Germany, Norway, Finland,
Switzerland, and the Czech Republic collected more general data on
antibiotic use. Norway and Switzerland are not EU countries, but they
are nevertheless sharing data about antibiotic use.
[16] Austria, Belgium, Cyprus, Estonia, Hungary, Ireland, Italy,
Lithuania, Luxembourg, Poland, Portugal, and Spain.
[17] USDA officials noted that there is no guarantee that animals
raised using alternative modes of production contain no antibiotic-
resistant bacteria.
[End of section]
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