• Legislation
• Federal Agencies
        Overview
        Food and Drug Administration
        Environmental Protection Agency
        United States Department of Agriculture

1. LEGISLATION

1a. Phase-out of nontherapeutics
KAW strongly supports federal bills to phase out "nontherapeutic" use (i.e., routine use in livestock and poultry that are not sick) of medically important antibiotics as feed additives. (See the bill summary.) S. 619 was introduced by Senators Ted Kennedy (D-MA) and Olympia Snowe (R-ME). Representative Louise Slaughter (D-NY) sponsored H.R. 1549. Also see the list of antibiotics covered by the legislation as well as a summary of their important clinical uses. For an overview of the facts of antibiotic use in animal agriculture and more info on PAMTA, see our latest fact sheet.

More than 350 organizations have endorsed this measure, including the American Nurses Association, American Academy of Pediatrics, American Public Health Association, and numerous other medical, public health, environmental, sustainable agriculture, and other groups.

1b. Minor Use/Minor Species Act
In August 2004, President Bush signed the Minor Use/Minor Species Act, which is intended to facilitate approvals of small-market veterinary drugs. Although we strongly opposed the bill as introduced because of its sloppy language that could have allowed additional overuse of antibiotics in agriculture, significant changes were made that largely addressed those concerns. The bill as enacted also contains language that - for the first time - expressly clarifies that antibiotic resistance is a key issue for consideration of “safety” under the Food Drug and Cosmetic Act.

1c. Animal Drug User Fee Amendments of 2008 (ADUFA)
In August 2008, Congress passed the Animal Drug User Fee Amendments of 2008. Although we strongly opposed the bill as introduced because it did nothing to protect public health, we succeeded in getting the final version to include language requiring the animal drug manufacturers to report to the Food and Drug Administration (FDA) on the quantity of antimicrobial drugs sold or distributed annually for use in food animals. The data will include the dosage form, the target animal, and the approved indication for use (such as growth promotion or therapy). The FDA will make these data public beginning in 2010.

2. FEDERAL AGENCIES

2a. Overview
In January 2001, a federal multi-agency task force issued "A Public Health Action Plan to Combat Antimicrobial Resistance." While the report correctly recognizes the severity of the antibiotic-resistance problem, its recommendations relating to use of antibiotics in agricultural animals were disappointingly limited. The Centers for Disease Control (CDC) helps administer the National Antimicrobial Resistance Monitoring System (NARMS), a monitoring program that gathers data on how prevalent antibiotic resistance is among a handful of different bacteria. NARMS collects bacteria both from human samples as well as from food-animal samples. Although CDC has considerable expertise on antibiotic resistance including agricultural aspects of the problem, it does not have regulatory authority over the issue.

Antibiotics cannot be marketed for use in animals in the U.S. without prior approval by the Food and Drug Administration (FDA). The Environmental Protection Agency (EPA) also has some authority to regulate the management of manure and other waste emitted from confined animal feeding operations, which commonly contains antibiotics and antibiotic-resistant bacteria.

2b. Food and Drug Administration
Within FDA, the Center for Veterinary Medicine oversees the use of animal antibiotics. FDA has statutory authority to withdraw approval for an agricultural antibiotic to be marketed if there is information showing that the drug "is not shown to be safe" (21 U.S.C. §360b(e)(1)(B)), but it has never exercised this authority for an antibiotic. In 1977, FDA proposed to restrict nontherapeutic use of penicillin and tetracyclines. Before FDA could act, however, Congress directed the National Academy of Sciences to study the issue. The Academy concluded that then-available information was insufficient to reach a conclusion about whether nontherapeutic use of these drugs in animals was safe or harmful. FDA did not follow up on its own proposal, and took no further steps toward restricting agricultural use of antibiotics for some 20 years.

In the late 1990s, FDA began to re-engage on antibiotic-resistance issues in animal agriculture. Actions the agency has taken in the last few years include issuing several general policy documents and banning use in poultry of Cipro-like (fluoroquinolone) antibiotics.

2b(i). FDA Policy Documents

• In September 2002, FDA issued a draft guidance document describing a methodology for evaluating how agricultural use of antibiotics may impact human health via antibiotic resistance. The document is primarily intended to provide information to drug manufacturers about a process for seeking FDA approval to bring a new antibiotic to market for agricultural use, but it also has an Appendix in which FDA states that it intends to begin reviewing the safety of already-approved antibiotics. Both KAW and several of its member organizations submitted comments on the document. Those comments were supportive of the overall approach but urged that it be strengthened to better protect public health in several ways — most importantly by setting forth a specific schedule for reviewing already-approved antibiotics.
• The draft guidance document implicitly superceded the so-called "Thresholds" document that FDA had issued in draft form in December 2000. That document, titled "An Approach for Establishing Thresholds in Association with the Use of Antimicrobial Drugs in Food-Producing Animals," proposed that new agricultural antibiotics could be approved and used until resistance to them exceeded a particular threshold level. Several public-interest groups submitted comments challenging the effectiveness of the proposed approach, which totally failed to address the problem of antibiotics with existing approval for use in agriculture.
• The Thresholds document in turn elaborated on the FDA's 1999 proposed "framework" for how the agency would consider applications for new antibiotics to be used in food animals. The document, titled "Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food Producing Animals" (64 Fed. Reg. 887, Jan. 6, 1999) had two major components: (1) it described a pre-approval system under which FDA will consider the potential of new uses of antibiotics in animal agriculture to exacerbate problems of antibiotic resistance in human pathogens, and (2) it outlined requirements for post-approval studies and monitoring of resistance levels for new uses of antibiotics in animal agriculture. Public-interest organizations filed comments stating "the proposed Framework is extremely weak and needs to be substantially revised in order to protect the efficacy of antibiotics vital to human health." Among other weaknesses, the Framework did not directly address the serious problem of antibiotics already approved for use in animal agriculture.
• In October 2003, FDA released its Final Guidance to Industry #152, a nonbinding document which lays out the agency's current thinking on use of medically important antimicrobial new animal drugs with respect to potential adverse impacts on human health. Applying the Guidance's criteria to existing uses of medically important antibiotics as feed additives indicates that such most uses are presumptively impermissible. However, the Guidance fails to establish a timeline for re-evaluating existing approvals of these drugs.

On April 7 2005, the American Academy of Pediatrics and American Public Health Association joined KAW members Environmental Defense, Food Animal Concerns Trust, and Union of Concerned Scientists in filing a Citizen Petition with FDA, asking the agency to ban use of seven classe of antibiotics as feed additives for chicken, hogs, and beef cattle, and demonstrating that such use is inconsistent with FDA's own safety criteria under FDA Guidance 152. KAW issued a press release applauding the petition. See the Petition, Appendix, Addendum of Drugs, Letter of Support, and Press Release.

Abbott Laboratories, maker of one fluoroquinolone product for poultry, complied with FDA's proposal, withdrawing the product from the market. However, Bayer Corp., the sole remaining manufacturer of the poultry drug, demanded a formal hearing. Initial documents were submitted to the hearing officer on December 9, 2002, including testimony by McDonald's Corporation noting that its US suppliers have been able to discontinue use of fluoroquinolones with "no change in the quality, taste, price, or consumer acceptance of its chicken products." Final papers were submitted by the parties in August 2003, and the Administrative Law Judge issued his decision on March 16, 2004, upholding the FDA's proposed ban. Read the KAW summary of the 68-page decision. Bayer appealed the decision to the FDA commissioner.

On July 28, 2005, the Commissioner upheld the ALJ's decision, and noted that many of Bayer's contentions were "frivolous or trivial." (See FDA's decision.) This action is the first time that FDA has ever withdrawn an agricultural antibiotic from the market because of concerns about antibiotic resistance affecting human health (see KAW’s press release).

On August 26, Bayer petitioned FDA to stay the ban's scheduled September 12 effective date so that Bayer could seek judicial review of the decision (see KAW’s press release). The FDA Commissioner denied the request, noting that that Bayer failed to meet any of the four criteria for a stay. Bayer subsequently decided not to appeal, and the ban took effect on September 12, 2005 as scheduled. (See KAW’s press release). For more information, please see our page, Fluoroquinolones: a (slow) success story.

KAW provided testimony showing that approval of cefquinome would threaten public health, as did the Union of Concerned Scientists, the American Medical Association and the Infectious Disease Society of America (read the comments submitted by KAW, UCS, IDSA, and AMA). In the end, the VMAC rejected Intervet's claim that cefquinome could be considered safe for human health (meeting transcript and KAW's news release).

In spite of VMAC’s decision, Intervet continued to pursue approval of cefquinome by not withdrawing its application. To counter industry momentum, KAW wrote a letter to FDA urging the agency to heed the advice of its advisory committee, to which the agency replied that it was still considering the evidence (KAW news release). In addition, in January 2007, KAW sent a second letter to FDA about two recently published European studies that reported widespread resistance to drugs in the same class as cefquinome on farms. Moreover, that same month Rep. Louise Slaughter wrote to FDA and urged the agency not to approve cefquinome (KAW's news release).

In March 2007, the Washington Post published a front page story on the pending approval of cefquinome. This story led to numerous news and opinion pieces in newspapers and TV programs across the country (full list).

Prominent medical groups also weighed-in: AMA, APHA, IDSA, AAP and APUA wrote to the FDA and urged the agency to act in the interest of public health and not approve cefquinome.

In May 2007, KAW member groups sent a letter to drug manufacturer Intervet and called on the company to withdraw its application for approval (news release). The company declined to respond as it was in the middle of a merger with Schering-Plough and Schering-Plough did not want to yet analyze the issue.

Cefquinome remains unapproved as of early 2009. Since Intervet officially has been acquired by Schering-Plough, the company Intervet/Schering-Plough can now analyze and comment on the issues surrounding the cefquinome application. To that end, KAW has sent Schering-Plough a letter calling for a withdrawal of the company's new animal drug application for cefquinome. Considering the risks to public health involved in using cephalosporins in this manner, the time is ripe for the FDA to reject Intervet/Schering-Plough's application for cefquinome or for the company to withdraw its application.

2c. Environmental Protection Agency
The EPA has authority over water pollutants, and in January 2001 proposed to regulate runoff from industrial-scaled livestock operations, or CAFOs. Public-interest groups filed comments noting that EPA had failed to address issues of antibiotics and antibiotic-resistant bacteria in its proposal. Regrettably, the final rules also failed to address the issue. KAW member groups have filed suit challenging the rule.

In April 2006, KAW submitted comments to EPA on the agency's risk assessments for the pesticides streptomycin and oxytetracycline. In the comments, KAW encouraged EPA to quickly implement steps to address the risks of adverse human health impacts as determined by the Tolerance Reregistration Eligibility Decision Document (TRED). We also submitted comments urging EPA deny a request to use the pesticide gentamicin to control streptomycin-resistance fire blight.

2d. U.S. Department of Agriculture
Although the Department of Agriculture does not have direct regulatory authority over antibiotic use, the agency nonetheless plays an important role by defining how various label claims can be used on meat packages.

In March 2003, KAW and allied organizations succeeded in forcing USDA to withdraw ill-crafted proposals that would have created confusing and uninformative labels relating to antibiotic use in food animals. (See Label Facts for more information.) KAW participated in the subsequent round of stakeholder meetings, in which the agency committed to proposing alternate label claims, more consistent with the feedback it received from us and other consumer groups. In December 2005, KAW, along with 24 other consumer groups, also sent a letter to USDA urging the agency to quickly release the grass-fed label standard for red meat. On May 12, 2006, USDA issued a revised proposed standard for grass-fed beef. Thanks to the feedback and efforts of KAW member groups and other like-minded organizations, USDA published a final ruling in October 2007 that will benefit animal welfare and allow consumers to make informed beef purchasing decisions.

The standard states that grass and/or forage shall be the sole feed source consumed for the lifetime of any meat producing ruminant animal (cattle, goats and sheep) with the exception of milk consumed prior to weaning. Animals cannot be fed grain or grain byproducts and must have continuous access to pasture during the growing season. The claim, effective November 15, 2007, will also be verified through an audit of the production process to ensure that producers using the label abide by the standards.

KAW has also contributed to debate surrounding the 2007 Farm Bill. In December 2005 KAW submitted comments as requested by USDA Secretary Mike Johanns regarding recommendations for the 2007 Farm Bill. KAW also submitted comments to the U.S. House Agriculture Committee for consideration. As of June 2008, KAW secured provisions in the Farm Bill that will establish for the first time a research program focused on the development and control of antibiotic-resistant bacteria in the agricultural context. KAW welcomes this development and looks forward to seeing the the research that comes out of this new program.