By Lisa M. Campbell and Carla N. Hutton
On June 14, 2019, Canada’s Pest Management Regulatory Agency (PMRA) began a public consultation on Discussion Document DIS2019-01, “Consultation on Inspecting Confidential Test Data for Post-market Reviews in the Reading Room.” Before a pesticide can be registered for use in Canada, PMRA states that it reviews the available scientific test data to determine whether there are concerns for human health or safety, or the environment, when the product is used according to the label. Some of the data reviewed by the PMRA scientists include confidential test data on:
- Toxicology related to human health;
- Bystander and occupational exposure;
- Food residue trials;
- Environmental toxicology and fate;
- Product efficacy, crop tolerance, and benefits of the product; and
- Other scientific data or studies submitted to, or considered by the PMRA.
According to PMRA, the purpose of the consultation document is to seek input on a proposal to expand access to confidential test data by inviting interested members of the public to inspect these data at the proposed decision stage for post-market reviews such as re-evaluations and special reviews. Currently, PMRA prepares confidential test data for public inspection only after it makes a final decision. PMRA proposes to allow interested parties seeking to understand the scientific basis for a proposed re-evaluation or special review decision to inspect the data used by PMRA earlier in the process. PMRA states that by viewing these data earlier, comments submitted through the existing consultation process may be more well-informed.
PMRA notes that the proposed change would still require the inspection of confidential test data to take place at its National Head Office in Ottawa, Ontario. PMRA states that it is aware that this could be burdensome and is investigating alternative approaches for the future that may allow the inspection of data through other means, such as satellite reading rooms or secure portals. Publication of the consultation document began a 60-day comment period.
By Lisa M. Campbell and Lisa R. Burchi
On May 28, 2019, the California Department of Pesticide Regulation (DPR) posted a new presentation identifying the top ten agricultural pesticide use violations of 2018. Its announcement states that “DPR suggests reviewing these common violations of pesticide laws and regulations to help ensure … compliance.” The presentation, “Top 10 Agricultural Pesticide Use Violations of 2018,” is available here. The violations are listed from the least common (number 10) to the most common (number 1):
10. Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724. Examples of handler training violations listed in the presentation are: not updating employee training before a new pesticide is handled; and not providing employees handler training before they work on or repair equipment previously used to apply pesticides.
9. Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1. Examples of violations listed in the presentation are: not including a specific description of the location of the ASI on the Pesticide Safety Information Series (PSIS) A-9 leaflet so that workers have unimpeded access; and not displaying the ASI before fieldworkers work in a treated field.
8. Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761. Examples of these types of violations listed in the presentation are: not retaining Safety Data Sheets (SDS) for the pesticides listed in the pesticide use records within the past two years; and not informing employees or the Farm Labor Contractor (FLC) of the location of the pesticide use records before the employees enter a treated field.
7. Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734. Examples of these types of violations listed in the presentation are: not having an emergency eye flush station able to rinse the eye gently for 15 minutes at the mix and load site, when protective eyewear is required by the pesticide labeling; and handlers using hand sanitizer for decontamination instead of soap and water.
6. Availability of Labeling, regulated under 3 C.C.R. § 6602. Examples of labeling availability violations listed in the presentation are: not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklets on-site when mixing, loading, or applying.
5. Service Container Labeling, regulated under 3 C.C.R. § 6678. Examples of service container labeling violations listed in the presentation are: not including the signal word on a service container label; and not including the address of the company or person responsible for the container on the label.
4. Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732. An example of a violation is performing pest control activities in a county before registering with the County Agricultural Commissioner (CAC).
3. Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726. Examples of violations listed in the presentation are: not taking employees suspected of a pesticide illness to the doctor immediately; and failure to post the handler emergency medical care information.
2. Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738. Examples of violations listed in the presentation are: storing PPE in the same place pesticides are stored; and an employer not providing the proper PPE required by the labeling.
1. Labeling and Permit Conditions Compliance, regulated under FAC § 12973. Examples of violations listed in the presentation are: not following the pesticide storage requirements listed on the labeling; and applying a pesticide to a site or crop not listed on the labeling.
Additionally, DPR has created an informative presentation about the 2019 license renewal process to help spread awareness to those renewing this year (last names and business names starting with M-Z). DPR states that it encourages continuing education (CE) sponsors, CAC staff, and others to use the presentation to inform license and certificate holders renewing this year about DPR’s renewal process, CE requirements, important dates, and the benefits of renewing early. The 2019 Renewal Process presentation is available here.
By Lisa M. Campbell and Lisa R. Burchi
On May 21, 2019, the U.S. Environmental Protection Agency (EPA) announced that “to increase transparency and ensure information is easily accessible,” it has created a new web-based table of the most recent pesticide registration review actions that contains a list of the registration review actions EPA has taken over the current fiscal year, including the chemical name, docket number, and public comment period when applicable. EPA will update the table each time a registration review action is published. Stakeholders and the public can now quickly locate and sort through the following information for each active ingredient with a recent registration review action:
- The docket number (with a direct link to the docket);
- Comment period deadline (if applicable);
- Case number;
- Designated division;
- Registration review action type; and
- Contact information for the chemical review manager.
The new table also provides direct links to dockets, making it easy to access supporting information and documents related to a pesticide’s registration review. EPA states that it plans to update continuously this table as new registration review actions occur.
By Lisa M. Campbell and Heather F. Collins, M.S.
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food,” as EPA states was incorrectly implied by the previous regulatory text. EPA initially proposed this change on August 18, 2017 (82 Fed. Reg. 39399) because it agreed to do so in a settlement agreement with the American Chemistry Council (ACC) after ACC filed a petition for review of the 2013 final rule titled “Data Requirements for Antimicrobial Pesticides” (78 Fed. Reg. 26936 (May 8, 2013)) in the U.S. Court of Appeals for the District of Columbia Circuit. Specifically, EPA agreed to make this correction to “make the language consistent” with the U.S. Food and Drug Administration’s (FDA) policy set forth in FDA’s “Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002.” EPA states that the change is intended to “enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously promulgated requirements” and that it is not establishing “any new data requirements or any other revisions (substantive or otherwise) to existing requirements.” The final rule will become effective on July 2, 2019.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On April 19, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 8, 2019, from 9 a.m. to 5 p.m. and May 9, 2019, from 9 a.m. to 12:00 p.m. (EDT) in the first-floor conference center at One Potomac Yard South, 2777 South Crystal Drive in Arlington, Virginia. 84 Fed. Reg. 16486. The Federal Register notice states that the agenda is not yet available but that this meeting will provide advice and recommendations to EPA’s Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. The draft agenda will be available on or before May 5, 2019, on the PPDC webpage. The meeting is open to the public and no advance registration is required.
By Lisa M. Campbell, Sheryl Lindros Dolan, and Margaret R. Graham, M.S.
On March 25, 2019, the U.S. Environmental Protection Agency (EPA) posted Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. Comments on the draft guidance are due by May 28, 2019.
EPA states that the draft guidance is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and thereby distinguish claims that would not subject plant biostimulants (PBS) to regulation under FIFRA as plant regulators. While EPA has not yet promulgated a regulatory definition for a PBS, the draft guidance describes a PBS as “a naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.” EPA is seeking comment on the draft guidance itself, as well as on whether it should develop a definition for PBSs. EPA states that there is currently no statutory definition for PBSs under FIFRA and that development of a definition for PBSs would require rulemaking. The guidance also notes that the 2018 Farm Bill, enacted on December 20, 2018, does provide a statutory definition for PBSs, which is: “a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield.”
In developing the draft guidance, EPA states that it “considered whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators under FIFRA thereby triggering regulation as a pesticide” and that “a key consideration is what claims are being made on product labels.” Further, as FIFRA Section 2(v) both defines plant regulator and explains which substances are excluded from the definition, “many PBS products and substances may be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products.”
The draft guidance provides several examples of both product label claims that are considered plant regulator claims and claims that that are not considered plant regulator claims. The examples are described in the Tables below.
- “Product label claims generally considered ‘non-pesticidal’ (i.e. non-plant regulator claims),” including: “plant nutrition-based claims” (Table 1a); “plant inoculant-based claims” (Table 1b); and “soil amendment-based claims” (Table 1c):
- “Generic product label claims for products not covered by the exclusions in the FIFRA Section 2(v) definition of a plant regulator,” including “examples of generic product label claims generally considered by the Agency to be ‘non-pesticidal’” (Table 2):
- “Plant regulator product label claims that are consistent with the FIFRA Section 2(v) plant regulator definition” including “examples of label claims that are considered … to be plant growth regulator claims that trigger regulation under FIFRA as a pesticide” (Table 3):
- “EPA-registered, naturally-occurring, plant regulator active ingredients having modes of action and associated product label claims that are consistent with the FIFRA definition of a plant regulator” (Table 4):
By Heather F. Collins, M.S. and Margaret R. Graham, M.S.
The March 1, 2019, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2018 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “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, it saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.
Link 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.
Further information is available on EPA’s website.
By Lynn L. Bergeson and Margaret R. Graham
Due to the government shutdown and to the late notification to applicants, the U.S. Environmental Protection Agency (EPA) has extended the annual maintenance fee submission date for pesticide registrants from January 15, 2019, to February 15, 2019. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A), each registrant of a pesticide must pay an annual fee by January 15 of each year for each registration; the fee for 2019 is $ 3,392. The notification of the extension is only available if you call the Pesticide Maintenance Fee information line, however; EPA has provided the information in a voice message. More information on the annual maintenance fees is available on EPA’s website.
On another note, on January 2, 2018, we understood that EPA had confirmed that Imports and Notice of Arrivals (NOA) were continuing to be processed by EPA Regional offices notwithstanding the shutdown. We were mistaken. We now understand that EPA is not completely clear if NOAs are being processed during the shutdown. The EPA Regional offices are working with the U.S. Customs and Border Protection (CBP), but no additional information is available at this time on the processing of Imports and NOAs.
By Lisa M. Campbell and Heather F. Collins, M.S.
On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C. The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada. Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation.
During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration. The U.S. and Canadian agencies are working together to:
- Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
- Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
- Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
- Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
- Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.
Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.
Specific times for this and other breakout sessions, as well as more detail, will be made available online. The Stakeholder Forum is open to the public, with advance registration. Space is limited and registrations will be accepted on a first-come-first-served basis. Registration is available online.
By Lisa M. Campbell and Lisa R. Burchi
On November 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets. The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA.
EPA’s action, which it states applies to nationwide distribution, transport and sales of the product, follows a statewide stop-sale order issued earlier this month by the Arizona Department of Agriculture when state inspectors discovered the unregistered pesticide, which is used to disinfect pools, during an August 30 inspection of the company’s Phoenix warehouse.
This case exemplifies the need for companies to understand Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration and amendment requirements, and the importance that a product’s label, formula, and manufacturing process match exactly with the information submitted to EPA and upon which EPA relied in approving the registration. Many composition and processing changes require an amendment to be approved by EPA; failure to do so could result in an enforcement action such as this one.
More information on pesticide registration issues is available on our blog.