81 FR 38101 - D-glucurono-6-deoxy-L-manno-D-glucan, Acetate, Calcium Magnesium Potassium Sodium Salt (Diutan Gum); Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 113 (June 13, 2016)

This regulation establishes an exemption from the requirement of a tolerance for residues of D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) Chemical Abstract Service Registration Number ((CAS Reg. No.) 595585-15-2) when used as an inert ingredient stabilizer/suspension agent applied to crops pre- and post-harvest and to food contact surfaces. Keller and Heckman on behalf of CP Kelco U.S., Inc 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 D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum).

[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Rules and Regulations]
[Pages 38101-38104]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13805]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0350; FRL-9946-48]


D-glucurono-6-deoxy-L-manno-D-glucan, Acetate, Calcium Magnesium 
Potassium Sodium Salt (Diutan Gum); 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 D-glucurono-6-deoxy-L-manno-D-glucan, 
acetate, calcium magnesium potassium sodium salt (diutan gum) Chemical 
Abstract Service Registration Number ((CAS Reg. No.) 595585-15-2) when 
used as an inert ingredient stabilizer/suspension agent applied to 
crops pre- and post-harvest and to food contact surfaces. Keller and 
Heckman on behalf of CP Kelco U.S., Inc 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 D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium 
magnesium potassium sodium salt (diutan gum).

DATES: This regulation is effective June 13, 2016. Objections and 
requests for hearings must be received on or before August 12, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0350, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 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 Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0350 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 
August 12, 2016. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0350, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of Monday, April 25, 2016 (81 FR 24046) 
(FRL-9944-86), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10815) by Keller and Heckman LLP (1001 G Street NW., Suite 500 West, 
Washington, DC 20001), on behalf of CP Kelco U.S., Inc (3100 Cumberland 
Blvd., Suite 600, Atlanta, GA 30339). The petition requested that 40 
CFR 180.910 and 40 CFR 180.940 be amended by establishing an exemption 
from the requirement of a tolerance for residues of D-glucurono-6-
deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium 
salt (diutan gum) (CAS Reg. No. 595585-15-2) when used as an inert 
ingredient stabilizer/suspension agent in pesticide formulations 
applied to crops pre- and post-harvest and to food contact surfaces. 
That document referenced a summary of the petition prepared by Keller 
and Heckman on behalf of CP Kelco U.S., Inc., the petitioner, which is 
available in the docket, http://www.regulations.gov. There were no

[[Page 38102]]

comments of substance 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 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 D-glucurono-6-deoxy-L-manno-D-
glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with D-
glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 
potassium sodium salt (diutan gum) 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 D-glucurono-6-deoxy-L-manno-D-glucan, 
acetate, calcium magnesium potassium sodium salt (diutan gum) 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.
    D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 
potassium sodium salt (diutan gum) exhibits low levels of acute 
toxicity. The oral lethal dose (LD)50 in the rat is greater 
than 5 grams/kilograms (g/kg) (5,000 milligrams/kilograms (mg/kg)). The 
inhalation lethal concentration (LC)50 in the rat is > 0.316 
milligram/Liter (mg/L) (~81.9 mg/kg). It is minimally irritating to the 
rabbit eye. It is not an irritant to the rabbit skin and it was not a 
skin sensitizer in Dunkin-Hartley guinea pigs.
    In a 28-day repeat dose oral toxicity (OECD Test Guideline 407) 
study there were no treatment-related adverse toxicological effects at 
doses up to 1,000 mg/kg/day. The NOAEL is 1,000 mg/kg/day.
    The reverse gene mutation assay with Salmonella typhimurium and 
Escherichia coli and a chromosome aberration test with human 
lymphocytes show that the compound is neither mutagenic nor 
clastogenic, respectively.
    In a metabolism study in male and female rats the compound was 
absorbed, metabolized and excreted rapidly. The major route of 
excretion was the feces. There was no bioaccumulation.
    No toxicological point of departure (toxicological endpoint) was 
identified due to the low levels of toxicity exhibited and due to the 
very large molecular weight and lack of systemic absorption.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No toxicological point of departure (toxicological endpoint) was 
identified due to the low levels of acute and subchronic toxicity 
exhibited and due to the very large molecular weight and lack of 
systemic absorption.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to D-glucurono-6-deoxy-L-

[[Page 38103]]

manno-D-glucan, acetate, calcium magnesium potassium sodium salt 
(diutan gum), EPA considered exposure under the proposed exemption from 
the requirement of a tolerance. EPA assessed dietary exposures from D-
glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 
potassium sodium salt (diutan gum) in food as follows:
    Dietary exposure can occur from eating foods containing residues of 
D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 
potassium sodium salt (diutan gum). Because no hazard endpoint of 
concern was identified for acute and chronic dietary assessment (food 
and drinking water), a quantitative dietary exposure risk assessment 
was not conducted.
    2. Dietary exposure from drinking water. Residues of D-glucurono-6-
deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium 
salt (diutan gum) might be found in drinking water. However, since no 
toxicological endpoint of concern was identified for dietary risk 
assessment (food and drinking water), a quantitative dietary 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 (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    D-glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium 
potassium sodium salt (diutan gum) could be used in products that could 
result in short- or intermediate-term residential exposures. However, 
based on the lack of toxicity, a quantitative exposure assessment from 
residential exposures was not performed.
    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 D-glucurono-6-deoxy-L-manno-D-glucan, acetate, 
calcium magnesium potassium sodium salt (diutan gum) to share a common 
mechanism of toxicity with any other substances, and D-glucurono-6-
deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium 
salt (diutan gum) does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that D-glucurono-6-deoxy-L-manno-D-
glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) 
does not have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
Safety Factor (FQPA SF). In applying this provision, EPA either retains 
the default value of 10X, or uses a different additional safety factor 
when reliable data available to EPA support the choice of a different 
factor.
    Based on an assessment of D-glucurono-6-deoxy-L-manno-D-glucan, 
acetate, calcium magnesium potassium sodium salt (diutan gum), EPA 
concluded that there are no toxicological endpoints of concern for the 
U.S. population, including infants and children. As part of its 
qualitative assessment, the Agency did not use safety factors for 
assessing risk and no additional safety factor is needed for assessing 
risk to infants and children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    Based on the lack of any toxicological endpoints of concern, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to residues of D-glucurono-6-deoxy-L-manno-D-glucan, acetate, 
calcium magnesium potassium sodium salt (diutan gum).

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. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 and 40 CFR 180.940(a) for D-glucurono-
6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium 
salt (diutan gum) (CAS Reg. No. 595585-15-2) when used as an inert 
ingredient (stabilizer/suspension agent) in pesticide formulations 
applied to growing crops pre- and post-harvest and to food contact 
surfaces.

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.

[[Page 38104]]

    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: June 1, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.910 add alphabetically the 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
------------------------------------------------------------------------
 
                              * * * * * * *
D-glucurono-6-deoxy-L-manno-D-     ................  Stabilizer/
 glucan, acetate, calcium                             suspension agent.
 magnesium potassium sodium salt
 (diutan gum) (CAS Reg. No.
 595585-15-2).
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.940(a) add alphabetically the inert ingredients to the 
table to read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                   CAS Registration
       Pesticide chemical                 No.               Limits
------------------------------------------------------------------------
 
                              * * * * * * *
D-glucurono-6-deoxy-L-manno-D-    (CAS No. 595585-15- None.
 glucan, acetate, calcium          2).
 magnesium potassium sodium salt
 (diutan gum).
 
                              * * * * * * *
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[FR Doc. 2016-13805 Filed 6-10-16; 8:45 am]
BILLING CODE 6560-50-P