Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By James V. Aidala, Heather F. Collins, M.S., and Barbara A. Christianson

On August 13, 2021, the U.S. Environmental Protection Agency (EPA) announced that it appointed two new members, Cheryl A. Murphy, Ph.D., Professor, Director of Center for PFAS Research, Michigan State University, and Veronica J. Berrocal, Ph.D., Associate Professor, Department of Statistics, University of California, to serve on the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). The Chair and one other existing member also were reappointed. These appointments, effective July 30, 2021, were made by the EPA Administrator following nominations provided by the National Institutes of Health (NIH) and the National Science Foundation (NSF).

Members of the FIFRA SAP serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to human health and ecological risk assessment of pesticides. Members also have background and experiences that typically contribute to the diversity of scientific viewpoints on the Panel.

The FIFRA SAP serves as a primary scientific peer review mechanism of EPA’s Office of Pesticide Programs and is structured to provide independent scientific advice and recommendations to EPA on health and safety issues related to pesticides.

The FIFRA SAP is composed of the following scientists:

  • Robert E. Chapin, Ph.D., Chair
    • Affiliation:  Former Senior Research Fellow (Retired), Pfizer Global Research and Development, Groton, Connecticut
    • Expertise: In vitro predictive toxicology; pre-conception reproductive toxicology
    • Education: Ph.D., Pharmacology, University of North Carolina, Chapel Hill; B.A., Biology, Earlham College
  • Veronica, J. Berrocal, Ph.D., Member
    • Affiliation: Associate Professor, Department of Statistics, University of California, Irvine, California
    • Expertise: Statistics; spatial and spatio-temporal statistics; statistical methods for environmental exposure assessment; spatial and environmental epidemiology
    • Education: Ph.D. Statistics, University of Washington, Seattle, Washington; M.Sc. Statistics, Michigan State University, East Lansing, Michigan; Laurea in Mathematics, Universita’ “La Sapienza,” Roma, Italy; and Degree of Etudes Approfondis (DEA) en Mathematiques, Universite’ “Joseph Fourier,” now part of Universite’ Grenoble Alpes, Grenoble, France
  • Jeffrey R. Bloomquist, Ph.D., Member
    • Affiliation: Professor of Entomology, Entomology and Nematology Department, Emerging Pathogens Institute, University of Florida, Gainesville, Florida
    • Expertise: Chemistry, human and insect neurophysiology, neurochemistry, insecticide toxicology, mode of action, and resistance; including studies of comparative neurotoxicology and environmental Parkinsonism
    • Education: Ph.D. Entomology, University of California, Riverside, California; M.S. Entomology, Mississippi State University, Mississippi; B.S. Entomology, Purdue University, Indiana; and Postdoctoral appointment in Insecticide Toxicology, Cornell University, New York
  • Gaylia Jean Harry, Ph.D., Member
    • Affiliation: Group Leader, Neurotoxicology Laboratory, National Toxicology Program, National Institute of Environmental Health Sciences (NTP/NIEHS), Research Triangle Park, North Carolina
    • Expertise: Mode of action of environmental agents on the nervous system with focused interest on the developing nervous system, neurotoxicology, neuropathology, behavioral assessments, neuroinflammation, and developmental processes using in vivo and in vitro models
    • Education: Ph.D. Experimental Psychology, Virginia Commonwealth University; M.S. Psychology, Virginia Commonwealth University; and B.S. Psychology, Virginia Commonwealth University, Richmond, Virginia
  • Cheryl A. Murphy, Ph.D., Member
    • Affiliation: Professor, Director of Center for PFAS Research, Michigan State University, East Lansing, Michigan
    • Expertise: Ecological Toxicology, Adverse Outcome Pathways, Fish Physiology, Behavior
    • Education: Ph.D. Department of Oceanography and Coastal Sciences, Louisiana State University, Baton Rouge, Louisiana; M.S. Physiology and Cell Biology, University of Alberta, Edmonton, Alberta; and BSc (Honors) Marine Biology, Dalhousie University, Halifax Regional Municipality, Nova Scotia
  • Rebecca L Smith, D.V.M., Ph.D., Member
    • Affiliation: Assistant Professor, Department of Pathobiology, College of Veterinary Medicine, University of Illinois, Urbana-Champaign, Illinois
    • Expertise: Epidemiologic research on longitudinal data analysis and mathematical modeling of diseases for purposes of prediction and control, with a focus on One Health
    • Education: Ph.D. Epidemiology, Cornell University; M.S. Biosecurity and Risk Analysis, Kansas State University. D.V.M. Cornell University; B.A. Biology, Gustavus Adolphus College
  • Clifford P. Weisel, Ph.D., Member
    • Affiliation: Professor, Rutgers University, Piscataway, New Jersey
    • Expertise: Exposures to chemical agents; multi-route exposures to environmental contaminants; the association between exposure and adverse health effects; utilization of sensors for continuous exposure measurement; and development and application of biomarkers of exposure
    • Education: Ph.D. Chemical Oceanography, University of Rhode Island; M.S. Analytical Chemical, University of Rhode Island; and B.S. Chemistry, State University of New York at Stony Brook

Additional biographical details on the current members is available here.

Commentary

The FIFRA SAP has been an important element of EPA’s pesticide program scientific review procedures. The pesticide program has been able to use the FIFRA SAP as an outside review element to add credibility to its key scientific policies over the decades since it was created as part of the FIFRA legislative amendments in the 1970s. (In fact, the FIFRA SAP was created before the EPA-wide Science Advisory Board (SAB).) Also important is the statutory provision, added as part of the Food Quality Protection Act in 1996, to establish a Science Review Board made up of 60 scientists “who shall be available to the Scientific Advisory Panel to assist in reviews conducted by the Panel.” Together, the goal is to have a range of scientific discipline expertise available to offer outside peer review of the wide range of science questions that confront EPA when evaluating pesticide registration issues.


 

By Lynn L. Bergeson, Lisa M. Campbell, and Carla N. Hutton

The U.S. Consumer Product Safety Commission (CPSC) announced on July 14, 2021, that it filed an administrative complaint against Amazon.com, “the world’s largest retailer, to force Amazon to accept responsibility for recalling potentially hazardous products sold on Amazon.com.” CPSC claims that the specified products sold through Amazon’s “fulfilled by Amazon” (FBA) program are defective and pose a risk of serious injury or death to consumers and that Amazon is legally responsible to recall them. According to the complaint, the products include “24,000 faulty carbon monoxide detectors that fail to alarm, numerous children’s sleepwear garments that are in violation of the flammable fabric safety standard risking burn injuries to children, and nearly 400,000 hair dryers sold without the required immersion protection devices that protect consumers against shock and electrocution.”

CPSC filed the complaint under the Consumer Product Safety Act (CPSA). According to the complaint, Amazon acts as a “distributor,” as defined by CPSA, of its FBA products by: (a) receiving delivery of FBA consumer products from a merchant with the intent to distribute the product further; (b) holding, storing, sorting, and preparing for shipment FBA products in its warehouses and fulfillment centers; and (c) distributing FBA consumer products into commerce by delivering FBA products directly to consumers or to common carriers for delivery to consumers.

The complaint states that after CPSC notified Amazon about the hazards presented by the specified products, Amazon took “several unilateral actions,” including:

  • Removing the Amazon Standard Identification Numbers (ASIN) for certain of the specified products; and
  • Notifying consumers who purchased certain of the specified products that they could present a hazard. Amazon also offered a refund to these consumers in the form of an Amazon gift card credited to their account.

According to the complaint, these actions “are insufficient to remediate the hazards posed by the Subject Products and do not constitute a fully effectuated Section 15 mandatory corrective action ordered by” CPSC. The complaint states that “[a] Section 15 order requiring Amazon to take additional actions in conjunction with the CPSC as a distributor is necessary for public safety.” The complaint asks CPSC to:

  1. Determine that Amazon is a distributor of consumer products in commerce, as those terms are defined in the CPSA;
  2. Determine that the specified products are substantial product hazards under CPSA Sections 15(a)(1), 15(a)(2), and 15(j);
  3. Determine that public notification in consultation with CPSC is required to protect the public adequately from substantial products hazards created by the specified products, and order Amazon to take actions set out in CPSA Section 15(c)(1), including but not limited to:
    1. Cease distribution of the specified products, including removal of the ASINs and any other listings of the specified products and functionally identical products, from Amazon’s online marketplace and identifying such ASINs to CPSC;
    2. Issue a CPSC-approved direct notice to all consumers who purchased the specified products that includes a particularized description of the hazard presented by each specified product and encourage the return of the specified product;
    3. Issue a CPSC-approved press release, as well as any other public notice documents or postings required by CPSC staff, that inform consumers of the hazard posed by the specified products and encourage the return or destruction of the specified products;
  4. Order that Amazon facilitate the return and destruction of the specified products, at no cost to consumers, to protect the public adequately from the substantial product hazard posed by the specified products, and order Amazon to take actions set out in CPSA Section 15(d)(1), including but not limited to:
    1. Refund the full the purchase price to all consumers who purchased the specified products and, to the extent not already completed, conditioning such refunds on consumers returning the specified products or providing proof of destruction;
    2. Destroy the specified products that are returned to Amazon by consumers or that remain in Amazon’s inventory, with proof of such destruction via a certificate of destruction or other acceptable documentation provided to CPSC staff;
    3. Provide monthly progress reports to reflect, among other things, the number of specified products located in Amazon’s inventory, returned by consumers, and destroyed;
    4. Provide monthly progress reports identifying all functionally equivalent products removed by Amazon from amazon.com pursuant to the CPSC Order, including the ASIN, the number distributed prior to removal, and the platform through which the products were sold;
  5. Provide monthly reports summarizing the incident data submitted to CPSC through the Retailer Reporting Program;
  6. Order that Amazon is prohibited from distributing in commerce the specified products, including any functionally identical products; and
  7. Order that Amazon take other and further actions as CPSC deems necessary to protect the public health and safety and to comply with CPSA and the Flammable Fabrics Act (FFA).

CPSC “urges consumers to visit SaferProducts.gov to check for recalls prior to purchasing products and to report any incidents or injuries to the CPSC.” CPSC published the complaint in the July 21, 2021, Federal Register. 86 Fed. Reg. 38450.

Commentary

In CPSC’s July 14, 2021, press release, Acting Chair Robert Adler states that the decision to file an administrative complaint is “a huge step across a vast desert -- we must grapple with how to deal with these massive third-party platforms more efficiently, and how best to protect the American consumers who rely on them.” According to The Washington Post, CPSC issued the administrative complaint “after months of behind-the-scenes negotiations between regulators and Amazon as the agency tried to persuade the company to follow the CPSC’s rules for getting dangerous products off the market, according to a senior agency official who spoke on the condition of anonymity to comment on internal discussions.” This same official stated that “Amazon officials refused to acknowledge that the CPSC has the authority to compel the company to remove unsafe products.”

As reported in our February 16, 2018, blog item, “EPA Settles with Amazon on Distribution of Unregistered Pesticides,” the U.S. Environmental Protection Agency (EPA) and Amazon entered into a Consent Agreement and Final Order (CAFO) whereby Amazon agreed to pay $1,215,700 in civil penalties for approximately 4,000 alleged violations under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the distribution of unregistered pesticide products. EPA later issued stop sale, use, or removal orders (SSURO) to Amazon and eBay for selling certain pesticide products that EPA claims are unregistered, misbranded, or restricted-use pesticides, and pesticide devices that EPA asserts make false or misleading claims. More information on the SSURO is available in our June 17, 2020, blog item, “EPA Issues Stop Sale, Use, or Removal Orders to Amazon and eBay for Unregistered and Misbranded Pesticides and Devices, Including Products with Claims Related to COVID-19.”

As reported in our October 9, 2020, blog item, Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, requested that Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall practices. The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.” According to the press release, many of these products were never recalled and continue to be sold.

CPSC’s administrative complaint is just the latest indication of the pressure on Amazon to ensure the safety of the products the platform hosts. These federal agency and Congressional efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant with the relevant regulations.


 

By Lisa M. Campbell and Lisa R. Burchi

On July 12, 2021, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register a notice of availability of a petition filed on April 8, 2021, by the Center for Biological Diversity (CBD) requesting that EPA cancel Elanco US Inc.’s (formerly Bayer Healthcare LLC) Product, PNR1427, more commonly known as Seresto (Petition). 86 Fed. Reg. 36546. The Petition also requests that EPA suspend the registration pending the requested cancellation. Seresto has been registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) since 2012 for flea and tick treatment on adult dogs and puppies and on adult cats and kittens.

Comments on the Petition are due on or before September 10, 2021, in docket EPA-HQ-OPP-2021-0409.

Under FIFRA Section 6(b), EPA may cancel a pesticide product’s registration if it appears to EPA that the pesticide, “when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment.” In its Petition, CBD states that, “according to a recent aggregate incident summary report, since this product was introduced in 2012, EPA has received over 75,000 adverse incident reports, including at least 1,698 reports linking the use of this product to pet deaths and at least 700 involving human harm.” CBD states this product “contains as active ingredients the neonicotinoid imidacloprid (10%) and the pyrethroid flumethrin (4.5%).” CBD states further, “Understanding each of these ingredients, alone and in combination, is important for understanding the toxicity and risks that their use in Seresto presents to dogs, cats, humans, and exposed threatened and endangered species.” With regard to imidacloprid, CBD states in its Petition, “Neonicotinoids like imidacloprid are most well-known for the harms they cause to pollinator species, including threatened and endangered pollinators like the Poweshiek skipperling (endangered), Dakota skipper (threatened), and rusty patched bumble bee (endangered).” The Petition discusses several studies and EPA risk assessments related to both ingredients, as well as what it describes as the “synergistic effects” of the combination of imidacloprid and flumethrin. CBD argues that Seresto poses an unreasonable risk to human health, pets, and the environment and that EPA should cancel the registration pursuant to FIFRA Section 6(b).

CBD additionally argues that EPA should suspend the registration, asserting that EPA can suspend a pesticide’s registration under FIFRA Section 6(c)(1) when such action is necessary to prevent an “imminent hazard” during the time required for cancellation. The standard to be met to be considered an imminent hazard is high, as “imminent hazard” is defined under FIFRA Section 2(l) as “a situation which exists when the continued use of a pesticide during the time required for [a] cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered or threatened.” CBD argues that suspension is warranted in this case because, CDC asserts, both criteria for an imminent hazard are satisfied -- CDC asserts that the products at issue pose both “ongoing and imminent unreasonable adverse effects on the environment and unreasonable hazard to the survival of the endangered rusty patched bumble bee, as well as other imperiled pollinators).”

Commentary

This Petition is one prong in a larger effort by certain groups to halt sales and use of Seresto. EPA’s press release statements indicate that EPA shares some concerns raised by the petitioners, at least with regard to incidents involving pets. EPA further stated in its press release that it is reviewing additional information requested by EPA from the current and former registrant regarding these incidents, and that it will use that information “along with any relevant information received during the public comment on this petition, to determine if any additional action is needed.” It will be important to monitor EPA’s review and response to this petition.


 

By Lisa M. Campbell, Lisa R. Burchi, and Heather F. Collins, M.S.

On July 8, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a Stop Sale, Use or Removal Order (SSURO) to Allied BioScience for its product SurfaceWise2. SurfaceWise2, a residual antimicrobial surface coating, was previously authorized for emergency use in Arkansas, Oklahoma, and Texas to help address the COVID-19 pandemic. Specific use sites included American Airlines aircraft and airport facilities and two orthopedic facilities in Texas. A discussion of these emergency authorizations can be found here.

EPA asserts that the company was marketing, selling, and distributing SurfaceWise2 in ways that were inconsistent with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the terms and conditions of the emergency exemption authorizations, and issued an SSURO that requires Allied BioScience to stop selling and distributing SurfaceWise2 immediately. The SSURO will remain in effect unless revoked, terminated, suspended, or modified in writing by EPA.

Additionally, EPA states that it is revoking SurfaceWise2 emergency exemptions for Arkansas and Texas based on the FIFRA violations that EPA is alleging and scientific concerns regarding product performance. According to EPA, since January, new data became available that led EPA to review comprehensively new and existing information regarding product efficacy. EPA states that its laboratory testing indicates the product’s performance is less reliable under real-world conditions than, presumably, data that EPA previously reviewed may have indicated to EPA, particularly when it is exposed to moisture or abrasion.

In May 2021, EPA received a revocation request from Oklahoma indicating the emergency situation was no longer applicable in the state. EPA stated that it is accepting Oklahoma’s rationale and revoking the state’s emergency exemption on those grounds. This action is in addition to revoking the emergency exemptions for Arkansas and Texas.

Commentary

EPA initially approved in August 2020 the emergency exemptions for SurfaceWise2 for specific locations under Section 18 of FIFRA for use against SARS-CoV-2, the virus that causes COVID-19, on surfaces for up to seven days. In January 2021, EPA announced approval of extensions for the first-ever long-lasting antiviral product for use against SARS-CoV-2, with claims providing residual surface control of coronaviruses, including SARS-CoV-2, for up to 30 days on undisturbed (e.g., not routinely disinfected with List N products) non-porous treated surfaces. These approvals were novel and touted by EPA in its effort to combat the coronavirus. It is not unusual for EPA to issue an SSURO to stop sales for a product that is being marketed, sold, and distributed in a manner inconsistent with its label, but the issuance of an SSURO in this instance is noteworthy given EPA’s prior support of the product. Likewise, the fact that EPA conducted its own efficacy testing on this product is atypical. The implications of EPA’s conducting its own testing of the product could potentially have broader implications for novel antimicrobial products claiming long-term efficacy. Additionally noteworthy is the fact that this case emphasizes again EPA’s view that products intended to combat COVID-19 on surfaces are not in need of emergency or expedited approvals.


 

By Heather F. Collins, M.S. and Barbara A. Christianson

On July 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it is taking action to alleviate a supply-chain issue facing the pesticide industry. EPA stated that it is allowing registrants of non-antimicrobial pesticide products to substitute some combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide feedstocks that are in limited supply due to weather events that occurred in the U.S. Gulf Coast area in February 2021. EPA stated that it is allowing these substitutions even in cases where propylene glycol is added to the formulation or is part of a brand-name mixture in which the full composition is known to the registrant.

The pre-approved alternates are glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5); diethylene glycol (CAS RN 111-46-6); ethylene glycol (CAS RN 107-21-1); and 1,3-propanediol (CAS RN 504-63-2).

EPA emphasizes that this action, known as “Propylene Glycol Phase 2 -- ‘Not In-Kind’ Substitution Mechanism,” relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.

In April 2021, EPA implemented “Propylene Glycol Phase 1 -- ‘In-Kind’ Substitution Mechanism” to allow certain in-kind substitutions to address propylene glycol supply-chain shortages.

These actions require registrants to self-certify that the substitute inert ingredients serve the same function in the product as propylene glycol and that the change will not impact either the validity of any product-specific data submitted in support of the registration or the product’s acute toxicity category or physical/chemical characteristics in a way that would require label modifications. Registrants must also certify that the substitution will not affect the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, or any other factor.

This action is time limited, extending to December 31, 2021. Any registrants who wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.


 

By Carla N. Hutton

The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have received a draft assessment of glyphosate carried out by four European Union (EU) member states and have begun to consider the findings. According to ECHA’s June 15, 2021, press release, the national authorities of France, Hungary, the Netherlands, and Sweden -- known as the Assessment Group of Glyphosate (AGG) -- examined all the evidence submitted by the companies that are seeking renewed approval to market the glyphosate in the EU. Glyphosate is currently authorized for use in the EU until December 2022.

ECHA and EFSA will organize parallel consultations on the draft report. These will be open to the public and will be held in the first week of September 2021. According to ECHA, the consultations are the first step in the assessments. ECHA’s Committee for Risk Assessment (RAC) will review the classification of glyphosate under the Classification, Labeling and Packaging (CLP) Regulation. ECHA notes that chemical classification is based solely on the hazardous properties of a substance and does not consider the likelihood of exposure. Exposure is considered as part of the risk assessment process led by EFSA.

Glyphosate currently has a harmonized classification as causing serious eye damage and as toxic to aquatic life with long-lasting effects, prior to and following ECHA’s 2017 assessment. ECHA states that no classification for germ cell mutagenicity, carcinogenicity, or reproductive toxicity was warranted. The AGG proposal does not foresee a change to the existing classification.

Once ECHA adopts its opinion on the classification of glyphosate, EFSA will prepare a final peer review and publish its conclusions, expected in late 2022. Based on this risk assessment, the European Commission (EC) will decide whether to renew glyphosate.


 

By Lisa M. Campbell and Lisa R. Burchi

On June 7, 2021, Health Canada’s Pest Management Regulatory Agency (PMRA) announced the issuance of its Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices under the Pest Control Products Act (Interim Order), setting forth new requirements for certain devices claiming to control, destroy, make inactive, or reduce the level of bacteria, viruses, and other micro-organisms that are human pathogens. PMRA also issued an “Explanatory Note” and a Questions and Answers document regarding the Interim Order.

PMRA states that it issued the Interim Order following the increased sale of ultraviolet (UV) radiation-emitting and ozone-generating devices such as lights and wands in Canada since the COVID-19 pandemic. These devices are marketed to kill bacteria and viruses, including SARS-CoV-2, the virus that causes COVID-19. According to PMRA, it has not received enough evidence to confirm that UV radiation-emitting and ozone-generating devices are safe for users and the public, or that they are effective.

Thus, PMRA is now requiring that companies register certain UV radiation-emitting devices and ozone-generating devices before they may be sold or used in Canada. In its Explanatory Note, PMRA states:

By bringing certain UV and ozone-generating devices under the [Pest Control Products Act (PCPA)], they need to be registered or otherwise authorized in order to be on the Canadian market. An application to register a pest control product must be submitted to Health Canada in the form and manner directed by the Minister and must include any information and other material that is required by the Pest Control Products Regulations to accompany the application. Applications to register devices consist of a number of information and data requirements, including a cover letter stating the purpose of the application, an application and fee estimate forms, the proposed English and French product labels, as well as data to support the safety and efficacy of the device. A registration will be granted under the PCPA if the Minister considers that the health and environmental risks and the value of the device are acceptable after any required assessments.

The Interim Order clarifies that certain UV radiation-emitting devices and ozone-generating devices claiming to kill bacteria and viruses are not subject to the regulatory requirements of the PCPA and its Regulations. These include:

  • Devices that are manufactured, represented, distributed, or used to control, destroy, or inactivate viruses, bacteria, or other micro-organisms that are human pathogens for use in swimming pools, spas, or wastewater treatment systems;
  • Devices that meet the definition of “device” in Section 2 of the Food and Drugs Act and are classified as a Class II, III, or IV medical device under the Medical Devices Regulations; and
  • UV radiation-emitting devices that satisfy the following conditions:
    • The device is certified by a standards development organization accredited by the Standards Council of Canada as meeting the applicable Canadian electrical safety requirements;
    • The certification mark of the standards development organization appears on the label of the device;
    • Any efficacy claim that is made in respect of the device is only a claim of supplemental sanitization;
    • No express or implied reference to prevention, treatment, or mitigation of disease is made in respect of the device;
    • The device has at least one of the following mechanisms:
      • A mechanism that locks the device during operation, or
      • A mechanism that automatically shuts off the device if it is opened during operation; and
    • The UV lamp is fully shielded or enclosed in the device in a manner that prevents access to it by users of the device and prevents exposure to UV radiation.

For UV radiation-emitting devices that satisfy these conditions, there are additional labeling requirements for the display panels and operating manual.

Discussion

This Interim Order changes significantly the requirements applicable to these types of devices that did not previously require registration. PMRA is providing a 30-day transition period after the Interim Order is issued before companies must comply with these requirements. PMRA also is advising Canadians to “stop using UV lights and wands that claim to disinfect against the virus that causes COVID-19 especially if the product is for use on the skin.”

Companies that produce devices that may be subject to this Interim Order should review the new requirements and exemptions carefully. PMRA states that unregistered or unauthorized devices are prohibited and may be subject to compliance and enforcement action.


 

By Barbara A. Christianson

On June 4, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will host a webinar for pesticide registrants to provide registrants an overview on how to request Certificates of Registration, commonly known as Gold Seal letters, using the Pesticide Submission Portal. Gold Seal letters serve as proof for pesticide exporters that the product is registered with EPA and meets all necessary registration requirements.

According to EPA, since launching the digital platform in 2020 in response to the COVID-19 public health emergency, the electronic process has resulted in quicker processing of Gold Seal letters and thorough and complete internal tracking. Due to continuing safety precautions within EPA, it is still unable to produce traditional, paper-based Gold Seal letters. Accordingly, registrants must continue to submit requests through the Pesticide Submission Portal.

Stakeholders interested in attending the presentation can click here to join the online meeting (registration is not required). The webinar will be held on June 14, 2021, at 1:00 p.m. (EDT).

Information on how to request a Gold Seal certificate letter, including information on how registrants should present the letters to the U.S. Department of State when authentication is needed for business purposes, is available here.


 

By Heather F. Collins, M.S. and Barbara A. Christianson

On May 10, 2021, the U.S. Environmental Protection Agency (EPA) announced the launch of an electronic Confidential Statement of Formula application (eCSF builder) to support pesticide registration applications. The new electronic tool is part of EPA’s interest in improving and modernizing the internal processes and digital workflows for pesticide registration submissions.

As part of the registration process for new pesticide products, EPA requires the submission of a Confidential Statement of Formula (CSF). The form lists all the product’s components and percent by weight, along with various additional information.

Currently, CSF applications must be submitted to EPA in hard copy. The new eCSF builder will automatically validate certain data in a CSF application prior to submission to EPA. EPA states this functionality, along with real-time validation of chemical ingredients through EPA’s Substance Registry Services, will make the pesticide registration process more efficient, saving EPA and registrants time and resources. While paper CSF forms remain available, EPA encourages submitting applications electronically, as the review of paper applications could be a longer process.

Users can access the eCSF builder on the Central Data Exchange (CDX) under Pre-Submission Tools, Form Builders, by clicking the Create eCSF button. Users can provide feedback to EPA through the CDX.

Additional information is available on our blog.


 

By Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on May 6, 2021, that Bear River Supply Inc., based in Rio Oso, California, has agreed to pay a $50,578 penalty to resolve EPA’s findings that the Company produced pesticides in an unregistered establishment, distributed and sold misbranded pesticides, and failed to maintain equipment properly. According to EPA, the California Department of Pesticide Regulation (CDPR) and EPA discovered the violations during a series of inspections conducted at two separate facilities in Rio Oso. Inspectors found that “Vistaspray 440 Spray Oil” and “Roundup PowerMax” were being repackaged and distributed with improper labeling. In addition, EPA states, inspectors determined that Bear River Supply was producing pesticides in a facility that was not registered with EPA. While at the facilities, inspectors also found that a secondary containment unit and loading pad, both used to contain potential spills, were inadequate.  The Company has since corrected the violations.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), pesticide manufacturers must register their facilities with EPA and annually report their pesticide production. EPA states that production records provide information on the quantities of pesticides produced and distributed. EPA notes that in addition, the number assigned to the establishment must appear on the label. FIFRA’s reporting and labeling requirements allow EPA and state agencies to track pesticide products back to the companies that produced them and “are necessary to ensure safe management and distribution” of pesticides.


 
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