[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12782]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Guar Hydroxypropyltrimethylammo-nium Chloride; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 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
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 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: 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: [email protected].
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://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: 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
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.htm.
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 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, http://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
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
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
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
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
C. Exposure Assessment
1. Dietary exposure from food and feed uses, drinking water, and
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 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. 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
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
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
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.
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
Dated: May 20, 2013.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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.
* * * * *
Inert ingredients Limits Uses
* * * * * * *
Guar ............... Thickener/drift
hydroxypropyltrimethylammonium reduction agent.
chloride (CAS Reg. No. 71329-50-
* * * * * * *
[FR Doc. 2013-12782 Filed 5-28-13; 8:45 am]
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