Highlights of Importer Requirements in 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 importer-specific provisions of the House-passed version of H.R. 2749. See future issues of ITT for BP summaries of other aspects of the bill.

Importer Registration, Good Importer Practices, Etc.

Importers Would Need to Register and Submit Facility Identifier

H.R. 2749 would require an importer of food to be registered with the Health and Human Services (HHS) Secretary in a form and manner specified by the HHS Secretary; and submit appropriate unique facility identifiers as a condition of registration.

Good Importer Practices Needed to Maintain Registration

The maintenance of registration would be conditioned on compliance with good importer practices, in accordance with regulations the HHS Secretary, in consultation with U.S. Customs and Border Protection (CBP), would promulgate.

The regulations would establish good importer practices that specify the measures an importer should take to ensure imported food is in compliance with the Food, Drug, and Cosmetic Act (FD&C) Act, as amended by H.R. 2749. These measures should ensure an importer of food has adequate:

information about the imported food, its hazards, and the requirements of the FD&C Act;

information or procedures in place to verify that both the food and each person that produced, manufactured, processed, packed, transported, or held the food, including components of the food, are in compliance with the requirements of the FD&C Act;

procedures in place to take corrective action, such as the ability to trace, withhold and recall articles of food.

In promulgating good importer practices, H.R. 2749 states that the HHS Secretary may, as appropriate:

incorporate certification of compliance in high risk and other situations (see below);

incorporate participation in the safe and secure food importation program (see below);

take into account differences among importers and the types of imports, including based on the level of risk posed by the imported food.

Suspension/Cancellation of Registration, and Exemptions

An importer's registration could be suspended (after notice and an opportunity for an informal hearing), if the importer is found in violation of the FD&C Act or found to have knowingly or repeatedly made inaccurate or incomplete statements or submissions of information related to the importation of food. An importer's registration could also be canceled (after notice) if the registration was not updated correctly or contains false, incomplete, or inaccurate information.

The HHS Secretary would also establish an exemption from the importer registration requirements for importations for personal use, as well as have the authority to establish other exemptions.

Regulations on Importer Registration and Effective Dates

The HHS Secretary, in consultation with CBP would be required to promulgate the regulations required to carry out the above importer registration requirements. The regulations would have to provide a reasonable period of time for importers of food to comply with the good importer practices, taking into account differences among importers and the types of imports, including based on the level of risk posed by the imported food.

H.R. 2749 states that not later than 36 months after enactment, the HHS Secretary, in consultation with CBP, would be required to promulgate regulations to carry out the importer registration requirements. However, it also states that the registration requirements summarized above (as well as certain amendments related to prohibited acts and misbranding) would take effect 24 months after enactment.

(House Energy and Commerce Committee sources were unable to explain this language, noting that this aspect of the bill could have been better written.)

Annual Fee for Importer Registration

The HHS Secretary would collect an annual fee for the registration of an importer of food. The base amount for fiscal year 2010 would be $500. For subsequent fiscal years, the fee would be adjusted for inflation.

An importer that is also a required to pay an annual fee for registration of a food facility (also $500) would only be subject to one of the fees.

Inspection of Import Facilities and Records Upon Request

H.R. 2749 also states that every person engaged in the importing of any food would be required, upon request of an officer or employee designated by the HHS Secretary, to permit such officer or employee at all reasonable times to inspect the facilities of such person and have access to, and to copy and verify, any related records.

Programs/Requirements Based on Risk

Increased Random Facility Inspections Based on Risk

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 (including factories, warehouses, establishments, finished and unfinished materials, containers, etc. of any person who manufactures, processes, packs, transports, distributes, holds, or imports food) to require the HHS Secretary to create a risk-based inspection schedule for such facilities not later than 18 months after enactment.

The schedule would provide for a frequency of inspections commensurate with the risk presented by the facility and be 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.

Certification Could be Required for High Risk Foods, High Risk Countries, Etc.

Under H.R. 2749, the HHS Secretary may, as an additional entry condition for imports of food articles, require that a qualified certifying entity provide a certification that the article complies with specified requirements of the FD&C Act if it would assist the Secretary in determining whether to refuse to admit such articles. Such certification would only be for:

food from high risk countries or regions;

high risk foods; or

articles imported from a country with which the U.S. has an agreement requiring such certification.

Form. The certification would be able to take the form of a statement that the article of food or the facility or farm that manufactured, processed, packed, held, grew, harvested, sorted, or transported the article, as the case may be, complies with requirements of the FD&C Act as specified by the HHS Secretary, or any other form as the Secretary may specify, including a listing of certified facilities or other entities.

The HHS Secretary could also require that the certification include additional information regarding compliance. In addition, the Secretary would be required to provide, in coordination with CBP for the electronic submission of certifications.

HHS Could Create a Program for "Safe" Food Importers Similar to C-TPAT

H.R. 2749 would permit the HHS Secretary to establish by regulation or guidance, in coordination with CBP, a program to facilitate the movement of food through the importation process under the FD&C Act if the importer of such food verifies that each facility involved in the production, manufacture, processing, packaging, and holding of the food has been determined to be in compliance with food safety and security guidelines that the HHS Secretary, in consultation with CBP, would develop.

This program for such "safe" importers would take into account, to the extent appropriate, other relevant Federal programs such as CBP's Customs-Trade Partnership Against Terrorism (C-TPAT).

Misbranding/Prohibited Acts/Penalties

Food Would be Considered Misbranded If Importer Not Registered

H.R. 2749 would consider food misbranded (and introducing misbranded food into interstate commerce continues to be a prohibited act under 21 USC 331) if it is imported or offered for import by an importer not duly registered with the HHS Secretary.

Food Would be Considered Misbranded w/out Certain Country of Origin Labeling

Under H.R. 2749, the HHS Secretary would be required to promulgate final regulations effective two years after enactment, providing that food be considered misbranded (and introducing misbranded food into interstate commerce continues to be a prohibited act under 21 USC 331) in the following instances:

for processed food, if the labeling of the food fails to identify the country in which the final processing of the food occurs; and

for non-processed food, if the labeling of the food fails to identify the country of origin.

However, if the label of a processed food already informs the consumer of the country where the final processing occurred in compliance with CBP's country of origin requirements, the food would be deemed in compliance. In addition, if a non-processed food already informs the consumer of the country of origin pursuant to U.S. Department of Agriculture labeling requirements, the food would also be deemed in compliance.

New Prohibited Acts if Importer Submits Inaccurate Info, Doesn't Register, Etc.

H.R. 2749 would amend the list of prohibited acts in 21 USC 331 to include:

submission of information relating to food that is required by or under section 801 of the FD&C Act that is inaccurate or incomplete (including inaccurate or incomplete registration information or unique facility identifier information that importers would be required to submit to the HHS Secretary);

the failure to submit information relating to food that is required by or under Section 801 (including the registration information or unique facility identifiers importers would be required to submit to the HHS Secretary).

the failure to register with the HHS Secretary.

the violation of any requirement of the food tracing system that the HHS Secretary would be required to establish for food that is located in the U.S. or is for import into the U.S. (See future issues of ITT for BP summary of the food traceability requirement.)

the failure of a registered importer to notify the HHS Secretary if the importer has reason to believe an article of food is adulterated or misbranded in a manner that presents a reasonable probability of serious health consequences, etc.

New and Increased Civil Penalties for Violations Relating to Food

H.R. 2749 would amend section 303 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.

New Criminal Penalties for Violations Relating to Food

H.R. 2749 would amend section 303 to require, among other things, that any person who knowingly violates paragraph (a), (b), (c), (k) or (v) of section 301 with respect to any food that is misbranded or adulterated would be imprisoned for not more than 10 years or fined in accordance with 18 USC, or both.

(Paragraphs (a), (b), (c) and (k) have to do with adulterated or misbranded food in interstate commerce. Paragraph (v) has to do with unsafe dietary supplements in interstate commerce.)

Detention, Refused Admission, Seizure

Lower Threshold for and Longer Administrative Detention

H.R. 2749 would revise the administrative detention provisions in 21 USC 334(h) by:

lowering the standard for administrative detention to a "reason to believe that an article is adulterated, misbranded, or otherwise in violation of the FD&C Act" (from the current standard of "credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals").

extending the maximum administrative detention period to 60 days (from 30 days)

extending the period from five to fifteen days for the FDA to terminate or confirm a detention order after an appeal has been filed.

New Reasons to Refuse Admission of Food

H.R. 2749 would provide for the following new reasons to refuse admission to imports of food:

if the food traceability requirements that the HHS Secretary would be required to establish were not met;

if an article of imported food were not incompliance with the certification requirements that the HHS Secretary would be able to establish for high risk foods, high risk countries, etc.

if an article of food were subject to a cease distribution order or recall;

if the appropriate unique facility identifiers that H.R. 2749 would require were not provided for imported food.

Seizure Procedures

H.R. 2749 would revise the procedures for seizure in 21 USC 334(b) to state (new text is denoted by ):

The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty; except that on demand of either party any issue of fact joined in any such case shall be tried by jury and except that, with respect to proceedings relating to food, Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions shall not apply in any such case, exigent circumstances shall be deemed to exist for all seizures brought under this section, and the summons and arrest warrant shall be issued by the clerk of the court without court review in any such case.

(See future issues of ITT for other details affecting importers such as the requirement that the HHS Secretary establish and maintain a corps of inspectors dedicated to inspections of foreign food facilities.)

(See ITT's Online Archives or 07/31/09 news, 09073110, for BP summary of the House passing H.R. 2749.

See ITT's Online Archives or 07/30/09 news, 09073005, for BP summary of the House failing to pass H.R. 2749 under expedited procedures.

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 amendment in the nature of a substitute adopted by House available at http://www.rules.house.gov/111/SpecialRules/hr2749/111_substitute_hr2749.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