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          Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal FeedSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed
					
		
		August 2000


	 

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    PrintDocket Number:
		    FDA-2020-D-1956
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


**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 contamination 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:

(*See updated contact information below.)

FDA's Compliance Policy Guides are accessible via the Internet: https://www.fda.gov/.

Substance

AflatoxinAldrin & DieldrinBenzene HexachlorideCadmiumChlordaneChlordecone (Kepone)Dicofol (Kelthane)DDT, DDE, TDEDimethylnitrosamine (Nitrosodimethylamine)Ethylene Dibromide (EDB)Heptachlor & Heptachlor EpoxideLeadLindaneMercuryMethyl AlcoholMirexN-NitrosaminesParalytic Shellfish ToxinPolychlorinated Biphenyls (PCBs)

AFLATOXIN

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

**ALDRIN & DIELDRIN**

Commoditya
			Action Level (ppm)
			ReferenceAlfalfa
			0.03
			CPG 575.100Animal feed, processed
			0.03
			CPG 575.100Artichokes
			0.05
			CPG 575.100Asparagus
			0.03
			CPG 575.100Bananas
			0.02
			CPG 575.100Beets (garden and sugar)
			0.1
			CPG 575.100Beet tops (garden and sugar)
			0.05
			CPG 575.100Broccoli
			0.03
			CPG 575.100Brussel sprouts
			0.03
			CPG 575.100Bulb vegetables
			0.1
			CPG 575.100Cabbage
			0.03
			CPG 575.100Carrots
			0.1
			CPG 575.100Cauliflower
			0.03
			CPG 575.100Cereal grains (except buckwheat, millet, teosinte, and wild rice)
			0.02
			CPG 575.100Celery
			0.03
			CPG 575.100Clover
			0.03
			CPG 575.100Collards
			0.05
			CPG 575.100Cowpea hay
			0.03
			CPG 575.100Cucumbers
			0.1
			CPG 575.100Eggplant
			0.05
			CPG 575.100Eggs
			0.03
			CPG 575.100Endive (escarole)
			0.05
			CPG 575.100Fats and oils (animal feed)
			0.3
			CPG 575.100Figs
			0.05
			CPG 575.100Fish
			0.3 (edible portion)
			CPG 575.100Forage, fodder and straw of cereal grains (except those of millet, teosinte, and wild rice)
			0.03
			CPG 575.100Grapefruit
			0.02
			CPG 575.100Hay
			0.03
			CPG 575.100Horseradish
			0.1
			CPG 575.100Kale
			0.05
			CPG 575.100Kohlrabi
			0.05
			CPG 575.100Legume vegetables (except guar, jackbeans, lablab beans, and lentils)
			0.05
			CPG 575.100Lemons
			0.02
			CPG 575.100Lespedeza
			0.03
			CPG 575.100Lettuce
			0.03
			CPG 575.100Limes
			0.02
			CPG 575.100Mangoes
			0.03
			CPG 575.100Melons
			0.1
			CPG 575.100Milk
			0.3 (fat basis)
			CPG 575.100Mustard greens
			0.05
			CPG 575.100Oranges
			0.02
			CPG 575.100Parsnips
			0.1
			CPG 575.100Pea
			0.03
			CPG 575.100Peaches
			0.02
			CPG 575.100Peanuts
			0.05
			CPG 575.100Peanut hay
			0.03
			CPG 575.100Peppers
			0.05
			CPG 575.100Pimentos
			0.05
			CPG 575.100Pineapple
			0.03
			CPG 575.100Pome fruits (except crabapples and loquats)
			0.03
			CPG 575.100Potatoes
			0.1
			CPG 575.100Radishes
			0.1
			CPG 575.100Radish tops
			0.03
			CPG 575.100Rutabagas
			0.1
			CPG 575.100Salsify roots
			0.1
			CPG 575.100Salsify tops
			0.05
			CPG 575.100Small fruits and berries
			0.05
			CPG 575.100Soybean hay
			0.03
			CPG 575.100Spinach
			0.05
			CPG 575.100Squash
			0.1
			CPG 575.100Stone fruits (except Chickasaw, Damson, Japanese plums, and peaches)
			0.03
			CPG 575.100Sugarbeet pulp (animal feed)
			0.1
			CPG 575.100Sweet potatoes
			0.1
			CPG 575.100Swiss chard
			0.05
			CPG 575.100Tangerines
			0.02
			CPG 575.100Tomatoes
			0.05
			CPG 575.100Turnips
			0.1
			CPG 575.100Turnip tops
			0.05
			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)
			ReferenceAnimal feed, processed
			0.05
			CPG 575.100Apples
			0.05
			CPG 575.100Asparagus
			0.05
			CPG 575.100Avocadoes
			0.05
			CPG 575.100Beans
			0.05
			CPG 575.100*Brassica* (cole) leafy vegetables (except broccoli raab, and rape greens)
			0.05
			CPG 575.100Celery
			0.05
			CPG 575.100Carrots
			0.3
			CPG 575.100Cereal grains (except buckwheat, millet, popcorn, teosinte, and wild rice)
			0.05
			CPG 575.100Citrus fruits
			0.05
			CPG 575.100Cocoa beans
			0.5
			CPG 575.100Cucurbit vegetables (except Balsam pears, Chinese waxgourds, gherkins, and gourds)
			0.05
			CPG 575.100Eggplant
			0.05
			CPG 575.100Eggs
			0.05
			CPG 575.100Endive
			0.05
			CPG 575.100Figs
			0.05
			CPG 575.100Frog legs (edible portion)
			0.3
			CPG 575.100Guavas
			0.05
			CPG 575.100Hay
			0.05
			CPG 575.100Lettuce
			0.05
			CPG 575.100Mangoes
			0.05
			CPG 575.100Milk
			0.3 (fat basis)
			CPG 575.100Okra
			0.05
			CPG 575.100Onions
			0.05
			CPG 575.100Paprika
			1.0
			CPG 575.100Pears
			0.05
			CPG 575.100Peas
			0.05
			CPG 575.100Pecans
			0.05
			CPG 575.100Peppers
			0.05
			CPG 575.100Pineapples
			0.05
			CPG 575.100Quinces
			0.05
			CPG 575.100Rabbits
			0.3 (fat basis)b
			CPG 575.100Root and tuber vegetables (except carrots)
			0.05
			CPG 575.100Small fruits and berries
			0.05
			CPG 575.100Spinach
			0.05
			CPG 575.100Swiss chard
			0.05
			CPG 575.100Stone fruits (except Chickasaw, Damson, and Japanese plums)
			0.05
			CPG 575.100Tomatoes
			0.05
			CPG 575.100Turnip Greens
			0.05
			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.

(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**

Commodity
			Action Level (μg/mL leaching solution)
			ReferencePottery (ceramics)Flatware (average of 6 units)
			0.5
			CPG 545.400Small hollowware (any 1 of 6 units)
			0.5
			CPG 545.400Large hollowware (any 1 of 6 units)
			0.25
			CPG 545.400

**CHLORDANE**

Commoditya
			Action Level (ppm)
			ReferenceAnimal fat, rendered
			0.3
			CPG 575.100Animal feed, processed
			0.1
			CPG 575.100Asparagus
			0.1
			CPG 575.100Bananas
			0.1
			CPG 575.100Beans
			0.1
			CPG 575.100Beets (with or without tops)
			0.1
			CPG 575.100Beet greens
			0.1
			CPG 575.100*Brassica* (cole) leafy vegetables (except broccoli raab, Chinese mustard cabbage, and rape greens)
			0.1
			CPG 575.100Carrots
			0.1
			CPG 575.100Celery
			0.1
			CPG 575.100Citrus fruits
			0.1
			CPG 575.100Corn
			0.1
			CPG 575.100Cucumbers
			0.1
			CPG 575.100Eggplant
			0.1
			CPG 575.100Fish
			0.3 (edible portion)
			CPG 575.100Lettuce
			0.1
			CPG 575.100Melons
			0.1
			CPG 575.100Okra
			0.1
			CPG 575.100Onions
			0.1
			CPG 575.100Papayas
			0.1
			CPG 575.100Parsnips
			0.1
			CPG 575.100Peanuts
			0.1
			CPG 575.100Peas
			0.1
			CPG 575.100Peppers
			0.1
			CPG 575.100Pineapple
			0.1
			CPG 575.100Pome fruits (except crabapples and loquats)
			0.1
			CPG 575.100Potatoes
			0.1
			CPG 575.100Radishes
			0.1
			CPG 575.100Radish tops
			0.1
			CPG 575.100Rutabagas (with or without tops)
			0.1
			CPG 575.100Rutabaga tops
			0.1
			CPG 575.100Small fruits and berries (except cranberries, currants, elderberries, gooseberries, and olallie berries)
			0.1
			CPG 575.100Spinach
			0.1
			CPG 575.100Squash
			0.1
			CPG 575.100Stone fruits (except Chicasaw, Damson, and Japanese plums)
			0.1
			CPG 575.100Sweet potatoes
			0.1
			CPG 575.100Swiss chard
			0.1
			CPG 575.100Tomatoes
			0.1
			CPG 575.100Turnips (with or without tops)
			0.1
			CPG 575.100Turnip greens
			0.1
			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 (trade name Kepone)**

Commodity
			Action Level (ppm)
			ReferenceCrabmeat
			0.4
			CPG 575.100Fish
			0.3
			CPG 575.100

**DICOFOL**

**(trade name 1,1-Bis(p-chlorophenyl)-2,2,2,-trichloroethanol)
(Previously listed as "Kelthane,")**

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

**DDT, DDE, & TDE**

Commoditya
			Action Level (ppm)
			ReferenceAnimal feed, processed
			0.5
			CPG 575.100Artichokes
			0.5
			CPG 575.100Asparagus
			0.5
			CPG 575.100Avocadoes
			0.2
			CPG 575.100Beets (roots and tops)
			0.2
			CPG 575.100*Brassica* (cole) leafy vegetables (except broccoli raab, Chinese mustard cabbage, and rape greens)
			0.5
			CPG 575.100Carrots
			3
			CPG 575.100Cereal grains (except buckwheat, fresh sweetcorn, millet, popcorn, teosinte, and wild rice)
			0.5
			CPG 575.100Celery
			0.5
			CPG 575.100Citrus fruits
			0.1
			CPG 575.100Cocoa beans
			1
			CPG 575.100Corn, fresh sweet
			0.1
			CPG 575.100Cottonseed
			0.1
			CPG 575.100Cucumbers
			0.1
			CPG 575.100Eggplant
			0.1
			CPG 575.100Eggs
			0.5
			CPG 575.100Endive (escarole)
			0.5
			CPG 575.100Fish
			5 (edible portion)
			CPG 575.100Grapes
			0.05
			CPG 575.100Guavas
			0.2
			CPG 575.100Hay
			0.5
			CPG 575.100Hops
			0.1
			CPG 575.100Legume vegetables (except guar, jackbeans, lablab beans, and lentils)
			0.2
			CPG 575.100Lettuce
			0.5
			CPG 575.100Mangoes
			0.2
			CPG 575.100Melons
			0.1
			CPG 575.100Milk
			1.25 (fat basis)
			CPG 575.100Mushrooms
			0.5
			CPG 575.100Okra
			0.2
			CPG 575.100Onions (dry bulb)
			0.2
			CPG 575.100Papayas
			0.2
			CPG 575.100Parsnips (roots and tops)
			0.2
			CPG 575.100Peanuts
			0.2
			CPG 575.100Peppermint hay
			0.5
			CPG 575.100Peppermint oil
			1
			CPG 575.100Peppers
			0.1
			CPG 575.100Pineapples
			0.2
			CPG 575.100Pome fruits (except crabapples and loquats)
			0.1
			CPG 575.100Potatoes
			1
			CPG 575.100Radishes (roots and tops)
			0.2
			CPG 575.100Rutabagas (roots and tops)
			0.2
			CPG 575.100Small fruits and berries (except elderberries, grapes and olallie berries)
			0.1
			CPG 575.100Soybean oil (crude)
			1
			CPG 575.100Spearmint hay
			0.5
			CPG 575.100Spearmint oil
			1
			CPG 575.100Spinach
			0.5
			CPG 575.100Squash
			0.1
			CPG 575.100Stone fruits (except Chickasaw, Damson, and Japanese plums)
			0.2
			CPG 575.100Sweet potatoes
			1
			CPG 575.100Swiss chard
			0.5
			CPG 575.100Tomatoes
			0.05
			CPG 575.100Tomato pomance
			0.5
			CPG 575.100Turnips (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)
			ReferenceBarley malt
			10
			CPG 578.500Malt beverages
			5
			CPG 510.600

**ETHYLENE DIBROMIDE (EDB)**

Commodity
			Action Level (ppb)
			ReferenceGrain productsIntermediate (milled)
			(must be cooked prior to consumption)

			Examples: flour, cake mix, pancake mix,
			corn meal, grits, quick grits, oatmeal,
			instant oatmeal, hominy, brown and serve rolls,
			frozen bread dough
			150
			CPG 575.100Ready-to-eat (cooked)
			(require no cooking prior to consumption)

			Examples: bread, cakes, pancakes,
			corn bread, hushpuppies, cooked grits,
			cooked oatmeal, cooked hominy,
			crispy rice cereal, wheat flakes cereal,
			puffed oats, corn oil
			30
			CPG 575.100Honey, ready-to-eat
			(will not undergo further processing prior to consumption)
			30
			CPG 575.100

**HEPTACHLOR AND HEPTACHLOR EPOXIDE**

Commoditya
			Action Level (ppm)
			ReferenceAnimal feed, processed
			0.03
			CPG 575.100Artichokes
			0.05
			CPG 575.100Asparagus
			0.05
			CPG 575.100Beans, except snap beans
			0.05
			CPG 575.100Citrus fruits
			0.05
			CPG 575.100Cucumbers
			0.05
			CPG 575.100Eggs
			0.05
			CPG 575.100Eggplant
			0.03
			CPG 575.100Figs
			0.05
			CPG 575.100Fish (edible portion)
			0.3
			CPG 575.100Hay
			0.03
			CPG 575.100Leafy vegetables
			0.05
			CPG 575.100Melons
			0.05
			CPG 575.100Okra
			0.05
			CPG 575.100Pears
			0.05
			CPG 575.100Pimentos
			0.05
			CPG 575.100Pumpkins
			0.05
			CPG 575.100Quinces
			0.05
			CPG 575.100Rice
			0.3
			CPG 575.100Small fruits a,b
			0.05
			CPG 575.100Stone fruits a,b
			0.05
			CPG 575.100Squash
			0.05
			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) Refer to 40 CFR 180.34(f) for commodities covered by this food group.

(b) Other than those commodities specified in 40 CFR 180.104 and 180.319

**LEAD**

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

**LINDANE**

Commodity
			Action Level (ppm)
			ReferenceAnimal feed, processed
			0.1
			CPG 575.100Artichokes
			0.5
			CPG 575.100Barley
			0.1
			CPG 575.100Beans
			0.5
			CPG 575.100Citrus fruit(a)
			0.5
			CPG 575.100Cocoa beans, whole raw bean
			0.5
			CPG 575.100Corn, fresh sweet
			0.5
			CPG 575.100Corn
			0.1
			CPG 575.100Eggs
			0.5
			CPG 575.100Endive
			0.5
			CPG 575.100Figs
			0.5
			CPG 575.100Hay
			0.1
			CPG 575.100Milk
			0.3 (fat basis)
			CPG 575.100Oats
			0.1
			CPG 575.100Peas
			0.5
			CPG 575.100Rice
			0.1
			CPG 575.100Root vegetablesa,b
			0.5
			CPG 575.100Rye
			0.1
			CPG 575.100Small fruitsa,b
			0.5
			CPG 575.100Sorghum (milo)
			0.1
			CPG 575.100Turnip greens
			0.5
			CPG 575.100Wheat
			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
			ReferenceFish, shellfish, crustaceans, other aquatic animals (fresh, frozen or processed)
			1 ppm methyl mercury in edible portion
			CPG 540.600Wheat (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 (%)
			ReferenceImported brandy
			0.35
			CPG 510.200

**MIREX**

Commodity
			Action Level (ppm)
			ReferenceFish
			0.1 (edible portion)
			CPG 575.100

**N-NITROSAMINES**

Commodity
			Action Level (ppb)
			ReferenceRubber baby bottle nipples
			10
			CPG 500.450

**PARALYTIC SHELLFISH TOXIN**

Commodity
			Action Level
			ReferenceClams, mussels, oysters
			(fresh, frozen, and canned)
			80 μg/100 g meat
			CPG 540.250

**POLYCHLORINATED BIPHENYLS (PCB'S)**

Commodity
			Action Level (ppm)
			ReferenceRed meat
			3 (fat basis)
			CPG 565.200

Related Information

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						All written comments should be identified with this document's docket number: FDA-2020-D-1956.

                                                                                  Content current as of:
      09/20/2018
         
                  
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