Rule2022-23682
Pesticides; Addition of Chitosan (Including Chitosan Salts) to the List of Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 8, 2022
Effective
January 9, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is adding a substance commonly referred to as chitosan (also known by its chemical name: poly-D-glucosamine) (CAS No. 9012-76-4) to the list of active ingredients eligible for use in minimum risk pesticide products exempt from registration and other requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In doing so, EPA is specifying that the listing also includes those chitosan salts that can be formed when chitosan is mixed with the acids that are listed as active or inert ingredients eligible for use in minimum risk pesticide products.
Full Text
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<title>Federal Register, Volume 87 Issue 215 (Tuesday, November 8, 2022)</title>
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[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Rules and Regulations]
[Pages 67364-67371]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23682]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 152
[EPA-HQ-OPP-2019-0701; FRL-7542-05-OCSPP]
RIN 2070-AK56
Pesticides; Addition of Chitosan (Including Chitosan Salts) to
the List of Active Ingredients Permitted in Exempted Minimum Risk
Pesticide Products
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is adding a
substance commonly referred to as chitosan (also known by its chemical
name: poly-D-glucosamine) (CAS No. 9012-76-4) to the list of active
ingredients eligible for use in minimum risk pesticide products exempt
from registration and other requirements of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). In doing so, EPA is specifying
that the listing also includes those chitosan salts that can be formed
when chitosan is mixed with the acids that are listed as active or
inert ingredients eligible for use in minimum risk pesticide products.
DATES: This final rule is effective on January 9, 2023.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPP-2019-0701, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Biopesticides
and Pollution Prevention Division (7511M), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 566-2427; email
address: <a href="/cdn-cgi/l/email-protection#6e2c3e3e2a283c20011a070d0b1d2e0b1e0f40090118"><span class="__cf_email__" data-cfemail="165446465250445879627f7573655673667738717960">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
distribute, sell, or use minimum risk pesticide products. Minimum risk
pesticide products are exempt from registration and other FIFRA
requirements and are described in 40 CFR 152.25(f). The following list
of North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
<bullet> Pesticide and other agricultural chemical manufacturers
(NAICS codes 325320 and 325311), as well as other manufacturers in
similar industries such as animal feed (NAICS code 311119), cosmetics
(NAICS code 325620), and soap and detergents (NAICS code 325611).
<bullet> Manufacturers who may also be distributors of these
products, including farm supplies merchant wholesalers (NAICS code
424910), drug and druggists merchant wholesalers (NAICS code 424210).
<bullet> Retailers of minimum risk pesticide products, including
nursery, garden center, and farm supply stores (NAICS code 444220);
outdoor power equipment stores (NAICS code 444210); and supermarkets
(NAICS code 445110).
<bullet> Users of minimum risk pesticide products, including the
public in general, exterminating and pest control services (NAICS code
561710), landscaping services (NAICS code 561730), and sports and
recreation institutions (NAICS code 611620). Many of these entities
also manufacture minimum risk pesticide products.
B. What action is the Agency taking?
EPA is adding chitosan to the list of active ingredients allowed in
minimum risk pesticide products exempt from registration and other
requirements of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. In addition, EPA is specifying that the
listing also includes those chitosan salts that can be formed with the
acids that are listed as active or inert ingredients eligible for use
in minimum risk pesticide products.
Chitosan is a naturally occurring substance found in the cell walls
of many fungi. Chitosan also occurs in the shells of all crustaceans
(e.g., crab, shrimp, and lobster) and in the exoskeletons of most
insects. Microorganisms in nature produce enzymes that break down
chitosan, resulting in sugars that are metabolized as a carbon and
nitrogen source.
C. What is EPA's authority for taking this action?
This action is issued under the authority of FIFRA, 7 U.S.C. 136 et
seq., particularly FIFRA sections 3 and 25.
D. Why is EPA taking this action?
EPA may exempt from the requirements of FIFRA any pesticide that is
``. . . of a character which is unnecessary to be subject to [FIFRA]''
(FIFRA section 25(b). Pursuant to this authority, EPA has exempted from
the pesticide registration and requirements of FIFRA certain pesticide
products if they are composed of specified active and inert ingredients
which are listed and labeled according to EPA's regulations in 40 CFR
152.25(f). The exemption for minimum risk pesticides eliminates the
need for the Agency to expend significant resources to regulate
products that were deemed to be of minimum risk to human health and the
environment, and for manufacturers and distributors to spend the
resources to register such products.
As discussed in the proposed rule (Ref. 1), this action was
initiated in response to a petition from Tidal Vision Products, LLC to
add chitosan to the list of active ingredients allowable in minimum
risk products (Refs. 2 and 3).
E. What are the estimated incremental impacts of this rule?
After reviewing the Cost Analysis that EPA prepared for the
proposed rule (Ref. 4), EPA determined that the analysis presented in
that document did not warranted changes for the final rule. A copy of
the Cost Analysis is in the docket and is summarized in this unit.
If chitosan and chitosan salts formed from mixing with eligible
active and
[[Page 67365]]
inert ingredients were not included in this exemption, persons seeking
to manufacture or distribute pesticide products containing chitosan
would be required to register those product(s) under FIFRA. This could
entail generating supporting data, incurring submission costs, and
paying registration fees. In addition, the petitioner could incur
annual maintenance fees on the registrations. EPA's 2019 cost analysis
estimates the cost savings of listing chitosan as an active ingredient
that can be used in minimum risk pesticide products under 40 CFR
152.25(f) to be between $53,000 and $116,000 initially and about $3,400
per year thereafter for each pesticide product registered containing
chitosan (Ref. 4). EPA has also determined that the estimated costs
savings per product registered containing chitosan salts would be the
same as those containing chitosan.
For EPA, this action may reduce the Agency's level-of-effort that
would otherwise be spent on registering pesticide products with little
risk. The impact on state regulatory costs is uncertain, as states have
wide variability in how they regulate pesticide products registered by
EPA and products exempt from registration under FIFRA section 25(b)
(which include minimum risk pesticide products). The impact to each
state will depend on how each state regulates pesticides registered by
EPA versus how they regulate FIFRA section 25(b) products. States which
register pesticides that are registered by EPA but not FIFRA section
25(b) products would see a reduced burden from the addition of chitosan
(including chitosan salts, as specified) to the FIFRA section 25(b)
list. However, since most states defray that burden through
registration fees, the overall impact is expected to be negligible.
Because the EPA does not review labels of FIFRA section 25(b) products,
states may see an increased burden related to enforcing the conditions
for labeling these products. Also, as a result of this action there may
be more products seeking state registrations.
In the absence of an exemption, manufacturers may be foregoing
development and production of chitosan-based products due to cost
concerns. Thus, the exemption may ultimately benefit consumers who may
see more of these products available at lower costs.
II. Background
A. FIFRA Section 25(b) Exemptions
As authorized by FIFRA section 25(b), EPA has exempted from the
requirement of registration certain pesticide products if they are
composed of specified ingredients (recognized active and inert
substances which are listed in the regulations) and labeled according
to EPA's regulations in 40 CFR 152.25(f). Starting in 1996, EPA
exempted such products to reduce the cost and regulatory burdens on
businesses and the public for pesticides posing little or no risk, and
to focus the Agency's resources on pesticides that pose greater risk to
humans and the environment.
B. Petition To Exempt Chitosan
On October 10, 2018, EPA received a petition from Tidal Vision
Products, LLC (Ref. 2) requesting that chitosan be added to the list of
active ingredients eligible for use in exempted minimum risk pesticide
products under 40 CFR 152.25(f)(1). Subsequently, on April 4, 2019, EPA
received an amendment to Tidal Vision Products, LLC's petition,
requesting that chitosan also be added to the list of inert ingredients
allowed in exempted minimum risk pesticide products under 40 CFR
152.25(f)(2) (Ref. 3).
The Agency deferred a decision on the 2019 petition regarding
whether to add chitosan to the list of allowable inert ingredients, but
granted the petition with respect to inclusion of chitosan as an
eligible active ingredient for the minimum risk exemption.
C. EPA's Proposed Rule
On November 2, 2020, EPA issued a proposal to address the 2018
petition (Ref. 1). In the proposal, EPA stated that based on all the
information available to the Agency, there are low risk concerns for
human health or the environment if chitosan is intended for use as a
minimum risk pesticide. For a more detailed explanation of the review
that EPA conducted in support of the proposal, see Unit III. of the
proposed rule (Ref. 1).
In the Federal Register of May 6, 2022 (Ref. 5), EPA announced the
availability of and sought public comment on two aquatic toxicity
reports on chitosan salts that were submitted to the Agency by Tidal
Vision Products, LLC (Refs. 6 and 7).
III. Public Comments and EPA's Responses
EPA received ten public comments on the proposed rule but did not
receive any additional comments in response to the May 2022 document.
This unit summarizes the comment received and the Agency's responses to
those comments. The comments received included comments that raised
questions about the human health and environmental impacts of chitosan,
comments related to chitosan salts, comments on EPA's assessment of the
impacts of the rulemaking, comments raising implementation issues
related minimum risk pesticide products generally and chitosan
specifically, and other general comments.
A. Chitosan Salts
1. Comment. Some commenters raised questions regarding chitosan
salts such as chitosan hydrochloride (CAS No. 70694-72-3), chitosan
acetate (CAS No. 87582-10-3), chitosan lactate (CAS No. 66267-50-3), or
chitosan salicylate (CAS No. 84563-67-7). One of the commenters stated
that chitosan itself is insoluble and that due to its insolubility,
chitosan must first be converted into a soluble chitosan salt before it
can be effectively utilized in many different industries (water
treatment, drug delivery, pest control, etc.). This process involves
reacting chitosan with an acid to produce a chitosan salt. The salts
are water soluble and functional for a wide range of uses. The
commenter stated that the salts are bioavailable to organisms and
develop the ability to cause toxicity to gilled organisms at relatively
low concentrations. The commenter also stated that studies have shown
acute toxicity of chitosan acetate to fish at less than 1 mg/L and that
fish and gilled organisms exposed to chitosan salts experience
respiratory stress that can lead to death by hypoxia. The commenter
recommended that EPA make clear differentiation between chitosan and
chitosan salts. According to the commenter, chitosan is not equal to,
nor interchangeable with chitosan acetate, chitosan lactate, and
chitosan hydrochloride. Chitosan is a different chemical with a
different CAS number than each chitosan salt.
2. EPA Response. EPA reviewed the information provided by the
commenter and searched the public literature on this point. The Agency
also reviewed two aquatic toxicity reports on chitosan salts submitted
by Tidal Vision Products, LLC (Refs. 6 and 7). EPA announced the
availability of and sought comments on both reports in May 2022 (Ref.
5) and did not receive any comments.
In addition, EPA performed an extensive literature search and data
analysis for all chitosan salts with an emphasis on those created in
the pesticide products currently registered
[[Page 67366]]
with the Agency. EPA also developed an addendum to the science review
in support of the addition of chitosan to the list of minimum risk
pesticides contained in 40 CFR 152.25(f) (Ref. 8). In that document,
EPA noted that the petition to include chitosan on the list of minimum
risk pesticides specifically requests addition of chitosan with CAS No.
9012-76-4 to the list, which is the chitosan polymer produced from
deacetylation of chitin, an insoluble chemical commonly referred to
``dry'' chitosan. Through further investigation, the Agency believes
that some registered products containing `dry' chitosan as active
ingredients along with solubilizing acids as inert ingredients form
chitosan salts (Ref. 8).
The Agency's overall analysis of the available data suggests that
these substances are of low toxicity to humans. No risks of concern
have been identified. However, EPA notes that the human health
assessment database is limited both in terms of studies performed and
representative chitosan salts tested.
EPA has not found any evidence that chitosan salts have adverse
effects on non-target terrestrial organisms. While the form and
exposure from dry chitosan used in fish feed suggests low risk to
aquatic taxa, studies identified in the scientific literature indicate
chitosan acetate has the potential to be highly toxic to rainbow trout.
Guideline studies available in the Agency's database, on the other
hand, indicate that chitosan acetate is moderately toxic to fish and
aquatic invertebrates. Studies used in this assessment were selected
because they reported the necessary information (e.g., LC50 values) for
risk calculations and adhered to Agency guidelines. Calculated risks
quotients (RQs) based on non-target organism toxicity data and aquatic
exposure modeling are below the Agency's level of concern by several
orders of magnitude. Therefore, EPA is adding chitosan and any salts
formed from the mixing of chitosan with minimum risk active or inert
ingredients to the list of eligible active ingredients at 40 CFR
152.25(f)(1).
B. Human and Environmental Health
1. Comments. EPA received a comment in general support of the
rulemaking, stating that the scientific evidence is clear and
consistent in showing that chitosan is safe to humans and the
environment. Another commenter opposed the addition of chitosan to the
list of active ingredients allowed in minimum risk pesticide products,
stating that that there are numerous concerns with the potential
composition and purity of chitosan produced for minimum risk pesticide
products as well as potential adverse effects due to significant
increase in exposure. The commenter also noted that any adverse effects
from the use of chitosan in minimum risk pesticide products would not
be required to be reported under FIFRA section 6(a)(2). This would
include adverse effects to humans, domestic animals, and the
environment, such as bee kills.
2. EPA response. Reporting under FIFRA section 6(a)(2) is outside
the scope of this rulemaking, as it applies to the minimum risk
exemption in general. EPA acknowledges that the FIFRA section 6(a)(2)
reporting requirement is limited to registered pesticides, and that
minimum risk pesticide products, which are not registered, would not be
subject to this requirement. Substances placed on the minimum risk list
are not expected to present significant hazard to humans or non-target
organisms. The available data do not indicate that chitosan or its
salts present a significant hazard to bees or other insects.
3. Comment. One commenter states that a search of the Food and Drug
Administration (FDA) inventory of Generally Recognized as Safe (GRAS)
Notices indicates that chitosan does not have FDA GRAS status under 21
CFR 170.36. Another commenter wrote that chitosan is used in
pharmaceutical manufacturing and as a supplement and the FDA has
approved chitosan as safe for use in food in drugs, and that the
chemical is not considered hazardous by the Occupational Safety and
Health Administration.
4. EPA response. While the Agency does consider whether a substance
is recognized by the FDA as safe (see e.g., 61 FR 8876, March 6, 1996
(FRL-4984-8)), whether or not a substance is GRAS is not necessarily
dispositive. GRAS status is initiated via a notification to the Food
and Drug Administration from a company, so the lack of GRAS status may
not reflect safety. (Ref. 9). In EPA's previous science review (Ref.
10), the Agency identified that a fungal based chitosan derived from
Aspergillus niger has GRAS status. The status pertains to the specific
intended conditions of use as a secondary direct food ingredient in the
manufacture of alcoholic beverages. The EPA acknowledges that other
forms of chitosan (e.g., chitosan derived from crustacea) do not have
GRAS designations.
5. Comment. The commenter also noted that there may be
allergenicity concerns for exempted chitosan products. Chitosan
products which are currently registered by the EPA have undergone the
EPA registration process and are produced by entities registered with
the EPA as pesticide producing establishments. The commenter expressed
a concern that if chitosan is added to the list of exempted active
ingredients, products will be produced using inadequate extraction and
purification processes and will contain chitosan of substandard purity
and composition. According to the commenter, such products may be quite
harmful to individuals with allergies. The commenter wrote that there
may be little concern for allergenic response following exposure to
highly purified chitosan, but that there is no control over the
production and resulting level of purity for EPA exempted products.
6. EPA response. Allergenicity concerns were addressed in the
assessment supporting the original proposed rule (Ref. 10), which
discussed the manufacturing process for chitosan and some reports
related to potential allergenicity. As noted in that assessment,
industrially-manufactured chitosan is not likely to have allergenicity
concerns provided that all animal proteins are removed during the
extraction and purification process from chitin. The manufacturing
process that involves demineralization with hydrochloric acid, protein
removal with sodium hydroxide and a final extraction with organic
solvents is likely sufficient to remove and/or denature any proteins,
fats and other contaminants of allergenic or other toxic concern. While
there has been research into other methods of manufacturing chitosan,
this process is understood to be the industry standard and other
methods have not been shown to be viable on the scale required to
produce chitosan at its current level of demand. Presence of materials
(e.g., shellfish proteins) that are not listed as active or inert
ingredient eligible to be used in a minimum risk pesticide product
would make a product ineligible for the exemption. It is also noted
that although chitosan is not a food, it has numerous food related uses
and is frequently consumed as a dietary supplement.
7. Comment. One commenter noted that EPA's statement in the
proposal stated that ``no increased risk to human health or the
environment is expected from chitosan,'' is based on current use
patterns and use rates of chitosan. The commenter believes it is
impossible to know what future uses may be developed. In addition,
currently registered chitosan products with a relatively low percentage
of active ingredient (0.25%) bear labeling which warns of moderate eye
irritation. All EPA registered chitosan products have extensive First
Aid Statements regarding eye and skin protection. Agricultural
[[Page 67367]]
products bear extensive Personal Protective Equipment (PPE)
requirements for applicators, mixers and loaders which include long
sleeved shirt, long pants, waterproof gloves and protective eyewear.
Minimum risk pesticide products are exempt from the Worker Protection
Standard and they are not required to have any precautionary and first
aid statements. Therefore, the commenter believes it is highly likely
that there will be significant exposure if chitosan is added to the
list of permitted active ingredients for minimum risk pesticide
products. According to the commenter, increase in use with additional
use patterns and potentially higher concentrations with unknown purity
without the current precautionary and first aid label statements will
result in significant exposure.
8. EPA response. The Agency understands that with the addition of
chitosan to the minimum risk pesticides active ingredient list, the
uses and application rates could be expanded. However, EPA notes that
the uses for currently registered agricultural products are extensive.
The Agency has also registered products containing chitosan for
antimicrobial uses to control odor causing, spoilage, and discoloration
for microbes on textiles and surfaces which present additional exposure
pathways that have been determined to not present risk to human health
or the environment. The percentage of chitosan in end use products
currently ranges from 0.05% to 85%, and chitosan is present at <5% in
most products upon application. Agricultural application rates range
from 0.11-2.5 lbs active ingredient (AI)/Acre for foliar sprays, 0.24-
2.5 lbs AI/Acre for chemigation, and 0.11-0.33 lbs AI/10 gallons for
seed treatments based on the end-use products (EP) use sites (Ref. 8).
With respect to the commenter's contention that registered chitosan
products have extensive First Aid Statements regarding eye and skin
protection, EPA notes that precautionary language on registered product
labels is based on the acute toxicity profile of the entire EP
formulation, which is the active and inert ingredients. These inert
ingredients may be contributing to the toxicity profile. EPA
acknowledges that an acute eye irritation study done on a 99.9%
chitosan MP was moderately irritating (Tox Cat III). This could result
in eye irritation due to incidental exposure (splashing) when handling
the 85% undiluted end product, but not once products are diluted and
being applied.
9. Comment. A commenter notes that there is one CAS No. for
``Chitosan'' listed in the petition, but that it is widely reported
that this or similar materials are available in a range of varieties
(e.g., different molecular weights), are often modified or made into
chemical derivatives, or otherwise complexed with other materials
(e.g., metal ions) to change the functional properties or to increase
or change functional activity. Given that these modifications can
significantly alter the functionality and by extension, the pesticidal
activity, the commenter believes it is incumbent upon the EPA to
consider and address how the limits or boundaries of the use of such a
raw material and the possible derivations of it would be regulated and
enforced as being exempt.
10. EPA response. The status of chitosan salts is discussed in more
detail in Unit III.A. EPA notes that the listing for chitosan refers
specially to poly-D-glucosamine (CAS Reg. No. 9012-76-4). The
specifications that EPA is including in the regulatory text would
include chitosan salts formed by solubilization with acids from the
minimum risk pesticide active or inert ingredient lists and would not
include other chitosan derivatives. For a more detailed discussion of
molecular weight, please see the addendum to the science review in
support of the addition of chitosan to the list of minimum risk
pesticides contained in 40 CFR 152.25(f) (Ref. 8).
11. Comment. One commenter stated that chitosan's safety has not
been thoroughly studied and there are still many unknowns. The
commenter further stated it is not known whether chitosan is safe to
take by women who are pregnant or breastfeeding and most doctors advise
pregnant women to avoid products that contain it. Additionally, the
commenter believes chitosan has the potential to interfere with how
blood thinners work in your body.
12. EPA response. The risk assessments performed on chitosan and
chitosan salts determined that there are no hazard concerns in humans
associated with pesticidal use of chitosan. Exposure is expected to be
incidental when chitosan is used as a pesticide with good agricultural
practices and would not include exposure amounts that would be expected
to result from intentional ingestion. Chitosan is frequently consumed
as a dietary supplement, is also included as a component of drugs, and
it is exempted from the requirement of a tolerance on food and feed
when used in pesticide products. While there are websites that
recommend against chitosan intake by pregnant women, there is no
information available to the Agency to evaluate these recommendations
or their scientific basis. Additionally, the Agency is not aware of any
adverse developmental or reproductive toxicity effects from exposure to
chitosan at doses relevant to pesticide risk assessment and did not
find reports of developmental effects in an extensive search of the
public literature. With respect to chitosan's interactions with
anticoagulants, EPA was able to find only one study in the literature
that described a possible potentiation of warfarin's effect in an 83-
year-old male consuming 1,200 mg of chitosan twice per day (Ref. 11).
There are no other reported incidents of this effect in the scientific
literature, and little additional information on this potential
interactive effect is available.
C. Costs, Benefits, and Implementation Concerns
1. Comment. One commenter expressed a concern that the proposal
underestimates costs associated with minimum risk pesticides, noting
that numerous states are now requiring generation of additional data as
a condition of state registration which obviates financial and
regulatory relief described in the proposal. The commenter states that
it is confusing as to why this was noted in the Cost Analysis document
but was not discussed in the proposal itself. Another commenter noted
that the main reason given to add chitosan, and other active
ingredients, to the list of active ingredients allowed in minimum risk
pesticide products is to save money associated with EPA fees
established under the Pesticide Registration Improvement Extension Act
(PRIA fees) and registration maintenance fees, as well as saving EPA
resources that would be used reviewing and registering pesticide
products of minimum concern. The commenter believes the aforementioned
burden of review and registration is shifted to the states. The
commenter states that currently, only nine states do not require state
registration of minimum risk pesticide products. According to the
commenter, the amount of time, effort and resources expended by the
states for the review and registration of minimum risk pesticide
products is compounded due to the lack of central EPA oversight.
2. EPA response. These comments are generic to the minimum risk
exemption and therefore outside the scope EPA's proposal to add
chitosan to the list of active ingredients allowed in minimum risk
pesticide products. EPA notes that on April 8, 2021 (Ref. 12), EPA
[[Page 67368]]
published an advanced notice of proposed rulemaking (ANPRM) that
requested public comment on, among other things, modifications to the
existing regulations at 40 CFR 152.25, including the exemption for
minimum risk products. EPA is currently evaluating these public
comments and considering potential program improvements that the Agency
could propose, and EPA will consider this comment as part of that
evaluation. The concerns commenters are raising could apply equally to
any of the active or inert ingredients eligible for use in minimum risk
pesticide products, as well as any future ingredient. While EPA is
currently evaluating potential improvements it could propose for the
minimum risk pesticide program, the Agency is not considering a
moratorium on adding ingredients to these lists pending completion of
that effort.
EPA notes that in the Cost Analysis (Ref. 4), the Agency
acknowledges that the impact on state regulatory costs is uncertain--
states have wide variability in how they regulate pesticides that are
registered by EPA versus FIFRA section 25(b) pesticide products.
Because the Agency does not review labels of FIFRA section 25(b)
products, states may see an increased burden associated with enforcing
the conditions for labeling products containing chitosan. EPA also
noted in that document that some states require registration of FIFRA
section 25(b) products. If the Petitioner or another entity wants to
sell their product in these states, they may face data generation costs
similar to those that would be imposed by EPA for a national
registration, potentially eliminating or reducing the savings described
in the Cost Analysis. The Petitioner could avoid these costs but would
forego marketing in those states.
3. Comment. A commenter also states that there are currently
numerous registered FIFRA products containing chitosan and it is
unlikely that the registrants of these products will cancel or
discontinue their registrations due to the costs already incurred. The
commenter believes it is unclear whether state lead agencies will
register a minimum risk pesticidal product containing the same active
ingredient as a FIFRA-registered product, or at least require
additional testing to support the state registration. This would again
incur additional costs or burden not adequately captured in the
proposed rule.
4. EPA response. This rule will not affect the status of already
registered products or create additional costs for already registered
products. Additionally, state requirements for additional testing are
not affected by this rule.
D. Miscellaneous Comments
1. Comment. One commenter noted concerns regarding inappropriate
use and claims for the control of bacteria and mold. The commenter
states that chitosan is currently registered as an antimicrobial
pesticide active ingredient to inhibit growth of bacteria, mold,
mildew, and fungi. The commenter is concerned that exempt products will
be produced with false and misleading statements regarding efficacy
against bacteria or for mold remediation.
2. EPA response. Per the requirements of 40 CFR 152.25(f) minimum
risk pesticide are subject to certain restrictions. Products that do
not meet these requirements would not be eligible for the exemption.
One such restriction prohibits minimum risk products from bearing
claims to control any microorganism that pose a threat to human health.
However, some types of claims regarding microorganisms can meet the
conditions of the minimum risk exemption. An example would be an
antimicrobial pesticide product that bears a claim to control
microorganisms of economic or aesthetic significance, and the presence
of the microorganism would not normally lead to infection or disease in
humans.
3. Comment. One commenter expressed a concern regarding the
potential for false or misleading claims on chitosan products, should
chitosan be added the active ingredient list for minimum risk
pesticides. The commenter writes that chitosan used in pesticide
products is not a naturally occurring substance and must be chemically
derived. Therefore, industrially manufactured chitosan would not be
considered ``organic'' or ``natural'' and such claims would be false
and misleading.
4. EPA response. This comment is outside the scope EPA's proposal
to add chitosan to the list of active ingredients allowed in minimum
risk pesticide products. The commenter's concern could apply equally to
any minimum risk pesticide product and is not specific to those
containing chitosan. By way of background, EPA does note that per the
requirements of 40 CFR 152.25(f)(3)(iv) the labels of minimum risk
product cannot include any false or misleading statements, including
those listed in 40 CFR 156.10(a)(5)(i) through (viii). However, EPA
acknowledges that 40 CFR 156.10(a)(5)(x) which prohibits ``[n]on-
numerical and/or comparative statements on the safety of the product,
including but not limited to: (A) `Contains all natural ingredients';
(B) `Among the least toxic chemicals known' [or] (C) `Pollution
approved''' does not directly apply to minimum risk products, but EPA
notes that 40 CFR 152.25(f)(3)(iv) contains a general prohibition on
false or misleading statements.
5. Comment. One commenter writes that given that chitosan is
currently on the FIFRA inert ingredients list and is approved for non-
food use, it is unclear how a registrant or state lead agency would
determine whether chitosan is acting as an active ingredient or inert.
This is an area that the states lead agencies have expressed as
particularly challenging with inert ingredients and the proposal does
not address this consideration. If the material is considered exempt
from FIFRA regulation only as an active ingredient and not as an inert
ingredient, then this question carries significant importance in
determination of whether a product containing it is considered exempt
or not from FIFRA regulation.
6. EPA response. The commenter is correct that the active
ingredient and inert ingredient lists are not interchangeable. Unless
the ingredient appears on both lists, it can only be used based on the
list it appears on. So, in this case, chitosan may only be used in
minimum risk pesticide products as an active ingredient. The
regulations at 40 CFR 152.3 define an active ingredient to mean, in
relevant part, ``any substance . . . that will prevent, destroy, repel
or mitigate any pest, or that functions as a plant regulator,
desiccant, or defoliant . . . .'' An inert ingredient means ``any
substance . . . other than an active ingredient, which is intentionally
included in a pesticide product . . . .'' Accordingly, chitosan in
minimum risk pesticide products must prevent, destroy, repel or
mitigate a pest, or function as a plant regulator, desiccant, or
defoliant.
7. Comment. One commenter suggested that adding chitosan to the
list of minimum risk active ingredients would have the effect of
switching the burden to the states. The commenter believes that
maintaining EPA's registration and central oversight would be the best
option. The commenter suggested the creation of separate lower fee PRIA
categories to review and register chitosan and other minimum risk
pesticide products.
8. EPA response. This comment raises generic issues with the
Minimum Risk Pesticide Program that go beyond the specific issues
raised in this rulemaking, namely the addition of chitosan and chitosan
salts to the list of active ingredients. As previously noted, EPA
published an ANPRM that requested
[[Page 67369]]
public comment on, amongst other things, modifications to the existing
regulations at 40 CFR 152.25, including the exemption for minimum risk
products (Ref. 12). EPA is currently evaluating these public comments
and considering potential program improvements that the Agency could
propose, and EPA will consider this comment as part of that evaluation.
9. Comment. The commenter states that some agricultural and
commercial pesticide users are hesitant to use products that are not
EPA registered because there is a question as to whether the products
are compliant with all exemption criteria. The commenter states that
the lack of an easily identifiable EPA Registration Number and
associated product label is very problematic because it is difficult to
ascertain whether a product is legal and compliant.
10. EPA response. This comment also raises generic issues with the
Minimum Risk Pesticide Program that go beyond the specific issues
raised in this rulemaking, namely the addition of chitosan and chitosan
salts to the list of active ingredients. As previously noted, EPA is
currently evaluating these public comments on the ANPRM (Ref. 12) and
considering potential program improvements that the Agency could
propose, and EPA will consider this comment as part of that evaluation.
11. Comment. One commenter notes that minimum risk pesticide
products are not covered under the EPA provisions which protect
confidential business information (CBI).
12. EPA response. In general, EPA would not routinely be in
possession of confidential business information on minimum risk
pesticide products because such products are not reported to EPA.
Regardless, the Agency disagrees with the commenter that minimum risk
pesticide products are not protected by the business confidentiality
provisions in FIFRA section. Exemption of pesticides under section
25(b) pertains to ``the requirements of this subchapter [FIFRA]''. That
does not leave companies bereft of the confidentiality protections in
FIFRA section 10.
13. Comment. Another commenter suggested that EPA correct an
apparent spelling error on its website for ``Inert Ingredients Eligible
for FIFRA 25(b) Pesticide Products.'' On this website list, the name
for CAS No. 6132-04-3 is listed as Trisodium citrate dehydrate (as
label display name) and Citric acid, trisodium salt, dehydrate (as the
chemical name). However, in 40 CFR 180.950(e) the CAS No. 6132-04-3 is
associated with Citric acid, trisodium salt, dihydrate. The comment
suggests that the ``dehydrate'' on the website be changed to be
``dihydrate'' in conformance with the regulations.
14. EPA response. This comment is outside of the scope of the
proposed rulemaking. However, in reviewing the comment, EPA has
determined the commenter is correct in that there is a typographical
error and that the correct label display name associated with CAS No.
6132-04-3 should be ``Trisodium citrate dihydrate''. EPA notes that the
website the commenter is referring to merely duplicates the list of
inert ingredients codified at 40 CFR 152.25(f)(2)(iv), where CAS No.
6132-04-3 is associated with the label display name ``Trisodium citrate
dehydrate'' and the chemical name ``Citric acid, trisodium salt,
dehydrate.'' EPA did not propose to make any change to the entry for
this chemical, but because this is purely a typographical error, EPA is
correcting that error in this action.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. Pesticides; Proposal to Add Chitosan to the List of Active
Ingredients Permitted in Exempted Minimum Risk Pesticide Products;
Proposed Rule. Federal Register. 85 FR 69307, November 2, 2020 (FRL-
10009-24).
2. Tidal Vision Products, LLC. Petition to list the material
Chitosan CAS# 9012-76-4 on the U.S. EPA FIFRA Minimum Risk List 40
CFR 152.25(f). October 10, 2018.
3. Tidal Vision Products, LLC. Amendment to the Petition to add
Chitosan to the Minimum Risk Pesticide Inert Ingredient List at the
same time as adding Chitosan to the Minimum Risk Pesticide Active
Ingredient List; Re: Petition to list the material Chitosan CAS#
9012-76-4 on the U.S. EPA FIFRA Minimum Risk Pesticide List 40 CFR
152.25(f). April 4, 2019.
4. EPA. Cost Analysis of the Proposed Modification to the Minimum
Risk Pesticide Listing Program. Prepared by Biological and Economic
Analysis Division, Office of Pesticide Programs. July 2020.
5. EPA. Pesticides; Proposal to Add Chitosan to the List of Active
Ingredients Permitted in Exempted Minimum Risk Pesticide Products;
Notice of Data Availability on Chitosan and Chitosan Salts;
Notification of data availability. Federal Register. 87 FR 27059,
May 6, 2022 (FRL-7542-03-OCSPP).
6. Tidal Vision USA. Aquatic Toxicology Report by Eurofins
Environmental Testing Test America. Lab I.D. No. B4345. Report Date:
June 17, 2019. EPA Master Record Identification (MRID) 51861901.
7. Tidal Vision USA. Aquatic Toxicology Report by Eurofins
Environmental Testing Test America. Lab I.D. No. B4421. Report Date:
August 28, 2019. EPA Master Record Identification (MRID) 51861902.
8. EPA. Addendum to the science review in support of the addition of
chitosan (Poly-D-Glucosamine) to the list of minimum risk pesticides
(MRPs) contained in 40 CFR 152.25(f). September 2022.
9. FDA. Intended for Use in Human Food or Animal Food on the Basis
of the Generally Recognized as Safe (GRAS) Provision of the Federal
Food, Drug, and Cosmetic Act: Guidance for Industry. November 2017.
Available at <a href="https://www.fda.gov/media/109117/download">https://www.fda.gov/media/109117/download</a>.
10. EPA. Science review in support of the addition of Chitosan
(Poly-D-Glucosamine) to the list of minimum risk pesticides (MRPs)
contained in 40 CFR 152.25(f). August 23, 2019.
11. Huang, S. S., Sung, S. H., & Chiang, C. E. (2007). Chitosan
potentiation of warfarin effect. The Annals of Pharmacotherapy,
41(11), 1912-1914. November 1, 2007. Available at <a href="https://doi.org/10.1345/aph.1K173">https://doi.org/10.1345/aph.1K173</a>.
12. EPA. Pesticides; Modification to the Minimum Risk Pesticide
Listing Program and Other Exemptions Under FIFRA Section 25(b);
Federal Register. 86 FR 18232, April 8, 2021 (FRL-10016-29).
V. FIFRA Review Requirements
In accordance with FIFRA section 25(a), EPA submitted a draft of
this final rule to the United States Department of Agriculture (USDA)
and the FIFRA Scientific Advisory Panel (SAP) for review. A draft of
the rule was also submitted to the appropriate Congressional
Committees.
USDA responded without comments on October 7, 2022. The FIFRA SAP
waived its scientific review of this rule on October 13, 2022, because
the rule does not contain scientific issues that warrant review by the
Panel.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review; and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action and was
therefore not
[[Page 67370]]
submitted to the Office of Management and Budget (OMB) for review under
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection
requirements that would require additional review or approval by OMB
under the PRA, 44 U.S.C. 3501 et seq. The information collection
activities required under the exemption are covered by an existing
Information Collection Request (ICR), entitled ``Labeling Requirements
for Certain Minimum Risk Pesticides under FIFRA Section 25(b),''
approved under OMB Control No. 2070-0187 and identified by EPA ICR No.
2475. The existing ICR estimates the burden of displaying mandatory
active and inert ingredient and producer information on the labels of
minimum risk pesticide products. To maintain exemption status, an
exempt pesticide product must display the following information on its
label; the label display name and the percentage (by weight) of all
active ingredients, the label display name of all inert ingredients,
and the name of the producer or the company for whom the product was
produced, along with the producer/company's contact information. Labels
provide important regulatory information for the Federal, State, and
Tribal authorities that regulate or enforce minimum risk pesticide
products.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this rule is any significant adverse economic
impact on small entities, and the Agency is certifying that this rule
will not have a significant economic impact on a substantial number of
small entities because the rule relieves regulatory burden. This action
adds substances to the list of active ingredients allowed in exempted
minimum risk pesticide products reduces existing regulatory burden and
will not have a significant economic impact on a substantial number of
small entities. The cost savings are summarized in Unit I.E. We have
therefore concluded that this action will relieve regulatory burden for
all directly regulated small entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action imposes no enforceable duty on any
state, local, or Tribal governments because there are no known
instances where such governments currently produce any pesticides such
that they would be subject to this rulemaking. Accordingly, this action
is not subject to the requirements of UMRA.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the states, on the relationship between
the National Government and the states, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action will
not have any effect on Tribal governments, on the relationship between
the Federal Government and the Indian tribes, or the distribution of
power and responsibilities between the Federal Government and Indian
tribes. Currently, there are no known instances where a Tribal
government is the producer of a minimum risk pesticide product exempt
from regulation.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866 and because this action has not otherwise been
designated as a significant energy action by the Administrator of the
Office of Information and Regulatory Affairs.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards as specified in
NTTAA section 12(d), 15 U.S.C. 272 note.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special consideration of environmental
justice issues as delineated by Executive Order 12898 (59 FR 7629,
February 16, 1994) and Executive Order 14008 (86 FR 7619, January 27,
2021), because this rule does not establish an environmental health or
safety standard.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and the
EPA will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 152
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 21, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES
0
1. The authority citation for 40 CFR part 152 continues to read as
follows:
Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31
U.S.C. 9701.
0
2. Amend Sec. 152.25 by:
0
a. Adding alphabetically the entry ``Chitosan'' to table 1 to paragraph
(f)(1); and
0
b. Removing the entry for ``Trisodium citrate dehydrate'' and adding in
its place the entry ``Trisodium citrate dihydrate'' in table 2 to
paragraph (f)(2).
The addition and revision read as follows:
[[Page 67371]]
Sec. 152.25 Exemptions for pesticides of a character not requiring
FIFRA regulation.
* * * * *
(f) * * *
(1) * * *
Table 1--Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products
----------------------------------------------------------------------------------------------------------------
Label display name Chemical name Specifications CAS No.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Chitosan.............................. Poly-D-glucosamine....... Includes chitosan salts 9012-76-4
(consisting solely of those
salts that can be formed
with the acids listed in
this table or table 2 to
paragraph (f)(2) of this
section).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(2) * * *
Table 2--Inert Ingredients Permitted in Minimum Risk Pesticide Products
------------------------------------------------------------------------
Label display name Chemical name CAS No.
------------------------------------------------------------------------
* * * * * * *
Trisodium citrate dihydrate....... Citric acid, 6132-04-3
trisodium salt,
dihydrate.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-23682 Filed 11-7-22; 8:45 am]
BILLING CODE 6560-50-P
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