Inert Ingredients in Pesticides for Organic Production, 54173-54178 [2022-18928]
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54173
Proposed Rules
Federal Register
Vol. 87, No. 170
Friday, September 2, 2022
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.
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
Agricultural Marketing Service,
USDA.
ACTION: Advance notice of proposed
rulemaking.
AGENCY:
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–
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SUMMARY:
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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: jared.clark@
usda.gov.
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
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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).
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).
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
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.
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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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
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
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%26
Transcripts%201992-2009.pdf.
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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
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.
In October 2015, the NOSB
recommended an annotation change to
address the National List references to
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.
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%20
in%20Pesticides.pdf.
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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:
• 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
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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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).
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.
III. Potential Replacements for EPA List
3 and/or List 4
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.
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.
B. Allow Specific Inert Ingredients
Permitted by EPA
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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).
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 § 205.601(m) and
§ 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.
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
10 ‘‘Minimum Risk Pesticide: Definition and
Product Confirmation,’’ U.S. Environmental
Protection Agency, February 1, 2021, https://
www.epa.gov/minimum-risk-pesticides/minimumrisk-pesticide-definition-and-product-confirmation.
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listed at 40 CFR part 180 subpart D
(§§ 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 EPAAllowed 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
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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
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• 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
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
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%20
Procedures.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/NOPNotice-11-6.pdf.
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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
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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.
lotter on DSK11XQN23PROD with PROPOSALS1
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
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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?
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))?
13 ‘‘Petitioned
Substances,’’ United States
Department of Agriculture, National Organic
Program, https://www.ams.usda.gov/rulesregulations/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.
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
54177
• 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
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Federal Register / Vol. 87, No. 170 / Friday, September 2, 2022 / Proposed Rules
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]
BILLING CODE P
DEPARTMENT OF ENERGY
10 CFR Part 851
[EHSS–RM–20–WSHP]
RIN 1992–AA61
Worker Safety and Health Program
Office of Environment, Health,
Safety and Security, U.S. Department of
Energy.
ACTION: Notice of proposed rulemaking
and request for public comment.
AGENCY:
The U.S. Department of
Energy (DOE or the Department) is
proposing to amend its current worker
safety and health program regulation.
The proposed amendment would make
corrections to the worker safety and
health program regulation requirements
related to beryllium and beryllium
compounds for purposes of accuracy
and consistency with DOE’s Chronic
Beryllium Disease Prevention Program
regulation, and to clarify that DOE did
not intend to adopt the 2016 American
Conference of Governmental Industrial
Hygienists threshold limit value for
beryllium and beryllium compounds.
DATES: Written comments on this
proposed rulemaking must be received
by the Department on or before October
3, 2022. Please refer to section IV
(Public Participation—Submission of
Comments) for additional information
on the comment period.
lotter on DSK11XQN23PROD with PROPOSALS1
SUMMARY:
VerDate Sep<11>2014
16:17 Sep 01, 2022
Jkt 256001
You may submit comments
identified by docket number EHSS–RM–
20–WSHP and/or Regulation
Identification Number (RIN) 1992–
AA61, in one of two ways (please
choose only one of the ways listed):
1. Federal e-Rulemaking Portal:
www.regulations.gov. Follow the
instructions in the portal for submitting
comments.
2. Email: Rulemaking.851@
hq.doe.gov. Include docket number
EHSS–RM–20–WSHP and/or RIN 1992–
AA61 in the subject line of the email.
Please include the full body of your
comments in the text of the message or
as an attachment. For detailed
instructions on submitting comments
and additional information on the
rulemaking process, see section IV of
this document.
Docket: The docket, which includes
Federal Register notices, comments,
and other supporting documents/
materials, is available for review at
www.regulations.gov. All documents in
the docket are listed in the
www.regulations.gov index. However,
some documents listed in the index,
such as those containing information
that is exempt from public disclosure,
may not be publicly available. A link to
the docket web page can be found at:
www.energy.gov/ehss/worker-safetyand-health-program-10-cfr-851doe-o4401b. This web page contains a link to
the docket for this notice on the
www.regulations.gov site. The
www.regulations.gov web page contains
instructions on how to access all
documents, including public comments,
in the docket. See section IV of this
document for further information on
how to submit comments through
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
James Dillard, U.S. Department of
Energy, Office of Environment, Health,
Safety and Security, Mailstop EHSS–11,
1000 Independence Ave. SW,
Washington, DC 20585, Telephone:
301–903–1165, or by Email at:
james.dillard@hq.doe.gov.
SUPPLEMENTARY INFORMATION: DOE
incorporates by reference into part 851
the following publication:
American Conference of
Governmental Industrial Hygienists
(ACGIH®), Threshold Limit Values for
Chemical Substances and Physical
Agents and Biological Exposure Indices
(2016), excluding beryllium and
beryllium compounds.
A copy of this publication can be
obtained from: ACGIH®, 1330 Kemper
Meadow Drive, Cincinnati, OH 45240;
telephone number 513–742–2020; or go
to: https://www.acgih.org.
ADDRESSES:
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
For a further discussion of this
publication, see section III.M of this
document.
Table of Contents
I. Authority and Background
A. Authority
B. Background
II. Discussion
III. Procedural Issues and Regulatory Review
A. Review Under Executive Order 12866
B. Review Under the Regulatory Flexibility
Act
C. Review Under the Paperwork Reduction
Act of 1995
D. Review Under the National
Environmental Policy Act of 1969
E. Review Under Executive Order 12988
F. Review Under Executive Order 13132
G. Review Under Executive Order 13175
H. Review Under the Unfunded Mandates
Reform Act of 1995
I. Review Under Executive Order 12630
J. Review Under Executive Order 13211
K. Review Under the Treasury and General
Government Appropriations Act, 1999
L. Review Under the Treasury and General
Government Appropriations Act, 2001
M. Materials Incorporated by Reference
IV. Public Participation—Submission of
Comments
V. Approval by the Office of the Secretary of
Energy
I. Authority and Background
A. Authority
DOE has broad authority to regulate
worker safety and health with respect to
its nuclear and nonnuclear functions
pursuant to the Atomic Energy Act of
1954 (AEA), 42 U.S.C. 2011 et seq.; the
Energy Reorganization Act of 1974
(ERA), 42 U.S.C. 5801 et seq.; and the
Department of Energy Organization Act
(DOEOA), 42 U.S.C. 7101 et seq.
Specifically, the AEA authorized and
directed the Atomic Energy Commission
(AEC) to protect health and promote
safety during the performance of
activities under the AEA. (See Sec.
31a.(5) of the AEA, 42 U.S.C. 2051(a)(5);
Sec. 161b. of the AEA, 42 U.S.C.
2201(b); Sec. 161i.(3) of the AEA, 42
U.S.C. 2201(i)(3); and Sec. 161p. of the
AEA, 42 U.S.C. 2201(p)). In addition,
Congress amended the AEA in 2002 by
adding section 234C, 42 U.S.C. 2282c,
which, among other things, directed
DOE to ‘‘promulgate regulations for
industrial and construction health and
safety at Department of Energy facilities
that are operated by contractors covered
by agreements of indemnification under
section 2210(d) of’’ title 42 of the United
States Code. In 1974, the ERA abolished
the AEC and replaced it with the
Nuclear Regulatory Commission (NRC),
which became responsible for the
licensing of commercial nuclear
activities, and the Energy Research and
Development Administration (ERDA),
E:\FR\FM\02SEP1.SGM
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]]>Agencies
[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
________________________________________________________________________
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.
========================================================================
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
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\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]
BILLING CODE P
