Highlights of Facility & Export Provisions of House-Passed Food Safety Bill

(Although the House has passed H.R. 2749, it is not yet in effect. Generally, in order for a bill to be implemented, identical versions of that bill must be passed by both the House and Senate, and then the bill must be approved (enacted) by the President.)

The following are highlights of certain facility and export provisions of House-passed H.R. 2749. (See ITT's Online Archives or 08/12/09, 08/10/09 and 08/04/09 news, 09081205, 09081015 and 09080415, for BP summaries of the food tracing, broker and importer-specific requirements of the bill. See future issues of ITT for BP summaries of other aspects of the bill.)

Meat, Poultry or Egg - Regulated Facilities Exemption

H.R. 2749 would exempt from all its requirements facilities that are regulated as an official establishment by the Secretary of Agriculture under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act or under a program recognized by the Secretary of Agriculture as at least equal to Federal regulation under those acts.

(There would also be certain exceptions for alcohol-related facilities. See H.R. 2749 for details.)

Facility Registration

Existing Food Facility Registration Requirements Would Change

H.R. 2749 would make the following changes to the existing food facility registration requirements under Section 415 of the Food, Drug, and Cosmetic Act (FD&C) Act (21 USC 350d):

Definition of facility. The term 'facility' for purposes of registration would continue to mean any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Facilities would continue to include both domestic and foreign facilities. Farms, restaurants, other retail food establishments, etc., would continue to be excluded, however definitions for the exclusions would be added.

Registration for facilities w/food for export. The food facility registration requirement would be expanded to include facilities engaged in manufacturing, processing, packing or holding food for export from the U.S., in addition to food for consumption in the U.S.

Annual registration. The registration requirement would become annual, with food facilities required to register on or before December 31st of each year. H.R. 2749 would also require the registration information to be submitted in an electronic format.

Fee. A fee would be required for registration, starting at $500 for fiscal year 2010 and adjusted for inflation thereafter. A person who owns or operates multiple facilities for which a fee must be paid would not be liable for more than $175,000 in aggregate fees.

More information. More information would be required for registration. The expanded list of information would include the: (i) name, address, and emergency contact information of the facility being registered; (ii) primary purpose and business activity of the facility, including the dates of operation if the facility is seasonal; (iii) general food category of each food manufactured, processed, packed, or held at the facility; (iv) all trade names under which the facility conducts business related to food; (v) name, address, and 24-hour emergency contact information of the U.S. distribution agent for the facility;

(vi) unique facility identifier; (vii) such additional information as may be required by regulation; and (viii) if the facility is located outside of the U.S., the name, address, and emergency contact information for a U.S. agent.

Suspension. Registration could be suspended for a violation of the FD&C Act that could result in serious adverse health consequences or death to humans or animals.

Food Would be Considered Misbranded If from an Unregistered Facility, Etc.

H.R. 2749 would consider food misbranded if it were manufactured, processed, packed, or held in a facility that was not duly registered or whose registration was canceled or suspended.

Hazard Analysis, Controls, Safety Plans & Standards

Facility Would Conduct Hazard Analysis, Implement Preventive Controls

H.R. 2749 would add new hazard analysis and risk-based preventive control requirements for registered food facilities. These would include conducting a hazard analysis; identifying and implementing preventive controls; monitoring those controls; instituting corrective actions; maintaining records of all such actions; etc.

(Hazards would include: (i) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, filth, decomposition, parasites, allergens, and unapproved food and color additives; and (ii) hazards that occur naturally or that may be unintentionally introduced.)

Guidance or regulations. The Health and Human Services (HHS) Secretary would be required to issue guidance or promulgate regulations to establish science-based standards for conducting a hazard analysis, documenting hazards, identifying and implementing preventive controls, etc. The Secretary could also establish by regulation or guidance preventive controls for specific product types to prevent unintentional contamination throughout the supply chain.

Facility Would Need Safety/Defense Plans Before Food is in Interstate Commerce

With certain exceptions, before a facility could introduce or deliver for introduction into interstate commerce any shipment of food, the facility would be required to develop and implement a written:

food safety plan that includes the hazard analysis described above along with a description of the procedures and preventive controls in place regarding that analysis;

food defense plan that identifies conditions and practices that may permit a hazard to be intentionally introduced, including by an act of terrorism; describes preventive measures to minimize such risks; etc.

Safety Standards for Raw Fruit, Vegetables, Nuts, Fungus Would be Established

The HHS Secretary would be required to establish by regulation scientific and risk-based food safety standards for the growing, harvesting, processing, packing, sorting, transporting, and holding of raw fruit, vegetables, nuts or fungus for which the Secretary has determined such standards are necessary to minimize the risk of serious adverse health consequences or death to humans or animals.

Performance Standards to Prevent Food-Borne Contaminants Would be Established

The Secretary would also be required to issue, as soon as practicable, through guidance or by regulation, science-based performance standards applicable to foods or food classes, as appropriate, to minimize to an acceptable level, prevent, or eliminate the occurrence of the most significant food-borne contaminants and the most significant resulting hazards.

Food Not Meeting Hazard, Safety Requirements Would be Considered Adulterated

H.R. 2749 would consider food that was manufactured, processed, packed, transported or held under conditions not meeting the above hazard analysis, food safety plan, food defense plan, and performance standard requirements to be adulterated. In addition, food grown, harvested, processed, packed, sorted, transported, or held under conditions not meeting the safety standards would be considered adulterated.

Inspections/Testing

Random Facility Inspections Based on Risk Would Increase

H.R. 2749 would add a new paragraph to section 704 of the FD&C Act (21 USC 374) on HHS inspection of registered food facilities to require the HHS Secretary to create a risk-based inspection schedule not later than 18 months after enactment based on the following categories and inspection frequencies:

Category 1 - every 6 to 12 months. A category 1 food facility is a high-risk facility that manufactures or processes food. The HHS Secretary would be required to randomly inspect a category 1 food facility at least every 6 to 12 months.

Category 2 - every 18 months to 3 years. A category 2 food facility is a low-risk facility that manufactures or processes food or a facility that packs or labels food. The HHS Secretary would be required to randomly inspect a category 2 facility at least every 18 months to 3 years.

Category 3 - every 5 years. A category 3 food facility is a facility that holds food. The HHS Secretary would be required to randomly inspect a category 3 facility at least every 5 years.

Finished Product Testing Would be Required for Category 1 Facilities

The HHS Secretary would require, after public notice and an opportunity for comment, the submission of finished product test results from Category 1 facilities, as the Secretary determines feasible and appropriate.

Delaying, Limiting or Refusing Inspection Would be Considered Adulteration

Food would be considered adulterated if it were produced, manufactured, processed, packed, or held in any farm, factory, warehouse, or establishment and the agent of such an entity or the agent of a government authority in the foreign country of such an entity delays or limits an inspection or refuses to permit entry or inspection.

Inspection of Foreign Food Facilities

H.R. 2749 would also amend the inspection requirements of 21 USC 374 to allow the HHS Secretary to inspect foreign food factories, warehouses, and establishments, as well as such domestic entities, bearing on whether such food is adulterated, misbranded, or otherwise in violation of the FD&C Act. The Secretary would be required to establish and maintain a corps of inspectors dedicated to inspections of foreign food facilities.

Penalties

New and Increased Civil Penalties for Violations Relating to Food

H.R. 2749 would amend section 303(f) of the FD&C Act to require that any person who violates a provision of section 301 (Prohibited Acts) relating to food would be subject to a civil penalty for each such violation of not more than $20,000 in the case of an individual, not to exceed $50,000 in a single proceeding; and $250,000 in the case of any other person, not to exceed $1,000,000 in a single proceeding.

"Knowing" violations. In addition,any person who knowingly violates a provision of section 301 (Prohibited Acts) relating to food would be subject to a civil penalty for each such violation of not more than $50,000 in the case of an individual, not to exceed $100,000 in a single proceeding; and $500,000 in the case of any other person, not to exceed $7,500,000 in a single proceeding.

Separate offense. Each violation and each day during which the violation continues would be considered a separate offense.

Notifications/Recalls

HHS Notification of Certain Adulterated/Misbranded Food

The party who submits a food facility registration would be required to notify the HHS Secretary of the identity and location of an article of food that the party has a reason to believe is adulterated or misbranded in a manner that could cause a threat of serious adverse health consequences or death to humans or other animals.

New Recall and Cease Distribution Authority

The HHS Secretary would be able to request any person who distributes an article of food that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of the FD&C Act to voluntarily recall such article. The Secretary would also be able to issue an immediate cease distribution order if there reason to believe that the use or consumption of, or exposure to, an article of food may cause adverse health consequences or death to humans or other animals.

Food Tracing System

H.R. 2749 would require the HHS Secretary to establish by regulation a tracing system for food that is located in the U.S. or is for import into the U.S.

The food tracing system would enable the Secretary to identify each person who grows, produces, manufactures, processes, packs, transports, holds, or sells such food in as short a timeframe as practicable but no longer than 2 business days.

The HHS Secretary could include in the regulations establishing the food tracing system: (i) the establishment and maintenance of lot numbers; (ii) a standardized format for pedigree information; and (iii) the use of a common nomenclature for food.

(It would appear that food facilities that manufacture, pack, hold, or process food, etc. would be subject to this requirement.) (See ITT's Online Archives or 08/12/09 news, 09081205, for BP summary of the food tracing system under H.R. 2749.)

Export Certification

HHS Would Certify Upon Request that a Food for Export Meets FD&C Act

H.R. 2749 would allow any person who exports food (including animal feed) from the U.S. to request the HHS Secretary to certify that the food meets certain applicable requirements of the FD&C Act, based on whatever criteria the HHS Secretary determines appropriate. (The FD&C Act already allows for such certification for exported drugs, animal drugs, and devices.)

(See ITT's Online Archives or 07/31/09 and 07/30/09 news, 09073110 and 09073005, for BP summaries of the House passing H.R. 2749 and the House failing to pass H.R. 2749 under expedited procedures, respectively.

See ITT's Online Archives or 07/08/09, 07/02/09, 06/30/09, 06/26/09, and 06/25/09 news, 09070820, 09070210, 09063015, 09062625 and 09062515, for BP summaries of various aspects of the House Energy and Commerce Committee version of H.R. 2749.)

H.R. 2749 as passed by the House available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h2749rfs.txt.pdf

House Committee on Energy and Commerce short bill summary (dated July 2009) available at http://energycommerce.house.gov/Press_111/20090729/hr2749_floorsummary.pdf

House Committee on Energy and Commerce section-by-section bill summary (dated July 2009) available at

http://energycommerce.house.gov/Press_111/20090729/hr2749_sectionsummary.pdf