Carbon Dioxide; Exemption From the Requirement of a Tolerance, 25236-25240 [2011-10889]
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Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Rules and Regulations
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–1846; e-mail address:
shah.pv@epa.gov.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–1077; FRL–8873–1]
Carbon Dioxide; Exemption From the
Requirement of a Tolerance
This regulation establishes an
exemption from the requirement of a
tolerance for residues of carbon dioxide
(CAS Reg. No. 124–38–9) when used as
an inert ingredient as a propellant in
pre-harvest and post-harvest
applications and when applied to
animals. Whitmire Micro-Gen Research
Laboratories, Inc., c/o Landis
International, 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 carbon dioxide.
DATES: This regulation is effective May
4, 2011. Objections and requests for
hearings must be received on or before
July 5, 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).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–1077. All documents in the
docket are listed in the docket index
available at https://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
https://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: P. V.
Shah, Registration Division (7505P),
Office of Pesticide Programs,
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I. General Information
A. Does this action apply to me?
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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 https://
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–2007–1077 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before July 5, 2011. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 78, 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–2007–1077, by one of
the following methods:
• Federal eRulemaking Portal: https://
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 December
22, 2010 (75 FR 80489) (FRL–8857–8),
EPA issued a notice pursuant to section
408 of FFDCA, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP 0E7811) by Whitmire
Micro-Gen Research Laboratories, Inc.,
c/o Landis International, Inc., P.O. Box
5126, Valdosta, GA 31603–5126. The
petition requested that 40 CFR 180.910
and 40 CFR 180.930 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of carbon dioxide (CAS Reg. No. 124–
38–9) when used as an inert ingredient
as a propellant in pesticide formulations
applied pre–harvest and post–harvest
under 40 CFR 180.910 and applied to
animals under 40 CFR 180.930. That
notice referenced a summary of the
petition prepared by Whitmire MicroGen Research Laboratories, Inc., c/o
Landis International, Inc., the petitioner,
which is available in the docket,
https://www.regulations.gov. (Docket ID
number EPA–HQ–OPP–2007–1077).
There were no comments received in
response to the notice of filing.
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 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 carbon dioxide
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with carbon dioxide follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data for carbon dioxide 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. The
primary sources of data for this
assessment are the U.S. EPA’s 1991,
Reregistration Eligibility Decision
document (RED) that included carbon
dioxide (US EPA RED, 1991), and the
Report of the FQPA Tolerance
Reassessment Progress and Risk
Management Decision (TRED) for
Carbon Dioxide issued by EPA in 2004.
The Agency has not found any more
recent information that would change
the conclusions found in these
documents. Therefore, these documents
are being used to evaluate the proposed
exemption from the requirement of a
tolerance for use as an inert ingredient
as a propellant applied pre-harvest and
post-harvest under 40 CFR 180.910 and
applied to animals under 40 CFR
180.930. Specific information on the
studies received and the nature of the
adverse effects caused by carbon
dioxide can be found in these
documents at https://
www.regulations.gov, ‘‘Reregristration
Eligibility Document (RED) for Carbon
and Carbon Dioxide’’, ‘‘Lower Risk
Pesticide Chemical Focus Group’s
Assessment for Carbon Dioxide
Tolerance Reassessment (TRED)’’, and
‘‘PC code 800029; Decision Document
for Pesticide Petition 0E7811; Carbon
Dioxide (CAS Reg. No. 124–38–9) for
Use as an Inert Ingredient as a
Propellant Applied Pre-Harvest and
Post-Harvest Under 40 CFR 180.910 and
For Use on Animals Under 40 CFR
180.930.’’ found in docket ID number
EPA–HQ–OPP–2007–1077.
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The toxicology data for carbon
dioxide are all derived from inhalation
studies using high concentrations of
carbon dioxide. Although these data
show carbon dioxide does pose some
hazard at concentrations well above
normal atmospheric levels, these data
have limited relevance to evaluating the
safety of carbon dioxide residues in
food. Because it is a gas, carbon dioxide
would be expected to leave little or no
residues on plant commodities, and, to
the extent carbon dioxide is absorbed by
the plant, it would likely be converted
by the photosynthesis process into
sugars and other organic compounds
that are not of toxicological concern.
In evaluating the human toxicity of
carbon dioxide, it is relevant to consider
that ‘‘carbon dioxide is produced by the
body’s metabolism and is always
present in the body at about 6 percent
concentration. An average adult human
will produce more than 500g of carbon
dioxide daily under resting conditions,
and will produce much more when
active.’’ (US EPA RED, 1991). It is on
this basis that the Food and Drug
Administration has classified carbon
dioxide as Generally Recognized As
Safe (21 CFR 184.1240) as a direct food
additive. As the discussion in Unit IV.D.
on exposure reveals, even worst case
theoretical levels of carbon dioxide
residues in food would be dwarfed by
normal body levels of carbon dioxide.
B. Toxicological Points of Departure/
Levels of Concern
Considering its presence in the
environment and in the human body,
the additional toxicological contribution
of carbon dioxide through the proposed
use is expected to be minimal.
Therefore, the Agency has determined
that a qualitative assessment for all
pathways of human exposure to carbon
dioxide (food, drinking water, and
residential) is appropriate.
C. Aggregate Exposures
1. Dietary exposures (from food and
drinking water). In evaluating dietary
exposure to carbon dioxide, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from carbon
dioxide in food and drinking water as
follows:
No residue data were submitted for
carbon dioxide; however, carbon
dioxide is not expected to accumulate in
treated raw agricultural commodities,
rather, it will diffuse into the
atmosphere following application due to
its physical and chemical properties. In
the absence of reliable data regarding
dietary exposures to carbon dioxide, the
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Agency assessed dietary exposure using
its highly conservative Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM–FCID TM, Version 2.03). This
approach uses surrogate information to
derive upper bound exposure estimates
for the subject inert ingredient. Upper
bound exposure estimates are based on
the highest tolerance for a given
commodity from a list of high-use
insecticides, herbicides, and fungicides.
A complete description of the general
approach taken to assess inert
ingredient risks in the absence of
residue data is contained in the
memorandum entitled ‘‘Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and
Chronic Aggregate (Food and Drinking
Water) Dietary Exposure and Risk
Assessments for the Inerts.’’ (D361707,
S. Piper, 2/25/09) and can be found at
https://www.regulations.gov in docket ID
number EPA–HQ–OPP–2008–0738.
The Agency believes the assumptions
used to estimate dietary exposures led
to an extremely conservative assessment
of dietary risk due to a series of
compounded conservatisms. For
example, the model assumes that the
inert ingredients are used on all
commodities and that residues will be
present for every consumed commodity
at the highest tolerance level residue for
all food forms (including meat, milk,
poultry, and eggs), using default
processing factors for dried
commodities and assuming that 100%
of all crops are ‘‘treated’’ with the inert
ingredient. In addition, a default
concentration of 100 parts per billion
(ppb) was assumed for the inert
ingredient residues in drinking water.
Accordingly, although sufficient
information to quantify actual residue
levels in food is not available, the
compounding of these conservative
assumptions will lead to a significant
exaggeration of actual exposures. EPA
does not believe that this approach
underestimates exposure in the absence
of residue data. Even with the extremely
conservative nature of this screening
level model, the estimated dietary (food
and drinking water) exposures from
carbon dioxide when used in pesticide
formulations are 10,000 fold less than
the amount of carbon dioxide naturally
produced by the human body each day.
2. 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).
Obviously, humans are exposed through
respiration to carbon dioxide in the
atmosphere. Dietary exposure from
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naturally-carbonated and artificiallycarbonated beverages is also ubiquitous.
The discussion in this Unit focuses on
additional exposures from use of carbon
dioxide as a propellant in pesticide
products.
i. Dermal exposure. In evaluating the
potential for exposure from the use of
carbon dioxide in residential pesticide
products, dermal exposures of concern
are not anticipated due to its physical
and chemical properties and dissipating
nature.
ii. Inhalation exposures. Inhalation is
the primary route of exposure from
carbon dioxide because of its high vapor
pressure. Because of the potential
increased risk to acute inhalation
exposure from indoor uses, EPA used its
conservative Exposure and Fate
Assessment Screening Tool (E–FAST
v.2.0) screening level model to estimate
the potential for inhalation exposures
from indoor uses of carbon dioxide as a
propellant in residential pesticide
products. E–Fast was developed by
EPA’s Office of Pollution, Prevention
and Toxics as a tool to estimate
concentrations of chemicals released
from consumer products. Modeled
estimates of concentrations and doses
are designed to significantly
overestimate exposures for use in a
screening level assessment. For carbon
dioxide, E–FAST’s aerosol paint
scenario was selected because it
potentially resembles a use of a
residential pesticide product using
carbon dioxide as a propellant. This
scenario estimates potential acute
inhalation exposure over 20 minutes of
aerosol paint use in an enclosed utility
room. The Agency considers an acute
inhalation exposure to be a single event
occurring over a period of less than 24
hours. In this case, the E–FAST model
generated estimates of exposure are
expected to be greater than what is
reasonably anticipated from the use of
carbon dioxide as an inert ingredient in
residential-use pesticide products. The
concentration of carbon dioxide in
aerosol paint products used in the E–
FAST model was 100%. The results of
the conservative E–FAST modeling
show a peak concentration potential of
4,923 parts per million (ppm) (8,860
mg/m3). EPA does not expect actual
exposure from residential use of carbon
dioxide as a propellant as an inert
ingredient in pesticide products to
exceed these modeling estimates (peak
concentration potential of 4,923 ppm
(8,860 mg/m3)) and expects that outdoor
exposure concentrations would also be
lower.
3. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
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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 carbon dioxide to
share a common mechanism of toxicity
with any other substances, and carbon
dioxide does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that carbon dioxide 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
In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
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.
EPA has not used a quantitative risk
assessment approach based on safety
factors for carbon dioxide residues given
that normal atmospheric levels of
carbon dioxide do not pose a hazard,
carbon dioxide is necessary to the
proper functioning of the human body,
and exposure to carbon dioxide residues
from use in pesticide products is
miniscule compared to existing
environmental levels. For the same
reasons, an additional safety factor to
protect children is not needed.
E. Aggregate Risks and Determination of
Safety
EPA expects aggregate exposure to
carbon dioxide residues to pose no
appreciable risk to human health given
that normal atmospheric levels of
carbon dioxide do not pose a hazard.
Carbon dioxide is necessary to the
proper functioning of the human body,
and it is unlikely that the use of carbon
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dioxide as an inert ingredient as a
propellant in pesticide products will
result in residues in food that
measurably add to carbon dioxide
exposure. Even potential non-dietary
acute inhalation exposure from indoor
uses was conducted using the extremely
conservative E–FAST screening level
model (described under Unit IV.C.2b),
showed maximum levels of exposure of
4,923 ppm, well below the maximum
permitted exposure limits established as
safe by Office of Safety Health
Administration (OSHA) or National
Institute of Occupational and Health
(NIOSH) (30,000 ppm).
Taking into consideration all available
information on carbon dioxide, 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 carbon dioxide under
reasonably foreseeable circumstances.
Therefore, the establishment of an
exemption from tolerance for residues of
carbon dioxide (CAS Reg. No. 124–38–
9) when used as an inert ingredient as
a propellant in pesticide formulations
applied pre- and post-harvest under 40
CFR 180.910 and when applied to
animals under 40 CFR 180.930 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.
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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 carbon dioxide.
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VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 and 40 CFR
180.930 for residues of carbon dioxide
(CAS Reg. No. 124–38–9) when used as
an inert ingredient in pesticide
formulations as a propellant in pre- and
post-harvest applications under 40 CFR
180.910 and when applied to animals
under 40 CFR 180.930.
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
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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
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: April 26, 2011.
G. Jeffrey Herndon,
Acting 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 § 180.910, the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
■
§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from
the requirement of a tolerance.
*
E:\FR\FM\04MYR1.SGM
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*
04MYR1
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Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Rules and Regulations
Inert ingredients
Limits
*
*
*
*
Carbon Dioxide (CAS Reg. No. 124–38–9) ...................................................................
*
*
None ...................................
*
*
*
3. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
■
*
Uses
*
*
*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
*
*
*
Inert ingredients
Limits
*
*
*
*
Carbon Dioxide (CAS Reg. No. 124–38–9) ...................................................................
*
*
None ...................................
*
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*
[FR Doc. 2011–10889 Filed 5–3–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0771; FRL–8873–3]
Clothianidin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of clothianidin in
or on mustard, seed. Bayer CropScience
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May
4, 2011. Objections and requests for
hearings must be received on or before
July 5, 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–2008–0771. All documents in the
docket are listed in the docket index
available at https://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
SUMMARY:
mstockstill on DSKH9S0YB1PROD with RULES
*
Propellant.
VerDate Mar<15>2010
16:43 May 03, 2011
Jkt 223001
*
*
available in the electronic docket at
https://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:
Marianne Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8043; e-mail address:
lewis.marianne@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 those engaged in the
following activities:
• 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 to provide 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
PO 00000
Frm 00030
Fmt 4700
Uses
Sfmt 4700
*
*
Propellant.
*
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 access electronic copies of
this document?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I file an objection or hearing
request?
Under section 408(g) of FFDCA, 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–2008–0771 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before July 5, 2011.
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 that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
E:\FR\FM\04MYR1.SGM
04MYR1
Agencies
[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Rules and Regulations]
[Pages 25236-25240]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10889]
[[Page 25236]]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-1077; FRL-8873-1]
Carbon Dioxide; 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 carbon dioxide (CAS Reg. No. 124-38-9)
when used as an inert ingredient as a propellant in pre-harvest and
post-harvest applications and when applied to animals. Whitmire Micro-
Gen Research Laboratories, Inc., c/o Landis International, 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 carbon dioxide.
DATES: This regulation is effective May 4, 2011. Objections and
requests for hearings must be received on or before July 5, 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-2007-1077. All documents in the
docket are listed in the docket index available at https://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 https://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: P. V. Shah, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-1846; e-mail address: shah.pv@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 https://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-2007-1077 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 5, 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 78, 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-2007-1077, by one of the following methods:
Federal eRulemaking Portal: https://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 December 22, 2010 (75 FR 80489) (FRL-
8857-8), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP 0E7811)
by Whitmire Micro-Gen Research Laboratories, Inc., c/o Landis
International, Inc., P.O. Box 5126, Valdosta, GA 31603-5126. The
petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by
establishing an exemption from the requirement of a tolerance for
residues of carbon dioxide (CAS Reg. No. 124-38-9) when used as an
inert ingredient as a propellant in pesticide formulations applied pre-
harvest and post-harvest under 40 CFR 180.910 and applied to animals
under 40 CFR 180.930. That notice referenced a summary of the petition
prepared by Whitmire Micro-Gen Research Laboratories, Inc., c/o Landis
International, Inc., the petitioner, which is available in the docket,
https://www.regulations.gov. (Docket ID number EPA-HQ-OPP-2007-1077).
There were no comments received in response to the notice of filing.
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
[[Page 25237]]
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 carbon dioxide including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with carbon dioxide
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data for carbon dioxide
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. The primary sources of data for this
assessment are the U.S. EPA's 1991, Reregistration Eligibility Decision
document (RED) that included carbon dioxide (US EPA RED, 1991), and the
Report of the FQPA Tolerance Reassessment Progress and Risk Management
Decision (TRED) for Carbon Dioxide issued by EPA in 2004. The Agency
has not found any more recent information that would change the
conclusions found in these documents. Therefore, these documents are
being used to evaluate the proposed exemption from the requirement of a
tolerance for use as an inert ingredient as a propellant applied pre-
harvest and post-harvest under 40 CFR 180.910 and applied to animals
under 40 CFR 180.930. Specific information on the studies received and
the nature of the adverse effects caused by carbon dioxide can be found
in these documents at https://www.regulations.gov, ``Reregristration
Eligibility Document (RED) for Carbon and Carbon Dioxide'', ``Lower
Risk Pesticide Chemical Focus Group's Assessment for Carbon Dioxide
Tolerance Reassessment (TRED)'', and ``PC code 800029; Decision
Document for Pesticide Petition 0E7811; Carbon Dioxide (CAS Reg. No.
124-38-9) for Use as an Inert Ingredient as a Propellant Applied Pre-
Harvest and Post-Harvest Under 40 CFR 180.910 and For Use on Animals
Under 40 CFR 180.930.'' found in docket ID number EPA-HQ-OPP-2007-1077.
The toxicology data for carbon dioxide are all derived from
inhalation studies using high concentrations of carbon dioxide.
Although these data show carbon dioxide does pose some hazard at
concentrations well above normal atmospheric levels, these data have
limited relevance to evaluating the safety of carbon dioxide residues
in food. Because it is a gas, carbon dioxide would be expected to leave
little or no residues on plant commodities, and, to the extent carbon
dioxide is absorbed by the plant, it would likely be converted by the
photosynthesis process into sugars and other organic compounds that are
not of toxicological concern.
In evaluating the human toxicity of carbon dioxide, it is relevant
to consider that ``carbon dioxide is produced by the body's metabolism
and is always present in the body at about 6 percent concentration. An
average adult human will produce more than 500g of carbon dioxide daily
under resting conditions, and will produce much more when active.'' (US
EPA RED, 1991). It is on this basis that the Food and Drug
Administration has classified carbon dioxide as Generally Recognized As
Safe (21 CFR 184.1240) as a direct food additive. As the discussion in
Unit IV.D. on exposure reveals, even worst case theoretical levels of
carbon dioxide residues in food would be dwarfed by normal body levels
of carbon dioxide.
B. Toxicological Points of Departure/Levels of Concern
Considering its presence in the environment and in the human body,
the additional toxicological contribution of carbon dioxide through the
proposed use is expected to be minimal. Therefore, the Agency has
determined that a qualitative assessment for all pathways of human
exposure to carbon dioxide (food, drinking water, and residential) is
appropriate.
C. Aggregate Exposures
1. Dietary exposures (from food and drinking water). In evaluating
dietary exposure to carbon dioxide, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from carbon dioxide in food and drinking water as
follows:
No residue data were submitted for carbon dioxide; however, carbon
dioxide is not expected to accumulate in treated raw agricultural
commodities, rather, it will diffuse into the atmosphere following
application due to its physical and chemical properties. In the absence
of reliable data regarding dietary exposures to carbon dioxide, the
[[Page 25238]]
Agency assessed dietary exposure using its highly conservative Dietary
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID \TM\, Version 2.03). This approach uses surrogate
information to derive upper bound exposure estimates for the subject
inert ingredient. Upper bound exposure estimates are based on the
highest tolerance for a given commodity from a list of high-use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.''
(D361707, S. Piper, 2/25/09) and can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
The Agency believes the assumptions used to estimate dietary
exposures led to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. For example, the model
assumes that the inert ingredients are used on all commodities and that
residues will be present for every consumed commodity at the highest
tolerance level residue for all food forms (including meat, milk,
poultry, and eggs), using default processing factors for dried
commodities and assuming that 100% of all crops are ``treated'' with
the inert ingredient. In addition, a default concentration of 100 parts
per billion (ppb) was assumed for the inert ingredient residues in
drinking water. Accordingly, although sufficient information to
quantify actual residue levels in food is not available, the
compounding of these conservative assumptions will lead to a
significant exaggeration of actual exposures. EPA does not believe that
this approach underestimates exposure in the absence of residue data.
Even with the extremely conservative nature of this screening level
model, the estimated dietary (food and drinking water) exposures from
carbon dioxide when used in pesticide formulations are 10,000 fold less
than the amount of carbon dioxide naturally produced by the human body
each day.
2. 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). Obviously, humans
are exposed through respiration to carbon dioxide in the atmosphere.
Dietary exposure from naturally-carbonated and artificially-carbonated
beverages is also ubiquitous. The discussion in this Unit focuses on
additional exposures from use of carbon dioxide as a propellant in
pesticide products.
i. Dermal exposure. In evaluating the potential for exposure from
the use of carbon dioxide in residential pesticide products, dermal
exposures of concern are not anticipated due to its physical and
chemical properties and dissipating nature.
ii. Inhalation exposures. Inhalation is the primary route of
exposure from carbon dioxide because of its high vapor pressure.
Because of the potential increased risk to acute inhalation exposure
from indoor uses, EPA used its conservative Exposure and Fate
Assessment Screening Tool (E-FAST v.2.0) screening level model to
estimate the potential for inhalation exposures from indoor uses of
carbon dioxide as a propellant in residential pesticide products. E-
Fast was developed by EPA's Office of Pollution, Prevention and Toxics
as a tool to estimate concentrations of chemicals released from
consumer products. Modeled estimates of concentrations and doses are
designed to significantly overestimate exposures for use in a screening
level assessment. For carbon dioxide, E-FAST's aerosol paint scenario
was selected because it potentially resembles a use of a residential
pesticide product using carbon dioxide as a propellant. This scenario
estimates potential acute inhalation exposure over 20 minutes of
aerosol paint use in an enclosed utility room. The Agency considers an
acute inhalation exposure to be a single event occurring over a period
of less than 24 hours. In this case, the E-FAST model generated
estimates of exposure are expected to be greater than what is
reasonably anticipated from the use of carbon dioxide as an inert
ingredient in residential-use pesticide products. The concentration of
carbon dioxide in aerosol paint products used in the E-FAST model was
100%. The results of the conservative E-FAST modeling show a peak
concentration potential of 4,923 parts per million (ppm) (8,860 mg/
m\3\). EPA does not expect actual exposure from residential use of
carbon dioxide as a propellant as an inert ingredient in pesticide
products to exceed these modeling estimates (peak concentration
potential of 4,923 ppm (8,860 mg/m\3\)) and expects that outdoor
exposure concentrations would also be lower.
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 carbon dioxide to share a common mechanism of
toxicity with any other substances, and carbon dioxide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
carbon dioxide 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
In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall
apply an additional tenfold (10X) margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the 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.
EPA has not used a quantitative risk assessment approach based on
safety factors for carbon dioxide residues given that normal
atmospheric levels of carbon dioxide do not pose a hazard, carbon
dioxide is necessary to the proper functioning of the human body, and
exposure to carbon dioxide residues from use in pesticide products is
miniscule compared to existing environmental levels. For the same
reasons, an additional safety factor to protect children is not needed.
E. Aggregate Risks and Determination of Safety
EPA expects aggregate exposure to carbon dioxide residues to pose
no appreciable risk to human health given that normal atmospheric
levels of carbon dioxide do not pose a hazard. Carbon dioxide is
necessary to the proper functioning of the human body, and it is
unlikely that the use of carbon
[[Page 25239]]
dioxide as an inert ingredient as a propellant in pesticide products
will result in residues in food that measurably add to carbon dioxide
exposure. Even potential non-dietary acute inhalation exposure from
indoor uses was conducted using the extremely conservative E-FAST
screening level model (described under Unit IV.C.2b), showed maximum
levels of exposure of 4,923 ppm, well below the maximum permitted
exposure limits established as safe by Office of Safety Health
Administration (OSHA) or National Institute of Occupational and Health
(NIOSH) (30,000 ppm).
Taking into consideration all available information on carbon
dioxide, 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 carbon dioxide under reasonably
foreseeable circumstances. Therefore, the establishment of an exemption
from tolerance for residues of carbon dioxide (CAS Reg. No. 124-38-9)
when used as an inert ingredient as a propellant in pesticide
formulations applied pre- and post-harvest under 40 CFR 180.910 and
when applied to animals under 40 CFR 180.930 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 carbon dioxide.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 and 40 CFR 180.930 for residues of
carbon dioxide (CAS Reg. No. 124-38-9) when used as an inert ingredient
in pesticide formulations as a propellant in pre- and post-harvest
applications under 40 CFR 180.910 and when applied to animals under 40
CFR 180.930.
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 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: April 26, 2011.
G. Jeffrey Herndon,
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 ingredient to read as follows:
Sec. 180.910 Inert ingredients used pre-harvest and post-harvest;
exemptions from the requirement of a tolerance.
* * * * *
[[Page 25240]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Carbon Dioxide (CAS Reg. No. 124- None.............. Propellant.
38-9).
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, the table is amended by adding alphabetically the
following inert ingredient to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Carbon Dioxide (CAS Reg. No. 124- None.............. Propellant.
38-9).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2011-10889 Filed 5-3-11; 8:45 am]
BILLING CODE 6560-50-P