President to Sign Food Safety Bill on Jan 4 (Comprehensive Summary)

(H.R. 2751 was passed by the House on December 21, 2010 and by the Senate on December 19, 2010. See ITT’s Online Archives or 12/22/10 and 12/20/10 news, 10122111 and 10122015, for BP summaries.)

Virtually Identical to Recent Versions, Except Qualified Importer Surcharge Added

H.R. 2751 is virtually identical to other recent versions of the bill (including the November 30, 2010 Senate-passed version and the December 8, 2010 House-passed version).

The only substantive change is that for the first five fiscal years after enactment, the fee to participate in the voluntary qualified importer program will include a surcharge that provides a recoupment of the costs expended by the Food and Drug Administration (FDA) to establish and implement such a program. Other minor technical changes were also made to address certain “revenue” issues that surfaced with this bill. (See ITT’s Online Archives or 12/02/10 news, 10120223, for BP summary of the revenue issues.)

Importer Requirements

Importers Will Need Foreign Supplier Verification Programs

Two years after H.R. 2751’s enactment, each importer of food will be required to perform risk-based verification activities as part of a “foreign supplier verification program” that provides assurances that each foreign supplier produces imported food that is:

• produced in compliance with either: (i) the hazard analysis and preventive controls that H.R. 2751 will require food facilities to implement (see below); or (ii) the production and harvesting standards that H.R. 2751 will require for certain produce (see below); and
• not adulterated under section 402 of the FD&C Act (21 USC 342) or misbranded under section 403(w) of the FD&C Act (21 USC 343(w)), which covers major food allergen labeling.

Importer defined. For purposes of this requirement, importer means the U.S. owner or consignee of the article of food at the time of entry of such article into the U.S. or if there were no U.S. owner or consignee, the U.S. agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the U.S.

Verification activities. Verification activities, which will be established by regulation, could include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

Regulations. Not later than 1 year after H.R. 2751’s enactment, the FDA¹ will be required to issue regulations to provide for the content of the foreign supplier verification program, taking into account differences among importers and types of imported foods, including the risk level of the imported food.

Recordkeeping. Records of an importer related to a foreign supplier verification program will have to be maintained for at least 2 years and be made available promptly to an FDA representative upon request.

Lack of verification program. It will be a prohibited act to import or offer for importation a food if the importer does not have in place a foreign supplier verification program in compliance with H.R. 2751. In addition, any article of food imported by an importer that is in violation of the foreign supplier verification program will be refused entry into the U.S.

Exemptions. These verification requirements will not apply to: (1) articles of food imported in small quantities for research and evaluation purposes or for personal consumption that are not intended for retail sale; or (2) a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, one of the following: (i) the Seafood Hazard Analysis Critical Control Points (HACCP) Program; (ii) the Juice HACCPP; or (iii) the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards, but only as they relate to microbiological hazards.

“Qualified Importer Program” with 3rd-Party Facility Certification

Not later than 18 months after enactment, FDA will be required to establish a voluntary “qualified importer program” and issue guidance, in consultation with the Department of Homeland Security (DHS).

(For this program, the term ‘importer’ means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the U.S.)

Food risk, compliance considered. In reviewing the applications and making determinations on requests to participate in the program, FDA will consider the risk of the food to be imported based on factors, such as the:

• known safety risks of the food to be imported;
• compliance history of foreign suppliers used by the importer, as appropriate;
• capability of the regulatory system of the country of export to ensure compliance with U.S. food safety standards for a designated food;
• compliance of the importer with the requirements of foreign supplier verification program;
• recordkeeping, testing, inspections, and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer;
• potential risk for intentional adulteration of the food; and
• any other factor that FDA determines appropriate.

Third-party facility certification. Participants in the program will have to import food from foreign facilities with certifications resulting from an audit by an accredited third-party auditor (see facility section below) in order to receive the program’s benefits. These certifications will be written and, as appropriate, electronic and accompany each food shipment for import into the U.S.

Expedited review. The program will provide for expedited review and importation of food for importers who have voluntarily agreed to participate and meet the criteria for the program.

Participant reevaluation. Any importer determined to be qualified will be reevaluated at least once every three years, and FDA will be required to promptly revoke the qualified importer status of any importer found not to be in compliance with the eligibility criteria.

Certification and Inspection of High-Risk Food Imports

FDA will be able to require as a condition of granting admission to an article of food imported or offered for import into the U.S. that a “certifying entity” provide a certification or such other assurances as FDA determines appropriate, that the article of food complies with applicable requirements of the FD&C Act.

Certifying entity. Certifying entities will be: (i) an agency or a representative of the government of the country from which the article of food at issue originated, as designated by FDA; or (ii) a third-party accredited auditor (see below).

Risk factors. FDA will base its decision of whether to require certification for an article of food on factors such as the: (i) known safety risks associated with the food; (ii) known food safety risks associated with the country, territory, or region of origin of the food; (iii) a FDA finding that the food safety programs, systems, or standards in the country or region of origin are inadequate to ensure that the food is as safe as a similar article of food that is manufactured, processed, packed, or held in the U.S. in accordance with the FD&C Act; (iv) etc.

Format. Such certification or assurances may be provided in the form of shipment-specific certificates; a listing of certified facilities that manufacture, process, pack, or hold such food; or in such other form as FDA may specify. FDA will have to provide for electronic submission of any such certifications.

Import inspections. H.R. 2751 will also require FDA, in consultation with DHS to allocate resources to inspect articles of food imported into the U.S. according to the known safety risks of the article of food (e.g., the known safety risks of the food imported or the country of origin, the importer’s compliance history, whether the importer participates in the qualified importer program, etc.).

Additional recordkeeping. Not later than one year after enactment, FDA will have to designate high-risk foods for which additional recordkeeping requirements would apply, in addition to those under 21 USC 350c. Not later than two years after enactment, FDA will be required to publish a proposed rule to establish these additional recordkeeping requirements which will apply to facilities that manufacture, process, pack, or hold such high-risk foods. Among other things, these requirements will have to take into account international trade obligations and could not require a full pedigree, nor product tracking to the case level, etc.

Prior Notice if Food Refused Entry by Another Country

Not later than 120 days after H.R. 2751’s enactment, FDA will be required to issue an interim final rule amending 21 USC 381(m)(1) on “prior notice of imported food shipments” to require prior notification of any country to which an article of food has been refused entry. This prior notification requirement will take effect 180 days after enactment.

FDA Notification on “Port Shopping” Until Final Rule

Until FDA finalizes its rulemaking to reduce certain food “port shopping,” FDA must notify DHS of all instances in which the agency refuses to admit a food into the U.S. under 21 USC 381(a) because it is adulterated, misbranded, etc. This will help U.S. Customs and Border Protection (CBP) to prevent food that is refused admittance into one U.S. port of entry from being admitted by another. (See ITT’s Online Archives or 09/22/08 news, 08092215, for BP summary of FDA’s proposed rule.)

Access to Importer’s Records if Safety/Health Concerns

The records inspection requirements of 21 USC 350c will be expanded such that if FDA has reasonable belief that an article of food is adulterated or its use presents serious adverse health consequences, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article will be required, upon request, to permit a FDA-designated official, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article of food.

New Fees for Reinspection, Qualified Importer Program, Recalls

For fiscal year 2010 and each subsequent fiscal year, FDA will be required to assess and collect fees from:

• each importer participating in the voluntary qualified importer program who will be required to pay an annual fee to cover the administrative costs of the program (for the first five fiscal years after enactment, this fee will have to include a reasonable surcharge that provides a recoupment of the costs expended by FDA to establish and implement the program):
• each importer subject to a reinspection² in order to cover reinspection-related costs for such year; 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 FDA, including technical assistance, follow up effectiveness checks, and public notifications.

Facility Requirements

Foreign Facilities May Need Certification by Accredited Third Party Auditors

The following are highlights of certification provisions that may affect foreign food facilities:

High risk imported food. As stated above, FDA could require some form of “certification” for imported food articles determined to be of higher-risk or from higher risk countries. Among other options, this certification could be a list, provided by a certifying entity, of certified facilities that manufacture, process, pack or hold a high-risk food.

Qualified importer program. Under the “qualified importer program,” where foreign facility certification will be required, the use of third-party accredited auditors in the foreign facility certification process will be mandatory.

To fulfill these requirements, the bill states that foreign facilities in the food import supply chain could choose to be audited by an accredited third-party auditor to determine whether they are in compliance with the provisions of the FD&C Act. The results of this audit will determine whether: (i) an article of food manufactured, processed, packed, or held by such facility is eligible to receive a food certification (if one is required); or (ii) whether a facility is eligible to receive a facility certification for purposes of participating in the voluntary qualified importer program.

(The term “foreign facility” under 21 USC 350d means a facility that manufacturers, processes, packs, or holds food, but only if food from such facility is exported to the U.S. without further processing or packaging outside the U.S.)

Third-party auditor accreditation. Third-party auditors will have to be accredited by an accrediting body in order to conduct audits of foreign facilities to certify that they meet applicable requirements of the FD&C Act. Accredited third-party auditors could include an individual, foreign government, agency of a foreign government, cooperative, etc.

Facilities Will Have to Institute Hazard Analysis, Controls, Etc

Not later than 18 months after enactment, H.R. 2751 will require FDA to promulgate regulations to establish science-based minimum standards for facilities that are required to register under current 21 USC 350d (which includes any factory, warehouse, or establishment (including those of an importer) that manufactures, processes, packs, or holds food for consumption in the U.S.) to:

Analyze hazards, establish controls -- identify and evaluate the hazards that may be associated with the facility (e.g. chemical hazards, toxins, pesticides, drug residues, allergens, unapproved food and color additives, etc.); implement preventive controls to significantly minimize or prevent the occurrence of such hazards; provide assurances that food is not adulterated or misbranded; and monitor the effectiveness of controls.

Corrective action -- establish procedures to follow if the preventive controls are not properly implemented or are found to be ineffective to ensure: (i) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; (ii) all affected food is evaluated for safety; and (iii) all affected food is prevented from entering into commerce if the facility cannot ensure that the affected food is not adulterated or misbranded.

Verification -- verification by the owner, operator or agent in charge of a facility that the preventive controls implemented are adequate, that the required monitoring is taking place, that appropriate decisions about corrective actions are being taken, etc.

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.

Reanalysis -- conduct a reanalysis whenever a significant change occurs that creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less than every three years, whichever is earlier.

Penalties -- operating a facility that manufactures, processes, packs, or holds food for sale in the U.S. that is not in compliance with the bill’s hazard analysis and controls provisions will be a prohibited act subject to civil penalties.

Small facility exemption. H.R. 2751 will exempt very small facilities (as defined in the rulemaking FDA will be required to issue) and those with limited annual sales from the hazard analysis and preventive controls requirements. However, such facilities will have to provide FDA documentation showing they qualify for the exemption as well as documents (inspection reports, certificates, etc.) which demonstrate they are in compliance with state, local, country or other non-federal food safety laws. In addition, FDA could remove an entity’s exempt status if it determines it is necessary to protect public health.

Other exemptions. The hazard analysis and preventive control requirements will not apply to facilities that: (1) must comply with H.R. 2751’s standards for produce safety; (2) that manufacture, process, pack, or hold dietary supplements and that are in compliance with good manufacturing processes, etc; and (3) that are compliant with one of the following: (i) the Seafood HACCP; (ii) the Juice HACCP; (iii) the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards, but only for microbiological hazards regulated under these standards.

In addition, FDA could exempt, by regulation, facilities solely engaged in production of animal feed, the storage of packaged goods that are not exposed to the environment, and the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.

Facility Inspections Will Increase, Including Foreign Facilities

In general, beginning on the date of enactment, H.R. 2751 will require an increase in the frequency of inspection of all food facilities, domestic and foreign.

Domestic. Domestic food facilities (including importer facilities) identified as being high-risk (due to their compliance history, effectiveness of safety controls, etc.) will be inspected by FDA not less than once in the five year period following enactment and at least every three years after that. Non-high-risk domestic facilities will be inspected at least once in the seven year period after enactment and at least once every five years after that.

Foreign. For foreign food facilities, in the one year period following enactment, FDA will have to inspect no fewer than 600 foreign facilities. In the five year period thereafter, FDA will have to inspect no fewer than twice the number of foreign facilities inspected by FDA during the previous year. H.R. 2751 will allow FDA to enter into agreements with foreign governments to facilitate the inspection of foreign facilities and to direct resources toward such inspections.

In addition, H.R. 2751 will require that food be refused admission into the U.S. if it were from a foreign factory, warehouse, or other establishment that refused to permit entry of U.S. inspectors during the 24 hour period (or other agreed time period) after the request to inspect is made.

New Fees for Facility Reinspection, Recalls

For fiscal year 2010 and each subsequent fiscal year, FDA will be required to assess and collect fees from the responsible party for:

• each domestic food facility (which includes any importer food facilities located in the U.S.) and the U.S. agent for each foreign facility subject to a reinspection³ in such fiscal year, to cover reinspection-related costs for such year;
• a domestic facility which does not comply with a food recall order in such fiscal year to cover FDA activities associated with such order.

Facility Registration Will be Required Every Two Years, Could be Suspended, Etc.

H.R. 2751 will amend the food facility registration requirements of 21 USC 350d which currently mandate (one-time) registration of any domestic or foreign facility (including those of an importer) engaged in manufacturing, processing, packing, or holding food for consumption in the U.S by:

• requiring that such registration be renewed every two years;
• expanding the submission requirements to include the e-mail address for the contact person of the facility or, in the case of a foreign facility, the U.S. agent for the facility;
• requiring an assurance that FDA 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 FDA determines that food manufactured, processed, packed, or held by the registered facility had a reasonable probability of causing serious adverse health consequences or death to humans or animals. If a facility’s registration were suspended, no person would be able to import or export food into the U.S. from such facility, offer to import or export food into the U.S. from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the U.S.

Other FDA Requirements, Authorities

FDA Product Tracing Pilots and Tracing System

Not later than 270 days after enactment, FDA will have to establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a food-borne illness outbreak and to address credible health threats as a result of adulterated or misbranded food. These pilots will develop and demonstrate methods and technologies for tracking and tracing food. FDA will report its findings to Congress no later than 18 months after enactment.

FDA tracing system for imported/domestic food. Supported by the results of these pilot projects and other assessments, FDA in consultation with the U.S. Department of Agriculture (USDA) will be required, as appropriate, to establish within the FDA a product tracing system to receive information that improves FDA’s capacity to effectively and rapidly track and trace food that is in the U.S. or offered for import into the U.S.

Lab Accreditation System for Testing Certain Food

Not later than two years after enactment, FDA will be required to establish a program for the testing of food by accredited laboratories, including foreign laboratories. Not later than 30 months after enactment, food testing will have to be conducted by an accredited lab whenever the following testing is conducted:

• by or on behalf of an owner or consignee: (i) in response to a specific testing requirement under the FD&C Act or implementing regulations, when applied to address an identified or suspected food safety problem; and (ii) as required by FDA, as FDA deems appropriate, to address an identified or suspected food safety problem; or
• on behalf of an owner or consignee: (i) in support of admission of an article of imported food; and (ii) under an Import Alert that requires successful consecutive tests.

The results of such testing will be sent directly to FDA, except that FDA could, by regulation, exempt test results from such submission if it does not contribute to the protection of public health.

Rulemaking on Produce Standards

Not later than 1 year after enactment, FDA in coordination with USDA and representatives of State departments of agriculture will 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, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which FDA has determined that such standards minimize the risk of serious adverse health consequences or death.

A final rule establishing these produce standards will be required not later than one year after the close of the proposed rule’s comment period.

Foreign requests for variances. Under the bill, a State or foreign country from which produce is imported into the U.S. will be able to ask FDA for a variance from these standards. Such requests will have to demonstrate that the variance does not increase the likelihood that the food will be adulterated and that the variance provides the same level of public health protection as the requirements of the regulations. FDA will review such requests, and could deny them or approve them in whole or in part.

Flexibility for small businesses. For a small business (which would be defined in the rulemaking) the produce standards will only apply one year after the effective date of the final rule; and for very small businesses (also defined by rule), they will only apply two years after the final rule’s effective date. In addition, farms that mostly profit from direct sales to end users will be exempt if certain conditions are met.

Mandatory Recall Authority

If FDA determines that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and that the use of or exposure to such article would cause serious adverse health consequences or death to humans or animals, FDA must provide the responsible party with an opportunity to cease distribution and recall such article.

If the responsible party refuses or does not voluntarily cease distribution or recall the article, FDA could order the party to immediately cease distribution of the article and, as applicable, immediately notify all persons to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.

Info for 3PLs. Under the bill, if an article of food covered by a mandatory recall order has been distributed to a warehouse-based third party logistics provider (3PL) without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order will have to include such information as is necessary for the warehouse-based 3PL to identify the food.

Penalties. Refusal or failure to follow a recall order will be a prohibited act subject to civil penalties.

Lower Threshold for Administrative Detention, Etc.

Not later than 120 days after H.R. 2751’s enactment, FDA will be required to issue an interim final rule amending 21 USC 334(h)(1)(A) to lower the threshold 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, Studies, Strategies

H.R. 2751 will require various new food programs, studies, and strategies including on:

• Facility & broker IDs -- a study on the need for unique food facility identification numbers and, as appropriate, each broker that imports food into the U.S.;
• Food smuggling - a strategy to better identify smuggled food and prevent entry of such food into the U.S.;
• Food defense - a national food defense strategy;
• Coordinating councils -- a report on the progress of food and agriculture coordinating councils; and
• Food capacity -- a report on building domestic food capacity.

More Funding and Staff

The bill will provide authorize appropriations for FDA “as may be necessary” to carry out H.R. 2751’s requirements from fiscal years 2011 through 2015. It will also allow for increased FDA staffing.

(The bill also contains a section which states that for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, the budgetary effects of H.R. 2751 will be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act, submitted for printing in the Congressional Record by the Chairman of the Senate Budget Committee, provided that such statement has been submitted prior to the vote on passage.)

WTO Consistency

There is a provision in H.R. 2751 which states that nothing in the bill (or an amendment made by it) should be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the U.S. is a party.

Specific Products

Alcoholic Beverage Limited Exemption

The bill includes a limited exemption for alcoholic beverage facilities. Specifically, facilities that are required to register with FDA as facilities because they are engaged in manufacturing, processing, packing or holding one or more alcoholic beverages and are required to obtain a permit or register with the Treasury Department as a condition of doing business in the U.S. are only subject to certain listed provisions of H.R. 2751 (mandatory recalls, administrative detention, etc.).

Dietary Supplements

Facilities that manufacture, process, pack, or hold dietary supplements and that are in compliance with 21 USC 342(g)(2) and 379aa-1 do not need to comply with the bill’s hazard analysis and prevention control provisions.

In addition, if FDA determines that the information in a new dietary ingredient notification submitted under 21 USC 350b for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, FDA must notify the Drug Enforcement Administration of such determination.

FDA will also be required to publish guidance, not later than 180 days after enactment, that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide FDA with the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient.

Seafood

The bill contains various provisions specific to seafood inspections and safety. One allows FDA, DHS and other federal agencies to enter into cooperative agreements to improve examining and testing of imported seafood, coordinate seafood inspections, etc. Another allows the Commerce Department, in coordination with FDA, to send inspectors to a country or facility of an exporter from which seafood imports originate to assess practices and processes used in connection with the farming, cultivation, harvesting, preparation for market, or transportation of such seafood and may provide technical assistance related to such activities. There are also requirements for guidance relating to post harvest processing of raw oysters.

¹Note that the bill requires that most of its provisions be carried out by the “Secretary,” which under the FD&C Act (21 USC 321) means the Secretary of Health and Human Services. As FDA is under HHS and this bill is directed at FDA, this summary uses the term FDA instead of “Secretary” for ease of reference.

²Reinspection for importers will be considered one or more examinations conducted under 21 USC 381 (Imports and Exports) subsequent to an examination 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 FDA’ satisfaction.

³Reinspection for domestic facilities will 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 FDA’ satisfaction.

(See ITT’s Online Archives or 11/30/10 news, 10113032, for BP summary of the Senate passing a virtually identical bill, the Senator Harkin amendment in the nature of a substitute to S.510 on November 30, 2010, which contained a problematic “revenue” provision that required the House and Senate to re-pass the food safety legislation.

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 H.R. 2749, previous House-passed food safety legislation.)

White House press release, dated 01/03/11, available here.