The company explained in a press release that <561> is the USP general chapter that encompasses articles of botanical origin, involving all botanicals in commerce. "It addresses a lot of topics, but in terms of pesticides lists 70 reportable compounds covering 121 individual analytes," Alkemist noted in the release. Alkemist conducts four assays using three different instruments to cover the entire USP Panel: one run each of UPLC-MS/MS, APGC-MS/MS, and two runs of GC-MS/MS.
But, Alkemist maintains, not all labs do this.
“Ninety eight percent of the compounds tested for UPLC-MS/MS and the APGC-MS/MS; the other 2% requires two additional analytical runs,” explained Anthony Fontana, Ph.D., Lab Director at Alchemist. “What we have learned is that a lot of labs skip those, quite possibly because of the time and processing you need to run it. You are changing over the same instrument twice, each time to search for one more analyte, which can take half a day. Skipping these two runs only omits two analytes from an already lengthy report, so they may be easily overlooked.”To ensure that testing is complete, Alkemist Labs offered some advice: carefully check pesticide testing reports to ensure that results include Inorganic bromide and Dithiocarbamates measured and reported as carbon disulfide (CS2).
If these compounds are omitted, Alkemist cautioned, then USP <561> pesticides testing is incomplete. And this is an issue. "From the reports Alkemist has seen, some C of A’s are transparent about the missing compounds, but others are not. Sometimes the cost to the manufacturer doubles if those two last analytes are added to the test run."
Another concern about pesticide testing
Use of the phrase “USP <561> modified.”
Alkemist explained: Use of “modified” in relation to USP usually means newer instrumentation or column technology is being used than described in the USP chapter. "However, USP <561> is not a detailed analytical method, but rather a table of pesticides that must be tested to confirm they are below the listed thresholds. So showing USP <561>Modifiedon a report appears to indicate that some pesticides are not being tested for at all."The problem: Depending upon how a company has set its specifications, it may be out of compliance with cGMPs. This, Alkemist notes, is a fundamental error. It could be caught in an audit if they have set a spec they are not testing to.
Consumer trust is an issue here as well. If a company says it does comprehensive pesticide testing but in reality does not, consumers will lose trust. Add to that the safety risk due to toxic pesticides that haven't been screened for.
Elan Sudberg, CEO of Alkemist Labs, weighed in. “I understand why some labs may use this practice, which would necessarily make testing more expensive, but it’s misleading. The industry has to be better than that.”
