Import Alert 99-15

Import Alert # 99-15

Published Date: 05/06/2021

Type: DWPE

"Countrywide Detention Without Physical Examination of Processed Foods for Pesticides"

The revision to this Import Alert dated August 5, 2020 updates the 'Guidance' section with provisions for private lab analysis for individual entries subject to DWPE, organizational contact changes, and updates to policy and external internet links for Center and DIO contacts, adds a new product codes, updates charge code language. Changes are noted and bracketed by asterisks (***).

The revision of this Import Alert dated 04/27/2011, removes Guatemalan snow peas from detention without physical examination. Changes bracketed by ***

This alert was created to cover Countrywide Detention Without Physical Examination (DWPE) of processed agricultural products due to illegal pesticide residues. Individual growers/shippers will continue to be covered by Import Alert #99-08.

Divisions may detain without physical examination any shipment of the listed products where countrywide detention has been initiated as identified below in this alert if the shipper or grower fails to provide a valid certificate of analysis showing the product does not contain illegal residues of the cited pesticide(s).

A firm subject to countrywide detention without physical examination under this import alert may also be subject to detention without physical examination under Import Alert #99-08 for another pesticide. If the firm does not provide certification to demonstrate that the product is free from pesticide residues shown in both Import Alert #99-08 and this alert (#99-15), the product should be detained using the ***charge below***, naming all the pesticides for which the firm is being recommended for DWPE.

Individual growers, ***processors*** or shippers can be exempted from countrywide detention without physical examination by providing substantial evidence that their product is in compliance. Exempted growers, ***processors*** or shippers are identified in the Green List for this alert.

If a firm is listed in the Green List as exempt from countrywide detention without physical examination under this import alert but is subject to detention without physical examination under ***Import Alert #99-08*** for another pesticide, the procedures in ***Import Alert #99-08*** should be followed.

***Release of Articles Subject to Detention without Physical Examination under this Import Alert:

In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the detained product, which demonstrates that the product does not bear or contain pesticide chemical residues that are unsafe within the meaning of section 408(a) of the Federal Food,
Drug & Cosmetic Act (21 U.S.C. 346a(a)).

Proper sampling and analytical records should be submitted to the appropriate FDA District compliance office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.

For residues regulated as combined residues (including isomers) or residues including metabolites and degradates, FDA will consider whether the private laboratory analyses address all the residues, including isomers, metabolites, or degradates, as listed in 40 CFR part 180 in the applicable regulation.

Resources for private laboratory testing are available at
https://www.fda.gov/media/73540/download

In order to remove a firm from detention without physical examination, information should be provided which enables the Agency to assess whether the firm has identified the source of the problem and has taken the appropriate steps to correct and prevent future occurrences. FDA recommends a firm requesting removal from detention without physical examination provide the following information:

a. Documentation showing preventative action(s) taken to ensure future shipments of product will be in compliance with the U.S. FFD&CA. This should include, at a minimum:

1) A description of current processes which ensure non-permitted pesticides are not being used; and

2) Verification of the process's adequacy.

b. Documentation confirming a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses of shipments.

Requests to remove a firm from DWPE under this alert that produces various agricultural products should include twelve (12) import entries representative of these products. ***

For additional guidance on removal from detention without physical examination, refer to FDAs' Regulatory Procedures Manual, ***Chapter 9-8, "Detention without Physical Examination (DWPE)"***

If a firm and/or a representative thereof would like to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov.

***Requests for removal from detention without physical examination will be evaluated by DIO and CFSAN.***

***Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov.

Questions or issues involving science policy, analysis, sample preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

For questions on policy or sample collection recommendations contact CFSAN, Division of Enforcement, Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Processed Foods


PRODUCTS SUBJECT TO COUNTRYWIDE DWPE:

COUNTRY: HONG KONG
1. Duck eggs, in shell

COUNTRY: TURKEY
1. Raisins (dried grapes) (berry)
2. Raisins (dried or paste)

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:" [ADULTERATION, Section 402(a)(2)(B)]

OASIS CHARGE CODE - PESTICIDE

Desc: Raisins