Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 111/2/19

10 January 2011

Dear Sirs,

Commercial Information Circular No. 29/2011

US : FDA Food Safety Modernization Act of 2010

The United States (US) enacted a food safety act (the FDA Food Safety Modernization Act of 2010) ("the Act") on 4 January 2011 to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply in the US. A number of provisions in the Act are relevant to imported food and foreign food facilities. The full text and other details of the Act can be found at the website of the library of the US Congress at: http://thomas.loc.gov/cgi-bin/bdquery/z?d111:h.r.02751: .

DETAILS

2.The Act would expand the food safety activities of the US Food and Drug Administration (FDA) to improve prevention and detection of food safety problems and response to such problems. A summary of the main provisions relevant to imported food and foreign food facilities is set out below.

Certification and Inspection of High-risk Imported Food

3.The Act empowers the FDA to require, as a condition of granting admission to an article of food imported or offered for import into the US, a certification or other assurances as the FDA determines appropriate that the food meets applicable requirements of the Federal Food, Drug, and Cosmetic Act. To determine whether to require certification of an article of food, the FDA will base on the risk of the food, including the following factors:

1. the known safety risks associated with the food;
2. the known food safety risks associated with the country, territory, or region of origin of the food;
3. a finding by the FDA, supported by scientific, risk-based evidence that the food safety programs, systems or standards in the country, territory, or region of origin of the food are inadequate to ensure the food is safe as a similar article of food manufactured, processed, packed, or held in the US in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act; and
4. other information submitted to the FDA.

4.The certification or assurance would be issued by a "certifying entity", which is

1. an agency or a representative of the government of the country from which the article of food is originated from, as designated by the FDA; or
2. an accredited third-party auditor.

Such certification or assurance may be 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 the FDA specifies. The FDA will provide for electronic submission of such certifications.

5.The FDA may refuse admission to importation of an article of food if the certification requirement is not complied with.

Additional Information required for the Prior Notice of Imported Food Shipments

6.Not later than 180 days of the enactment of the Act, the FDA will require additional information for the prior notice of imported food shipments on whether the shipment has been refused entry by any country.

Amendments to the Registration of Foreign Food Facilities

7.Currently, food facilities, including both domestic and foreign facilities, engaging in manufacturing, processing, packing or holding food for consumption in the US are required to be registered with the FDA. The Act amends the food facility registration requirements by:

1. requiring the registration be renewed every 2 years instead of the existing one-time registration arrangement. The renewal of registration will be held during 1 October to 31 December of each even-numbered year;
2. expanding the submission requirements to include the e-mail address for the contact person of the facility or, in case of a foreign facility, the US agent for the facility;
3. requiring an assurance that the FDA be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug, and Cosmetic Act;
4. providing for the suspension of a facility's registration if the FDA determines that the food manufactured, processed, packed, or held by the registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. If a facility's registration is suspended, no person will be allowed to import or export food into the US from such facility, offer to import or export food into the US from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the US.

8.Owners, operators or agents of food facilities are required to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by the facilities. The records documenting the monitoring of the preventive controls implemented, instances of non-conformance material to food safety, the results of testing and other appropriate means of verification, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions must be maintained for at least 2 years.

Inspection of Foreign Food Facilities

9.The Act provides authority to the FDA to enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign food facilities. If the owner, operator, or agent in charge of a foreign factory, warehouse, or other establishment, or the government of the foreign country refuses to permit entry of the US inspectors or other individuals duly designated by the FDA to inspect such food facilities, the food from the concerned facilities will be refused admission into the US.

10.The Act requires the FDA to inspect not fewer than 600 foreign food facilities in the first year of its enactment and to inspect at least twice that number in each of the 5 subsequent years.

Certification of Foreign Food Facilities by Accredited Third-party Auditors

11.In the following circumstances, foreign food facilities may require certification issued by an accredited third-party auditor:

1. foreign food facilities that produce high-risk food (determined by FDA as described in paragraph 3 above) may require certification or assurance issued by a "certifying entity" in the form of a listing of certified facilities. The "certifying entity" can be an accredited third-party auditor;
2. under the "Qualified Importer Program" (detailed in paragraphs 16-17 below) where foreign food facility certification is required, the use of accredited third-party auditors in the certification process is mandatory.

The FDA will establish a publicly available registry of accredited third-party auditors.

12.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 the applicable requirements of the US. Details of the requirements for accreditation as a third-party auditor can be found in section 307 of the Act.

Importer Requirements

Foreign Supplier Verification Program

13.Two years after the enactment of the Act, each importer of food (defined as the US owner or consignee of the article of food at the time of entry of such article into the US or, if there is no US owner or consignee, the US agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the US) will be required to perform risk-based verification activities as part of a "Foreign Supplier Verification Program" that provides assurance that each foreign supplier produces imported food that is produced in compliance with applicable requirements related to hazard analysis and preventive controls or the production and harvesting standards as specified in the Act; and is not adulterated or misbranded.

14.The verification activities by the importer 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. Importers will have to maintain the records related to the "Foreign Supplier Verification Program" for at least 2 years and made them available promptly to an FDA representative upon request. If an importer does not have in place a "Foreign Supplier Verification Program", it would be prohibited to import or offer for importation a food. 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 US.

15.As required by the Act, the FDA will promulgate regulations to provide content of the "Foreign Supplier Verification Programs" not later than 1 year after the enactment of the Act.

Voluntary "Qualified Importer Program" with Third Party Facility Certification

16.The FDA is required to establish a voluntary "Qualified Importer Program" and issue guidance within 18 months after the enactment of the Act. The program will provide expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program.

17.To participate in the "Qualified Importer Program", an importer has to import food from foreign facilities with certifications resulting from an audit by an accredited third-party auditor. These certifications will be written and, as appropriate, electronic and accompany each food shipment for import into the US. In reviewing the applications and making determinations on requests of an importer to participate in the program, the FDA will consider the risk of the food to be imported based on a list of factors as specified in section 302 of the Act. Any importer determined to be qualified will be re-evaluated at least once every 3 years and the FDA will promptly revoke the qualified importer status of any importer found not to be in compliance with the eligibility criteria.

Other Provisions

18.Other important provisions of the Act include:

1. provision of authority to the FDA to inspect records related to food;
2. requiring the FDA to issue guidance documents to reduce the risk from the most significant foodborne contaminants;
3. requiring the FDA to establish scientific-based standards for the safe production and harvesting of fruits and vegetables based on known safety risks;
4. requiring the FDA to establish a product tracing system to track and trace food that is in the US or offered for import into the US;
5. requiring the FDA to establish a program for testing of food by accredited laboratories, including foreign laboratories and requiring food testing be conducted by an accredited laboratory;
6. requiring the Centres for Disease Control and Prevention (CDC) to enhance foodborne illness surveillance systems;
7. provision of authority to the FDA to order for mandatory recall of food considered unsafe;
8. allowing the FDA to collect fees from importers or US agents for foreign facilities in cases of re-inspection, participation in the "Qualified Importer Program" and recalls to cover the costs of the implementation of measures under the Act.

19.Please refer to the full text of the Act for details of the requirements and other requirements on specific products, such as seafood and dietary supplements, as well as the limited exemptions applicable to specific provisions under the Act.

20.Traders are advised to visit the website of the FDA at http://www.fda.gov/Food/default.htm for the latest information. Traders are also strongly advised to seek clarifications with their importers in the US in order to comply with the necessary requirements.

ENQUIRIES

21.For enquiries concerning this circular, please contact the undersigned at telephone number 2398 5682.

Yours faithfully,

(Miss Carmen CHAN)

for Director-General of Trade and Industry