[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5051]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Potassium Benzoate; 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 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
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)
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:
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
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
(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
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
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
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
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
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
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
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
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
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.
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
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.
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: February 25, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, 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. 180.910, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
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
* * * * *
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
* * * * *
[FR Doc. 2011-5051 Filed 3-8-11; 8:45 am]
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