FW: [Pharmwaste] FDA - are they restricting drug use in animals?

Tenace, Laurie Laurie.Tenace at dep.state.fl.us
Thu Jan 5 10:58:38 EST 2012

I am not certain that this email made it to the whole list. If it did, I apologize for re-posting it.

-----Original Message-----
From: Andrea Bennett [mailto:Bennett.Andrea at epamail.epa.gov]
Sent: Thursday, January 05, 2012 10:12 AM
To: Tenace, Laurie
Cc: pharmwaste at lists.dep.state.fl.us; pharmwaste-bounces at lists.dep.state.fl.us
Subject: Re: [Pharmwaste] FDA - are they restricting drug use in animals?

These are two separate issues, the December 22, 2011 Federal Register Notice is for the withdrawal of notices of opportunity for a hearing; penicillin and tetracycline used in animal feed. A Notice of Opportunity for Hearing provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action (such as disqualification), before a presiding officer designated by the Commissioner (FDA), so it's removing the opportunity for a public hearing though the notice said comments can be sent in.

The second article addresses restricting cephalosporins.  I'm working on ag/antibiotics summary but someone else may have an existing antibiotic/livestock/CAFO, etc. summary, I know Tammy Jones-Lepp has conducted research on this issue.

Andrea Bennett
US EPA Region 3
1650 Arch Street
Philadelphia, PA  19103-2029
Tel: (215) 814-5736
Fax: (215) 814-2318
bennett.andrea at epa.gov

From:   "Tenace, Laurie" <Laurie.Tenace at dep.state.fl.us>
To:     "pharmwaste at lists.dep.state.fl.us"
            <pharmwaste at lists.dep.state.fl.us>
Date:   01/05/2012 09:58 AM
Subject:        [Pharmwaste] FDA - are they restricting drug use in animals?
Sent by:        pharmwaste-bounces at lists.dep.state.fl.us

I read what seems to be two conflicting articles about antibiotic use in animals. Does anyone know what is actually happening? - Laurie

I saw this article Wednesday and the following article this morning:


The U.S. Food and Drug and Administration announced only days before Christmas that it has decided to back off a 34-year attempt to regulate the use of antibiotics in livestock feed for animals intended for human consumption, despite mounting scientific evidence that has linked the practice to the development of potentially fatal antibiotic-resistant superbugs in humans.

With no other notice aside from an obscure posting in the Federal Register on Dec. 22, the FDA declared it will now focus on encouraging "voluntary reform" within the industry instead of enforcing actual regulatory action, in addition to the "promotion of the judicious use of antimicrobials in the interest of public health." The agricultural industry began administering livestock feed with small doses of antibiotics in the 1950s, not to treat sick animals, but to attack bacteria that animals' would typically expend energy to fight off.
Consuming low-levels of antibiotics allows livestock to fatten up faster and more efficiently, from a producers point of view.

The practice is often used by large-scale factory farmers, even though scientific literature dating from 1960s has connected it with the emergence of antibiotic-resistant bacteria that is hazardous to human health. The FDA acknowledged that risk in its original 1977 Notice of Opportunity for a Hearing to withdraw penicillin from animal feeds, where it warned that "animals that have received either subtherapeutic and/or therapeutic amounts of antibiotic and sulfonamide drugs in feeds may serve as a reservoir of antibiotic resistant pathogens and non-pathogens. These reservoirs of pathogens can produce human infections."

Later that year, the agency submitted an additional NOOH to withdraw the antibiotic tetracycline from animal feeds as well. Those are the notices the FDA withdrew on Dec. 22, after spending more than 30 years in virtual limbo on the issue.

A combination of opposition from the agricultural industry, lobbying and lack of funding has kept the FDA from following through on its intention to regulate growth-promoting antibiotics in large-scale agriculture, even as scientists report that antibiotic use in animal agriculture has continued to rise.

Reports of Contaminated Meat Prevalent in 2011

The consequences are already apparent. A report published in the April
2011 edition of Clinical Infectious Diseases found that nearly half of
136 samples -- coming from 80 different brands -- of beef, turkey, pork and chicken from grocery stores across the nation were contaminated with multi-drug resistant strains of the bacteria Staphylococcus aureus. The bacteria, according to the report, has been linked with the development of rashes, sepsis, endocarditis and pneumonia.

In response, U.S. Department of Agriculture spokesman said the study's relevance to human health is "unclear," while the American Meat Institute issued a statement saying the study's scientific sample was too small to reach the "sweeping conclusions" conveyed by the authors.

In April of last year, Jennie-O was forced to recall almost 55,000 pounds of ground turkey burgers after drug-resistant salmonella was found in its products, with Cargill following suit in August after being linked with a nationwide outbreak of salmonella sickness. One person died and at least 76 were sickened as a result of the Cargill contamination, The New York Times reported.

A coalition of medical and public health groups referred to the increase in salmonella outbreaks, as well as an abundance of other scientific studies and U.S. government reviews, in a September 2011 letter urging federal authorities -- including the FDA, the U.S. Centers of Disease Control and President Obama's Chief of Staff William Daley -- to take action on the issue.

"The evidence is so strong of a link between misuse of antibiotics in food animals and human antibiotic resistance that FDA and Congress should be acting much more boldly and urgently to protect these vital drugs for human illness. In fact, government data show that the vast majority of antibiotics in the U.S. are sold for use in food animals, not people," the letter states.

In 2009, the FDA itself reported that 70 to 80 percent of antibacterial drugs in the U.S. were sold for use in livestock animals to promote growth, prevent disease and treat illnesses caused by unsanitary conditions.

Multiple Groups Sue FDA for Not Curtailing Antibiotic Use

While it may seem strange that the FDA suddenly decided to withdraw its petition urging regulation after keeping it on the back-burner for more than 30 years,  Avinash Kar, a staff attorney with the Natural Resources Defense Council, told the International Business Times the agency likely did it in reaction to a lawsuit filed by a coalition of organizations in May 2011.

"We think the FDA is supposed to protect people's food and human health.
What they're doing is only resolving us toward pursuing our suit," Kar said, describing the FDA's NOOH withdrawal as a "step backwards."

The lawsuit, filed by the NRDC along with the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizens and the Union of Concerned Scientists, claims the FDA has failed to meet its legal responsibility to address the escalating health threat posed by the rise of drug-resistant infections linked to the overuse of antibiotics in animal feed, a move the NRDC said in especially heinous since the agency itself acknowledged the threats posed by the practice in 1977.

By withdrawing the original 1977 notice, the FDA may be attempting to remove the entire pretense for the NRDC lawsuit, Kar said.

"Once the FDA made that finding, we believe the law required them to remove approval for those antibiotics in animal feed," Kar said.

The NRDC lawsuit also called for the FDA to respond to two citizen petitions filed by some of the plaintiffs in 1999 and 2005. The agency quickly denied the petitions once the lawsuit was filed, after ignoring them for years.

In addition to running counter to the FDA's own research, current FDA Commissioner Margaret Hamburg published scientific literature also warning of the threat posed by the development of antibiotic-resistant bacteria as the result of animal livestock's excessive consumption of antibiotics. In 2003, while serving as the Vice President for Biological Problems for the Nuclear Threat Initiative, Hamburg co-authored "Microbial Threats to Health: Emergence, Detection and Response," which names drug-resistant bacteria as one of several infectious diseases that could hypothetically cause a global health hazard.

The FDA did not return multiple requests for comment regarding Hamburg's previous stance on the issue.

FDA Notice Leaves Room for Future Change

While the Dec. 22 notice in the Federal Register has effectively allowed the agricultural industry to pursue its questionable business model despite scientific warnings, the FDA emphasized the action "should not be interpreted as a sign that GFA no longer has safety concerns or that FDA will not consider re-proposing withdrawal proceedings in the future, if necessary."

Some suspect the language indicates the FDA may be delaying real action on the issue until after the 2012 election, which Mother Jones' Tom Philpott writes is an "effort to keep meat-industry 'dark money' from flowing to President Obama's opponent."


WASHINGTON - Federal drug regulators announced on Wednesday that farmers and ranchers must restrict their use of a critical class of antibiotics in cattle, pigs, chickens and turkeys because such practices may have contributed to the growing threat in people of bacterial infections that are resistant to treatment.

The medicines are known as cephalosporins and include brands like Cefzil and Keflex. They are among the most common antibiotics prescribed to treat pneumonia, strep throat, and skin and urinary tract infections.
Surgeons also often use them before surgery, and they are particularly popular among pediatricians.

The drugs' use in agriculture has, according to many microbiologists, led to the development of bacteria that are resistant to their effects, a development that many doctors say has cost thousands of lives.

Antibiotics were the wonder drugs of the 20th century, and their initial uses in both humans and animals were indiscriminate. Farmers became so enamored of the miraculous effects of penicillin and tetracycline on the robustness of cattle, chickens and pigs that the drugs were added in bulk to feed and water, with no need for prescriptions or any sign of sickness in the animals.

By the 1970s, public health officials had become worried that overuse was leading to the birth of killer infections resistant to treatment.
Since then, the Food and Drug Administration has undertaken fitful efforts to wean farmers, ranchers and veterinarians from excessive use of the medicines, but the vast majority of antibiotics used in the United States still go to treat animals, not humans. Meanwhile, outbreaks of illnesses from antibiotic-resistant bacteria have grown in number and severity.

A decade ago, the F.D.A. banned indiscriminate agricultural uses of a powerful class of antibiotics, called fluoroquinolones, that includes the medicine Cipro. Wednesday's announcement was another of the F.D.A.'s incremental steps.

"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals," said Michael R.
Taylor, deputy commissioner for foods at the agency.

Cephalosporins are not used as widely in livestock as penicillin, since they require a prescription from veterinarians. But the drugs are routinely injected into broiler eggs and used in large doses to treat infections in cattle and other animals.

The new rule will restrict only some of these uses and is therefore a modest step that, while applauded by consumer advocates, led many to call for far tougher measures.

"This is particularly important because cephalosporins are so important to human health, but it's only a first step," said Laura Rogers of the Pew Charitable Trusts, which has advocated restricting agricultural uses of antibiotics.

The F.D.A. initially proposed cephalosporin restrictions in 2008 but withdrew the rule before it could take effect because of opposition from veterinarians, farmers and drug companies. The rule announced Wednesday is less strict than that one, since it still allows veterinarians to use the drugs in to treat sick animals in some ways the F.D.A. has not specifically approved, and wide discretion to treat small-scale-production animals like ducks and rabbits. The rule bans routine injections of cephalosporins into chicken eggs and large and lengthy dosing in cattle and swine.

Dr. Christine Hoang, assistant director of scientific activities at the American Veterinary Medical Association, said the new rule was a vast improvement over the one proposed in 2008.

"We thought the original order was too broad and unnecessarily prohibited uses that were not likely to cause problems for human health," Dr. Hoang said.

Dr. Scott A. Brown of Pfizer, which makes cephalosporins used in animals, said the company "acknowledges the intent of the proposed order to respect veterinary discretion in determining the appropriate and responsible use of cephalosporin antibiotic medicines in the interest of animal health and human health."

The F.D.A. has yet to make final a guideline proposed in 2010 that would edge the agency closer to banning uses of penicillin and tetracycline in feed and water for the sole purpose of promoting the growth of animals or preventing illness that results from unsanitary living conditions.
This issue has generated intense controversy among farmers and ranchers who contend that public health officials have exaggerated the danger of agricultural uses of antibiotics to humans.

When asked about the penicillin guideline, Mr. Taylor of the F.D.A.
said, "We're hopeful that in the coming months, we'll be able to carry forward on that work."

Representative Louise M. Slaughter, a Democrat from New York and a microbiologist, said the F.D.A. had been too slow and too timid. "We are staring at a massive public health threat in the rise of antibiotic-resistant superbugs," she said. "We need to start acting with the swiftness and decisiveness this problem deserves."

But Dr. Gatz Riddell, executive vice president of the American Association of Bovine Practitioners, a veterinarian group, said the dangers of agricultural uses of antibiotics had been greatly exaggerated. "It is highly misunderstood in the human-health community how much antibiotics are used in animals who are not sick or at risk of becoming sick," he said.

Laurie Tenace
Environmental Specialist III
Waste Reduction Section
Florida Department of Environmental Protection
2600 Blair Stone Rd., MS 4555
Tallahassee FL 32399-2400
P: 850.245.8759
F: 850.245.8811
Laurie.Tenace at dep.state.fl.us
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