10178 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0146; FRL–10018–54] 

Complex Polymeric Polyhydroxy Acids 

(CPPA); Amendment to the Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing tolerance exemption for 

residues of Complex Polymeric 

Polyhydroxy Acids (CPPA) in or on all 

food commodities as a plant growth 

regulator to add use as a nematicide in 

pesticide formulations. FBSciences, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) requesting this amendment. 

This regulation adds use as a nematicide 

to the existing tolerance exemption of 

CPPA under FFDCA. 

DATES: This regulation is effective 

February 19, 2021. Objections and 

requests for hearings must be received 

on or before April 20, 2021, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2020–0146, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, 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. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. 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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Publishing 

Office’s e-CFR site at http:// 

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2020–0146 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing and must be received 

by the Hearing Clerk on or before April 

20, 2021. Addresses for mail and hand 

delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2020–0146, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Background 

In the Federal Register of May 05, 

2020 (85 FR 26684) (FRL–10008–46), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 0F8822) 

by FBSciences, Inc., 153 N. Main Street, 

Ste. 100, Collierville, TN 38017–2691. 

The petition requested that 40 CFR 

180.1321 be amended by the addition of 

use as a nematicide to the already 

established exemption from the 

requirement of a tolerance for residues 

of Complex Polymeric Polyhydroxy 

Acids (CPPA). That document 

referenced a summary of the petition 

prepared by the petitioner FBSciences, 

Inc., which is available in the docket for 

this action at http:// 

www.regulations.gov. Although 

comments were received on the notice 

of filing, none were relevant to this 

tolerance rulemaking. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement of a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Pursuant to 

FFDCA section 408(c)(2)(B), in making a 

determination to establish or maintain 

in effect an exemption from the 


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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations 10179 

requirement of a tolerance, EPA must 

take into account the factors set forth in 

FFDCA section 408(b)(2)(C), which 

require EPA to give special 

consideration to exposure of infants and 

children to the pesticide chemical 

residue in establishing a tolerance to 

‘‘ensure that there is a reasonable 

certainty that no harm will result to 

infants and children from aggregate 

exposure to the pesticide chemical 

residue. . . .’’ Additionally, FFDCA 

section 408(b)(2)(D) requires that the 

Agency consider ‘‘available information 

concerning the cumulative effects of 

such residues and other substances that 

have a common mechanism of 

toxicity. . . .’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

II. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its risk. EPA has 

also considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

A. Overview of Complex Polymeric 

Polyhydroxy Acids 

Complex Polymeric Polyhydroxy 

Acids (CPPA) is a complex mixture of 

naturally occurring organic substances 

found in dead plant materials. The 

components of CPPA are widespread in 

nature, being found in soils and fresh 

and saltwater environments as a result 

of decaying plant materials and are used 

to condition agricultural soils. Its major 

components are humic acid, fulvic acid, 

and tannins, and their relative 

concentrations in soil and water systems 

are influenced by environmental 

conditions, such as climate, soil types, 

vegetation, and hydrology. CPPA is 

made by concentrating the organic 

substances from water leached through 

forest soil using a proprietary 

manufacturing process. 

B. Biochemical Pesticide Toxicology 

Data Requirements 

All applicable mammalian toxicology 

data requirements supporting the 

existing tolerance exemption for 

residues of CPPA in or on all food 

commodities as a plant growth regulator 

have been fulfilled. The mammalian 

toxicology data requirements supporting 

the addition of nematicide use to the 

existing tolerance exemption have also 

been fulfilled as EPA has relied upon 

the same mammalian toxicology data 

that supported the existing tolerance 

exemption for CPPA. No acute, 

subchronic, or chronic toxicity 

endpoints were identified in guideline 

studies or in data obtained from open 

technical literature. Moreover, CPPA is 

not a mutagen, and is not a 

developmental toxicant. There are no 

known effects on endocrine systems via 

oral, dermal, or inhalation exposure. A 

more in-depth synopsis of the data upon 

which EPA relied and its human health 

risk assessment based on that data can 

be found in the document 

‘‘Biopesticides Registration Action 

Document, Complex Polymeric 

Polyhydroxy Acids (CPPA),’’ which is 

available in Docket Number EPA–HQ– 

OPP–2009–0917–0011, as well as the 

docket for this action, via 

www.regulations.gov as described under 

ADDRESSES. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

The proposed use pattern may result 

in dietary exposure with possible 

residues in or on agricultural 

commodities. No significant exposure 

via drinking water is expected beyond 

what is already present, when CPPA is 

used according to the product label 

directions, because the active ingredient 

biodegrades rapidly (half-life = 25.7 

days) in the environment, is applied at 

low application rates, and is not directly 

applied to water. Should exposure 

occur, however, minimal to no risk is 

expected for the general population, 

including infants and children, due to 

low toxicity of CPPA and its 

components as demonstrated in the data 

submitted and evaluated by the Agency. 

In addition, the lack of reported 

incidents in spite of the exposure from 

use in commercial agriculture for years 

to condition soils and its abundance in 

nature support a conclusion that 

minimal to no risk is expected. 

B. Other Non-Occupational Exposure 

Non-occupational exposure is not 

expected because CPPA will be applied 

as a plant growth regulator and 

nematicide for agricultural purposes 

only and there are no residential uses. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, in establishing a tolerance 

or tolerance exemption for a pesticide 

chemical residue, the Agency consider 

‘‘available information concerning the 

cumulative effects of such residues and 

other substances that have a common 

mechanism of toxicity. . . .’’ EPA has 

determined CPPA to have a non-toxic 

mode of action; therefore, 

408(b)(2)(D)(v) does not apply. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

FFDCA section 408(b)(2)(C) provides 

that, in establishing a tolerance or 

tolerance exemption for a pesticide 

chemical residue, EPA shall assess the 

available information about 

consumption patterns among infants 

and children, special susceptibility of 

infants and children to pesticide 

chemical residues, and the cumulative 

effects on infants and children of the 

residues and other substances with a 

common mechanism of toxicity. In 

addition, FFDCA section 408(b)(2)(C) 

provides that EPA shall apply an 

additional tenfold (10X) margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure, unless EPA determines 

that a different margin of safety will be 

safe for infants and children. This 

additional margin of safety is commonly 

referred to as the Food Quality 

Protection Act Safety Factor. In 

applying this provision, EPA either 

retains the default value of 10X, or uses 

a different additional safety factor when 

reliable data are available to support the 

choice of a different safety factor. As 

part of its qualitative assessment, EPA 

evaluated the available toxicity and 

exposure data on CPPA and considered 

its validity, completeness, and 

reliability, as well as the relationship of 

this information to human risk. EPA 

considers the toxicity database to be 

complete and has identified no residual 

uncertainty with regard to prenatal and 

postnatal toxicity or exposure. No 

hazard was identified based on the 

available studies. Based upon its 

evaluation, EPA concludes that there are 

no threshold effects of concern to 

infants, children, or adults when CPPA 


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10180 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations 

is applied as a plant growth regulator or 

nematicide and used in accordance with 

label directions and good agricultural 

practices. As a result, EPA concludes 

that no additional margin of exposure 

(safety) is necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for Complex Polymeric Polyhydroxy 

Acids (CPPA) because EPA is amending 

an exemption from the requirement of a 

tolerance without any numerical 

limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

Codex is a joint United Nations Food 

and Agriculture Organization/World 

Health Organization food standards 

program, and it is recognized as an 

international food safety standardssetting organization in trade agreements 

to which the United States is a party. 

EPA may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established an MRL for CPPA. 

VIII. Conclusion 

EPA concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of CPPA. 

Therefore, EPA is establishing an 

exemption from the requirement of a 

tolerance for residues of CPPA in or on 

all food commodities when applied as a 

nematicide and used in accordance with 

good agricultural practices. 

IX. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

the Agency. The Office of Management 

and Budget (OMB) has exempted these 

types of actions from review under 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993). Because 

this action has been exempted from 

review under Executive Order 12866, 

this action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled ‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997), 

nor is it considered a regulatory action 

under Executive Order 13771, entitled 

‘‘Reducing Regulations and Controlling 

Regulatory Costs’’ (82 FR 9339, February 

3, 2017). This action does not contain 

any information collections subject to 

OMB approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled ‘‘Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). This action does not 

involve any technical standards that 

would require Agency consideration of 

voluntary consensus standards pursuant 

to section 12(d) of the National 

Technology Transfer and Advancement 

Act (NTTAA) (15 U.S.C. 272 note). 

X. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 16, 2021. 

Charles Smith, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Revise § 180.1321 to read as 

follows: 

§ 180.1321 Complex Polymeric 

Polyhydroxy Acids; exemption from the 

requirement of a tolerance. 

(a) An exemption from the 

requirement of a tolerance is established 

for the residues of complex polymeric 

polyhydroxy acids in or on all food 

commodities when applied as a plant 

growth regulator and used in 

accordance with good agricultural 

practices. 

(b) An exemption from the 

requirement of a tolerance is established 

for the residues of complex polymeric 

polyhydroxy acids in or on all food 

commodities when applied as a 

nematicide and used in accordance with 

good agricultural practices. 

[FR Doc. 2021–03362 Filed 2–18–21; 8:45 am] 

BILLING CODE 6560–50–P 


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