[Federal Register Volume 85, Number 212 (Monday, November 2, 2020)]
[Proposed Rules]
[Pages 69307-69311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22646]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[EPA-HQ-OPP-2019-0701; FRL-10009-24]
RIN 2070-AK56


Pesticides; Proposal To Add Chitosan to the List of Active 
Ingredients Permitted in Exempted Minimum Risk Pesticide Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to add 
the substance commonly referred to as chitosan (also known by its 
chemical name: poly-D-glucosamine) (CAS Reg. No. 9012-76-4) 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). Tidal Vision Products, LLC 
submitted a petition to EPA requesting that chitosan be added to both 
the lists of active and inert ingredients allowed in exempted minimum 
risk pesticide products. At this time, EPA is deferring a decision on 
whether to add chitosan to the list of allowable inert ingredients.

DATES: Comments must be received on or before January 4, 2021.

ADDRESSES: Submit your comments, identified by the docket 
identification (ID) number EPA-HQ-OPP-2019-0701, through the Federal 
eRulemaking Portal at http://www.regulations.gov. Follow the online 
instructions for submitting comments. Do not submit electronically any 
information you consider to be Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.
    Please note that due to the public health emergency the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, Deputy Director, 
Biopesticides and Pollution Prevention Division (7511P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-
7090; email address: BPPDFRNotices@epa.gov.

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:
     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

[[Page 69308]]

soap and detergents (NAICS code 325611).
     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.
     Retailers of minimum risk pesticide products (some of who 
may also be manufacturers), including nursery, garden center, and farm 
supply stores (NAICS code 444220); outdoor power equipment stores 
(NAICS code 444210); and supermarkets (NAICS code 445110).
     Users of minimum risk pesticide products, including the 
public in general, exterminating and pest control services (NAICS code 
561710), landscaping services (NAICS code 561730), sports and 
recreation institutions (NAICS code 611620), and child daycare services 
(NAICS code 624410). Many of these entities also manufacture minimum 
risk pesticide products.

B. What action is the Agency taking?

    EPA is proposing to add the substance commonly referred to as 
chitosan (also known by its chemical name poly-D-glucosamine) (CAS Reg. 
No. 9012-76-4) 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.

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 ingredients (recognized 
active and inert substances which are listed in the regulations (40 CFR 
part 152)) and labeled according to EPA's regulations in 40 CFR 
152.25(f). EPA created the exemption for minimum risk pesticides to 
eliminate 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.

E. What are the estimated incremental impacts of the proposal?

    EPA has evaluated the potential incremental impacts of this 
proposed exemption in the document entitled ``Cost Analysis of the 
Proposed Modification to the Minimum Risk Pesticide Listing Program. 
Prepared by Biological and Economic Analysis Division, Office of 
Pesticide Programs'' (Ref. 1), which is available in the docket and is 
briefly summarized here.
    Without this exemption, the petitioner would be required to 
register the chitosan product(s) as a pesticide 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 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 as explained in 
the following paragraph.
    EPA has previously estimated the costs of guideline studies (Ref. 
2) and registration fees (Ref. 3) are available on EPA's website. EPA 
estimates the cost of submitting an application for a product 
registration to be about $1,300 (Ref. 4). For a new product, data 
generation costs could be as much as $109,000 and fees would be $5,363; 
including submission costs, the petitioner could avoid registration 
costs of nearly $116,000. For products that are substantially similar 
to existing registered products, data generation costs could be around 
$51,000 with fees of $1,342; including submission costs, the petitioner 
could avoid registration costs of about $53,000. (Ref. 1). Tidal Vision 
Products, LLC, indicated in its petition that it plans to register six 
chitosan pesticide products. Assuming the six products meet all the 
criteria for exemption (exempt products must only contain substance 
listed in 40 CFR 152.25(f), list all ingredients on the label, and may 
not make any claims to control public health pests), EPA estimates the 
total savings to be between $318,000 and $696,000 initially and about 
$20,000 per year thereafter in maintenance fees. There may be 
additional savings if production establishments and production levels 
do not have to be registered or reported under FIFRA section 7. The 
magnitude of savings depends, in part, on whether Tidal Vision, LLC., 
would normally be eligible for reductions in fees that are available to 
a small business. (Ref.1)
    For EPA, this action may reduce the Agency's level-of-effort that 
would otherwise be spent on registering pesticide products with little 
risk. However, PRIA fees are meant to support the Agency's work, so 
this action has negligible impact on overall resources. The impact on 
State regulatory costs is uncertain, as States have wide variability in 
how they regulate conventional pesticide products versus minimum risk 
pesticide products; this Federal action, however, is unlikely to 
significantly change how States register chitosan-containing pesticide 
products.
    In the absence of an exemption, manufacturers may forego 
development and production of chitosan-based products. Thus, the 
exemption may ultimately benefit consumers who may see more of these 
products available at lower costs. An analysis of the cost and savings 
of adding chitosan to the list of active ingredients that can be used 
in minimum risk pesticide products under 40 CFR 152.25(f) can be found 
in the docket for this action.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    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). EPA created the exemption for

[[Page 69309]]

minimum risk pesticides to eliminate 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.
    Chitosan is a naturally occurring substance that is produced in 
nature and is found in the cell walls of many fungi. Chitin and its 
derivative chitosan also occur naturally 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.
    On October 10, 2018, EPA received a petition from Tidal Vision 
Products, LLC, requesting that the substance commonly known as chitosan 
(also known by its chemical name poly-D-glucosamine) (CAS Reg. No. 
9012-76-4) be added to the list of active ingredients allowed in 
exempted minimum risk pesticide products under 40 CFR 152.25(f)(1). 
(Ref. 5). 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. 6)
    This proposed rule addresses the 2018 petition and EPA is currently 
deferring a decision on the 2019 petition regarding whether to add 
chitosan to the list of allowable inert ingredients.

III. Proposal To Add Chitosan To the Minimum Risk Active Ingredient 
List

A. EPA's Decision on Tidal Vision Products, LLC's 2018 Petition

    EPA finds that Tidal Vision Products LLC's 2018 petition to add 
chitosan to the list of active ingredients in 40 CFR 152.25(f)(1) has 
merit. Therefore, the Agency is granting the 2018 petition and 
proposing this rulemaking to add chitosan to the list of active 
ingredients allowed in exempted minimum risk pesticide products in 40 
CFR 152.25(f)(1). EPA has determined that there is sufficient 
scientific evidence to support a conclusion of minimum risk for 
chitosan.

B. EPA's Scientific Review Supporting Its Decision

    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. This conclusion is 
supported by information in EPA's reviews of registered pesticide 
products containing chitosan as an active ingredient. The conclusions 
are documented in EPA's August 23, 2019, scientific review memorandum, 
entitled ``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),'' (Ref. 7), the Chitin and Chitosan Summary 
Document Registration Review: Initial Docket September 2007, (Ref. 8), 
the Chitin and Chitosan Final Registration Review Decision Case 6063. 
December 11, 2008, (Ref. 9) and in the Chitin and Chitosan Final Work 
Plan Registration Review--Case 6063, January 2008, (Ref. 10).

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. ``Cost Analysis of the Proposed Modification to the Minimum 
Risk Pesticide Listing Program.'' Prepared by Biological and Economic 
Analysis Division, Office of Pesticide Programs, EPA. July 2020.
    2. EPA. ``Cost Estimates of Studies Required for Pesticide 
Registration.'' 2018. Accessed on September 30, 2019 at https://www.epa.gov/pesticide-registration/cost-estimates-studies-required-pesticide-registration.
    3. EPA. ``PRIA Fee Category Table--Biopesticides Division--New 
Products: Table 13''. 2019b. Accessed on October 4, 2019 at https://www.epa.gov/pria-fees/pria-fee-category-table-biopesticides-division-new-products.
    4. EPA. ``Application for New and Amended Pesticide Registration: 
Supporting Statement for An Information Collection Request (ICR).'' 
2015. Accessed on October 16, 2019 at https://www.federalregister.gov/documents/2016/07/01/2016-15737/agency-information-collection-activities-information-collection-request-submitted-to-omb-for-review.
    5. 2018 Petition. 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.
    6. 2019 Petition (Amendment). Tidal Vision Products, LLC amendment 
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.
    7. 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.
    8. EPA. Chitin and Chitosan Summary Document Registration Review: 
Initial Docket September 2007. Submitted to Docket EPA-HQ-EPA-2006-
0566.
    9. EPA. Chitin and Chitosan Final Registration Review Decision Case 
6063. Signed December 11, 2008. Submitted to Docket EPA-HQ-EPA-2007-
0566.
    10. EPA. Chitin and Chitosan Final Work Plan Registration Review--
Case 6063. January 2008. Submitted to Docket EPA-HQ-EPA-2007-0566.

V. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), EPA submitted a draft of 
this proposed rule to the United States Department of Agriculture 
(USDA) and the FIFRA Scientific Advisory Panel (SAP) for review. A 
draft of the proposed rule was also submitted to the appropriate 
Congressional Committees.
    USDA responded without comments. The FIFRA SAP waived review of 
this proposed rule, concluding that the proposed rule does not contain 
scientific issues that warrant scientific review by the Panel.

VI. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review; and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was 
therefore not 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. Executive Order 13771: Reducing Regulation and Controlling 
Regulatory Costs

    This action is expected to be an Executive Order 13771 deregulatory 
action (82 FR 9339, February 3, 2017). Details on the estimated cost 
savings of this proposed rule can be found in EPA's cost analysis (Ref. 
1), which are briefly summarized in Unit I.E.

[[Page 69310]]

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection 
requirements that require additional review or approval by OMB under 
the PRA, 44 U.S.C. 3501 et seq. The information collection activities 
required under the proposed exemption are covered by the existing 
Information Collection Request (ICR), entitled ``Labeling Requirements 
for Certain Minimum Risk Pesticides under FIFRA Section 25(b)'' (OMB 
Control No. 2070-0187; EPA ICR No. 2475.03). 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.

D. 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. In 
making this determination, the impact of concern is any significant 
adverse economic impact on small entities. An agency may certify that a 
rule will not have a significant economic impact on a substantial 
number of small entities if the rule relieves regulatory burden, has no 
net burden or otherwise has a positive economic effect on the small 
entities subject to the rule.
    This proposal to add a substance 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/
have no net regulatory burden for all directly regulated small 
entities.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more 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 or the 
private sector Accordingly, this action is not subject to the 
requirements of UMRA.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. 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 (Executive 
Order 13132 (64 FR 43255, August 10, 1999).

G. 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. Thus, Executive Order 13175 does not apply to this 
action.

H. 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.

I. 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.

J. National Technology Transfer and Advancement Act (NTTAA)

    NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this 
proposed rule because it does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order 
12898 (59 FR 7629, February 16, 1994), because it does not establish an 
environmental health or safety standard. This rule proposes to add the 
substance commonly referred to as chitosan the list of active 
ingredients allowed in minimum risk pesticide products.

List of Subjects in 40 CFR Part 152

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting, and 
recordkeeping requirements.

Andrew Wheeler,
Administrator.

    Therefore, for the reasons stated in the preamble, it is proposed 
that 40 CFR chapter I be amended as follows:

Part 152--[Amended]

0
1. The authority citation for 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. In section 152.25 amend the table in paragraph (f)(1) by adding in 
alphabetical order the entry for ``Chitosan, Poly-D-glucosamine (CAS 
No. 9012-76-4)'' to the table to read as follows:


Sec.  152.25  Exemptions for pesticides of a character not requiring 
FIFRA regulation.

* * * * *
    (f) * * *
    (1) * * *

[[Page 69311]]



                                           Table 1 of Paragraph (f)(1)
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             Label display name                         Chemical name            Specifications       CAS No.
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                                                  * * * * * * *
Chitosan....................................  Poly-D-glucosamine..............  ................       9012-76-4
 
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[FR Doc. 2020-22646 Filed 10-30-20; 8:45 am]
BILLING CODE 6560-50-P


