[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Rules and Regulations]
[Pages 65561-65565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26241]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0165; FRL-9901-95]


D-Glucopyranose, oligomeric, decyl octyl glycosides; 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

[[Page 65562]]

tolerance for residues of D-Glucopyranose, oligomeric, decyl octyl 
glycosides when used as an inert ingredient (surfactant) in 
antimicrobial formulations (food-contact surface sanitizing solutions) 
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils. Lewis 
& Harrison, on behalf of BASF Corporation, 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-Glucopyranose, oligomeric, decyl octyl glycosides.

DATES: This regulation is effective November 1, 2013. Objections and 
requests for hearings must be received on or before December 31, 2013, 
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-2013-0165, 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), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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.

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-2013-0165 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 
December 31, 2013. 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-2013-0165, 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 June 5, 2013 (78 FR 33785) (FRL-9386-2), 
EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP IN-10545) by Lewis & 
Harrison, LLC, 122 C St. NW., Suite 740, Washington, DC 20001 on behalf 
of BASF Corporation, 100 Park Ave., Florham Park, NJ 07932. The 
petition requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of alkyl 
(C8-C10) polyglucosides (CAS Reg. No. 68515-73-1) 
when used as an inert ingredient (surfactant) in antimicrobial 
formulations (i.e., food contact surface sanitizing solutions) applied 
to food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils.
    That document referenced a summary of the petition prepared by 
Lewis & Harrison, LLC, on behalf of BASF Corporation, the petitioner, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.
    EPA is establishing a tolerance using a different chemical name 
than the one requested by the petitioner for the reasons discussed in 
Unit V.B.

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.

[[Page 65563]]

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-Glucopyranose, oligomeric, 
decyl octyl glycosides including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with D-Glucopyranose, oligomeric, decyl octyl glycosides 
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-Glucopyranose, oligomeric, decyl 
octyl glycosides 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.
    In order to make a safety finding on D-Glucopyranose, oligomeric, 
decyl octyl glycosides, EPA used data on the chemical itself and 
structurally similar chemicals--alkyl (C12-C14) 
polyglycosides and alkyl (C10-C16) polyglycosides 
(also known as D-glycopyranose, oligomeric, C10-
C16- alkyl glycosides). These three chemicals differ from 
one another only in the length of the alkyl chain. Given these 
structural similarities, these chemicals are expected to have similar 
toxicological characteristics. Therefore, data on alkyl 
(C10-C16) polyglycosides and alkyl 
(C12-C14) polyglycosides have been used to make a 
safety finding on alkyl (C8-C10) polyglycosides. 
For ease of reading, alkyl polyglycosides will be collectively known 
throughout the document as ``APG'' with the specific carbon chain 
length identified as ``(Cx-Cx),'' when 
appropriate.
    Acute studies indicate low acute oral and dermal toxicity. Studies 
using APG (C8-C10) did not show evidence of eye 
or skin irritation. Repeat dose studies for APGs include a 90-day 
gavage study, a 14-day dermal, a reproduction study, and a 
developmental study. In the 90-day rat oral (gavage) study APG 
(C12-C14) was administered at dose levels of 0, 
250, 500, or 1,000 milligram/kilogram/day (mg/kg/day) for 5 days/week. 
There were no treatment-related adverse effects on body weight, body 
weight gain, food consumption, hematological or clinical chemistry 
parameters, or organ weights. Adverse treatment-related effects were 
limited to irritation in the forestomach in both males and females 
receiving 500 or 1,000 mg/kg/day. Effects were reversible following the 
cessation of treatment, but not reversible during treatment. Because 
humans do not have a forestomach that serves as a storage reservoir as 
in rodents, the effects seen in the rat forestomach are likely to be 
significantly more severe than what would be expected from the compound 
in the glandular stomach in humans and subsequently, have less 
relevance to humans. Therefore, the EPA determined the systemic oral 
toxicity NOAEL was 1,000 mg/kg/day. A LOAEL was not determined.
    A 14-day dermal study on APGs (C8-C10) was 
conducted on rabbits (New Zealand white) at doses of 0, 60, 180, 540, 
1,500, and 3,000 mg/kg/day. While skin irritation was observed at doses 
above 180 mg/kg/day and changes in hematological and clinical 
parameters and testicular degeneration were observed at the dose levels 
of 1,500 and 3,000 mg/kg/day, these effects are likely attributable to 
stress and inflammation due to the severe irritation caused by the test 
substance and therefore a NOAEL for systemic effects was not 
established.
    A 1-generation reproductive screening study on APG (C10-
C16) was conducted on male and female rats following daily 
administration (gavage) of 100, 300, and 1,000 mg/kg/day. No effects 
indicative of general toxicity were observed in parental animals. 
Relative and absolute weights of testes, epididymides, and seminal 
vesicles did not differ between test and control animals. No 
reproductive parameters were affected including mean litter weights, 
mean pup weights, sex ratios, and gestation periods. Pre-weaning 
clinical signs showed no treatment-related effects in pups, nor did 
necropsy reveal any effects in decedent or Fl pups. Macroscopic 
examination revealed no difference between treated and control animals. 
A NOAEL of 1,000 mg/kg/day for reproductive effects can be deduced.
    In a rat developmental toxicity study, APG (C12-
C14) was administered by gavage at dose levels of 0, 100, 
300, and 1,000 mg/kg/day on gestation days 6 to 15. No treatment-
related maternal deaths; clinical signs; or decreases in mean body 
weight, weight gain, corrected weight gain, or gross lesions were 
observed in this study. In addition, there were no treatment-related 
developmental effects (e.g., external abnormalities, visceral 
abnormalities, or skeletal malformations/variations). Therefore, the 
developmental and maternal NOAEL is 1,000 mg/kg/day. A LOAEL was not 
determined.
    No immunotoxicity or neurotoxicity studies are available in the 
database; however, APGs (C8-C10) are unlikely to 
produce neurotoxicity or evoke immunological response given the lack of 
any toxicity, including any immunotoxicity or neurotoxicity, at high 
doses (1,000 mg/kg/day). Mutagenicity studies on various chain

[[Page 65564]]

lengths of APGs were negative indicating that APGs are not likely to be 
mutagenic. No carcinogenicity studies are available on APGs; however, 
APGs are not expected to be carcinogenic based on lack of mutagenicity, 
lack of any systemic toxicity at doses up to and including 1,000 mg/kg/
day, and the rapid metabolism of these chemicals to sugars and alcohols 
and excretion from the body.

B. Toxicological Points of Departure/Levels of Concern

    Metabolism studies on structurally related chemicals indicate that 
the body can effectively metabolize D-glucopyranose, oligomeric, 
C10-C16-alkyl glycosides to water-soluble 
substances (predominantly sugar and various alcohols) that are readily 
excreted from the body. No adverse effects were seen any of the repeat 
dose studies conducted via the oral route of exposure at or above the 
limit dose. No endpoint of concern was identified based on the 
available studies in the database.

C. Exposure Assessment

    Because no endpoint of concern was identified based upon available 
data, a qualitative risk assessment was conducted.
    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to D-Glucopyranose, oligomeric, decyl octyl glycosides, EPA 
considered exposure under the proposed exemption from the requirement 
of a tolerance. For purposes of this action, EPA qualitatively assessed 
dietary exposures from D-Glucopyranose, oligomeric, decyl octyl 
glycosides as follows:
    Dietary exposure could potentially occur from consuming foods 
directly treated with pesticide products containing the inert 
ingredient. In addition, dietary exposure to APGs could occur as a 
result of contact with surfaces treated with antimicrobial formulations 
containing the inert ingredient, including food-contact surfaces in 
public eating places, dairy-processing equipment, or food-processing 
equipment and utensils. Dietary exposure may also come from consuming 
animal products from animals exposed to the inert ingredient via 
pesticide application or from eating feed treated with pesticide 
products containing the inert ingredient.
    2. Dietary exposure from drinking water. Dietary exposure from 
drinking water to D-Glucopyranose, oligomeric, decyl octyl glycosides 
can occur by drinking water that has been contaminated by contact with 
pesticide treated areas, such as countertops. Since an endpoint for 
risk assessment was not identified, a quantitative dietary exposure 
assessment from drinking water for D-Glucopyranose, oligomeric, decyl 
octyl glycosides 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). APGs 
are used in laundry detergents, hard surface and household cleaners, as 
rinse aids in dishwashers and in personal care products. Non-dietary 
exposure could result from both pesticidal and non-pesticidal uses.
    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-Glucopyranose, oligomeric, decyl octyl 
glycosides to share a common mechanism of toxicity with any other 
substances, and D-Glucopyranose, oligomeric, decyl octyl glycosides 
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-Glucopyranose, oligomeric, decyl octyl glycosides 
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

    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. The toxicity 
database for APGs contains several acute studies, a 90-day oral 
toxicity study, a 14-dermal study, a developmental toxicity study, and 
a reproductive screening toxicity study. No hazard was identified based 
on those studies. The toxicity database does not contain a 
carcinogenicity study, an immunotoxicity study, or a neurotoxicity 
study, but for the reasons stated in Unit IV.A., the Agency has 
concluded that there are no concerns for carcinogenicity, 
immunotoxicity, or neurotoxicity for this chemical. No developmental or 
reproductive effects were seen in the available studies. Thus, there is 
no residual uncertainty regarding prenatal and/or postnatal toxicity of 
D-Glucopyrnose, oligomeric, decyl octyl glycosides.
    Based on this information, there is no concern at this time for 
increased sensitivity to infants and children to D-Glucopyrnose, 
oligomeric, decyl octyl glycosides when used as an inert ingredient in 
antimicrobial formulations applied to food-contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on D-
Glucopyranose, oligomeric, decyl octyl glycosides, EPA has determined 
that there is a reasonable certainty that no harm to any population 
subgroup will result from aggregate exposure to D-Glucopyranose, 
oligomeric, decyl octyl glycosides under reasonably foreseeable 
circumstances. Therefore, the establishment of an exemption from 
tolerance under 40 CFR 180.940(a) for residues of D-Glucopyranose, 
oligomeric, decyl octyl glycosides when used as an inert ingredient in 
in antimicrobial food-contact surface sanitizing solutions is safe 
under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. Revisions to Petitioned-For Tolerances

    Alkyl (C8-C10) polyglycosides and D-
Glucopyranose, oligomeric, decyl octyl glycosides are alternate names 
for the chemical with the CAS Reg. No. 68515-73-1 and therefore, 
represent the same chemical. EPA is using the latter name because it is 
the one used in the Chemical Abstract (CA) Index and the one EPA has 
used to establish other exemptions from the requirement of tolerance 
for this chemical.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for D-Glucopyranose, oligomeric, 
decyl octyl glycosides (CAS Reg. No. 68515-73-1) when used as an inert 
ingredient (surfactant) in antimicrobial

[[Page 65565]]

formulations (i.e., food contact surface sanitizing solutions) applied 
to food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This final rule 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 final rule has been exempted from review 
under Executive Order 12866, this final rule is not subject to 
Executive Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under 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 final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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 of 1995 (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: October 22, 2013.
Lois Rossi,
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.  180.940, add alphabetically the following entry to the 
table in paragraph (a) 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) * * *

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                    Pesticide chemical                      CAS Reg. No.                   Limits
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                                                  * * * * * * *
D-Glucopyranose, oligomeric, decyl octyl glycosides......      68515-73-1  None
 
                                                  * * * * * * *
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[FR Doc. 2013-26241 Filed 10-31-13; 8:45 am]
BILLING CODE 6560-50-P