Document ID: EPA-HQ-OPP-2008-0040-0005
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Potassium Benzoate
Posted Date: 2011-03-10T05:00Z

[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Rules and Regulations]
[Pages 12873-12877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5051]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2011-0117; FRL-8863-2]

Potassium Benzoate; 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 potassium benzoate (Cas No. 582-25-2) 
under 40 CFR 180.910 when used as an inert ingredient (preservative) in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest, and under 40 CFR 180.930 when used as an 
inert ingredient (preservative) in pesticide formulations applied to 
animals (used for food). Landis International, on behalf of Whitmire 
Micro-Gen submitted two petitions 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 potassium 
benzoate.

DATES: This regulation is effective March 9, 2011. Objections and 
requests for hearings must be received on or before May 9, 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-2011-0117. 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: Elizabeth Fertich, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 347-8560; e-mail address: 
fertich.elizabeth@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.

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.gpoaccess.gov/ecfr.

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-2011-0117 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 
May 9, 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-2011-0117, 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

[[Page 12874]]

(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 6, 2008 (73 FR 6964) (FRL-8350-
9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 7E7241) by 
Landis International, on behalf of Whitmire Micro-Gen, 3185 Madison 
Highway, P.O. Box 5126, Valdosta, GA 31603-5126, under docket ID number 
EPA-HQ-OPP-2008-0040. The petition requested that 40 CFR 180.910 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of potassium benzoate (Cas No. 582-25-2) when 
used as an inert ingredient (preservative) in pesticide formulations 
applied pre- and post-harvest. In the Federal Register of June 4, 2008 
(73 FR 31862) (FRL-8365-3), EPA issued a notice pursuant to section 408 
of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition 
(PP 8E7333) by Landis International, on behalf of Whitmire Micro-Gen, 
3185 Madison Highway, P.O. Box 5126, Valdosta, GA 31603-5126, under 
docket ID number EPA-HQ-OPP-2008-0059. The petition requested that 40 
CFR 180.930 be amended by establishing an exemption from the 
requirement of a tolerance for residues of potassium benzoate (Cas No. 
582-25-2) when used as an inert ingredient (preservative) in pesticide 
formulations applied to animals. Both notices referenced a summary of 
the petition prepared by Landis International, on behalf of Whitmire 
Micro-Gen, the petitioner, which is available in the docket, http://www.regulations.gov. Two comments were received in the docket for PP 
7E7241, however they are unrelated to potassium benzoate and the Agency 
believes they were placed in this docket in error by the commenters. 
There were no comments received in response to the notice of filing for 
PP 8E7333.

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 for potassium benzoate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with potassium benzoate 
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.
    Potassium benzoate is an approved food preservative, similar in 
structure and reactivity to the more widely used sodium benzoate. Both 
are classified by the U.S. Food and Drug Administration (FDA) as 
Generally Recognized as Safe (GRAS). In conducting this assessment, 
toxicity data on potassium benzoate and the surrogate chemicals sodium 
benzoate and benzoic acid were used. Both potassium benzoate and sodium 
benzoate are salts of benzoic acid. Because all benzoates, in 
particular benzoic acid and sodium benzoate, react similarly to 
potassium benzoate, they were used as surrogates in the development of 
this profile.
    Available data show that the acute toxicity of potassium benzoate 
is negligible, having an oral median lethal dose (LD50) of 
>10,000 milligrams per kilogram body weight (mg/kg/bw). Acute dermal 
and inhalation toxicity is low as indicated by the >2,000 mg/kg/bw 
LD50 and >12.2 milligrams per liter (mg/L) median lethal 
concentration (LC50) of benzoic acid. Sodium benzoate was 
not irritating to the skin and induced only slight eye irritation in 
rabbits. Sodium benzoate and benzoic acid were non-sensitizing in 
animal tests but showed a very low incidence of sensitization in humans 
patch tested. Both sodium benzoate and benzoic acid are known to induce 
non-immunogenic contact reactions, and that is the likely explanation 
for the low positive response.
    Subacute, subchronic and chronic toxicity data also indicate that 
potassium benzoate should be relatively nontoxic. Available oral and 
dermal studies had a no-observed-adverse-effect-level (NOAEL) >=2,000 
mg/kg/bw and the inhalation study had a NOAEL >25 milligrams per cubic 
meter (mg/m\3\). Sodium benzoate was not

[[Page 12875]]

carcinogenic in a lifetime mouse feeding study and there is no 
indication that potassium benzoate should be neurotoxic. Genotoxicity 
studies indicate the benzoates are not mutagenic; however chromosomal 
aberration studies gave ambiguous results. Benzoic acid did not induce 
reproductive toxicity in a 4-generation study. In the human body under 
normal physiological conditions, potassium benzoate changes from the 
ionized form to the undissociated benzoic acid. Benzoic acid and its 
salts are rapidly absorbed by mammals, conjugated with glycine, and 
rapidly excreted in the urine as hippuric acid. There is no reported 
accumulation of benzoate in the body. However, the ability to conjugate 
benzoic acid depends upon adequate liver function and nutritional 
supply of glycine.
    All data indicates that potassium benzoate is relatively non-toxic 
as are the other benzoates. No toxicity would be expected from 
potassium benzoate when used at low concentrations in pesticides.
    No developmental toxicity studies are available in the database. 
However, no systemic toxicity was observed at doses up to 750 mg/kg/
day, the highest dose tested (HDT), in a 4-generation reproductive 
study with benzoic acid. In addition, no systemic toxicity was observed 
in the laboratory animals at high doses >2,000 mg/kg/day of potassium 
benzoate and benzoates indicating relatively low hazard potential.
    Specific information on the studies received and the nature of the 
adverse effects caused by potassium benzoate as well as the NOAEL and 
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in the document ``PC 
Code 709103: Potassium Benzoate (CAS Reg. No. 582-25-2); Human Health 
Risk Assessment and Ecological Effects Assessment to the Support 
Proposed Exemption from the Requirement of a Tolerance When Used as an 
Inert Ingredient in Pesticide Formulations,'' page 7 docket ID number 
EPA-HQ-OPP-2011-0117.

B. Toxicological Points of Departure/Levels of Concern

    Subacute, subchronic and chronic toxicity data indicate that 
potassium benzoate is relatively nontoxic. Available oral and dermal 
toxicity studies had a NOAEL greater than or equal to 2,000 mg/kg/day 
and the inhalation study had a NOAEL greater than 25 mg/m\3\. Sodium 
benzoate was not shown to be carcinogenic and there is no indication 
that potassium benzoate will be neurotoxic. Studies also indicate that 
benzoates are not mutagenic and benzoic acid did not induce 
reproductive toxicity in a 4-generation study. Since no toxicity was 
observed at high doses, quantitative risk assessment is deemed 
unnecessary.

 C. Exposure Assessment

    No hazard was identified for the acute and chronic dietary 
assessment (food and drinking water), or for the short, intermediate, 
and long term residential assessments, therefore no aggregate risk 
assessments were performed. Available toxicological studies indicate 
lack of systemic toxicity at doses up to 2,000 mg/kg/day. Therefore, no 
quantitative dietary or occupational and residential risk assessment 
was conducted.
    1. Dietary exposure from food and feed uses and drinking water. In 
evaluating dietary exposure to potassium benzoate, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance. Since toxicity was seen only at doses greater than 2,000 mg/
kg/day for potassium benzoate, a quantitative exposure assessment for 
potassium benzoate was not conducted. Any possible dietary exposure to 
potassium benzoate from its use as an inert ingredient in pesticide 
products would be through consumption of food to which pesticide 
products containing it have been applied and possibly through drinking 
water (from runoff). Metabolism data indicates that potassium benzoate 
would be rapidly absorbed, metabolized, and excreted.
    2. 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). 
Potassium benzoate is used in pharmaceuticals and cosmetics. It can 
also be used in nonfood use pesticide products. Considering the low 
toxicity of potassium benzoate, residues of concern are not anticipated 
from residential exposures (inhalation and dermal) and therefore a 
quantitative aggregate risk assessment was not performed.
    3. 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 potassium benzoate to share a common mechanism of 
toxicity with any other substances, and potassium benzoate does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
potassium benzoate does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the 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.
    No developmental toxicity studies are available in the database. 
However, no systemic toxicity was observed at doses up to 750 mg/kg/day 
in a 4-generation reproductive study with benzoic acid. In addition, no 
systemic toxicity was observed in the laboratory animals at high doses 
>2,000 mg/kg/day of potassium benzoate and benzoates indicating 
relatively low hazard potential. There was no evidence of clinical 
signs of neurotoxicity, therefore, a developmental neurotoxicity study 
is not required. In addition, no evidence of immunotoxicity is 
available in the database, therefore, an immunotoxicity study is not 
required. In terms of hazard, there are low concerns and low residual 
uncertainties regarding prenatal and/or postnatal toxicity. Based on 
this information, there is no concern at this time for increased 
sensitivity to infants and children to potassium benzoate when used as 
an inert ingredient in pesticide formulations and a safety factor 
analysis has not been used to assess risk. For the same reason, EPA has 
determined that an additional safety factor is not needed to protect 
the safety of infants and children.

[[Page 12876]]

E. Aggregate Risks and Determination of Safety

    Given the lack of concern for hazard posed by potassium benzoate, 
EPA concludes that there are no dietary or aggregate dietary/non-
dietary risks of concern as a result of exposure to potassium benzoate 
in food and water or from residential exposure. Residues of concern are 
not anticipated for dietary exposure (food and drinking water) or for 
residential exposure (dermal and inhalation) from the use of potassium 
benzoate as an inert ingredient in pesticide products. As discussed in 
this unit, EPA expects aggregate exposure to potassium benzoate to pose 
no appreciable dietary risk given that the data show a lack of any 
systemic toxicity at doses up to 2,000 mg/kg/day and a lack of any 
apparent developmental effects.
    Taking into consideration all available information on potassium 
benzoate, 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 potassium benzoate under 
reasonably foreseeable circumstances. Therefore, the establishment of 
an exemption from tolerance under 40 CFR 180.910 for residues of 
potassium benzoate when used as an inert ingredient in pesticide 
formulations applied pre- and post-harvest and under 40 CFR 180.930 for 
residues of potassium benzoate when used as an inert ingredient in 
pesticide formulations applied to animals, 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 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 potassium benzoate.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 and 40 CFR 180.930 for potassium 
benzoate when used as an inert ingredient (preservative) in pesticide 
formulations applied pre- and post-harvest and applied to animals.

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 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: February 25, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.910, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

[[Page 12877]]

Sec.  180.910  Inert ingredients used pre-harvest and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                                * * * * *
Potassium benzoate (as No. 582-   none..............  preservative
 25-2).
 
                                * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                                * * * * *
Potassium benzoate (as No. 582-   none..............  preservative
 25-2).
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2011-5051 Filed 3-8-11; 8:45 am]
BILLING CODE 6560-50-P