March 4, 2014

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

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Department of Health and Human Services
Regulatory Identification Number
Reportcard Final Score
11 / 30 (36.7%)
Rule Publication Date
Public Interest Comment Filed Date
Comment Period Closing Date

The Food Safety Modernization Act, signed in 2011, directs the Food and Drug Administration (FDA) to adopt regulations requiring facilities that manufacture, process, pack, or hold food, including animal food, to implement preventive controls to ensure that the food is not “adulterated,” as defined in section 402 of the Food, Drug, and Cosmetic Act.1 The proposed regulation applies both to pet food and to livestock feed, and it contains two principal requirements. First, it requires that facilities implement a set of “current good manufacturing practices” (CGMPs) intended to prevent contamination of animal food.2 Second, it requires covered facilities to develop a written food-safety plan, conduct a hazard analysis, implement preventive controls for hazards that are reasonably likely to occur, monitor the controls, verify that they are effective, take corrective actions, and maintain records.

The proposed regulation also establishes criteria that exempt certain “qualified facilities” and activities from the requirement for hazard analysis and risk-based preventive controls. Particularly noteworthy are proposed exemptions for “small” businesses (average annual sales below $500,000 and at least half of sales to consumers or local retailers or restaurants), “small” businesses performing on-farm activities (fewer than 500 employees), or “very small” businesses (total annual sales below a threshold to be determined by the FDA). The FDA seeks comment on the dollar threshold to use in defining “very small” businesses.4 

Unfortunately, the Regulatory Impact Analysis (RIA) accompanying the proposed regulation provides scant assessment of the nature, cause, and significance of the problem the regulation seeks to solve. In the absence of such an assessment, the RIA has no basis for estimating the benefits of the proposed rule or the benefits associated with the alternative definitions of “very small” business. It estimates the costs of the alternatives, but since the differential benefits of the alternatives are unknown, there is no way to determine whether the more restrictive definitions of “small business” produce benefits that justify the additional costs. Indeed, the analysis fails to prove that the regulation would produce any significant benefits at all. Our own estimate of the benefits suggests that the costs of the proposed rule estimated by the FDA ($87–129 million annually) substantially outweigh any possible benefits (about $30 million per year). 

Before issuing a final regulation, the FDA should:


  • Use empirical evidence to evaluate whether a market failure exists. A market failure exists if the level of animal food safety expected in the future is likely to depart from the optimal level because consumers or producers lack sufficient information to detect and deter hazards.
  • Assess whether a more limited regulation, inspection, or enforcement initiative targeting bad actors in the marketplace could accomplish many of the goals of the Food Safety Modernization Act more effectively or at lower cost than the proposed regulation.
  • Assess whether emphasizing tracebacks and attribution might create sufficient incentive for manufacturers to exercise due diligence.5
  • Assess whether a less-intrusive labeling regulation or public education campaign could reduce the incidence of salmonella infection from animal food more effectively or at a lower cost than the proposed regulation.
  • Assesses whether a regulation targeted only at pet food could achieve most of the goals of the proposed regulation at lower cost.
  • Demonstrate with empirical evidence that any new regulation is likely to produce significant, quantifiable benefits by reducing the risk of hazards below the level that is likely to occur in the absence of a new regulation.