U. S. Food and Drug Administration
Industry Activities Staff Booklet
August 2000


ACTION LEVELS FOR POISONOUS OR DELETERIOUS SUBSTANCES IN HUMAN FOOD AND ANIMAL FEED

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

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
Commodity Action Level (ppb) Reference
Animal Feeds
    Corn and peanut products intended for finishing (i.e., feedlot) beef cattle 300 CPG 683.100
    Cottonseed meal intended for beef, cattle, swine, or poultry (regardless of age or breeding status) 300 CPG 683.100
    Corn and peanut products intended for finishing swine of 100 pounds or greater 200 CPG 683.100
    Corn and peanut products intended for breeding beef cattle, breeding swine, or mature poultry 100 CPG 683.100
    Corn, peanut products, and other animal feeds and feed ingredients but excluding cottonseed meal, intended for immature animals 20 CPG 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 known 20 CPG 683.100
Brazil nuts 20 CPG 570.200
Foods 20 CPG 555.400
Milk 0.5 (aflatoxin M1) CPG 527.400
Peanuts and Peanut products 20 CPG 570.375
Pistachio nuts 20 CPG 570.500


ALDRIN & DIELDRIN
Commoditya Action Level (ppm) Reference
Alfalfa 0.03 CPG 575.100
Animal feed, processed 0.03 CPG 575.100
Artichokes 0.05 CPG 575.100
Asparagus 0.03 CPG 575.100
Bananas 0.02 CPG 575.100
Beets (garden and sugar) 0.1 CPG 575.100
Beet tops (garden and sugar) 0.05 CPG 575.100
Broccoli 0.03 CPG 575.100
Brussel sprouts 0.03 CPG 575.100
Bulb vegetables 0.1 CPG 575.100
Cabbage0.03 CPG 575.100
Carrots 0.1 CPG 575.100
Cauliflower0.03 CPG 575.100
Cereal grains (except buckwheat, millet, teosinte, and wild rice) 0.02 CPG 575.100
Celery0.03 CPG 575.100
Clover0.03 CPG 575.100
Collards0.05 CPG 575.100
Cowpea hay0.03 CPG 575.100
Cucumbers0.1 CPG 575.100
Eggplant0.05 CPG 575.100
Eggs0.03 CPG 575.100
Endive (escarole)0.05 CPG 575.100
Fats and oils (animal feed) 0.3 CPG 575.100
Figs0.05 CPG 575.100
Fish0.3 (edible portion) CPG 575.100
Forage, fodder and straw of cereal grains (except those of millet, teosinte, and wild rice) 0.03 CPG 575.100
Grapefruit0.02 CPG 575.100
Hay0.03 CPG 575.100
Horseradish0.1 CPG 575.100
Kale0.05 CPG 575.100
Kohlrabi0.05 CPG 575.100
Legume vegetables (except guar, jackbeans, lablab beans, and lentils) 0.05 CPG 575.100
Lemons0.02 CPG 575.100
Lespedeza0.03 CPG 575.100
Lettuce0.03 CPG 575.100
Limes0.02 CPG 575.100
Mangoes0.03 CPG 575.100
Melons0.1 CPG 575.100
Milk0.3 (fat basis) CPG 575.100
Mustard greens0.05 CPG 575.100
Oranges0.02 CPG 575.100
Parsnips0.1 CPG 575.100
Pea hay0.03 CPG 575.100
Peaches0.02 CPG 575.100
Peanuts0.05 CPG 575.100
Peanut hay0.03 CPG 575.100
Peppers0.05 CPG 575.100
Pimentos0.05 CPG 575.100
Pineapple0.03 CPG 575.100
Pome fruits (except crabapples and loquats) 0.03 CPG 575.100
Potatoes0.1 CPG 575.100
Radishes0.1 CPG 575.100
Radish tops0.03 CPG 575.100
Rutabagas0.1 CPG 575.100
Salsify roots0.1 CPG 575.100
Salsify tops0.05 CPG 575.100
Small fruits and berries0.05 CPG 575.100
Soybean hay0.03 CPG 575.100
Spinach0.05 CPG 575.100
Squash0.1 CPG 575.100
Stone fruits (except Chickasaw, Damson, Japanese plums, and peaches) 0.03 CPG 575.100
Sugarbeet pulp (animal feed)0.1 CPG 575.100
Sweet potatoes0.1 CPG 575.100
Swiss chard0.05 CPG 575.100
Tangerines0.02 CPG 575.100
Tomatoes0.05 CPG 575.100
Turnips0.1 CPG 575.100
Turnip tops0.05 CPG 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)
Commoditya Action Level (ppm) Reference
Animal feed, processed0.05 CPG 575.100
Apples0.05 CPG 575.100
Asparagus0.05 CPG 575.100
Avocadoes0.05 CPG 575.100
Beans0.05 CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, and rape greens) 0.05 CPG 575.100
Celery0.05 CPG 575.100
Carrots0.3 CPG 575.100
Cereal grains (except buckwheat, millet, popcorn, teosinte, and wild rice) 0.05 CPG 575.100
Citrus fruits0.05 CPG 575.100
Cocoa beans0.5 CPG 575.100
Cucurbit vegetables (except Balsam pears, Chinese waxgourds, gherkins, and gourds) 0.05 CPG 575.100
Eggplant0.05 CPG 575.100
Eggs0.05 CPG 575.100
Endive0.05 CPG 575.100
Figs0.05 CPG 575.100
Frog legs (edible portion)0.3 CPG 575.100
Guavas0.05 CPG 575.100
Hays (animal feed)0.05 CPG 575.100
Lettuce0.05 CPG 575.100
Mangoes0.05 CPG 575.100
Milk0.3 (fat basis) CPG 575.100
Okra0.05 CPG 575.100
Onions0.05 CPG 575.100
Paprika1.0 CPG 575.100
Pears0.05 CPG 575.100
Peas0.05 CPG 575.100
Pecans0.05 CPG 575.100
Peppers0.05 CPG 575.100
Pineapples0.05 CPG 575.100
Quinces0.05 CPG 575.100
Rabbits0.3 (fat basis)b CPG 575.100
Root and tuber vegetables (except carrots)0.05 CPG 575.100
Small fruits and berries0.05 CPG 575.100
Spinach0.05 CPG 575.100
Swiss chard0.05 CPG 575.100
Stone fruits (except Chickasaw, Damson, and Japanese plums) 0.05 CPG 575.100
Tomatoes0.05 CPG 575.100
Turnip Greens0.05 CPG 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.


CADMIUM
Commodity Action 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
Commoditya Action Level (ppm) Reference
Animal fat, rendered0.3 CPG 575.100
Animal feed, processed0.1 CPG 575.100
Asparagus0.1 CPG 575.100
Bananas0.1 CPG 575.100
Beans0.1 CPG 575.100
Beets (with or without tops)0.1 CPG 575.100
Beet greens0.1 CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, Chinese mustard cabbage, and rape greens) 0.1 CPG 575.100
Carrots0.1 CPG 575.100
Celery0.1 CPG 575.100
Citrus fruits0.1 CPG 575.100
Corn0.1 CPG 575.100
Cucumbers0.1 CPG 575.100
Eggplant0.1 CPG 575.100
Fish0.3 (edible portion) CPG 575.100
Lettuce0.1 CPG 575.100
Melons0.1 CPG 575.100
Okra0.1 CPG 575.100
Onions0.1 CPG 575.100
Papayas0.1 CPG 575.100
Parsnips0.1 CPG 575.100
Peanuts0.1 CPG 575.100
Peas0.1 CPG 575.100
Peppers0.1 CPG 575.100
Pineapple0.1 CPG 575.100
Pome fruits (except crabapples and loquats)0.1 CPG 575.100
Potatoes0.1 CPG 575.100
Radishes (with or without tops)0.1 CPG 575.100
Radish tops0.1 CPG 575.100
Rutabagas (with or without tops)0.1 CPG 575.100
Rutabaga tops0.1 CPG 575.100
Small fruits and berries (except cranberries, currants, elderberries, gooseberries, and olallie berries) 0.1 CPG 575.100
Spinach0.1 CPG 575.100
Squash0.1 CPG 575.100
Stone fruits (except Chicasaw, Damson, and Japanese plums) 0.1 CPG 575.100
Sweet potatoes0.1 CPG 575.100
Swiss chard0.1 CPG 575.100
Tomatoes0.1 CPG 575.100
Turnips (with or without tops)0.1 CPG 575.100
Turnip greens0.1 CPG 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)
Commodity Action Level (ppm) Reference
Crabmeat 0.4 (edible portion) CPG 575.100
Fish and shellfish 0.3 (edible portion) CPG 575.100


DICOFOL
(1,1-Bis(p-chlorophenyl)-2,2,2,-trichloroethanol)
(Previously listed as "Kelthane," the trade name for dicofol)

Commodity Action Level (ppm) Reference
Animal feed, processed 0.5CPG 575.100


DDT, DDE, & TDE
Commoditya Action Level (ppm) Reference
Animal feed, processed0.5 CPG 575.100
Artichokes0.5 CPG 575.100
Asparagus0.5 CPG 575.100
Avocadoes0.2 CPG 575.100
Beets (roots and tops)0.2 CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, Chinese mustard cabbage, and rape greens) 0.5 CPG 575.100
Carrots3 CPG 575.100
Cereal grains (except buckwheat, fresh sweetcorn, millet, popcorn, teosinte, and wild rice) 0.5 CPG 575.100
Celery0.5 CPG 575.100
Citrus fruits0.1 CPG 575.100
Cocoa beans1 CPG 575.100
Corn, fresh sweet0.1 CPG 575.100
Cottonseed0.1 CPG 575.100
Cucumbers0.1 CPG 575.100
Eggplant0.1 CPG 575.100
Eggs0.5 CPG 575.100
Endive (escarole)0.5 CPG 575.100
Fish5 (edible portion) CPG 575.100
Grapes0.05 CPG 575.100
Guavas0.2 CPG 575.100
Hay0.5 CPG 575.100
Hops0.1 CPG 575.100
Legume vegetables (except guar, jackbeans, lablab beans, and lentils) 0.2 CPG 575.100
Lettuce0.5 CPG 575.100
Mangoes0.2 CPG 575.100
Melons0.1 CPG 575.100
Milk1.25 (fat basis) CPG 575.100
Mushrooms0.5 CPG 575.100
Okra0.2 CPG 575.100
Onions (dry bulb)0.2 CPG 575.100
Papayas0.2 CPG 575.100
Parsnips (roots and tops)0.2 CPG 575.100
Peanuts0.2 CPG 575.100
Peppermint hay0.5 CPG 575.100
Peppermint oil1 CPG 575.100
Peppers0.1 CPG 575.100
Pineapples0.2 CPG 575.100
Pome fruits (except crabapples and loquats)0.1 CPG 575.100
Potatoes1 CPG 575.100
Radishes (roots and tops)0.2 CPG 575.100
Rutabagas (roots and tops)0.2 CPG 575.100
Small fruits and berries (except elderberries, grapes and olallie berries) 0.1 CPG 575.100
Soybean oil (crude)1 CPG 575.100
Spearmint hay0.5 CPG 575.100
Spearmint oil1 CPG 575.100
Spinach0.5 CPG 575.100
Squash0.1 CPG 575.100
Stone fruits (except Chickasaw, Damson, and Japanese plums) 0.2 CPG 575.100
Sweet potatoes1 CPG 575.100
Swiss chard0.5 CPG 575.100
Tomatoes0.05 CPG 575.100
Tomato pomance0.5 CPG 575.100
Turnips (roots and tops)0.2 CPG 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)
Commodity Action Level (ppb) Reference
Barley malt 10 CPG 578.500
Malt beverages 5 CPG 510.600


ETHYLENE DIBROMIDE (EDB)
Commoditya Action Level (ppb) Reference
Grain products, intermediate (milled), must be cooked prior to consumption 150 CPG 575.100
Grain products, ready-to-eat (cooked), require no cooking prior to consumption 30 CPG 575.100
Honey, ready-to-eat (will not undergo further processing prior to consumption) 30 CPG 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
Commoditya Action Level (ppm) Reference
Animal feed, processed 0.01 CPG 575.100
Artichokes 0.01 CPG 575.100
Asparagus 0.01 CPG 575.100
Brassica (cole) leafy vegetables 0.01 CPG 575.100
Bulb vegetables 0.01 CPG 575.100
Cereal grains 0.01 CPG 575.100
Citrus fruits 0.01 CPG 575.100
Cottonseed 0.02 CPG 575.100
Cucurbit vegetables 0.02 CPG 575.100
Eggs 0.01 CPG 575.100
Figs 0.01 CPG 575.100
Fish 0.3 (edible portion) CPG 575.100
Fruiting vegetables 0.01 CPG 575.100
Grass forage, fodder, and hay 0.01 CPG 575.100
Leafy vegetables (except Brassica) 0.01 CPG 575.100
Legume vegetables 0.01 CPG 575.100
Milk 0.1 (fat basis) CPG 575.100
Nongrass animal feeds 0.01 CPG 575.100
Peanuts 0.01 CPG 575.100
Pineapple 0.02 CPG 575.100
Pome fruits 0.01 CPG 575.100
Rabbit 0.2 (fat basis)b CPG 575.100
Root and tuber vegetables 0.01 CPG 575.100
Salsify tops 0.01 CPG 575.100
Small fruits and berries 0.01 CPG 575.100
Stone fruits 0.01 CPG 575.100
Sugarcane 0.01 CPG 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
Commodity Action Level (µg/ml leaching solution) Reference
Ceramicware
    Flatware (average of 6 units) 3.0 CPG 545.450
    Small hollowware (other than cups and mugs) (any 1 of 6 units) 2.0 CPG 545.450
    Large hollowware (other than pitchers) (any 1 of 6 units) 1.0 CPG 545.450
    Cups and mugs (any 1 of 6 units) 0.5 CPG 545.450
    Pitchers (any 1 of 6 units) 0.5 CPG 545.450
Silver-plated hollowware
    Product intended for use by adults (average of 6 units) 7 CPG 545.500
    Product intended for use by infants and children (any 1 of 6 units) 0.5 CPG 545.500


LINDANE
Commodity Action Level (ppm) Reference
Animal feed, processed 0.1 CPG 575.100
Artichokes 0.5 CPG 575.100
Barley 0.1 CPG 575.100
Beans 0.5 CPG 575.100
Citrus fruit(a) 0.5 CPG 575.100
Cocoa beans, whole raw bean 0.5 CPG 575.100
Corn, fresh sweet 0.5 CPG 575.100
Corn0.1 CPG 575.100
Eggs 0.5 CPG 575.100
Endive 0.5 CPG 575.100
Figs 0.5 CPG 575.100
Hay 0.1 CPG 575.100
Milk 0.3 (fat basis) CPG 575.100
Oats 0.1 CPG 575.100
Peas 0.5 CPG 575.100
Rice 0.1 CPG 575.100
Root vegetablesa,b 0.5 CPG 575.100
Rye 0.1 CPG 575.100
Small fruitsa,b 0.5 CPG 575.100
Sorghum (milo) 0.1 CPG 575.100
Turnip greens 0.5 CPG 575.100
Wheat 0.1 CPG 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
Commodity Action Level Reference
Fish, shellfish, crustaceans, other aquatic animals (fresh, frozen or processed) 1 ppm methyl mercury in edible portion CPG 540.600
Wheat (pink kernels only) 1 ppm on pink kernels and an average of 10 or more pink kernels/500 g CPG 578.400


METHYL ALCOHOL
Commodity Action Level (%) Reference
Imported brandy 0.35 CPG 510.200


MIREX

Commodity Action Level (ppm) Reference
Fish 0.1 (edible portion) CPG 575.100


N-NITROSAMINES
Commodity Action Level (ppb) Reference
Rubber baby bottle nipples 10 CPG 500.450


PARALYTIC SHELLFISH TOXIN
Commodity Action Level Reference
Clams, mussels, oysters
(fresh, frozen, and canned)		 80 µg/100 g meat CPG 540.250


POLYCHLORINATED BIPHENYLS (PCB'S)
Commodity Action Level (ppm) Reference
Red meat 3 (fat basis) CPG 565.200


Industry Activities Staff Booklet: August 2000

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