[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Proposed Rules]
[Pages 54173-54178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18928]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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  Federal Register / Vol. 87, No. 170 / Friday, September 2, 2022 / 
Proposed Rules  

[[Page 54173]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Doc. No. AMS-NOP-21-0008]
RIN 0581-AE02


Inert Ingredients in Pesticides for Organic Production

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: This advance notice of proposed rulemaking (ANPR) seeks input 
from stakeholders about how to update the United States Department of 
Agriculture (USDA) organic regulations on inert ingredients in 
pesticides used in organic production. The USDA Agricultural Marketing 
Service (AMS) seeks comments on alternatives to its existing 
regulations that would align with the Organic Foods Production Act of 
1990 (OFPA) and the U.S. Environmental Protection Agency's (EPA) 
regulatory framework for inert ingredients. Information from public 
comments would inform AMS's approach to this topic, including any 
proposed revisions of the USDA organic regulations.

DATES: Comments must be received by November 1, 2022.

ADDRESSES: To submit comments on the ANPR, use any of the following 
procedures:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. You can access this 
ANPR and instructions for submitting public comments by searching for 
document number, AMS-NOP-21-0008.
     Mail: Jared Clark, Standards Division, National Organic 
Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-S., Ag Stop 
0268, Washington, DC 20250-0268.
    All submissions received must include the docket number AMS-NOP-21-
0008, and/or Regulatory Information Number (RIN) 0581-AE02 for this 
ANPR. AMS seeks information and feedback on specific topics listed in 
this ANPR. Commenters are also invited to provide information and 
perspectives on inert ingredients for topics not requested by AMS in 
this notification. Specific and relevant information and data to 
support your comments is encouraged, including, scientific, 
environmental, manufacturing, industry, or impact information. Comments 
received will be posted to https://www.regulations.gov.
    To access the document, related documents, and comments received, 
go to https://www.regulations.gov/ (search for Docket ID AMS-NOP-21-
0008).

FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division, 
National Organic Program. Telephone: (202) 720-3252. Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Summary

    This ANPR seeks input from stakeholders about how to rectify the 
USDA organic regulations' references to outdated EPA policy on inert 
ingredients used in pesticide products. The outdated references are 
inconsistent with current EPA requirements. This causes problems in the 
organic industry and for AMS's administration of the USDA organic 
regulations (see Background section).
    Inert ingredients (``inerts''--also identified as ``other 
ingredients'' on pesticide labels) are substances other than the 
``active'' (i.e., pesticidal) ingredients included in formulated 
pesticide products. Inert ingredients added to pesticides may function, 
for example, as adjuvants, solvents, diluents, stabilizers, or 
preservatives. Pesticide labels do not typically disclose the identity 
(common or chemical name) of the inert ingredients in the product.
    For organic crop and livestock production, current USDA organic 
regulations allow EPA List 3 and List 4 inert ingredients to be used in 
pesticide products when the product includes active ingredients 
permitted by the organic regulations. Together, EPA List 3 and List 4 
include more than 2,700 inert ingredients.\1\ AMS does not know how 
many of these inert ingredients are included in products used in 
organic production, but it is likely a relatively small subset of these 
2,700 ingredients. These lists were last updated by the EPA in 2004 and 
will not be updated again (see Background section).
---------------------------------------------------------------------------

    \1\ ``Categorized List of Inert Ingredients (Old Lists),'' U.S. 
Environmental Protection Agency, https://www.epa.gov/pesticide-registration/categorized-lists-inert-ingredients-old-lists.
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    In this ANPR, AMS's National Organic Program (NOP) seeks comments 
that will assist the Agency in assessing the feasibility of 
alternatives that could replace the references to these outdated EPA 
lists. Information from public comments would inform AMS's approach to 
this topic, including any proposed revisions of the USDA organic 
regulations. AMS seeks comments to identify alternatives as well as to 
receive information about obstacles and the costs and benefits of 
options. Stakeholders that may be affected by future actions on this 
topic include pesticide manufacturers, certified organic operations, 
consumers, certifying agents, and other interested parties.

II. Background

    Inert ingredients are key components of formulated pesticide 
products. These ingredients can, for example, increase the 
effectiveness of pesticidal products, increase a product's shelf-life, 
or prevent degradation.\2\ Inert ingredients, being a key component of 
pesticide products, are specifically identified in the Organic Foods 
Production Act of 1990 (OFPA). Under OFPA at 7 U.S.C. 
6517(c)(1)(B)(ii), the National List may provide for the use of 
substances in an organic farming or handling operation if the substance 
is used in production and contains synthetic inert ingredients that are 
not classified as inerts of toxicological concern by the EPA, in 
addition to the general considerations for National List substances at 
7 U.S.C. 6517(c)(1)(A) and 6518(m).
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    \2\ ``Inert Ingredient Frequently Asked Questions,'' U.S. 
Environmental Protection Agency, Office of Chemical Safety and 
Pollution Prevention, December 2015, https://www.epa.gov/sites/default/files/2015-12/documents/faqs.pdf.
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    In a December 16, 1997, proposed rule to establish the National 
Organic Program (62 FR 65850), AMS proposed that all inert ingredients 
not classified by the EPA as ``of toxicological

[[Page 54174]]

concern'' be allowed when formulated with allowed active ingredients. 
During this time, the EPA classified inert ingredients using 
categorical lists to group these substances by toxicological concern 
and risk. While the proposed regulatory text did not reference the EPA 
Lists, AMS stated in the preamble of the proposed rule that only EPA 
List 1 was to be used to identify inert ingredients of toxicological 
concern.
    In February 1999, in response to this proposed rule, the National 
Organic Standards Board (NOSB or Board), a Federal advisory committee 
established by the OFPA, recommended that inert ingredients appearing 
on:
     EPA List 1 and List 2 be prohibited;
     EPA List 3 be prohibited unless specifically approved by 
the NOSB; and
     EPA List 4 should generally be allowed, unless explicitly 
recommended for prohibition.\3\
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    \3\ National Organic Standards Board Joint Committee Meetings, 
Washington, DC, May 1-2, 1992; Minneapolis, Minnesota, May 4-6, 
1992, https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf.
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    AMS agreed with the NOSB's recommendation. In the December 21, 
2000, final rule (65 FR 80547), EPA List 4 was added to the National 
List. This allowed any synthetic substance on EPA List 4 to be in 
pesticide products used in organic crop and livestock production (when 
used in conjunction with pesticides containing allowed active 
ingredients). Subsequently, AMS amended the National List to include an 
allowance for EPA List 3 inert ingredients for use in crop production 
only in passive pheromone dispensers, effective November 3, 2003 (68 FR 
61987). EPA List 1 and List 2 contain only synthetic substances. They 
remain prohibited and are not listed as allowed on the National List.
    When NOP added these lists, referencing an entire set of substances 
in a single entry on the National List, as recommended by the NOSB, 
limited disruption to the organic industry because it allowed most 
inert ingredients that were approved by organic certifying agents prior 
to implementation of the USDA organic regulations. The regulatory 
framework that relied on EPA List 3 and List 4 also reduced the 
administrative burden on the NOSB and on AMS, as the effort to evaluate 
each allowed synthetic inert substance on the National List would have 
likely exceeded available resources. As a result, pesticides containing 
inert ingredients of toxicological concern (i.e., EPA List 1 and List 
2) were not allowed in organic production, but organic producers 
continued to have access to pesticides containing inert ingredients on 
EPA List 3 and List 4.
    The EPA moved away from their own categorical list system while AMS 
developed regulations to establish the NOP and the USDA organic 
requirements (7 CFR part 205). The passage of the Food Quality 
Protection Act of 1996 (FQPA, 7 U.S.C. 136 et seq.) mandated that the 
EPA develop tolerances (or tolerance exemptions) for inert ingredients 
used in food-contact products. These tolerances, which are the maximum 
amount of a pesticide allowed to remain in or on a food, are codified 
in EPA regulations at 40 CFR part 180. As a result, new and existing 
inert ingredients are approved for use through EPA's rulemaking 
process, and the EPA Lists referenced in the USDA organic regulations 
are no longer updated.\4\
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    \4\ ``Categorized Lists of Inert Ingredients (Old Lists),'' U.S. 
Environmental Protection Agency, https://www.epa.gov/pesticide-registration/categorized-lists-inert-ingredients-old-lists.
---------------------------------------------------------------------------

    In response to these lists no longer being updated, the NOSB passed 
an April 2010 recommendation to replace references to EPA List 3 and 
List 4.\5\ This recommendation proposed a system in which the NOSB 
would evaluate inert ingredients on EPA List 3 and List 4 for a 
synthetic or nonsynthetic determination (the terms ``synthetic'' and 
``nonsynthetic (natural)'' are defined in the organic regulations at 7 
CFR 205.2). Following classification, the list of the nonsynthetic 
inert ingredients would be presented as the ``first choice,'' or 
preferred, inert ingredients for manufacturers when formulating 
pesticide products for organic production. Under this recommendation, 
synthetic inert ingredients could only be added to the National List 
through the petition process to the NOSB. This work was to be conducted 
through a working group comprised of NOSB members, representatives from 
the EPA's Design for the Environment/Safer Choice program, and AMS. 
This working group eventually led to the development of a subsequent 
October 2015 NOSB recommendation.
---------------------------------------------------------------------------

    \5\ ``Inerts in Pesticides Allowed for use in Organic 
Production,'' Formal Recommendation by the National Organic 
Standards Board (NOSB) to the National Organic Program (NOP), April 
29, 2010, https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20on%20Inerts%20in%20Pesticides.pdf.
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    In October 2015, the NOSB recommended an annotation change to 
address the National List references to EPA List 3 and List 4.\6\ This 
recommendation, like the 2010 recommendation, suggested a change to the 
annotations at 7 CFR 205.601(m) and 205.603(e) to remove references to 
EPA List 3 and List 4. This recommendation suggested replacing these 
references as follows:
---------------------------------------------------------------------------

    \6\ ``Formal Recommendation from National Organic Standards 
Board (NOSB) to the National Organic Program (NOP),'' October 29, 
2015, https://www.ams.usda.gov/sites/default/files/media/CS%20LS%20EPA%20List%204InertsAnnotation_final%20rec.pdf.
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     Allow inert ingredients that are permitted in ``minimum 
risk pesticide'' products that are exempt from registration as 
described in the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA). (Note: as of February 2016 (80 FR 80653), this list of inert 
ingredients is codified at 40 CFR 152.25(f)(2));
     Allow substances listed on EPA's Safer Choice program's 
Safer Chemical Ingredients List; and
     Allow inert ingredients exempt from the requirement of a 
tolerance at 40 CFR 180.1122 (only for use in passive pheromone 
dispensers).
    The working group continued through 2017 with a goal of rulemaking 
prior to the NOSB's 2020 List 4 sunset review (a process in which 
National List substances are reviewed every five years to assess 
continued OFPA compliance).
    Given the emphasis the NOSB gave the Safer Choice program to help 
resolve the issue with the outdated lists, AMS consulted with the Safer 
Choice program in September 2021. This consultation explored ways EPA's 
program could assist with a solution to the references to EPA List 3 
and List 4 in the National List. The meeting highlighted many reasons 
why the Safer Choice program is not well suited to help address this 
issue. First, there is a discrepancy between the structure of the 
programs: the NOP is a regulatory program, while the Safer Choice 
program is a voluntary program that exists outside of a regulatory 
framework. The issues associated with this discrepancy are further 
explained in the Regulatory Challenges section.
    Second, the expertise, review criteria, and structure of the Safer 
Choice program is focused on review of cleaners and disinfectants, not 
crop and livestock pest control products. As a result, it does not 
directly translate to review of crop and livestock pest control 
materials. Further, the Safer Choice program generally does not meet 
the needs of AMS or NOSB in addressing the outdated references to the 
EPA lists in the organic regulations, as replacement inert ingredients 
in the

[[Page 54175]]

National List must meet specific requirements of the OFPA, including 
human and environmental health impacts, natural substitute products, 
toxicological concerns, and compatibility with organic farming. While 
Safer Choice may consider similar criteria in their review of products, 
they do not consider them in the scope of crop and livestock 
production, nor are they considerations which would be easily 
integrated into their system.
    At the conclusion of the NOSB's October 2020 sunset review for EPA 
List 4 substances, AMS had not yet initiated rulemaking to address 
these references, for reasons discussed in the Regulatory Challenges 
section and elsewhere in this ANPR. Acknowledging the lack of 
rulemaking on this topic, the NOSB discussed voting to remove EPA List 
4 from the National List to encourage rulemaking action.\7\ Ultimately, 
the Board voted to not recommend removal of EPA List 4 inert 
ingredients from the National List,\8\ noting a desire to minimize 
market disruption. In August 2021, AMS renewed the listing of EPA List 
4 on the National List until March 15, 2027 (86 FR 41699).
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    \7\ ``Public Comment Webinar,'' United States Department of 
Agriculture, National Organic Standards Board, October 20, 2020, 
https://www.ams.usda.gov/sites/default/files/media/TranscriptsNOSBOctober2020.pdf.
    \8\ ``Formal Recommendation from National Organic Standards 
Board (NOSB) to the National Organic Program (NOP),'' 2022 Sunset 
Reviews--Crops, October 30, 2020, https://www.ams.usda.gov/sites/default/files/media/CS2022SunsetRecs_webpost.pdf.
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    During its October 2020 meeting, the Board also passed a resolution 
encouraging coordination between the Board and the NOP to replace the 
outdated reference to EPA List 4 on the National List.\9\ This 
resolution requested that AMS work with NOSB to develop an alternative 
review process for inerts, work with NOSB to develop an implementation 
timeline, and coordinate with NOSB on progress to develop an 
alternative to EPA List 4. This ANPR solicits feedback on alternatives, 
and comments received would inform AMS's approach on this topic, which 
may include further consultation with the NOSB and proposed revisions 
to the USDA organic regulations.
---------------------------------------------------------------------------

    \9\ ``NOSB Resolution from National Organic Standards Board 
(NOSB) to the National Organic Program (NOP),'' Resolution on EPA 
List 4 Inerts, October 30, 2020, https://www.ams.usda.gov/sites/default/files/media/NOSBResolutionList4InertsRec_webpost.pdf.
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III. Potential Replacements for EPA List 3 and/or List 4

    In this ANPR, AMS describes five options (in sections A-E) for 
updating references to inert ingredients in the USDA regulations on 
organic production. These options were received as recommendations from 
the NOSB or identified as possibilities by AMS. AMS also outlines some 
of the advantages and disadvantages of each option. We did not include 
an option that references the Safer Choice program for reasons 
explained in the Background section. A robust alternative to the 
existing regulations may require implementing more than one option. 
Commenters are invited to comment on the costs and benefits, obstacles 
or other aspects of these options.

A. Allow Inert Ingredients Permitted by EPA in Minimum Risk Pesticides

    This option would replace the reference to EPA List 4, in part, 
with an allowance for inert ingredients allowed by EPA regulations in 
``minimum risk pesticides.'' Minimum risk pesticides are pesticides 
that are exempt from regulation under FIFRA because they pose little to 
no risk to human health or the environment.\10\ These inerts are listed 
in Table 2 at 40 CFR 152.25(f).
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    \10\ ``Minimum Risk Pesticide: Definition and Product 
Confirmation,'' U.S. Environmental Protection Agency, February 1, 
2021, https://www.epa.gov/minimum-risk-pesticides/minimum-risk-pesticide-definition-and-product-confirmation.
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    This option would:
     Satisfy the OFPA requirement that inert ingredients not be 
classified by the EPA as ``inerts of toxicological concern,'' as the 
EPA review process for all food-use inert ingredients includes a robust 
evaluation of toxicity and exposure risks;
     Be similar to current regulations, and relies on the EPA's 
assessment of inert ingredients; and
     Not allow substances currently used in formulated 
pesticide products (in compliance with current USDA organic regulations 
at Sec.  205.601(m) and Sec.  205.603(e)) that are not on EPA Table 2 
at 40 CFR 152.25(f). This could eliminate products currently available 
to organic producers and/or require manufacturers to reformulate.

B. Allow Specific Inert Ingredients Permitted by EPA

    This option focuses on List 4 only, to explore a partial solution 
with respect to that list. This option would replace reference to EPA 
List 4 with an allowance for an inert ingredient that is exempt from 
the requirement of a tolerance. These inert ingredients are listed at 
40 CFR part 180 subpart D (Sec. Sec.  180.900-180.1381). Active 
ingredients in these sections that are exempt from the requirements of 
a tolerance that do not have an allowed use as an inert would not be 
permitted.
    This option would:
     Satisfy the OFPA requirement that inert ingredients not be 
classified by the EPA as ``inerts of toxicological concern,'' as the 
EPA review process for all food-use inert ingredients includes a robust 
evaluation of toxicity and exposure risks;
     Be similar to current regulations, as this option relies 
on the EPA's assessment of inert ingredients. Inerts permitted by the 
EPA are codified (appear in the Code of Federal Regulations [CFR]) and 
could be easily cross-referenced within the USDA organic regulations. 
When EPA adds or removes inert ingredients, the USDA organic 
regulations would not require corresponding revisions. Additional 
engagement with EPA in their rulemaking process by AMS and stakeholders 
may be warranted to stay informed of changes to EPA regulations; and
     Potentially permit the use of more inert substances 
compared to the number of inert substances on EPA List 4 (approximately 
870 substances) and EPA List 3 (approximately 1,850 substances).

C. Replace EPA List 3 With EPA-Allowed Inert Ingredients of 
Semiochemical Dispensers

    This option would focus on List 3 only, to explore a partial 
solution with respect to that list. This option would replace the 
current reference to EPA List 3 (for inert ingredients used in passive 
pheromone dispensers) at 7 CFR 205.601(m)(2) with reference to the 
current EPA framework for inert ingredients in ``semiochemical 
dispensers.'' Semiochemicals are chemicals that are emitted by plants 
or animals and modify the behavior of the receiving species (e.g., 
disruption of mating for the purposes of pest control). Special 
conditions for the exemption of these inert ingredients appear in EPA 
regulations at 40 CFR 180.1122 (``Inert ingredients of semiochemical 
dispensers; exemptions from the requirement of a tolerance''). These 
special conditions include, among other things: (1) Exposure that must 
be limited to inadvertent physical contact only; and (2) design of the 
dispenser must preclude any contamination by its components of the raw 
agricultural commodity or processed foods/feeds derived from the 
commodity by virtue of its proximity to the raw agricultural

[[Page 54176]]

commodity or as a result of its physical size (see 40 CFR 
180.1122(a)(1)). Exposure must be limited to inadvertent physical 
contact only. The design of the dispenser must be such as to preclude 
any contamination by its components of the raw agricultural commodity 
or processed foods/feeds derived from the commodity by virtue of its 
proximity to the raw agricultural commodity or as a result of its 
physical size.
    This option would:
     Continue to allow passive pheromone dispensers; and
     Simplify the review of formulated products for certifying 
agents and third parties who review inputs for compliance with USDA 
organic regulations.

D. List Inert Ingredients Individually on the National List

    As a replacement to List 3 and/or List 4, inert ingredients could 
be migrated to the USDA organic regulations at 7 CFR part 205 as 
individual itemized or grouped listings. This would result in a 
codified list of inert ingredients, contained within the National List. 
In developing a list of inert ingredients, EPA List 3 and List 4, as 
well as work done by the EPA (either by AMS in cooperation with EPA or 
extracted from the list of inerts permitted in minimum risk pesticides 
at 40 CFR 152.25(f)(2)), could be used to identify inert ingredients 
for proposal for inclusion on the National List. Alternatively, inert 
ingredients for consideration could be identified by pesticide 
manufacturers or other parties through petitions to the NOSB. In either 
case, the individual substances would be reviewed by the NOSB, and, if 
recommended, inert ingredients could be added to the National List by 
AMS through the rulemaking process.
    This option would require substantial work by both the NOSB and 
AMS. Specifically, this option would:
     Require coordination or validation of these inert 
ingredients by the EPA to verify they are not of toxicological concern 
to meet the OFPA requirement that synthetic inert ingredients not be 
classified by the Administrator of the EPA as ``inerts of toxicological 
concern'';
     Require a sunset review of approximately 190 substances 
currently in use in organic-compliant pest control products every five 
years as required by OFPA at 7 U.S.C. 6517(e). This change would nearly 
double the number of substances currently present on the National List 
(approximately 230 substances) and would significantly increase the 
NOSB's and NOP's workload; and
     Likely require a lengthy implementation period to minimize 
disruption and provide adequate time for submission of petitions, NOSB 
review, and AMS rulemaking.

E. Take No Action (Status Quo)

    This option would maintain the status quo and continue to rely on 
historical EPA List 3 and List 4. Any person may submit a petition to 
add an inert ingredient to the National List according to 7 CFR 205.607 
and the procedures in NOP 3011.\11\ Currently, NOSB consideration of 
these petitions are at the discretion of the Board.\12\
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    \11\ ``Procedure: National List Petition Guidelines,'' United 
States Department of Agriculture, National Organic Program, https://www.ams.usda.gov/sites/default/files/media/NOP%203011%20Petition%20Procedures.pdf.
    \12\ ``Petitions for Inert Ingredients under the National 
Organic Program,'' Notice 11-6, United States Department of 
Agriculture, National Organic Program, February 3, 2011, https://www.ams.usda.gov/sites/default/files/media/NOP-Notice-11-6.pdf.
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    This option would:
     Continue to conflict with current EPA regulations. EPA has 
revoked the use of certain List 4 inert ingredients in pesticide 
formulations. AMS would need an effective mechanism to identify and 
communicate these discrepancies between EPA tolerance assessments and 
List 4 inert ingredients;
     Potentially lead to stagnation in development of 
alternative products for organic production, including products with 
potentially lower toxicity, and loss of confidence among stakeholders/
industry in NOP's ability to address pressing regulatory needs; and
     Potentially result in the removal of EPA List 3 and List 4 
from the National List at the conclusion of NOSB's next sunset review. 
AMS would prefer not to remove List 3 and List 4 from the National List 
in the absence of a viable alternative.

IV. Regulatory Challenges

    In this section, AMS describes the regulatory challenges related to 
updating the USDA organic regulations on synthetic inert ingredients 
used in organic crop and livestock production. AMS invites specific 
comments related to these topics in the Request for Public Comments 
section below.

Referencing Third-Party Lists

    All options discussed in this ANPR would rely on lists or 
regulations maintained by EPA. Some options would rely on codified 
listings that have completed notice-and-comment rulemaking. NOSB's 
recommendation that AMS reference the EPA Safer Chemical Ingredients 
List brings the regulatory challenges associated with third-party lists 
to the forefront of this discussion. Referring to a third-party (non-
codified) list would pose several regulatory challenges:
     Updates to third-party lists would require oversight and 
management by the third party, rather than AMS. For example, 
opportunities for public input about revisions to the list (or 
revisions to the standards/criteria used to assess substances) may be 
more limited or less transparent than provided by AMS during its 
notice-and-comment rulemaking.
     Any reference to a list that is not within the CFR--and 
that is required to understand or comply with the regulations--would 
require approval by the Director of the Federal Register, as dictated 
by the Federal regulations related to ``incorporation by reference'' 
(see 1 CFR part 51). The Director's decision is outside of AMS's 
control.
     AMS would be required to refer to only one publication 
(i.e., an edition with a specific publication date) of a list within 
the USDA organic regulations (see 1 CFR 51.1). Providing notice of the 
change in the Federal Register and updating the CFR would be some of 
the steps necessary to update the reference to a new edition of the 
list (1 CFR 51.11).

Individual Listings for Inert Ingredients on the National List

    As discussed in the Background section of this ANPR, AMS originally 
referenced EPA Lists in the USDA organic regulations to prevent 
disruption to the industry and to reduce the administrative burden on 
the NOSB and AMS. AMS is aware that some stakeholders may prefer to 
include permitted inert ingredients to be individually listed in the 
USDA organic regulations. AMS also recognizes that stakeholders may 
believe that the intent of OFPA was to individually list inert 
ingredients on the National List.
    Individual listings of inert ingredients on the National List would 
greatly increase the Board's and AMS's workloads due to the required 
process and timeline. Generally, petitioned substances undergo an NOSB 
review process that can take one to two years. This review process is 
supported by third-party technical reports, stakeholder engagement, and 
NOP staff. If the review process results in a recommendation for 
rulemaking, the rulemaking process can take an additional one and a 
half to three years. In total, this means a petition to add or remove a 
substance can take up to two and a half to five years before the 
process is completed. Substances

[[Page 54177]]

recommended for removal through the sunset process would need to 
undergo rulemaking, which takes approximately two years before the 
recommended removal is reflected in the regulations. This increased 
workload may be beyond the administrative capacity of the NOSB, 
contracted partners, and NOP staff.

V. Request for Public Comments

    Over the years, AMS's references to third-party lists of substances 
(i.e., the EPA Lists) served to reduce the impact on the NOSB and on 
AMS to review each inert substance separately. As AMS considers options 
for future rulemaking to replace these obsolete lists, the Agency seeks 
comments on how to balance: (1) The disadvantages of relying on 
external agencies/organizations or external lists; (2) available 
resources (including time) of the NOSB and AMS; and (3) statutory 
requirements under OFPA. AMS also invites comments from the public on 
the topic areas listed in this section of the ANPR. We would also 
consider comments on other topic areas related to inert ingredients in 
organic production.

General

     Should AMS replace the references in the USDA organic 
regulations to the outdated EPA List 3 and List 4? What problems are 
caused by the current references to EPA List 3 and List 4?
     How do various options align (or not align) with the 
statute (OFPA) and with AMS's authority, as provided under the statute, 
to regulate inert ingredients?
     What other options might be available that AMS and NOSB 
have not considered?

Third-Party (Non-Codified) Lists

     Should AMS rely on third-party list(s) as a means of 
evaluating inert ingredients permitted in organic production? If so, 
which third-party list(s) would be appropriate, and why?
     To what degree should the National List include individual 
substances allowed as synthetic inert ingredients versus referencing 
third-party lists established outside of AMS?
     How feasible or acceptable is it for AMS to reference 
third-party lists (lists that exist outside of Federal regulations that 
are not published in the CFR) to update current references on the 
National List to EPA List 3 and List 4?
     How does the approval and update process (via 
incorporation by reference) affect the feasibility of referencing a 
third-party list(s) for inert ingredients on the National List? For 
example, if a third-party list of inerts is not published in editions, 
it is ineligible for incorporation by reference. Conversely, if a 
third-party list were published in editions, AMS would need to take 
rulemaking action to update the reference to a newer edition.

Administrative Capacity

     AMS recognizes that it takes time and effort for the NOSB 
to perform a sunset review for each item on the National List, and 
there are likely hundreds of substances used as inert ingredients under 
current USDA organic regulations. How could AMS and the NOSB complete 
the necessary sunset reviews if substances were listed individually on 
the National List?
     How should the time constraints influence the approach 
that AMS should take regarding inert ingredients?
     The referenced Safer Choice program framework includes 
accreditation of third-party organizations, evaluation of substances 
against published standards by those accredited organizations, agency 
review of the evaluation, and publication of a list of approved 
substances. If AMS adopted a similar framework to that of the Safer 
Choice program, what would this look like, and would it address the 
regulatory challenges and capacity constraints outlined in this ANPR? 
What additional AMS staff resources would be required to accomplish 
this?
     If inert ingredients are individually listed, which set of 
substances from EPA List 3 and List 4 should be initially migrated to 
the National List, and how would those substances be identified?
     AMS notes that the NOSB has received more than 15 
petitions to add specific inert ingredients to the National List, yet 
none have been recommended for addition to the National List.\13\ If 
the established petition process is used to amend the National List to 
add or remove inert ingredients \14\ would this approach satisfy the 
needs of the organic industry?
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    \13\ ``Petitioned Substances,'' United States Department of 
Agriculture, National Organic Program, https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned.
    \14\ ``Procedure NOP 3011,'' March 11, 2016, National Organic 
Program Handbook, United States Department of Agriculture, National 
Organic Program, https://www.ams.usda.gov/sites/default/files/media/Program%20Handbk_TOC.pdf.
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EPA Process and References

     How should the phrase in OFPA ``not classified by the 
Administrator of the Environmental Protection Agency as inerts of 
toxicological concern'' be interpreted in light of the EPA's current 
regulations and regulatory scheme for inert ingredients (see 7 U.S.C. 
6517(c))?
     If none of the inert ingredients permitted under EPA 
regulations are considered to be of toxicological concern to the EPA, 
should AMS permit all EPA allowed inert ingredients in pesticides for 
organic production? What are the risks and benefits associated with 
this option?
     If any inert ingredients that are allowed by EPA should 
not be permitted under USDA organic regulations, what are those 
substances and why should they not be permitted as inert ingredients 
used in organic production?
     Can inert ingredients currently allowed by EPA regulations 
(i.e., in the Code of Federal Regulations) be sorted or classified 
according to toxicological concern? If some substances are of more 
concern, should AMS prohibit specific substances, or groups of 
substances, while allowing all other substances allowed as inert 
ingredients by the EPA? What criteria, specifically, would be 
appropriate for AMS to consider when assessing ``toxicological 
concern''?
     If inerts at 40 CFR 152.25(f)(2) were used with active 
ingredients in pesticide products that are not exempt from regulation 
(i.e., not ``minimum risk pesticides'') the inert ingredient would 
require a tolerance (or exemption from the requirements of a tolerance) 
at 40 CFR part 180 for use in food or feed crops. AMS understands that 
there is not uniformity among 40 CFR 152.25(f)(2), 40 CFR part 180, and 
EPA List 4 (e.g., a substance may be listed on EPA List 4 and 40 CFR 
152.25(f)(2) but not be present at 40 CFR part 180). What combination 
of these EPA regulatory citations, if any, would be acceptable and 
provide the least disruption to industry?
     Would the scope of allowed inert ingredients be clear if 
AMS adopted a reference to 40 CFR part 180 subpart D (or a subsection 
therein)? Is there a subsection of Subpart D that would be preferable 
to a reference to the entire Subpart D? Are there inert ingredients 
listed on EPA List 4 that are being used in organic-compliant 
herbicides for farmstead maintenance (roadways, ditches, right of ways, 
etc.) and ornamental crops, which do not appear in 40 CFR part 180 
subpart D? Are there alternatives within Subpart D that could 
substitute for inerts in currently formulated products?

VI. Conclusion and Next Steps

    Given the background, key regulatory challenges, and options for 
consideration outlined in this ANPR, AMS is seeking comment on 
potential and preferred paths forward. Specifically, we seek comment on 
feasible alternatives to the allowance of

[[Page 54178]]

EPA List 3 and List 4, unforeseen legal and regulatory challenges not 
mentioned in this ANPR, estimated impacts to industry of each option, 
and preferred method (or combination of methods) for addressing these 
listings. When possible, comments should be accompanied by citations of 
supporting sources.
    Comments received in response to this ANPR would inform AMS's 
approach on this topic regarding the allowance of inert ingredients in 
organic production. Substantive, well-reasoned, constructive comments 
would assist in identifying if there are unforeseen challenges or a 
viable alternative to move forward into rulemaking. Comments generally 
in support or opposition to alternatives identified in the ANPR would 
assist AMS in identifying the acceptability of the presented options in 
the absence of other alternatives.

Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-18928 Filed 9-1-22; 8:45 am]
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