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August 1, 2008

Ginseng Dietary Supplements Special Survey
(CFSAN Assignments and Field Regulatory Monitoring
for FY 2003 and FY 2004)

Background:

In FYs 2003 and 2004 FDA issued two field assignments covering pesticide residues in ginseng.

The first assignment, "Pesticides in Imported Bulk Ginseng and Domestic Ginseng Dietary Supplements, Division of Field Programs (DFP) Assignment # 03-01," was issued on October 4, 2002. The second assignment, "Sample Collection and Analysis of Dietary Supplement Ginseng for Pesticides, DFP # 04-25," was issued on June 8, 2004.

The FY 2004 assignment was a follow-up to the FY 2003 assignment, calling for visits to select firms to collect official samples of ginseng dietary supplements suspected of containing unlawful pesticide residues. The collection and analyses of the ginseng products for both assignments were concluded in FY 2004. In a few cases, it was difficult to determine if a particular ginseng sample was collected as part of the assignments or as part of field regulatory monitoring. Results for all import and domestic ginseng samples collected and analyzed in FYs 2003 and 2004 are contained in this report.

Ginseng is generally characterized by species. According to The American Herbal Products Association's Herbs of Commerce, 2^nd Edition, the standardized common name for Panax ginseng is Asian ginseng; other common names are Chinese ginseng and Korean ginseng. The standardized common name for Panax quinquefolius is American ginseng. The standardized common name for Panax pseudoginseng Wall. var. notoginseng is Tienchi ginseng. The standardized common names and other common names refer to the species and variety and not (necessarily) to the locale where grown.

DFP Assignment 03-01 "Pesticides in Imported Bulk Ginseng and Domestic Ginseng Dietary Supplements" Issued October 4, 2002.

The stated objectives of the assignment were:

To obtain comprehensive data on levels of pesticide residues in imported bulk ginseng and ginseng dietary supplements sold in the U.S; and
To take appropriate regulatory action against those products that contain unlawful pesticide residues.

Import Component:

The assignment called for the collection of 60 samples of imported bulk ginseng for pesticide analysis. The samples of ginseng were to originate from Canada, Hong Kong, The People's Republic of China (PROC), and the Republic of Korea. Samples were to consist of the Panax species of ginseng and to be in the following forms - dried root, ground or powdered root, liquid or powdered extracts or concentrates, or finished products shipped in bulk for re-packing in the U. S. in any form (liquid, capsules, or tablets). Imported products already packaged for retail sale were not to be collected.

Domestic Component:

The assignment also called for the collection of up to 83 products that CFSAN had previously identified as products available for purchase on the internet and marketed as dietary supplements containing a single ginseng source of Panax ginseng. The samples were requested to be purchased over the Internet, with the option of obtaining the samples at the manufacturer (if in the assigned district), or at a retail establishment.

DFP Assignment 04-25, "Sample Collection and Analysis of Dietary Supplement Ginseng for Pesticides, High Priority," Issued June 8, 2004.

The stated objectives of the assignment were:

To visit select firms, collect official samples of domestic ginseng supplements, and analyze for unlawful pesticide residues which cause the products to be adulterated.
To obtain documentary samples of Siberian ginseng, if the firm is marketing such products.
To take appropriate regulatory action against those products that contain unlawful pesticide residues or are misbranded as ginseng.

Domestic Component:

Nineteen firms were identified to be covered in the assignment by 9 FDA districts (CHI-DO, DEN-DO, LOS-DO, MIN-DO, NYK-DO, NWE-DO, NWJ-DO, SAN-DO, and SEA-DO). While at the firm the district was requested to: identify and document the origin of all bulk ginseng used in finished products; collect 1 sample for pesticide residue analysis of a ginseng supplement from the largest finished lot available; and determine and document if the firm markets Siberian ginseng.

Import Component:

None.

Analytical Guidance for Ginseng Analyses (both assignments):

All samples were to be analyzed for organochlorine and organophosphate pesticides using procedures in the Pesticide Analytical Manual (PAM) or other appropriate methodology. All residues were requested to be identified. However, in cases where residues of a particular pesticide (e.g., quintozene) consist of multiple components, only those components that were estimated to contribute significantly to the total were to be quantitated, and a total of the combined residue was to be reported.

Attachment 1 contains a listing of EPA tolerances and FDA enforcement levels for chlorinated and phosphorus pesticides in ginseng.

Note: For this report all residues recorded by the analyzing labs as having no established tolerance, or exceeding an existing tolerance, and meeting or exceeding the limits of quantitation of the method employed were recorded as violative residues.

Regulatory Guidance:

Domestic Component (applies to both assignments):

For products containing illegal residues, FDA districts were to pursue seizures or issue Warning Letters depending on the circumstances of the lot samples (e.g., could manufacturer/distributor be located as many samples were internet purchases, were lots of seizeable size?). In several cases recalls of violative lots occurred.

Import Component (applies to DFP # 03-01):

Violative product entries were both to be detained and recommended for Detention Without Physical Examination (which would automatically detain future entries of the product unless an acceptable lab analysis for a particular entry was provided to FDA establishing entry compliance).

Results (includes all ginseng samples collected and analyzed in FYs 2003 and 2004):

Import Samples:

Sixty-two import samples were collected and analyzed during FY 2003 and FY 2004 from the following countries of origin (country of origin as recorded on Sample Collection Record in FACTS): People's Republic of China or PROC (32); Canada (15); Hong Kong (6); Republic of Korea (3); Italy (2); and one each from Indonesia, Netherlands, Switzerland, and Taiwan.
Of the 62 total import samples, 37 samples (60%) were classified as Lab Class 3 (Adverse Findings or "Violative"), from the following countries of origin: PROC (17), Canada (11), Hong Kong (6), and Republic of Korea (3).
The balance of the samples (25) had laboratory classifications that were non-violative.
Thirty-one of the samples were documented in the collection records as consisting of Panax, Asian, Chinese, or Korean Ginseng (i.e., "Panax ginseng"). Twenty of these samples (65%) were violative.
Five of the samples were documented in the collection records as consisting of American Ginseng (i.e., "Panax quinquefolius"). Three of these samples (60%) were violative.
Of the remaining 14 violative samples, one was documented in the collection records as consisting of "North American Ginseng;" a second as "Canadian Ginseng," and the remaining 12 did not record a species or type of ginseng.
Of the remaining 12 non-violative samples, one was documented as "Kirin" ginseng, one as "Oriental" ginseng, and 10 did not specifically record a species or type of ginseng.

Attachment 2 is a table of FY 2003 and 2004 import ginseng violative samples listing country of origin, sample number, product description (species of ginseng and form of product), and the violative residue(s) reported for each.

Attachment 3 is a table of the FY 2003 and 2004 non-violative import ginseng samples listing country of origin, sample number, and product description (species of ginseng and form of product).

Import Violative Residue Findings:

For the 37 violative samples, 23 different violative residues were reported (see below).
The three most common violative residues reported were Pentachloroaniline, Quintozene, and Pentachlorobenzene.
Violative samples had up to 10 violative residues reported.
Twenty-eight samples had three or more violative residues reported.

The violative residues reported, the number of violative occurrences, and the range found (ppm) included:

Import Violative Residue Findings
Violative Residue	# Occurrences (of 37 Violative Samples)	Range (ppm)
Pentachloroaniline	27	0.03-5.15
Quintozene	27	0.03-16.84
Pentachlorobenzene	24	0.01-3.04
Tecnazene	17	0.01-1.05
Alpha BHC	15	0.17-1.76
Delta BHC	15	0.05-5.12
Hexachlorobenzene (HCB)	15	0.03-1.94
Pentachlorophenyl Methyl Sulfide	11	0.02-1.47
DDE p,p'	8	0.02-0.67
2,3,5,6-Tetrachloroaniline	6	0.01- 0.14
DCPA	6	0.02-0.18
Difenoconazole	6	0.02-0.29
Beta BHC	5	0.34-0.59
DDT p,p'	5	0.03-0.09
Lindane	4	0.70-1.27
Procymidone	4	0.16-2.17
Heptachlor Epoxide	2	0.01-0.09
DDT o,p'	1	0.03
Dieldrin	1	0.14
Endosulfan I	1	0.16
Endosulfan II	1	0.08
Endosulfan Sulfate	1	0.02
Pentachlorobenzonitrile	1	0.03

Domestic Samples:

Seventy-nine domestic ginseng samples were collected and analyzed in FYs 2003 and 2004. Forty-five of the samples (57%) were classified as Lab Class 3 (Adverse Findings or "Violative"). The balance of the samples (34) had laboratory classifications that were non-violative.
Sixty-seven of the samples were dietary supplement capsules, five were ginseng fluid extracts, four were raw material ginseng powder, and three were teas.
Forty-nine samples were documented in the collection records as consisting of Panax, Chinese, or Korean Ginseng (i.e., "Panax ginseng"). Twenty-six of these samples (53%) were violative.
Twenty-eight samples were documented in the collection records as consisting of American Ginseng (i.e., "Panax quinquefolius"). Eighteen of these were found "violative" (64%).
One violative sample was recorded as containing "Tienchi ginseng" (i.e., Panax pseudoginseng Wall. var. notoginseng), and one non-violative sample recorded as containing "Panax and Siberian Ginseng Root."

Attachment 4 is a table of FY 2003 and 2004 domestic ginseng violative samples listing sample number, product description (species of ginseng and form of product), and the violative residue(s) reported for each.

Attachment 5 is a table of the FY 2003 and 2004 non-violative domestic ginseng samples listing sample number and product description (species of ginseng and form of product).

Domestic Violative Residue Findings:

For the 45 violative samples, 23 different violative residues were reported.
The three most common violative residues were Quintozene, Pentachloroaniline, and Pentachlorobenzene.
Samples had up to 11 different violative residues reported.
Thirty-two samples had three or more violative residues.

The violative residues reported, the number of violative occurrences, and the range found (ppm) included:

Domestic Violative Residue Findings
Violative Residue	# of Occurrences (of 45 Violative Samples)	Range (ppm)
Quintozene	36	0.02-15.1
Pentachloroaniline	33	0.03- 2.23
Pentachlorobenzene	30	0.02-1.71
Hexachlorobenzene (HCB)	22	0.01-1.75
Tecnazene	19	0.01-0.82
Alpha BHC	18	0.02-1.59
Pentachlorophenyl Methyl Sulfide	16	0.02-0.75
Delta BHC	15	0.03-3.06
Beta BHC	12	0.03-1.80
2,3,5,6-Tetrachloroaniline	9	0.04-0.20
DCPA	8	0.02-0.21
Lindane	6	0.54-1.42
DDE p,p'	5	0.01-2.95
DDT p,p'	3	0.04-1.21
Heptachlor Expoxide	3	0.05-0.16
1,2,3,5-Tetrachlorobenzene	2	0.02-0.03
DDT o,p'	2	0.04-0.43
Procymidone	2	0.39-1.69
Difenconazole	1	0.08
Fluvalinate	1	0.04
Oxidixyl	1	0.93
Pentachlorobenzonitrile	1	0.19
Piperonyl Butoxide	1	2.62

Comparison of Results: Import vs. Domestic Samples:

Violation rates were similar, 60% for imports and 57% for domestic ginseng samples.
Of the violative samples, the percentage with three or more violative residues was similar, 76% for imports and 71% for domestic ginseng samples.
Residue profiles for the violative import and violative domestic ginseng samples were similar; import and domestic samples each collectively had 23 violative residues, 19 of which were common to both import and domestic samples.
The top three residue occurrences for violative import and domestic samples were the same (Quintozene, Pentachloroaniline, and Pentachlorobenzene).

Attachment 6 is a table listing the violative pesticides reported in the ginseng dietary supplement samples and the action, use, or chemical characterization of each.

Attachments 1-6

Attachment 1: EPA Tolerances and FDA Enforcement Levels for Chlorinated and Phosphorus Pesticides in Ginseng
(Includes Root Vegetable Group Tolerances Applicable to Ginseng)
Pesticide	EPA Tolerance/FDA Enforcement Level
2,4D	1.0/0.1 ppm (diethylamine salt from water hyacinth control/Diethylamine Salt Negligible Residue Tolerance)
BHC (Benzene Hexachloride)	0.05 ppm (FDA Enforcement Level 40 CFR 108.34, total of individual isomers alpha, beta, delta, gamma)
Boscalid	0.70 ppm
Carfentrazone-ethyl	0.10 ppm
Clethodim	1.0 ppm
Chlorothalonil	0.1 ppm
(Zeta-)Cypermethryn	0.1 ppm
DCPA	2.0, however tolerance established effective 8/20/04; no DCPA tolerance in effect for the samples reported
Diazinon	0.75 ppm
Fenhexamid	0.3 ppm
Imidacloprid	0.40 ppm
Iprodione	2.00 ppm (4.00 ppm dried ginseng)
Myclobutanil	0.03 ppm
Lindane	0.50 ppm (FDA Enforcement Level 40 CFR 108.34)
(S-)Metolachlor Acetamid (Metolachlor related compound)	0.30 ppm
Pyraclostrobin	0.40 ppm
Sulfosate	0.15 ppm
Thiamrthoxam	0.02 ppm
Zoximide	0.06 ppm (Regional Tolerance)

Attachment 2: FY 2003 and 2004 Import Ginseng Violative Samples
Entry Country of Origin	Sample #	Product Description	Violative Residue(s) Reported
PROC (Mainland China)	101407	Panax Ginseng 20% Extract (powder)	Difenococazole, Pentachloroaniline
PROC	201066	Dried Ginseng Root	Alpha BHC, Delta BHC, Pentachloroaniline, HCB, Quintozene, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide
PROC	203768	Chinese Ginseng	Total BHCs (Alpha, Beta, Delta Lindane), HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Qunitozene, Tecnazene
PROC	203770	Chinese White Ginseng	DCPA
PROC	206376	Ginseng Root	DCPA, DDE p,p', DDT p,p', Heptachlor epoxide, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene
PROC	209080	Panax Ginseng Red Root Powder	Delta BHC, HCB, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene
PROC	211498	Korean Ginseng	DDE p,p', Procymidone, Quntozene
PROC	211740	Panax Ginseng Powder Extract 80% (Tea Use)	Difenoconazole
PROC	215775	Chinese Ginseng	Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlororphenyl Methyl Sulfide, Quintozene, Tecnazene
PROC	217387	White Chinese Ginseng Fiber (Panax C.A. Meyer)	Pentachlorobenzene, Quintozene
PROC	217388	White Chinese Ginseng Fiber (Panax C.A. Meyer)	Alpha BHC, Pentachloroaniline, Pentachlorobenzene, Pentachlororphenyl Methyl Sulfide, Quintozene,Tecnazene
PROC	226588	Panax Ginseng White Powder	2,3,5,6-Tetrachloroaniline, Alpha BHC, Delta BHC, HCB, Pentachlororaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene
PROC	228598	Ginsen Extract	Difenoconazole, Pentachloroaniline, Procymidone
PROC	240400	Panax Ginseng Berry Extract Powder PE 60%	Difenoconazole, Pentachloroaniline
PROC	244119	Ginseng	Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
PROC	292884	Ginseng Powder	Pentachloroaniline
PROC	295484	Ginseng Leaves	Difenoconazole
Canada	205466	Ginseng (North American cultivated ginseng)	DDE, p,p', DDT p,p', Dieldrin, Heptachlor Epoxide, Lindane, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Tecnazene
Canada	209753	Dried Cultivated American Ginseng Root	Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
Canada	220370	Ginseng Capsules(Canadian ginseng)	DCPA, DDE, p,p', DDT o,p', DDT p,p', Pentachloroaniline, Pentachlorobenzene, Quintozene
Canada	220402	Red Chinese Ginseng Tablets	2,3,5,6-Tetrachloroaniline, HCB, Pentachlororaniline, Pentachlorobenzene, Quintozene, Tecnazene.
Canada	220553	Softgel Ginseng Capsules (Panax C.A. Meyer)	2,3,5,6-Tetrachloroaniline, Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
Canada	220789	Korean Panax Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
Canada	224422	Korean Red Ginseng Capsules	Procymidone
Canada	224494	Korean Panax Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Beta BHC, Delta BHC, HCB, Lindane, Pentachloroaniline, Pentachlororbenzene, Quintozene, Tecnazene
Canada	235553	Korean Panax Ginseng Capsules	Alpha BHC, Delta BHC, HCB, Lindane, Pentachloroaniline, Pentachlororbenzene, Quintozene
Canada	243392	Ginseng Root	DCPA, DDE p,p', Pentachloroaniline, Pentachlorobenzene, Pentachlororbenzonitrile, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
Canada	288423	Ginseng Powder	DDE p'p', DDT p,p'
Hong Kong	200583	Panax Ginseng Root	DCPA, DDE p,p', DDT p,p', Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
Hong Kong	203774	Sliced China Red Ginseng	Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
Hong Kong	206978	Ginseng	DCPA, DDE p,p', Pentachlroraniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene.
Hong Kong	208283	American Ginseng	Alpha BHC, Beta BHC, Delta BHC, Quintozene
Hong Kong	208287	American Ginseng	Alpha BHC, Beta BHC, Delta BHC, Pentachloroaniline, Quintozene, Tecnazene
Hong Kong	246702	Radix Ginseng	2,3,5,6-Tetrachloroaniline, Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlororphenyl Methyl Sulfide, Quintozene, Tecnazene
Republic of Korea	201359	Panax Ginseng	Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene
Republic of Korea	207036	Red Ginseng	Difenoconazole, Endosulfan I, Endosulfan II, Endosulfan Sulfate, Pentachlorophenyl Methyl Sulfide, Procymidone, Quintozene
Republic of Korea	288107	Ginseng Powder	HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene

Attachment 3: FY 2003 and 2004 Import Ginseng Samples - Non Violative
Entry Country of Origin	Sample #	Product Description
PROC (Mainland China)	155786	Panax Ginseng Herb Tea Bags (Made in China, DI Sample)
PROC	197912	American Ginseng Seeds
PROC	199633	Panax Ginseng Extract
PROC	202672	Ginseng
PROC	213436	Kirin Ginseng Loose
PROC	216176	Ginseng Oriental Root
PROC	217390	Red Chinese Ginseng Fiber (Panax C.A. Meyer)
PROC	217396	White Chinese Ginseng Root & Prong (Panax C.A. Meyer)
PROC	217399	Red Chinese Ginseng Root & Prong (Panax C.A. Meyer)
PROC	220657	Panax Ginseng Powder Extract
PROC	244282	Ginseng Extract
PROC	247741	Panax Ginseng
PROC	266194	Panax Ginseng
PROC	275957	Siberian Ginseng
PROC	282923	American Ginseng Root
Canada	202565	Ginseng Powder
Canada	220618	Korean Ginseng Tablets (Induced Sample¹)
Canada	220810	Panax Korean Ginseng Capsules (Induced Sample¹)
Canada	224183	Panex Ginseng Capsules (Induced Sample¹)
Italy	274302	Ginseng
Italy	296097	Ginseng Dry Extract
Indonesia	195797	Powdered Ginseng (Domestic-Import sample; bulk product sampled @ Herbal Powers, Chicago IL)
Netherlands	261602	Ginseng Root
Switzerland	233364	Ginseng Powder
Taiwan (Republic of China)	285187	Ginseng Capsules

¹Induced sample - product viewed on Canadian dealer's website and ordered undercover for mail delivery.

Attachment 4: Domestic Ginseng Violations FY 2003 and FY 2004
Sample #	Product	Violative Residue(s) Reported
101406	Korean Ginseng Capsules	Difenconazole, Pentachloroaniline
173969	Korean Red Ginseng Capsules	Procymidone, Pentachloroaniline
173987	Chinese Red Ginseng Capsules	1,2,3,5-Tetrachlorobenzene, 2,3,5,6-Tetrachloroaniline, Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene.
173988	Panax Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene.
186354	Time Release Korean Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Beta BHC, Delta BHC, HCB, Lindane, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
197112	American Ginseng Capsules	Pentachlorobenzene
197113	Korean Ginseng Capsules	Alpha BHC, HCB, Pentachloroaniline, Pentachlororbenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
197115	Chinese Red Ginseng Capsules	HCB, Pentachloroaniline, Pentachlorbenzene, Pentachlorophenyl Methyl Sulfide, Piperonyl Butoxide, Quintozene, Tecnazene
197120	American Ginseng Capsules	DCPA, Lindane, Pentachloroaniline, Pentachlororbenzene, Pentachlororphenyl Methyl Sulfide, Quintozene
200488	American Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
208993	Pure Korean Ginseng Capsules	1,2,3,5-Tetrachlorobenzene, Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
208994	American Ginseng Capsules	DCPA, Pentachloroaniline, Pentaclorobenzene, Quintozene
208995	American Ginseng Capsules	DCPA, Heptachlor Epoxide, Lindane, Pentachloroaniline, Pentachlorobenzene, Pentachlororphenyl Methyl Sulfide, Quintozene
293284	Panax Ginseng Powder Extract (Raw Material Imported from PROC)	Pentachloroaniline, Procymidone
293285	White Ginseng Powder (Raw Material Imported from PROC)	Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
214794	American Ginseng Capsules	Alpha BHC, DCPA, DDE p,p', Delta BHC, HCB, Pentachlorobenzene, Pentachloroaniline, Quintozene, Tecnazene
217962	Korean White Ginseng Capsules	Alpha BHC, HCB, Quintozene
218850	Panax Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
218978	American Ginseng Capsules	DDE p,p', DDT o,p', DDT p,p', Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
220667	Panax Ginseng Softgel Capsules	Fluvalinate
220946	Korean Panaz Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Beta BHC, Delta BHC, DDE p'p', HCB, Pentachloroaniline, Quintozene, Tecnazene
220948	Korean White Ginseng Root Capsules	Quintozene
220949	Korean ginseng Root Capsules	Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene,
220951	Korean Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Beta BHC, Delta BHC, HCB, Lindane, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
226211	American Ginseng Root Capsules	Quintozene, Pentachlorobenzene
227252	American Ginseng Capsules	Pentachlorobenzene
227254	Korean Ginseng Root Capsules	Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene
240412	American Ginseng Capsules	Oxadixyl, Pentachloroaniline, Quintozene
240613	Korean Ginseng Capsules	Alpha BHC, Beta BHC, Delta BHC, Pentachloroaniline, Pentachlorophenyl Methyl Sulfide, Quintozene
240618	American Ginseng Root Capsules	Alpha BHC, HCB, Lindane, Pentachlorobenzne, Quintozene, Tecnzene
248496	American Ginseng Capsules	DCPA, HCB, Heptachlor Epoxide, Pentachloroaniline, Pentachlorobenzene, Pentachlorobenzonitrile, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
256505	American Ginseng Capsules	Pentachloroaniline
256506	Korean Panax Ginseng Capsules	Quintozene
257853	Korean Ginseng Root Capsules	Quintozene
257854	Korean Ginseng Root Capsules	Quintozene
257857	Korean Ginseng Root (raw material ginseng and finished product capsules)	HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene
287692	American Ginseng Capsules	Alpha BHC, Beta BHC, Delta BHC, DCPA, DDE p,p', DDT p,p', HCB, Pentachloroaniline, Pentachlorobenzene, Quintozene, Tecnazene
284192	American Ginseng Capsules	DCPA, Heptachlor Epoxide, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnzene
290461	Korean ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Quintozene
290462	Korean Ginseng Capsules	2,3,5,6-Tetrachloroaniline, Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachloroaniline, Pentachlorobenzene, Pentachlorophenyl Methyl Sulfide, Quintozene, Tecnazene
290703	American Ginseng Capsules	Lindane, Pentachloroaniline, Pentachlorobenzene, Quintozene
292008	American Ginseng Powder	DCPA, DDE p,p', DDT o,p', DDT p,p', Pentachloroaniline, Pentachlorobenzene
292079	American Ginseng Fluid Extract Herbal Supplement	Pentachloroaniline
297875	Tienchi Ginseng Capsules	HCB, Pentachlorobenzene, Quintozene
297876	Chinese Red Ginseng Capsules	Alpha BHC, Beta BHC, Delta BHC, HCB, Pentachlorophenyl Methyl Sulfide, Quintozene

Attachment 5: FY 2003 and 2004 Domestic Ginseng Samples - Non Violative
Sample #	Product Description
115145	American ginseng Capsules
141627	Korean Ginseng Capsules
155785	American Ginseng Root (Glycerine Base, Fluid)
155787	Ginseng Capsules (Oriental Ginseng Root (Panex Ginseng) 50 mg & Siberian Ginseng Root and active base 350 mg)
173727	North American Ginseng Capsules
173986	Panax Ginseng Tea Bags
173989	Chinese Red Panax Root Ginseng Extractum (Fluid)
186355	Korean ginseng Capsules
197114	Chinese Red Ginseng Capsules
197116	American Ginseng Instant Tea
197117	Red Panax Ginseng Extractum (Fluid) (collected as a domestic sample but labeled "Product of China")
197118	Korean Ginseng Root Extract Tonic for Tea
197119	American Ginseng Liquid Extract
214795	Korean Ginseng Capsules
217960	Red Chinese Ginseng Capsules
217961	Korean Ginseng Capsules
220943	Korean Ginseng Capsules
220947	Korean Ginseng Extract Capsules
220950	Korean Ginseng Root Capsules
220952	American Ginseng Extract (Fluid)
226208	Korean Ginseng Capsules
226209	Korean Ginseng Capsules (collected as a domestic sample but labeled "Product of England")
226210	Korean Ginseng Capsules (collected as a domestic sample but labeled "Product of England")
227253	Korean Ginseng Root Capsules
227255	Panax Ginseng Extract Capsules
227404	American Ginseng Capsules
229276	Chinese Red Panax Ginseng Softgels
240615	American Ginseng Root Capsules
248498	Asian Chinese Red Ginseng Capsules
254481	American Ginseng Capsules
257852	Korean Ginseng (Raw Material)
257855	Korean Ginseng Capsules
287919	American Ginseng Capsules
289415	Korean Ginseng Capsules

Attachment 6: Violative Residues Detected - Action, Use, or Chemical Characterization
Residue	Action/Use/Characterization
1,2,3,5-Tetrachlorobenzene	Insecticide/Chemical Intermediate for Herbicides and Defoiliants
2,3,5,6-Tetrachloroaniline	Metabolite of Tecnazene
Alpha BHC	Insecticide
Beta BHC	Insecticide
DCPA	Herbicide
DDE p,p'	Insecticide
DDT o,p'	Insecticide
DDT p,p'	Insecticide
Delta BHC	Insecticide
Difenoconazole	Fungicide
Dieldrin	Insecticide
Endosulfan I	Insecticide
Endosulfan II	Insecticide
Endosulfan Sulfate	Metabolite of Endosulfan (Insecticide)
Fluvalinante	Insecticide
Heptachlor Epoxide	Insecticide
Hexachlorobenzene (HCB)	Impurity of Quintozene
Lindane	Insecticide
Oxidixyl	Fungicide
Pentachloroaniline	Metabolite of Quintozene
Pentachlorobenzene	Impurity of Quintozene
Pentachlorobenzonitrile	Metabolite of Chlorothalonil (Fungicide)
Pentachlorophenyl Methyl Sulfide	Metabolite of Quintozene
Piperonyl Butoxide	Insecticide
Procymidone	Fungicide
Quintozene (PCNB)	Fungicide
Tecnazene (TCNB)	Plant Growth Regulator

Pesticides, Metals, Chemical Contaminants & Natural Toxins

FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by dav August 1, 2008

Ginseng Dietary Supplements Special Survey (CFSAN Assignments and Field Regulatory Monitoring for FY 2003 and FY 2004)

Background:

DFP Assignment 03-01 "Pesticides in Imported Bulk Ginseng and Domestic Ginseng Dietary Supplements" Issued October 4, 2002.

Import Component:

Domestic Component:

DFP Assignment 04-25, "Sample Collection and Analysis of Dietary Supplement Ginseng for Pesticides, High Priority," Issued June 8, 2004.

Domestic Component:

Import Component:

Analytical Guidance for Ginseng Analyses (both assignments):

Attachment 1 contains a listing of EPA tolerances and FDA enforcement levels for chlorinated and phosphorus pesticides in ginseng.

Regulatory Guidance:

Domestic Component (applies to both assignments):

Import Component (applies to DFP # 03-01):

Results (includes all ginseng samples collected and analyzed in FYs 2003 and 2004):

Import Samples:

Attachment 2 is a table of FY 2003 and 2004 import ginseng violative samples listing country of origin, sample number, product description (species of ginseng and form of product), and the violative residue(s) reported for each.

Attachment 3 is a table of the FY 2003 and 2004 non-violative import ginseng samples listing country of origin, sample number, and product description (species of ginseng and form of product).

Import Violative Residue Findings:

Domestic Samples:

Attachment 4 is a table of FY 2003 and 2004 domestic ginseng violative samples listing sample number, product description (species of ginseng and form of product), and the violative residue(s) reported for each.

Attachment 5 is a table of the FY 2003 and 2004 non-violative domestic ginseng samples listing sample number and product description (species of ginseng and form of product).

Domestic Violative Residue Findings:

Comparison of Results: Import vs. Domestic Samples:

Attachment 6 is a table listing the violative pesticides reported in the ginseng dietary supplement samples and the action, use, or chemical characterization of each.

Attachments 1-6

Ginseng Dietary Supplements Special Survey
(CFSAN Assignments and Field Regulatory Monitoring
for FY 2003 and FY 2004)