Below is a summary of the FDA Food Safety Modernization Act (S. 510) a bill that the Senate has been sitting on for 13 months while over 500 million eggs have been recalled, thousands of pounds of other foods have been recall and at least 1,850 people have reported being sickened by food. The key provision in this bill, Section 207, gives federal health officials the authority to recall food that is adulterated with a foodborne pathogen.
Expanded Authority to Inspect Records: (Sec. 101) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Secretary of Health and Human Services (HHS) to inspect records related to food, including to: (1) allow the inspection of records of food that the Secretary reasonably believes is likely to be affected in a similar manner as an adulterated food; and (2) require that each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports an article of food permit inspection of his or her records if the Secretary believes that there is a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death.
Authority to Suspend Registration of a Food Facility: (Sec. 102) Authorizes the Secretary to suspend the registration of a food facility if the food manufactured, processed, packed, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
Preventive Controls Requirements: (Sec. 103) Requires each owner, operator, or agent in charge of a food facility to: (1) evaluate the hazards that could affect food; (2) identify and implement preventive controls; (3) monitor the performance of those controls; and (4) maintain records of such monitoring. Deems facilities required to comply with certain food-specific standards to be in compliance with this section. Requires the Secretary to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting such implementation. This section also prohibits the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with this section.
Establishment of Minimum Standards of Safety: (Sec. 105) Sets forth provisions related to produce safety, including to require the Secretary to: (1) establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities to minimize the risk of serious adverse health consequences or death; and (2) publish updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce.
Regulations to Prevent Intentional Adulteration of Food: (Sec. 106) Requires the Secretary to promulgate regulations to protect against the intentional adulteration of food.
Regulations for Sanitary Transportation of Food: (Sec. 111) Requires the HHS Secretary to promulgate regulations on sanitary transportation practices for the transportation of food.
Inspection of Facilities and Imported Food: (Sec. 201) Requires the Secretary to: (1) allocate resources to inspect facilities and articles of food imported into the United States based on their risk profiles; (2) increase the frequency of inspection of all facilities; and (3) report to the appropriate congressional committees annually on food facility and food import inspections.
Accredited Laboratories and Mandatory Testing: (Sec. 202) Requires the Secretary to: (1) recognize bodies that accredit laboratories with a demonstrated capability to conduct analytical testing of food products; (2) establish a publicly available registry of accreditation bodies; (3) develop model standards that an accreditation body shall require laboratories to meet; and (4) periodically reevaluate accreditation bodies and revoke recognition of any not in compliance with this section. This section also sets forth requirements for mandatory testing, including that: (1) testing be conducted by federal laboratories or accredited nonfederal laboratories; and (2) results of such testing be sent directly to the Food and Drug Administration (FDA). Requires the Secretary to review results from any sampling and testing that lead to a state or locality issuing a food recall to evaluate the need for a national recall or other compliance and enforcement activities.
Tracking and Tracing of Produce: (Sec. 204) Requires the HHS Secretary to: (1) improve tracking and tracing of fruits and vegetables that are raw agricultural commodities in the event of a foodborne illness outbreak; and (2) establish standards for the type of information, format, and timeframe for persons to submit records to aid the Secretary in such tracking and tracing.
Tracking and Tracing of Processed Food: (Sec. 205) Requires the Secretary to establish a pilot project to explore and evaluate methods for rapidly and effectively tracking and tracing processed food so that the Secretary may quickly identify the source of an outbreak involving such a processed food and the recipients of the contaminated food.
Recall Authority: (Sec. 207) Authorizes the Secretary to: (1) provide a responsible party with an opportunity to cease distribution and recall an adulterated or misbranded article of food if the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals; (2) order a responsible party to immediately cease distribution and provide notice to relevant persons if the responsible party does not voluntarily cease distribution of or recall such article of food; and (3) order a recall if the Secretary determines that removal of the article from commerce is necessary, but only after providing an opportunity for a hearing.
Improving the Safety of Imported Food - (Sec. 301) Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded. Requires the Secretary to issue guidance to assist U.S. importers in developing foreign supplier verification programs.
(Sec. 302) Requires the Secretary to: (1) establish a program to provide for the expedited review and importation of food offered for importation by U.S. importers who have voluntarily agreed to participate in such program; and (2) issue a guidance document related to participation and compliance with such program.
(Sec. 303) Requires imported food that fails to meet requirements for a certification or other assurance that the food meets applicable FFDCA requirements to be refused admission.
Authorizes the Secretary to require, as a condition of granting admission to an article of food into the United States, that an entity provide a certification or other assurances that the article of food complies with applicable FFDCA requirements.
(Sec. 304) Directs the Secretary to require, prior to importation of an article of food, notice of any country to which such article has been refused entry.
(Sec. 305) Requires the Secretary to determine whether a country can provide reasonable assurances that the food supply of the country meets or exceeds the safety of food manufactured, processed, packed, or held in the United States.
(Sec. 306) Directs the Secretary to develop a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and food industries from which foods are exported to the United States.
(Sec. 307) Authorizes the Secretary to enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities. Requires the Secretary to direct resources to inspections of foreign facilities, supplies, and food types to help ensure the safety and security of the U.S. food supply.
Requires food to be refused admission into the United States if permission to inspect the food facility is denied by the facility owner, operator, or agent or the foreign country.
(Sec. 308) Sets forth provisions governing the establishment of a system to recognize bodies that accredit third-party auditors and audit agents to certify that eligible entities meet applicable FFDCA requirements for importation of food into the United States.
(Sec. 309) Requires the Secretary to establish offices of the Food and Drug Administration (FDA) in foreign countries to provide assistance to the appropriate governmental entities with respect to measures to provide for the safety of articles of food and other products regulated by the FDA that are exported by such countries to the United States.
(Sec. 310) Requires the Secretary to: (1) develop and implement a strategy to better identify sand prevent entry into the United States of smuggled food; and (2) notify the DHS Secretary not later than ten days after identifying a smuggled food that would cause serious adverse health consequences or death to humans or animals. Requires a press release to warn consumers and vendors about a potential threat from smuggled food if certain requirements are met.