Crop industry wants EPA to boost lab inspections for pesticide research
BY RACHEL FRAZIN - 10/31/2020
© istock
A dwindling number of Environmental Protection Agency lab inspectors for studies supporting pesticide re-approval is prompting industry calls for more government oversight.
The EPA has just five inspectors tasked with evaluating the laboratory practices of hundreds of labs that conduct studies surrounding pesticide regulations, marking a steady decline over the past 25 years for the officials in charge of inspecting compliance with the agency’s Good Laboratory Practice Standards.
Those standards were adopted decades ago after major issues in private lab testing were uncovered by investigators. Now, inspectors review reports deemed suspicious and carry out spot inspections that function much like an IRS audit and are seen as a way to prevent fraudulent research.
CropLife America, a major industry group whose members include companies like Bayer CropScience, John Deere and PepsiCo., is among those pushing the EPA for more lab inspections.
Proponents argue the lend legitimacy to industry lab results in the eyes of worldwide regulators. A lack of inspections, in turn, is seen as hurting the integrity of U.S. industry in a global marketplace.
Under the Good Laboratory Practices (GLP) program, the EPA inspects the quality and integrity of data submitted in support of approving a pesticide. But some industry groups say the agency should augment its program.
In a 2018 email to the EPA that was obtained by the Center for Biological Diversity and shared with The Hill, CropLife America’s senior director for regulatory policy expressed concern about the low staffing number for the program.
“The GLP inspection and audit program is being starved of resources and personnel,” Ray McAllister wrote.
“There are some 1400 laboratories, facilities, and field sites in the US participating in GLP research on pesticides,” he added in the email. “With current staffing of the audit and inspection program, keeping up with that number of facilities seems like an impossible task.”
The EPA said the number of facilities in the U.S. is closer to 1,200.
Bill Jordan, who ran the EPA’s Office of Pesticide Programs during the Obama administration said that during his tenure, there were “not more than a dozen” people and "probably considerably fewer" working on Good Laboratory Practice Inspections.
“As budget resources shrank, the size of that group in particular also got smaller and they were able... to keep up with the referrals of suspicious reports but I don’t know how well they did the kind of routine inspections of laboratories that were doing large numbers of studies,” he said.
Jordan explained how companies that submitted studies to the agency would need to verify whether they followed the standards.
“EPA would then review the study and go over it with a fine-toothed comb or microscope...to look for any indication that there might be something fake, unreliable, about the way the study was conducted,” he said.
The EPA said it has five inspectors and two in training. From 2016 through 2019, the agency had four inspectors.
CropLife’s McAllister told The Hill that staffing has been in “a gradual decline over the past 26 years.” His email to the EPA noted that there were 19 inspectors and six support staffers in 1994.
He argued in the 2018 email that in other countries, the ratio of labs to inspectors is more “balanced.”
The EPA says its staffing level is sufficient to provide adequate oversight, citing a 2018 law that set aside more money that the agency can use for the GLP program.
The agency’s website also has a list of nearly 1,000 inspections taken by the agency since 2006. The list shows an average of about 59 inspections annually for the first three years of the Trump administration, about 71 each year under former President Obama and 77 inspections for the three years during the George W. Bush administration.
McAllister said in his EPA email that if the U.S. doesn’t do enough inspections, companies might be more inclined to take their research to foreign organizations.
“A robust GLP program...demonstrates to all stakeholders the integrity of industry-supported and generated data that underpin pesticide regulations,” he wrote.
Environmentalists agree that the laboratory standards inspections help prevent fraud, although they argue the industry needs more oversight beyond what they see as a very basic measurement of scientific integrity.
Nathan Donley, a senior scientist at the Center for Biological Diversity said that while he believes GLP inspections play an important role, he’d like to see even more scrutiny on the science behind the industry’s findings.
“While it’s very important to make sure these inspections are occurring, this is also not an industry that has much oversight,” Donley said. “Although they have to meet some bookkeeping requirements, this is not the best scientific evidence.”
The EPA has just five inspectors tasked with evaluating the laboratory practices of hundreds of labs that conduct studies surrounding pesticide regulations, marking a steady decline over the past 25 years for the officials in charge of inspecting compliance with the agency’s Good Laboratory Practice Standards.
Those standards were adopted decades ago after major issues in private lab testing were uncovered by investigators. Now, inspectors review reports deemed suspicious and carry out spot inspections that function much like an IRS audit and are seen as a way to prevent fraudulent research.
CropLife America, a major industry group whose members include companies like Bayer CropScience, John Deere and PepsiCo., is among those pushing the EPA for more lab inspections.
Proponents argue the lend legitimacy to industry lab results in the eyes of worldwide regulators. A lack of inspections, in turn, is seen as hurting the integrity of U.S. industry in a global marketplace.
Under the Good Laboratory Practices (GLP) program, the EPA inspects the quality and integrity of data submitted in support of approving a pesticide. But some industry groups say the agency should augment its program.
In a 2018 email to the EPA that was obtained by the Center for Biological Diversity and shared with The Hill, CropLife America’s senior director for regulatory policy expressed concern about the low staffing number for the program.
“The GLP inspection and audit program is being starved of resources and personnel,” Ray McAllister wrote.
“There are some 1400 laboratories, facilities, and field sites in the US participating in GLP research on pesticides,” he added in the email. “With current staffing of the audit and inspection program, keeping up with that number of facilities seems like an impossible task.”
The EPA said the number of facilities in the U.S. is closer to 1,200.
Bill Jordan, who ran the EPA’s Office of Pesticide Programs during the Obama administration said that during his tenure, there were “not more than a dozen” people and "probably considerably fewer" working on Good Laboratory Practice Inspections.
“As budget resources shrank, the size of that group in particular also got smaller and they were able... to keep up with the referrals of suspicious reports but I don’t know how well they did the kind of routine inspections of laboratories that were doing large numbers of studies,” he said.
Jordan explained how companies that submitted studies to the agency would need to verify whether they followed the standards.
“EPA would then review the study and go over it with a fine-toothed comb or microscope...to look for any indication that there might be something fake, unreliable, about the way the study was conducted,” he said.
The EPA said it has five inspectors and two in training. From 2016 through 2019, the agency had four inspectors.
CropLife’s McAllister told The Hill that staffing has been in “a gradual decline over the past 26 years.” His email to the EPA noted that there were 19 inspectors and six support staffers in 1994.
He argued in the 2018 email that in other countries, the ratio of labs to inspectors is more “balanced.”
The EPA says its staffing level is sufficient to provide adequate oversight, citing a 2018 law that set aside more money that the agency can use for the GLP program.
The agency’s website also has a list of nearly 1,000 inspections taken by the agency since 2006. The list shows an average of about 59 inspections annually for the first three years of the Trump administration, about 71 each year under former President Obama and 77 inspections for the three years during the George W. Bush administration.
McAllister said in his EPA email that if the U.S. doesn’t do enough inspections, companies might be more inclined to take their research to foreign organizations.
“A robust GLP program...demonstrates to all stakeholders the integrity of industry-supported and generated data that underpin pesticide regulations,” he wrote.
Environmentalists agree that the laboratory standards inspections help prevent fraud, although they argue the industry needs more oversight beyond what they see as a very basic measurement of scientific integrity.
Nathan Donley, a senior scientist at the Center for Biological Diversity said that while he believes GLP inspections play an important role, he’d like to see even more scrutiny on the science behind the industry’s findings.
“While it’s very important to make sure these inspections are occurring, this is also not an industry that has much oversight,” Donley said. “Although they have to meet some bookkeeping requirements, this is not the best scientific evidence.”
No comments:
Post a Comment