The U.S. Department of Agriculture (USDA) Office of Risk Assessment and Cost-Benefit Analysis (ORACBA) was established by the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994. The office's primary role is to ensure that major human health, safety, environmental regulations proposed by USDA are based on sound scientific and economic analysis. A major regulation is one that is projected to have an incremental economic cost of at least $100 million per year. The office is responsible for providing technical assistance, for coordinating risk-analysis activities across USDA, that the statutory requirements of the act are met. This section offers several recommendations that should be considered as the office's activities take shape.

FINDING 6.4.1: USDA's Office of Risk Assessment and Cost Benefit Analysis (ORACBA) has the statutory authority to review a major regulation before it is submitted to the Secretary of Agriculture, but only at the end of the regulation-development procedure.

RECOMMENDATION: ORACBA should become involved in regulation development as soon as the impetus for a regulation is identified.

RATIONALE

Waiting until a regulation has been under development for a year or more and is virtually complete to determine whether it meets risk and cost criteria does not make sense. Considerations of context, risk, and cost should be included in the regulation-development process from the start and, to the extent that they are consistent with statute, should help guide it. Risk and cost evaluations performed only when a regulation is almost complete are unlikely to be useful because much time and resources will already have been invested in the outcome.

FINDING 6.4.2: USDA has no formal procedure for external peer review of its risk assessments or economic analyses.

RECOMMENDATION: ORACBA should establish formal guidelines for peer review of the procedures, practices, and products of risk assessment and economic analysis at USDA.

RATIONALE

As noted in section 5.5 of this report, peer review is an essential part of the regulatory process. Peer review should encompass review of the raw technical data that underlie a risk assessment or benefit-cost analysis, the models and assumptions used and their interpretation, and how those data were cited in a regulatory decision. Involving independent peer reviewers in the regulatory process can help to clarify the objectives and scope of rule-making and verify the quality of the technical information considered. It can also ensure that the information evaluated at the start of the process has been used in a technically defensible manner. More detailed recommendations about the role of peer-review panels in regulatory decision-making are in section 5.5. When USDA's regulatory actions involve some types of pesticide or food-safety issues, it might be appropriate to coordinate their peer review with EPA or FDA.

FINDING 6.4.3: In January 1993, pathogenic E. coli caused at least four deaths, dozens of cases of kidney failure in children, and over 600 illnesses in one outbreak linked to undercooked, contaminated ground beef. This toll would have been far greater had an excellent public-health science base and surveillance and investigation activity not been in place at the local and state health departments and the University of Washington's School of Public Health, which relied on modern genetic techniques for detecting and tracing contamination. Salmonella contamination of chicken and eggs has also led to fatal illnesses. Those and similar incidents focused public attention on the protection of our food supply from microbial contamination. However, the methods currently used by USDA to assess microbial risks for the purpose of evaluating and regulating food safety are rudimentary, conflicting, and based on inadequate data.

RECOMMENDATION: USDA should develop and improve methods for assessing microbial risks for food safety evaluation. It should also develop information and data-reporting requirements to gather data to support those risk assessments.

RATIONALE

A key responsibility of USDA, together with FDA, is protecting the nation's food supply from microbial contaminants. USDA's meat and poultry inspection program and FDA's food inspection program were not designed to prevent food-safety problems. Inspections involve visual reviews of operating procedures, with little knowledge of conditions prior to the inspection or ability to predict future conditions. Agencies and industries have been expanding their use of the concept of hazard analysis and critical control points (HACCP). Pathways for contamination are identified, controls are designed and installed, monitoring is supposed to be performed, and records are made available for audits. Problems are expected to stimulate a feedback to critical control points and control measures. This food-industry program is a counterpart to manufacturing aspects of responsible care in the chemical industry. Combining this preventive approach with an effective public-health surveillance scheme could raise public confidence in the safety of our food supply domestically and help set an international standard for safe food. For example, beginning in 1995 all seafood exported to the European Community had to be produced under standards certified by the exporting country and accepted by the EC as equivalent to their HACCP standards. At the state level, HACCP plans are being used to update and unify ordinances regarding retail food handling and sanitation, together with such industry groups as the National Fisheries Institute, the National Food Processors Association, public-health agencies, and consumer groups. As emphasized by Michael Taylor, formerly of FDA and now at USDA, prevention's key elements are anticipation of the problems to be prevented and design of appropriate preventive methods. These require a useful knowledge base and continuous scientific progress from research on such topics as viable-but-not-cultural microorganisms, biofilms that harbor microorganisms shielded from sanitizing techniques, emerging foodborne pathogens, and conditions that affect the virulence (hazard) of potentially pathogenic microorganisms. Also, there is need for more information about food processing, packaging, and distribution techniques.

Risk assessment should play a key role in this activity, but methods of evaluating risks associated with microbial contaminants are in their developmental stages and require more rigorous application and evaluation. Many microbial-risk problems require the development of new methods and models. In addition, there are no databases on microbial diseases and risks comparable with those on chemical hazards. More detailed recommendations on the development of microbial risk-assessment methods are in section 3.6 of this report. Collaboration with the EPA Office of Water, whose Information Collection Rule establishing monitoring and data-reporting requirements for public water-supply systems might be a good model for a similar USDA rule, would be appropriate (see section 6.1.4).