Senate Committee Food Safety Bill Would Add Facility Certification & Produce Requirements, Enforcement Authority

Similarities and Differences with House-Passed Food Safety Bill

Like the food safety legislation passed by the House in July 2009 (H.R. 2749), S. 510 would require certification for certain high risk food imports; increase food-related inspections; require food facility hazard analysis and preventive controls; institute a program for "safe" food importers; require certain food tracing and food standards; and give the Food and Drug Administration (FDA) new authority.

Unlike the house bill, S. 510 would not require food importers and brokers to register or pay registration fees; would not increase civil penalties; would not introduce as many prohibited acts and reasons for denied entry; and would limit the food tracing and food standards to produce. However, S. 510 contains certain provisions not found in the house bill such as a foreign supplier verification program for importers, new fees, new FDA programs, etc.

The following are highlights of S. 510's provisions regarding food facility certification, inspection, registration, and fees; produce tracing and standards; and new agency authorities. (See ITT's Online Archives or 12/01/09 news, 09120110, for BP summary of S. 510's provisions on new importer programs and fees):

3rd-Party Certification Could be Required for Certain Foreign Facilities

The Health and Human Services (HHS) Secretary would be able to require third-party certifications for foreign facilities if there were risks associated with the food or the place of origin of the facility. The certification would also be used for designated food imported from countries with which the FDA has an agreement to establish a certification program. In addition, certification could be used for purposes of the voluntary qualified importer program.

Could be required to import food. The HHS Secretary, based on public health considerations, including risks associated with the food or its place of origin, would be able to require as a condition of granting admission to the U.S., certification or such other assurances as the HHS Secretary determines appropriate that the article of food complies with some or all applicable requirements of the FD&C Act, as specified by the Secretary.

Could be shipment-specific. Facility certification or assurances could be provided in the form of shipment-specific certificates, a listing of certified entities or in such other form as the HHS Secretary may specify. The Secretary would have to provide for the electronic submission of the certifications.

Agency/gov't to provide. The certification would be provided by an accredited agency or a representative of the government of the country from which the article of food at issue originated, as designated by such government or the HHS Secretary; or such other persons or entities accredited to provide such certification or assurance. Prior to accrediting a foreign government, the HHS Secretary would be required to review its food safety programs, systems and standards.

"Qualified Importer Program". Foreign facilities in the food import supply chain could also choose to be audited by a third-party auditor to determine whether they are in compliance with the relevant provisions of the FD&C Act in order to be certified for purposes of the voluntary qualified importer program. (This program requires qualified importers to meet certain criteria - including the use of certified facilities - to receive expedited review and importation.)

Facilities Would Have to Institute Hazard Analysis and Preventive Controls

Not later than 18 months after enactment, S. 510 would require the HHS Secretary to promulgate regulations to establish science-based minimum standards for domestic or foreign facilities that are required to register under 21 USC 350d to:

Analyze hazards, maintain controls - evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility; identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards; provide assurances that such food is not adulterated or misbranded and monitor the performance of those controls as a matter of routine practice.

Maintain records - maintain for at least two years records documenting the monitoring of these preventive controls, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification, instances when corrective actions were implemented, etc.

Exemptions. The hazard analysis and preventive controls requirements would not apply to facilities that have to comply with S. 510's standards for produce safety. In addition, a facility that is required to comply with one of the following would automatically be deemed to be in compliance: (i) the Seafood Hazard Analysis Critical Control Points Program; (ii) the Juice Hazard Analysis Critical Control Points Program; (iii) the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards (or any successor standards).

All Facility Inspections Would Increase, Foreign Facilities Would be Inspected

In general, S. 510 would require, beginning on its date of enactment, an increase in the frequency of inspection of all facilities. For the first two years after enactment, facilities identified as being high-risk (due to their compliance history, effectiveness of safety controls, etc.) would be inspected at least once every two years and at least once a year thereafter. Each non-high risk facility would be inspected at least once every four years.

S. 510 would allow the HHS Secretary to enter into agreements with foreign governments to facilitate the inspection of foreign facilities and direct resources toward such inspections. In addition, S. 510 would require that food be refused admission into the U.S. if it were from a registered foreign facility that refused to permit entry of U.S. inspectors, upon request, to inspect the facility.

Would Introduce Facility Reinspection and Recall Fees

For fiscal year 2010 and each subsequent fiscal year, the HHS Secretary would be required to assess and collect fees from:

the responsible party for each domestic facility required to register under 21 USC 350d and the U.S. agent for each foreign facility subject to a reinspection² in such fiscal year, to cover reinspection-related costs for such year;

the responsible party for a domestic facility required to register under 21 USC 350d (and an importer) who does not comply with a recall order in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow up effectiveness checks, and public notifications.

Facility Registration Would Become Biennial, Could be Suspended, Etc.

S. 510 would amend the food facility registration requirements of 21 USC 350d which mandate (one-time) registration of any domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the U.S by:

requiring that such registration be renewed biennially;

requiring an assurance that the HHS Secretary be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act; and

providing for the suspension of a facility's registration if the HHS Secretary determines that food manufactured, processed, packed, or held by the facility had a reasonable probability of causing serious adverse health consequences or death to humans or animals. If a facility's registration were suspended, it would not be able to import food or offer to import food into the U.S., or otherwise introduce food into interstate or intrastate commerce in the U.S.

Would Require Produce Tracing Proposed Rule, Standards for Certain Produce

S. 510 would require the following regarding produce:

Produce tracing proposed rule. Not later than 3 years after enactment, S. 510 would require the HHS Secretary to publish a proposed rule to establish standards for the type of information, format, and timeframe for persons to submit records to aid the Secretary in effectively and rapidly tracking and tracing, in the event of a food-borne illness outbreak, fruits and vegetables that are raw agricultural commodities.

Standards for certain produce. Not later than 1 year after enactment, the HHS Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture would be required to publish a proposed rule to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. A final rule would be required not later than one year after the close of the proposed rule's comment period.

New Recall Authority, Lower Standard for Administrative Detention, Etc.

S. 510 would provide for the following new agency authorities and programs:

Mandatory recalls. If the HHS Secretary determines that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded, that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, and the responsible party refuses or does not voluntarily recall the article, the Secretary could order the party to immediately cease distribution of the article. Refusal or failure to follow a recall order would be a prohibited act subject to civil penalties.

Administrative detention. Not later than 120 days after S. 510's enactment, the HHS Secretary would be required to issue an interim final rule amending 21 USC 334(h) (1)(A) to lower the standard for administrative detention to a "reason to believe that such article is adulterated or misbranded" (from "credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.")

New programs & strategies. S. 510 would require various new food programs and strategies including on: food smuggling; a national food defense strategy; food and agriculture coordinating councils; building domestic food capacity; food allergy and anaphylaxis management in schools, etc.

¹The bill was approved as an amendment in the nature of a substitute which is an amendment that strikes out the entire text of a bill and inserts a different full text. An amendment in the nature of a substitute can be similar to the bill it replaces, or quite different. In this case, it was similar, and only certain minor amendments were made.

²Reinspection for domestic facilities would be considered one or more inspections conducted under 21 USC 374 (Factory Inspection) subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of the FD& C Act, specifically to determine whether compliance has been achieved to the Secretary's satisfaction.

(See ITT's Online Archives or 09/01/09, 08/25/09, 08/12/09, 08/10/09 and 08/04/09 news, 09090120, 09082510, 09081205, 09081015 and 09080415, for BP summaries of House-passed H.R. 2749's provisions on: ceramicware, Bisphenol A & infant formula; facilities and exporting; food tracing; broker registration and new reasons to detain food; and importer registration, certification for high-risk imports, and increased inspections.

See ITT's Online Archives or 03/09/09 news, 09030915, for BP summary of S. 510 as introduced in the Senate in March 2009.)

S. 510 as ordered reported with an amendment in the nature of a substitute available at http://help.senate.gov/Hearings/2009_11_18_E/WHI09A06.pdf