Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Chemical Handler's Manual

APPENDIX D – Thresholds for Regulated Transactions in List I and List II Chemicals

Information regarding this subject may be found at 21 C.F.R. § 1310.04. For those listed chemicals for which thresholds have been established, the quantitative threshold or the cumulative amount for multiple transactions within a calendar month, to be utilized in determining whether a receipt, sale, importation, or exportation is a regulated transaction is as follows:

Chemical code List I Chemical Threshold by
base weight
8522 N-Acetylanthranilic acid and its salts and esters 40 kilograms
8530 Anthranilic acid and its salts and esters 30 kilograms
8256 Benzaldehyde 4 kilograms
8735 Benzyl cyanide 1 kilogram
8675 Ergonovine and its salts 10 grams
8676 Ergotamine and its salts 20 grams
8678 Ethylamine and its salts 1 kilogram
6695 Hydriodic acid (57%) 1.7 kilograms (or
1 liter by volume)
8704 Isosafrole 4 kilograms
8520 Methylamine and its salts 1 kilogram
8502 3,4-Methyenedioxyphenyl-2-propanone 4 kilograms
8115 N-Methylephedrine and its salts, optical isomers, and salts of optical isomers 1 kilogram
8119 N-Methylpseudoephedrine and its salts, optical isomers, and salts of optical isomers 1 kilogram
6724 Nitroethane 2.5 kilograms
8317 Norpseudoephedrine and its salts, optical isomers, and salts of optical isomers 2.5 kilograms
8791 Phenylacetic acid and its salts and esters 1 kilogram
2704 Piperidine and its salts 500 grams
8750 Piperonal (heliotropin) 4 kilograms
8328 Propionic anhydride 1 gram
8323 Safrole includes safrole-rich essential oils, such as sassafras oil and camphor oil 1070 4 kilograms

 

List II Chemicals Domestic Sales Imports and Exports
By volume By weight By volume By weight
Acetic anhydride 250 gallons 1023 kgs 250 gallons 1023 kgs
Acetone 50 gallons1 150 kgs1 500 gallons2 1500 kgs2
Benzyl chloride Not applicable 1 kg Not applicable 4 kgs
Ethyl ether 50 gallons 135.8 kgs 500 gallons 1364 kgs
Hydrochloric acid2 Not regulated Not regulated 50 gallons3 Not applicable4
Anhydrous hydrogen chloride2 Not applicable 0.0 kgs4 Not applicable 27 kgs3
Potassium permanganate Not applicable 55 kgs Not applicable 500 kgs
Methyl ethyl ketone
(2-Butanone)
50 gallons1 145 kgs1 500 gallons2 1455 kgs2
Methyl isobutyl ketone (MIBK) Not regulated Not regulated 500 gallons3 1523 kgs3
Sulfuric acid Not regulated Not regulated 50 gallons3 Not applicable4
Toluene 50 gallons1 159 kgs1 500 gallons2 1591 kgs2
Sodium permanganate Not applicable 55 kgs Not applicable 500 kgs

1 The cumulative threshold is not applicable to domestic sales of acetone, 2-butanone (methyl ethyl ketone or MEK), and toluene.

2 The 15 day advance notification requirement for imports is waived. Importers must provide quarterly reports as indicated in 21 C.F.R. § 1313.12(e) and 21 C.F.R. 1313.12(f).

3 Threshold applies to exports, transshipments, and international transactions to Western Hemisphere except Canada. Imports are not regulated.

4 Except for exports to all South American countries and Panama.

Exports, transshipments and international transactions to designated countries, except those that are excluded as set forth in APPENDIX E.

Chemical Threshold by volume Threshold by weight
Hydrochloric acid 50 gallons  
Anhydrous hydrogen chloride   27 kilograms
Sulfuric acid 50 gallons  

 

Export and international transactions to designated countries, and importations for transshipment or transfer to designated countries, except those that are excluded as set forth in APPENDIX E.

Chemical Threshold by volume Threshold by weight
Methyl isobutyl ketone (MIBK) 500 gallons 1523 kilograms

 

For listed chemicals for which no thresholds have been established, the size of the transaction is not a factor in determining whether the transaction meets the definition of a regulated transaction as set forth in 21 C.F.R. § 1300.02(b). All such transactions, regardless of size, are subject to recordkeeping and reporting requirements as set forth in 21 C.F.R. part 1310 and notification provisions for importation, exportation, international transactions, and transshipment as set forth in 21 C.F.R. part 1313.

List I chemicals for which no thresholds have been established:

  1. Ephedrine, its salts, optical isomers, and salts of optical isomers
  2. Ergocristine and its salts
  3. Gamma-butyrolactone (other names include: GBL; dihydro-1(3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone)
  4. Hypophosphorous acid and its salts (including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, magnesium hypophosphite, and sodium hypophosphite)
  5. Iodine
  6. N-phenethyl-4-piperidone (NPP)
  7. Pseudoephedrine, its salts, optical isomers, and salts of optical isomers
  8. Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers
  9. Red phosphorus
  10. White phosphorus (other names: yellow phosphorus)

The thresholds and conditions described above will apply to transactions involving regulated chemical mixtures. For purposes of determining whether the weight or volume of a chemical mixture meets or exceeds the applicable quantitative threshold, the following rules apply:

  1. For chemical mixtures containing List I or List II chemicals other than those listed in bullet #2 below, the threshold is determined by the weight of the listed chemical in the chemical mixture.
  2. For the List II chemicals acetone, ethyl ether, 2-butanone, toluene, and methyl isobutyl ketone, the threshold is determined by the weight of the entire chemical mixture.
  3. If two or more listed chemicals are present in a chemical mixture, and the quantity of any of these chemicals equals or exceeds the threshold applicable to that chemical, then the transaction is regulated.

 

Appendix CTable of Contents | Appendix E

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