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[Federal Register: September 1, 2010 (Volume 75, Number 169)]
[Rules and Regulations]               
[Page 53577-53581]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se10-5]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0233; FRL-8841-6]

 
Choline hydroxide; 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 choline hydroxide (CAS Reg. No. 123-41-
1) when used as an inert ingredient that acts as a neutralizer in food 
use, acidic, preharvest herbicide products. The Dow AgroSciences, LLC, 
has submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting establishment of an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of choline 
hydroxide.

DATES: This regulation is effective September 1, 2010. Objections and 
requests for hearings must be received on or before November 1, 2010, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0233. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Mark Dow, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5533; e-mail address: dow.mark@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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.gpoaccess.gov/ecfr.

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-2010-0233 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 
November 1, 2010. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0233, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One

[[Page 53578]]

Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. 
Deliveries are only accepted during the Docket Facility's normal hours 
of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays). Special arrangements should be made for deliveries of 
boxed information. The Docket Facility telephone number is (703) 305-
5805.

II. Petition for Exemption

    In the Federal Register of May 19, 2010 (75 FR 28009)(FRL-9153-1), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 0E7686)(75 FR 28012) 
by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN, 
46268. The petition requested that 40 CFR 180.920 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of choline hydroxide (CAS Reg. No. 123-41-1) when used as an 
inert ingredient (a neutralizer) in acidic herbicide formulations 
applied preharvest. That notice referenced a summary of the petition 
prepared by Dow AgroSciences, the petitioner, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the exemption requested to pesticide formulations rather than 
herbicide formulations.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of 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....''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for choline hydroxide including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with choline hydroxide 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. Specific information on the studies received and the nature 
of the adverse effects caused by choline hydroxide as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this 
unit.
    No toxicity data are available for choline hydroxide. Upon contact 
with water, choline hydroxide is expected to dissociate into the 
cationic form (choline) and the anionic form (hydroxide ions). Choline 
hydroxide added to an acidic herbicide, forms an herbicide-choline salt 
product which will be sold in concentrate form. When the concentrate is 
mixed with water prior to application, the salt dissociates to the 
cationic form (choline). Choline cation therefore, is the moiety of 
interest. Since no toxicological studies are available in the 
literature, studies on choline chloride and other salts were used for 
evaluating the risk from exposure to choline hydroxide.
    According to the Organisation for Economic Co-operation and 
Development (OECD) due to its caustic nature (pH 14), acute toxicity 
testing of choline hydroxide would not be appropriate (OECD Guidelines 
for the Testing of Chemicals, Procedure 404 (2002); OECD Guideline for 
testing of Chemicals, Procedure, 405, 2002). Choline hydroxide is known 
as a skin, eye and respiratory irritant. It should be noted here that 
there will be essentially no contact with choline hydroxide in an end-
use product.
    As was discussed above, the hydroxy moiety dissociates and 
essentially ceases to exist upon mixing with water in preparation for 
application and in the body. The choline cation is what is left to be 
considered. The Agency has extensively assessed the effects of choline 
upon human systems and the environment. A summary of the Agency's 
findings are recorded in: Final Rule, Choline Chloride; Exemption from 
the Requirement of a Tolerance, EPA-HQ-OPP-2008-0671; FRL-8802-4 (75 FR 
760, January 6, 2010). Details of the Agency's assessment are found in: 
Decision Document for Petition Number 8E7387; Choline Chloride, CAS 
Reg. No 67-48-1; Memorandum, D. Sunderland, RD/OPP, 16 OCT 2009.
    Choline is an essential component of the human diet and acts as a 
precursor to acetylcholine, phospholipids, and the methyl donor 
betaine. It is important for the structural integrity of cell 
membranes, cholinergic

[[Page 53579]]

neurotransmission, transmembrane signaling, methyl metabolism, and 
lipid and cholesterol transport and metabolism.
    Choline was officially made an ``essential nutrient'' in 1998 and 
adequate intake (AI) levels were established (women - 425 milligrams/
day (mg/day), pregnant women - 450 mg/day, men and lactating women - 
550 mg/day). The Daily Upper Intake Level for choline is 3.5 grams (g) 
for adults. Research indicates that many individuals are not getting 
enough choline, with daily intake levels far below the AI.
    One study in mice evaluated the impact of 200 milligram/kilogram/
day (mg/kg/day) choline chloride given orally or intranasally for 28 
days. No adverse effects were observed with regards to body weight, 
food and water consumption, hematology, clinical biochemistry, or 
histopathology of various organs (lung, heart, liver, spleen, and 
kidney). Results from intranasal exposure to choline chloride were 
comparable with their respective controls and to other treatment 
groups. The no-observed-adverse-effect-level (NOAEL) for oral and 
intranasally administered choline chloride is >= 200 mg/kg/day.
    A 72-week feeding study was conducted in rats administered 500 mg/
kg/day of choline chloride; the animals were observed for 30 weeks post 
exposure. There were no significant differences between the control and 
treated group in relation to body weights, relative liver weight, 
survival rates, and the number of neoplastic liver nodules, 
hepatocellular carcinomas, lung tumors, leukemia, or other tumors. This 
study resulted in a NOAEL of 500 mg/kg/day (the highest dose tested).
    Choline is a precursor to the vital neurotransmitter acetylcholine. 
Studies show that choline has beneficial effects on the nervous system 
and memory. Choline is necessary to promote proper development in the 
fetus and infant and prevent cognitive problems. Choline chloride is 
not expected to cause neurotoxicity and it is not a known endocrine 
disruptor nor are its metabolites related to any class of known 
endocrine disruptors. Based on the results of the in vitro and in vivo 
studies the Agency concluded that choline chloride is not expected to 
be carcinogenic or mutagenic.
    Since the 1930's choline chloride has been used as a widespread 
nutrient in animal feed without adverse effects reported on fertility 
or teratogenicity. The Food and Drug Administration (FDA) requires 
choline be added to non-milk based infant formulas at a minimum 
concentration of 7 mg for every 100 kilocalories (21 CFR 107.100). 
Although one study did show developmental effects, they were only seen 
at very high doses (>= 4,160 mg/kg/day) and only in the presence of 
maternal toxicity. There were no observed adverse effects for both 
mothers and pups exposed to 1,250 mg/kg/day. Based on this information 
the Agency concluded that choline chloride, when used as an inert 
ingredient, will not cause reproductive or developmental toxicity and 
therefore, does not anticipate an increased risk to infants and 
children.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL of concern are 
identified. Uncertainty/safety factors are used in conjunction with the 
POD to calculate a safe exposure level - generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No toxicological endpoints have been identified in the available 
toxicological database. Considering the low toxicity of choline 
chloride, its natural occurrence, the body's ability to synthesize the 
nutrient, and the relatively small amount in the formulation, it is not 
necessary to conduct a quantitative risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to choline hydroxide, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from choline hydroxide in food as follows:
    Choline is a natural component of a variety of commonly consumed 
foods (e.g. (per 100 g food) - eggs (251 mg), wheat germ (152 mg), 
bacon (125 mg), dried soybeans (116 mg), pork (103 mg), cod (83 mg), 
beef (80 mg), chicken (70 mg), and salmon (65 mg)) United States 
Department of Agriculture (USDA, 2004). It has been added as a 
supplement to infant formula in the United States for decades 
(Politizer Shronts, 1997). In addition to dietary consumption, choline 
is made endogenously in the human body.
    Humans are currently exposed to choline on a daily basis through 
commonly eaten foods (both naturally occurring and when added as a 
nutrient) and through the bodies natural ability to synthesize the 
nutrient. It is unlikely that the exposure from choline chloride, when 
used as an inert ingredient applied preharvest to food commodities, 
will significantly increase the natural concentration of choline 
present in foods. Because of its high water solubility it is expected 
that most of the inert will be washed from the plant prior to 
consumption. Once in water, it will be broken into in a quaternary 
hydroxyl alkylammonium ion and a chloride ion.
    2. Dietary exposure from drinking water. A quantitative drinking 
water assessment was not performed because it is expected that upon 
contact with water choline chloride will be broken into a quaternary 
hydroxyl alkylammonium ion and a chloride ion. Therefore, direct 
contact with choline hydroxide is not expected through drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
     Occupational exposure to choline chloride is expected via dermal 
and inhalation routes of exposure. Since an endpoint for risk 
assessment was not identified, a quantitative occupational and 
residential exposure assessment for choline hydroxide was not 
conducted. Residential (dermal and inhalation) exposures from home 
garden uses are possible.
    4. 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

[[Page 53580]]

cumulative effects of a particular pesticide's residues and ``other 
substances that have a common mechanism of toxicity.''
     EPA has not found choline hydroxide to share a common mechanism of 
toxicity with any other substances, and choline hydroxide 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 hydroxide 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

     There is no evidence of increased susceptibility in the available 
developmental toxicity study in mice. Choline is a natural component of 
a variety of commonly consumed foods. It has been added as a supplement 
to infant formula in the United States for decades. In addition to 
dietary consumption of choline, choline is made endogenously in the 
human body. Choline is a precursor to the vital neurotransmitter 
acetylcholine. Studies show that choline has beneficial effects on the 
nervous system and memory. Choline is necessary to promote proper 
development in the fetus and infant and prevent cognitive problems. 
Choline hydroxide is not expected to cause neurotoxicity. Exposure to 
choline hydroxide is not expected to significantly increase the pre-
existing levels found in commonly eaten foods. Due to the negligible 
anticipated crop residues and subsequent exposure, the low toxicity of 
the chemical and its metabolites, and the body's need for choline from 
a dietary source, EPA has determined that a quantitative risk 
assessment using safety factors is unnecessary. For the same reason, no 
additional safety factor for the protection of infants and children is 
needed.

 E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on choline 
hydroxide, EPA has determined that there is a reasonable certainty that 
no harm to any population subgroup will result from aggregate exposure 
to choline hydroxide under reasonably foreseeable circumstances.
    In addition to its low toxicity, exposure to choline hydroxide will 
be limited. The expected exposure pathway is via the oral and the 
dermal routes. Humans are currently exposed to choline on a daily basis 
through commonly eaten foods (both naturally occurring and when added 
as a nutrient) and through the bodies natural ability to synthesize the 
nutrient. It is unlikely that the exposure from choline hydroxide, when 
used as an inert ingredient applied preharvest to food commodities, 
will significantly increase the natural concentration of choline and 
chloride in foods. Choline is also found naturally in the environment.
    Taking into consideration all available information on choline 
hydroxide, it has been determined that there is a reasonable certainty 
that no harm to any population subgroup, including infants and 
children, will result from aggregate exposure to this chemical. 
Therefore, the establishment of an exemption from tolerance under 40 
CFR 180.920 for residues of choline hydroxide when used as an inert 
ingredient in pesticide formulations applied to preharvest applications 
of pesticides, is safe under FFDCA section 408.

V. 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 U.N. 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 hydroxide.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for choline hydroxide (CAS Reg. No. 
123-41-1) when used as an inert ingredient (in acidic herbicides to act 
as a neutralizer]) in pesticide formulations applied to preharvest 
applications.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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 final rule has been 
exempted from review under Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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

[[Page 53581]]

67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: August 20, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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. In Sec. 180.920 add alphabetically the following inert ingredient to 
the table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Choline hydroxide (CAS Reg No.    Without limitation  Neutralizer
 123-41-1)
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-21544 Filed 8-31-10; 8:45 am]
BILLING CODE 6560-50-S
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