FDA’S Regulatory Principles and Approaches Underpinning the Phasing Out of Antibiotics in Food-Producing Animals

The food risk analysis regime developed by the WHO/FAO suggests several policy principles and approaches that may assist risk managers in deciding on an appropriate policy option.^[42] Overall, two approaches reflect the regulatory phi­losophy surrounding the governance of antibiotic problems, namely the pre­cautionary and cost-benefit analysis approaches.

A. Rebirth of Precaution or Hidden Precaution?

The precautionary principle or approach has become a regulatory discipline to avoid irreversible damage when scientific uncertainty for a given risk exists. The principle is recognized as a general principle of international law, which may guide states in protecting environmental and health interests.^[43] The prin­ciple has also been clearly written in the EU legal systems that address public health and environmental concerns. The Treaty on European Union specifies the principle as the basis of public policy.^[44] In terms of food regulations, pre­caution is also incorporated as one of the governing principles in the European General Food Law^[45] and genetically modified food regulations.^[46]

The term of “precautionary principle” does not plainly appear in the U.S. statutes. However, the idea influenced U.S. regulatory regimes in dealing with potential health and environmental risks during the 1970s. The legis­lative approach in the pursuit of qualitative goals for controlling health and environmental risks^[47] leaves much space for competent authorities, including

Phasing Out Antibiotics in Food Animals 19 Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), FDA, and so on, to take precautionary actions on a case-by-case basis.

Since the use of precaution is subject to agency discretion, their actions would be scrutinized by the court. In reviewing the EPA’s decision to ban lead in gasoline, the Supreme Court in Ethyl^[48] favored the EPA action, although no rigid scientific evidence supports the linkage between lead in gas and dam­age to public health. By contrast, in the Benzene ruling,^[49] the Court rebutted OSHA’s standard-setting for benzene exposure on the ground that the agency failed to demonstrate a “significant risk” to justify the proposed standard.^[50] Therefore, as the qualitative orientation of federal statutes remains, the latitude and justification of applying precautionary measures will depend on the will of competent administrative agencies and the position of the judicial branches. If the agencies tend to be more cautious about public interests at the expense of the industry, they will be more willing to take precautionary measures. In this case, the court can uphold the actions by deferring to the decisions of agencies. Alternatively, the courts may denounce such overreaching actions because they lack solid scientific evidence.

Certain precautionary approaches have also affected U.S. food regulations. The Delaney Clause is a vivid statute requiring the FDA to ban the use of additives if they may induce cancer without necessarily engaging in quantita­tive risk assessment.^[51] Shifting the burden of proof of safety to the industry also reflects the spirit of precaution.^[52] For instance, the FDA normally will require the industry to demonstrate the safety of food additives, food-borne patho­gens, or chemical contamination.^[53] The industry’s implementation of the FDA’s Hazard Analysis and Critical Control Points (HACCP) is another example of applying risk-based precaution to prevent food-borne diseases.^[54] Charnley and Rogers observe that the U.S.

The procedure of the withdrawal of NADA to some extent reflects the pre­cautionary approach. The governing law does not demand the FDA engage in a rigid evaluation of the level of safety. The application of the withdrawal process

normally reduces the burden of agencies in showing the risks, either in qualita­tive or quantitative form, and then shifts the burden to drug companies to prove safety. In effect, the FDCA requires regulators to demonstrate the prima facie unsafe evidence of the targeted animal drugs according to the result of a risk assessment.^[56] The drug sponsors need to prove their safety in order to nullify the initial unsafe finding.^[57] Otherwise, approval for marketing the drug will be terminated.

The FDA’s failure to finalize the withdrawal process does not prevent it from engaging in the persuasive approach, even voluntarily, which was indicative of applying precautionary measures. As previously noted, it remains questionable if solid scientific evidence is available so as to justify the withdrawal of such permission. No definitive scientific consensus on the relationship between the consumption of food animals and human antibiotic resistance has been fully established. However, the FDA still continues on the path to phase out the use of drugs for growth promotion.

B. The Hurdle Raised by Cost-Benefit Analysis

Toward risk governance on the environment, health, and safety, states are expected to avoid unjust and unnecessary interference in the market. To real­ize better decision-making quality, risk managers normally need to conduct a regulatory impact assessment (RIA), in which the CBA has become one of its core mandates.^[58] In effect, to justify the intervention, the benefits of a proposed regulation must outweigh the costs arising from its implementation.^[59]

The Regan administration, in signing Executive Order 12291, began to require all agencies to fulfill CBA in producing regulations, which will be sub­ject to the review of the Office of Information and Regulatory Affairs (OIRA) under the Office of Budget and Management (OBM).^[60] Subsequently, both President Clinton and President Obama continued to honor the requirement,

Phasing Out Antibiotics in Food Animals 21 with some elaboration.^[61] The Clinton administration, noting the limit of quan­tifiable methods, especially recognized qualitative evaluation.^[62] Obama’s era was the first time allowing the value of human dignity, which is difficult to quantify, to be considered in CBA.^[63] Currently, there is no sign that the status of the CBA will be modified.^[64]

The U.S.

In practice, governmental compliance with CBA could be burdensome and costly. The FDA usually has to face the challenges of the OMB/OIRA for failing the CBA requirement in drafting regulations. For instance, the issuance of the rules implementing the Food Safety Modernization Act was delayed due to the OMB’s lengthy review process.^[69] The CBA burden combined with the unbearable costs arising from the notice-and-comment procedures have discouraged the agency from engaging in a formal rulemaking process.^[70] Such bureaucratic constraints, in conjunction with other concerns of time-consum­ing and resource limitations in rulemaking, now entail the FDA to increasingly

favor the issuance of “guidance” documents as a tool to affect the industry rather than resorting to binding regulations.^[71]

The industry’s rebuttal to the FDA’s withdrawal of NADA on the ground that the agency’s failure to adequately fulfill a CBA may raise another hurdle for the agency in resorting to drafting regulations. Unless certain federal laws explicitly prohibit or require CBA, it may be up to the court to decide whether the analysis has been lawfully undertaken. In practice, some rulings did not mandate the weighing of costs and benefits in addressing the safety of drugs in question,^[72] while other decisions required the task.^[73] The litigation costs and the unpredictability of the rulings may dissuade the FDA from proceeding with a withdrawal process.

V.