FDA 2020 D 1956 0001 - Attachment - 1

GUIDANCE DOCUMENT
Guidance for Industry: Action Levels for Poisonous or

Deleterious Substances in Human Food and Animal
Feed
AUGUST 2000
Final
Docket Number:
FDA-2013-S-0610 (https://www.regulations.gov/docket?D=FDA-2013-S-0610)
Issued by:
(/regulatory-information/search-fda-guidance-documents/guidance-industry-action-levels-
poisonous-or-deleterious-substances-human-food-and-animal-feed)
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:
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
Commodity Action Level (ppb) Reference
Animal Feeds
Corn and peanut products intended for finishing (i.e., feedlot) beef 300 CPG 683.100
cattle
Cottonseed meal intended for beef, cattle, swine, or poultry 300 CPG 683.100
(regardless of age or breeding status
Corn and peanut products intended for finishing swine of 100 200 CPG 683.100
pounds or greater
Corn and peanut products intended for breeding beef cattle, 100 CPG 683.100
breeding swine, or mature poultry
Corn, peanut products, and other animal feeds and feed ingredients 20 CPG 683.100
but excluding cottonseed meal, intended for immature animals
Corn, peanut products, cottonseed meal, and other animal feed 20 CPG 683.100
ingredients intended for dairy animals, for animal species or uses
not specified above, or when the intended use is not known
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
Cabbage 0.03 CPG 575.100
Carrots 0.1 CPG 575.100
Cauliflower 0.03 CPG 575.100
Cereal grains (except buckwheat, millet, teosinte, and wild rice) 0.02 CPG 575.100
Celery 0.03 CPG 575.100
Clover 0.03 CPG 575.100

Collards 0.05 CPG 575.100
Cowpea hay 0.03 CPG 575.100
Cucumbers 0.1 CPG 575.100
Eggplant 0.05 CPG 575.100
Eggs 0.03 CPG 575.100
Endive (escarole) 0.05 CPG 575.100
Fats and oils (animal feed) 0.3 CPG 575.100
Figs 0.05 CPG 575.100
Fish 0.3 (edible portion) CPG 575.100
Forage, fodder and straw of cereal grains (except those of millet, 0.03 CPG 575.100
teosinte, and wild rice)
Grapefruit 0.02 CPG 575.100
Hay 0.03 CPG 575.100
Horseradish 0.1 CPG 575.100
Kale 0.05 CPG 575.100
Kohlrabi 0.05 CPG 575.100
Legume vegetables (except guar, jackbeans, lablab beans, and 0.05 CPG 575.100
lentils)
Lemons 0.02 CPG 575.100
Lespedeza 0.03 CPG 575.100
Lettuce 0.03 CPG 575.100
Limes 0.02 CPG 575.100
Mangoes 0.03 CPG 575.100
Melons 0.1 CPG 575.100

Milk 0.3 (fat basis) CPG 575.100
Mustard greens 0.05 CPG 575.100
Oranges 0.02 CPG 575.100
Parsnips 0.1 CPG 575.100
Pea 0.03 CPG 575.100
Peaches 0.02 CPG 575.100
Peanuts 0.05 CPG 575.100
Peanut hay 0.03 CPG 575.100
Peppers 0.05 CPG 575.100
Pimentos 0.05 CPG 575.100
Pineapple 0.03 CPG 575.100
Pome fruits (except crabapples and loquats) 0.03 CPG 575.100
Potatoes 0.1 CPG 575.100
Radishes 0.1 CPG 575.100
Radish tops 0.03 CPG 575.100
Rutabagas 0.1 CPG 575.100
Salsify roots 0.1 CPG 575.100
Salsify tops 0.05 CPG 575.100
Small fruits and berries 0.05 CPG 575.100
Soybean hay 0.03 CPG 575.100
Spinach 0.05 CPG 575.100
Squash 0.1 CPG 575.100
Stone fruits (except Chickasaw, Damson, Japanese plums, and 0.03 CPG 575.100
peaches)
Sugarbeet pulp (animal feed) 0.1 CPG 575.100
Sweet potatoes 0.1 CPG 575.100
Swiss chard 0.05 CPG 575.100
Tangerines 0.02 CPG 575.100
Tomatoes 0.05 CPG 575.100
Turnips 0.1 CPG 575.100
Turnip 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)
Apples 0.05 CPG 575.100
Avocadoes 0.05 CPG 575.100
Beans 0.05 CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, and rape 0.05 CPG 575.100
greens)
Celery 0.05 CPG 575.100
Cereal grains (except buckwheat, millet, popcorn, teosinte, and wild 0.05 CPG 575.100
rice)
Citrus fruits 0.05 CPG 575.100
Cocoa beans 0.5 CPG 575.100

Cucurbit vegetables (except Balsam pears, Chinese waxgourds, 0.05 CPG 575.100
gherkins, and gourds)
Eggs 0.05 CPG 575.100
Endive 0.05 CPG 575.100
Figs 0.05 CPG 575.100
Frog legs (edible portion) 0.3 CPG 575.100
Guavas 0.05 CPG 575.100
Hay 0.05 CPG 575.100
Okra 0.05 CPG 575.100
Onions 0.05 CPG 575.100
Paprika 1.0 CPG 575.100
Pears 0.05 CPG 575.100
Peas 0.05 CPG 575.100
Pecans 0.05 CPG 575.100
Pineapples 0.05 CPG 575.100
Quinces 0.05 CPG 575.100
Rabbits 0.3 (fat basis)b CPG 575.100
Root and tuber vegetables (except carrots) 0.05 CPG 575.100
Small fruits and berries 0.05 CPG 575.100

Stone fruits (except Chickasaw, Damson, and Japanese plums) 0.05 CPG 575.100
Turnip 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) Reference
Pottery (ceramics)
Flatware (average of 6 units) 0.5 CPG 545.400
Small hollowware (any 1 of 6 units) 0.5 CPG 545.400
Large hollowware (any 1 of 6 units) 0.25 CPG 545.400
CHLORDANE
Animal fat, rendered 0.3 CPG 575.100

Bananas 0.1 CPG 575.100
Beans 0.1 CPG 575.100
Beets (with or without tops) 0.1 CPG 575.100
Beet greens 0.1 CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, Chinese 0.1 CPG 575.100
mustard cabbage, and rape greens)
Celery 0.1 CPG 575.100
Corn 0.1 CPG 575.100
Okra 0.1 CPG 575.100
Onions 0.1 CPG 575.100
Papayas 0.1 CPG 575.100
Parsnips 0.1 CPG 575.100
Peas 0.1 CPG 575.100

Pineapple 0.1 CPG 575.100
Potatoes 0.1 CPG 575.100
Radishes 0.1 CPG 575.100
Radish tops 0.1 CPG 575.100
Rutabagas (with or without tops) 0.1 CPG 575.100
Rutabaga tops 0.1 CPG 575.100
Small fruits and berries (except cranberries, currants, elderberries, 0.1 CPG 575.100
gooseberries, and olallie berries)
Stone fruits (except Chicasaw, Damson, and Japanese plums) 0.1 CPG 575.100
Sweet potatoes 0.1 CPG 575.100
Turnips (with or without tops) 0.1 CPG 575.100
Turnip 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.
noted.
CHLORDECONE
(The trade name for chlordecone is Kepone)
Commodity Action Level (ppm) Reference
Crabmeat 0.4 CPG 575.100
Fish 0.3 CPG 575.100
DICOFOL
(1,1-Bis(p-chlorophenyl)-2,2,2,-trichloroethanol)
(Previously listed as "Kelthane," the trade name for dicofol)
DDT, DDE, & TDE
Avocadoes 0.2 CPG 575.100
Beets (roots and tops) 0.2 CPG 575.100
Brassica (cole) leafy vegetables (except broccoli raab, Chinese 0.5 CPG 575.100
mustard cabbage, and rape greens)
Carrots 3 CPG 575.100

Cereal grains (except buckwheat, fresh sweetcorn, millet, popcorn, 0.5 CPG 575.100
teosinte, and wild rice)
Celery 0.5 CPG 575.100
Cocoa beans 1 CPG 575.100
Corn, fresh sweet 0.1 CPG 575.100
Cottonseed 0.1 CPG 575.100
Eggs 0.5 CPG 575.100
Endive (escarole) 0.5 CPG 575.100
Fish 5 (edible portion) CPG 575.100
Grapes 0.05 CPG 575.100
Guavas 0.2 CPG 575.100
Hay 0.5 CPG 575.100
Hops 0.1 CPG 575.100
Legume vegetables (except guar, jackbeans, lablab beans, and 0.2 CPG 575.100
lentils)
Mushrooms 0.5 CPG 575.100
Okra 0.2 CPG 575.100

Onions (dry bulb) 0.2 CPG 575.100
Papayas 0.2 CPG 575.100
Parsnips (roots and tops) 0.2 CPG 575.100
Peppermint hay 0.5 CPG 575.100
Peppermint oil 1 CPG 575.100
Pineapples 0.2 CPG 575.100
Potatoes 1 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 0.1 CPG 575.100
berries)
Soybean oil (crude) 1 CPG 575.100
Spearmint hay 0.5 CPG 575.100
Spearmint oil 1 CPG 575.100
Stone fruits (except Chickasaw, Damson, and Japanese plums) 0.2 CPG 575.100
Sweet potatoes 1 CPG 575.100
Tomato pomance 0.5 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.
noted.
DIMETHYLNITROSAMINE (NITROSODIMETHYLAMINE)
Barley malt 10 CPG 578.500
Malt beverages 5 CPG 510.600
ETHYLENE DIBROMIDE (EDB)
Grain products
Intermediate (milled) 150 CPG 575.100

(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
Ready-to-eat (cooked) 30 CPG 575.100

(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
Honey, ready-to-eat 30 CPG 575.100

(will not undergo further processing prior to consumption)
HEPTACHLOR AND HEPTACHLOR EPOXIDE
Beans, except snap beans 0.05 CPG 575.100
Eggs 0.05 CPG 575.100
Figs 0.05 CPG 575.100
Fish (edible portion) 0.3 CPG 575.100
Hay 0.03 CPG 575.100
Leafy vegetables 0.05 CPG 575.100
Melons 0.05 CPG 575.100
Okra 0.05 CPG 575.100
Pears 0.05 CPG 575.100
Pimentos 0.05 CPG 575.100
Pumpkins 0.05 CPG 575.100
Quinces 0.05 CPG 575.100
Rice 0.3 CPG 575.100
Small fruits a,b 0.05 CPG 575.100
Stone fruits a,b 0.05 CPG 575.100

Squash 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) Reference
Ceramicware
Flatware (average of 6 units) 3.0 CPG 545.450
Small hollowware (other than cups and mugs) 2.0 CPG 545.450
(any 1 of 6 units)
Large hollowware (other than pitchers) (any 1 1.0 CPG 545.450
of 6 units)
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 7 CPG 545.500

6 units)
Product intended for use by infants and 0.5 CPG

children (any 1 of 6 units) 545.500
LINDANE

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
Corn 0.1 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
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 1 ppm methyl mercury in edible portion CPG 540.600
animals (fresh, frozen or processed)
Wheat (pink kernels only) 1 ppm on pink kernels and an average of CPG
10 or more pink kernels/500 g 578.400
METHYL ALCOHOL
Commodity Action Level (%) Reference
Imported brandy 0.35 CPG 510.200
MIREX
N-NITROSAMINES
Rubber baby bottle nipples 10 CPG 500.450
PARALYTIC SHELLFISH TOXIN
Commodity Action Level Reference
Clams, mussels, oysters 80 µg/100 g meat CPG 540.250

(fresh, frozen, and canned)
POLYCHLORINATED BIPHENYLS (PCB'S)
Red meat 3 (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 (/compliance-policy-guides)
Submit Comments
Submit Comments Online (https://www.regulations.gov/docket?D=FDA-2013-S-0610)
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-S-0610
(https://www.regulations.gov/docket?D=FDA-2013-S-0610).
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GUIDANCE DOCUMENT

Guidance for Industry: Action Levels for Poisonous or

Single copies of this booklet are available from:

Industry Activities Staff (HFS-565)

National Technical Information Service (NTIS)

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

Commodity Action Level (ppb) Reference

Brazil nuts 20 CPG 570.200

Milk 0.5 (aflatoxin M1) CPG 527.400

Peanuts and Peanut products 20 CPG 570.375

Pistachio nuts 20 CPG

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

Cabbage 0.03 CPG 575.100

Carrots 0.1 CPG 575.100

Cauliflower 0.03 CPG 575.100

Celery 0.03 CPG 575.100

Clover 0.03 CPG 575.100

Collards 0.05 CPG 575.100

Cowpea hay 0.03 CPG 575.100

Cucumbers 0.1 CPG 575.100

Eggplant 0.05 CPG 575.100

Eggs 0.03 CPG 575.100

Endive (escarole) 0.05 CPG 575.100

Fats and oils (animal feed) 0.3 CPG 575.100

Figs 0.05 CPG 575.100

Fish 0.3 (edible portion) CPG 575.100

Grapefruit 0.02 CPG 575.100

Hay 0.03 CPG 575.100

Horseradish 0.1 CPG 575.100

Kale 0.05 CPG 575.100

Kohlrabi 0.05 CPG 575.100

Lemons 0.02 CPG 575.100

Lespedeza 0.03 CPG 575.100

Lettuce 0.03 CPG 575.100

Limes 0.02 CPG 575.100

Mangoes 0.03 CPG 575.100

Melons 0.1 CPG 575.100

Milk 0.3 (fat basis) CPG 575.100

Mustard greens 0.05 CPG 575.100

Oranges 0.02 CPG 575.100

Parsnips 0.1 CPG 575.100

Pea 0.03 CPG 575.100

Peaches 0.02 CPG 575.100

Peanuts 0.05 CPG 575.100

Peanut hay 0.03 CPG 575.100

Peppers 0.05 CPG 575.100

Pimentos 0.05 CPG 575.100

Pineapple 0.03 CPG 575.100

Pome fruits (except crabapples and loquats) 0.03 CPG 575.100

Potatoes 0.1 CPG 575.100

Radishes 0.1 CPG 575.100

Radish tops 0.03 CPG 575.100