Document ID: EPA-HQ-OPP-2023-0420-0001
Agency: epa
Document Type: Proposed Rule
Title: Pesticides: Review of Requirements Applicable to Treated Seed and Treated Paint Products; Request for Information and Comments
Posted Date: 2023-10-12T04:00Z

[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Proposed Rules]
[Pages 70625-70634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22558]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[EPA-HQ-OPP-2023-0420; FRL-10637-01-OCSPP]
RIN 2070-AL13

Pesticides; Review of Requirements Applicable to Treated Seed and 
Treated Paint Products; Request for Information and Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advanced notice of proposed rulemaking.

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SUMMARY: The Environmental Protection Agency (EPA) is soliciting public

[[Page 70626]]

comments and suggestions about seeds treated with a pesticide 
registered under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) as well as treated paint. The Agency is considering whether 
a rule under FIFRA to regulate certain use of treated seed and treated 
paint products or other administrative action is appropriate 
considering questions raised by stakeholders. To inform this 
consideration, EPA is requesting comment and information from all 
stakeholders on the use and usage of treated seed, including storage, 
planting, and disposal of the treated seed, and on whether or to what 
extent treated seed products are being distributed, sold, and used 
contrary to treating pesticide and treated seed product labeling 
instructions. Similarly, EPA is requesting comment from stakeholders on 
the addition of labeling requirements on the labels of treated paint 
products and potential language that should be included in those 
labels.

DATES: Comments must be received on or before December 11, 2023.

ADDRESSES: The docket for this action, identified under docket 
identification (ID) number EPA-HQ-OPP-2023-0420, is available online at 
https://www.regulations.gov. Additional instructions on visiting the 
docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Bartow, Chemical Review Manager, 
Pesticide Reevaluation Division, Office of Chemical Safety and 
Pollution Prevention (7508M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; phone: 202-566-2280; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you manufacture, distribute, 
sell, treat, or use pesticide-treated seed or treated paint products. 
EPA has promulgated several exemptions for pesticide products of a 
character not requiring regulation under FIFRA, including for treated 
articles and substances; EPA is now considering modifying the treated 
article exemption. This exemption is codified in 40 CFR 152.25(a). The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, rather it provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Pesticide and other agricultural chemical manufacturers 
(NAICS codes 325320 and 325311).
     Manufacturers who may also be distributors of these 
products, which includes farm supplies merchant wholesalers (NAICS code 
424910).
     Retailers of pesticide products (some of which may also be 
manufacturers), which includes nursery, garden center, and farm supply 
stores (NAICS code 444220).
     Government establishments engaged in regulation, 
licensing, and inspection (NAICS code 926150).
     Users of treated seed products and persons involved in 
crop production (NAICS code 111).
     Persons involved in support activities for crop production 
(NAICS code 1151).
    If you have questions regarding the applicability of this action to 
a particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    This advance notice of proposed rulemaking (ANPRM) is issued under 
the authority of FIFRA, 7 U.S.C. 136 et seq., particularly FIFRA 
sections 3 and 25. FIFRA section 3(a) authorizes EPA to regulate the 
distribution, sale, or use of any unregistered pesticide ``[t]o the 
extent necessary to prevent unreasonable adverse effects on the 
environment'' (defined at FIFRA section 2(bb), in pertinent part, as 
``any unreasonable risk to man or the environment, taking into account 
the economic, social, and environmental costs and benefits of the use 
of any pesticide''). 7 U.S.C. 136a(a) and 136(bb). Exemptions to the 
requirements of FIFRA are issued under the authority of FIFRA section 
25(b). Eligible products may be exempted from among other things, 
registration requirements under FIFRA section 3. In addition, FIFRA 
section 25(a) authorizes EPA to ``prescribe regulations to carry out 
the provisions of [FIFRA]'' and FIFRA section 25(b) authorizes 
exemptions from, among other things, registration requirements under 
FIFRA section 3. 7 U.S.C. 136w(a) and (b).

C. What action is the Agency taking?

    EPA is requesting comments on specific issues related to seed 
treated with conventional pesticides (``treated seed'') and paint 
treated with conventional or antimicrobial pesticides (``treated 
paint''). As to treated seed products, EPA has typically included on 
the label of the treating pesticide labeling instructions regarding 
both the use of the treating pesticide and the distribution, sale, and 
use of the treated seed product, and EPA's exposure assessments and 
registration decisions take those instructions into consideration. 
However, states and other stakeholders have raised questions about the 
clarity and enforceability of instructions specifically relating to use 
of the treated seed products (i.e., instructions relating to the 
storage, planting, and management of the treated seed). EPA is seeking 
to improve labeling on both treating pesticide labeling and labeling on 
treated seed products (e.g., seed bag tags) during registration and 
registration review processes, and is requesting comment in response to 
this FRN on such labeling instructions. EPA is also requesting comment 
on use and usage of treated seed products, including storage, planting, 
and disposal of treated seed, and on whether or to what extent treated 
seed products are being distributed, sold, and/or used contrary to 
treating pesticide labeling instructions for each separate crop seed 
product. To EPA's knowledge, treated seed are generally being used 
consistent with the instructions on the label of the treated seed 
product. However, the Agency is seeking any specific information from 
all stakeholders to further inform this issue (e.g., whether there are 
specific cases of use contrary to label instructions) before 
considering EPA's next steps with respect to how EPA regulates treated 
seed products. EPA is looking for this information from a broad range 
of stakeholders, including those who treat seed in commercial 
facilities or on the farm and those who use treated seed products.
    For treated paint products, pesticide labeling requirements do not 
currently exist. EPA is exploring the option of requiring labeling 
instructions on treated paint products to address potential risks of 
concern for professional painters exposed to the pesticide in the 
treated paint without the use of personal protection equipment (PPE), 
such as respirators, when applying the paint using a spray method. Thus 
far, labeling for treated paint has been proposed for only one active 
ingredient (i.e., diuron), but is being considered for other active 
ingredients that are registered for use as paint preservatives. EPA is 
requesting comments among other things on requiring such labeling 
instructions on treated paint containers.
    EPA will consider comments and information to determine whether to 
amend its approach for allowing treated

[[Page 70627]]

seed and treated paint products to be wholly exempt from FIFRA 
requirements (e.g., through issuance of a rule pursuant to FIFRA 
section 3(a) to regulate distribution, sale, and use of treated seed 
product and/or other administrative action). FIFRA section 3(a) 
authorizes EPA to limit the distribution, sale, or use of an 
unregistered pesticide ``[t]o the extent necessary to prevent 
unreasonable adverse effects on the environment.'' Such a FIFRA section 
3(a) rule and conforming amendments to the treated article exemption 
would be intended to allow for enforcement of certain use instructions 
on labeling of treated seed and treated paint as an alternative to 
registration of such products. Other actions could include amending the 
treated article exemption to limit the scope of the exemption so that 
some FIFRA requirements would still apply (e.g., requiring seed 
treatment facilities to identify as establishments), and other 
administrative actions could include addressing specific use concerns 
with treated seed through further action on the specific treating 
pesticide registration (e.g., clarifying labeling instructions, 
reducing or eliminating use of the treating pesticide for some seed 
treatments, or including terms and conditions on the registration for 
expiration of the use or imposition of use restrictions should use 
contrary to labeling instructions be reported). This ANPRM initiates 
the rulemaking process by specifically soliciting public comments and 
suggestions about the potential FIFRA 3(a) rule and/or other related 
amendments, as it relates to treated seed and paint products.

D. What are the incremental costs and benefits of this action?

    This ANPRM does not impose or propose any requirements, and instead 
seeks comments and suggestions that will help the Agency identify 
whether and to what extent there is a potential need for a FIFRA 
section 3(a) rule and/or other regulatory or administrative action. If 
EPA decides to propose changes to the regulations, it will conduct the 
appropriate assessments of the costs and benefits of those changes and 
provide opportunities for further public comment.

E. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI.
    Do not submit CBI to EPA through https://www.regulations.gov or 
email. If you wish to include CBI in your comment, please follow the 
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that 
you claim to be CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2.
    2. Tips for preparing your comments.
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. Brief Summary of EPA's Registration Process for Pesticides

    Applications for registration of a pesticide may be submitted to 
EPA and must meet the requirements in FIFRA sections 3(c) and 33. 7 
U.S.C. 136a and 136w-8. Those requirements include, among other things, 
submission of complete labeling of the pesticide, including claims made 
for the pesticide and instructions on use; complete data in support of 
that registration request; and requisite fees in support of that 
application. 7 U.S.C. 136a(c); 7 U.S.C.136a(b); and 7 U.S.C. 136w-8; 
see also, 40 CFR part 152 for application procedures and part 158 for 
data requirements. FIFRA section 3(c)(4) requires EPA to issue a 
Federal Register notice and opportunity for comment in relation to 
``each application for registration of any pesticide if it contains any 
new active ingredient or if it would entail a changed use pattern.'' 7 
U.S.C. 136a(c)(4). See also 40 CFR 152.105.
    To grant a pesticide registration, FIFRA requires EPA to consider 
whether the pesticide meets the FIFRA standard that use of the 
pesticide has no ``unreasonable adverse effects'' to human health and 
the environment. 7 U.S.C. 136a(c)(5). FIFRA section 2(bb) defines 
``unreasonable adverse effects on the environment'' to mean, among 
other things, ``any unreasonable risk to man or the environment, taking 
into account the economic, social, and environmental costs and benefits 
of the use of any pesticide'' or ``a human dietary risk from residues 
that result from a use of a pesticide in or on any food inconsistent 
with the standard under section 408 of the Federal, Food, Drug, and 
Cosmetic Act'' (FFDCA). 7 U.S.C. 136(bb). EPA is required to review 
each pesticide registration every 15 years to determine whether the 
pesticide continues to satisfy the FIFRA standard for registration. 7 
U.S.C. 136a(g) and 40 CFR Part 155, subpart C.
    It is a violation under FIFRA to sell or distribute an unregistered 
pesticide or to use a registered pesticide in a manner inconsistent 
with its labeling. 7 U.S.C. 136j(a)(1)(A) and 136j(a)(2)(G). FIFRA 
section 12 does not make it a violation to use an unregistered 
pesticide. However, under FIFRA section 3(a), EPA may, by regulation, 
impose limits on the distribution, sale, and use of any pesticide that 
is not registered ``to the extent necessary to prevent unreasonable 
adverse effects on the environment,'' and compliance with such 
regulation is enforceable under FIFRA section 12(a)(2)(S). 7 U.S.C. 
136a(a) and 136j(a)(2)(S).

B. Background on the Treated Article or Substance Exemption

    FIFRA section 25(b)(2) provides that the Administrator may, by 
regulation, exempt from the requirements of FIFRA, including the 
registration requirements, any pesticide which the Administrator 
determines to be of ``a character which is unnecessary'' to be subject 
to FIFRA ``in order to carry out the purposes'' of FIFRA. 7 U.S.C. 
136w(b)(2). Several exemptions under FIFRA section 25(b)(2) were 
adopted in 1988 and included a ``treated articles and substances'' 
exemption at 40 CFR 152.25(a).
    The regulation at 40 CFR 152.25 provides that ``the pesticides or 
classes of pesticides listed in this section have been determined to be 
of character not requiring regulation under FIFRA and are therefore 
exempt from all provisions of FIFRA when intended for use, only in the 
manner specified.'' The regulation in 40 CFR 152.25 identifies the 
types of pesticides and conditions applicable for an exemption to 
apply. 40 CFR 152.25(a) identifies treated articles or substances and 
defines them as ``an article or substance treated with, or containing, 
a pesticide to protect the article or substance itself (for example, 
paint treated with a pesticide to protect the paint coating, or wood 
products treated to protect the wood against insect or fungus 
infestation), if the pesticide is registered for such use.''
    It has been EPA's longstanding position that FIFRA section 25(b)(2) 
authorized the 1988 final rule exempting pesticide-treated articles or 
substances because EPA's assessment of the treating pesticide 
comprehensively addresses the use of and exposure to the treating 
pesticide and to the article or substance that is permissibly treated 
and distributed, sold, and used consistent with labeling instructions. 
The FIFRA finding to grant the

[[Page 70628]]

registration or continue the registration of the pesticide is based on 
that assessment, which again addresses the risks from use of the 
treating pesticide and use of the treated article or substance. No new 
assessment or risk finding is necessary for the exemption to apply and 
no new FIFRA section 25(b)(2) finding is required for each and every 
article or substance treated. Rather, once a pesticide is registered 
under FIFRA for use in treating an article or substance, the only 
conditions applicable to a determination as to whether the treated 
article exemption applies to the article or substance treated by that 
pesticide are those stated in the regulatory text at 40 CFR 152.25(a).
    It has also been EPA's longstanding position that treated seed 
products meeting the regulatory conditions at 40 CFR 152.25(a) are 
exempt from FIFRA requirements. Those conditions include that a 
pesticide ``registered for such use'' is used, which EPA has 
interpreted to require compliance with labeling instructions relating 
to distribution, sale, and use of the pesticide registered under FIFRA 
to treat seed and the distribution, sale, and use of the treated seed 
product itself. If distribution, sale, and/or use of the treating 
pesticide or treated seed product is not consistent with such labeling 
for the treating pesticide or treated seed product, then the 
``registered for such use'' criterion is not met and the exemption does 
not apply. For example, if the treating pesticide requires that the 
treated seed bag tag include specific labeling information and 
instructions, but such bag tag does not include the required labeling 
or instructions, the ``registered for such use'' condition is not met. 
In such a case, the exemption does not apply and the treated seed 
product must be registered under FIFRA and must comply with other FIFRA 
requirements, such as the requirement in FIFRA section 7 to register 
the establishment in which the pesticide is produced and the 
requirements in FIFRA section 17(c) and 19 CFR 2.110 through 2.117 to 
file an EPA Notice of Arrival of Pesticides and Devices (EPA Form 3540-
1) or its electronic equivalent for importation of treated seed product 
(Ref. 1). Similarly, if the treated seed product is not used consistent 
with the instructions on treating pesticide labeling as communicated on 
the seed bag tag, the condition that a pesticide ``registered for such 
use'' is not met and use of the treated seed product would be use of an 
unregistered pesticide. The required labeling information and 
instructions are helpful to farmers who use the treated seed and may be 
considered in EPA risk assessments. As a result, compliance with the 
requirements for such labeling and the instructions relating to 
distribution, sale, and use may be necessary to protect against 
unreasonable risks to the environment.
    A more thorough discussion of EPA's approach for evaluating 
pesticides for use in treating seeds, which includes an evaluation of 
the use of the treated seed product itself, and the treated article 
exemption is discussed in EPA's Treated Seed Petition Response which is 
discussed in the next section.

C. Background on the Petition Relating to Treated Seed and EPA's 
Response

    In April 2017, the Center for Food Safety (CFS or the Petitioner) 
filed a petition with EPA seeking a rulemaking or a formal agency 
interpretation relating to pesticide treated seed (hereinafter Treated 
Seed Petition) (Ref. 2). Specifically, CFS petitioned EPA to take the 
following actions: (1) Amend 40 CFR 152.25(a) to clarify that it does 
not apply to seeds for planting coated with systemic pesticides, such 
as the neonicotinoids, that are intended to kill pests of the plant 
instead of pests of the seed itself; (2) Alternatively, publish a 
final, formal, Agency interpretation in the Federal Register stating 
that EPA interprets the exemption in 40 CFR 152.25(a) not to apply to 
seeds for planting coated with systemic pesticides, such as the 
neonicotinoids, that are intended to kill pests of the plant instead of 
pests of the seed itself; and (3) Aggressively enforce FIFRA's numerous 
pesticide registration and labeling requirements for each separate crop 
seed product that is coated with a neonicotinoid or other systemic 
insecticidal chemical.
    EPA responded to the petition on September 27, 2022 (hereinafter 
Treated Seed Petition Response) (Ref. 1). In that response, EPA 
explained the history of the regulatory treated article exemption, the 
comprehensive nature of assessments of pesticides that are intended for 
use in treating seeds which includes assessment of the impact with use 
of the treated seed, and the regulatory conditions for the article 
exemption to apply. EPA noted that if the conditions for the exemption 
are met, the exemption applies; no new assessment or risk finding is 
necessary and no new FIFRA section 25(b)(2) finding specific to the 
article or substance treated is required. EPA also noted that it has 
been reviewing and will continue to review labeling instructions for 
pesticides registered for seed treatment use(s) in registration and 
registration review to verify the completeness of these instructions 
for both use of the treating pesticide and the distribution, sale, and 
use of the treated seed products. Finally, EPA acknowledged that use of 
the treated seed product in a manner contrary to labeling instructions 
is not generally enforceable under FIFRA. As a result, while the Agency 
did not grant the petition requests, it noted that it intends to issue 
this ANPRM to seek additional information on pesticide seed treatment, 
including use and usage information and whether treated seed products 
are being used contrary to labeling instructions, and to explore the 
option of issuing a rule pursuant to FIFRA section 3(a) to regulate the 
use of treated seed products. As explained in the petition response, 
plant-incorporated protectants (PIPs) are not subject to the treated 
article exemption for reasons articulated at 40 CFR 174.1 (because the 
characteristics of PIPs ``distinguish them from traditional chemical 
pesticides,'' PIPs are subject to ``different regulatory requirements, 
criteria, and procedures than traditional chemical pesticides''). As a 
result, PIPs are not within the scope of this ANPRM. For further 
information, please see docket ID number EPA-HQ-OPP-2018-0805 at 
https://www.regulations.gov/docket/EPA-HQ-OPP-2018-0805.

D. State FIFRA Issues Research and Evaluation Group (SFIREG) Treated 
Seed Issue Paper

    In August 2022, SFIREG provided EPA with the ``Treated Seed Issue 
Paper'' for consideration and response (Ref. 3). Shortly following the 
submittal of this issue paper by SFIREG, EPA released the Treated Seed 
Petition Response discussed in Unit II.C., which addressed many of the 
issues raised in the SFIREG issue paper in full or in part. In June 
2023, the Agency responded to the SFIREG issue paper, based on its 
understanding of the issues that were raised (Ref. 4). Part of that 
response included EPA's intention to include in this ANPRM the issues 
that were raised and to particularly focus on those not fully addressed 
in the Treated Seed Petition Response. Some of the issues raised in the 
SFIREG issue paper that are included in this ANPRM include use of 
treated seed products and available data systems to track the active 
ingredients used for seed treatments, change in use patterns of other 
pesticides due to availability of treated seeds, and label language on 
seed treatment products and treated seed products (e.g., seed bag 
tags). Other issues raised in the SFIREG issue paper that were 
addressed in the Treated Seed Petition Response, some of which have

[[Page 70629]]

requests for comment discussed in Unit III., include assessments of 
treated seed and effects to different taxa, including pollinators, non-
target terrestrial and aquatic organisms, and human health.

E. Background on Treated Paint

    Paint and coating products are often treated with pesticides for a 
variety of reasons, such as to increase the longevity of the products 
by controlling microbial contamination of the paint applied to a 
surface. Pesticide labeling requirements for treated paint or coatings 
do not currently exist. However, recent EPA risk assessments on paint 
preservative pesticides suggest that there may be risks of concern for 
professional painters exposed to treated paint without use of PPE such 
as respirators when applying paint using a spray method. The concept of 
adding labeling requirements for treated paint on the paint container 
has, thus far, only been proposed for one active ingredient (i.e., 
Diuron Proposed Interim Registration Review Decision Case Number 0046) 
but is being considered for many other active ingredients that are 
registered for use as paint preservatives and using the spray method of 
application. The Agency believes that the proposed labeling 
requirements for paint containers would help occupational users of 
paint, particularly those using sprayers to apply the paint, mitigate 
any potential risks of concern. EPA notes that similar risk mitigation 
measures are in the process of being implemented in Canada by the Pest 
Management Regulatory Agency.

III. Request for Comment and Information

A. General

    EPA invites public feedback on the questions posed in this document 
regarding use and usage of treated seed products and whether there are 
cases of use contrary to treating pesticide or treated seed product 
(e.g., seed bag tag) labeling instructions. EPA also invites comments 
on whether the Agency should take action through a potential FIFRA 3(a) 
rule and conforming amendments and/or other regulatory or 
administrative action to address concerns with the potential for 
noncompliance with labeling instructions. EPA is also requesting public 
feedback regarding similar questions with respect to treated paint. 
Please provide EPA with your thoughts as well as a rationale supporting 
your suggestions. If you can, provide examples or describe situations. 
Commenters are encouraged to present any data or information that 
should be considered by EPA during its consideration of these issues 
with treated seed and treated paint products and for the potential 
development of a section 3(a) rule and/or other regulatory or 
administrative action. EPA is not seeking comment to this docket on EPA 
assessments to support any particular registration or registration 
review decision. Such comments must be timely submitted to the dockets 
for those actions.
    As explained in the Treated Seed Petition Response, EPA's 
assessments for treating pesticides are based on all reasonably 
available and reliable information, including exposure assessments 
based on the treating pesticide labeling instructions defining the 
maximum amount of active ingredient that may be used on the seed. These 
assessments and labeling instructions are subject to public comment 
during the registration and registration review processes. In addition, 
outside of the registration and registration review processes, EPA 
recently solicited further public comment on proposed updates to all 
treated seed labeling on treating pesticide products and on treated 
seed products, to reduce exposures to non-target organisms, which might 
include federally listed threatened or endangered species. EPA has 
updated the labeling language for such products for future active 
ingredients undergoing registration review in response to comments and 
in anticipation of seeking further comment in response to this ANPRM. 
In addition, its public processes under registration and registration 
review for specific pesticide products intended for use in treating 
seed, EPA will continue to consider further updates to treated seed 
product label language to take into account additional public comments 
and new information, if any submitted.
    This ANPRM is a separate effort to consider whether to amend its 
approach for regulation of treated seed products (e.g., through 
issuance of a rule pursuant to FIFRA section 3(a) to regulate 
distribution, sale, and use of treated seed products and/or other 
regulatory or administrative action).
    This ANPRM is also intend to explore the option of adding 
instructions on the labels of pesticides used to treat paint, similar 
to the approach take for labeling of treated seed, and/or whether to 
amend its approach for allowing treated paint to be exempt from FIFRA 
requirements (e.g., through issuance of a rule pursuant to FIFRA 
section 3(a) to regulate distribution, sale, and use of treated seed 
products and/or other regulatory or administrative action).

B. Specific Topics Related to Treated Seed and Paint

    EPA is specifically requesting comment and information on the 
following topics:
     Effectiveness of instructions on treated seed product 
labeling (e.g., on the seed bag tags) to mitigate potential risks;
     Use, usage, and tracking of treated seed products;
     Management of spilled or excess treated seed;
     Treated paint; and
     Administrative action, amendment of the treated article 
exemption, and/or FIFRA section 3(a) Rule.
    1. Effectiveness of instructions on treated seed product labeling 
(e.g., on the seed bag tags) to mitigate potential risks.
    EPA currently is reviewing labeling instructions for pesticides 
registered for seed treatment use(s) in registration and registration 
review. EPA intends to ensure that treating pesticide labeling 
instructions include: (1) the requirement that seed bag tag labeling 
accompany the treated seed when distributed and sold; (2) that such 
labeling include specified clear and effective instructions on use of 
the treated seed, including the name of the active ingredient and 
pesticide product used (including the EPA product registration number), 
and instructions on the storage, planting, and/or management of spilled 
or excess treated seed, as appropriate; and, (3) that the distribution 
or sale of the treated seed products without such labeling is the 
distribution or sale of an unregistered pesticide.
    The Treated Seed Petition raised a number of issues with the 
potential for harm from the planting of treated seed or with the 
planting process used to plant treated seed. The Treated Seed Petition 
Response discusses each of the issues, including how EPA assessments of 
the treating pesticide address these issues. The response also 
discusses the regulatory conditions for application of the treated 
article exemption and how those conditions apply to treated seed 
products, including, among other things, the need for use of the 
treating pesticide and treated seed products to be consistent with the 
treating pesticide and related seed product labeling instructions. 
Examples of such labeling are in the document ``Labeling Instructions 
for Pesticide-Treated Seed and Pesticide-Treated Paint Products'' 
(referred to as the ``Labeling Instructions'' document from hereon) 
(Ref. 5), which can be found in the

[[Page 70630]]

docket EPA-HQ-OPP-2023-0420. For example, the specified labeling 
language on storage includes instructions on storing away from food and 
feedstuffs and not allowing children, pets, or livestock to have access 
to treated seed. Other instructions on use include, for example, the 
prohibition on use of the treated seed for food or feed; instructions 
detailing planting methods or management of spilled or excess seed to 
ensure reduced risk, for example, to pollinators and aquatic 
environments; and instructions on managing the potential for dusts 
generated from the abrasion of treated seed coatings during planting 
(i.e., dust-off).
    EPA is requesting comment on the following:
     Labeling instructions presented in the Labeling 
Instructions document (Ref. 5) and whether there are any necessary 
improvements to such language.
     Are the examples of current instructions for storage, 
planting, and management of treated seed clear, generally achievable, 
etc.?
     Are there other recommendations to increase the clarity of 
instructions on treated seed product (i.e., seed bag tag labeling) for 
the end user?
     Are there additional or alternative instructions that 
would be effective in reducing dust-off?
    2. Use, usage, and tracking of treated seed products.
    EPA's exposure estimates reflect both use and usage information. 
Use information is focused on the maximum amount of particular 
pesticide that may be applied based on the treating pesticide labeling 
instructions (e.g., total active ingredient that may be applied to the 
seed). Exposure estimates are also based on the modeling parameters for 
the assessment (e.g., the seeding rate for a particular crop per acre). 
For FIFRA ecological assessments of seed treatment uses, EPA assumes 
that the maximum amount of the pesticide is available as if the maximum 
permitted amount of the pesticide had been directly applied to the soil 
as shown in the T-Rex User Guide (Ref. 6). The term ``usage'' has been 
used broadly to refer to documented applications of a pesticide, 
including information such as actual application rates and timing, and 
spatial distribution of applications (usually based on survey data) 
(Ref. 7 and Ref. 8). Usage information is typically used to allow 
assessments to be more precise as compared to using worst case 
assumptions (e.g., on the percentage of a particular crop that is 
treated with every pesticide registered for use on that crop). EPA does 
not have current and reliable information quantifying the total pounds 
of active ingredient used to treat seed or the location and the number 
of acres planted with treated seed. Kynetec USA, the primary source of 
agricultural usage data for seed treatment in the years 2005-2014, 
stopped providing seed treatment estimates and supporting use of the 
existing 2005-2014 estimates in 2015 due to concerns about the 
reliability of those data (Ref. 7). However, applications of pesticides 
to treat seed may be generally characterized as common for a wide 
variety of crop seeds and seed pieces for planting based on 
agricultural extension services' recommendations and other information. 
EPA assessments detail the basis for use and usage information and such 
details are subject to public comment during the registration and 
registration review processes and the Agency continues to work to 
identify, investigate, and procure additional sources of usage data for 
seed treatments. As suitable data are procured and determined to meet 
EPA data quality standards, they will be integrated into usage analyses 
to help inform risk assessments (Ref. 9).
    The Treated Seed Petition noted the lack of pesticide usage data 
collected by EPA but acknowledged that one EPA assessment assumed 
nearly 100% of one crop is treated with the referenced pesticide and in 
another case identified the percentage of the pesticide use that is on 
treated seed. In response, EPA acknowledged the lack of usage data but 
more recently, data from two sources (i.e., Ben Kirk and Kline and 
Company) were identified, procured, and determined to meet EPA data 
quality standards. Data from those sources have been evaluated and will 
be integrated into usage analyses to inform risk assessments as 
appropriate.
    The SFIREG issue paper sought additional information on the general 
use of treated seed and data systems to track use of active ingredients 
to treat seed. The SFIREG issue paper also sought more information on 
the impact of the use of treated seed on the other types of 
applications such as soil or foliar applications (i.e., replacement and 
reduction in use of other types of applications). Finally, the SFIREG 
issue paper noted that there is no clear mechanism to address 
interstate commerce of treated seed and thus no means for a 
comprehensive state review of environmental impacts of seeds that could 
be legally planted in that state. The paper notes that state regulation 
of treated seed would conflict with the regulatory exemption for 
treated articles, and thus one state is considering prohibiting use of 
certain types of treated seed.
    EPA is seeking comment on the certain issues summarized below as 
raised in the SFIREG issue paper and the Treated Seeds Petition.
     Information on the use and usage of treated seed.
     Given the scope of EPA assessments, whether the potential 
for tracking of treated seed distribution, sale, and/or use would 
provide any meaningful improvements in the assessment of the risks of 
pesticides used to treat seeds.
     Are there available data detailing the replacement or 
reduction of other types of pesticides with increasing use of treated 
seed, since this issue is of interest to states and other stakeholders? 
EPA would normally address replacement and use reduction on an 
individual chemical basis, taking into account alternative control 
strategies to seed treatment (e.g., application of a pesticide at-plant 
(soil level) or immediately upon germination (foliar)) when there are 
risks associated with the treated seed (Ref. 10).
     Are there additional data sets available that may serve to 
complement the recently acquired data sources (e.g., data that trade 
organizations might have that can provide a better picture of how much 
of an active ingredient is used in seed treatment)?
     EPA requests information on the volume of imported treated 
seed products and whether amending the treated article exemption so 
that importers of treated seed products must comply with FIFRA section 
17(c) and 19 CFR 12.110 through 2.117, including filing an EPA Notice 
of Arrival of Pesticides and Devices (EPA Form 3540-1) or its 
electronic equivalent would assist in tracking the import and 
distribution of treated seed products (e.g., to track compliance with 
the exemption conditions).
     Should the treated article exemption be amended so that 
treated seed manufacturers would be subject to FIFRA section 7 
registration and reporting requirements (Ref. 11)? Would this 
information help track use of seed treatment pesticides or provide any 
helpful treated seed usage information?
    3. Management of spilled or excess treated seed.
    EPA included additional labeling instructions for management of 
spilled and excess treated seed in the registration review Proposed 
Interim Decisions (PIDs) and Interim Decisions (IDs) of several 
chemicals (see for example Ref. 12 and Ref. 13) as appropriate. This 
labeling included instructions on the collection and burial

[[Page 70631]]

of spilled treated seed, incorporation of treated seed into soil, 
limiting the broadcast planting of treated seed, and proper disposal of 
excess treated seed. In 2022, EPA requested additional comment on the 
labeling instructions as part of the ESA Workplan Update (Ref. 14) to 
reduce the potential for exposures to non-target organisms from spilled 
treated seed or disposal of excess treated seed, which might include 
federally listed threatened/endangered species.
    Comments on the ESA Workplan Update (Ref. 14) raised concerns with 
disposal of treated seed, particularly for use in ethanol production. 
The proposed labeling instructions that are presented in Labeling 
Instructions document (Ref. 5) are intended to address concerns 
relating to disposal of treated seed, exposure to wildlife, 
contamination of ground and surface water, sufficiency of current 
disposal instructions on both the registered treating pesticide product 
and treated seed product labeling, and disposal by way of ethanol 
production (for oil seed crops such as corn and soybeans). The concern 
regarding disposal of treated seeds stems from the possibility of a 
buildup of pesticide material as a byproduct of ethanol production.
    The Agency previously approved labels for oil seed crops that 
allowed for the use of excess treated seeds in ethanol production. EPA 
became aware of the potential for the use of excess, unmarketable 
treated seeds of oilseed crops in ethanol production and was concerned 
about the potential for pesticide residues found in the ethanol 
production by-products getting into food or feed. The byproducts of the 
process (e.g., wet distiller's grain or spent mash) can be used as 
livestock feed or applied as fertilizer but may also contain pesticide 
residues. To mitigate the risk, EPA allowed the use of treated seeds of 
oilseed crops for ethanol production but with the following conditions: 
(1) Byproducts are not used for livestock feed; and (2) No measurable 
residues of pesticide remain in ethanol byproducts that are used in 
agronomic practice. However, these measures may not be sufficient to 
protect against pesticide buildup after ethanol production. To address 
this concern, the Agency's proposed labeling instructions include 
language to prohibit the use of excess treated seeds for ethanol 
production (see Ref. 5).
    EPA requests comment on the following:
     Are additional instructions for collection of spilled seed 
needed?
     What is currently done with excess treated seed if not 
used in a planting season? For example, what do farming operations do 
with excess seed; can that seed be returned to the distributor or seed 
company?
     Similarly, what do distributors and seed companies do with 
excess treated seed that is not sold or delivered to or is returned 
from farming operations?
    4. Treated paint.
    Paints and coatings are often treated with pesticides for a variety 
of reasons, such as to increase the longevity of the products by 
controlling microbial contamination of the paint applied to a surface. 
Pesticide labeling requirements for treated paint do not currently 
exist. However, recent EPA risk assessments on paint preservative 
pesticides suggest that some treated paints may pose risks of concern 
to professional painters when applying paint using a spray method, 
without use of PPE such as respirators. The concept of adding labeling 
requirements for treated paint on the paint container has, thus far, 
only been proposed for one active ingredient (i.e., Diuron Proposed 
Interim Registration Review Decision Case Number 0046) but is being 
considered for many other active ingredients that are registered for 
use as paint preservatives (Ref. 15). The Agency proposed labeling 
requirements for paint containers that would help occupational users of 
paint, particularly those using sprayers to apply the paint, to 
potentially mitigate the identified risks of concern.
    EPA assesses risks to Do-It-Yourself painters as well as 
professional painters (i.e., those who provide the service of applying 
paint to the interior and exterior of homes, businesses, other building 
projects, machinery, and industrial equipment for compensation) from 
use of treated paint, and such assessments are based on long-standing 
EPA modeling parameters. An example includes the default value that 5 
gallons of paint (applied by a brush or roller) or 50 gallons of paint 
(applied by airless sprayer) are typically used daily by a professional 
painter. For Do-It-Yourself painters, the default value is 2 gallons 
(brush or roller) or 15 gallons (airless sprayer) of paint are 
typically used daily. EPA has used these values for many years. These 
values are used to estimate exposure from treated paint. Based on that 
exposure and the severity of inhalation and dermal hazard of the 
chemical, EPA determines the level of risk posed by those paints. EPA 
requests specific comment on the topics discussed further in this unit.
    a. Implementation and enforcement concerns.
    EPA is considering requiring certain treated paint products to 
include labeling instructions relating to precautionary label language 
and proper use. See Ref. 5. Distribution and sale of the treated paint 
products with such instructions would be an exempted treated substance 
and thus registration of the treated paint would not be required. For 
the exemption to apply, and similar to treated seed, the registration 
and labeling for the treating pesticide will make clear that specified 
instructions and precautionary language must appear on the treated 
paint labeling. If more than one pesticide is used to treat the paint, 
the registration and labeling for the treating pesticides will also 
likewise make clear that the exemption will only apply if the most 
restrictive label language is used on the paint label. If the 
appropriate instructions and precautionary language are not on the 
paint product labeling, the treated paint would not qualify as an 
exempt treated article, making it an unexempt, unregistered pesticide 
that may not be sold or distributed under FIFRA section 3 and subject 
to enforcement under FIFRA section 12(a)(1)(A).
    EPA is also considering adding specific use instructions for 
professional painters based on recent risk assessments for paint 
preservatives that have identified risks for professional painters. EPA 
may propose a FIFRA section 3(a) rule to apply to certain treated 
paint, making certain use instructions enforceable under FIFRA section 
12(a)(2)(S). Similar to the discussion on treated seed, other 
administrative actions may also be considered (e.g., limiting or 
cancelling use of specific active ingredients to treat paint based on 
risk assessment).
    EPA requests specific comment on the following topics:
     If EPA were to establish label requirements for treated 
paint products, what should be included to increase the clarity of the 
labeling and its safe use for the end user and the environment?
     Is there evidence that the lack of label or labeling 
requirements on treated paint has resulted in harm to human health or 
the environment? This may include harm experienced by professional 
painters from use of treated paint, improper disposal of treated paint, 
etc. This evidence could come in the form of work-related treated paint 
accident reports.
     Would requiring on the treated paint label the EPA 
registration number for each treating pesticide and the appropriate use 
instructions relating to painter protection be effective in reducing 
the identified risk concerns? If not, what additional information or 
requirements should EPA consider?

[[Page 70632]]

     Should the treated article exemption be amended so that 
paint manufacturing establishments producing pesticide-treated paint 
would be subject to FIFRA section 7 registration and reporting 
requirements (Ref. 11)? If so, should the establishment registration 
number be included on the label of the treated paint? How many paint 
manufacturers might be subject to such a requirement?
     If EPA were to establish enforceable use requirements for 
professional painters using treated paint, what additional information 
or requirements should EPA consider in this rulemaking to ensure 
effective enforcement? This may include information on additional 
resources, processes, etc. needed by states for enforcement.
    b. Importation.
    As noted previously, the condition in the exemption that the 
treating pesticide be ``registered for such use'' specifies that the 
exemption only applies to treated paint that is formulated with a 
FIFRA-registered pesticide product. EPA requests information on the 
volume of imported treated paint and whether amending the treated 
article exemption so that importers of treated paint must comply with 
FIFRA section 17(c) and 19 CFR 12.110 through 2.117, including filing 
an EPA Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) or 
its electronic equivalent would assist in tracking the import and 
distribution of treated paint (e.g., to track compliance with the 
exemption conditions).
    5. Administrative action, amendment of the treated article 
exemption, and/or FIFRA section 3(a) rule.
    EPA's assessments for seed and paint treatment uses are 
comprehensive, and EPA processes allow for comment on those 
assessments. As noted in the Treated Seed Petition Response, amending 
the regulatory exemption for treated articles to require registration 
of pesticide-treated seed where there is general compliance with 
labeling instructions for the FIFRA registered pesticides and treated 
seed products would provide little to no human health or environmental 
benefits. This is based on the comprehensive nature of EPA assessments 
for treating pesticides and treated seed and given EPA has no 
information suggesting that users of treated seed products are 
distributing, selling, or using the seed products contrary to labeling 
instructions. This is the same case for other treated articles and 
substances, including treated paint. However, concerns were raised by 
the Treated Seed Petition and the SFIREG issue paper regarding a lack 
of enforceability relating to use of treated seeds contrary to label 
instructions and possible effects of such use on human health and the 
environment. The same concerns also apply to treated paint products. 
Thus, EPA is requesting comment from stakeholders on whether or to what 
extent there might be use of treated seed and paint products contrary 
to labeling instructions for the treated seed and paint.
    EPA will take into consideration comments and information submitted 
in response to this ANPRM to determine whether to amend its approach 
for regulation of treated seed and treated paint (e.g., through 
issuance of a rule pursuant to FIFRA section 3(a) to regulate 
distribution, sale, and use of treated seed and paint products and/or 
other regulatory or administrative action). FIFRA section 3(a) 
authorizes EPA to limit the distribution, sale, or use of an 
unregistered pesticide ``[t]o the extent necessary to prevent 
unreasonable adverse effects on the environment.'' EPA believes a FIFRA 
section 3(a) rulemaking could be a more efficient and less resource-
intensive means to address some of the concerns that have been raised 
by Petitioner and states relating to use of the treated seed, where 
there is some indication that compliance with such labeling is in 
question. Other regulatory approaches could include limiting the scope 
of the exemption so that some FIFRA requirements would still apply 
(e.g., requiring seed treatment facilities to identify as 
establishments). Other administrative approaches could include 
addressing specific use concerns through further action during 
registration review for specific active ingredients (e.g., clarifying 
labeling instructions, further reducing or eliminating use of the 
treating pesticide for some seed or paint treatments, or including 
further terms and conditions on the registration for expiration of the 
use or imposition of use restrictions should use contrary to labeling 
instructions be reported).
    EPA requests comment on the following:
     Is a FIFRA section 3(a) rule and/or other regulatory or 
administrative action necessary or appropriate to prevent unreasonable 
adverse effects on human health and the environment, considering the 
concerns raised regarding enforceability of any particular type of 
labeling instructions on use of treated seed and paint products? Is a 
FIFRA section 3(a) rule and/or other regulatory or administrative 
action the best way of ensuring use consistent with instructions on the 
treating pesticide labeling relating to use of the treated seed or 
paint?
     Are there examples of use of treated seed contrary to 
labeling instructions, and whether adopting a FIFRA section 3(a) rule 
or the other options noted are the best means of ensuring appropriate 
use of treated seed?
     Would there be any impacts that might result to states if 
such a FIFRA section 3(a) rule is finalized? Are there existing tools 
that would be impacted, or are new ones needed for state investigation 
and enforcement? For example, state statutes or rules may need to be 
amended, new standard operating procedures developed, additional 
personnel hired, or some form of record keeping added.
     Are there specific examples of misuse by seed treatment 
applicators or from on-farm seed treatments and what type of evidence 
has been collected to support this claim?
     What are the enforcement measures that are used in regions 
and individual states for misuse of pesticides and are there barriers 
to applying such measures to treated articles, such as treated seed and 
treated paint?
     What are some examples of state statutory authority 
concerning treated seed and/or paint, and successful enforcement 
measures that have been exercised regarding treated seed and/or paint?
     What are some considerations, including enforcement 
considerations, that need to be included in EPA's approach for 
assessment and management of pesticide-treated seed and paint?

C. Potential Environmental Justice Concerns

    Under EPA policy, environmental justice is ``the fair treatment and 
meaningful involvement of all people regardless of race, color, 
national origin, or income, with respect to the development, 
implementation, and enforcement of environmental laws, regulations, and 
policies.'' See https://www.epa.gov/environmentaljustice. In addition, 
Executive Order 12898 (59 FR 7629, February 16, 1994), entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations,'' directs agencies, to the 
greatest extent practicable and permitted by law, to make environmental 
justice part of their mission by identifying and addressing, as 
appropriate, disproportionately high and adverse human health or 
environmental effects of their programs, policies, and activities on 
minority (people of color and/or indigenous

[[Page 70633]]

peoples) and low-income populations. EPA has not identified any such 
disproportionate effects from the issuance of this ANPRM as specified 
in Executive Order 12898. This ANPRM solicits comments from the public 
regarding pesticides under the treated article exemption including 
treated seed and treated paint. The Agency welcomes public input on the 
consideration of environmental justice concerns in the context of the 
issues raised in this ANPRM. 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.
    1. Environmental justice concerns for treated seed.
    It is estimated that there are 2.5-3 million agricultural workers 
in the United States. The Department of Labor conducted a National 
Agricultural Workers Survey in 2019-2020. In this survey, more than 
2,100 farmworkers were interviewed in person. Approximately 78% of 
those workers identified themselves as Hispanic and 62% said that 
Spanish was the language in which they were most comfortable 
conversing. Among U.S.-born farmworkers, 32% were Hispanic. Ten percent 
of farmworkers were self-identified as indigenous. EPA requests 
specific comment on the following topic:
     Are there any sources of data that could address whether 
exposure to treated seeds may be an environmental justice concern 
(e.g., given the potential for language barriers)?
    2. Environmental justice concerns for treated paint.
    EPA has limited sources of data to address whether there could be 
disproportionate impact to certain demographics that might be more 
likely to be exposed to treated paint. The Bureau of Labor Statistics 
(BLS) data from 2021 include demographics on ``painting workers'' and 
``painters and paperhangers.'' For both categories, the BLS data 
suggest that the majority of workers are Hispanic or Latino. According 
to 2021 U.S. Census data, Hispanics/Latinos make up 18.9% of the 
population. However, according to BLS, 32.3% of ``painting workers'' 
and 59.3% of ``painter and paperhangers'' are Hispanic or Latino. EPA 
requests specific comment on the following topics:
     Are there any sources of data that could address whether 
exposure to treated paint may be an environmental justice concern?
     Does either, or both, of the BLS categories (i.e., 
painting workers; painters and paperhangers) represent the type of 
painter that may be exposed to treated paint?

D. Potential Impacts on Children's Health

    In addition to the statutory obligations in FIFRA and FFDCA to 
consider children's health in registration decisions, EPA's 2021 Policy 
on Children's Health (Ref. 16) states that protecting children's health 
from environmental risks is fundamental to EPA's mission because 
varying behavioral and physiological characteristics can affect 
children's exposure and health risks, children's health should be 
viewed through the lens of a sequence of ``lifestages'' (from 
conception, infancy, early childhood, and adolescence through until 21 
years of age).
    Children may be more susceptible to environmental exposures and/or 
the associated health effects, and therefore more at risk than adults. 
These risks arise because children generally eat more food, drink more 
water, and breathe more air relative to their body size than adults do, 
and consequently may be exposed to relatively higher amounts of 
contaminants. Normal childhood activity, such as putting hands and 
objects in mouths, playing on the ground, or crawling, can result in 
exposures to contaminants that adults do not face. In addition, 
environmental contaminants may affect children disproportionately 
because they are still developing; for example, their immune system 
defenses are not fully developed, and their growing organs are more 
easily harmed.
    The Agency welcomes public comment and information regarding the 
consideration of potential children's health concerns in the context of 
the issues raised in this ANPRM. If and when the Agency proposes 
regulatory options regarding exemptions under FIFRA, other actions or 
the related procedures, EPA will seek additional input from the public 
to facilitate the Agency's consideration of potential children's health 
concerns related to those actions.

IV. Next Steps

    EPA intends to review all the comments and information received in 
response to this ANPRM, as well as previously collected and assembled 
information, to help determine whether to propose a FIFRA section 3(a) 
rule or take other regulatory or administrative action to adjust its 
approach for treated seed or treated paint. In addition to comments 
received in response to this ANPRM, EPA may seek additional information 
from states, industry or other stakeholders. Should EPA decide to move 
forward with changes to the program, the next step would be to 
identify, develop and evaluate specific options, including whether 
amendment to the current regulation in 40 CFR 152.25(a) is appropriate, 
and if so, to develop a proposed rule for public review and comment. 
During the development of the proposed rule, the Agency may also engage 
stakeholders or provide other opportunities for public engagement and 
comment before issuing a final action.

V. References

    The following is a list of the documents that are specifically 
referenced in this document. The docket includes these references and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the reference is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. United States Environmental Protection Agency (USEPA). 2022. EPA 
Response to the April 2017 Petition from Center for Food Safety and 
Others Relating to EPA Regulation of Pesticide-Treated Seed. 
September 27, 2022. https://www.regulations.gov/document/EPA-HQ-OPP-2018-0805-0104.
2. Center for Food Safety (CFS) et al. 2017. Citizen Petition to the 
United States Environmental Protection Agency. April 26, 2017. 
https://www.regulations.gov/document/EPA-HQ-OPP-2018-0805-0002. 
Federal Register. 83 FR 66260, December 26, 2018 (FRL-9987-54).
3. SFIREG (State FIFRA Issues Research and Evaluation Group). 2022. 
SFIREG Treated Seed Regulation Issue Paper. August 31, 2022.
4. USEPA. 2023. EPA Response to 08/31/2022--(State FIFRA Issues 
Research and Evaluation Group SFIREG) Treated Seed Issue Paper. June 
28, 2023.
5. USEPA. 2023. Labeling Instructions for Pesticide-Treated Seed and 
Pesticide-Treated Paint Products. September 2023. https://www.regulations.gov (under Docket ID No. EPA-HQ-OPP-2023-0420).
6. USEPA. 2012. T-REX Version 1.5 User's Guide for Calculating 
Pesticide Residues on Avian and Mammalian Food Items. March 22, 
2012. https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/t-rex-version-15-users-guide-calculating-pesticide#Section2_1.
7. USEPA. 2019. Assessment of Usage, Benefits, and Impacts of 
Potential Mitigation in Stone Fruit Production for Four 
Nitroguanidine Neonicotinoid Insecticides (Clothianidin, 
Dinotefuran, Imidacloprid, and Thiamethoxam). December 6, 2019. 
https://

[[Page 70634]]

www.regulations.gov/document/EPA-HQ-OPP-2011-0865-1178.
8. USEPA. 2020. Revised Method for National Level Listed Species 
Biological Evaluations of Conventional Pesticides. March 12, 2020. 
https://www.epa.gov/endangered-species/revised-method-national-
level-listed-species-biological-evaluations-
conventional#:~:text=The%20Revised%20Method%20for%20National,to%20dev
elop%20BEs%20for%20pesticides.
9. USEPA 2022. Response to Public Comments Received on Draft 
Biological Evaluations for Imidacloprid, Thiamethoxam, and 
Clothianidin. June 2022. https://www3.epa.gov/pesticides/nas/final/cloth-imi-thixam-rtc.docx.
10. USEPA. 2018. Benefits and Impacts of Potential Mitigation for 
Neonicotinoid Seed Treatments on Small Grains, Vegetables, and 
Sugarbeet Crops. August 30, 2018. https://www.regulations.gov/document/EPA-HQ-OPP-2008-0844-1622.
11. USEPA. 2022. Pesticide Establishment Registration and Reporting. 
November 30, 2022. https://www.epa.gov/compliance/establishment-registration-and-reporting.
12. USEPA. 2022. Tebuconazole Proposed Interim Registration Review 
Decision Case Number 7004. June 30, 2022. https://www.regulations.gov/document/EPA-HQ-OPP-2015-0378-0095.
13. USEPA. 2021. Triticonazole Interim Registration Decision Case 
Number 7036. March 17, 2021. https://www.regulations.gov/document/EPA-HQ-OPP-2015-0602-0039.
14. USEPA. 2022. ESA Workplan Update: Nontarget Species Mitigation 
for Registration Review and Other FIFRA Actions. November 2022. 
https://www.epa.gov/endangered-species/epas-workplan-and-progress-toward-better-protections-endangered-species.
15. USEPA. 2022. Diuron Proposed Interim Registration Review 
Decision Case Number 0046. April 2, 2022. https://www.regulations.gov/document/EPA-HQ-OPP-2015-0077-0065.
16. USEPA. 2021. 2021 Policy on Children's Health. October 5, 2021. 
https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 14094: Modernizing Regulatory Review

    This action is not a significant regulatory action as defined in 
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by 
Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore 
not subject to a requirement for Executive Order 12866 review.

B. Other Regulatory Assessment Requirements

    Because this action does not impose or propose any requirements, 
and instead seeks comments and suggestions for the Agency to consider 
in possibly developing a subsequent proposed rule, the various other 
review requirements in statutes and Executive Orders that apply when an 
agency imposes requirements do not apply to this ANPRM. Should EPA 
subsequently determine to pursue a rulemaking, EPA will address the 
requirements in the statutes and Executive Orders as applicable to that 
rulemaking.
    Nevertheless, the Agency welcomes comments and/or information that 
would help the Agency to assess any of the following:
     Potential economic impacts of a rulemaking on small 
entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.);
     Potential impacts on Federal, state, or local governments 
pursuant to the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-
1538);
     Potential federalism implications pursuant to Executive 
Order 13132, entitled Federalism (64 FR 43255, November 2, 1999);
     Potential Tribal implications pursuant to Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000);
     As discussed in Unit III.C., potential human health or 
environmental effects on minority or low-income populations pursuant to 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994);
     As discussed in Unit III.D., potential disproportionate 
environmental health or safety effects on children pursuant to 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997);
     Potential availability of voluntary consensus standards 
pursuant to section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA) (15 U.S.C. 272).
     Potential energy effects pursuant to Executive Order 
13211, entitled Actions Concerning Regulations that Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001); 
and
     Potential impacts in terms of costs and burdens associated 
with regulation options that the Agency may consider in developing a 
proposed rulemaking or other requirements, including potential 
activities and burdens associated with potential paperwork burdens 
pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
    The Agency will consider such comments and information in 
developing options as it considers appropriate steps to address any 
applicable requirements.

List of Subjects in 40 CFR Part 152

    Administrative practice and procedure; Agricultural commodities; 
Environmental protection; Exemptions from pesticide regulation; 
Pesticides and pests; Reporting and recordkeeping requirements.

Michael S. Regan,
Administrator.
[FR Doc. 2023-22558 Filed 10-11-23; 8:45 am]
BILLING CODE 6560-50-P