15P-0280 BILLING CODE 6560-50-P

ENVIRONMENTAL PRO TECTION 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 exem ption from the requirement of a tolerance for residues of th e 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 resi dues of Choline Chloride. DATES: This regulation is effective [ insert date of publication in the Federal Register ]. Objections and requests for hearings must be received on or before [ insert date 60 days after date of publication in the Federal Register ], 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, iden tified by docket id entification (ID) number EPA-HQ-OPP-2015-0023, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulator y Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson2 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 additiona l 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 pestic ide 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 dete rmine 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?3 You may access a frequently updated el ectronic version of 40 CFR part 180 through the Government Printi ng 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 Obj ection 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 al so request a hearing on those objections. You must file your objection or request a heari ng 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 reque sts for a hearing must be in writing, and must be received by the Hearing Clerk on or before [ insert date 60 days after date of publication in the Federal Register ]. Addresses for mail and hand delivery of objections and hearing requests are pr ovided in 40 CFR 178.25(b). In addition to filing an objection or h earing request with th e Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for in clusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Subm it the non-CBI copy of your objection or hearing request, identified by docket ID number EP A-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 w hose disclosure is re stricted by statute.4

• Mail: OPP Docket, Environm ental Protecti on Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave ., NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements fo r 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 ge nerally, is available at http://www.epa.gov/dockets

. II. Background and Statutory Findings In the Federal Register of March 4, 2015 (42 FR 11611) (FRL-9922-68), EPA issued a document pursuant to FFDCA s ection 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide toleran ce petition (PP 4F8287) by CP Bio, Inc., 4802 Murrieta Street, Chino, CA 91710. The petiti on requested that 40 CFR part 180 be amended by establishing an exemption from th e 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 petiti on 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 allo ws 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 exemp tion is “safe.” Secti on 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 resi due, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This5 includes exposure through dri nking w ater 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 considerat ion to exposure of infants and ch ildren to the pesticide chemical residue in establishing a toleran ce 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 mech anism of toxicity.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxi city of pesticides. Second, EPA examines exposure to the pesticide th rough 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 rele vant 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 in formation concerning the variability of the sensitivities of major identif iable subgroups of consumers, including infants and children. A. Overview of Choline Chloride Choline Chloride is an ammonium sa lt that readily dissociates into two constituents – Choline and Chloride. It pres ents as a white crystalline solid that is6 odorless. Each constituent is ubiq uitous in th e 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 an imal fat. It is a precursor of a vital neurotransmitter; and it is cr itical for the structural integrity of cell membranes and various metabolic functions. Chloride is also a regular part of the hum an diet, particularly as a constituent of edible salt, and serv es many functions in human biology. Chiefly, Chloride is an essential el ectrolyte responsible for main taining 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 lim itation for pre-harves t use (40 CFR 180.920). Additionally, Choline Chloride is designated as GRAS (Gener ally Recognized as Safe) and is approved by the Food and Drug Admini stration (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 c onsidered a plant growth regulator (PGR) intended for use to increase growth and decrease stress in growing crops. It has a nontoxic 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 fu lfilled through guideline studies. The Acute Oral Toxicity Category is III; all other categories are IV. Additionally, the information7

subm itted in support of the application indica te that Choline Chloride is non-mutagenic and that it is not subchronically or devel opmentally toxic. Subchronic oral toxicity, mutagenicity and developmental toxicity data requirements were satisfied through scientific literature. Subchronic dermal and i nhalation requirements were waived for lack of exposure. (A complete assessment of th e toxicology submission for Choline Chloride can be found in the docket.) C. EPA’s Safety Determination EPA evaluated the available toxicity a nd exposure data on Choline Chloride and considered its validity, completeness, and reli ability, 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 re levant information, is av ailable in the docket for this action as described under ADRESSES . Based upon its evaluation, EPA concludes that there is a reasonable certai nty 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 accord ance with label directions a nd good agricultural practices. IV. Aggregate Exposures In examining aggregate exposure, FFDC A section 408 directs EPA to consider available information concerning exposures fr om the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface8 water and exposure through pestic ide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure Food Exposure. Dietary exposure to the pesticid al residues of Choline Chloride is expected to be negligible. (1) Choline Ch loride is a PGR and is necessarily applied at low concentrations. (High concentrations resu lt in detrimental effects to the plant). (2) Choline Chloride biodegrades rapidly. A MITI-I test demonstrated that Choline Chloride is 93% degraded with in 14 days. (3) As a salt, Choline Chloride dissociates readily when in contact with water, maki ng 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. Nota bly, humans are already dietarily exposed to Choline Chloride. It is produced endogenous ly, and is found natura lly in foods in the human diet. Indeed, it is c onsidered an essential human dietary component, serving critical functions in nerve transmission, ce ll membrane integrity and lipid metabolism. Drinking Water Exposure. No significant resid ues o f C ho line C hloride are

ex p ected in drinking water when products ar e used according to label instructions. The active ingred ient is applied terrestrially atlo w concentrations; it is very soluble in water; a n d it b io d eg r ad es r ap id ly , o n ce ap p lied

. As su ch, any residues of C holine C hloride in drinking water a re anticipa ted to b e n eglig ible. It should be additional ly noted that both C holine a nd C hloride, the constituen ts of C h o line C hloride, are ubiquit ous in the envir o nment; and there is a long history of incidental, but minor, ex p osur e through drin k ing water.9 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. None theless, 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 require s that, when considering whether to establish, modify, or revoke a tolerance, th e Agency consider “available information” concerning the cumulative effects of a part icular pesticide’s residues and “other substances that have a comm on mechanism of toxicity.” EPA has not found Choline C hloride to s h are a common mechan ism of to xicity with any other substances, and Choline Ch loride does not appear to produce a toxic metabolite produced b y other substances. For the purposes of this tolerance action, therefore, EPA has assumed that Choline Chlorid e does not have a common mechanism

o f toxicity with other substances. For info r mation regarding EPA’s ef for ts to determine wh ich ch emicals have a common mechanism of toxicity an d to evaluate the cumulative ef f ects of such chemicals, see EPA’s website at h ttp : //www.epa.gov/pesticides/cumulative. VI. Determination of Safety for U.S. Population, Infants and Children FFDCA section 408(b)(2)(C) pr ovides that, in consideri ng the establishment of a tolerance or tolerance exemption for a pest icide chemical residue, the EPA shall assess the available information about consumption patterns among infants and children, special10 susceptibility of infants and children to pest icid e chemical residues, and the cumulative effects on infants and children of the re sidues and other substa nces with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) pr ovides 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 pos tnatal 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 in fants 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 reta ins the default value of 10X, or uses a different additional or no safety factor wh en reliable data are available to support a different additional or no safety factor. Because there are no threshold effects a ssociated with this biochemical, an additional margin of safety for infant s and children is not necessary. EPA has determined that there are no foreseeable dietary risks to the U.S. population, including infants and ch ildren, from the pesticidal use of Choline Chloride. Exposure to the residues of Choline Chloride is expected to be neg ligible due to the low concentrations associated with its use as a PGR, its high solubility and its rapid biodegradability. Moreover, any exposure to Ch oline Chloride residu es are not expected to pose a risk. No toxic endpoints have been identified for Cholin e 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.11

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 require ment of a tolerance without any numerical limitation. B. International Residue Limits In making its tolerance decisions, EPA s eeks 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 A limentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Orga nization 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, FFD CA section 408(b)(4) requires that EPA explain the reasons for depart ing from the Codex level. The Codex has not establishe d 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 on12 all food commodities when applied pre-harves t in accordance with la bel 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 O ffice of Management and Budget (OMB) has exempted these types of actions from re view under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executi ve 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 Childre n 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 sp ecial considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Lo w-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 regu lates growers, food processo rs, food handlers, and food retailers, not States or tribes, nor does this ac tion alter the relationshi ps or distribution of power and responsibilities established by Congress in the preemption provisions of13 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 St ates or tribal governments, or on the distribution of power and re sponsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Fed eralism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation a nd 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 cons ensus standards pursuant to s ection 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 Comptr oller 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).14 List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: ____________________

________________________________________

Director, Office of Pesticide Programs.15 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 commod ities when Choline Chloride is applied preharvest and used in accord ance with label directions and good agricultu ral practices.