Document ID: EPA-HQ-OPP-2011-0531-0001
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of Tolerance: Carboxymethyl guar gum sodium salt and Carboxymethyl-hydroxypropyl guar
Posted Date: 2011-07-27T04:00Z

[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Rules and Regulations]
[Pages 44811-44815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18588]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0531; FRL-8880-5]

Carboxymethyl Guar Gum Sodium Salt and Carboxymethyl-
Hydroxypropyl Guar; 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 carboxymethyl guar gum sodium salt (CAS 
Reg. No. 39346-76-4) and carboxymethyl-hydroxypropyl guar (CAS Reg. No. 
68130-15-4); when used as an inert ingredient (thicker/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 carboxymethyl guar gum sodium salt and carboxymethyl-
hydroxypropyl guar.

DATES: This regulation is effective July 27, 2011. Objections and 
requests for hearings must be received on or before September 26, 2011, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0531 All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Alganesh Debesai, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8353; e-mail address: 
debesai.alganesh@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 44812]]

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-2011-0531 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 
September 26, 2011. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0531, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

    In the Federal Register of February 4, 2011 (76 FR 6467) (FRL-8858-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petitions (PP 0E7784) under 
docket ID number EPA-HQ-OPP-2010-0878 and (PP 0E7803) under docket ID 
number EPA-HQ-OPP-2010-1019 by SciReg Inc., on behalf of Rhodia Inc., 
12733 Director's Loop, Woodbridge VA 22192. The petitions requested 
that 40 CFR 180.920 be amended by establishing an exemption from the 
requirement of a tolerance for residues of carboxymethyl guar gum 
sodium salt (CAS Reg. No. 39346-76-4) and carboxymethyl-hydroxypropyl 
guar (CAS Reg. No. 68130-15-4); when used as an inert ingredients 
(thicker/drift reduction agent) in pesticide formulations applied to 
growing crops. Those notices referenced a summary of the petitions 
prepared by SciReg Inc., on behalf of Rhodia Inc., the petitioner, 
which is available in the docket, http://www.regulations.gov. Comments 
were received on both notices 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. 
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 section 408(c)(2)(A) of FFDCA, 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 of carboxymethyl guar gum sodium 
and carboxymethyl-hydroxypropyl guar including exposure resulting from 
the exemption established by this action. EPA's assessment of exposures 
and risks associated with carboxymethyl guar gum sodium and 
carboxymethyl-hydroxypropyl guar 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 carboxymethyl guar gum sodium and

[[Page 44813]]

carboxymethyl-hydroxypropyl guar as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies are discussed in this unit.
    The following provides a brief summary for the risk assessment and 
conclusions for the Agency's review for the guar gums, which include 
carboxymethyl guar gum sodium and carboxymethyl-hydroxypropyl guar. The 
Agency's full decision document for this action is available in the 
Agency's electronic docket (regulations.gov) under the docket number 
EPA-HQ-OPP-2011-0531. Based upon the structural similarities between 
carboxymethyl guar gum, carboxymethyl-hydroxypropyl guar, guar gum, and 
hydroxypropyl guar, the risk assessment for carboxymethyl guar and 
carboxymethyl-hydroxypropyl guar relies upon available data on all four 
substances.
    Acute oral toxicity studies conducted with guar, hydroxypropyl 
guar, and carboxymethyl guar resulted in oral LD50 values 
ranging from 7,060 milligrams per kilogram of body weight (mg/kg bw) to 
17,800 mg/kg bw. Dermal irritation studies conducted with guar, 
hydroxypropyl guar, and carboxymethyl guar resulted in no irritation to 
slight irritation. Eye irritation studies conducted with guar, 
hydroxypropyl guar, and carboxymethyl-hydroxypropyl guar demonstrated a 
range of results from non-irritation to severe irritation. Results of 
skin sensitization and mutagenicity studies performed with guar gum, 
hydroxypropyl guar, and carboxymethyl-hydroxypropyl guar were all 
negative. There are three 90-day toxicity studies available for guar 
gums. In one study, the LOAEL of guar gum in a diet was 1% (equivalent 
to 580 mg/kg/day) based on effects on body weight gains, and dose 
related decrease in kidney weights. The NOAEL was not established in 
this study. In the second study, no effects were observed in male rats 
at doses up to 6% (equivalent to 3,000 mg/kg/day). In the third study 
in rats, decreased in body weight gains, decreased in food efficiency, 
increased in blood urea nitrogen and thyroid toxicity (males only) were 
observed at a dietary concentration of 2 and 5%. The NOAEL in this 
study was 1% (equivalent to 500 mg/kg/day). No adverse effects were 
reported in dogs that were fed 0, 1, 5, or 10% (approximately 0, 250, 
1,250, or 2,500 mg/kg/day) of a precooked mixture of guar and carob 
bean for 30 weeks. No effects were observed in monkeys that were fed 1 
gram (equal to 10 mg/kg/day) of guar flour for 2 months. Teratogenicity 
studies with guar gum in mice, rats, and hamsters did not indicate that 
guar gum is a teratogen; in mice at doses up to 800 mg/kg/day, in rats 
up to 900 mg/kg/day and in hamsters up to 600 mg/kg/day. Male and 
female Osborne-Mendel rats were fed guar gum at 0, 1, 2, 4, 7. 5, or 
15% (approximately 0, 500, 1,000, 2,000, 3,750 or 7,500 mg/kg/day) in 
the diet for 13 weeks before mating, during mating, and throughout 
gestation. No effects on parental fertility, fetal development, sex 
distribution, and no malformations of the pups were observed. The NOAEL 
for parental, developmental and reproductive toxicity is 7,500 mg/kg/
day. No evidence of carcinogenicity was found in male and female F344 
rats and B6C3F1 mice administered diets containing 25,000 or 50,000 ppm 
(approximately 3,570 or 7,140 mg/kg/day) guar gum for 103 weeks. A 
reduction in the mean body weight of the higher dose females and of the 
feed consumption was observed, as compared with the controls. No 
compound-related clinical signs of adverse effects on survival were 
observed. There was no increase in the incidence of tumors that could 
be related to the test substance.
    Subchronic, reproductive and developmental, and carcinogenicity 
studies with guar gum showed no long term, reproductive/developmental, 
or carcinogenic effects. Overall, a low toxicity profile is expected 
with both carboxymethyl guar and carboxymethyl-hydroxypropyl guar 
because of likelihood of low absorption via any route of exposure due 
to their high molecular weights.

B. Toxicological Points of Departure/Levels of Concern

    Majority of the available studies suggest that high levels of guars 
were well tolerated by laboratory animals. In the two 90-day toxicity 
studies, the body weight gains appears to be depressed at 500 mg/kg/day 
dose levels and above, however, generally the food consumption was not 
affected, indicating low food conversion efficiency. 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 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, the 
Agency has determined that a qualitative assessment for all pathways of 
human exposure to both carboxymethyl guar and carboxymethyl-
hydroxypropyl guar (food, drinking water, and residential) is 
appropriate.

C. Aggregate Exposure

    In examining aggregate exposure, the Federal Food, Drug, And 
Cosmetic Act (FFDCA) section 408 directs EPA to consider available 
information concerning exposures from the pesticide residues 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 outdoor uses). There are 
no residential uses proposed at this time. No quantification of 
aggregate exposure was performed because no end point of concern was 
identified in the available toxicity studies.
    1. Dietary and non-dietary exposure. Carboxymethyl guar and 
carboxymethyl-hydroxypropyl guar are slightly modified forms of guar 
gum, a natural polymer which is an affirmed GRAS substance of low 
toxicity. Carboxymethyl guar and carboxymethyl-hydroxypropyl guar are 
also structurally similar to hydroxypropyl guar, another slightly 
modified form of guar gum. EPA reassessed the tolerance exemption for 
hydroxypropyl guar in 2005 and concluded that there is a reasonable 
certainty of no harm to any population subgroup that will result from 
aggregate exposure to hydroxypropyl guar when considering dietary 
exposure and all other nonoccupational sources of pesticide exposure 
for which there is reliable information. Based on their close 
structural relationship to guar gum and hydroxypropyl guar, as well as 
their high molecular weights and likelihood of low absorption via any 
route of exposure, both carboxymethyl guar and carboxymethyl-
hydroxypropyl guar can also be considered to be low toxicity substances 
with a reasonable certainty of no harm from dietary exposure and all 
other nonoccupational sources of exposure.
    2. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA

[[Page 44814]]

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.''
    Carboxymethyl guar and carboxymethyl-hydroxypropyl guar are 
slightly modified form of guar gum, a natural polymer that has been 
affirmed as generally recognized as safe (GRAS) substance of low 
toxicity. Carboxymethyl guar and carboxymethyl-hydroxypropyl guar are 
also structurally similar to hydroxypropyl guar, another slightly 
modified form of guar gum. They all have same toxicity pattern but the 
exact mode of action is not known. Therefore, cumulative risk 
assessment was not conducted. 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

    In general. 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 (FQPA) Safety Factor (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.
    Carboxymethyl guar and carboxymethyl-hydroxypropyl guar are slight 
modified forms of guar gum, a natural polymer which is an affirmed GRAS 
substance of low toxicity. Carboxymethyl guar and carboxymethyl-
hydroxypropyl guar gum are also structurally similar to hydroxypopyl 
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; in mice at doses up to 800 mg/kg/day, in rat up to 
900 mg/kg/day and in hamsters up to 600 mg/kg/day. 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. Based on the 
structural similarities to guar gum and hydroxyporpyl guar, as well as 
their high molecular weights and low likelihood of absorption via any 
route of exposure, carboxymethyl guar and carboxymethyl-hydroxypropyl 
guar are unlikely to elicit a toxic response in infants and children 
when used as an inert ingredient in pesticide products. Available 
toxicity studies confirm this belief and indicate low toxicity; 
therefore, the Agency did not use a safety factor analysis 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 expects aggregate exposure to carboxymethyl guar gum sodium 
salt and carboxymethyl-hydroxypropyl guar residues to pose no 
appreciable risk to human health given that they both are a polymer 
with high molecular weight that are devoid of reactive functional 
groups and which are not absorbed by any route of human exposure. 
Taking into consideration all available information on carboxymethyl 
guar gum sodium salt and carboxymethyl-hydroxypropyl guar, 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 carboxymethyl guar gum sodium salt and 
carboxymethyl-hydroxypropyl guar under reasonably foreseeable 
circumstances. Therefore, the establishment of an exemption from a 
tolerance under 40 CFR 180. 920 for residues of carboxymethyl guar gum 
sodium salt and carboxymethyl-hydroxypropyl guar when used as inert 
ingredients in pesticide formulations applied to growing crops under 40 
CFR 180.920 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 not establishing a numerical tolerance for residue of 
carboxymethyl guar gum sodium salt and carboxymethyl-hydroxypropyl guar 
in or on any food commodities.

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 U.N. 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 carboxymethyl guar gum 
sodium salt and carboxymethyl-hydroxypropyl guar.

C. Response to Comments

    Two comments, one for each notice of filing were received from 
private citizens who opposed the authorization to sell any pesticide 
that leaves a residue on food. The Agency understands the commenter's 
concerns and recognizes 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 carboxymethyl guar gum sodium salt 
(CAS Reg. No. 39346-76-4) and carboxymethyl-hydroxypropyl guar (CAS 
Reg. No. 68130-15-4); when used as an inert ingredient (thicker/drift 
reduction agent) in pesticide formulations applied to growing crops 
under 40 CFR 180.920.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and

[[Page 44815]]

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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: July 12, 2011.
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.  180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

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

* * * * *

----------------------------------------------------------------------------------------------------------------
       Inert ingredients                      Limits                                    Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Carboxymethyl guar gum sodium   Without limitation................  Thicker/drift reduction agent.
 salt (CAS Reg. No. 39346-76-
 4).
 
                                                  * * * * * * *
Carboxymethyl-hydroxypropyl     Without limitation................  Thicker/drift reduction agent.
 guar (CAS Reg. No. 68130-15-
 4).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-18588 Filed 7-26-11; 8:45 am]
BILLING CODE 6560-50-P