By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA researchers are evaluating a number of commercially available products for potential long-lasting effectiveness against SARS-CoV-2, the novel human coronavirus that causes COVID-19. This research is being conducted at EPA’s Office of Research and Development's Center for Environmental Solutions and Emergency Response in Research Triangle Park, North Carolina, using surfaces that mimic the high touch points in mass transit trains and stations.
EPA states that it is working directly with New York’s Metropolitan Transportation Authority, North America’s largest transportation network, on evaluating EPA-registered antimicrobial products across New York City Transit to determine their ability to provide effective anti-virus protection over time.
Currently, EPA-registered products that claim long-lasting effectiveness are limited to those that control odor-causing bacteria on hard, non-porous surfaces. At this time, there are no EPA-registered products that claim long-lasting disinfection. EPA researchers hope to determine whether antimicrobial products can provide residual disinfection on surfaces over time and how durable the disinfection ability of the product is with normal use, including routine cleaning and natural weathering. According to EPA, data generated by EPA researchers will inform any regulatory decisions (including the approval and use of these products according to the label) made as part of the pesticide registration process through EPA’s Office of Pesticide Programs.
EPA researchers are also evaluating other possible high-efficiency alternative methods to disinfect, such as ultraviolet light (UV), ozone, and steam, that could be used on public transit systems to keep trains, buses, and facilities clean and safe for passengers. EPA is additionally studying disinfectant application methods, such as electrostatic sprayers or foggers, that EPA believes are promising.
As part of this effort, EPA has partnered with the Los Angeles County Metropolitan Transportation Authority, the third largest transit agency in the United States, to evaluate a number of new technologies, including UVC lighting and air filtration systems, to combat SARS-CoV-2 on public transit systems.
EPA states that it will make the results of this research available to help inform decisions on the use of longer-lasting disinfection products, including information on the frequency of use to maintain disinfection capabilities over time.
Additional information on EPA’s research on COVID-19 in the environment is available here.
By Lisa M. Campbell and Timothy D. Backstrom
On December 6, 2018, the U.S. Environmental Protection Agency (EPA) announced it was proposing a rule (83 Fed. Reg. 62760) to harmonize the EPA-specific regulations regarding research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes with the revised regulations of the Federal Policy for the Protection of Human Subjects (Common Rule) issued on January 19, 2017 (82 Fed. Reg. 7149). Specifically, EPA is proposing to amend subparts C, D, K, and M of its regulations relating to human research. Subpart K, titled “Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults,” contains the majority of the revisions. Subparts C and D will be revised to update several numerical citations and subpart M will be revised to correct a typographical error.
By way of background, the Common Rule governs research with human subjects conducted or supported by federal agencies, but EPA has also promulgated parallel requirements governing research conducted by third parties and then submitted to EPA for regulatory purposes. In particular, Subpart K addresses human research that may be conducted by third parties and then utilized to support registration of pesticides. Congress mandated various revisions to the Common Rule (including additional requirements for research involving pregnant women, fetuses, and children), and EPA is now modifying the EPA-specific requirements for human research to assure consistency and uniformity. These changes are also intended to assure that a single Institutional Review Board (IRB) review meeting the requirements of the Common Rule will be sufficient for any given study.
The proposed rule states that subpart K, “in establishing a process for review of third-party research involving intentional exposure of human subjects, borrows heavily from the provisions contained in the previous version of the Common Rule,” and that it will be revised to “maintain consistency of [IRB] review between agency-conducted or agency-sponsored human research and third-party human research.” EPA states the consequence of not resolving these discrepancies will be to “create confusion and, more seriously, potential compliance and/or legal liabilities for researchers, institutions, and sponsors who must follow EPA regulations.” Comments on the proposed rule are due by February 4, 2019.
Compliance with the revisions to the Common Rule originally was set for January 19, 2018, but it has been extended to January 21, 2019. The compliance date for the “cooperative research” Section remains January 20, 2020. This proposed rule to revise the requirements for third-party research submitted to EPA would not make substantive changes to the previously adopted final revisions to the Common Rule. The final rule states that cooperative research projects are “those projects covered by this policy that involve more than one institution,” any institution located in the United States that is engaged in cooperative research must “rely upon approval by a single IRB for that portion of the research that is conducted in the United States,” and the reviewing IRB “will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the federal department or agency supporting the research.”
More information on the revision to the Common Rule is available in our blog item “Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects” and on our blog under key phrase Common Rule.
By Lisa M. Campbell and James V. Aidala
Recently, the results of a three-year University of Maryland study assessing the potential chronic sublethal effects on whole honey bee colonies of a diet containing imidacloprid, an insecticide that belongs to the neonicotinoid class of chemicals, at 5, 20, and 100 μg/kg over multiple brood cycles have been released. The study, Assessment of Chronic Sublethal Effects of Imidacloprid on Honey Bee Colony Health, funded primarily by a Cooperative Agreement with the U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) Bee Research Laboratory, concludes that: “chronic exposure to imidacloprid at the higher range of field doses…could cause negative impacts on honey bee colony health and reduced overwintering success, but the most likely encountered high range of field doses relevant for seed-treated crops (5 μg/kg) had negligible effects on colony health and are unlikely a sole cause of colony declines.”
This study examines a number of recent controversial issues behind the bee health discussion, including: whether pesticides have an impact when one examines exposure levels approximating actual field condition exposure levels and whether the pesticide use has a substantial impact on hive and hive survival (and not just an impact on individual bees). The study results will likely be used by others to help evaluate the meaning of many of the studies various researchers have conducted over the past three to five years that are often cited in the media. Critics of these other studies have noted the “excessive” amounts of the pesticides used in the research protocol. They have also noted that, as insecticides, the neonicotinoid products are designed to kill insects, and since bees are insects, some bee mortality can be expected if exposed to the material. The University of Maryland study sought to emulate more realistic field conditions in the study protocol. Its conclusion, that there were “negligible effects on colony health” over a three-year period, is significant.
Also fairly recently, the Congressional Research Service (CRS) issued a report on bee health and pesticides, Bee Health: the Role of Pesticides. The report states that although the report focuses on bee exposure to pesticides, this does not imply that pesticides have a higher influence on the health and wellness of bees than other identified factors. The report states: “Although pesticides have been shown to damage bee health, it is unclear whether the level of harm is sufficient to attribute pesticides as the single or as the major cause of honey bee population declines.” The report further states that there is “the possibility that bees are being negatively affected by cumulative, multiple exposures and/or the interactive effects of several of these factors.” The CRS report refers to conclusions outlined in the USDA and the U.S. Environmental Protection Agency’s (EPA) joint Report on the National Stakeholders Conference on Honey Bee Health, including that “no research conclusively points to one single cause for the large number of honey bee deaths.”
The report details several actions the federal government is taking to promote the health of honey bees and other pollinators:
* The establishment of a Pollinator Health Task Force co-chaired by USDA and EPA that will “focus federal efforts on understanding, preventing, and recovering from pollinator losses.”
* EPA’s pesticide registration review of all neonicotinoid insecticides, and EPA’s development of new pesticide labels that prohibit use of some neonicotinoid pesticide products where bees are present, including products containing imidacloprid, dinotefuran, clothianidin, thiamethoxam, tolfenpyrad, and cyantraniliprole.
* The U.S. Fish and Wildlife Service (FWS) will be phasing out the use of neonicotinoid pesticides in all of its wildlife refuges as well as the feeding of genetically engineered crops to wildlife by January 2016.
By James V. Aidala
On June 20, 2014, President Obama issued a Presidential memorandum entitled “Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators.” The memorandum creates a Pollinator Health Task Force, which will be co-chaired by the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA). The Task Force will develop a National Pollinator Health Strategy, which includes a Pollinator Research Action Plan, Public Education Plan, and public-private partnerships. In addition, Task Force members will take steps to increase and improve pollinator habitat. The Presidential memorandum is available online.
Various stakeholders anticipated some kind of Presidential activity during Pollinator Week, and these pronouncements establish some new initiatives that are not likely too controversial among the pesticide registrant community. Nevertheless, their issuance and activities that will take place as a result of them bear close attention and monitoring from the registrant community, particularly as advocacy groups may see the actions as too little.
Under the Presidential memorandum, the Pollinator Health Task Force has 180 days to develop a National Pollinator Health Strategy, which shall include explicit goals, milestones, and metrics to measure progress.