A Salem medical marijuana dispensary is the first to receive permission to sell marijuana - after obtaining a temporary waiver from the state's strict testing guidelines.
The Massachusetts Department of Public Health has said it will reconsider its medical marijuana testing standards. Advocates and experts knowledgeable about the testing process say Massachusetts' current standards are stricter than those in other states and difficult to meet.
"We carefully considered the initial testing results and we will review the standards going forward," said Dr. Monica Bharel, commissioner of the Department of Public Health.
The reconsideration of testing standards is yet another hurdle for the state's troubled medical marijuana process. Although voters voted for medical marijuana in 2012, the licensing progress has been marred by delays and missteps.
In April, Gov. Charlie Baker announced that his administration was revamping the entire licensing process
. Those who already received provisional licenses could continue taking the steps needed to get final approval.
So far, four dispensaries have received approval to grow marijuana, and Alternative Therapies Group in Salem is the furthest along in the process. The issue with the testing has only emerged now because Alternative Therapies Group was the first company to reach the stage where it was ready to test the drug for sale. The dispensary still needs a final inspection before it can open its doors.
State government officials and laboratory officials say the marijuana sold by Alternative Therapies Group will not pose any health threat even though it has not yet met all the state testing guidelines.
"We believe these levels provide for patient health protections while allowing the first dispensary to distribute marijuana for medical use as voted on in 2012," Bharel said.
The marijuana will have a label disclosing the chemicals that it has not been tested for. The three-month waiver will allow Alternative Therapies Group to dispense a limited amount of marijuana to each patient – 4.23 ounces for a 60-day supply - with an instruction that they consume no more than 2 grams per day.
Christopher Hudalla, chief scientific officer at ProVerde Laboratories, which did the testing for Alternative Therapies Group, said Massachusetts' standards are stricter than those in other states. Colorado, for example, set a limit on lead of 15,000 parts per billion. Massachusetts' limit is 212 parts per billion.
Hudalla said one problem with the standards is some metals are naturally occurring, and the standards are so strict that tests might pick up naturally occurring metal – which is different from contamination.
The Department of Public Health said it will review its standards for naturally occurring material.
According to Baker's office, the lab was also unable to test for seven of 18 mandated pesticides. Hudalla said because the pesticides are all different, different instruments and techniques are needed for the testing, which is expensive and time consuming. The lab has been gradually developing the equipment and techniques it needs to test for pesticides, but it is still unable to test for the level of sensitivity required on all of them.
Hudalla said he is not worried about public safety, because the pesticides are those that the cultivation facilities are banned from using anyway, and the facilities have been inspected to ensure that the pesticides are not present.
"I don't have concern over consumer safety because I know dispensaries are not using these pesticides," Hudalla said.
Hudalla did not fault the state, which he said acted responsibly by starting with conservative limits. There is little published research about proper standards because marijuana is still federally prohibited. "They started with very conservative limits based on ensuring public safety...and then as they learn more information, they can loosen the limits to make it more realistic for products," Hudalla said.
Baker said he granted the waiver because he wanted to give the labs time to ramp up their testing abilities while not further delaying the availability of medical marijuana.
"Patients have waited to access marijuana for medical purposes for far too long," Baker said. "This waiver will allow industry laboratories a little more time to reach full operation while providing safe amounts of medical marijuana for qualifying patients who need it."
Secretary of Health and Human Services Marylou Sudders stressed that the goal is to allow small amounts of marijuana while giving testing facilities time to ramp up. "We are not lowering our standards for the testing of marijuana for medical purposes," Sudders said.
Advocates for patients and dispensaries praised the Baker administration for granting the waiver. But they said they remain concerned about the strict standards and plan to work with the Department of Public Health to get the standards loosened. For example, they say the standards are based on an unrealistic assumption of how much marijuana a patient will consume at one time.
"We appreciate that the Administration will review their testing levels during this three month reprieve," said Kevin Gilnack, executive director of the Commonwealth Dispensary Association, a trade group representing dispensaries. "Massachusetts has the most conservative testing standards in the nation and is the only state that has established its standards on the unsupported assumption that a patient might consume an entire ounce of cannabis in one sitting."
Nichole Snow, executive director of the Massachusetts Patient Advocacy Alliance, which represents medical marijuana patients, said the alliance hopes to work with the state to develop standards that accurately reflect proper dosages of medical marijuana. "The Massachusetts Patient Advocacy Alliance thinks that the testing criteria is far too stringent for the medicine they're trying to pass," Snow said. "Part of it is that the DPH doesn't understand completely how patients use this medicine."