Pennsylvania Marijuana Testing License

Does Pennsylvania Require Testing for Marijuana and Marijuana Products?

The State of Pennsylvania requires all medical marijuana and medical marijuana products produced and sold in the state to be tested to ascertain that:

• There are no harmful contaminants in the product
• The labels on the packaging of the products accurately reflect the content and the concentration of the active components of the medical marijuana products.

Section 29(C) of Title 28, Chapter 1171 of the Pennsylvania Code mandates that prescribed tests by the Pennsylvania Department of Health are performed by approved laboratories. The prescribed tests by the Pennsylvania Department of Health include tests of samples from:

• A harvest batch or harvest lot before they are used for the production of medical marijuana products.
• Medical marijuana products from either a harvest batch or a harvest lot before they are offered for sale to other medical marijuana organizations.

The Pennsylvania Department of Health provides a guide for quality testing and sampling by approved laboratories. The guide requires harvest batches, harvest lots, and production batches of medical marijuana products in Pennsylvania to do a chemical profile and contaminant analysis of the marijuana in their possession. Other tests for chemical profiles of marijuana and marijuana products include tests conducted on:

• Terpenes
• Pesticide residues
• Residual solvents
• Heavy metals
• Moisture content and water activity
• Significant microbiological contents.

Some of the significant contaminants in medical marijuana harvest and final medical marijuana products that require a chemical profile are:

• Metals such as Arsenic, Cadmium, Lead, and Mercury
• Mycotoxins such as Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2, and Ochratoxin A
• Microbes such as Salmonella, E. Coli, Mold, and Yeast, Total viable Aerobic Bacteria
• Bile tolerant gram-negative bacteria
• Solvents such as Butane and Ethanol
• Pesticides that are not among the list of acceptable pesticides published in the Pennsylvania Code.

The chemical profile of acceptable chemicals used by the Pennsylvania Pesticide Control Act will also be tested to ascertain that their presence in the marijuana is within acceptable limits. The Department of Health may also require samples for certain tests to be taken at different stages of the production of marijuana or marijuana products. Below are some tests and the points of sample collection for the tests required by the Department of Health.

• Test for moisture content and water activity. Samples required to be taken include:
  • Samples of harvest lot (before processing)
  • Samples of process lot of final flower
  • Samples for stability testing (for the flower only)
• Test for microbiological content. Samples required to be taken include:
  • Samples of harvest lot (before processing)
  • Samples of process lot of extraction-based final product
  • Samples of process lot of final flower
  • Samples of process lot of empty vape pen
  • Samples for stability testing
• Test for mycotoxins. Samples required to be taken include:
  • Samples of harvest lot (before processing)
  • Samples of process lot of extraction-based final product
  • Samples of process lot of final flower
  • Samples for stability testing
• Test for heavy metals. Samples required to be taken include:
  • Samples of harvest lot (before processing)
  • Samples of process lot of extraction-based final product
  • Samples of process lot of final flower
  • Samples of process lot of empty vape pen
  • Samples for stability testing
• Test for solvents. The only sample required to be taken is that of the process lot of extraction-based final products.
• Test for pesticides. The only sample required to be taken is that of the harvest lot (before processing)
• Test for potency. Samples required to be taken include:
  • Samples of harvest lot (before processing)
  • Samples of process lot of extraction-based final product
  • Samples of process lot of final flower
  • Samples of process lot of empty vape pen
  • Samples for stability testing
• Test for terpenes. Samples required to be taken include:
  • Samples of harvest lot (before processing)
  • Samples of process lot of extraction-based final product
  • Samples of process lot of final flower
  • Samples of process lot of empty vape pen
  • Samples for stability testing.

Does Pennsylvania License Independent Marijuana Testing Facilities?

Yes, the State of Pennsylvania licenses independent medical marijuana testing laboratories for the testing of marijuana and marijuana products. There is no state agency testing marijuana. As of January 2024, five testing laboratories have been approved and accredited to test marijuana and marijuana products in the state. The names, addresses, and contact persons in each of the approved medical marijuana testing laboratories are as follows:

ACT Laboratories of Pennsylvania LLC

190 River Street,

Clearfield, PA 16830

or

109 Brinton Avenue

Trafford, PA 15085

Official contact person: Jeff Nemeth

Telephone: (517) 278-9333

Keystone State Testing LLC

4949 Queen Avenue,

Harrisburg, PA 17019

Official contact person: Dr. Kelly Greenland

Telephone: (717) 585-0393

Steep Hill Pennsylvania

6360 Flank Drive, Suite 700,

Harrisburg, PA 17112

Official contact person: Dr. Andrew Rosenstein

Telephone: (814) 419-6347

US Cannalytics, LLC

3535 High Point Boulevard. Suite 400

Bethlehem, PA 18017

Official contact person: Timothy Schnupp

Telephone: (610) 798-6040

Coral Reef Labs

2632 North State Route 72,

Jonestown, PA 17038

Official contact person: Andrew Blasco

Telephone: (800) 287-3729

What Accreditations Do Marijuana Testing Facilities Need in Pennsylvania?

Every medical marijuana testing facility in the State of Pennsylvania is required to obtain an ISO/IEC 17025 accreditation. Chapter 1171.23 (b)(4) of Title 28 of the Pennsylvania Code mandates prospective medical marijuana testing laboratories to submit copies of their most recent ISO/17025 certificates of accreditation with their applications. The ISO/IEC 17025 certificate is a document issued by the American National Standards Institute (ANSI) National Accreditation Board as evidence of compliance with required laboratory operation standards. It affirms that the testing facility is competent to carry out tests, calibrations, sampling, etc. It also affirms that the laboratory has a quality management system and that their test results are reliable.

To obtain an ISO/IEC 17025 accreditation, a medical marijuana testing facility will be required to:

• Participate in appropriate proficiency testing (PT)/Inter-laboratory comparison (ILC) that represents the parameters, test technologies, and methods described in the scope of the accreditation. Proficiency testing is a term used to describe an evaluation of participants’ performance in relationship with established criteria using inter-laboratory comparisons.
• Maintain a documented plan of how they want to ensure they carry out representative sampling of all activities identified in the scope of the accreditation for at least a minimum of three years. There must also be an evaluation of the risk associated with the scope of the accreditation, and the risk management plan should be incorporated in the proficiency testing plan.
• Demonstrate a commitment to investigate test results that fall outside predefined performance criteria, such as unsatisfactory results. Some of the actions that the testing laboratory shall take are:
  • Promptly notify the ANSI National Accreditation Board of the unsatisfactory result. This is typically done by sending an email to the board using the ANAB FM 2830 Client Notification form.
  • Specify a stated time frame within which corrective actions shall be taken
  • Maintain a record of the investigation summary and the conclusion on every case of unsatisfactory results.
• Ensure that it is not the same staff that always undertakes performance testing activities for the testing laboratory if there are other qualified persons in the organization that can perform the same work.

How to Get a Marijuana Testing Laboratory License in Pennsylvania

A prospective medical marijuana testing laboratory in Pennsylvania must submit a completed Application to Become an Approved Laboratory for Marijuana Testing Form designed by the Pennsylvania Department of Health. Chapter 1171.23 of Title 28, the Pennsylvania code, states some specific details about the testing laboratory that must be written in the application form or included in the application package. These specific details include:

• The name and address of the applicant for the medical marijuana testing laboratory of the name and address of their authorized agent
• The name and address of the owner of the prospective medical marijuana laboratory, and if applicable, the medical or pharmacy licensure information regarding the owner
• The name of the director for the prospective medical marijuana testing laboratory and the name(s) of the technical personnel who will work at the testing laboratory
• A copy of the prospective medical marijuana laboratory’s ISO/IEC 17025 certificate of accreditation
• Copies of documents containing the standard operating procedures and sampling procedures to be used by the testing laboratory and approved by the body that approved the ISO/IEC 17025 accreditation
• A document containing the list of equipment to be used by the laboratory for their testing operations. This should include the manufacturer’s name, serial number, and model number of each piece of equipment, as well as other specific information about each equipment
• Description of each test that the medical marijuana testing laboratory shall conduct when they begin operation
• A document stating how the testing laboratory plans to manage its quality assurance program. This document is expected to comply with the standard quality assurance program stated in Chapter 1171.32 of Title 28 Pennsylvania Code
• A document containing the procedures of action when collecting samples for tests
• A document containing the mechanism the testing laboratory will use to evaluate the competency of their staff in the course of discharging their duties
• Other specific information that the Department of Health may demand

When a testing facility submits an application to the Pennsylvania Department of Health for approval, they automatically consent to the department sending anyone to visit the facility. This is to investigate the physical location of the laboratory and its authorized persons to ascertain that the applicant meets the requirements for approval. The application form should be printed and completed, and other supporting documents as stated above should be saved as PDF files on either a USB drive, an external hard drive, CD-ROM, or DVD. They are to be named “Laboratory Approval Application.pdf” or in a similar naming format for the series of documents. Applications must be properly signed and dated. The signature of the laboratory owner must also be scanned and provided electronically in a pdf file. Applications are to be mailed to:

PA Department of Health

Office of Medical Marijuana

Laboratory Approval

Room 628, Health and Welfare Building

625 Forster Street Harrisburg, PA 17120

The Department of Health will assess the application and issue an approval if they find the applicant professionally and financially capable of conducting reliable tests according to their standards.

How Much Does a Marijuana Testing Laboratory License Cost in Pennsylvania?

The Pennsylvania Department of Health does not publicize the fee requirements to set up a medical marijuana testing facility. However, application fees of other medical marijuana organizations are public. The Department may communicate a cost to the applicant after the application for the license is filed.

All medical marijuana organizations in Pennsylvania will be required to pay a fee of $250 either by a certified check or through money order addressed in favor of the Pennsylvania Department of Health whenever:

• They want to apply for a change of ownership of their medical marijuana organization
• They want to apply for approval to change the location of their facility from the address authorized in their permit
• They want to apply for approval to alter the address of their facility as written in their permit under any situation

The approvals granted to testing laboratories by the Pennsylvania Department of Health are valid only for the laboratory locations specified in the approvals. The approvals are also only valid for 2 years before they need to be renewed.

Are there Local Regulations for Cannabis Testing Facilities in Pennsylvania?

The only regulations available in Pennsylvania for cannabis testing facilities are the conditions given by the Pennsylvania Department of Health and the Pennsylvania Code. There are no local regulations in Pennsylvania for medical marijuana testing laboratories. The laboratories can perform tests for medical marijuana growers/processors in the state if they have met all the conditions stated by the code and the department.