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: 01/19/2023
Type: DWPE

Import Alert Name:

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

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 01/19/2023 updates the reason for alert, guidance section including agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***).

This alert was created to cover Countrywide Detention Without Physical Examination (DWPE) of raw agricultural products due to illegal pesticide residues. ***Individual firms will continue to be covered by Import Alert #99-05, "Detention Without Physical Examination of Raw Agricultural Products for Pesticides." ***

Guidance:

Divisions may detain without physical examination any shipment of the ***identified products in this alert, except from a firm identified on the Green List of this Alert.***

***Please note that fuzzy squash (Benincasa hispida var. chieh-gua) is a variety of Chinese waxgourd (Benincasa hispida), which is listed under crop group 9, cucurbit vegetables (see 40 CFR 180.41). Chinese waxgourd belongs to crop subgroup 9B, squash/cucumber subgroup. Please note that fuzzy squash is neither a summer squash nor a winter squash per 40 CFR 180.41 (c)(13)(ii). Fuzzy squash resembles a large zucchini in shape but have small white hairs.***

***A firm/product subject to DWPE under this import alert may also be subject to DWPE under Import Alert #99-05, "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" for another pesticide. If the firm does not provide evidence to demonstrate that the product is free from pesticide residues shown in both Import Alert #99-05 and this alert, the product should be detained per each alert, listing all the pesticides for which the firm is recommended for DWPE. ***

***If a firm listed on the Green List of this Import Alert (exempt from DWPE) but is subject to DWPE under Import Alert #99-05 for another pesticide, the procedures in Import Alert #99-05 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 DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence 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 and Cosmetic Act (21 U.S.C 346a(a)). Such evidence may include private laboratory analytical package.

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical 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.***

***Removal from Detention Without Physical Examination (ADD TO GREEN LIST):

In order to remove a firm from detention without physical examination (add to Green List), information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."

*** 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.

If a firm and/or a representative thereof would like to request removal from detention without physical examination***(i.e. addition to Green List) under this Import Alert, all relevant information supporting the request should be forwarded to 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 ***addition to Green List*** will be evaluated by DIO and CFSAN.

Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@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 with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, 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 identified in the Countries section***


(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 - - 51 Peas
Date Published: 02/22/2012

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

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