By Heather F. Collins, M.S.

The March 1, 2023, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2022 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered under [Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”

Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.

EPA has created the electronic reporting system to submit pesticide-producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics. EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report.

Links to EPA Form 3540-16, as well as instructions on how to report and how to add and use EPA’s SSTS electronic filing system, are available below.

• EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments;
• Instructions for Completing EPA Form 3540-16 (available within the ZIP file); and
• Electronic Reporting for Pesticide Establishments.

Further information is available on EPA’s website.

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By Lisa R. Burchi, James V. Aidala, and Barbara A. Christianson

On November 15, 2022, the California Department of Pesticide Regulation (DPR) made two announcements: an enforcement action relating to 1,3-Dichloropropene (1,3-D) and chloropicrin and an announcement on a proposed rule on additional use restrictions on 1,3-D. These actions may have significant impacts on registrants and growers who use soil fumigants.

Enforcement Action

DPR issued a licensing action against TriCal, a company that performs field fumigations, primarily using chloropicrin and 1,3-D. DPR found that TriCal had numerous violations that resulted in serious illness and injury and dozens of other violations. During a licensing action, DPR can seek civil penalties or seek to revoke or suspend the license of a company that is licensed to do pest control work, sell pesticides, or advise on pest control in California.

DPR states that TriCal has been subject to past enforcement actions dating back to 2014. These past violations include a combined 40 incidents -- four of which were “priority episodes” (i.e., incidents involving serious illness or injury, or an episode involving five or more people). Specifically, TriCal paid over $125,000 in administrative civil penalties to County Agricultural Commissioners and a $44,275 fine to the U.S. Environmental Protection Agency (EPA).

DPR’s press release states that nine episodes were cited in the most recent licensing action, including the following:

• In October 2020, DPR alleged 20 residential bystanders and three members of the Salinas Fire Department experienced symptoms of pesticide exposure from a TriCal misapplication.
• In October 2019, DPR alleged 39 fieldworkers were exposed to 1,3-D and chloropicrin due to TriCal’s misapplication. Thirty-two fieldworkers experienced symptoms of pesticide exposure, and three people sought medical care for their symptoms.
• In October 2018, DPR alleged TriCal misapplied a product containing 1,3-D and chloropicrin and, as a result, 13 residential bystanders experienced symptoms of pesticide exposure.

This licensing action comes as DPR announces proposed regulatory requirements to strengthen use restrictions on 1,3-D to protect public health. In its proposed regulation, DPR 22-005 Health Risk Mitigation and Volatile Organic Compound Emission Reduction for 1,3-Dichloropropene, DPR states its “broad objectives of the proposed regulations are to mitigate the potential 72-hour acute risk and 70-year lifetime cancer risk to non-occupational bystanders from the use of 1,3-D, and to reduce [volatile organic compound] VOC emissions from 1, 3-D field soil fumigations.” This proposal is based in part on a health-protective regulatory target established last year after consultation with state and local agencies. Specifically, the proposed action, if issued in final, would:

1. Allow the use of 1,3-D only for the production of agricultural commodities, effectively prohibiting other uses that are not currently registered;
2. Establish mandatory setbacks (distances from occupied structures where 1,3-D cannot be applied);
3. Set limits on the application rate and acres treated for individual field soil fumigations;
4. Place restrictions on multiple field soil fumigations that do not meet distance or time separation criteria;
5. Limit the allowed methods to apply 1,3-D, including establishing criteria for acceptable types of tarpaulins that can be used;
6. Require an annual report from DPR that includes evaluations of 1,3-D use and air monitoring results; and
7. Require the inclusion of certain information in existing pesticide use records and pesticide use reports.

Comments are due on or before January 18, 2023. DPR will accept written comments that are submitted via U.S. mail and postmarked no later than January 18, 2023. Comments also may be transmitted via e-mail to .(JavaScript must be enabled to view this email address) or by facsimile at 916-324-1491 and must be received no later than 5:00 p.m. (PST) on January 18, 2023.

DPR will conduct a public hearing to accept comments on these amendments. The public hearing is scheduled for January 18, 2023, starting at 9:30 a.m. (PST). The hearing will be in a hybrid format with both a physical location and an option to participate remotely:

Physical Location:

CalEPA Headquarters Building

Byron Sher Auditorium

1001 I Street, 2nd Floor

Sacramento, CA 95814

Remote Location:

Zoom

Webinar ID: 826 1358 3257

Password: 045724

Direct link to join the meeting from a web browser or Zoom client:

https://us02web.zoom.us/j/82613583257?pwd=UGJ0WkxtbFlFYUdrQmJYb3V3QyszUT09

One tap to join from a mobile phone: +16699009128,,82613583257#,,,,*045724#

Or call from a landline: +1-669-900-9128 and enter the Webinar ID and Password (above) when prompted

The hearing also will be accessible via public webcast for persons who would like to watch this hearing without participating. The public webcast can be accessed by visiting the following web address: https://video.calepa.ca.gov/#/

Commentary

These actions add many new restrictions on the use of these pesticides. Growers who rely on these products will have to comply with the new restrictions and hope that they address the state’s concerns or face additional restrictions or even a decision by DPR to not register the pesticides regardless of what EPA’s federal label allows. The state actions may in turn raise new issues for EPA. DPR’s justification for greater controls mentions the possible impact on local communities, which may cause greater focus on environmental justice matters, and the evolution of this issue should be monitored.

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By Lisa R. Burchi and Barbara A. Christianson

On November 3, 2022, the California Department of Pesticide Regulation (DPR) announced it reached a settlement agreement with Amazon.com Services, LLC (Amazon) regarding the illegal sale of pesticides in California. According to DPR, its review of Amazon uncovered multiple violations. Among them, it sold unregistered pesticides in California, failed to report and pay required mill assessment fees associated with the sale of registered pesticides in California, and failed to hold a valid pesticide broker’s license.

Under the terms of the agreement, Amazon will pay DPR a total of $4.97 million -- $3.69 million in unpaid pesticide sales assessment fees and related late penalties, and $1.28 million in civil penalties associated with retail sales of unregistered pesticides into California. DPR states that Amazon also agreed to register as a pesticide broker and report and pay the mill assessment fees associated with all future retail sales of registered pesticides into California.

Under California law, pesticides that are registered by EPA also must be registered by the state before they are used, possessed, or offered for sale in California. Based on DPR’s evaluation of a product’s potential human health and environmental risks and efficacy, DPR may impose state-specific requirements, including additional data requirements or label use restrictions.

California also has its own state requirements for mill assessments, which is a fee to be paid for sales of pesticides that are registered with DPR and sold into California. Specifically, a mill assessment is charged at the first point of sale of a pesticide in California. Generally, the registrant is responsible for reporting sales and paying the mill assessment when it has knowledge, at the time of sales, that the pesticide is being sold in California. If the registrant does not have knowledge at the time of sale, the party that is the first to sell the pesticide in California is responsible for reporting and paying the mill assessment. If a party other than the registrant is the first to sell a pesticide into or within California, this first seller party must obtain either a pesticide broker or a pest control dealer license (whichever is appropriate) from DPR.

Additional information on DPR’s programs is available here.

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By Heather F. Collins, M.S.

The March 1, 2022, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2021 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”

Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information, such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.

EPA has created the electronic reporting system to submit pesticide-producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics. EPA is encouraging all reporters to submit electronically to ensure proper submission and a timely review of the report.

Links to EPA Form 3540-16, as well as instructions on how to report and how to add and use EPA’s SSTS electronic filing system, are available below.

• EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments;
• Instructions for Completing EPA Form 3540-16 (available within the ZIP file); and
• Electronic Reporting for Pesticide Establishments.

Further information is available on EPA’s website.

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By Lisa R. Burchi and Barbara A. Christianson

On December 30, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule rescinding the March 2, 2020, final rule (2020 inspection rule) regarding EPA’s procedures for conducting on-site civil inspections. This final rule applies to on-site inspections conducted by EPA civil inspectors, federal contractors, and Senior Environmental Employment employees conducting inspections on behalf of EPA.

This rule is effective immediately, as EPA states this rulemaking is procedural rather than substantive.

The 2020 inspection rule was promulgated to implement Executive Order (EO) 13892, “Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication” (84 Fed. Reg. 55239). The 2020 inspection rule, codified at 40 C.F.R. Part 31, set forth the elements of the process to conduct on-site civil inspections (e.g., timing of inspections, opening and closing conferences, document review) and guidance regarding each element.

EPA states it is rescinding the 2020 inspection rule in accordance with EO 13992, “Revocation of Certain Executive Orders Concerning Federal Regulation,” issued by President Biden on January 20, 2021 (86 Fed. Reg. 7049). Specifically, EO 13992 revokes EO 13892, stating that it is the policy of the Biden Administration “to use available tools to confront the urgent challenges facing the Nation, including the coronavirus disease 2019 (COVID-19) pandemic, economic recovery, racial justice, and climate change. To tackle these challenges effectively, executive departments and agencies (agencies) must be equipped with the flexibility to use robust regulatory action to address national priorities. This order revokes harmful policies and directives that threaten to frustrate the Federal Government's ability to confront these problems, and empowers agencies to use appropriate regulatory tools to achieve these goals.”

According to EPA, the 2020 inspection rule being rescinded converted a subset of what had been long-standing civil inspection practices, guided by applicable Agency policies, into “rules” of EPA procedure by which “all” civil inspections “shall be conducted.” 40 C.F.R. Part 31.1(a). EPA states:

Although not altering the rights of parties outside of EPA, the change from an Agency practice to a rule of procedure reduces the flexibility that is inherent in implementing agency policies in a case-by-case manner. The procedures for inspections must be adaptable to the site-specific conditions that the Agency faces in conducting its investigations. By rescinding the 2020 inspection rule, EPA is restoring the flexibility needed when carrying out civil inspections under a myriad of circumstances.

EPA notes that it will continue to employ its policies and methods for public transparency of Agency procedures for conducting on-site civil inspections. For example, EPA notes procedures described in this rule already exist in inspection guidance documents and manuals, which are accessible to the public through EPA’s website. Additionally, EPA states it has met and will meet all statutory obligations pertaining to posting documents for public accessibility. To the extent that concerns arise regarding Agency guidance, a person may -- consistent with the Administrative Procedure Act -- petition EPA, including a request to issue, amend, or repeal EPA guidance, by contacting the EPA program office or regional office that is responsible for administering the area of stakeholder interest.

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By Lisa R. Burchi

On October 7, 2021, U.S. Environmental Protection Agency (EPA) Region 2 announced a settlement with Reckitt Benckiser, LLC (Reckitt Benckiser) regarding alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The specific alleged violations relate to 239 sales and distributions of two rodenticide products in the United States that EPA asserts had misleading advertising claims on the packaging. Reckitt Benckiser has agreed to pay a civil penalty of $458,000 under the settlement to resolve these violations.

Reckitt Benckiser is a supplemental distributor of two rodenticide products that are bait stations registered under FIFRA to kill mice. EPA states that in 2019, it conducted inspections of a Home Depot in South Plainfield, New Jersey, and Reckitt Benckiser’s offices in Parsippany, New Jersey. EPA thereafter determined that Reckitt Benckiser was selling these two rodenticide products in packaging or labeling that made comparative claims as to the effectiveness of the product. Specifically, the packaging stated that the products were “10x Tastier Than Lead Competitor.” The labels EPA approved for the two products did not contain this comparative claim language, and at the time of registration, data associated with the products’ claims were never provided. EPA’s regulations at 40 C.F.R. Section 156.10(a)(5)(iv) provide that statements or representations in the labeling which constitute misbranding include a “false or misleading comparison with other pesticides or devices.” EPA states that because "the comparative claims were not subject to verification, they were ‘false and misleading comparisons’ prohibited under [FIFRA].” 

This case serves as another reminder to registrants and supplemental distributors to review all labeling and advertising claims to ensure conformity with EPA-approved labels and avoidance of claims that EPA identifies as false or misleading. 

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By Kelly N. Garson and Barbara A. Christianson

On August 25, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a penalty against Seychelle Environmental Technologies, Inc. (Seychelle), based in Aliso Viejo, California, for violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The violations, which EPA states that Seychelle has since corrected, involved the sale of unregistered antimicrobial products and the manufacture of products in an unregistered establishment.

According to EPA, in 2017 and 2018, Seychelle sold a collection of related water filtration products known as the “Seychelle Standard Filter” and the “Seychelle Advanced Filter.” EPA states that these Seychelle filter products made “numerous” antimicrobial claims, and thus under FIFRA, EPA considered these products to be pesticides that must be registered with EPA. Additionally, under FIFRA, pesticide manufacturers must register their facilities with EPA as establishments and annually report their pesticide production. Since Seychelle’s water filter products were not produced in an EPA-registered establishment, EPA determined there was another FIFRA violation. Based on the sale or distribution of an unregistered pesticide and the unregistered establishment, EPA assessed a penalty to Seychelle in the amount of $150,000 (USD).

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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.

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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.

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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.

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