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U.S. Department of Health and Human Services

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Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed

Contains nonbinding recommendations

August 2000

 

This booklet lists action levels established by the Food and Drug Administration (FDA) for poisonous or deleterious substances in human food and animal feed. Action levels for poisonous or deleterious substances are established by the FDA to control levels of contaminants in human food and animal feed.

Action levels and tolerances are established based on the unavoidability of the poisonous or deleterious substances and do not represent permissible levels of contaminantion where it is avoidable. The blending of a food or feed containing a substance in excess of an action level or tolerance with another food or feed is not permitted, and the final product resulting from blending is unlawful, regardless of the level of the contaminant.

Action levels and tolerances represent limits at or above which FDA will take legal action to remove products from the market. Where no established action level or tolerance exists, FDA may take legal action against the product at the minimal detectable level of the contaminant.

The action levels are established and revised according to criteria specified in Title 21, Code of Federal Regulations, Parts 109 and 509 and are revoked when a regulation establishing a tolerance for the same substance and use becomes effective.

This booklet is arranged by substance, with the applicable human food and animal feed products listed therein. An index is located at the front of this booklet.

This list is current as of August, 2000. Notices will be published in the Federal Register as new action levels are established or as existing action levels are revised or revoked. It is the responsibility of the user of the list to keep up to date on changes in the action levels.

Single copies of this booklet are available from:

Industry Activities Staff (HFS-565)
CFSAN/FDA
200 C Street, S.W.
Washington, DC 20204
Telephone (202) 205-5251
*
(*See updated contact information below.)

 

Copies of the Compliance Policy Guides (CPG) referenced in the action level list may be purchased from:

National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
Telephone (703) 605-6000
Order number: PB97 915 400

FDA's Compliance Policy Guides are accessible via the Internet:

http://www.fda.gov

 

Substance

Aflatoxin
Aldrin & Dieldrin
Benzene Hexachloride
Cadmium
Chlordane
Chlordecone (Kepone)
Dicofol (Kelthane)
DDT, DDE, TDE
Dimethylnitrosamine (Nitrosodimethylamine)
Ethylene Dibromide (EDB)
Heptachlor & Heptachlor Epoxide
Lead
Lindane
Mercury
Methyl Alcohol
Mirex
N-Nitrosamines
Paralytic Shellfish Toxin
Polychlorinated Biphenyls (PCBs)
 

 

AFLATOXIN
CommodityAction Level (ppb)Reference
Animal Feeds
    Corn and peanut products intended for finishing (i.e., feedlot) beef cattle300CPG 683.100
    Cottonseed meal intended for beef, cattle, swine, or poultry (regardless of age or breeding status)300CPG 683.100
    Corn and peanut products intended for finishing swine of 100 pounds or greater200CPG 683.100
    Corn and peanut products intended for breeding beef cattle, breeding swine, or mature poultry100CPG 683.100
    Corn, peanut products, and other animal feeds and feed ingredients but excluding cottonseed meal, intended for immature animals20CPG 683.100
    Corn, peanut products, cottonseed meal, and other animal feed ingredients intended for dairy animals, for animal species or uses not specified above, or when the intended use is not known20CPG 683.100
Brazil nuts20CPG 570.200
Foods20CPG 555.400
Milk0.5 (aflatoxin M1)CPG 527.400
Peanuts and Peanut products20CPG 570.375
Pistachio nuts20CPG 570.500

 

ALDRIN & DIELDRIN
CommodityaAction Level (ppm)Reference
Alfalfa0.03CPG 575.100
Animal feed, processed0.03CPG 575.100
Artichokes0.05CPG 575.100
Asparagus0.03CPG 575.100
Bananas0.02CPG 575.100
Beets (garden and sugar)0.1CPG 575.100
Beet tops (garden and sugar)0.05CPG 575.100
Broccoli0.03CPG 575.100
Brussel sprouts0.03CPG 575.100
Bulb vegetables0.1CPG 575.100
Cabbage0.03CPG 575.100
Carrots0.1CPG 575.100
Cauliflower0.03CPG 575.100
Cereal grains (except buckwheat, millet, teosinte, and wild rice)0.02CPG 575.100
Celery0.03CPG 575.100
Clover0.03CPG 575.100
Collards0.05CPG 575.100
Cowpea hay0.03CPG 575.100
Cucumbers0.1CPG 575.100
Eggplant0.05CPG 575.100
Eggs0.03CPG 575.100
Endive (escarole)0.05CPG 575.100
Fats and oils (animal feed)0.3CPG 575.100
Figs0.05CPG 575.100
Fish0.3 (edible portion)CPG 575.100
Forage, fodder and straw of cereal grains (except those of millet, teosinte, and wild rice)0.03CPG 575.100
Grapefruit0.02CPG 575.100
Hay0.03CPG 575.100
Horseradish0.1CPG 575.100
Kale0.05CPG 575.100
Kohlrabi0.05CPG 575.100
Legume vegetables (except guar, jackbeans, lablab beans, and lentils)0.05CPG 575.100
Lemons0.02CPG 575.100
Lespedeza0.03CPG 575.100
Lettuce0.03CPG 575.100
Limes0.02CPG 575.100
Mangoes0.03CPG 575.100
Melons0.1CPG 575.100
Milk0.3 (fat basis)CPG 575.100
Mustard greens0.05CPG 575.100
Oranges0.02CPG 575.100
Parsnips0.1CPG 575.100
Pea hay0.03CPG 575.100
Peaches0.02CPG 575.100
Peanuts0.05CPG 575.100
Peanut hay0.03CPG 575.100
Peppers0.05CPG 575.100
Pimentos0.05CPG 575.100
Pineapple0.03CPG 575.100
Pome fruits (except crabapples and loquats)0.03CPG 575.100
Potatoes0.1CPG 575.100
Radishes0.1CPG 575.100
Radish tops0.03CPG 575.100
Rutabagas0.1CPG 575.100
Salsify roots0.1CPG 575.100
Salsify tops0.05CPG 575.100
Small fruits and berries0.05CPG 575.100
Soybean hay0.03CPG 575.100
Spinach0.05CPG 575.100
Squash0.1CPG 575.100
Stone fruits (except Chickasaw, Damson, Japanese plums, and peaches)0.03CPG 575.100
Sugarbeet pulp (animal feed)0.1CPG 575.100
Sweet potatoes0.1CPG 575.100
Swiss chard0.05CPG 575.100
Tangerines0.02CPG 575.100
Tomatoes0.05CPG 575.100
Turnips0.1CPG 575.100
Turnip tops0.05CPG 575.100
(a) Action levels for crop groups cover all commodities specified in 40 CFR 108.34(f), unless an exception is noted.

 

BENZENE HEXACHLORIDE (BHC)
CommodityaAction Level (ppm)Reference
Animal feed, processed0.05CPG 575.100
Apples0.05CPG 575.100
Asparagus0.05CPG 575.100
Avocadoes0.05CPG 575.100
Beans0.05CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, and rape greens)0.05CPG 575.100
Celery0.05CPG 575.100
Carrots0.3CPG 575.100
Cereal grains (except buckwheat, millet, popcorn, teosinte, and wild rice)0.05CPG 575.100
Citrus fruits0.05CPG 575.100
Cocoa beans0.5CPG 575.100
Cucurbit vegetables (except Balsam pears, Chinese waxgourds, gherkins, and gourds)0.05CPG 575.100
Eggplant0.05CPG 575.100
Eggs0.05CPG 575.100
Endive0.05CPG 575.100
Figs0.05CPG 575.100
Frog legs (edible portion)0.3CPG 575.100
Guavas0.05CPG 575.100
Hays (animal feed)0.05CPG 575.100
Lettuce0.05CPG 575.100
Mangoes0.05CPG 575.100
Milk0.3 (fat basis)CPG 575.100
Okra0.05CPG 575.100
Onions0.05CPG 575.100
Paprika1.0CPG 575.100
Pears0.05CPG 575.100
Peas0.05CPG 575.100
Pecans0.05CPG 575.100
Peppers0.05CPG 575.100
Pineapples0.05CPG 575.100
Quinces0.05CPG 575.100
Rabbits0.3 (fat basis)bCPG 575.100
Root and tuber vegetables (except carrots)0.05CPG 575.100
Small fruits and berries0.05CPG 575.100
Spinach0.05CPG 575.100
Swiss chard0.05CPG 575.100
Stone fruits (except Chickasaw, Damson, and Japanese plums)0.05CPG 575.100
Tomatoes0.05CPG 575.100
Turnip Greens0.05CPG 575.100

The figures listed are for residues of total BHC. However, in adding amounts of individual isomers, do not count alpha, gamma, or delta BHC at a level below 0.02 ppm in milk and rabbits, and 0.01 ppm for all other commodities listed. Do not count beta BHC at a level below 0.05 ppm for milk and rabbits, and 0.02 ppm for all other commodities listed.

(a) Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), unless an exception is noted.

(b) For rabbits that contain insufficient fat to conduct an analysis on a fat basis, analyze the rabbits on a whole product basis (edible portion) and use 0.1 ppm, the limit of determination, as the action level.


 

 

CADMIUM
CommodityAction Level (µg/mL leaching solution)Reference
Pottery (ceramics)
    Flatware (average of 6 units)0.5CPG 545.400
    Small hollowware (any 1 of 6 units)0.5CPG 545.400
    Large hollowware (any 1 of 6 units)0.25CPG 545.400

 

CHLORDANE
CommodityaAction Level (ppm)Reference
Animal fat, rendered0.3CPG 575.100
Animal feed, processed0.1CPG 575.100
Asparagus0.1CPG 575.100
Bananas0.1CPG 575.100
Beans0.1CPG 575.100
Beets (with or without tops)0.1CPG 575.100
Beet greens0.1CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, Chinese mustard cabbage, and rape greens)0.1CPG 575.100
Carrots0.1CPG 575.100
Celery0.1CPG 575.100
Citrus fruits0.1CPG 575.100
Corn0.1CPG 575.100
Cucumbers0.1CPG 575.100
Eggplant0.1CPG 575.100
Fish0.3 (edible portion)CPG 575.100
Lettuce0.1CPG 575.100
Melons0.1CPG 575.100
Okra0.1CPG 575.100
Onions0.1CPG 575.100
Papayas0.1CPG 575.100
Parsnips0.1CPG 575.100
Peanuts0.1CPG 575.100
Peas0.1CPG 575.100
Peppers0.1CPG 575.100
Pineapple0.1CPG 575.100
Pome fruits (except crabapples and loquats)0.1CPG 575.100
Potatoes0.1CPG 575.100
Radishes (with or without tops)0.1CPG 575.100
Radish tops0.1CPG 575.100
Rutabagas (with or without tops)0.1CPG 575.100
Rutabaga tops0.1CPG 575.100
Small fruits and berries (except cranberries, currants, elderberries, gooseberries, and olallie berries)0.1CPG 575.100
Spinach0.1CPG 575.100
Squash0.1CPG 575.100
Stone fruits (except Chicasaw, Damson, and Japanese plums)0.1CPG 575.100
Sweet potatoes0.1CPG 575.100
Swiss chard0.1CPG 575.100
Tomatoes0.1CPG 575.100
Turnips (with or without tops)0.1CPG 575.100
Turnip greens0.1CPG 575.100

The listed action levels are for residues of chlordane, including cis- and trans-chlordane, cis- and trans-nonachlor, oxychlordane, alpha-, beta-, and gamma-chlordene, and chlordene. Levels of individual components must be quantitated at 0.02 ppm or above and confirmed in order to be added into the "chlordane" total value.

The GLC pattern of the residue determines which reference standard(s) will be used for quantitation. If the residue pattern matches that of technical chlordane, quantitate against a technical chlordane reference standard. If the residue consists of identifiable individual components (i.e., cis- and trans-chlordane, cis- and trans-nonachlor, oxychlordane, alpha-, beta-, and gamma-chlordene, and chlordene), quantitate individual components against their respective standards. Sum individual values to obtain the total "chlordane" level. Do not include levels of heptachlor epoxide in the summation.

(a) Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), unless an exception is noted.

 

CHLORDECONE
(Decachlorooctahydro-1,3,4-methano-2H-cyclobuta(cd)pentalen-2-one)
(Previously listed as "Kepone," the trade name for chlordecone)
CommodityAction Level (ppm)Reference
Crabmeat0.4 (edible portion)CPG 575.100
Fish and shellfish0.3 (edible portion)CPG 575.100

 

DICOFOL
(1,1-Bis(p-chlorophenyl)-2,2,2,-trichloroethanol)
(Previously listed as "Kelthane," the trade name for dicofol)
CommodityAction Level (ppm)Reference
Animal feed, processed0.5CPG 575.100

 

DDT, DDE, & TDE
CommodityaAction Level (ppm)Reference
Animal feed, processed0.5CPG 575.100
Artichokes0.5CPG 575.100
Asparagus0.5CPG 575.100
Avocadoes0.2CPG 575.100
Beets (roots and tops)0.2CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, Chinese mustard cabbage, and rape greens)0.5CPG 575.100
Carrots3CPG 575.100
Cereal grains (except buckwheat, fresh sweetcorn, millet, popcorn, teosinte, and wild rice)0.5CPG 575.100
Celery0.5CPG 575.100
Citrus fruits0.1CPG 575.100
Cocoa beans1CPG 575.100
Corn, fresh sweet0.1CPG 575.100
Cottonseed0.1CPG 575.100
Cucumbers0.1CPG 575.100
Eggplant0.1CPG 575.100
Eggs0.5CPG 575.100
Endive (escarole)0.5CPG 575.100
Fish5 (edible portion)CPG 575.100
Grapes0.05CPG 575.100
Guavas0.2CPG 575.100
Hay0.5CPG 575.100
Hops0.1CPG 575.100
Legume vegetables (except guar, jackbeans, lablab beans, and lentils)0.2CPG 575.100
Lettuce0.5CPG 575.100
Mangoes0.2CPG 575.100
Melons0.1CPG 575.100
Milk1.25 (fat basis)CPG 575.100
Mushrooms0.5CPG 575.100
Okra0.2CPG 575.100
Onions (dry bulb)0.2CPG 575.100
Papayas0.2CPG 575.100
Parsnips (roots and tops)0.2CPG 575.100
Peanuts0.2CPG 575.100
Peppermint hay0.5CPG 575.100
Peppermint oil1CPG 575.100
Peppers0.1CPG 575.100
Pineapples0.2CPG 575.100
Pome fruits (except crabapples and loquats)0.1CPG 575.100
Potatoes1CPG 575.100
Radishes (roots and tops)0.2CPG 575.100
Rutabagas (roots and tops)0.2CPG 575.100
Small fruits and berries (except elderberries, grapes and olallie berries)0.1CPG 575.100
Soybean oil (crude)1CPG 575.100
Spearmint hay0.5CPG 575.100
Spearmint oil1CPG 575.100
Spinach0.5CPG 575.100
Squash0.1CPG 575.100
Stone fruits (except Chickasaw, Damson, and Japanese plums)0.2CPG 575.100
Sweet potatoes1CPG 575.100
Swiss chard0.5CPG 575.100
Tomatoes0.05CPG 575.100
Tomato pomance0.5CPG 575.100
Turnips (roots and tops)0.2CPG 575.100

The listed action levels are for residues of the above pesticides individually, or in combination. However, in adding amounts of DDT, DDE and TDE, do not count any of the three found below 0.02 ppm for non-fatty food, and 0.2 ppm for fish, eggs, and grains.

(a) Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), unless an exception is noted.

 

DIMETHYLNITROSAMINE (NITROSODIMETHYLAMINE)
CommodityAction Level (ppb)Reference
Barley malt10CPG 578.500
Malt beverages5CPG 510.600


 

 

ETHYLENE DIBROMIDE (EDB)
CommodityaAction Level (ppb)Reference
Grain products, intermediate (milled), must be cooked prior to consumption150CPG 575.100
Grain products, ready-to-eat (cooked), require no cooking prior to consumption30CPG 575.100
Honey, ready-to-eat (will not undergo further processing prior to consumption)30CPG 575.100
Fish0.3 (edible portion)CPG 575.100
Fruiting vegetables0.01CPG 575.100
Grass forage, fodder, and hay0.01CPG 575.100
Leafy vegetables (except Brassica)0.01CPG 575.100
Legume vegetables0.01CPG 575.100
Milk0.1 (fat basis)CPG 575.100
Nongrass animal feeds0.01CPG 575.100
Peanuts0.01CPG 575.100
Pineapple0.02CPG 575.100
(a) Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f).


 

 

HEPTACHLOR AND HEPTACHLOR EPOXIDE
CommodityaAction Level (ppm)Reference
Animal feed, processed0.01CPG 575.100
Artichokes0.01CPG 575.100
Asparagus0.01CPG 575.100
Brassica (cole) leafy vegetables0.01CPG 575.100
Bulb vegetables0.01CPG 575.100
Cereal grains0.01CPG 575.100
Citrus fruits0.01CPG 575.100
Cottonseed0.02CPG 575.100
Cucurbit vegetables0.02CPG 575.100
Eggs0.01CPG 575.100
Figs0.01CPG 575.100
Fish0.3 (edible portion)CPG 575.100
Fruiting vegetables0.01CPG 575.100
Grass forage, fodder, and hay0.01CPG 575.100
Leafy vegetables (except Brassica)0.01CPG 575.100
Legume vegetables0.01CPG 575.100
Milk0.1 (fat basis)CPG 575.100
Nongrass animal feeds0.01CPG 575.100
Peanuts0.01CPG 575.100
Pineapple0.02CPG 575.100
Pome fruits0.01CPG 575.100
Rabbit0.2 (fat basis)bCPG 575.100
Root and tuber vegetables0.01CPG 575.100
Salsify tops0.01CPG 575.100
Small fruits and berries0.01CPG 575.100
Stone fruits0.01CPG 575.100
Sugarcane0.01CPG 575.100

The listed figures are for residues of the pesticide and its metabolite individually or in combination. However, do not count heptachlor or heptachlor epoxide found at a level below 0.1 ppm for fish, 0.05 ppm (fat basis) for milk, and 0.01 ppm for nonfatty foods.

(a) Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f).

(b) For rabbits that contain insufficient fat to conduct an analysis on a fat basis, analyze the rabbits on a whole product basis (edible portion) and, assuming 10 percent fat content, use 0.02 ppm as the action level.

 

LEAD
CommodityAction Level (µg/ml leaching solution)Reference
Ceramicware
    Flatware (average of 6 units)3.0CPG 545.450
    Small hollowware (other than cups and mugs) (any 1 of 6 units)2.0CPG 545.450
    Large hollowware (other than pitchers) (any 1 of 6 units)1.0CPG 545.450
    Cups and mugs (any 1 of 6 units)0.5CPG 545.450
    Pitchers (any 1 of 6 units)0.5CPG 545.450
 
Silver-plated hollowware
    Product intended for use by adults (average of 6 units)7CPG 545.500
    Product intended for use by infants and children (any 1 of 6 units)0.5CPG 545.500

 

LINDANE
CommodityAction Level (ppm)Reference
Animal feed, processed0.1CPG 575.100
Artichokes0.5CPG 575.100
Barley0.1CPG 575.100
Beans0.5CPG 575.100
Citrus fruit(a)0.5CPG 575.100
Cocoa beans, whole raw bean0.5CPG 575.100
Corn, fresh sweet0.5CPG 575.100
Corn0.1CPG 575.100
Eggs0.5CPG 575.100
Endive0.5CPG 575.100
Figs0.5CPG 575.100
Hay0.1CPG 575.100
Milk0.3 (fat basis)CPG 575.100
Oats0.1CPG 575.100
Peas0.5CPG 575.100
Rice0.1CPG 575.100
Root vegetablesa,b0.5CPG 575.100
Rye0.1CPG 575.100
Small fruitsa,b0.5CPG 575.100
Sorghum (milo)0.1CPG 575.100
Turnip greens0.5CPG 575.100
Wheat0.1CPG 575.100

(a) Refer to 40 CFR 180.34(f) for commodities covered by this food group.

(b) Other than those commodities specified in 40 CFR 180.133.


 

 

MERCURY
CommodityAction LevelReference
Fish, shellfish, crustaceans, other aquatic animals (fresh, frozen or processed)1 ppm methyl mercury in edible portionCPG 540.600
Wheat (pink kernels only)1 ppm on pink kernels and an average of 10 or more pink kernels/500 gCPG 578.400


 

 

METHYL ALCOHOL
CommodityAction Level (%)Reference
Imported brandy0.35CPG 510.200


 

 

MIREX
CommodityAction Level (ppm)Reference
Fish0.1 (edible portion)CPG 575.100

 

N-NITROSAMINES
CommodityAction Level (ppb)Reference
Rubber baby bottle nipples10CPG 500.450

 

PARALYTIC SHELLFISH TOXIN
CommodityAction LevelReference
Clams, mussels, oysters
(fresh, frozen, and canned)
80 µg/100 g meatCPG 540.250

 

POLYCHLORINATED BIPHENYLS (PCB'S)
CommodityAction Level (ppm)Reference
Red meat3 (fat basis)CPG 565.200

 


For questions regarding this document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2023).

FDA Compliance Policy Guides Manual

 

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