[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Rules and Regulations]
[Page 9226-9232]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe08-22]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0916; FRL-8343-6]
Formetanate Hydrochloride; Pesticide Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
[[Page 9227]]
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of formetanate hydrochloride, m-
[[(dimethylamino)methylene]amino]phenyl methylcarbamate hydrochloride,
in or on dry bulb onions. This action is in response to EPA's granting
of emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on dry bulb onions. This regulation establishes a maximum permissible
level for residues of formetanate hydrochloride in this food commodity.
The tolerance expires and is revoked on December 31, 2008.
DATES: This regulation is effective February 20, 2008. Objections and
requests for hearings must be received on or before April 21, 2008, 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-2006-0916. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are 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: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: ertman.andrew@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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA),
any person may file an objection to any aspect of this regulation and
may also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0916 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 on or
before April 21, 2008.
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 your copies, identified by docket ID
number EPA-HQ-OPP-2006-0916., by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket'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. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of FFDCA, 21 U.S.C. 346a, is establishing a tolerance for
residues of the insecticide formetanate hydrochloride, m-
[[(dimethylamino)methylene]amino]phenyl methylcarbamate hydrochloride,
in or on onions, dry bulb at 0.02 parts per million (ppm). This
tolerance expires and is revoked on December 31, 2008. EPA will publish
a document in the Federal Register to remove the revoked tolerance from
the CFR.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances
[[Page 9228]]
to set binding precedents for the application of section 408 of FFDCA
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Formetanate Hydrochloride on Dry Bulb
Onions and FFDCA Tolerances
The states of Idaho, Oregon, Colorado, Michigan, Ohio, Wisconsin,
Texas and New York requested the use of formetanate hydrochloride,
formulated as the product Carzol, on dry bulb onions to control thrips.
According to these states, the available registered alternatives were
not providing adequate control of this pest and without the use of
Carzol, growers would suffer significant economic losses. After having
reviewed the submissions, EPA concurred that emergency conditions exist
and authorized under FIFRA section 18 the use of formetanate
hydrochloride on dry bulb onions for control of thrips in Idaho,
Oregon, Colorado, Michigan, Ohio, Wisconsin, Texas and New York.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of formetanate hydrochloride
in or on dry bulb onions. In doing so, EPA considered the safety
standard in section 408(b)(2) of FFDCA, and EPA decided that the
necessary tolerance under section 408(l)(6) of FFDCA would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment as provided in
section 408(l)(6) of FFDCA. Although this tolerance expires and is
revoked on December 31, 2008, under section 408(l)(5) of FFDCA,
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on dry bulb onions after that date will not
be unlawful, provided the pesticide is applied in a manner that was
lawful under FIFRA, and the residues do not exceed a level that was
authorized by this tolerance at the time of that application. EPA will
take action to revoke this tolerance earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether formetanate
hydrochloride meets EPA's registration requirements for use on dry bulb
onions or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
tolerance serves as a basis for registration of formetanate
hydrochloride by a State for special local needs under FIFRA section
24(c). Nor does this tolerance serve as the basis for persons in any
State other than Idaho, Oregon, Colorado, Michigan, Ohio, Wisconsin,
Texas and New York to use this pesticide on this crop under section 18
of FIFRA. For additional information regarding the emergency exemption
for formetanate hydrochloride, contact the Agency's Registration
Division at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
Consistent with section 408(b)(2)(D) of FFDCA, 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
formetanate hydrochloride and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of FFDCA, for a time-
limited tolerance for residues of formetanate hydrochloride in or on
onions, dry bulb at 0.02 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerance follows. In
addition, an Interim Reregistration Eligibility Decision (IRED)
Document was published in March 2006. This IRED was proposed to become
a final RED in the N-methyl Carbamate Revised Cumulative Risk
Assessment that was made available for public comment on September 26,
2007. This IRED/RED provides additional information and more detail on
the dietary exposures and risks associated with formetanate
hydrochloride. The link for this document on the EPA website is: http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf
.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose where the RfD is
equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF).
Where an additional safety factor is retained due to concerns unique to
the FQPA, this additional factor is applied to the RfD by dividing the
RfD by such additional factor. The acute population Adjusted Dose
(aPAD) is a modification of the RfD to accommodate this type of FQPA
SF.
For non-dietary risk assessments (other than cancer) the UF is used
to
[[Page 9229]]
determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for formetanate hydrochloride used for human risk assessment
is shown in the following Table. In addition, as noted above in Unit
IV., a detailed summary of the toxicological endpoints can be found in
the Formetanate Hydrochloride IRED (which, as noted previously, is now
proposed to become a final RED) (http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf
).
Table 1.--Summary of Toxicological Endpoints and Doses for Formetanate Hydrochloride Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Hazard Based FQPA Endpoint for Risk
Exposure Scenario Dose UF/MOE Safety Factor Assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of Not applicable; the endpoint selected for the general population (see
age below) based on, and therefore protective of, this population subgroup.
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population BMDL110 = 0.065 mg/kg 1X BMDL10 for female pup
UF = 100 (a)........... Acute PAD = 0.00065 mg/ brain AChE in the
aRfD = 0.00065 mg/kg... kg.. Comparative ChE study.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary Not applicable; data on formetanate hydrochloride indicate that the
magnitude of cholinesterase inhibition (ChEI) does not increase with
continued exposure because of the rapid reversibility of ChEI.
Therefore, chronic exposure to formetanate hydrochloride may be
considered as a series of acute exposures.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short and Not applicable. There are no current registrations for residential uses.
intermediate terms
----------------------------------------------------------------------------------------------------------------
Cancer Group E Carcinogen; Classification: ``Not likely.''
----------------------------------------------------------------------------------------------------------------
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.276) for the residues of formetanate
hydrochloride, in or on a variety of raw agricultural commodities. Risk
assessments were conducted by EPA to assess dietary exposures from
formetanate hydrochloride in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. A tier 3, acute probabilistic dietary risk
assessment was conducted using the Dietary Exposure Evaluation Model
(DEEM-FCID, Version 2.03), which uses food consumption data from the
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from
1994-1996 and 1998. Drinking water exposure was incorporated directly
into the dietary exposure analysis. The dietary assessment relies on
Pesticide Data Program (PDP) monitoring data from 2001 for oranges,
grapefruit and pears. Anticipated residues for apples are derived using
field trial data, since the PDP data reflect the late-season use on
apples, which is no longer being supported by the registrant. Field
trial residue data were submitted with the exemption request for both
peeled and unpeeled onions. Since onions are generally peeled prior to
eating, the peeled onion data were used in this assessment. No
adjustment was made to account for the percent of onions treated (i.e.,
100% crop treated was assumed).
ii. Chronic exposure. Cholinesterase inhibition (ChEI) is the only
manifestation of exposure to formetanate HCl observed in the variety of
toxicity studies conducted to support reregistration of this active
ingredient. These formetanate HCl studies indicate that the magnitude
of cholinesterase inhibition (ChEI) does not increase with continued
exposure because of the rapid reversibility of ChEI. Therefore, chronic
exposure to formetanate HCl may be considered as a series of acute
exposures, indicating that a chronic dietary exposure assessment is not
necessary.
iii. Cancer. Formetanate hydrochloride is classified as a group
``E'' carcinogen, and therefore a cancer exposure assessment is not
required.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated levels of pesticide residues in food and
the actual levels of pesticide chemicals that have been measured in
food. If EPA relies on such information, EPA must pursuant to FFDCA
section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a
[[Page 9230]]
comprehensive dietary exposure analysis and risk assessment for
formetanate hydrochloride in drinking water. Because the Agency does
not have comprehensive monitoring data, drinking water concentration
estimates are made by reliance on simulation or modeling taking into
account data on the physical characteristics of formetanate
hydrochloride. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.
Tier II screening models, Pesticide Root Zone Model and Exposure
Analysis Modeling System (PRZM and EXAMS) with the Index Reservoir and
Percent Cropped Area adjustment (IR-PCA PRZM/EXAMS) were used to
determine estimated surface water concentrations of formetanate HCL
following application to apples in North Carolina, Pennsylvania and
Oregon. As noted in previous sections of this document, additional
detailed information regarding formetanate hydrochloride, including
dietary exposure from drinking water can be found in the March 2006
IRED (http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf).
Based on the PRZM/EXAMS model described above, the highest
estimated environmental concentration (EEC) of formetanate
hydrochloride for acute exposures is estimated to be 7.7 parts per
billion (ppb) for surface water based on applications to apples in
North Carolina.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\, Version 2.03).
For the acute dietary risk assessment, the entire distribution of
estimated daily exposure values from the PRZM-EXAMS run was used
probabilistically in the analysis to assess the contribution to
drinking water.
3. Non-dietary exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Formetanate hydrochloride is not registered for use on any sites
that would result in residential exposure.
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.''
Formetanate hydrochloride belongs to the N-methyl carbamate class
of chemicals for which a revised cumulative assessment has recently (72
FR 54656, September 26, 2007) been published by the Agency in the
Federal Register for comment (http://www.epa.gov/oppsrrd1/REDs/nmc_revised_cra.pdf
). This ``Revised N-Methyl Carbamate Cumulative Risk
Assessment'' concludes that the cumulative risks from food, water, and
residential exposure to N-methyl carbamates do not exceed the Agency's
level of concern.
Field trial data for formetanate hydrochloride residues on peeled
onion (the value used in dietary risk assessment) are below the LOD of
0.0007 ppm. Field trial data are much more conservative (often 1 to 2
orders of magnitude higher in residue) than the PDP data generally used
for registered uses in the cumulative assessment. Using residue values
at half the LOQ of 0.002 ppm had negligible impact on dietary risk for
formetanate hydrochloride in the N-methyl carbamate cumulative
assessment. Furthermore, food derived from onion is not a significant
contributor to the diet of infants less than 1 year old (the most
sensitive subpopulation in the N-methyl carbamate cumulative
assessment).
If a tolerance were currently in place for formetanate
hydrochloride use on onion, it would be among the ``Insignificant
Contributors'' that, in their entirety, account for only 3% of the
total risk in the N-methyl carbamate ``risk cup.'' These
``Insignificant Contributors'' had their tolerances fully reassessed on
June 29, 2006 prior to completion of the full N-methyl carbamate
cumulative assessment. See http://www.epa.gov/pesticides/cumulative/carbamates_commodity.pdf
.
In light of these residue findings for formetanate hydrochloride on
onion, the Agency does not expect any significant contribution of
exposure to the cumulative assessment and therefore, the conclusions
from the revised cumulative risk assessment for the N-methyl carbamates
remain unaffected by this emergency use on onions.
C. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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 that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. Formetanate HCl did not
result in developmental toxicity in either rats or rabbits or in
reproductive effects in the multi-generation reproduction study. There
was no indication of increased offspring susceptibility in these
studies.
3. Conclusion. There is a complete toxicity database for
formetanate hydrochloride and exposure data are complete or are
estimated based on data that reasonably accounts for potential
exposures. The Agency determined that the FQPA Safety Factor can be
removed (reduced to 1X) due to lack of concern and no residual
uncertainties for prenatal and/or postnatal toxicity. Due to the
conservative, health-protective nature of the models and the input
parameters, EPA believes exposure via drinking water will not be
underestimated. Therefore, the current hazard and exposure data support
reducing the FQPA Safety Factor to 1X. Additional information may be
found in the March 2006 IRED (http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf
)
D. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on the
concentration of a pesticide in drinking water that can be considered
safe in light of total aggregate exposure to a pesticide in food and
residential uses. More information on the use of DWLOCs in dietary
aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic
[[Page 9231]]
estimate of exposure because actual body weights and water consumption
from the CSFII are used. The combined food and water exposures are then
added to estimated exposure from residential sources to calculate
aggregate risks. The resulting exposure and risk estimates are still
considered to be high end, due to the assumptions used in developing
drinking water modeling inputs. The risk assessment for formetanate
hydrochloride used in this tolerance document uses this approach of
incorporating water exposure directly into the dietary exposure
analysis.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to formetanate hydrochloride will occupy 36% of the aPAD for the U.S.
population, 29% of the aPAD for females 13 years and older, 117% of the
aPAD for all infants less than 1 year old and 69% of the aPAD for
children 1 to 2 years old.
These risk estimates are based on upper-end (99.9th percentile)
exposure estimates for each population. The 99.9th percentile is used
``in the first instance'' in estimating exposure for probabilistic
acute dietary exposure assessments which are based on highly refined
exposure inputs. EPA evaluates whether to vary from use of the 99.9th
percentile in assessing exposure based on considerations primarily
related to the conservativeness or lack thereof of the various inputs
to the assessment, with particular emphasis on an examination of the
conservativeness of those inputs that most greatly influence the risk
estimate. There are several inputs to the current assessment that are
quite conservative. First, anticipated residue data for apples is based
on field trial data as opposed to PDP data; this is likely to
substantially overstate residue levels in apples as consumed. Second,
EPA assumed that 100% of the onion crop will be treated with
formetanate. Actual percent crop treated is likely to be substantially
lower than that, if for no other reason than use is only permitted in a
few States. Third, and most important, the estimated residue levels in
water are very conservative compared to the refined food estimates that
generally cause EPA to rely on the 99.9th percentile. This is
particularly critical because the estimated dietary exposure from
drinking water is the principal driver of the risk assessment,
accounting for 106% of the aPAD for infants when considered alone.
The drinking water exposure estimates were based on PRZM-EXAMS
surface water modeling results. The PRZM-EXAMS model is intended to
provide upper-end estimates of pesticide residues in surface water. The
models use an Index Reservoir based on an actual drinking water
reservoir in Illinois (Shipman City Lake) that is known to be
vulnerable to pesticide contamination. Pesticide loadings to the water
body are modeled using local soils and weather data to reflect crop-
specific scenarios around the country. The conservativeness of this
model and its tendency to overestimate residues was documented by EPA
in an earlier tolerance proceeding. (69 FR 30042, 30060-30063, May 26,
2004). Additionally, there are pesticide-specific factors here that
insure that PRZM-EXAMS modeling results will overestimate residue
levels in drinking water.
The modeling results were adjusted by a Percent Cropped Area (PCA)
factor of 0.87. In other words, the results assume that 87% of the
watershed is cropped in apples (or other crops with similar use of
formetanate) and that 100% of these crops are treated with formetanate
HCl. The PCA factor does not consider the percent of the crop that is
actually treated because detailed pesticide usage data (i.e., at the
state or watershed level) are generally unavailable or inadequate. In
the case of formetanate HCl, however, the national usage estimates
suggest that a PCA factor of 0.87 significantly overestimates drinking
water concentrations in many areas. Maximum percent crop treated (PCT)
estimates for apple, pear, peach, orange and grapefruit are 5% or less,
and maximum PCT estimates for lemon/lime and nectarine are 15% and 46%,
respectively. Thus, while it is theoretically possible there could be
water basins in the United States that are planted almost entirely with
crops that may lawfully be treated with formetanate HCl and that all
crops in that water basin would be treated with formetanate HCl, the
probability of these two unlikely events occurring together is very
low.
Accordingly, it is EPA's judgment that use of the 99.9th percentile
to estimate exposure significantly overstates exposure and thus the
estimated slight exceedance of the aPAD (117%) for infants does not
show a risk of concern. This is confirmed by the fact the estimated
exposure for this population group declines below the aPAD at the
99.86th percentile level.
2. Chronic risk. As noted in Unit IV.B.1.ii. of this preamble,
cholinesterase inhibition (ChEI) is the only manifestation of exposure
to formetanate hydrochloride observed in the variety of toxicity
studies conducted to support reregistration of this active ingredient.
These formetanate hydrochloride studies indicate that the magnitude of
cholinesterase inhibition (ChEI) does not increase with continued
exposure because of the rapid reversibility of ChEI. Therefore, chronic
exposure to formetanate hydrochloride may be considered as a series of
acute exposures, indicating that a chronic dietary risk assessment is
not necessary. Inasmuch as EPA has concluded that there is no acute
risk of concern, chronic risk is also not of concern.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Formetanate hydrochloride is not registered for use on any sites
that would result in residential exposure. Therefore, the aggregate
risk is the sum of the chronic risk from food and water, which was
previously addressed and is not of concern.
4. Aggregate cancer risk for U.S. population. Formetanate
hydrochloride is classified as a group ``E'' carcinogen and is
therefore not expected to pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to formetanate hydrochloride residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate method is available for enforcement of the currently
established plant tolerances Gas Chromatography with Electron Capture
Detection (GC/ECD method (Method I); PAM Vol. II). For purposes of the
Section 18 emergency exemption, EPA concludes that this method is
sufficient to enforce the recommended onion tolerance.
B. International Residue Limits
There are no CODEX residue limits for residues of formetanate
hydrochloride on onions, therefore, harmonization is not an issue.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
formetanate hydrochloride; m-[[(dimethylamino)methylene]amino]phenyl
methylcarbamate hydrochloride in or on onion, dry bulb at 0.02 ppm.
This time-limited tolerance expires and is revoked on December 31,
2008.
[[Page 9232]]
VII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of FFDCA. 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 rule has been exempted from review under Executive Order
12866, this rule is not subject to Executive Order 13211, 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 FIFRA section 18 exemption under section 408 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 6, 2000) do not apply to this rule. In addition, This
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) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. Section 180.276 is amended by adding text to paragraph (b) to reads
as follows:
Sec. 180.276 Formetanate hydrochloride; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the insecticide formetanate hydrochloride
(m-[[(dimethylamino) methylene]amino]phenyl methylcarbamate
hydrochloride) in connection with use of the pesticide under section 18
emergency exemptions granted by EPA. The tolerances in this paragraph
will expire and are revoked on the date specified in the following
table.
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Onion, dry bulb 0.02 12/31/08
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-2906 Filed 2-19-08; 8:45 am]
BILLING CODE 6560-50-P