FDA International Food Investigator

1. FDA International Food Investigator LCDR Jane C. Chen, RD, BS, MBA, DHSc. US PHS Conference June 21st, 2011

2. Overview • FDA International Programs • Dedicated Food Cadre • Questions

3. FDA International Program • FDA has conducted international inspections since 1955 • Over the years, international inspections have increased in both complexity and frequency and cover all food products subject to regulation by FDA. • FDA is increasing the number of inspections of foreign food processing facilities

4. Foreign inspections are designed to: • Identify potential food safety problems before products arrive in the United States, to determine compliance status of firms to FDA’s requirements and food safety standards • Help the agency make admissibility decisions when food products are offered for importation into the U.S. • Help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act.

5. FDA focuses its inspections on high risk establishments High risk food establishments are growers / harvesters, manufacturers / processors, packers, repackers, and holders of “high risk foods,” i.e., those foods that may present hazards which FDA believes may present a high potential to cause harm from their consumption.

6. High risk food establishments include, but are not limited to: • Modified atmosphere packaged products • Acidified and Low Acid Canned Foods (AF/LACF) • Seafood • Dairy (including soft, semi-soft, soft ripened cheese and cheese products) • Fresh/ Processed Fruits and Vegetables • Spices • Unpasteurized juices • Sprouts Ready-to-Eat • Prepared Salads • Medical foods and Infant formula

7. FDA also identified the following as high risk: • products whose formulations do not include an allergenic ingredient but, because the products are made in a firm that also makes allergen-containing foods, may inadvertently contain an allergen which is not declared on the label. • products with common allergenic substances including: milk, eggs, fish, crustaceans, tree nuts, peanuts or soybeans

8. Criteria Used for Selecting Facilities for Inspection • Selection of foreign high risk establishments is based on a risk evaluation of foods imported into the United States. • FDA analyzes global and country specific data regarding high risk products in order to determine the countries/firms to inspect which includes: • The number of import entry lines (importation volume) • and other considerations such as refusal rates on denied entries.

9. Typical International Trip • Generally, FDA is in each country for three-weeks during each visit • FDA plans to inspect six to nine food facilities during each visit. • Generally, each food facility inspection should take one to three days to complete.

10. International Trips (cont.) • A country might be visited by FDA at different intervals throughout the fiscal year to complete all planned inspections • Starting in fiscal year 2010, FDA notifies the embassy prior to contacting the competent authorities and the firms and provides the embassy with some basic information regarding the FDA Foreign Inspection process. • FDA will ask the competent authorities for assistance in order to coordinate the inspections.

11. International Trips (cont.) • FDA contacts the firm again by letter with specific information regarding: • proposed inspection dates, • logistical information • availability of interpreter assistance. • These letters are written in English and the foreign country’s official language

12. Inspectional Focus FDA focuses on the firm’s adherence to the Federal Food, Drug, and Cosmetic Act and relevant regulations of Title 21 of the U.S. Code of Federal Regulations, specifically Part 110 (Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food) and any other U.S. regulations applicable to the specific type of food produced by the facility selected for inspection.

13. Inspectional Observations • FDA investigators and analysts will make every reasonable effort to discuss all observations with the management of the establishment: • As they are observed during the course of the inspection, and/or • On a daily basis before leaving the facility, and; • During the inspection closeout meeting at the facility. • FDA investigators will verify the completed corrective actions. This may also be completed during the FDA compliance review process • in communications with the firm, • during examinations/sampling at the port of entries, • and/or during a follow up inspection.

14. Conclusion of Inspection • When applicable, FDA issues an FDA-483 (Inspectional Observations form) to the company’s management at the end of the inspection • When applicable, FDA takes any necessary enforcement actions. • Once it is evident to FDA that the firm is in compliance with FDA’s requirements and food safety standards, a copy of the Establishment Inspection Report (EIR) is sent to the firm.

15. Refusal of Inspection may result in the following Regulatory Options: • including taking the refusal into account in determining whether to sample products or • otherwise examine products from the firm when offered for import into the United States and in determining whether such products are subject to refusal of admission into U.S. commerce. • Section 801(a) of the U.S. Food, Drug and Cosmetic Act authorizes FDA to conduct examinations, samplings, detentions and refusals, as they may apply, on articles under FDA jurisdiction offered for importation into the United States.

16. Food Modernization Act • Signed into law on December 22, 2010 • Doubles the number of foreign inspections every year for the next five years • Projected Foreign Facility Inspection Breakdown • 2011: 600 inspections • 2012: 1200 inspections • 2013: 2400 inspections • 2014: 4800 inspections • 2015: 9600 inspections

17. Dedicated Foreign Food Cadre • Established in 2009 • Consists of 15 members • Solely dedicated to conducting international food inspections • Stationed throughout the U.S. • Report directly to headquarters • Expected to complete approximately 40 inspections per year

18. Additional Information • For more information please contact or visit: • FDA’s Foreign Food Inspection Program website at: • http://www.fda.gov/Food/InternationalActivities/ucm196386.htm • Office of International Programs • (Tel) 301-796-4600 • (Fax) 301-595-5063 • http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofInternationalPrograms/default.htm5 • Importing into the United States • http://www.fda.gov/Food/InternationalActivities/Imports/default.htm6 • http://www.fda.gov/Food/InternationalActivities/ucm202422.htm7 • http://www.fda.gov/ForIndustry/ImportProgram/default.htm8 • FDA Industry Systems • https://www.access.fda.gov/9 • FDA – Food’s Section • http://www.fda.gov/Food/default.htm10

19. Reference Information for slides obtained directly from FDA Foreign Food Inspection Program http://www.fda.gov/Food/InternationalActivities/ucm196386.htm

20. Summery • FDA International Programs • Dedicated Food Cadre • Questions

21. Questions?