# Presentation: 320939

## U.S. FOOD and DRUG ADMINISTRATION

- ENHANCING THE SAFETY OF IMPORTED FOOD

- and
- U.S. CUSTOMS SERVICE

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## BACKGROUND

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _BACKGROUND_
- GAO REPORT
- PRESIDENTIAL DIRECTIVE

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## GAO REPORT

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _GAO REPORT_
- 	Illicit Distribution
- 	Port Shopping
- 	Private Laboratories
- 	Inadequate Deterrents

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## PRESIDENTIAL DIRECTIVE

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _PRESIDENTIAL DIRECTIVE_
- 	Objectives
- 	FDA/Customs Taskforce
- 	Report

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## OBJECTIVES

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _OBJECTIVES_
- 	Prevent Distribution
- 	Destruction
- 	Prevent Re-importation

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## 	OBJECTIVES

- ENHANCING THE SAFETY OF IMPORTED FOOD

- 	_OBJECTIVES_
- 	Private Labs
- 	Bonds
- 	Enhance Enforcement

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## TASKFORCE

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _TASKFORCE_
- 	FDA
- 	Customs
- 	Other Agencies

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## REPORT

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _REPORT_
- www.foodsafety.gov
- www.customs.treas.gov
- 12/11/99 Radio Address
- Comprehensive Plan

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## SECURED STORAGE (Plan):

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _SECURED STORAGE (Plan)_:
- Prevent distribution of imported unsafe food by means such as requiring food to be held until reviewed by FDA.

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## SECURED STORAGE(Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _SECURED STORAGE(Plan)_
- Planned CRITERIA:
- 	Failure to hold (twice)
- 	Failure to redeliver (twice)
- 	False or misleading information
- 	Substitution

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## SECURED STORAGE (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _SECURED STORAGE (Plan)_
- FDA field recommendation to FDA HQ
- FDA HQ request to Customs HQ
- Customs HQ directive to Customs field

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## SECURED STORAGE (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _SECURED STORAGE (Plan)_
- Warning Letter to Importer
- 12 month period
- Period can be extended

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## SECURED STORAGE (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _SECURED STORAGE (Plan)_
- Under Customs control
- At importer’s expense
- Removal for export or destruction
- Controlled removal for testing or reconditioning

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## SECURED STORAGE (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _SECURED STORAGE (Plan)_
- Regulatory Procedures Manual
- Customs Field/Trade Guidance

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## DESTRUCTION (Plan) :

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _DESTRUCTION (Plan) _:
- Destroy imported food that poses a serious public health threat.

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## DESTRUCTION (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _DESTRUCTION (Plan)_
- Customs seizure & forfeiture
- Class I recall criteria
- Review & Concurrence by HQ

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## DESTRUCTION (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _DESTRUCTION (Plan)_
- Class I recall definition - 21CFR 7.3(m)(1)
- “... serious adverse health consequences or death.”

- Presentation at Public Meetings of 2/10/00 and 2/17/00

##            DESTRUCTION (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

-            _DESTRUCTION (Plan)_
- _Potential Reasons for Destruction:_
- pathogens		toxins
- heavy metals		chemicals
- adverse reactions	infant formula
- LACF/AF			histamines

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## DESTRUCTION (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _DESTRUCTION (Plan)_
- 19 U.S.C. 1595a(c)
- Importation contrary to law
- Government bears cost of storage and destruction

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## DESTRUCTION (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _DESTRUCTION (Plan)_
- Reconditioning considered
- Public health hazard affirmed by FDA
- USCS destruction=no Refusal

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## DESTRUCTION (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _DESTRUCTION (Plan)_
- Regulatory Procedures Manual
- Customs Field Guidance

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## MARKING (Plan): Prohibit the re-importation of food that has been previously refused admission and has not been brought into compliance with US laws and regulations, and 

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _MARKING (Plan)_: Prohibit the re-importation of food that has been previously refused admission and has not been brought into compliance with US laws and regulations, and

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## MARKING (Plan):  Require the marking of shipping containers and/or papers of imported food that is refused admission for safety reasons.

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _MARKING (Plan)_:  Require the marking of shipping containers and/or papers of imported food that is refused admission for safety reasons.

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## MARKING (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _MARKING (Plan)_
- Refused for Safety Reasons
- Reconditioning considered
- Proposed Rule - mid-2000

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## MARKING (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _MARKING (Plan)_
- Plan for Proposed Rule:
- By importer or consignee
- Affixed to outside container
- Also affixed to documents
- Bulk = documents only

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## MARKING (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _MARKING (Plan)_
- 	Planned Proposed Rule:
- 	Affixed before exportation
- 	Clear
- 	Conspicuous
- 	Permanent

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## MARKING (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _MARKING (Plan)_
- Planned Proposed Rule:
- Prohibit refusal to mark
- Prohibit re-import of marked product
- Prohibit altering, removing, tampering with, or concealing mark

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## MARKING (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _MARKING (Plan)_
- Customs will verify mark prior to permitting exportation
- Final rule - late 2000
- Guidance to follow

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## PRIVATE LABS (Plan):  Set standards for private laboratories for the collection and analysis of samples of imported food for the purpose of gaining entry into the United States.

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _PRIVATE LABS (Plan)_:  Set standards for private laboratories for the collection and analysis of samples of imported food for the purpose of gaining entry into the United States.

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## PRIVATE LABS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _PRIVATE LABS (Plan)_
- Proposed rule
- late-2000
- Guidance to follow

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## PRIVATE LABS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _PRIVATE LABS (Plan)_
- Planned Proposed Rule:
- Requirements for importers
- Standards for sample collection
- Standards for analysis

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## PRIVATE LABS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _PRIVATE LABS (Plan)_
- Planned Proposed Rule:
- Notification of intent to use private lab
- Direct submission of results to FDA

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## PRIVATE LABS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _PRIVATE LABS (Plan)_
- Planned Proposed Rule:
- Samples properly identified
- Samples properly collected
- Samples properly maintained

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## PRIVATE LABS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _PRIVATE LABS (Plan)_
- Planned Proposed Rule:
- Labs accredited
- Methods validated
- Samples properly analyzed

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## BONDS (Plan):  Increase the amount of the bond posted for imported foods when necessary to deter premature and illegal entry into the United States.

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _BONDS (Plan)_:  Increase the amount of the bond posted for imported foods when necessary to deter premature and illegal entry into the United States.

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## BONDS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _BONDS (Plan)_
- Current = 3X entered value
- GAO - 3X not deterrent to illegal distribution

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## BONDS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _BONDS (Plan)_
- Proposed Rule  8/2/99
- 64 Federal Register 41851
- Liquidated Damages = Full Domestic Value

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## BONDS (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _BONDS (Plan)_
- Comment period closed 10/1/99
- Customs evaluating comments
- Final Rule expected mid-2000

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## CIVIL MONETARY PENALTIES (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _CIVIL MONETARY PENALTIES __(Plan)_
- Enhance enforcement against violations of United States laws related to the importation of foods, including through the imposition of civil monetary penalties.

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## CIVIL MONETARY PENALTIES (Plan)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _CIVIL__ MONETARY PENALTIES __(Plan)_
- 19 U.S.C. 1592
- Material false statement, act, or omission
- Penalties up to domestic value of merchandise

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## 19 U.S.C 1595a(b)

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _CIVIL MONETARY PENALTIES(Plan)_
- Importation contrary to law
- Penalties equal to domestic value of merchandise

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## Planned:

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _CIVIL MONETARY PENALTIES (Plan)_
- FDA will alert Customs of situations where CMP are appropriate
- Customs will inform FDA of imposition of CMP

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## Planned:

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _CIVIL MONETARY PENALTIES (Plan)_
- FDA & Customs will meet regularly
- FDA & Customs will continue to pursue joint criminal investigations & prosecutions

- Presentation at Public Meetings of 2/10/00 and 2/17/00

## CONCLUSIONS

- ENHANCING THE SAFETY OF IMPORTED FOOD

- _CONCLUSIONS_
- Focus on problem importers
- Ensure safe food supply
- Deterrent

- Presentation at Public Meetings of 2/10/00 and 2/17/00