Document ID: EPA-HQ-OPP-2015-0023-0016
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirements of a Tolerance: Choline Chloride,
Posted Date: 2015-12-16T05:00Z

[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Rules and Regulations]
[Pages 78146-78149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31464]

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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.

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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/text-idx?&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 pre-harvest). 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

[[Page 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 non-occupational 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.

[[Page 78148]]

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 pre-harvest 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

[[Page 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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Add Sec.  180.1334 to subpart D to read as follows:

Sec.  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