Sodium Bisulfate; Exemption From the Requirement of a Tolerance, 32662-32666 [2014-13229]
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32662
Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations
(2) The veteran was receiving serviceconnected disability compensation on
the date of death;
(3) The veteran would have been
receiving service-connected disability
compensation on the date of death, but
for the receipt of military retired pay or
non-service-connected disability
pension; or
(4) The Secretary determines the
veteran is eligible for a burial allowance
under § 3.1708.
(c) Amount payable. The amount
payable under this section will not
exceed the cost of transporting the
remains to the national cemetery closest
to the veteran’s last place of residence
in which burial space is available, and
is subject to the limitations set forth in
paragraph (d) of this section.
(d) Reimbursable transportation
expenses. (1) VA will reimburse
reasonable transportation expenses,
including but not limited to the costs of
shipment via common carrier (i.e.,
procuring permits for shipment, a
shipping case, sealing of the shipping
case, and applicable Federal taxes) and
costs of transporting the remains to the
place of burial.
(2) A reasonable transportation
expense is an expense that is usual and
customary in the context of burial
transportation, with a corresponding
charge that is the usual and customary
charge made to the general public for
the same or similar services.
(Authority: 38 U.S.C. 2303, 2308)
Burial Benefits: Other
§ 3.1710 Escheat (payment of burial
benefits to an estate with no heirs).
VA will not pay burial benefits if the
payment would escheat (that is, would
be turned over to the State because there
are no heirs to the estate of the person
to whom such benefits would be paid).
(Authority: 38 U.S.C. 501(a))
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§ 3.1711 Effect of contributions by
government, public, or private
organizations.
(a) Contributions by government or
employer. With respect to claims for a
plot or interment allowance under
§ 3.1707, if VA has evidence that the
U.S., a State, any agency or political
subdivision of the U.S. or of a State, or
the employer of the deceased veteran
has paid or contributed payment to the
veteran’s plot or interment expenses,
VA will pay the claimant up to the
lesser of:
(1) The allowable statutory amount; or
(2) The amount of the total plot or
interment expenses minus the amount
of expenses paid by any or all of the
organizations described in this
paragraph (a).
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(b) Burial expenses paid by other
agencies of the U.S. (1) Burial allowance
when Federal law or regulation also
provides for payment. VA cannot pay
the non-service-connected burial
allowance when any Federal law or
regulation also specifically provides for
the payment of the deceased veteran’s
burial, funeral, or transportation
expenses. However, VA will pay the
non-service-connected burial allowance
when a Federal law or regulation allows
the payment of burial expenses using
funds due, or accrued to the credit of,
the deceased veteran (such as Social
Security benefits), but the law or
regulation does not specifically require
such payment. In such cases, VA will
pay the maximum amount specified in
38 U.S.C. 2302.
(2) Payment by military service
department. VA will not pay or will
recoup the non-service-connected burial
allowance for deaths occurring during
active service or for other deaths for
which the service department pays the
burial, funeral, or transportation
expenses.
(3) When a veteran dies while
hospitalized. When a veteran dies while
hospitalized at the expense of the U.S.
government (including, but not limited
to, death in a VA facility) and benefits
would be otherwise payable under 10
U.S.C. 1482 and a provision of this
subpart B, only one of these benefits is
payable. VA will attempt to locate a
relative of the veteran or another person
entitled to reimbursement under
§ 3.1702(b) and will ask that person to
elect between these benefits.
(Authority: 38 U.S.C. 2302, 2303(b))
§ 3.1712 Effect of forfeiture on payment of
burial benefits.
(a) Forfeiture for fraud. VA will pay
burial benefits, if otherwise in order,
based on a deceased veteran who
forfeited his or her right to receive
benefits due to fraud under § 3.901,
Fraud. However, VA will not pay burial
benefits to a claimant who participated
in fraudulent activity that resulted in
forfeiture under § 3.901.
(b) Forfeiture for treasonable acts or
for subversive activity. VA will not pay
burial benefits based on a period of
service commencing before the date of
commission of the offense if either the
veteran or the claimant has forfeited the
right to all benefits except insurance
payments under § 3.902, Forfeiture for
treasonable acts, or § 3.903, Forfeiture
for subversive activities, because of a
treasonable act or subversive activities,
unless the offense was pardoned by the
President of the U.S.
(Authority: 38 U.S.C. 6103, 6104, 6105)
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Cross Reference: § 3.1(aa), for the definition
of ‘‘fraud.’’
§ 3.1713
1958.
Eligibility based on status before
When any person dies who had a
status under any law in effect on
December 31, 1957, that afforded
entitlement to burial benefits, burial
benefits will be paid, if otherwise in
order, even though such status does not
meet the service requirements of 38
U.S.C. chapter 23.
(Authority: 38 U.S.C. 2305)
[FR Doc. 2014–13230 Filed 6–5–14; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0922; FRL–9910–50]
Sodium Bisulfate; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of sodium
bisulfate when used as an inert
ingredient in antimicrobial formulations
on food contact surfaces in public eating
places, dairy processing equipment and
food processing equipment and utensils
at no more than 2,000 ppm in final
formulation. Exponent on behalf of
Ecolab, 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 sodium bisulfate.
DATES: This regulation is effective June
6, 2014. Objections and requests for
hearings must be received on or before
August 5, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0922, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
ADDRESSES:
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a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2012–0922 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 August 5, 2014. Addresses for
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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–
2012–0922, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Petition for Exemption
In the Federal Register of January 16,
2013 (78 FR 3377) (FRL–9375–4), EPA
issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing
the filing of a pesticide petition (PP IN–
10526) by Ecolab, Inc., 370 N. Wabasha
Street, St. Paul, MN 55102. The petition
requested that 40 CFR 180.940(a) be
amended by establishing an exemption
from the requirement of a tolerance for
residues of sodium bisulfate (CAS Reg.
No. 7681–38–1) when used as an inert
ingredient in antimicrobial pesticide
formulations applied to food contact
surfaces in public eating places, dairy
processing equipment and food
processing equipment and utensils at no
more than 2,000 ppm in final
formulation. That document referenced
a summary of the petition prepared by
Exponent, 1150 Connecticut Ave. NW.,
Suite 1100, Washington, DC 20036, the
petitioner, which is available in the
docket, https://www.regulations.gov.
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
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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
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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 sodium bisulfate
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with sodium bisulfate
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 sodium bisulfate as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in this unit.
The acute oral toxicity of sodium
bisulfate is low. The acute oral LD50 in
male rats was 2,800 mg/kg. It was
minimally irritating to the rabbit’s skin
and mildly irritating to the eyes. An
acute inhalation study was available
with sodium sulfate. Inhalation toxicity
was not observed at 0.01 mg/l (the only
dose tested). No dermal toxicity or
dermal sanitization studies were
available in the database.
Due to the lack of data for sodium
bisulfate, both human metabolic
processes and toxicity data for sodium
sulfate were used for the risk
characterization. Both sodium bisulfate
and sodium sulfate readily undergo
hydrolysis and dissociate to sodium
ions and sulfate ions in the body.
Sodium sulfate was administered to
male Sprague-Dawley rats at a dietary
concentration of 0.84% (approximately
320–400 mg/kg/day) for 27 and 44
weeks. There was no mortality, tumors,
body weight change or significant
changes in food and/or water
consumption. The NOAEL was ∼320–
400 mg/kg/day. In another study, male
Sprague-dawley rats were given in diet
0.0, 0.125, 0.250, 0.5, 1 and 2% sodium
sulfate (approximately 0, 125, 250, 500,
1,000 and 2,000 mg/kg/day) for 4 weeks.
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No changes in food and water
consumption, body weight gain, food
conversion efficiency, urine production
or diarrhea. Blood hemoglobin, white
blood count, serum alkaline
phosphatase, inorganic phosphate and
gross organ pathology were also
unaffected. The NOAEL was 2,000 mg/
kg/day (highest dose tested). A LOAEL
was not observed in this study.
Sodium sulfate showed no mutagenic
effect in the Ames test using various
strains of S. typhimurium (TA1535,
TA1537, TA100, TA98) both with and
without S9 activation.
No carcinogenicity studies were
available in the database. The National
Toxicology Program (NTP),
International Agency for Research on
Cancer (IARC), and Occupational Safety
& Health Administration (OSHA) have
not listed sodium bisulfate as a
carcinogen. A DEREK analysis was
performed on sodium bisulfate and no
structural alerts were detected. EPA
concluded that sodium bisulfate is
unlikely to pose a carcinogenic risk to
humans based on lack of mutagenicity
concerns for sodium sulfate, lack of any
structural alerts for carcinogenicity, lack
of any systemic toxicity at doses up to
2,800 mg/kg/day, and its metabolism to
form a sulfate which is natural
constituent present in the body.
Sodium sulfate was included in a test
of a method for rapid assessment of
teratogenicity. Pregnant ICR/SIM mice
were given a saturated aqueous solution
of sodium sulfate orally by gavage to
deliver a dose of 2,800 mg/kg/day on
days 8–12 of gestation. No maternal
deaths occurred and the average
maternal weight gain during the
treatment period was not significantly
different from that of water-treated
controls. Twenty-four litters were
delivered alive, and none were resorbed.
The mean numbers of neonates
delivered alive and dead in each litter
and the survival of neonates on day 3
were not statistically significantly
different from those of controls. Only
body weight on day 1 was statistically
significantly greater than that of
controls. The maternal and
developmental NOAEL = 2,800 mg/kg
bw, the only dose tested.
No immunotoxicity, neurotoxicity or
reproductive toxicity studies were
available in the database.
Sodium bisulfate mammalian
metabolism is essentially that of the
sodium cation and sulfate anion. As
previously noted, when sodium
bisulfate is added to food products
containing water or after ingestion of
sodium bisulfate it ionizes to sodium
ions, hydrogen ions and sulfate ions.
Following ingestion, sulfate anions are
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predominantly not absorbed from the
gastrointestinal tract and are excreted
unchanged in urine. However, the
sulfate anion is a normal constituent in
the body, predominantly resulting from
the body’s metabolism of sulfurcontaining food sources such as foods
containing the essential amino acids
cysteine and methionine. Sulfate anions
are vital components in a number of
human biosynthetic pathways such as
cartilage production and the formation
of pancreatic digestive enzymes.
Additionally, the sulfate anion is also an
important conjugate in the Phase II
conjugation/elimination of oxidized
(OH) aromatic ring metabolites and for
hydroxyl steroid hormones, such as
estrogen, where it acts as a transport
agent to target organ tissue receptors.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
There was no hazard identified in
repeat dose developmental studies at
the limit dose of 2,800 mg/kg/day of
sodium sulfate to either parental
animals or their offspring. No effects
were seen in two subchronic oral
toxicity up to approximately 2,000 mg/
kg/day of sodium sulfate. Based on the
metabolism of sodium bisulfate to
sulfate and sodium ions, both of which
are essential components in the human
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metabolic processes, there is a lack of
toxicological concern. Thus, due to its
low potential hazard and lack of hazard
endpoint, the Agency has determined
that a quantitative risk assessment using
safety factors applied to a point of
departure protective of an identified
hazard endpoint is not appropriate.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to sodium bisulfate, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance (40 CFR
180.940(a)) such as food in contact with
sanitized counters in public eating
places, utensils, dairy processing
equipment and food processing
equipment as well as other uses which
may result in dietary exposure.
However, because 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,
no quantitative aggregate exposure
assessments were performed.
2. Dietary exposure from drinking
water. Residues of sodium bisuflate
from uses in food contact sanitizing
solutions, utensil, dairy processing
equipment and food processing
equipment may enter drinking water.
However, because no hazard was
identified for the acute and chronic
dietary assessment, or for the short-,
intermediate-, and long-term residential
assessments as listed in this unit, no
quantitative aggregate exposure
assessments were performed.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Residential (dermal and inhalation)
exposure from food contact surface
sanitizing solutions for public eating
places, dairy-processing equipment,
food-processing equipment and utensils
are possible. Since an endpoint for risk
assessment was not identified, a
quantitative residential exposure
assessment for sodium bisulfate was not
conducted.
4. 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
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substances that have a common
mechanism of toxicity.’’
EPA has not found sodium bisulfate
to share a common mechanism of
toxicity with any other substances, and
sodium bisulfate does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that sodium bisulfate 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 https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
The toxicity database for sodium
bisulfate is adequate for assessment of
risks to infants and children and the
potential exposure is adequately
characterized given the low toxicity of
the chemical and formation of sulfate
ion. No hazard was identified and there
is no residual uncertainty regarding
prenatal and/or postnatal toxicity. No
acute or subchronic neurotoxicity
studies are available, but there were no
clinical signs of neurotoxicity or any
systemic toxicity observed in the
available database at doses up to 2,800
mg/kg/day. No developmental,
reproductive, or teratogenic effects were
seen in the available studies at doses up
to and including 2,800 mg/kg/day.
Based on this information, there is no
concern at this time for increased
sensitivity to infants and children to
sodium bisulfate when used as an inert
ingredient in pesticide formulations for
food contact surface sanitizing
applications 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
Taking into consideration all available
information on sodium bisulfate, 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 sodium bisulfate under
reasonable foreseeable circumstances.
Therefore, the establishment of an
exemption from tolerance under 40 CFR
180.940(a) for residues of sodium
bisulfate when used as an inert
ingredient in pesticide formulations
applied to food contact surface
sanitizing solutions for public eating
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32665
places, dairy processing equipment,
food processing equipment and utensils
at no more than 2,000 ppm in
formulation, 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 residues of sodium
bisulfate in or on any food commodities.
EPA is establishing a limitation on the
amount of sodium bisulfate that may be
used in pesticide formulations. The
limitation will be enforced through the
pesticide registration process under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136
et seq. EPA will not register any
pesticide for sale or distribution that
contains greater than 2,000 ppm of
sodium bisulfate in the pesticide
formulation.
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 sodium bisulfate.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.940(a) for sodium
bisulfate (CAS Reg. No. 7681–38–1)
when used as an inert ingredient in
antimicrobial pesticide formulations
applied to food contact surface
sanitizing solutions for public eating
places, dairy processing equipment,
food processing equipment and utensils
at no more than 2,000 ppm in
formulation.
E:\FR\FM\06JNR1.SGM
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32666
Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations
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.
Pesticide chemical
*
mstockstill on DSK4VPTVN1PROD with RULES
[EPA–HQ–OPP–2013–0654 and EPA–HQ–
OPP–2013–0655; FRL–9910–38]
Flutriafol; Pesticide Tolerances
Environmental Protection
Agency (EPA).
AGENCY:
Final rule.
13:35 Jun 05, 2014
Jkt 232001
*
This regulation is effective June
6, 2014. Objections and requests for
hearings must be received on or before
August 5, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
PO 00000
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 2, 2014.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.940, in the table in
paragraph (a), alphabetically add the
following inert ingredient to read as
follows:
■
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
*
This regulation establishes,
amends, and removes tolerances for
residues of flutriafol in or on multiple
commodities which are identified and
discussed later in this document.
Cheminova A/S c/o Cheminova, Inc.
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
40 CFR Part 180
List of Subjects in 40 CFR Part 180
*
*
*
*
*
*
When ready for use, the end-use concentration is not to exceed 2,000 ppm.
SUMMARY:
ENVIRONMENTAL PROTECTION
AGENCY
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).
Limits
*
BILLING CODE 6560–50–P
VerDate Mar<15>2010
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
*
7681–38–1
[FR Doc. 2014–13229 Filed 6–5–14; 8:45 am]
ACTION:
VIII. Congressional Review Act
CAS Reg. No.
*
*
Sodium bisulfate ........................................
*
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).
Frm 00034
Fmt 4700
Sfmt 4700
*
*
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0654 and
EPA–HQ–OPP–2013–0655, is available
at https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton 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
ADDRESSES:
E:\FR\FM\06JNR1.SGM
06JNR1
Agencies
[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Rules and Regulations]
[Pages 32662-32666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13229]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0922; FRL-9910-50]
Sodium Bisulfate; 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 sodium bisulfate when used as an inert
ingredient in antimicrobial formulations on food contact surfaces in
public eating places, dairy processing equipment and food processing
equipment and utensils at no more than 2,000 ppm in final formulation.
Exponent on behalf of Ecolab, 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 sodium bisulfate.
DATES: This regulation is effective June 6, 2014. Objections and
requests for hearings must be received on or before August 5, 2014, 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-2012-0922, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30
[[Page 32663]]
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPP Docket is (703) 305-5805. Please review
the visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/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-2012-0922 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
August 5, 2014. 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-2012-0922, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10526) by
Ecolab, Inc., 370 N. Wabasha Street, St. Paul, MN 55102. The petition
requested that 40 CFR 180.940(a) be amended by establishing an
exemption from the requirement of a tolerance for residues of sodium
bisulfate (CAS Reg. No. 7681-38-1) when used as an inert ingredient in
antimicrobial pesticide formulations applied to food contact surfaces
in public eating places, dairy processing equipment and food processing
equipment and utensils at no more than 2,000 ppm in final formulation.
That document referenced a summary of the petition prepared by
Exponent, 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036,
the petitioner, which is available in the docket, https://www.regulations.gov.
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
[[Page 32664]]
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 sodium bisulfate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with sodium bisulfate
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 sodium bisulfate 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 acute oral toxicity of sodium bisulfate is low. The acute oral
LD50 in male rats was 2,800 mg/kg. It was minimally
irritating to the rabbit's skin and mildly irritating to the eyes. An
acute inhalation study was available with sodium sulfate. Inhalation
toxicity was not observed at 0.01 mg/l (the only dose tested). No
dermal toxicity or dermal sanitization studies were available in the
database.
Due to the lack of data for sodium bisulfate, both human metabolic
processes and toxicity data for sodium sulfate were used for the risk
characterization. Both sodium bisulfate and sodium sulfate readily
undergo hydrolysis and dissociate to sodium ions and sulfate ions in
the body.
Sodium sulfate was administered to male Sprague-Dawley rats at a
dietary concentration of 0.84% (approximately 320-400 mg/kg/day) for 27
and 44 weeks. There was no mortality, tumors, body weight change or
significant changes in food and/or water consumption. The NOAEL was
~320-400 mg/kg/day. In another study, male Sprague-dawley rats were
given in diet 0.0, 0.125, 0.250, 0.5, 1 and 2% sodium sulfate
(approximately 0, 125, 250, 500, 1,000 and 2,000 mg/kg/day) for 4
weeks. No changes in food and water consumption, body weight gain, food
conversion efficiency, urine production or diarrhea. Blood hemoglobin,
white blood count, serum alkaline phosphatase, inorganic phosphate and
gross organ pathology were also unaffected. The NOAEL was 2,000 mg/kg/
day (highest dose tested). A LOAEL was not observed in this study.
Sodium sulfate showed no mutagenic effect in the Ames test using
various strains of S. typhimurium (TA1535, TA1537, TA100, TA98) both
with and without S9 activation.
No carcinogenicity studies were available in the database. The
National Toxicology Program (NTP), International Agency for Research on
Cancer (IARC), and Occupational Safety & Health Administration (OSHA)
have not listed sodium bisulfate as a carcinogen. A DEREK analysis was
performed on sodium bisulfate and no structural alerts were detected.
EPA concluded that sodium bisulfate is unlikely to pose a carcinogenic
risk to humans based on lack of mutagenicity concerns for sodium
sulfate, lack of any structural alerts for carcinogenicity, lack of any
systemic toxicity at doses up to 2,800 mg/kg/day, and its metabolism to
form a sulfate which is natural constituent present in the body.
Sodium sulfate was included in a test of a method for rapid
assessment of teratogenicity. Pregnant ICR/SIM mice were given a
saturated aqueous solution of sodium sulfate orally by gavage to
deliver a dose of 2,800 mg/kg/day on days 8-12 of gestation. No
maternal deaths occurred and the average maternal weight gain during
the treatment period was not significantly different from that of
water-treated controls. Twenty-four litters were delivered alive, and
none were resorbed. The mean numbers of neonates delivered alive and
dead in each litter and the survival of neonates on day 3 were not
statistically significantly different from those of controls. Only body
weight on day 1 was statistically significantly greater than that of
controls. The maternal and developmental NOAEL = 2,800 mg/kg bw, the
only dose tested.
No immunotoxicity, neurotoxicity or reproductive toxicity studies
were available in the database.
Sodium bisulfate mammalian metabolism is essentially that of the
sodium cation and sulfate anion. As previously noted, when sodium
bisulfate is added to food products containing water or after ingestion
of sodium bisulfate it ionizes to sodium ions, hydrogen ions and
sulfate ions. Following ingestion, sulfate anions are predominantly not
absorbed from the gastrointestinal tract and are excreted unchanged in
urine. However, the sulfate anion is a normal constituent in the body,
predominantly resulting from the body's metabolism of sulfur-containing
food sources such as foods containing the essential amino acids
cysteine and methionine. Sulfate anions are vital components in a
number of human biosynthetic pathways such as cartilage production and
the formation of pancreatic digestive enzymes. Additionally, the
sulfate anion is also an important conjugate in the Phase II
conjugation/elimination of oxidized (OH) aromatic ring metabolites and
for hydroxyl steroid hormones, such as estrogen, where it acts as a
transport agent to target organ tissue receptors.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
There was no hazard identified in repeat dose developmental studies
at the limit dose of 2,800 mg/kg/day of sodium sulfate to either
parental animals or their offspring. No effects were seen in two
subchronic oral toxicity up to approximately 2,000 mg/kg/day of sodium
sulfate. Based on the metabolism of sodium bisulfate to sulfate and
sodium ions, both of which are essential components in the human
[[Page 32665]]
metabolic processes, there is a lack of toxicological concern. Thus,
due to its low potential hazard and lack of hazard endpoint, the Agency
has determined that a quantitative risk assessment using safety factors
applied to a point of departure protective of an identified hazard
endpoint is not appropriate.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sodium bisulfate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance (40 CFR
180.940(a)) such as food in contact with sanitized counters in public
eating places, utensils, dairy processing equipment and food processing
equipment as well as other uses which may result in dietary exposure.
However, because 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, no quantitative
aggregate exposure assessments were performed.
2. Dietary exposure from drinking water. Residues of sodium
bisuflate from uses in food contact sanitizing solutions, utensil,
dairy processing equipment and food processing equipment may enter
drinking water. However, because no hazard was identified for the acute
and chronic dietary assessment, or for the short-, intermediate-, and
long-term residential assessments as listed in this unit, no
quantitative aggregate exposure assessments were performed.
3. 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).
Residential (dermal and inhalation) exposure from food contact
surface sanitizing solutions for public eating places, dairy-processing
equipment, food-processing equipment and utensils are possible. Since
an endpoint for risk assessment was not identified, a quantitative
residential exposure assessment for sodium bisulfate was not conducted.
4. 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 sodium bisulfate to share a common mechanism of
toxicity with any other substances, and sodium bisulfate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
sodium bisulfate 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
The toxicity database for sodium bisulfate is adequate for
assessment of risks to infants and children and the potential exposure
is adequately characterized given the low toxicity of the chemical and
formation of sulfate ion. No hazard was identified and there is no
residual uncertainty regarding prenatal and/or postnatal toxicity. No
acute or subchronic neurotoxicity studies are available, but there were
no clinical signs of neurotoxicity or any systemic toxicity observed in
the available database at doses up to 2,800 mg/kg/day. No
developmental, reproductive, or teratogenic effects were seen in the
available studies at doses up to and including 2,800 mg/kg/day.
Based on this information, there is no concern at this time for
increased sensitivity to infants and children to sodium bisulfate when
used as an inert ingredient in pesticide formulations for food contact
surface sanitizing applications 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
Taking into consideration all available information on sodium
bisulfate, 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 sodium bisulfate under
reasonable foreseeable circumstances. Therefore, the establishment of
an exemption from tolerance under 40 CFR 180.940(a) for residues of
sodium bisulfate when used as an inert ingredient in pesticide
formulations applied to food contact surface sanitizing solutions for
public eating places, dairy processing equipment, food processing
equipment and utensils at no more than 2,000 ppm in formulation, 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 residues of
sodium bisulfate in or on any food commodities. EPA is establishing a
limitation on the amount of sodium bisulfate that may be used in
pesticide formulations. The limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will
not register any pesticide for sale or distribution that contains
greater than 2,000 ppm of sodium bisulfate in the pesticide
formulation.
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 sodium bisulfate.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for sodium bisulfate (CAS Reg. No.
7681-38-1) when used as an inert ingredient in antimicrobial pesticide
formulations applied to food contact surface sanitizing solutions for
public eating places, dairy processing equipment, food processing
equipment and utensils at no more than 2,000 ppm in formulation.
[[Page 32666]]
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 2, 2014.
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. 180.940, in the table in paragraph (a), alphabetically add
the following inert ingredient to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
Sodium bisulfate............... 7681-38-1 When ready for use, the
end-use concentration
is not to exceed 2,000
ppm.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2014-13229 Filed 6-5-14; 8:45 am]
BILLING CODE 6560-50-P