Import Alert 99-14

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 99-14
Published Date: 10/16/2020
Type: DWPE

Import Alert Name:

"Countrywide Detention Without Physical Examination Of Raw Agricultural Products for Pesticides"

Reason for Alert:

This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and products at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.

The revision to this import alert, dated 10/16/2020, updates guidance section to update agency contacts and add new product code for fuzzy squash under this alert. Changes are noted and bracketed by three asterisks (***).

This alert was created to cover Countrywide Detention Without Physical Examination (DWPE) of raw agricultural products due to illegal pesticide residues. Individual growers/shippers will continue to be covered by Import Alert #99-05.

Guidance:

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 #99-05 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 #99-05 and this alert (#99-14), the product should be detained using the charge listed in this alert, naming all the pesticides for which the firm is recommended for DWPE.

Individual growers or shippers can be exempted from countrywide detention without physical examination by providing substantial evidence that their product is in compliance. Exempted growers/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 #99-05 for another pesticide, the procedures in Import Alert #99-05 should be followed.

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. Federal Food, Drug & Cosmetic Act. 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.

***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***
For additional guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, ***Chapter 9-8, "Detention without Physical Examination (DWPE)” available at: https://www.fda.gov/media/71776/download***

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, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
Questions or issues on policy, sample collection recommendations, or any additional questions, should be addressed to CFSAN/Division of Enforcement’s Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Product Description:

Raw agricultural products

24A - - 51) Peas (Desc: snow peas)
Notes:12/16/1988
Problems: CHLORPYRIFOS; DICROTOPHOS; PROFENOFOS; MONOCROTOPHOS; METHAMIDOPHOS

(24A - - 82) Snow peas (Desc: snow peas)
Notes:12/16/1988
Problems: CHLORPYRIFOS; DICROTOPHOS; METHAMIDOPHOS; MONOCROTOPHOS; PROFENOFOS

(24A - - 83) Pea Pod (Desc: snow peas)
Notes:12/16/1988
Problems: CHLORPYRIFOS; METHAMIDOPHOS; DICROTOPHOS; PROFENOFOS; MONOCROTOPHOS

(24A - - 84) Sugar Snap Peas (Desc: snow peas)
Notes:12/16/1988
Problems: MONOCROTOPHOS; PROFENOFOS; METHAMIDOPHOS; CHLORPYRIFOS; DICROTOPHOS

(24F - - 06) Squash (Desc: Fuzzy squash)
Notes:12/16/1988
Problems: DIMETHOATE; METHAMIDOPHOS; MONOCROTOPHOS

***(24F - - 09) Gourd (Desc: Fuzzy squash)
Problems: DIMETHOATE; METHAMIDOPHOS; MONOCROTOPHOS***

Charge:

"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

Countries

DOMINICAN REPUBLIC (THE)

  • (24 F - - 06) Squash, Summer (Fruit Used as Vegetable)
    Desc: Fuzzy squash
    Notes: 12/16/1988
    Problems:DIMETHOATE;METHAMIDOPHOS;MONOCROTOPHOS;
  • (24 A - - 51) Peas
    Desc: Snow peas
    Notes: 12/16/1988
    Problems:CHLORPYRIFOS;DICROTOPHOS;METHAMIDOPHOS;MONOCROTOPHOS;PROFENOFOS;
  • (24 A - - 82) Snow Peas
    Desc: Snow peas
    Notes: 12/16/1988
    Problems:CHLORPYRIFOS;DICROTOPHOS;METHAMIDOPHOS;MONOCROTOPHOS;PROFENOFOS;
  • (24 A - - 83) Pea Pod
    Desc: Snow peas
    Notes: 12/16/1988
    Problems:CHLORPYRIFOS;DICROTOPHOS;METHAMIDOPHOS;MONOCROTOPHOS;PROFENOFOS;
  • (24 A - - 84) Sugar Snap Peas
    Desc: Snow peas
    Notes: 12/16/1988
    Problems:CHLORPYRIFOS;DICROTOPHOS;METHAMIDOPHOS;MONOCROTOPHOS;PROFENOFOS;
  • (24 F - - 09) Gourd (Fruit Used as Vegetable)
    Desc: Fuzzy squash
    Problems:DIMETHOATE;METHAMIDOPHOS;MONOCROTOPHOS;

List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)


DOMINICAN REPUBLIC (THE)


Angel Yi dba Produccion Agricola Universal S A
Date Published : 09/16/2009
Avenida 27 de Febrero No 513 , Santo Domingo, DOMINICAN REPUBLIC (THE)
24 A - - 51 Peas
Date Published: 09/16/2009

Notes: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 82 Snow Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 83 Pea Pod
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 84 Sugar Snap Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

Exportadora Nicolas Rosario
Date Published : 09/16/2009
Las Cabuyas , Calle Principal # 51 , La Vega, La Vega DOMINICAN REPUBLIC (THE)
24 A - - 14 Stringbeans
Date Published: 08/16/2019

Desc: Long Beans
Notes: 9/5/2006

24 A - - 51 Peas
Date Published: 02/22/2012

24 F - - 08 Pepper, Hot, N.E.C. (Fruit Used as Vegetable)
Date Published: 08/16/2019

Desc: Hot Peppers
Notes: 11/28/2000

24 F - - 11 Chinese Eggplant, Thai Eggplant (Fruit Used as Vegetable)
Date Published: 08/16/2019

Desc: Chinese Eggplant
Notes: 4/5/2011

Exportadora Oba CXA
Date Published : 11/05/2013
Calle 2 #4 Villa Paraiso , Jeremias , La Vega, La Vega DOMINICAN REPUBLIC (THE)
24 A - - 51 Peas
Date Published: 11/05/2013

Desc: Peas

24 A - - 82 Snow Peas
Date Published: 11/05/2013

Desc: Peas

24 A - - 83 Pea Pod
Date Published: 11/05/2013

Desc: Peas

24 A - - 84 Sugar Snap Peas
Date Published: 11/05/2013

Desc: Peas

Expotardora Tateyama S.A.
Date Published : 09/16/2009
Calle 7 No 1 Prolongacion , L A Colonia Calle 5 No 53 , Colonia Agricola, Jarabacoa, DOMINICAN REPUBLIC (THE)
24 A - - 51 Peas
Date Published: 09/16/2009

Notes: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 82 Snow Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 83 Pea Pod
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 84 Sugar Snap Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 F - - 01 Egg Plant (Fruit Used as Vegetable)
Date Published: 08/21/2019

Desc: Eggplant

24 F - - 06 Squash, Summer (Fruit Used as Vegetable)
Date Published: 08/21/2019

Desc: Squash

24 F - - 08 Pepper, Hot, N.E.C. (Fruit Used as Vegetable)
Date Published: 08/21/2019

Desc: Hot Pepper
Notes: 5/21/1997

24 F - - 11 Chinese Eggplant, Thai Eggplant (Fruit Used as Vegetable)
Date Published: 08/21/2019

Desc: Eggplant

Fina Miches Importado Exportador
Date Published : 09/16/2009
Av HNAS Miraval 48 , Carretra Villa Mella , Santo Domingo, DOMINICAN REPUBLIC (THE)
24 A - - 51 Peas
Date Published: 09/16/2009

Notes: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 82 Snow Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 83 Pea Pod
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 84 Sugar Snap Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

Maximiliano Rijo Cedeno
Date Published : 09/16/2009
Presidente Vazquez No 139 , Santo Domingo, DOMINICAN REPUBLIC (THE)
24 A - - 51 Peas
Date Published: 09/16/2009

Notes: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 82 Snow Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 83 Pea Pod
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

24 A - - 84 Sugar Snap Peas
Date Published: 01/12/2010

Desc: Chinese peas; peapods; snow peas; sugar peas; sugar snap peas

V&D Agropecuaria
Date Published : 09/16/2009
Autopista Duarte Km. 14, Burende , La Vega, DOMINICAN REPUBLIC (THE)
24 A - - 83 Pea Pod
Date Published: 01/25/2012

World Agro Marketing Dominicana
Date Published : 01/12/2010
Zona Franca Especial , Duverga, Independencia DOMINICAN REPUBLIC (THE)
24 F - - 06 Squash, Summer (Fruit Used as Vegetable)
Date Published: 01/12/2010

Desc: Fuzzy squash
Notes: Exempt - 11/8/2006