Guar Hydroxypropyltrimethylammo-nium Chloride; Exemption From the Requirement of a Tolerance, 32152-32155 [2013-12782]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32152-32155]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12782]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0558; FRL-9387-2]


Guar Hydroxypropyltrimethylammo-nium Chloride; 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 guar hydroxypropyltrimethylammonium 
chloride (CAS Reg. No. 71329-50-5) when used as an inert ingredient 
(thickener/drift reduction agent) in pesticide formulations applied to 
growing crops. SciReg. Inc., on behalf of Rhodia 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 guar hydroxypropyl trimethylammonium 
chloride.

DATES: This regulation is effective May 29, 2013. Objections and 
requests for hearings must be received on or before July 29, 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-2012-0558, is available at https://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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: William Cutchin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7099; email address: cutchin.william@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 https://ecfr.gpoaccess.gov/cgi/t/text/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-2012-0558 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 
July 29, 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-2012-0558, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of September 28, 2012 (77 FR 59581) (FRL-
9364-6), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 2E8017) by 
SciReg. Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of 
Rhodia Inc. The petition requested that 40 CFR 180.920 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of guar hydroxypropyl trimethylammonium chloride (CAS No. 
71329-50-5) when used as an inert ingredient (thickener/drift reduction 
agent) in pesticide formulations applied to growing crops under 40 CFR 
180.920. That notice referenced a summary of the petition prepared by 
Rhodia, Inc. the petitioner, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit V.C.

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

[[Page 32153]]

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. Nevertheless, in most instances, EPA 
generally exempts 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 guar 
hydroxypropyltrimethylammonium chloride including exposure resulting 
from the exemption established by this action. EPA's assessment of 
exposures and risks associated with guar hydroxypropyltrimethylammonium 
chloride 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 guar hydroxypropyltrimethylammonium 
chloride 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.
    Acute toxicity studies and mutagenicity studies were conducted with 
guar hydroxypropyltrimethylammonium chloride. However, guar 
hydroxypropyltrimethylammonium chloride has the same basic molecular 
structure (a high molecular weight polysaccarhide backbone) as guar 
gum, and other slightly modified forms of guar gum. Based on common 
molecular structure of guar hydroxypropyltrimethylammonium chloride 
with guar gum, hydroxyproplyl guar, carboxymethyl guar and 
carboxymethyl hydroxylpropyl guar, it is expected that these substances 
would share chemical and toxicological properties.
    Guar hydroxypropyltrimethylammonium chloride has a low toxicity 
profile. The acute oral LD50 (lethal dose) is greater than 
2,000 milligrams/kilogram (mg/kg). No dermal irritation, dermal 
sensitization, or mutagenicity was observed. Eye irritation was mild to 
none. Since no subchronic, reproductive and developmental, and 
carcinogenicity studies are available for guar 
hydroxypropyltrimethylammonium chloride, EPA relied on studies 
conducted on the structurally similar compounds guar gum, hydroxypropyl 
guar, and carboxymethyl guar, and carboxymethyl-hydroxypropyl guar. 
Subchronic, reproductive and developmental, and carcinogenicity studies 
with guar gum showed no long-term, reproductive/developmental toxicity 
or carcinogenic effects. Also teratogenicity studies with guar gum in 
mice, rats, and hamsters did not indicate that guar gum is a teratogen, 
up to levels of 800 mg/kg/day, 900 mg/kg/day, and 600 mg/kg/day, 
respectively. In addition, no effects on parental fertility, fetal 
development, sex distribution, and no malformations of the pups were 
observed at doses up to 7,500 mg/kg/day in the one-generation 
reproduction study in rats. No evidence of immunotoxicity (spleen, 
thymus, blood) was observed in the available toxicity studies on 
structurally related chemicals. Furthermore, no clinical signs of 
neurotoxicity were observed at very high doses in the available 
database for structurally similar compounds.
    Based on these data, EPA concludes that guar 
hydroxypropyltrimethylammonium chloride has a low toxicity profile. 
These findings are supported by what would be expected based on the 
physical characteristics of the substance. As a cationic form of guar, 
guar hydroxypropyltrimethylammonium chloride would be expected to be a 
dermal and eye irritant. Its high molecular weight as a polysaccharide 
polymer limits its ability to be absorbed through the skin, lungs, or 
gastrointestinal tract; therefore, guar hydroxypropyltrimethylammonium 
chloride is of low concern for acute and chronic effects, reproductive/
developmental toxicity, immunotoxic, neurotoxic, and carcinogenic 
effects.

B. Toxicological Points of Departure/Levels of Concern

    The majority of the available studies suggest that high levels of 
guars were well tolerated by laboratory animals. Although there were 
two studies that showed some effects, they appear to be outliers since 
those results were not replicated in the longer-term studies. In the 
two 90-day toxicity studies, the body weight gain appears to be 
depressed at 500 mg/kg/day dose levels and above. However, generally 
the food consumption was not affected. In a third 90-day toxicity study 
in rats, no effect on body weight was observed at doses up to 3,000 mg/
kg/day. No effect on the body weights were observed in the reproduction 
study in rats at doses up

[[Page 32154]]

to 7,500 mg/kg/day. In the carcinogenicity studies in mice and rats by 
the National Toxicology Program (NTP) (1982), no adverse effects were 
observed at doses up to 3,570 mg/kg/day. Based on their large molecular 
weights, these two chemicals are not expected to be significantly 
absorbed via oral, dermal and inhalation routes of exposure. This is 
further supported by the animal toxicity studies where no significant 
effects were observed in a carcinogenicity studies in mice and rats and 
reproduction study in rats at doses up to and including 3,500 mg/kg/
day. Based on the above weight of evidence, no endpoint of concern was 
identified; therefore, it is not appropriate to conduct a quantitative 
assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses, drinking water, and 
non-dietary exposure.
    Exposure to guar hydroxypropyltrimethylammonium chloride through 
food, water and non-dietary sources are likely to occur. However, a 
quantitative exposure assessment was not conducted because no endpoint 
of concern (hazard) was identified in the available database.
    2. 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.''
    Results of toxicological studies conducted with guar 
hydroxypropyltrimethylammonium chloride demonstrate the substance is of 
low toxicity. In addition, guar hydroxypropyltrimethylammonium chloride 
is a slightly modified form of guar gum, a natural polymer which is an 
affirmed GRAS (generally recognized as safe) substance of low toxicity. 
Guar hydroxypropyltrimethylammonium chloride is also structurally 
similar to hydroxypropyl guar, carboxymethyl guar, and carboxymethyl-
hydroxypropyl guar, other slightly modified forms of guar gum and all 
of which are exempt from the requirement of a tolerance. As part of its 
qualitative assessment of guar hydroxypropyltrimethylammonium chloride, 
EPA is not concerned about the potential for cumulative effects given 
the low toxicity of this substance and its structurally similar 
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 https://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. Guar 
hydroxypropyltrimethylammonium chloride is a slightly modified form of 
guar gum, a natural polymer which is an affirmed GRAS substance of low 
toxicity. Guar hydroxypropyltrimethylammonium chloride is also 
structurally similar to hydroxypropyl guar, another slightly modified 
form guar gum. According to EPA's 2005 tolerance exemption reassessment 
document for hydroxypropyl guar, it was concluded that hydroxypropyl 
guar is a high molecular weight polymer that is devoid of reactive 
functional groups and which is not absorbed by any route of human 
exposure. Also teratogenicity studies with guar gum in mice, rats, and 
hamsters did not indicate that guar gum is a teratogen, up to levels of 
800 mg/kg, 900 mg/kg, and 600 mg/kg, respectively. In addition, no 
effects on parental fertility, fetal development, sex distribution, and 
no malformations of the pups were observed at doses up to 7,500 mg/kg/
day in the 1-generation reproduction study in rats. Based on the 
structural similarities to guar gum and hydroxypropyl guar, as well as 
its high molecular weights and low likelihood of absorption via any 
route of exposure, guar hydroxypropyltrimethylammonium chloride is 
unlikely to elicit a toxic response in infants and children when used 
as an inert ingredient in pesticide products. Available toxicity 
studies support this conclusion of low toxicity.

E. Aggregate Risks and Determination of Safety

    In examining aggregate exposure, EPA considers available 
information concerning exposures from the pesticide residue in food and 
all other nonoccupational exposures, including drinking water from 
ground water or surface water and exposure through pesticide use in 
gardens, lawns, or buildings (residential and other indoor uses). Based 
on results from toxicological studies, its close structural 
relationship to guar gum, hydroxypropyl guar, carboxymethyl guar, and 
carboxymethyl-hydroxypropyl guar, as well as its high molecular weight 
and low likelihood of absorption via any route of exposure, guar 
hydroxypropyltrimethylammonium chloride is considered to be a low 
toxicity substance. Taking into consideration all available information 
on guar hydroxypropyltrimethylammonium chloride, EPA has determined 
that there is a reasonable certainty that no harm to any population 
subgroup, including infants and children, will result from aggregate 
exposure to guar hydroxypropyltrimethylammonium chloride under 
reasonably foreseeable circumstances. Therefore, the establishment of 
an exemption from tolerance under 40 CFR 180.920 for residues of guar 
hydroxypropyltrimethylammonium chloride when used as an inert 
ingredient in pesticide formulations applied, is safe under FFDCA 
section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for guar 
hydroxypropyltrimethylammonium chloride.

C. Response to Comments

    One comment was received for a notice of filing from a private 
citizen who opposed the authorization to sell any pesticide that leaves 
a residue on food. The Agency understands the commenter's concerns and 
recognizes

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that some individuals believe that no residue of pesticides should be 
allowed. However, under the existing legal framework provided by 
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA is 
authorized to establish pesticide tolerances or exemptions where 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by the statute.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for guar 
hydroxypropyltrimethylammonium chloride (CAS No. 71329-50-5) when used 
as an inert ingredient (thickener/drift reduction agent) in pesticide 
formulations applied to growing crops.

VII. Statutory and Executive Order Reviews

    This final rule establishes 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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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: May 20, 2013.
Lois Rossi,
Director, 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.


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2. In Sec.  180.920, the table is amended by alphabetically adding the 
following inert ingredient to read as follows:


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

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        Inert ingredients               Limits              Uses
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                              * * * * * * *
Guar                               ...............  Thickener/drift
 hydroxypropyltrimethylammonium                      reduction agent.
 chloride (CAS Reg. No. 71329-50-
 5).
 
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[FR Doc. 2013-12782 Filed 5-28-13; 8:45 am]
BILLING CODE 6560-50-P