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By Lisa M. Campbell and Lisa R. Burchi

On April 8, 2021, the U.S. Environmental Protection Agency (EPA) issued an Advance Notice of Proposed Rulemaking (ANPR) to solicit information on the current pesticide exemption provision process.  86 Fed. Reg. 18232.  EPA announced its intent to issue this ANPR on January 19, 2021, as discussed here.  The issuance of the ANPR was paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies.

EPA states that it is soliciting comments and suggestions to determine whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPR are due before July 7, 2021.  Discussed below are the issues raised in the ANPR for stakeholder consideration and changes made since the ANPR was first announced in January 2021.

The ANPR is generally the same as what was first announced in January 2021, in which EPA states it is seeking public input for two main categories:

  • Whether EPA should be streamlining the petition process and revisions to how EPA evaluates the potential minimum risk active and inert substances, factors used in classes of exemptions, state implementation of the minimum risk program, and the need for any future exemptions or modifications to current exemptions; and
  • Whether EPA should consider amending existing exemptions or adding any new classes of pesticidal substances for exemption.

One important difference is that the April 2021 ANPR now includes a discussion of environmental justice.  EPA states that Executive Order 12989 directed agencies, “to the greatest extent practicable and permitted by law, to identify and address, as appropriate, disproportionately high and adverse human health or environmental effects of its actions on minority and low-income populations.”  EPA states in the ANPR that it has not identified any such disproportionate effects, since this ANPR is soliciting comments and is not proposing any specific actions or regulatory changes.

Specific questions posed that relate to environmental justice include the following:

  1. Given the identified minimum risk characteristics of these products and anticipated low impacts on communities, are current approaches effective for seeking input from the public and stakeholders, including state, local, tribal, and territorial officials, scientists, labor unions, environmental advocates, and environmental justice organizations?  Are there particular approaches that are more or less effective?
  2. Are there other policies that EPA should consider in determining whether a substance should be exempt from FIFRA regulation via the Minimum Risk Pesticide Listing Program?  For example, should EPA consider additional environmental justice and pollution prevention policies?
  3. When considering products that are a “minimum risk” to public health and the environment, should the product also be considered to be of low impact to all communities, including low-income and minority populations?  Please explain why or why not.
  4. When considering whether a category or class of products are a “minimum risk” to public health and the environment, should the category or class of products also be considered as being of low impact to all communities, including low-income and minority populations?  Are there other factors that EPA should consider?

Other questions posed that have not changed substantively since the 2021 ANPR include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  3. Are there other pesticidal substances or systems (e.g., peat) that EPA should consider adding as new classes at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?  How do these other pesticidal substances or systems meet the existing factors?
  4. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  5. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and labeling changes, made it easier for manufacturers, the public, and federal, state, and tribal inspectors to identify specific chemicals used in minimum risk pesticide products?
  6. Are there state challenges to implementing the minimum risk program?  Can EPA address those challenges with changes to its program?  Do states have suggestions for improvements to the program?

Commentary

Given the change in Administrations and the “pause” that was imposed and further review that was required before this proposed rulemaking could be issued, it was unclear whether EPA would issue this proposal.

Now that EPA has issued the ANPR, it is important for stakeholders to review these issues carefully and consider submitting comments to identify challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  EPA also notes that with regard to environmental justice, it is seeking public input on the consideration of environmental justice concerns in the context of the issues raised in the ANPR, and that “if and when the Agency proposes regulatory options regarding exemptions under FIFRA or the related procedures, EPA will seek additional input from the public, as appropriate.”


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On January 19, 2021, the U.S. Environmental Protection Agency (EPA) announced it will issue an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process.

EPA announced that it is considering whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient.

Comments on the ANPRM would be due on or before 90 days after publication of the ANPRM in the Federal Register in docket ID number EPA-HQ-OPP-2020-0537.  Although the issuance of this proposed rulemaking has been paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies, should it proceed, it will be important for stakeholders to review carefully.  Discussed below are the issues raised in the ANPRM for stakeholder consideration.

EPA states it is seeking public input on:

  • Whether programmatic changes are necessary to ease state regulation of federally exempt products; and
  • Whether EPA should consider adding any new classes of pesticidal substances for exemption.

Specific questions posed include the following:

  1. Do you have any suggestions for improving the processes for initiating a review of a substance or for implementing a decision that a substance may be used or may no longer be used in a minimum risk pesticide process?  Please explain how changes could increase efficiencies.
  2. Are these factors appropriate for EPA to consider in determining whether a substance should be exempted from FIFRA regulation via the minimum risk exemption?
  3. Are there other factors that should be considered?  Please explain how these factors should be weighed in a minimum risk determination.
  4. EPA broadly requests comment on the utility, clarity, functioning, and implementation of the provisions in 40 C.F.R. Section 152.25.
  5. Are there other pesticidal substances or systems (e.g., peat), that EPA should consider adding as a new class at 40 C.F.R. Section 152.25 for exemption from registration under FIFRA?
  6. What other factors should EPA consider in determining whether a category or class of products should be exempted from FIFRA regulation?  Please explain how these factors should be weighed in a determination.
  7. Have the changes to the federal program in the 2015 rule, which provided specific chemical identifiers and the labeling changes, made it easier to identify specific chemicals used in minimum risk pesticide products?
  8. Are there state challenges to implementing the minimum risk program you would like to share with EPA?  Do you have suggestions for improvements to the program to address these issues?

Commentary

In the ANPRM, EPA states it is soliciting information that will help determine if any changes in the regulations should be made.  The ANPR does not contain specific possible changes to FIFRA exemptions.  EPA states:  “Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options for amending the current regulations in 40 CFR 152.25, and issue a proposed rule for public review and comment.”  Given the change in Administrations and the current “pause” on issuance of this proposed rulemaking, it is unclear whether EPA will issue this proposal, and if so whether EPA will take further steps regarding the exemption after reviewing the comments received.  Should EPA proceed to issue the ANPR, it will provide an opportunity for stakeholders to submit comments on these issues, and companies should consider identifying challenges with the current regulatory criteria and procedures, as well as potential modifications that could improve the regulatory process.

It is noteworthy that EPA received a petition from the Consumer Specialty Products Association in 2006 requesting that EPA address issues related to efficacy claims for Section 25(b) products and that EPA promised to address this petition by rulemaking or other avenues.  The potential for changes to the Section 25(b) requirements thus is not a new concern for EPA, and it will be important to monitor this issue.


 

By Heather F. Collins, M.S.

The March 1, 2021, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2020 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, as the majority of EPA staff are still working remotely and may not be on site to receive mailed reports.

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.

Further information is available on EPA’s website.


 

By Lisa M. Campbell, Lisa R. Burchi, and Barbara A. Christianson

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307.

The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting that chitosan be added to the list of active ingredients eligible for EPA’s minimum risk exemption, followed by an April 4 2019, amended petition seeking also to add chitosan to the list of inert ingredients eligible for the minimum risk exemption.  EPA on August 20, 2020, issued a Federal Register notice stating that a draft regulatory document on this issue had been forwarded to the U.S. Department of Agriculture (USDA).  EPA states that no comments were submitted on that notice by USDA or any other person.  EPA also forwarded the draft to the FIFRA Scientific Advisory Panel for review, but according to EPA, the Panel “waived review of this proposed rule, concluding that the proposed rule does not contain scientific issues that warrant scientific review by the Panel.”  On October 8, 2020, EPA again announced it was considering adding chitosan to the list of active ingredients allowed for use in minimum risk pesticides and provided a pre-publication version of the proposed rule.

EPA states in the November 2, 2020, Federal Register notice regarding the proposed rule: “Based on all the information available to the Agency, there are low risk concerns for human health or the environment if chitosan is intended for use as a minimum risk pesticide.”  According to EPA, adding chitosan to this list may save stakeholders time and money through waived FIFRA registration requirements for certain products containing chitosan.  Specifically, EPA estimates the cost savings of avoiding the application process (e.g., guideline studies, registration fees) to be up to $116,000 initially and approximately $3,400 per year thereafter for each new product.

Comments on EPA’s proposal to add chitosan to its list of active ingredients for use on minimum risk pesticides are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2019-0701.   EPA states that it is currently deferring a decision regarding the amended petition to add chitosan to the list of inert ingredients permitted in minimum risk pesticides.

Additional information on chitosan is available on our blog.


 

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

On August 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  A minimum risk product must meet six specific conditions to be exempted from pesticide registration.  One of those conditions is that the active ingredient in the minimum risk pesticide be one that is listed specifically by EPA.  If added to the list of minimum risk pesticide active ingredients, pesticide products containing chitosan could qualify as minimum risk pesticides provided the other conditions are also satisfied (e.g., using inert ingredients approved by EPA for use in minimum risk pesticides, not making any public health claims).

Chitosan is a naturally occurring polymer that is derived from the shells of crustaceans.  It is currently registered as a fungicide, antimicrobial agent, and plant growth regulator that boosts the ability of plants to defend against fungal infections.  For uses as a plant growth regulator, chitosan is applied to treat field crops, ornamentals, turf, home gardens, and nurseries.  Target pests include early and late blight, downy and powdery mildew, and gray mold.  As an antimicrobial agent, chitosan is used on textiles to protection the fabric from bacterial and fungal growth.  Chitosan is exempt from the requirement for a pesticide tolerance.

History -- The Caesar Salad Chemicals

The origin of the Section 25(b) list came from an effort by EPA to deregulate products which, while meeting the definition of being a pesticide (a product with the intended purpose of being sold or distributed to kill or repel a pest as defined under FIFRA), were common products of established safety.  More precisely, products with a lack of toxicity such that it was a “waste of resources” for EPA to subject such products to the bureaucratic requirements of FIFRA registration.

In particular, at an oversight Congressional hearing on the lack of progress being made at the time on EPA’s attempt to complete re-registration (now referred to as registration review), the EPA witness was asked about some most recently released re-registration assessments.  These referred to the four registered pesticides:  garlic, capsicum, acetic acid, and citric acid.  These are pesticides formulated into various products, and in the hearing were referred to by more common names: garlic, pepper, vinegar, and lemon juice.  This led to a famous oversight question to the EPA witness:  “Are you making progress or Caesar Salad?”

This led, in part, to the Office of Pesticide Programs (OPP) allowing very low risk pesticides to be exempt from registration.  It eventually issued the original Section 25(b) list to conserve review resources.  At the same time, since these products no longer had to be registered, it allowed label language such as “natural,” “non-toxic,” and “safe around children and pets,” which are disallowed registered product label claims.  Not surprisingly, label language allowing the word “safe” has proven to be a popular marketing claim for products that meet the exemption requirements.

At the same time, the fine print of the Section 25(b) exemption did not allow health and safety claims on such products even if they were made from Section 25(b) ingredients.  In particular, this led to concerns about insect repellents that could be made from Section 25(b) ingredients and were labeled as repelling mosquitoes or ticks or other public health pests; they could include the word “safe” as long they did not also mention any disease or other public health claims.  The average consumer, however, likely does not distinguish between insect repellents (or other products) that fit EPA’s definition of public health claims and those simply listing the target pest (e.g., mosquitoes, ticks, or rodents).  The average consumer is unlikely to realize the distinction between a product labeled as “XX insect repellent -- repels mosquitoes -- all natural and safe,” which may not have evidence of efficacy, and another product that says “YY insect repellent -- made from natural ingredients and repels mosquitoes, which may carry West Nile Virus” -- which is required to be registered and include proof of efficacy for any public health claims.

This possible consumer confusion was the subject of a FIFRA petition filed in 2006 by the Consumer Specialty Products Association (CSPA).  The petition suggests that EPA modify the Section 25(b) regulation to exclude products claiming to control public health pests from the Section 25(b) exemption -- which would then require registration, including data proving efficacy (Docket: EPA-HQ-OPP-2006-0687-0002).

EPA responded to the CSPA petition in 2007, essentially agreeing about the problem of possible consumer confusion.  In a letter to CSPA, EPA stated:

…. whether we decide to pursue rulemaking or some other avenue, we intend to move as expeditiously as possible to identify the most efficient approach to protect the public from unknowingly relying on products that target public health pests and have not been shown to work.

EPA later announced that it would embark on rulemaking to address this possible consumer confusion.  It is, however, unclear whether this is still a pending matter on EPA’s agenda.  No docket materials have been added in many years.  As part of its Semiannual Regulatory Agenda in fall 2011, EPA included an entry that stated a Section 25(b) proposed rule would be issued before February 2013.  It is not clear if EPA continues to have plans to issue such a proposal.

Commentary

EPA’s August 20 proposal is an interesting development, as EPA’s other revisions and proposals for minimum risk pesticides trend toward adding restrictions to the conditions to be satisfied, thus limiting exemptions.  The current proposal would expand the exemptions by adding another active ingredient to the otherwise limited approved list.  Since changes to the Section 25(b) list will require a rulemaking, it is unclear what happened to the earlier plan to issue a proposed rule addressing the long-ago CSPA petition response.

EPA states that it has forwarded to the Secretary of the United States Department of Agriculture (USDA) a draft regulatory document concerning “Pesticides; Addition of Chitosan to the List of Active Ingredients Allowed in Exempted Minimum Risk Pesticides Products.”  EPA will not make this draft regulatory document available to the public until after it has been signed.  When it is available, that document and additional information will be available in docket EPA-HQ-OPP-2019-0701.


 

Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another.  Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

In September 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) plans to convene a Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting to discuss New Approach Methodologies (NAM) for organophosphate (OP) pesticides.  EPA states that these NAMs could reduce reliance on default uncertainty factors for human health risk assessment and also reduce animal testing.

Under Administrator Wheeler’s directive to prioritize efforts to reduce animal testing, EPA is developing NAMs based on in vitro techniques and computational approaches that will also provide the opportunity to incorporate information relevant to humans.  OPP states that it is evaluating use of “in vitro data for 16 organophosphate compounds to reduce potentially reliance on default risk assessment uncertainty factors in favor of more refined data-derived factors.”  Human health risk assessment for OP pesticides has recently been focused primarily on potential developmental neurotoxicity, and the Office of Research and Development (ORD) has been working to develop a NAM to evaluate developmental neurotoxicity.  Initial analyses of data derived from neuron cell models have been completed for specific OP pesticides as a case study and, when possible, compared to in vivo results (an in vitro to in vivo extrapolation).

This case study of a NAM for developmental neurotoxicity using OP pesticides will be presented to the FIFRA SAP at the September meeting for its consideration and advice.  EPA will request external review and public comment on this research before implementing NAMs in human health risk assessments.  Additional details, including dates, times and agenda, will be forthcoming at www.epa.gov/sap.

Commentary

EPA has for some time had a general policy that it will try to develop and to implement alternatives to in vivo animal testing.  These alternatives to animal testing are typically based on new in vitro assays and modeling methodologies.  It is interesting that OPP has selected an in vitro NAM to assess developmental neurotoxicity of OP pesticides as a case study, given the controversy surrounding EPA’s use of the default Food Quality Protection Act (FQPA) uncertainty factor for all OP pesticides, which was based primarily on epidemiology data that EPA claimed may suggest a link between chlorpyrifos exposure and developmental neurotoxicity.  Prior to this determination, human health risk assessment for OP pesticides was generally based on expert judgments by EPA that neurotoxicity would not be expected below the established threshold for acetylcholinesterase (AChE) inhibition, and that infants and children are not likely to be more sensitive to neurotoxic effects than adults.  OPP adopted the FQPA determination for all OP pesticides even though it could not determine or propose a mechanism for the presumed developmental neurotoxicity of chlorpyrifos below the threshold for AChE inhibition, or evaluate whether other OP pesticides might share a similar mechanism.  Since the 2015 release of the Literature Review, additional epidemiology studies have become available and a number of concerns regarding the reliability of the epidemiology data have been raised.  EPA has also expressed concerns with the availability and reliability of the epidemiology studies.  These developments bring into question the accuracy and reliability of the Literature Review.

In its announcement, OPP states that the new NAM is intended “to reduce potentially reliance on default risk assessment uncertainty factors,” although it does not state which uncertainty factors may be supplanted or modified.  Standard uncertainty factors which may be implicated include the factor for extrapolating from animal data to human effects (“interspecies variation”), the factor for human variability (“intraspecies variation”), and the default uncertainty factor for potential increased sensitivity of infants and children (“FQPA uncertainty factor”).  The issues may spark additional controversy.  Additionally, even if OPP and the FIFRA SAP conclude that the proposed NAM for developmental neurotoxicity is a viable approach to human health risk assessment for OP pesticides, there are likely to be many related policy issues.  For example, it is unclear whether OPP would be sufficiently confident in the reliability of such an assay to propose cancellation or suspension of affected pesticide products based on a resultant human health risk assessment.


 

By Lynn L. Bergeson and Carla N. Hutton

As reported in our February 13, 2020 blog item, the U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  According to a February 27, 2020, memorandum placed in Docket ID EPA-HQ-OPP-2020-0043, EPA received a request to extend the comment period 30 days to allow additional time to review the documentation contained in the docket.  The memorandum states that EPA “feels that 15 additional days should be sufficient to allow for adequate review of the Proposed Decision and supporting documentation.”  Comments are now due March 30, 2020.


 

By Lisa M. Campbell and Lisa R. Burchi

On March 2, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on 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 March 2, 2020.

This rule explains how EPA inspectors should conduct on-site civil administrative inspections and addresses common elements applicable to on-site civil inspections for compliance with environmental laws. 

The elements of the process for conducting on-site civil inspections, and some EPA guidance regarding each element, is as follows. 

  • Timing of Inspections and Facility Notification -- EPA inspectors should generally conduct inspections during the facility's normal work hours and take reasonable steps to work with the facility to agree on a workable schedule for accessing areas for the inspection.
  • Inspector Qualifications -- EPA inspectors must hold a valid credential to perform the inspection, which are issued to inspectors that have completed relevant training.
  • Obtaining Consent to Enter -- Upon arrival at a facility, EPA inspectors shall present their valid EPA Inspector Credentials to a facility employee, describe the authority and purpose of the inspection, and where possible seek the facilities' consent to enter. Inspectors are required under certain statutes to advise facility personnel that they can deny entry, but EPA may then seek a warrant for entry. 
  • Opening Conference -- The EPA inspector shall request an opening conference with available facility representatives or employees, where practicable. The EPA inspector shall discuss the overall objectives of the inspection and may request access to/copies of facility records and request to interview facility employees, as necessary.
  • Physical Inspection -- EPA inspectors shall inspect the areas, units, sources and processes relevant to the scope of the inspection. The inspectors will generally document their observations with photos and notes.
  • Managing Confidential Business Information (CBI) -- Pursuant to existing statutory and regulatory requirements, inspectors shall complete appropriate, statute-specific, CBI training before managing CBI. The EPA inspectors shall manage all CBI claims made by a facility during an inspection in accordance with 40 CFR part 2, subpart B.
  • Interview Facility Personnel -- EPA inspectors may conduct interviews of facility personnel as appropriate. Interviews may include, but are not limited to, the environmental contacts, process operators, contractors, maintenance personnel, process engineers, control room operators, and other employees working in the area(s) of interest.
  • Records Review -- Once the records requested by the EPA inspector are assembled, the EPA inspector shall review any records relevant to the facility inspection/field investigation. EPA inspectors may request copies of many different types of records (paper, electronically scanned, downloaded or recorded through other digital storage devices), when appropriate, and record copies of records taken from the facility. An EPA inspector may request records before, during, or after an inspection.
  • Sampling -- EPA inspectors may take samples when appropriate. Where applicable and practicable, during the opening conference, the inspector shall offer facility personnel the opportunity to obtain split samples or to collect duplicate samples.
  • Closing Conference -- EPA inspectors shall offer a closing conference with available facility employees, as practicable, to discuss any outstanding questions or missing documents and the process for follow up. EPA inspectors may also discuss next steps and how the facility will be contacted on the results of the inspection and identify the appropriate point of contact for further communication and coordination. EPA inspectors may also summarize any potential “areas of concern” identified in the inspection.
  • Inspection Reports -- After an inspection, EPA shall share an inspection report with the facility. The content and format of the report may vary depending on the facility, type of the inspection, and the statutory authority upon which the inspection is based.

Commentary

EPA states this rule was issued to fulfill the objectives outlined in Executive Order 13892 (Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication).  In addition to this rule, companies can find more detailed information in EPA’s FIFRA Inspection Manual, most recently updated in August 2019, and available here.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on February 12, 2020, that it is seeking public input on a proposal to incorporate a new nanosilver pesticide product into textiles to combat odors, discoloration, and other signs of wear.  The proposed registration decision is for NSPW Nanosilver, and the proposed pesticide product, Polyguard-NSPW Master Batch (Polyguard), will be incorporated into textiles to suppress bacteria, algae, fungus, mold, and mildew, which cause odors, discoloration, stains, and deterioration.  According to EPA, based on its human health and ecological risk assessment, it has preliminarily determined that the new active ingredient in Polyguard meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use as a materials preservative in textiles.  EPA invites public comment on its proposal and preliminary findings.  Comments are due March 13, 2020.  More information is available in Docket ID EPA-HQ-OPP-2020-0043

EPA notes that NSPW Nanosilver was the active ingredient in a previous conditional registration that it granted in 2015, for use as a materials preservative in textiles and plastics.  As reported in our May 31, 2017, memorandum, that decision was challenged, and the U.S. Court of Appeals for the Ninth Circuit “vacated it on grounds that EPA’s public interest finding for granting the registration was without support in the record.”  EPA states that the currently proposed product “is solely for use in specified textiles; therefore, Polyguard will have a more limited use authorization than the previously vacated conditional registration.”  EPA notes that Polyguard will be formulated as a master batch, meaning that NSPW Nanosilver would be embedded within plastic beads or pellets, in contrast to the previous product registration, which was in the form of a liquid suspension.


 
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