Open letter to:
Drug and Chemical Evaluation Section
Department of Justice
Drug Enforcement Administration
Office of Diversion Control
950 Pennsylvania Ave. NW
Washington, D.C. 20530-0001
Subject: Comments on proposed rules regarding “Use of Marijuana for Industrial Purposes”
Reference: Federal Register, Vol. 65, No. 231, November 30, 2000 (DOJ Regulatory Agenda, Sequence Number 1985)
Dear Mr. Marshall:
This letter summarizes our comments on and objections to the referenced proposed rules. Supporting documentation is attached. Our comments are based on our previous scientific research on several aspects of the use of hemp seeds in food and body care products, including both experimental studies and literature review. Particularly, we recently completed a study, which assessed the impact of the ingestion of THC via hemp food items on the outcome of urine testing for marijuana use.
We agree with the Drug Enforcement Administration that human consumption of hemp seed based foods and cosmetics raises valid concerns over their impact on the health of consumers and on the integrity of workplace drug testing programs. However, our experience suggests that the provision of the proposed rules that “…any substance containing any amount [emphasis added] of THC is a Schedule I controlled substance–even if such substance is made from ‘hemp’.” without referencing a finite limit of detection is not justified, provided that the rules are merely intended to address the named concerns. Rather, the adoption of scientifically based and enforceable non-zero limits for THC in foods and cosmetics appears to provide sufficient protection in both areas. Our comments relate to the following three issues.
1. CONSUMPTION OF PRESENT HEMP FOOD ITEMS NOT LIKELY TO PRODUCE CONFIRMED POSITIVE URINE TESTS FOR MARIJUANA
To evaluate the impact of THC ingestion via hemp food on the level of THC metabolites in urine, Leson Environmental Consulting conducted a toxicological study in 1999/2000. The study was funded by the Agricultural Research and Development Initiative (ARDI), a program of the Canadian federal and Manitoba provincial governments, the North American Industral Hemp Council, and by several Canadian and U.S. producers and distributors of hemp seed products. The draft report on the study, which has been tentatively accepted for publication by the Journal of Analytical Toxicology is attached (Attachment A).
The findings indicate that extended daily ingestion of up to 450 micrograms (µg) of THC is not likely to cause screening positives at the 50 ng/ml cutoff or confirmed positives by gas chromatography-mass spectrometry (GC/MS) at the 10 ng/ml cutoff. It has been reported by several processors of hemp seeds that thorough seed cleaning reduces THC levels in the two main commodities from hemp seeds available in the U.S., i.e. hemp seed oil and hulled seeds, to less than 5 and 2 parts per million (ppm or µg/g), respectively. At these levels, ingestion of 450 µg per day of THC requires unrealistically high consumption rates for hemp seed products, suggesting that adoption of THC limits at or below these currently achieved levels would allow elimination of undesirable interference of hemp food consumption with workplace drug testing programs.
I understand that a more extensive study of the issue of THC ingestion and workplace drug testing is currently conducted at the Research Triangle Institute. We expect that its results will confirm our findings.
2. USE OF HEMP SEED OIL COSMETICS EVEN LESS LIKELY TO RESULT IN POSITIVE URINE TESTS
The use of hemp seed oil containing cosmetics has been expected to cause THC uptake considerably less than from the consumption of hemp food items. This is due to the lower application rates of cosmetics, their low hemp seed oil content and the less efficient transdermal uptake of THC, compared to its ingestion.
Leson Environmental Consulting currently conducts a desktop study to estimate the maximum conceivable quantity of THC entering the human body from the topical application of hemp seed oil cosmetics. It is largely based on research previously conducted by Health Canada. Preliminary results indicate that even under highly conservative assumptions regarding product application rates, hemp seed oil content in the product, THC levels in oil, and transdermal uptake rates, THC uptake will be less than 30 µg/day. More realistic, yet still conservative scenarios indicate that THC uptake rates from the use of hemp cosmetics will generally be less than 1 µg/day. Either rate is considerably less than the maximum rates at which no screening positives were produced (450 µg/day) during the above referenced study on THC ingestion. Consequently, even daily, extensive use of cosmetics containing hemp seed oil, which meets THC limits for food grade oil, will not cause positive screening tests, much less confirmed positives.
A copy of the study, which is currently being reviewed internally, will be submitted to your office upon completion.
3. RECENT FEDERAL GERMAN HEALTH BASED GUIDELINES FOR THC CONTENT OF FOODS DESIGNED TO PROVIDE AMPLE MARGIN OF SAFETY
The presence of THC residues in foods containing hemp seeds has prompted the German federal government to develop health based guidelines for the maximum THC content of food items. Summaries of the guidelines, which were released in March 2000, and of the lead agency’s rational for selecting the THC limits are provided in Attachment B. The agency assumed that limiting the maximum allowable THC ingestion rate to 120 µg/day would provide an ample margin of safety from undesirable health effects.
The resulting stringent guidelines of 5 parts per million (ppm or µg/g) of THC in hemp seed oil and 0.15 ppm for all other ready-to-use food products, except beverages, are used for example to assess whether a product can be certified as “safe” for human consumption. German suppliers of hemp food items are, after initial opposition, apparently confident that these limits can be achieved through proper seed cleaning.
The above documents suggest that keeping daily THC uptake to less than 120 µg would eliminate concerns over its potential risk to human health or its negative impact on the reliability of workplace drug testing programs. Thus, we respectfully suggest that the Drug Enforcement Administration consider modification of the proposed rules as to:
- Eliminate the provision that “any amount of THC” would qualify a product as a Schedule I controlled substance;
- Specify scientifically based, enforceable THC limits for relevant categories of hemp foods and cosmetics.
In our opinion and that of health protection agencies of other Western countries, this approach will provide sufficient protection from undesirable effects and interference with drug testing from THC in consumer products while providing consumers continued access to the nutritional and skin care benefits of hemp seed products.
Dr. Gero Leson
LESON ENVIRONMENTAL CONSULTING
Berkeley, CA 94709
PHONE +1 (510) 525-9533
FAX +1 (510) 525-9432
Frank Sapienza, Chief, DEA, Office of Diversion Control
Raymond Kelly, Commissioner, U.S. Customs
Jakob J. Lew, Director, Office of Management and Budget
Lawrence H. Summers, Department of the Treasury
Norman Mineta, Secretary, Department of Commerce
Erwin Sholts, Chair, North American Industrial Hemp Council