FDA International FDA International Food InvestigatorFood Investigator

LCDR Jane C. Chen, RD, BS, MBA, DHSc.LCDR Jane C. Chen, RD, BS, MBA, DHSc.US PHS ConferenceUS PHS ConferenceJune 21June 21stst, 2011, 2011

OverviewOverview FDA International ProgramsFDA International Programs Dedicated Food CadreDedicated Food Cadre QuestionsQuestions

FDA International ProgramFDA International Program

FDA has conducted international FDA has conducted international inspections since 1955 inspections since 1955

Over the years, international inspections Over the years, international inspections have increased in both complexity and have increased in both complexity and frequency and cover all food products frequency and cover all food products subject to regulation by FDA.subject to regulation by FDA.

FDA is increasing the number of inspections FDA is increasing the number of inspections of foreign food processing facilities of foreign food processing facilities

Foreign inspections are Foreign inspections are designed to:designed to: Identify potential food safety problems before Identify potential food safety problems before

products arrive in the United States, to determine products arrive in the United States, to determine compliance status of firms to FDA’s compliance status of firms to FDA’s requirements and food safety standards requirements and food safety standards

Help the agency make admissibility decisions Help the agency make admissibility decisions when food products are offered for importation when food products are offered for importation into the U.S. into the U.S.

Help ensure that food products under FDA’s Help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act. Federal Food, Drug, and Cosmetic Act.

FDA focuses its inspections FDA focuses its inspections on high risk establishmentson high risk establishments

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

High risk food establishments High risk food establishments include, but are not limited to:include, but are not limited to:

Modified atmosphere packaged products Modified atmosphere packaged products Acidified and Low Acid Canned Foods Acidified and Low Acid Canned Foods

(AF/LACF)(AF/LACF) Seafood Seafood Dairy (including soft, semi-soft, soft ripened Dairy (including soft, semi-soft, soft ripened

cheese and cheese products)cheese and cheese products) Fresh/ Processed Fruits and VegetablesFresh/ Processed Fruits and Vegetables Spices Spices Unpasteurized juices Unpasteurized juices Sprouts Ready-to-Eat Sprouts Ready-to-Eat Prepared Salads Prepared Salads Medical foods and Infant formulaMedical foods and Infant formula

FDA also identified the FDA also identified the following as high risk:following as high risk:

products whose formulations do not products whose formulations do not include an allergenic ingredient but, include an allergenic ingredient but, because the products are made in a firm because the products are made in a firm that also makes allergen-containing that also makes allergen-containing foods, may inadvertently contain an foods, may inadvertently contain an allergen which is not declared on the allergen which is not declared on the label. label.

products with common allergenic products with common allergenic substances including: milk, eggs, fish, substances including: milk, eggs, fish, crustaceans, tree nuts, peanuts or crustaceans, tree nuts, peanuts or soybeanssoybeans

Criteria Used for Selecting Criteria Used for Selecting Facilities for InspectionFacilities for Inspection

Selection of foreign high risk establishments Selection of foreign high risk establishments is based on a risk evaluation of foods is based on a risk evaluation of foods imported into the United States. imported into the United States.

FDA analyzes global and country specific FDA analyzes global and country specific data regarding high risk products in order to data regarding high risk products in order to determine the countries/firms to inspect determine the countries/firms to inspect which includes: which includes: – The number of import entry lines (importation The number of import entry lines (importation

volume) volume) – and other considerations such as refusal rates on and other considerations such as refusal rates on

denied entries.denied entries.

Typical International TripTypical International Trip

Generally, FDA is in each country for Generally, FDA is in each country for three-weeks during each visit three-weeks during each visit

FDA plans to inspect six to nine food FDA plans to inspect six to nine food facilities during each visit.facilities during each visit.

Generally, each food facility inspection Generally, each food facility inspection should take one to three days to complete. should take one to three days to complete.

International Trips International Trips (cont.)(cont.)

A country might be visited by FDA at different A country might be visited by FDA at different intervals throughout the fiscal year to complete intervals throughout the fiscal year to complete all planned inspections all planned inspections

Starting in fiscal year 2010, FDA notifies the Starting in fiscal year 2010, FDA notifies the embassy prior to contacting the competent embassy prior to contacting the competent authorities and the firms and provides the authorities and the firms and provides the embassy with some basic information regarding embassy with some basic information regarding the FDA Foreign Inspection process. the FDA Foreign Inspection process.

FDA will ask the competent authorities for FDA will ask the competent authorities for assistance in order to coordinate the inspections.assistance in order to coordinate the inspections.

International Trips International Trips (cont.)(cont.)

FDA contacts the firm again by letter FDA contacts the firm again by letter with specific information regarding: with specific information regarding: – proposed inspection dates, proposed inspection dates, – logistical information logistical information – availability of interpreter assistance. availability of interpreter assistance.

These letters are written in English These letters are written in English and the foreign country’s official and the foreign country’s official languagelanguage

Inspectional FocusInspectional Focus FDA focuses on the firm’s adherence to FDA focuses on the firm’s adherence to

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

Inspectional ObservationsInspectional Observations FDA investigators and analysts will make every FDA investigators and analysts will make every

reasonable effort to discuss all observations with the reasonable effort to discuss all observations with the management of the establishment: management of the establishment: – As they are observed during the course of the inspection, and/or As they are observed during the course of the inspection, and/or – On a daily basis before leaving the facility, and; On a daily basis before leaving the facility, and; – During the inspection closeout meeting at the facility. During the inspection closeout meeting at the facility.

FDA investigators will verify the completed corrective FDA investigators will verify the completed corrective actions. This may also be completed during the FDA actions. This may also be completed during the FDA compliance review process compliance review process – in communications with the firm, in communications with the firm, – during examinations/sampling at the port of entries, during examinations/sampling at the port of entries, – and/or during a follow up inspection. and/or during a follow up inspection.

Conclusion of InspectionConclusion of Inspection When applicable, FDA issues an FDA-483 When applicable, FDA issues an FDA-483

(Inspectional Observations form) to the (Inspectional Observations form) to the company’s management at the end of the company’s management at the end of the inspection inspection

When applicable, FDA takes any necessary When applicable, FDA takes any necessary enforcement actions. enforcement actions.

Once it is evident to FDA that the firm is in Once it is evident to FDA that the firm is in compliance with FDA’s requirements and food compliance with FDA’s requirements and food safety standards, a copy of the Establishment safety standards, a copy of the Establishment Inspection Report (EIR) is sent to the firm. Inspection Report (EIR) is sent to the firm.

Refusal of Inspection may result in Refusal of Inspection may result in the following Regulatory Options:the following Regulatory Options:

including taking the refusal into account in determining including taking the refusal into account in determining whether to sample products or whether to sample products or

otherwise examine products from the firm when offered otherwise examine products from the firm when offered for import into the United States and in determining for import into the United States and in determining whether such products are subject to refusal of admission whether such products are subject to refusal of admission into U.S. commerce. into U.S. commerce.

Section 801(a) of the U.S. Food, Drug and Cosmetic Act Section 801(a) of the U.S. Food, Drug and Cosmetic Act authorizes FDA to conduct examinations, samplings, authorizes FDA to conduct examinations, samplings, detentions and refusals, as they may apply, on articles detentions and refusals, as they may apply, on articles under FDA jurisdiction offered for importation into the under FDA jurisdiction offered for importation into the United States. United States.

Food Modernization ActFood Modernization Act Signed into law on December 22, 2010Signed into law on December 22, 2010 Doubles the number of foreign inspections every Doubles the number of foreign inspections every

year for the next five yearsyear for the next five years Projected Foreign Facility Inspection Breakdown Projected Foreign Facility Inspection Breakdown

– 20112011: 600 inspections: 600 inspections– 20122012: 1200 inspections: 1200 inspections– 20132013: 2400 inspections: 2400 inspections– 20142014: 4800 inspections: 4800 inspections– 20152015: 9600 inspections : 9600 inspections

Dedicated Foreign Food Dedicated Foreign Food Cadre Cadre

Established in 2009Established in 2009 Consists of 15 membersConsists of 15 members Solely dedicated to conducting Solely dedicated to conducting

international food inspectionsinternational food inspections Stationed throughout the U.S.Stationed throughout the U.S. Report directly to headquartersReport directly to headquarters Expected to complete approximately 40 Expected to complete approximately 40

inspections per yearinspections per year

Additional InformationAdditional Information For more information please contact or visit:For more information please contact or visit: FDA’s Foreign Food Inspection Program website at: FDA’s Foreign Food Inspection Program website at:

– http://www.fda.gov/Food/InternationalActivities/ucm196386.htmhttp://www.fda.gov/Food/InternationalActivities/ucm196386.htm Office of International Programs Office of International Programs

– (Tel) 301-796-4600 (Tel) 301-796-4600 – (Fax) 301-595-5063 (Fax) 301-595-5063 – http://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofInternationalProgrhttp://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofInternationalProgr

ams/default.htmams/default.htm5 5

Importing into the United States Importing into the United States – http://www.fda.gov/Food/InternationalActivities/Imports/default.htmhttp://www.fda.gov/Food/InternationalActivities/Imports/default.htm6 6 – http://www.fda.gov/Food/InternationalActivities/ucm202422.htmhttp://www.fda.gov/Food/InternationalActivities/ucm202422.htm7 7 – http://www.fda.gov/ForIndustry/ImportProgram/default.htmhttp://www.fda.gov/ForIndustry/ImportProgram/default.htm8 8

FDA Industry Systems FDA Industry Systems – https://www.access.fda.gov/https://www.access.fda.gov/9 9

FDA – Food’s Section FDA – Food’s Section – http://www.fda.gov/Food/default.htmhttp://www.fda.gov/Food/default.htm10 10

ReferenceReference

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

SummerySummery FDA International ProgramsFDA International Programs Dedicated Food CadreDedicated Food Cadre QuestionsQuestions

Questions?Questions?