Hemp is regulated in the 2018 Farm Bill under Title X-Horticulture – Subtitle G – Hemp Production. § 10113 Hemp Production.2018 Farm Bill – Title X-Horticulture – Subtitle G – Hemp Production. § 101113 Hemp Production
The Agricultural Marketing Act of 1946(or the AMA) is amended by adding the definition of Hemp to mean:
• the plant Cannabis sativa L.
• any part of that plant, including the seeds thereof and all derivatives, extracts,
cannabinoids, isomers, acids, salts, and salts of isomers,
• whether growing or not,
• with a delta-9 tetrahydrocannabinol ( or more commonly referred to as THC)
concentration of not more than 0.3% on a dry weight basis
One of the great things about the new 2018 Farm bill is that it makes clear Cannabidiol (Canna bih die all) more commonly referred to as CBD from hemp is legal. One big myth that exists about the Farm Bill is that CBD is legalized. It is true that section 12619 of the Farm Bill removes hemp derived products from its Schedule I status under the Controlled Substances Act, but the legislation does not legalize CBD generally. CBD Generally remains a Schedule I substance under federal law. The Farm Bill ensures that any cannabinoid—will be legal, if and only if that hemp is produced in a manner consistent with the Farm Bill, associated federal regulations, association state regulations, and by a licensed grower. All other cannabinoids, produced in any other setting, remain a Schedule I substance under federal law and are thus illegal.
What is CBD?
Cannabidiol (CBD) is a naturally occurring compound found in the resinous flower of cannabis, a plant with a rich history as a medicine going back thousands of years. Today the therapeutic properties of CBD are being tested and confirmed by scientists and doctors around the world. A safe, non-addictive substance, CBD is one of more than a hundred “phytocannabinoids,” which are unique to cannabis and endow the plant with its robust therapeutic profile.
CBD is closely related to another important medicinally active phytocannabinoid: tetrahydrocannabinol (THC), the compound that causes the high that cannabis is famous for. These are the two components of cannabis that have been most studied by scientists.
Both CBD and THC have significant therapeutic attributes. But unlike THC, CBD does not make a person feel “stoned” or intoxicated. That’s because CBD and THC act in different ways on different receptors in the brain and body.
CBD can actually lessen or neutralize the psychoactive effects of THC, depending on how much of each compound is consumed. Many people want the health benefits of cannabis without the high – or with less of a high.
The fact that CBD is therapeutically potent as well as non-intoxicating, and easy to take as a CBD oil, makes it an appealing treatment option. Especially for any people are seeking alternatives to pharmaceuticals with harsh side effects. People often use CBD for relief with chronic pain, anxiety, inflammation, depression.
CBD falls under the definition of hemp since it is a cannabinoid, but the Food Drug and Cosmetic Act was not amended with respect to hemp or CBD, and the FDA still has jurisdiction over the sale of CBD in food drug and cosmetic products.
We are a start-up, incorporated in 2019 in the Commonwealth of Pennsylvania. The principals are Edgardo D. Santillán, John Clay and Bryan P. Keenan.
Frequently Asked Questions
– Addendum (from https://www.agriculture.pa.gov/Plants_Land_Water/industrial_hemp/Pages/Industrial-Hemp-Program-FAQs.aspx)
The following information is provided as a guide and is not a legal interpretation of the Act.
Q: What is industrial hemp?
A: Industrial hemp is a versatile plant that has been used for thousands of years as a source of fiber and food. While grown commercially in the United States until after World War II, industrial hemp became regulated along with marijuana and its cultivation was prohibited.
Q: What is the difference between industrial hemp and marijuana?
A: Industrial hemp and marijuana are different varieties of the same species of plant, Cannabis sativa. Marijuana is cultivated because of its production of the psychoactive plant chemical delta-9 tetrahydrocannabinol, or THC. Industrial hemp is cultivated for fiber, seed and other purposes, and federal and state law requires that the concentration of THC must be less than 0.3% in industrial hemp.
Q: Why is Pennsylvania allowing growth of industrial hemp now?
A: Through the 2018 Farm Bill, the federal government has changed the legal status of industrial hemp. It has been removed from regulation under the Controlled Substance Act, ending any restrictions on import or interstate movement of hemp seed, plants, or products. However, the 2018 Farm Bill still requires that every site where industrial hemp is grown be registered with the state or federal government under a program with requirements for inspection and testing.
Q: What is the difference between Pennsylvania’s industrial hemp program and the Pennsylvania medical marijuana program?
A: The two programs are separate and authorized by different Acts and Departments. Industrial hemp contains virtually no THC (less than 0.3%). Both plants do contain levels of other compounds of interest, for example cannabidiols (CBDs). The Medical Marijuana Act requires all the cannabis for medical use to be grown at a permitted growing/processing facility and the products to be tested before being sold in order to meet specific requirements for purity and standardized chemical concentrations. Industrial hemp growers must have a permit from the PA Department of Agriculture.
Q: What are some of the uses of industrial hemp?
A: There are thousands of uses for industrial hemp. Some of those include: fibrous stem products (paper products, molded plastics, textiles, construction materials, etc.); seed products (food products for human consumption, culinary oil, body care products, fuel, etc.) and floral/foliar products (CBD extracts). Part of the development of an industrial hemp industry is to determine what the most appropriate uses are for Pennsylvania in terms of growth, production and processing of hemp.
Q: Who can legally grow hemp in Pennsylvania?
A: Industrial hemp may be grown or cultivated in Pennsylvania by individuals with a valid permit from the PA Department of Agriculture.
Q: Has hemp been planted in Pennsylvania?
A: During the 2018 season, 33 permit holders planted and grew approximately 580 acres of industrial hemp. This was the second year that hemp was grown in the commonwealth after having been banned for approximately 80 years. PDA will be accepting additional applications for the 2019 growing season.
Q: How can I apply to grow hemp in Pennsylvania?
A: Interested persons or businesses should carefully review the parameters for permit approval and fill out the 2019 Industrial Hemp Program Permit Application.
Q: Will there be fees for the participants of the project?
A: Yes. PDA has established fees to cover the costs of administering the program, including obtaining a permit, covering inspections, sampling and necessary laboratory testing of the crop as required by the permit. Additionally, other agencies may charge fees for their services, such as FBI criminal history background checks, or inspection and testing requirements of other applicable statutes.
Q: Is the application fee refundable?
A: No. The law enabling industrial hemp production in Pennsylvania gave the Department of Agriculture the right to establish fees to cover the costs of administering the program. The use of these “user fees” is restricted to covering the costs incurred by the agency to administer the program.
Q: How many industrial hemp permits will be issued in 2019?
A: There is no limit to the number of permits, or the amount of hemp that will be permitted for the 2019 growing season. Any application that meets all requirements of the program will be approved.
Q: How many acres will be approved for each project?
A: There is no limit to the size of plantings covered under a permit. Cost of obtaining a permit increases with the number of properties on which hemp is grown.
Q: I had an industrial hemp permit in 2018. Do I need to renew my permit?
A: Yes. Permits expire on December 31st of each year; renewal is required each year. Changes are possible at the time of renewal, but may result in additional cost for renewal.
Q: How can a participant obtain industrial hemp seed?
A: Hemp seed may be obtained from other countries, from other states, or from Pennsylvania seed dealers. The grower is responsible for obtaining seed; the Department is not involved in that process. The Department does encourage growers to search for certified seed, if available.
Q: Can I sell the hemp from my project? Outside of the commonwealth?
A: Yes, products produced from hemp grown in Pennsylvania may be sold in Pennsylvania or interstate, as long as the receiving state has no prohibitions on the sale. All products or substances distributed or sold must meet all state and federal laws and regulations that are applicable to the commodity.
Q: Are hemp processors required to be licensed in PA?
A: At this time, the Department of Agriculture does not require a special license for hemp processors. Producers of hemp food products would need to be registered as a Food Establishment with PDA’s Bureau of Food Safety.
Q: What products/uses of industrial hemp will be permitted in PA?
A: Industrial hemp products are regulated by several different federal and state mandates, which can be confusing. It is the responsibility of the permit holder to ensure any products or substances derived from industrial hemp meet the requirements of all state and federal laws and regulations.
Q: Ca Industrial hemp be sold/commercially distributed as animal feed?
A. Not at this time. Before any ingredient can be sold or distributed as part of animal feed, the ingredient must be Generally Recognized as Safe (GRAS) by FDA and/or listed as a “recognized feed ingredient” by the American Association of Feed Control Officials (AAFCO). As part of the approval process, testing is currently being conducted to ensure the safety and nutritional value of hemp. Growers are advised that any research project that involves feeding hemp products to their own animals may result in regulatory restrictions in the sale of products (meat, milk, eggs, etc.) from these animals.
Q: What about cannabinoids, like CBD?
A: Cannabinoids, such as cannabidiol (CBD), are a group of chemicals concentrated in the female flower of the cannabis plant. While they are chemically similar to THC, they do not have the psychoactive effects of THC. PDA does permit growth of hemp for the purpose of producing CBD. However, it will be the permit holder’s responsibility to ensure that any CBD extraction or the production of CBD-containing substances complies with all laws and regulations.
To further clarify, the following responses are to questions listed on FDA’s website:
13. Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added?
A. No. Under section 301(ll) of the Federal Food Drug & Cosmetic Act (FD&C Act or the Act), it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.
15. Will FDA take enforcement action regarding THC and CBD products that are marketed as dietary supplements? What about foods to which THC and CBD has been added?
A. When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.
Q: What happens if the industrial hemp grown tests higher than the 0.3% permitted for THC content?
A: By definition, the plants are no longer considered industrial hemp. Crop destruction could result. If it is determined that high THC levels were produced intentionally or maliciously, growers may face criminal penalties.
Q: Can seed grown be saved and replanted?
A: To save seed for replanting, growers would need to obtain written permission from the seed source. In addition, the seed must be grown in conditions that meet the requirements of the Pennsylvania Seed Act.
Q: Can I grow transplants/cuttings for resale?
A: Growers would need to obtain written permission for replication from the plant variety source and would also need to receive a Nursery Certificate.
Q: What does Industrial hemp need to grow?
A: Two years of research projects showed that good soil fertility – with adequate nitrogen, proper planting depth, and pre-plant weed control – is important for a good crop. Growers also need to evaluate available harvesting options, because many combines are not designed for use with this crop, which is well known for its strong fiber and stalks.
Q: If approved to receive an industrial hemp permit, what are my responsibilities?
A: Persons or institutions receiving permits to grow industrial hemp must follow the requirements outlined in their permit/contract with PDA. This includes payment of fees, cooperation with onsite inspections, and destruction of hemp found growing in unregistered sites that are linked to the permit.