[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Rules and Regulations]
[Pages 14314-14318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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.

* * * * *

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              Inert ingredients                        Limits                             Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Sodium DL-lactate (CAS Reg. No. 72-17-3)....  .......................  Surfactant.
 
                                                  * * * * * * *
Sodium L-lactate (CAS Reg. No. 867-56-1)....  .......................  Surfactant.
 
                                                  * * * * * * *
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[FR Doc. 2015-06373 Filed 3-18-15; 8:45 am]
 BILLING CODE 6560-50-P