78146 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 

* * * * * 

[FR Doc. 2015–31518 Filed 12–15–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0023; FRL–9935–81] 

Choline Chloride; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the Choline 

Chloride (Acetyl Choline) in or on all 

food commodities when applied/used 

pre-harvest and used in accordance with 

label directions and good agricultural 

practices. CP Bio, Inc., submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Choline Chloride. 

DATES: This regulation is effective 

December 16, 2015. Objections and 

requests for hearings must be received 

on or before February 16, 2016, 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–2015–0023, 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. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Robert McNally, 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 Printing 

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, 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–2015–0023 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 February 16, 2016. 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– 

2015–0023, 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 and Statutory Findings 

In the Federal Register of March 4, 

2015 (80 FR 11611) (FRL–9922–68), 

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 4F8287) 

by CP Bio, Inc., 4802 Murrieta Street, 

Chino, CA 91710. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Choline Chloride in or on all 

food commodities (when applied preharvest). That document referenced a 

summary of the petition prepared by the 

petitioner CP Bio, Inc., which is 

available in the docket, http:// 

www.regulations.gov. There were no 

substantive comments received in 

response to the notice of filing. 

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

allows EPA to establish an exemption 

from the requirement for 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 a 

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 

establishing or maintaining in effect an 

exemption from the 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 


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Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 78147 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance and 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 a particular pesticide’s 

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. 

III. 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 validity, 

completeness and reliability, and the 

relationship of this information to 

human 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 Choline Chloride 

Choline Chloride is an ammonium 

salt that readily dissociates into two 

constituents—Choline and Chloride. It 

presents as a white crystalline solid that 

is odorless. Each constituent is 

ubiquitous in the environment, 

constitutes a regular part of the human 

diet, and serves many critical functions 

in the human body. Choline is found in 

such foods as egg yolk, vegetables and 

animal fat. It is a precursor of a vital 

neurotransmitter; and it is critical for 

the structural integrity of cell 

membranes and various metabolic 

functions. Chloride is also a regular part 

of the human diet, particularly as a 

constituent of edible salt, and serves 

many functions in human biology. 

Chiefly, Chloride is an essential 

electrolyte responsible for maintaining 

acid/base balance, transmitting nerve 

impulses and regulating fluid in and out 

of cells. 

Choline Chloride is already approved 

for use by EPA as an inert ingredient in 

pesticide products without numerical 

limitation for pre-harvest use (40 CFR 

180.920). Additionally, Choline 

Chloride is designated as GRAS 

(Generally Recognized as Safe) and is 

approved by the Food and Drug 

Administration (FDA) as a human 

nutrient under 21 CFR 182.8252 and as 

a nutrient in animal feeds under 21 CFR 

582.5252. 

As a biopesticide, Choline Chloride is 

considered a plant growth regulator 

(PGR) intended for use to increase 

growth and decrease stress in growing 

crops. It has a non-toxic mode of action; 

and as with most PGRs, it is applied at 

low concentrations because use at high 

concentrations result in detrimental 

effects to the plant. 

B. Biochemical Pesticide Toxicology 

Data Requirements 

All applicable mammalian toxicology 

data requirements supporting the 

petition to establish an exemption from 

the requirement of a tolerance for the 

use of Choline Chloride as an active 

ingredient for use as a PGR on food 

crops have been fulfilled. All acute 

toxicology data requirements were 

fulfilled through guideline studies. The 

Acute Oral Toxicity Category is III; all 

other categories are IV. Additionally, the 

information submitted in support of the 

application indicate that Choline 

Chloride is non-mutagenic and that it is 

not subchronically or developmentally 

toxic. Subchronic oral toxicity, 

mutagenicity and developmental 

toxicity data requirements were satisfied 

through scientific literature. Subchronic 

dermal and inhalation requirements 

were waived for lack of exposure. (A 

complete assessment of the toxicology 

submission for Choline Chloride can be 

found in the docket.) 

C. EPA’s Safety Determination 

EPA evaluated the available toxicity 

and exposure data on Choline Chloride 

and considered its validity, 

completeness, and reliability, as well as 

the relationship of this information to 

human risk. A full explanation of the 

data upon which EPA relied and its risk 

assessment based on that data can be 

found within the August 11, 2015, 

document entitled ‘‘Federal Food, Drug, 

and Cosmetic Act (FFDCA) 

Considerations for Choline Chloride.’’ 

This document, as well as other relevant 

information, is available in the docket 

for this action as described under 

ADDRESSES. Based upon its evaluation, 

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 Choline Chloride. Therefore, 

an exemption from the requirement of a 

tolerance is established for residues of 

Choline Chloride in or on all food 

commodities when applied pre-harvest 

and used in accordance with label 

directions and good agricultural 

practices. 

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 

Food Exposure. Dietary exposure to 

the pesticidal residues of Choline 

Chloride is expected to be negligible. (1) 

Choline Chloride is a PGR and is 

necessarily applied at low 

concentrations. (High concentrations 

result in detrimental effects to the 

plant). (2) Choline Chloride biodegrades 

rapidly. A MITI–I test demonstrated that 

Choline Chloride is 93% degraded 

within 14 days. (3) As a salt, Choline 

Chloride dissociates readily when in 

contact with water, making its 

persistence as a residue even more 

unlikely. 

Should exposure occur, however, 

minimal to no risk is expected for the 

general population, including infants 

and children. Notably, humans are 

already dietarily exposed to Choline 

Chloride. It is produced endogenously, 

and is found naturally in foods in the 

human diet. Indeed, it is considered an 

essential human dietary component, 

serving critical functions in nerve 

transmission, cell membrane integrity 

and lipid metabolism. 

Drinking Water Exposure. No 

significant residues of Choline Chloride 

are expected in drinking water when 

products are used according to label 

instructions. The active ingredient is 

applied terrestrially at low 

concentrations; it is very soluble in 

water; and it biodegrades rapidly, once 

applied. As such, any residues of 

Choline Chloride in drinking water are 

anticipated to be negligible. 

It should be additionally noted that 

both Choline and Chloride, the 

constituents of Choline Chloride, are 

ubiquitous in the environment; and 

there is a long history of incidental, but 

minor, exposure through drinking 

water. 

B. Other Non-Occupational Exposure 

Non-occupational exposure to 

Choline Chloride residues are not 

expected. Choline Chloride is not 

intended for use in residential settings; 

it is intended for agricultural use only. 


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78148 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 

Nonetheless, even in the event of 

incidental exposure, minimal to no risk 

is expected due to the low toxicity of 

the chemical as explained in the risk 

assessment found in the docket. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found Choline Chloride 

to share a common mechanism of 

toxicity with any other substances, and 

Choline Chloride does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that Choline Chloride does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

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

that, in considering the establishment of 

a tolerance or tolerance exemption for a 

pesticide chemical residue, the 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 the 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 the 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, the EPA either retains the 

default value of 10X, or uses a different 

additional or no safety factor when 

reliable data are available to support a 

different additional or no safety factor. 

Because there are no threshold effects 

associated with this biochemical, an 

additional margin of safety for infants 

and children is not necessary. 

EPA has determined that there are no 

foreseeable dietary risks to the U.S. 

population, including infants and 

children, from the pesticidal use of 

Choline Chloride. Exposure to the 

residues of Choline Chloride is expected 

to be negligible due to the low 

concentrations associated with its use as 

a PGR, its high solubility and its rapid 

biodegradability. Moreover, any 

exposure to Choline Chloride residues 

are not expected to pose a risk. No toxic 

endpoints have been identified for 

Choline Chloride. There has been a long 

history of significant human dietary and 

endogenous exposure without 

documented incident. And the 

constituents of Choline Chloride are 

known to be readily metabolized. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing 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). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

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 a MRL 

for Choline Chloride. 

VIII. Conclusions 

Based on its assessment of Choline 

Chloride, EPA concludes that there is a 

reasonable certainty that no harm will 

result to the general population, or to 

infants and children, from aggregate 

exposure to Choline Chloride. EPA is 

therefore establishing an exemption 

from the requirement of a tolerance for 

residues of Choline Chloride in or on all 

food commodities when applied preharvest in accordance with label 

directions and good agricultural 

practices. 

IX. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

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). 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 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 78149 

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: December 1, 2015. 

Jack E. Housenger, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Add § 180.1334 to subpart D to read 

as follows: 

§ 180.1334 Choline Chloride; Exemption 

from the Requirement of a Tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Choline Chloride in or on all food 

commodities when Choline Chloride is 

applied pre-harvest and used in 

accordance with label directions and 

good agricultural practices. 

[FR Doc. 2015–31464 Filed 12–15–15; 8:45 am] 

BILLING CODE 6560–50–P 


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