80_FR_14367 80 FR 14314 - Sodium L-Lactate and Sodium DL-Lactate; Exemption From the Requirement of a Tolerance

80 FR 14314 - Sodium L-Lactate and Sodium DL-Lactate; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 53 (March 19, 2015)

Page Range14314-14318
FR Document2015-06373

This regulation establishes an exemption from the requirement of a tolerance for residues of sodium L- lactate and sodium DL-lactate when used as inert ingredients (surfactants) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Exponent, on behalf of Archer Daniels Midland Company, 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 sodium L-lactate and sodium DL-lactate.

Federal Register, Volume 80 Issue 53 (Thursday, March 19, 2015)
[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Rules and Regulations]
[Pages 14314-14318]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06373]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0326; FRL-9924-24]


Sodium L-Lactate and Sodium DL-Lactate; 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 sodium L-

[[Page 14315]]

lactate and sodium DL-lactate when used as inert ingredients 
(surfactants) in pesticide formulations applied to growing crops or to 
raw agricultural commodities after harvest. Exponent, on behalf of 
Archer Daniels Midland Company, 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 sodium L-lactate and sodium DL-lactate.

DATES: This regulation is effective March 19, 2015. Objections and 
requests for hearings must be received on or before May 18, 2015, 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-2014-0326, is available at 
http:[sol][sol]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:[sol][sol]www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW. Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
http:[sol][sol]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-2014-0326 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 
May 18, 2015. 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-2014-0326, by one of 
the following methods:
     Federal eRulemaking Portal: 
http:[sol][sol]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:[sol][sol]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:[sol][sol]www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10693) by 
Exponent, 1150 Connecticut Ave. NW., Washington, DC 20036, on behalf of 
Archer Daniels Midland Company, 4666 E. Faries Parkway, Decatur, IL 
62526. The petition requested that 40 CFR 180.910 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of sodium L-lactate (CAS Reg. No. 867-56-1) and sodium DL-
lactate (CAS Reg. No. 72-17-3) when used as an inert ingredients 
(surfactants) in pesticide formulations applied to growing crops or to 
raw agricultural commodities after harvest. That document referenced a 
summary of the petition prepared by Exponent, the petitioner, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

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

[[Page 14316]]

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 FFDCA section 408(c)(2)(A), 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 sodium L-lactate and sodium DL-
lactate including exposure resulting from the exemption established by 
this action. EPA's assessment of exposures and risks associated with 
sodium L-lactate and sodium DL-lactate 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 sodium L-lactate and sodium DL-lactate 
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.
    The Agency has reviewed the data submitted by the petitioner. The 
data submitted includes data on lactic acid. Sodium lactate, the sodium 
salt of lactic acid, is expected to readily disassociate into the 
lactate and sodium ions in the body upon ingestion. Lactic acid also 
typically converts to lactate in the body. Because sodium L-lactate and 
sodium DL-lactate readily disassociate into the lactate and sodium ions 
in the body, the Agency has concluded that the data on L-lactic acid 
(often referred to as lactic acid) can be used in conjunction with the 
data on another lactate salt, calcium lactate, and that these data are 
adequate to characterize the toxicity of sodium L-lactate and sodium 
DL-lactate.
    Acute oral and inhalation toxicity of lactic acid to rats and acute 
dermal toxicity of lactic acid to rabbits are low (oral LD50 
>3,500 milligrams/kilogram (mg/kg); inhalation LC50 >5 
milligrams/Liter (mg/l); dermal LD50 >2,000 mg/kg). L-lactic 
acid is severely irritating and corrosive to rabbit skin. Dilute 
solutions of lactic acid are irritating to the eyes of rabbits. L-
Lactic acid is not a dermal sensitizer in guinea pigs. In an oral 
feeding study, two groups of (strain not-specified) received daily 
doses of 1,000 and 2,000 mg/kg/day of sodium lactate (as lactic acid) 
over 14 to 16 days. Body analyses of the animals showed no accumulation 
of lactate. No developmental or reproductive toxicity studies are 
available for sodium L-lactate or sodium DL-lactate; however, a 
developmental toxicity study for lactic acid resulted in no maternal or 
developmental effects and none of the reproductive parameters were 
affected in mice at 570 mg/kg/day. Additionally, sodium L-lactate and 
DL-lactate are not expected to be mutagenic or carcinogenic based on 
the presence of the lactic acid metabolite in the human body. Lactic 
acid is transported to the liver and converted by lactic acid 
dehydrogenase to pyruvate. Pyruvate, in turn can be converted into free 
glucose, stored as glycogen, and utilized in other metabolic 
transformations (Krebs cycle). In addition, in a 2-year combined 
chronic toxicity/carcinogenicity study in rats with calcium lactate, 
there was no evidence of carcinogenicity or systemic toxicity at doses 
up to 5,000 mg/kg/day.

B. Toxicological Points of Departure/Levels of Concern

    Sodium L-lactate and sodium DL-lactate are naturally occurring 
compounds and when disassociated, are normal constituents of the human 
body. No toxicological endpoint of concern has been identified.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sodium L-lactate and sodium DL-lactate, EPA considered 
likely exposure from the use of sodium L-lactate and sodium DL-lactate 
as an inert ingredient in pesticides applied to growing crops or to raw 
agricultural commodities after harvest. Since no toxicological endpoint 
of concern has been identified and since the metabolic processes 
involving sodium L-lactate and sodium DL-lactate are well understood, 
the Agency has determined that a quantitative dietary exposure 
assessment is not necessary. While dietary exposure may result from the 
use of sodium L-lactate and sodium DL-lactate as an inert ingredient in 
pesticide formulations applied to growing crops or to raw agricultural 
commodities after harvest, the amount of sodium L-lactate and sodium 
DL-lactate contained in pesticide formulations and applied to growing 
crops or to raw agricultural commodities after harvest would be at 
levels far below its natural occurrence in foods and endogenous 
production in the human body.
    By comparison, L-lactic acid (CAS Reg. No. 79-33-4) is a naturally 
occurring compound found in many foods and is also a human metabolite 
that results from various biochemical pathways. Humans are generally 
exposed to lactic acid on a daily basis in significant quantities 
because it is naturally present in many food products that are derived 
through natural fermentation, such as cheese, yogurt, soy sauce, 
sourdough, meat products, and pickled vegetables.
    2. Dietary exposure from drinking water. Dietary exposure from 
drinking water to sodium L-lactate and sodium DL-lactate can occur by 
drinking water that has been contaminated by run-off from a pesticide 
treated area. Since an endpoint for risk assessment was not identified, 
a quantitative dietary exposure assessment from drinking water for 
sodium L-lactate and sodium DL-lactate was not conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure

[[Page 14317]]

(e.g., textiles (clothing and diapers), carpets, swimming pools, and 
hard surface disinfection on walls, floors, tables).
    There is a potential for residential exposure to pesticide products 
containing sodium L-lactate and sodium DL-lactate, however, 
quantitative residential exposure assessment was not conducted since no 
endpoint of concern was identified.
    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 cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found sodium L-lactate and sodium DL-lactate to share a 
common mechanism of toxicity with any other substances, and sodium L-
lactate and sodium DL-lactate does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that sodium L-lactate and 
sodium DL-lactate 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:[sol][sol]www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children.
    Because of the non-toxic nature of sodium L-Lactate and sodium DL-
lactate, there are no threshold effects that would trigger the 
application of section 408(b)(2)(C).

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on sodium L-
lactate and sodium DL-lactate, EPA has determined that there is a 
reasonable certainty that no harm to any population subgroup will 
result from aggregate exposure to sodium L-lactate and sodium DL-
lactate under reasonable foreseeable circumstances. Therefore, the 
establishment of an exemption from tolerance under 40 CFR 180.910 for 
residues of sodium L-lactate and sodium DL-lactate when used as an 
inert ingredient (surfactant) in pesticide formulations applied to 
growing crops or to raw agricultural commodities after harvest, is safe 
under FFDCA section 408.

V. 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.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for sodium L-lactate (CAS Reg. No. 
867-56-1) and sodium DL-lactate (CAS Reg. No. 72-17-3) when used as an 
inert ingredient (surfactant) in pesticide formulations applied to 
growing crops or to raw agricultural commodities after harvest.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. 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: March 12, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

[[Page 14318]]

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. Amend Sec.  180.910, by adding alphabetically the following inert 
ingredients to the table to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
              Inert ingredients                        Limits                             Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Sodium DL-lactate (CAS Reg. No. 72-17-3)....  .......................  Surfactant.
 
                                                  * * * * * * *
Sodium L-lactate (CAS Reg. No. 867-56-1)....  .......................  Surfactant.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


[FR Doc. 2015-06373 Filed 3-18-15; 8:45 am]
 BILLING CODE 6560-50-P



                                             14314                Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Rules and Regulations

                                                The Congressional Review Act, 5                         shall not postpone the effectiveness of                 Intergovernmental relations, Operating
                                             U.S.C. 801 et seq., as added by the Small                  such rule or action. Parties with                       permits, Reporting and recordkeeping
                                             Business Regulatory Enforcement                            objections to this direct final rule are                requirements.
                                             Fairness Act of 1996, generally provides                   encouraged to file a comment in
                                                                                                                                                                 Dated: March 4, 2015.
                                             that before a rule may take effect, the                    response to the parallel notice of
                                             agency promulgating the rule must                          proposed rulemaking for this action                     Mark J. Hague,
                                             submit a rule report, which includes a                     published in the proposed rules section                 Acting Regional Administrator, Region 7.
                                             copy of the rule, to each House of the                     of this Federal Register, rather than file                For the reasons stated in the
                                             Congress and to the Comptroller General                    an immediate petition for judicial                      preamble, the Environmental Protection
                                             of the United States. EPA will submit a                    review of this direct final rule, so that               Agency amends 40 CFR parts 52 and 70
                                             report containing this action and other                    EPA can withdraw this direct final rule
                                                                                                                                                                as set forth below:
                                             required information to the U.S. Senate,                   and address the comment in the
                                             the U.S. House of Representatives, and                     proposed rulemaking. This action may                    PART 52—APPROVAL AND
                                             the Comptroller General of the United                      not be challenged later in proceedings to               PROMULGATION OF
                                             States prior to publication of the rule in                 enforce its requirements. (See section
                                                                                                                                                                IMPLEMENTATION PLANS
                                             the Federal Register. A major rule                         307(b)(2).)
                                             cannot take effect until 60 days after it                  List of Subjects                                        ■ 1. The authority citation for part 52
                                             is published in the Federal Register.
                                                                                                        40 CFR Part 52                                          continues to read as follows:
                                             This action is not a ‘‘major rule’’ as
                                             defined by 5 U.S.C. 804(2).                                  Environmental protection, Air                             Authority: 42 U.S.C. 7401 et seq.
                                                Under section 307(b)(1) of the CAA,                     pollution control, Carbon monoxide,
                                             petitions for judicial review of this                      Incorporation by reference,                             Subpart AA—Missouri
                                             action must be filed in the United States                  Intergovernmental relations, Lead,
                                             Court of Appeals for the appropriate                       Nitrogen dioxide, Ozone, Particulate                    ■ 2. In § 52.1320(c) the table is amended
                                             circuit by May 18, 2015. Filing a                          matter, Reporting and recordkeeping                     by revising the entry for 10–6.110 to
                                             petition for reconsideration by the                        requirements, Sulfur oxides, Volatile                   read as follows:
                                             Administrator of this final rule does not                  organic compounds.
                                             affect the finality of this action for the                                                                         § 52.1320    Identificaiton of Plan.
                                             purposes of judicial review nor does it                    40 CFR Part 70                                          *       *    *        *    *
                                             extend the time within which a petition                      Administrative practice and                               (c) * * *
                                             for judicial review may be filed, and                      procedure, Air pollution control,

                                                                                                       EPA-APPROVED MISSOURI REGULATIONS
                                                 Missouri                                                               State effective
                                                                                         Title                                               EPA approval date                        Explanation
                                                 citation                                                                    date

                                                                                                        Missouri Department of Natural Resources


                                                         *                        *                         *                      *                       *                      *                     *

                                              Chapter 6—Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of
                                                                                                           Missouri


                                                     *                        *                   *                                *                       *                    *                   *
                                             10–6.110 .......     Reporting Emission Data, Emission Fees,                      10/30/13     3/19/15 [Insert Fed-     Section (3)(A), Emissions Fees, has not
                                                                    and Process Information.                                                  eral Register cita-      been approved as part of the SIP.
                                                                                                                                              tion].

                                                         *                        *                         *                      *                       *                      *                     *



                                             *       *       *       *      *                           Missouri                                                ENVIRONMENTAL PROTECTION
                                                                                                        *        *      *      *       *                        AGENCY
                                             PART 70—STATE OPERATING PERMIT                                (dd) The Missouri Department of Natural
                                             PROGRAMS                                                   Resources submitted revisions to Missouri               40 CFR Part 180
                                                                                                        rule 10 CSR 10–6.110, ‘‘Reporting Emission              [EPA–HQ–OPP–2014–0326; FRL–9924–24]
                                             ■ 3. The authority citation for part 70
                                                                                                        Data, Emission Fees, and Process
                                             continues to read as follows:
                                                                                                        Information’’ on October 2, 2013. The state             Sodium L-Lactate and Sodium DL-
                                                 Authority: 42 U.S.C. 7401, et seq.                     effective date is October 30, 2013. This                Lactate; Exemption From the
                                                                                                        revision is effective May 18, 2015.                     Requirement of a Tolerance
                                             ■ 4. Appendix A to part 70 is amended
Rmajette on DSK2VPTVN1PROD with RULES




                                             by adding paragraph (dd) under                             *        *      *      *       *                        AGENCY:  Environmental Protection
                                             Missouri to read as follows:                               [FR Doc. 2015–06115 Filed 3–18–15; 8:45 am]
                                                                                                                                                                Agency (EPA).
                                                                                                        BILLING CODE 6560–50–P
                                             Appendix A to Part 70—Approval                                                                                     ACTION: Final rule.
                                             Status of State and Local Operating                                                                                SUMMARY:   This regulation establishes an
                                             Permits Programs                                                                                                   exemption from the requirement of a
                                             *       *       *       *      *                                                                                   tolerance for residues of sodium L-


                                        VerDate Sep<11>2014      15:06 Mar 18, 2015   Jkt 235001   PO 00000     Frm 00024   Fmt 4700   Sfmt 4700   E:\FR\FM\19MRR1.SGM   19MRR1


                                                               Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Rules and Regulations                                          14315

                                             lactate and sodium DL-lactate when                        • Animal production (NAICS code                       Additional instructions on
                                             used as inert ingredients (surfactants) in              112).                                                 commenting or visiting the docket,
                                             pesticide formulations applied to                         • Food manufacturing (NAICS code                    along with more information about
                                             growing crops or to raw agricultural                    311).                                                 dockets generally, is available at http://
                                             commodities after harvest. Exponent, on                   • Pesticide manufacturing (NAICS                    www.epa.gov/dockets.
                                             behalf of Archer Daniels Midland                        code 32532).                                          II. Petition for Exemption
                                             Company, submitted a petition to EPA
                                             under the Federal Food, Drug, and                       B. How can I get electronic access to                    In the Federal Register of August 1,
                                             Cosmetic Act (FFDCA), requesting                        other related information?                            2014 (79 FR 44729) (FRL–9911–67),
                                             establishment of an exemption from the                    You may access a frequently updated                 EPA issued a document pursuant to
                                             requirement of a tolerance. This                        electronic version of 40 CFR part 180                 FFDCA section 408, 21 U.S.C. 346a,
                                             regulation eliminates the need to                       through the Government Publishing                     announcing the filing of a pesticide
                                             establish a maximum permissible level                   Office’s e-CFR site at http://                        petition (PP IN–10693) by Exponent,
                                             for residues of sodium L-lactate and                    www.ecfr.gov/cgi-bin/text-                            1150 Connecticut Ave. NW.,
                                             sodium DL-lactate.                                      idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  Washington, DC 20036, on behalf of
                                                                                                     40tab_02.tpl.                                         Archer Daniels Midland Company, 4666
                                             DATES: This regulation is effective
                                                                                                                                                           E. Faries Parkway, Decatur, IL 62526.
                                             March 19, 2015. Objections and requests                 C. How can I file an objection or hearing             The petition requested that 40 CFR
                                             for hearings must be received on or                     request?                                              180.910 be amended by establishing an
                                             before May 18, 2015, and must be filed
                                                                                                       Under FFDCA section 408(g), 21                      exemption from the requirement of a
                                             in accordance with the instructions
                                                                                                     U.S.C. 346a, any person may file an                   tolerance for residues of sodium L-
                                             provided in 40 CFR part 178 (see also
                                                                                                     objection to any aspect of this regulation            lactate (CAS Reg. No. 867–56–1) and
                                             Unit I.C. of the SUPPLEMENTARY                                                                                sodium DL-lactate (CAS Reg. No. 72–
                                             INFORMATION).                                           and may also request a hearing on those
                                                                                                     objections. You must file your objection              17–3) when used as an inert ingredients
                                             ADDRESSES:    The docket for this action,                                                                     (surfactants) in pesticide formulations
                                                                                                     or request a hearing on this regulation
                                             identified by docket identification (ID)                                                                      applied to growing crops or to raw
                                                                                                     in accordance with the instructions
                                             number EPA–HQ–OPP–2014–0326, is                                                                               agricultural commodities after harvest.
                                                                                                     provided in 40 CFR part 178. To ensure
                                             available at http://www.regulations.gov                                                                       That document referenced a summary of
                                                                                                     proper receipt by EPA, you must
                                             or at the Office of Pesticide Programs                                                                        the petition prepared by Exponent, the
                                                                                                     identify docket ID number EPA–HQ–
                                             Regulatory Public Docket (OPP Docket)                                                                         petitioner, which is available in the
                                                                                                     OPP–2014–0326 in the subject line on
                                             in the Environmental Protection Agency                                                                        docket, http://www.regulations.gov.
                                                                                                     the first page of your submission. All
                                             Docket Center (EPA/DC), West William                                                                          There were no comments received in
                                                                                                     objections and requests for a hearing
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                                                                       response to the notice of filing.
                                                                                                     must be in writing, and must be
                                             Constitution Ave. NW., Washington, DC
                                                                                                     received by the Hearing Clerk on or                   III. Inert Ingredient Definition
                                             20460–0001. The Public Reading Room
                                                                                                     before May 18, 2015. Addresses for mail                  Inert ingredients are all ingredients
                                             is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                     and hand delivery of objections and                   that are not active ingredients as defined
                                             Monday through Friday, excluding legal
                                                                                                     hearing requests are provided in 40 CFR               in 40 CFR 153.125 and include, but are
                                             holidays. The telephone number for the
                                                                                                     178.25(b).                                            not limited to, the following types of
                                             Public Reading Room is (202) 566–1744,
                                                                                                       In addition to filing an objection or               ingredients (except when they have a
                                             and the telephone number for the OPP
                                                                                                     hearing request with the Hearing Clerk                pesticidal efficacy of their own):
                                             Docket is (703) 305–5805. Please review
                                                                                                     as described in 40 CFR part 178, please               Solvents such as alcohols and
                                             the visitor instructions and additional
                                                                                                     submit a copy of the filing (excluding                hydrocarbons; surfactants such as
                                             information about the docket available
                                                                                                     any Confidential Business Information                 polyoxyethylene polymers and fatty
                                             at http://www.epa.gov/dockets.
                                                                                                     (CBI)) for inclusion in the public docket.            acids; carriers such as clay and
                                             FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential
                                             Susan Lewis, Registration Division                                                                            diatomaceous earth; thickeners such as
                                                                                                     pursuant to 40 CFR part 2 may be                      carrageenan and modified cellulose;
                                             (7505P), Office of Pesticide Programs,                  disclosed publicly by EPA without prior
                                             Environmental Protection Agency, 1200                                                                         wetting, spreading, and dispersing
                                                                                                     notice. Submit the non-CBI copy of your               agents; propellants in aerosol
                                             Pennsylvania Ave., NW. Washington,                      objection or hearing request, identified
                                             DC 20460–0001; main telephone                                                                                 dispensers; microencapsulating agents;
                                                                                                     by docket ID number EPA–HQ–OPP–                       and emulsifiers. The term ‘‘inert’’ is not
                                             number: (703) 305–7090; email address:                  2014–0326, by one of the following
                                             RDFRNotices@epa.gov.                                                                                          intended to imply nontoxicity; the
                                                                                                     methods:                                              ingredient may or may not be
                                             SUPPLEMENTARY INFORMATION:                                • Federal eRulemaking Portal: http://               chemically active. Generally, EPA has
                                             I. General Information                                  www.regulations.gov. Follow the online                exempted inert ingredients from the
                                                                                                     instructions for submitting comments.                 requirement of a tolerance based on the
                                             A. Does this action apply to me?                        Do not submit electronically any                      low toxicity of the individual inert
                                                You may be potentially affected by                   information you consider to be CBI or                 ingredients.
                                             this action if you are an agricultural                  other information whose disclosure is
                                             producer, food manufacturer, or                         restricted by statute.                                IV. Aggregate Risk Assessment and
                                             pesticide manufacturer. The following                     • Mail: OPP Docket, Environmental                   Determination of Safety
                                             list of North American Industrial                       Protection Agency Docket Center (EPA/                    Section 408(c)(2)(A)(i) of FFDCA
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                                             Classification System (NAICS) codes is                  DC), (28221T), 1200 Pennsylvania Ave.                 allows EPA to establish an exemption
                                             not intended to be exhaustive, but rather               NW., Washington, DC 20460–0001.                       from the requirement for a tolerance (the
                                             provides a guide to help readers                          • Hand Delivery: To make special                    legal limit for a pesticide chemical
                                             determine whether this document                         arrangements for hand delivery or                     residue in or on a food) only if EPA
                                             applies to them. Potentially affected                   delivery of boxed information, please                 determines that the tolerance is ‘‘safe.’’
                                             entities may include:                                   follow the instructions at http://                    Section 408(b)(2)(A)(ii) of FFDCA
                                                • Crop production (NAICS code 111).                  www.epa.gov/dockets/contacts.html.                    defines ‘‘safe’’ to mean that ‘‘there is a


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                                             14316             Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Rules and Regulations

                                             reasonable certainty that no harm will                  information on the studies received and               B. Toxicological Points of Departure/
                                             result from aggregate exposure to the                   the nature of the adverse effects caused              Levels of Concern
                                             pesticide chemical residue, including                   by sodium L-lactate and sodium DL-                      Sodium L-lactate and sodium DL-
                                             all anticipated dietary exposures and all               lactate as well as the no-observed-                   lactate are naturally occurring
                                             other exposures for which there is                      adverse-effect-level (NOAEL) and the                  compounds and when disassociated, are
                                             reliable information.’’ This includes                   lowest-observed-adverse-effect-level                  normal constituents of the human body.
                                             exposure through drinking water and in                  (LOAEL) from the toxicity studies are                 No toxicological endpoint of concern
                                             residential settings, but does not include              discussed in this unit.                               has been identified.
                                             occupational exposure. Section
                                                                                                        The Agency has reviewed the data
                                             408(b)(2)(C) of FFDCA requires EPA to                                                                         C. Exposure Assessment
                                                                                                     submitted by the petitioner. The data
                                             give special consideration to exposure                                                                           1. Dietary exposure from food and
                                                                                                     submitted includes data on lactic acid.
                                             of infants and children to the pesticide                                                                      feed uses. In evaluating dietary
                                                                                                     Sodium lactate, the sodium salt of lactic
                                             chemical residue in establishing a                                                                            exposure to sodium L-lactate and
                                             tolerance and to ‘‘ensure that there is a               acid, is expected to readily disassociate
                                                                                                     into the lactate and sodium ions in the               sodium DL-lactate, EPA considered
                                             reasonable certainty that no harm will                                                                        likely exposure from the use of sodium
                                             result to infants and children from                     body upon ingestion. Lactic acid also
                                                                                                     typically converts to lactate in the body.            L-lactate and sodium DL-lactate as an
                                             aggregate exposure to the pesticide                                                                           inert ingredient in pesticides applied to
                                             chemical residue. . . . ’’                              Because sodium L-lactate and sodium
                                                                                                     DL-lactate readily disassociate into the              growing crops or to raw agricultural
                                                EPA establishes exemptions from the
                                                                                                     lactate and sodium ions in the body, the              commodities after harvest. Since no
                                             requirement of a tolerance only in those
                                                                                                     Agency has concluded that the data on                 toxicological endpoint of concern has
                                             cases where it can be clearly
                                                                                                     L-lactic acid (often referred to as lactic            been identified and since the metabolic
                                             demonstrated that the risks from
                                                                                                     acid) can be used in conjunction with                 processes involving sodium L-lactate
                                             aggregate exposure to pesticide
                                             chemical residues under reasonably                      the data on another lactate salt, calcium             and sodium DL-lactate are well
                                             foreseeable circumstances will pose no                  lactate, and that these data are adequate             understood, the Agency has determined
                                             appreciable risks to human health. In                   to characterize the toxicity of sodium L-             that a quantitative dietary exposure
                                             order to determine the risks from                       lactate and sodium DL-lactate.                        assessment is not necessary. While
                                             aggregate exposure to pesticide inert                                                                         dietary exposure may result from the
                                                                                                        Acute oral and inhalation toxicity of              use of sodium L-lactate and sodium DL-
                                             ingredients, the Agency considers the                   lactic acid to rats and acute dermal
                                             toxicity of the inert in conjunction with                                                                     lactate as an inert ingredient in
                                                                                                     toxicity of lactic acid to rabbits are low            pesticide formulations applied to
                                             possible exposure to residues of the                    (oral LD50 >3,500 milligrams/kilogram
                                             inert ingredient through food, drinking                                                                       growing crops or to raw agricultural
                                                                                                     (mg/kg); inhalation LC50 >5 milligrams/               commodities after harvest, the amount
                                             water, and through other exposures that                 Liter (mg/l); dermal LD50 >2,000 mg/kg).
                                             occur as a result of pesticide use in                                                                         of sodium L-lactate and sodium DL-
                                                                                                     L-lactic acid is severely irritating and              lactate contained in pesticide
                                             residential settings. If EPA is able to                 corrosive to rabbit skin. Dilute solutions
                                             determine that a finite tolerance is not                                                                      formulations and applied to growing
                                                                                                     of lactic acid are irritating to the eyes of          crops or to raw agricultural
                                             necessary to ensure that there is a                     rabbits. L-Lactic acid is not a dermal
                                             reasonable certainty that no harm will                                                                        commodities after harvest would be at
                                                                                                     sensitizer in guinea pigs. In an oral                 levels far below its natural occurrence
                                             result from aggregate exposure to the                   feeding study, two groups of (strain not-
                                             inert ingredient, an exemption from the                                                                       in foods and endogenous production in
                                                                                                     specified) received daily doses of 1,000              the human body.
                                             requirement of a tolerance may be
                                                                                                     and 2,000 mg/kg/day of sodium lactate                    By comparison, L-lactic acid (CAS
                                             established.
                                                Consistent with FFDCA section                        (as lactic acid) over 14 to 16 days. Body             Reg. No. 79–33–4) is a naturally
                                             408(c)(2)(A), and the factors specified in              analyses of the animals showed no                     occurring compound found in many
                                             FFDCA section 408(c)(2)(B), EPA has                     accumulation of lactate. No                           foods and is also a human metabolite
                                             reviewed the available scientific data                  developmental or reproductive toxicity                that results from various biochemical
                                             and other relevant information in                       studies are available for sodium L-                   pathways. Humans are generally
                                             support of this action. EPA has                         lactate or sodium DL-lactate; however, a              exposed to lactic acid on a daily basis
                                             sufficient data to assess the hazards of                developmental toxicity study for lactic               in significant quantities because it is
                                             and to make a determination on                          acid resulted in no maternal or                       naturally present in many food products
                                             aggregate exposure for sodium L-lactate                 developmental effects and none of the                 that are derived through natural
                                             and sodium DL-lactate including                         reproductive parameters were affected                 fermentation, such as cheese, yogurt,
                                             exposure resulting from the exemption                   in mice at 570 mg/kg/day. Additionally,               soy sauce, sourdough, meat products,
                                             established by this action. EPA’s                       sodium L-lactate and DL-lactate are not               and pickled vegetables.
                                             assessment of exposures and risks                       expected to be mutagenic or                              2. Dietary exposure from drinking
                                             associated with sodium L-lactate and                    carcinogenic based on the presence of                 water. Dietary exposure from drinking
                                             sodium DL-lactate follows.                              the lactic acid metabolite in the human               water to sodium L-lactate and sodium
                                                                                                     body. Lactic acid is transported to the               DL-lactate can occur by drinking water
                                             A. Toxicological Profile                                liver and converted by lactic acid                    that has been contaminated by run-off
                                               EPA has evaluated the available                       dehydrogenase to pyruvate. Pyruvate, in               from a pesticide treated area. Since an
                                             toxicity data and considered their                      turn can be converted into free glucose,              endpoint for risk assessment was not
                                             validity, completeness, and reliability as              stored as glycogen, and utilized in other             identified, a quantitative dietary
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                                             well as the relationship of the results of              metabolic transformations (Krebs cycle).              exposure assessment from drinking
                                             the studies to human risk. EPA has also                 In addition, in a 2-year combined                     water for sodium L-lactate and sodium
                                             considered available information                        chronic toxicity/carcinogenicity study                DL-lactate was not conducted.
                                             concerning the variability of the                       in rats with calcium lactate, there was                  3. From non-dietary exposure. The
                                             sensitivities of major identifiable                     no evidence of carcinogenicity or                     term ‘‘residential exposure’’ is used in
                                             subgroups of consumers, including                       systemic toxicity at doses up to 5,000                this document to refer to non-
                                             infants and children. Specific                          mg/kg/day.                                            occupational, non-dietary exposure


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                                                               Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Rules and Regulations                                              14317

                                             (e.g., textiles (clothing and diapers),                 under reasonable foreseeable                          the requirements of the Regulatory
                                             carpets, swimming pools, and hard                       circumstances. Therefore, the                         Flexibility Act (RFA) (5 U.S.C. 601 et
                                             surface disinfection on walls, floors,                  establishment of an exemption from                    seq.), do not apply.
                                             tables).                                                tolerance under 40 CFR 180.910 for                       This action directly regulates growers,
                                                There is a potential for residential                 residues of sodium L-lactate and sodium               food processors, food handlers, and food
                                             exposure to pesticide products                          DL-lactate when used as an inert                      retailers, not States or tribes, nor does
                                             containing sodium L-lactate and sodium                  ingredient (surfactant) in pesticide                  this action alter the relationships or
                                             DL-lactate, however, quantitative                       formulations applied to growing crops                 distribution of power and
                                             residential exposure assessment was not                 or to raw agricultural commodities after              responsibilities established by Congress
                                             conducted since no endpoint of concern                  harvest, is safe under FFDCA section                  in the preemption provisions of FFDCA
                                             was identified.                                         408.                                                  section 408(n)(4). As such, the Agency
                                                4. Cumulative effects from substances
                                                                                                     V. Analytical Enforcement Methodology                 has determined that this action will not
                                             with a common mechanism of toxicity.
                                                                                                       An analytical method is not required                have a substantial direct effect on States
                                             Section 408(b)(2)(D)(v) of FFDCA
                                                                                                     for enforcement purposes since the                    or tribal governments, on the
                                             requires that, when considering whether
                                                                                                     Agency is establishing an exemption                   relationship between the national
                                             to establish, modify, or revoke a
                                                                                                     from the requirement of a tolerance                   government and the States or tribal
                                             tolerance, the Agency consider
                                                                                                     without any numerical limitation.                     governments, or on the distribution of
                                             ‘‘available information’’ concerning the
                                                                                                                                                           power and responsibilities among the
                                             cumulative effects of a particular                      VI. Conclusion                                        various levels of government or between
                                             pesticide’s residues and ‘‘other
                                                                                                       Therefore, an exemption from the                    the Federal Government and Indian
                                             substances that have a common
                                                                                                     requirement of a tolerance is established             Tribes. Thus, the Agency has
                                             mechanism of toxicity.’’
                                                EPA has not found sodium L-lactate                   under 40 CFR 180.910 for sodium L-                    determined that Executive Order 13132,
                                             and sodium DL-lactate to share a                        lactate (CAS Reg. No. 867–56–1) and                   entitled ‘‘Federalism’’ (64 FR 43255,
                                             common mechanism of toxicity with                       sodium DL-lactate (CAS Reg. No. 72–                   August 10, 1999) and Executive Order
                                             any other substances, and sodium L-                     17–3) when used as an inert ingredient                13175, entitled ‘‘Consultation and
                                             lactate and sodium DL-lactate does not                  (surfactant) in pesticide formulations                Coordination with Indian Tribal
                                             appear to produce a toxic metabolite                    applied to growing crops or to raw                    Governments’’ (65 FR 67249, November
                                             produced by other substances. For the                   agricultural commodities after harvest.               9, 2000) do not apply to this action. In
                                             purposes of this tolerance action,                                                                            addition, this action does not impose
                                                                                                     VII. Statutory and Executive Order                    any enforceable duty or contain any
                                             therefore, EPA has assumed that sodium                  Reviews
                                             L-lactate and sodium DL-lactate does                                                                          unfunded mandate as described under
                                             not have a common mechanism of                             This action establishes an exemption               Title II of the Unfunded Mandates
                                             toxicity with other substances. For                     from the requirement of a tolerance                   Reform Act (UMRA) (2 U.S.C. 1501 et
                                             information regarding EPA’s efforts to                  under FFDCA section 408(d) in                         seq.).
                                             determine which chemicals have a                        response to a petition submitted to the                  This action does not involve any
                                             common mechanism of toxicity and to                     Agency. The Office of Management and                  technical standards that would require
                                             evaluate the cumulative effects of such                 Budget (OMB) has exempted these types                 Agency consideration of voluntary
                                             chemicals, see EPA’s Web site at http://                of actions from review under Executive                consensus standards pursuant to section
                                             www.epa.gov/pesticides/cumulative.                      Order 12866, entitled ‘‘Regulatory                    12(d) of the National Technology
                                                                                                     Planning and Review’’ (58 FR 51735,                   Transfer and Advancement Act
                                             D. Safety Factor for Infants and                        October 4, 1993). Because this action                 (NTTAA) (15 U.S.C. 272 note).
                                             Children                                                has been exempted from review under
                                               Section 408(b)(2)(C) of FFDCA                         Executive Order 12866, this action is                 VIII. Congressional Review Act
                                             provides that EPA shall apply an                        not subject to Executive Order 13211,
                                                                                                     entitled ‘‘Actions Concerning                           Pursuant to the Congressional Review
                                             additional tenfold (10X) margin of safety                                                                     Act (5 U.S.C. 801 et seq.), EPA will
                                             for infants and children in the case of                 Regulations That Significantly Affect
                                                                                                     Energy Supply, Distribution, or Use’’ (66             submit a report containing this rule and
                                             threshold effects to account for prenatal                                                                     other required information to the U.S.
                                             and postnatal toxicity and the                          FR 28355, May 22, 2001) or Executive
                                                                                                     Order 13045, entitled ‘‘Protection of                 Senate, the U.S. House of
                                             completeness of the database on toxicity                                                                      Representatives, and the Comptroller
                                             and exposure unless EPA determines                      Children from Environmental Health
                                                                                                     Risks and Safety Risks’’ (62 FR 19885,                General of the United States prior to
                                             based on reliable data that a different                                                                       publication of the rule in the Federal
                                             margin of safety will be safe for infants               April 23, 1997). This action does not
                                                                                                     contain any information collections                   Register. This action is not a ‘‘major
                                             and children.                                                                                                 rule’’ as defined by 5 U.S.C. 804(2).
                                               Because of the non-toxic nature of                    subject to OMB approval under the
                                             sodium L-Lactate and sodium DL-                         Paperwork Reduction Act (PRA) (44                     List of Subjects in 40 CFR Part 180
                                             lactate, there are no threshold effects                 U.S.C. 3501 et seq.), nor does it require
                                             that would trigger the application of                   any special considerations under                        Environmental protection,
                                             section 408(b)(2)(C).                                   Executive Order 12898, entitled                       Administrative practice and procedure,
                                                                                                     ‘‘Federal Actions to Address                          Agricultural commodities, Pesticides
                                             E. Aggregate Risks and Determination of                 Environmental Justice in Minority                     and pests, Reporting and recordkeeping
                                             Safety                                                  Populations and Low-Income                            requirements.
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                                               Taking into consideration all available               Populations’’ (59 FR 7629, February 16,                 Dated: March 12, 2015.
                                             information on sodium L-lactate and                     1994).
                                                                                                                                                           Susan Lewis,
                                             sodium DL-lactate, EPA has determined                      Since tolerances and exemptions that
                                             that there is a reasonable certainty that               are established on the basis of a petition            Director, Registration Division, Office of
                                                                                                                                                           Pesticide Programs.
                                             no harm to any population subgroup                      under FFDCA section 408(d), such as
                                             will result from aggregate exposure to                  the exemption in this final rule, do not                Therefore, 40 CFR chapter I is
                                             sodium L-lactate and sodium DL-lactate                  require the issuance of a proposed rule,              amended as follows:


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                                             14318                Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Rules and Regulations

                                             PART 180—[AMENDED]                                             ■ 2. Amend § 180.910, by adding                                 § 180.910 Inert ingredients used pre- and
                                                                                                            alphabetically the following inert                              post-harvest; exemptions from the
                                             ■ 1. The authority citation for part 180                       ingredients to the table to read as                             requirement of a tolerance.
                                             continues to read as follows:                                  follows:                                                        *         *         *         *          *
                                                 Authority: 21 U.S.C. 321(q), 346a and 371.

                                                                                               Inert ingredients                                                                          Limits                             Uses


                                                     *                   *                      *                                *                                 *                                 *                          *
                                             Sodium DL-lactate (CAS Reg. No. 72–17–3) ................................................................................    ........................................   Surfactant.

                                                     *                   *                       *                                *                                 *                                *                          *
                                             Sodium L-lactate (CAS Reg. No. 867–56–1) .................................................................................   ........................................   Surfactant.

                                                         *                         *                            *                        *                          *                                *                          *



                                             [FR Doc. 2015–06373 Filed 3–18–15; 8:45 am]                    treatment of their documents and how                            revised to reflect that the Secretary will
                                             BILLING CODE 6560–50–P                                         to mark confidential material. The                              also serve small claims complaints filed
                                                                                                            revision requires segregation and clear                         pursuant to 46 CFR subpart S.
                                                                                                            marking of confidential and non-
                                                                                                                                                                            List of Subjects in 46 CFR Part 502
                                             FEDERAL MARITIME COMMISSION                                    confidential information. The current
                                                                                                            confidentiality provisions in part 502                            Administrative practice and
                                             46 CFR Part 502                                                will benefit from a more consistent                             procedure, Claims, Equal access to
                                                                                                            format.                                                         justice, Investigations, Lawyers,
                                             [Docket No. 15–01]                                                                                                             Maritime carriers, Penalties, Reporting
                                                                                                               The revisions also correct an
                                             RIN 3072–AC59                                                  erroneous reference to                                          and recordkeeping requirements.
                                                                                                            § 502.201(i)(1)(vii) in the introductory                          For the reasons set forth in the
                                             Amendments to Rules Governing                                  text to § 502.5. The reference to                               preamble, the Federal Maritime
                                             Service of Private Party Complaints                            § 502.201(i)(1)(vii) in the introductory                        Commission amends 46 CFR part 502 as
                                             and Documents Containing                                       text was intended to refer to                                   follows:
                                             Confidential Materials                                         confidential information within
                                                                                                            protective orders, but the currently cited                      PART 502—RULES OF PRACTICE AND
                                             AGENCY: Federal Maritime Commission.                                                                                           PROCEDURE
                                             ACTION: Direct final rule, request for
                                                                                                            provision does not exist. The revision
                                             comments.                                                      corrects the citation to                                        ■ 1. The authority citation for part 502
                                                                                                            § 502.201(j)(1)(vii).                                           continues to read as follows:
                                             SUMMARY:  The Federal Maritime                                 46 CFR 502.113                                                    Authority: 5 U.S.C. 504, 551, 552, 553,
                                             Commission proposes to amend its rules                                                                                         556(c), 559, 561–569, 571–596; 5 U.S.C. 571–
                                             governing service of private party                                The Commission proposes to amend
                                                                                                                                                                            584; 18 U.S.C. 207; 28 U.S.C. 2112(a); 31
                                             complaints and the filing of documents                         § 502.113 of title 46 of the Code of                            U.S.C. 9701; 46 U.S.C. 305, 40103–40104,
                                             containing confidential material. These                        Federal Regulations concerning service                          40304, 40306, 40501–40503, 40701–40706,
                                             revisions will add clarifying                                  of private party complaints. 46 U.S.C.                          41101–41109, 41301–41309, 44101–44106;
                                             instructions for parties to proceedings.                       41301 requires the Commission to                                E.O. 11222 of May 8, 1965.
                                             DATES: This rule will become effective
                                                                                                            ‘‘provide a copy of the complaint to the
                                             June 24, 2015 unless significant adverse                       person named in the complaint.’’ This                           Subpart A—General Information
                                             comments are filed prior to May 26,                            revision would clarify and memorialize
                                                                                                            that the Commission will use U.S. mail                          ■   2. Revise § 502.5 to read as follows:
                                             2015.
                                                                                                            or express mail to serve the complaint.                         § 502.5 Documents containing confidential
                                             ADDRESSES:  Address all comments                               A notice is published, and will continue                        materials.
                                             concerning this proposed rule to: Karen                        to be published, in the Federal Register                           Except as otherwise provided in the
                                             V. Gregory, Secretary, Federal Maritime                        for each private party complaint for                            rules of this part, all filings that contain
                                             Commission, 800 North Capitol Street                           formal adjudication that is filed with the                      information for which confidential
                                             NW., Washington, DC 20573–0001,                                Commission. Additionally, a full copy                           treatment is sought or information
                                             Phone: (202) 523–5725, Email:                                  of the formal complaint is available on                         previously designated as confidential
                                             secretary@fmc.gov.                                             the Commission’s Web site,                                      pursuant to §§ 502.13, 502.167,
                                             FOR FURTHER INFORMATION CONTACT:                               www.fmc.gov, and available in the                               502.201(j)(1)(vii), or any other rules of
                                             Karen V. Gregory, Secretary, Federal                           Commission’s Docket Library. The                                this part, or for which a request for
                                             Maritime Commission, 800 North                                 proposed rule continues to allow for                            protective order pursuant to § 502.201(j)
                                             Capitol Street NW., Washington, DC                             alternative service by other means by                           is pending, are subject to the following
                                             20573–0001, Phone: (202) 523–5725,                             the Complainant but specifies that it                           requirements:
                                             Email: secretary@fmc.gov.                                      may only do so after the complaint has                             (a) Two versions of filings. Two
Rmajette on DSK2VPTVN1PROD with RULES




                                             SUPPLEMENTARY INFORMATION:                                     been filed with the Commission and                              versions of documents must be filed if
                                                                                                            must inform the Commission of the                               a document:
                                             46 CFR 502.5                                                   method, time, and place of service. To                             (1) Contains information previously
                                               The Commission proposes to amend                             conform to this clarification, 46 CFR                           designated by the Commission or
                                             § 502.5 of title 46 of the Code of Federal                     502.62(b)(1) is amended to clarify the                          presiding officer as confidential; or
                                             Regulations in order to instruct parties                       time an answer to the complaint is due.                            (2) Contains information for which
                                             on how to request confidential                                 Sections 502.304 and 502.305 are also                           confidential treatment is sought. Except


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Document Created: 2018-02-21 09:42:00
Document Modified: 2018-02-21 09:42:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective March 19, 2015. Objections and requests for hearings must be received on or before May 18, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW. Washington, DC 20460-0001; main telephone
FR Citation80 FR 14314 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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