FDA regulations on importing food

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FDA regulations on importing food
Ronald Pace Chief, Product Adulteration
Branch Center for Food Safety and Applied
Nutrition Food and Drug Administration Ronald.pace
_at_fda.hhs.gov
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U.S. Agencies involved with Food Safety

• Department of Health and Human Services Food and
  Drug Administration (FDA) ---- for the safety
  of all foods, with the exception of meat,
  poultry, and processed eggs
• Department of Agricultures Food Safety and
  Inspection Service (FSIS) ---- the safety of
  meat, poultry and processed eggs
• Environmental Protection Agency (EPA) ---- EPA
  regulates the use of pesticides and establishes
  maximum residue limits in foods that are enforced
  by FDA and FSIS

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U.S. Agencies involved with Food Safety

• Department of the Treasurys Alcohol and Tobacco
  Tax and Trade Bureau (TTB) ---- Alcoholic
  beverages
• Department of Agricultures Animal and Plant
  Health Inspection Service (APHIS)
• ---- Animal and plant health
• Centers for Disease Control and Prevention (CDC)
• U.S. Customs and Border Protection (CBP)
• State and Local Authorities

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Legal requirements

• Federal Food, Drug, and Cosmetic Act
• Sec 402 Adulterated Food
• Sec 403 Misbranded Food
• Sec 801 Imports and Export
• Code of Federal Regulation (21CFR)
• Parts 113 114 (Low acid canned foods and
  acidified foods)
• Parts 123 (Fish and Fishery Products)
• Parts 133 (Cheeses)

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Bioterrorism Act

• In effect since 2003
• Facility Registration
• Domestic and foreign facilities engaged in
  manufacturing, processing, packing and holding of
  food
• Prior Notification of Imported Foods - notice
  must be received and confirmed electronically by
  FDA no more than 5 days before arrival and, as
  specified by the mode of transportation, no fewer
  than
• 2 hours by land
• 4 hours by air
• 8 hours by sea
• Importer debarment

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Dairy requirements

• Milk used in the manufacture of imported dairy
  products is required by 21 CFR 1240.61 to be
  pasteurized unless the product meets the Standard
  of Identity in 21 CFR 133 for a hard cheese that
  has been aged for 60 days or longer at 35F or
  higher.

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What must be pasteurized?

• 21 CFR 1240.61
• Mandatory pasteurization for all milk and milk
  products in final package form intended for
  direct human consumption.

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Grade A Milk and Milk Products Import
Requirements

• Based on a 1977 Memorandum of Understanding
  (MOU), milk protection measures in the U.S. have
  been set by the combined efforts of FDA and the
  States under the National Conference on
  Interstate Milk Shippers (NCIMS).
• FDA and NCIMS have identified and mutually
  accepted three options which will allow States to
  receive Grade A milk and milk products produced
  outside of the U.S.

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Grade A Milk and Milk Products Import
Requirements

• The three options are
• The NCIMS will accept FDA findings of equivalence
  and accept products produced within the scope of
  such a finding.
• Contract with a NCIMS members regulatory/rating
  agency to provide the Grade A milk safety
  program.
• The exporting country, or a political subdivision
  thereof, may become a full member of the NCIMS
  subject to the NCIMS rules.

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National Shellfish Sanitation Program

• Molluscan shellfish imports must meet both
  Federal and state requirements to gain free
  access to U.S. markets
• A foreign country may export molluscan shellfish
  to the U.S. by agreeing to abide by the NSSP.

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Mandatory Label Requirement

• Statement of identity
• Net quantity of contents
• Ingredient declaration
• Name and address of manufacturer, packer, or
  distributor
• Nutrition labeling
• FALCPA (Allergen labeling)

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Language Requirements

• All mandatory labeling statements must appear in
  English
• If any required statements are in a foreign
  language, then all other required statements must
  in that language as well as in English
• (21 CFR 101.15)

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Food Allergen Labeling and Consumer Protection
Act 2004

• January 1, 2006
• Peanuts, soybeans, milk, eggs, fish,
• crustacean shellfish, tree nuts, wheat
• Ingredient name includes food source of allergen
• e.g., wheat flour, buttermilk, eggs, peanut
  butter
• Identification of allergen
• e.g., flour (wheat), casein (milk),
• artificial color (eggs), natural flavor (peanut)
• Or
• Ingredients .(Contains wheat, egg,
  peanut).

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Ensuring food safety-Imported foods

• Risk-based approach
• Foreign inspections
• Primary tool in ensuring food safety of imported
  foods is through the review and analysis of food
  product entering the U.S.
• Prior notice FDA admissibility
• FDA sample analysis

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Importing Foods Into the United States
NEW Transmitter submits prior notice (PN) to
FDA 2, 4, or 8 hours before food arrives in U.S.
Inadequate or no PN food held at U.S. port
until PN received and reviewed by FDA
ENTRY PROCESS1. Importer files Entry Notice
with U.S. Customs
2. FDA notified of entry
3. FDA reviews Entry Notice
4A. FDA does not want sample May Proceed Notice
sent to U.S. Customs and importer
4B. FDA wants sample Notice of Sampling sent to
U.S. Customs and importer
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Importing Foods Into the United States
5. FDA/U.S. CBP collects physical sample Sample
analyzed by FDA
6B. FDA finds sample is violative Notice of
Detention and Hearing sent to U.S. CBP and
importer
6A. FDA finds sample in compliance Release
Notice sent to U.S. CBP and importer
7A. Importer does not respond to Notice of
Detention and Hearing
7A. Importer responds to Notice of Detention and
Hearing
8B. FDA sends Notice of Refusal of Admission
8A. FDA holds hearing on detained product
9C. FDA receives verification of exportation or
destruction
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Importing Foods Into the United States
8A. FDA holds hearing on detained product
9A. Importer presents evidence that product is in
compliance
9B. Importer submits application to recondition
10A. FDA collects follow-up sample
10B. FDA reviews reconditioning procedure
proposed by importer
11A. Sample in compliance Release Notice sent
11B. FDA finds sample does not comply
11C. FDA approves importers reconditioning
proposal
8B. FDA sends Notice of Refusal of Admission
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Importing Foods Into the United States
11C. FDA approves importers reconditioning
proposal
12. Importer completes all reconditioning
procedures
13. FDA conducts follow-up inspection/sample
collection
14A. FDA finds sample in compliance Release
Notice sent to U.S. CBP and importer
14B. FDA finds that sample does not comply
8B. FDA sends Notice of Refusal of Admission
9C. FDA receives verification of exportation or
destruction
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Food Imports

• 1997- 2,800,000 line entries
• 2001- 5,000,000 line entries
• 2007- 11,500,000 line entries

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Examination

• FDA will pay for samples found to be in
  compliance. Payment not made for violative
  shipments
• Perishable products procedures
• Bond may be posted to move perishables
• Product cannot be distributed until released
• No preshipment sampling

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Enforcement tools- Imported foods

• Detention w/o Physical Examination (DWPE)
• Product/firm placed on DWPE (aka-Import alert)
• Automatic detention for sampling and testing
• Responsibility of importer to prove product is in
  compliance
• Procedure for removal from DWPE

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Enforcement tools- Imported foods

• DWPE- Countrywide
• Seizure- Section 304
• Debarment- Section 306(b)(1)-The
  Secretarymaydebar-(c) a person from importing
  an article of food or offering such an article
  for import into the US.
• Warning letters
• Recalls

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General experience

• Majority of companies export to U.S. try to
  comply with requirements
• A few companies are regular offenders
• Distribute product before clearance
• Misbrand
• Fail to recondition or relabel properly
• Falsify records or invoices

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Food safety regulations and standards

• Publicly available via internet
• (www.fda.gov, www.gpoaccess.gov/cfr/index.html,
  www.gpoaccess.gov/fr/index.html)

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Contacts for industry

• http//www.cfsan.fda.gov/7Edms/industry.html
• FDA Assistance- 1-888-723-3366 (1-888-SAFEFOOD)