NOTE

The following section-by-section analysis of S. 510 reflects the legislation, as reported to the Senate floor by the Health, Education, Labor, and Pensions Committee.

The FDA Food Safety Modernization Act would help to address serious deficiencies in our nation’s food safety system. As the legislation was developed, questions were raised about the applicability of certain provisions on the nation’s agricultural producers. The following Fact Sheet details both the sections of the legislation that have no impact on agricultural producers and those that may potentially affect their operations.

No Impact on Agricultural Producers

The following information identifies each section of the FDA Food Safety Modernization Act which may be of interest to the nation’s agricultural producers and explains how those provisions would not have an impact on their operations.

Section 101—record inspection. This section would give the Secretary of Health and Human Services (HHS) the authority to access records if they have a reasonable belief that a related article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FDA Food Safety Modernization Act would exclude farms and restaurants from the new authority given to the FDA to access food facility records.

Section 102—registration. This section would expand current registration requirements for food facilities and requires that those registered facilities renew their registration biennially. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 first established the requirement that food facilities register with the FDA. This law already excludes farms from registration requirements and theFDA Food Safety Modernization Act would maintain that exclusion.

Section 103—hazard analysis. The section would require all registered domestic facilities to identify known or reasonably foreseeable hazards and implement preventive controls to significantly minimize or prevent those identified hazards. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 excluded farms from the definition of a “facility” and the FDA Food Safety Modernization Act would maintain that exclusion for farms in that definition.

Section 106—intentional adulteration. This section would require the FDA, working with the Departments of Agriculture (USDA) and Homeland Security (DHS), to conduct vulnerability assessments and issue regulations to protect against the intentional adulteration of food. The legislation excludes farms, with the exception of dairy farms, from this provision of theFDA Food Safety Modernization Act.

Section 107—fees. This section would allow the FDA to assess feesfor compliance failures at facilities and for participation in a voluntary qualified importer program. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 excluded farms from the definition of a “facility” and the FDA Food Safety Modernization Act would maintain that exclusion for farms in that definition.

Section 111—sanitary transportation. This section would require the FDA to establish regulations on the sanitary transportation of food within one year, as currently required by the Federal Food, Drug, and Cosmetic Act. These future regulations only apply to shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food.

Section 201—targeting inspection resources. This section would require the FDA to allocate food inspection resources according to the risk profile of the facility and other important criteria. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 excluded farms from the definition of a “facility” and the FDA Food Safety Modernization Act would maintain that exclusion for farms in that definition.

Section 403—jurisdiction. This section states that no changes made by this legislation or to an amendment made by this legislation should be construed to alter the relationship between the Secretary of Agriculture and Secretary of Health and Human Services. Additionally, this section reiterates that no changes made by this legislation or to an amendment made by this legislation would “impede, minimize, or affect the authority of the Secretary of Agriculture to prevent, control, or mitigate a plant or animal health emergency, or a food emergency or food-borne illness outbreak involving products regulated under the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, or agreements regarding voluntary inspection under the Agricultural Marketing Act.”

Impact on Agricultural Producers

Section 105—produce safety. This section would require the Secretaries of Agriculture and Health and Human Services to set commodity-specific standards for produce within one year of enactment of the legislation. The legislation requires that these proposed standards provide flexibility to agricultural producers by considering the types of businesses that sell produce directly to consumers, naturally occurring hazards, terrorism, environmental protections, conflicts with organic programs, and additional types of agricultural criteria. The legislation would also allow states to apply for variances from the standards due to local growing conditions.

This provision of the FDA Food Safety Modernization Actwould codify the ongoing work by the FDA and USDA to develop safety standards for fresh produce. The codification of produce safety standards would ensure that the future standards take into consideration sustainable agriculture and conservation practices; accommodate concerns about the scale of the operations; prevent impacts to organic agriculture; and provide flexibility to direct-to-consumer operations. Today, the nation has issued only voluntary guidance to industry about produce safety standards.

Section 204—trace-back and record keeping. This section would require the FDA, in coordination with the produce industry, to establish three pilot projects to test and evaluate new methods for rapidly and effectively tracking and tracing fruits and vegetables. Upon completion of the pilot projects, the legislation would require the establishment of standards for the types of information, information format, and timeframes for submission of food records to aid the Secretary of Health and Human Services in rapidly performing trace back activities in the event of a food-borne illness outbreak from a raw agricultural commodity.

This provision of the FDA Food Safety Modernization Actwould not place any additional recordkeeping requirements on agricultural producers other than distribution records that are kept in the normal course of business. However, agricultural producers would have to be prepared to submit those records kept in the normal course of business to the Secretary.

Section 209—decontamination and disposal. This section would require the Environmental Protection Agency, in coordination with the Departments of Agriculture, Homeland Security, and Health and Human Services to develop decontamination and disposal standards and protocols to help state and local governments prepare for a food or agriculture emergency. This provision of the FDA Food Safety Modernization Act would impact agricultural producers only if those standards and protocols were used by the applicable state, local, or tribal governments.