[Federal Register: April 7, 2004 (Volume 69, Number 67)]
[Rules and Regulations]
[Page 18255-18263]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap04-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0257; FRL-7351-4]
Mesosulfuron-Methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
mesosulfuron-methyl in or on wheat. Bayer CropScience requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective April 7, 2004. Objections and
requests for hearings, identified by docket ID
[[Page 18256]]
number OPP-2003-0257, must be received on or before June 7, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: tompkins.jim@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 111), e.g., Agricultural
workers; Greenhouse, nursery, and floriculture workers; Farmers.
Animal production (NAICS 112), e.g., Cattle
ranchers and farmers, Dairy cattle farmers, Livestock farmers.
Food manufacturing (NAICS 311), e.g.,
Agricultural workers; Farmers; Greenhouse, nursery, and floriculture
workers; Ranchers; Pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g.,
Agricultural workers; Commercial applicators; Farmers; Greenhouse,
nursery, and floriculture workers; Residential users.
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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0257. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRI), Rm. 119, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. This docket facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.A frequently updated
electronic version of 40 CFR part 180 is available on E-CFR Beta Site
Two at http://www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of October 22, 2003 (68 FR 60378) (FRL-
7322-5), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 1F6298) by Bayer CropScience, 2 T.W.
Alexander Dr., Research Triangle Park, NC 27709. That notice included a
summary of the petition prepared by Bayer CropScience, the registrant.
One comment was received in response to the notice of filing from a
private citizen.
The petition requested that 40 CFR 180.428 be amended by
establishing a tolerance for residues of the herbicide methyl 2-
[[[[(4,6-dimethoxy-2-pyrimidinyl) amino]carbonyl]amino]sulfonyl]-4-
[[(methylsulfonyl)amino] methyl]benzoate, mesosulfuron-methyl, in or on
the raw agricultural commodities wheat grain at 0.03, wheat forage at
0.60, wheat straw at 0.30, wheat hay at 0.06, wheat germ at 0.10,
aspirated grain fractions at 0.25, and milled byproducts at 0.03 parts
per million (ppm). EPA determined that the tolerance for aspirated
grain fractions should be 0.60 ppm instead of 0.25 ppm as was proposed
by the registrant based on the results of submitted residue studies.
Further, based on the results of submitted studies of residues in
animal commodities, EPA determined that a tolerance should be set for
meat byproducts of cattle, goat, horse, and sheep at the limit of
quantitation (LOQ) for the enforcement method, which is 0.01 ppm. EPA
also determined that no tolerance is needed for milled byproducts
because mesosulfuron does not concentrate in milled byproducts and,
therefore, residues in milled byproducts are covered by the tolerance
for wheat grain.
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....''
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 the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this
[[Page 18257]]
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure, consistent with section 408(b)(2)
of FFDCA, for a tolerance for residues of mesosulfuron-methyl on the
raw agricultural commodities aspirated grain fractions at 0.60 ppm,
meat byproducts of cattle, goat, horse, and sheep meat byproducts at
0.01 ppm, wheat forage at 0.60 ppm, wheat germ at 0.10 ppm, wheat grain
at 0.03 ppm, wheat hay at 0.06 ppm, and wheat straw at 0.30 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
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 nature of the toxic effects caused by mesosulfuron-methyl
are discussed in Table 1 of this unit as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies reviewed.
Table 1.--Toxicology Profile for Mesosulfuron-Methyl
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 908/977 Male/
toxicity rodents Female (M/F)
milligram/kilogram/
day (mg/kg/day)
LOAEL = not observed.
---------------------------------------------------
-------------------------------
870.3150 90-Day oral NOAEL = 648/734 M/F
toxicity in mg/kg/day
nonrodents LOAEL = not observed.
-------------------------------
870.3200 21/28-Day dermal Study not required.
toxicity
-------------------------------
870.3250 90-Day dermal Study not required.
toxicity
-------------------------------
870.3465 90-Day inhalation Study not required.
toxicity
-------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 1,000 mg/kg/day
rodents LOAEL = not observed
Developmental NOAEL =
1,000 mg/kg/day
LOAEL = not observed
-------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 1,000 mg/kg/day
nonrodents LOAEL = not observed
Developmental NOAEL =
1,000 mg/kg/day
LOAEL = not observed
-------------------------------
870.3800 Reproduction and Parental/Systemic
fertility NOAEL = 1,175.2/
effects 1,387.6 M/F mg/kg/
day
LOAEL = not observed
Reproductive NOAEL =
1,175.2/ 1,387.6 M/F
mg/kg/day
LOAEL = not observed
Offspring NOAEL =
1,175.2/ 1,387.6 M/F
mg/kg/day
LOAEL = not observed
-------------------------------
870.4100 Chronic toxicity NOAEL = 764/ 952 M/F
rodents mg/kg/day
LOAEL = not observed.
-------------------------------
870.4100 Chronic toxicity NOAEL = 155 M mg/kg/
dogs day
LOAEL = 574 M mg/kg/
day based on
increased mucus
secretion in the
cardiac and fundic
sections of the
stomach of the males
dogs (highest dose
tested (HDT)) and
chronic superficial
gastritis (1/6).
-------------------------------
870.4200 Carcinogenicity NOAEL = 764/952 M/F
rats mg/kg/day
LOAEL = not observed.
(no) evidence of
carcinogenicity
-------------------------------
870.4300 Carcinogenicity NOAEL = 1,069.4/
mice 1,355.6 M/F mg/kg/
day
LOAEL = not observed.
(no) evidence of
carcinogenicity
-------------------------------
870.5100 Bacterial reverse Negative S9
up to cytotoxic
5,000 [mu]gram (g)/
milliliter (ml)
plate
-------------------------------
870.5300 Mammalian cell Negative S9
up to cytotoxic
2,500 [mu]g/ml and
precipitation 250
[mu]g/ml
-------------------------------
870.5395 Micronucleus test Negative at the HDT
Cytogenetics.................. on mouse (limit dose) 2,000
mg/kg.
-------------------------------
[[Page 18258]]
870.5375 Chromosomal Negative S9
precipitation =100 [mu]g/ml
-------------------------------
870.5550 Unscheduled DNA Negative S9
precipitation =100 [mu]g/ml
-------------------------------
870.6200 Acute Study not required.
neurotoxicity
screening
battery
-------------------------------
870.6200 Subchronic Study not required.
neurotoxicity
screening
battery
-------------------------------
870.6300 Developmental Study not required.
neurotoxicity
-------------------------------
870.7485 Metabolism and Overall recovery of
pharmacokinetics the radioactive dose
was 98-103%,
predominantly
recovered in the
feces within 24
hours (80-97% dose).
The onset of
absorption was quick
(detected in the
blood 15 minutes
post-dose), but the
quantity absorbed
was low. At 72 hours
post-dose (or 168
hours following the
final dose of the
repeated study),
urinary excretion
accounted for 1-4%
(except 13-14% in
the 10 mg/kg
animals), and
radioactivity in the
bile of the 10 mg/kg
animals was only 7-
9% dose by 12 hours
post-dose. The 10 mg/
kg rats had slightly
more radioactivity
in urine and
slightly less
radioactivity in
feces compared to
the 1,000 mg/kg
rats.
Bioaccumulation was
not observed, and
radioactivity in
tissues was <0.1%
dose in all animals
at each study
termination.
-------------------------------
870.7600 Dermal 100% dermal
penetration absorption factor
(default value)
-------------------------------
Special studies Study not required.
------------------------------------------------------------------------
B. 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 level of concern
(LOC). 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.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the 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). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). 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 mesosulfuron-methyl
used for human risk assessment is shown in Table 2 of this unit:
[[Page 18259]]
Table 2.--Summary of Toxicological Doses and Endpoints for Mesosulfuron-Methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary: No study in the toxicology database indicated there is an acute dietary
(All populations).................... endpoint of concern.
--------------------------------------
Chronic Dietary: NOAEL= 155 mg/kg/day FQPA SF = 1X Chronic oral toxicity
(All populations).................... UF = 100............... cPAD = chronic RfD/FQPA study in dogs.
Chronic RfD = 1.55 mg/ SF = 1.55 mg/kg/day. LOAEL = 574 mg/kg/day
kg/day. [M] based on increased
mucus secretion in the
cardiac and fundic
sections of the
stomach, and chronic
superficial gastritis
(1/6) of male dogs.
--------------------------------------
Incidental Oral: No residential uses are proposed for mesosulfuron-methyl.
(Short- and Intermediate-Term).......
--------------------------------------
Dermal Exposure: Quantification of dermal risk is not required for this route of exposure
(Short-, Intermediate-, and Long- due to the lack of dermal, systemic, neurological, and developmental
Term). toxicity concerns.
--------------------------------------
Inhalation Exposure: Oral Residential LOC for MOE Chronic oral toxicity
(Short-, Intermediate-, and Long- NOAEL= 155 mg/kg/day = NA study in dogs.
Term). (100% Oral Absorption Occupational LOC for LOAEL = 574 mg/kg/day
Factor). MOE = 100. [M] based on increased
mucus secretion in the
cardiac and fundic
sections of the
stomach, and chronic
superficial gastritis
(1/6) of male dogs.
--------------------------------------
Cancer: ``Not likely to be carcinogenic to humans'' based on the lack of evidence
(Oral, Dermal, and Inhalation)....... of carcinogenicity in the rats and mice.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL =
lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference
dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
proposed wheat and meat byproducts of cattle, goat, horse, and sheep.
Risk assessments were conducted by EPA to assess dietary exposures from
mesosulfuron-methyl 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 1-day or
single exposure.
Based on available data, a suitable endpoint for acute dietary risk
assessment was not identified because no effects were observed in oral
toxicity studies (including developmental studies) which could be
attributed to a single-dose exposure. Therefore, an acute dietary risk
assessment was not performed.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\T\) and the Lifeline\T\
Model Version 2.0,, which incorporates food consumption data as
reported by respondents in the USDA 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: tolerance
level residues, default processing factors, and 100% crop treated data,
with no refinements.
iii. Cancer. A quantitative cancer dietary exposure cancer dietary
assessment was not conducted because mesosulfuron-methyl was classified
as ``not likely to be carcinogenic to humans.''
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for mesosulfuron-methyl 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 mesosulfuron-methyl.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The SCI-GROW model is used to predict pesticide
concentrations in shallow ground water. For a screening-level
assessment for surface water EPA will use FIRST (a tier 1 model) before
using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the
PRZM/EXAMS model that uses a specific high-end runoff scenario for
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir
environment, and both models include a percent crop area factor as an
adjustment to account for the maximum percent crop coverage within a
watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates
[[Page 18260]]
of a pesticide's concentration in water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food, and from residential
uses. Since DWLOCs address total aggregate exposure to mesosulfuron-
methyl they are further discussed in the aggregate risk sections in
Unit III.E.
EPA determined that three degradates may be present at sufficient
quantities (found in aerobic soil and aerobic and anaerobic aquatic
environments at levels ranging from 5% to 20% of the applied dose) to
warrant inclusion in the drinking water assessment. The three
degradates are 2-[3-(4,6-dimethoxypyrimidin-2-yl)ureidosulfonyl]-4-
methanesulfonamidomethyl benzoic acid (AE F154851), methyl-2-[3-(4-
hydroxy-6-methoxypyrimidin-2-yl)ureidosulfonyl]-4-
methanesulfonamidomethylbenzoate (AE F160459), and 2-[3-(4-hydroxy-6-
methoxypyrimidine-2-yl)ureidosulfonyl]-4-methanesulfonamidomethyl
benzoic acid (AE F160460). EPA determined that these degradates were
not of concern for food due to low toxicity and low level of exposure
in food, and that, for food, parent mesosulfuron-methyl is the only
residue of concern.
Based on the FIRST and SCI-GROW models, the EECs of mesosulfuron-
methyl and its degradates for chronic exposures are estimated to be
0.15 parts per billion (ppb) for surface water and 0.015 ppb for ground
water.
3. From 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).
Mesosulfuron-methyl 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to mesosulfuron-methyl and
any other substances and mesosulfuron-methyl does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has not assumed that
mesosulfuron-methyl has 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 the policy statements
released by EPA's OPP concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/
.
D. 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 data base on toxicity and exposure
unless EPA determines based on reliable data 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. In
applying this provision, EPA either retains the default value of 10 X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There are no concerns or
residual uncertainties for pre- and/or post-natal toxicity.
3. Conclusion. There is a complete toxicity data base for
mesosulfuron-methyl and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. EPA
determined that the 10X FQPA safety factor to protect infants and
children should be removed. The FQPA factor is removed because:
i. There is no evidence of increased quantitative/qualitative
susceptibility in the available acceptable guideline studies.
ii. There are no residual uncertainties for pre- and/or post-natal
toxicity.
iii. Clear NOAELs have been identified for the effects of concern.
iv. No adverse effects were noted at the highest dose tested in the
acceptable guideline developmental toxicity and reproduction studies in
rats, and developmental toxicity study in rabbits.
v. There are no proposed residential uses.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
[[Page 18261]]
1. Acute risk. Based on available data, a suitable endpoint for
acute dietary risk assessment was not identified because no effects
were observed in oral toxicity studies (including developmental
studies) which could be attributed to a single-dose exposure.
Therefore, mesosulfuron-methyl is not expected to pose an acute dietary
risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
mesosulfuron-methyl from food will utilize <1% of the cPAD for the U.S.
population, <1% of the cPAD for infants < 1 year old, and <1% of the
cPAD for children 1-12. There are no residential uses for mesosulfuron-
methyl that result in chronic residential exposure to mesosulfuron-
methyl. In addition, there is potential for chronic dietary exposure to
mesosulfuron-methyl in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Mesosulfuron-Methyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. Population 1.55 <1 0.154 0.015 54,000
------------------------------------------------
All Infants (< 1 year old) 1.55 <1 0.154 0.015 16,000
------------------------------------------------
Children 1-2 years old 1.55 <1 0.154 0.015 16,000
------------------------------------------------
Children 3-5 years old 1.55 <1 0.154 0.015 16,000
------------------------------------------------
Children 6-12 years old 1.55 <1 0.154 0.015 16,000
------------------------------------------------
Youth 13-19 years old 1.55 <1 0.154 0.015 47,000
------------------------------------------------
Females 13-49 years old 1.55 <1 0.154 0.015 47,000
------------------------------------------------
Adults 20-49 years old 1.55 <1 0.154 0.015 54,000
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Mesosulfuron-methyl is not registered for use on any sites that
would result in residential exposure. Therefore, the aggregate risk is
the sum of the risk from food and water, which do not exceed the
Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Mesosulfuron-methyl is not registered for use on any sites that
would result in residential exposure. Therefore, the aggregate risk is
the sum of the risk from food and water, which do not exceed the
Agency's level of concern.
5. Aggregate cancer risk for U.S. population. The EPA classified
mesosulfuron-methyl as ``not likely to be carcinogenic to humans.''
Therefore, mesosulfuron-methyl is not expected to pose a cancer risk.
6. 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, and to infants and children from aggregate
exposure to mesosulfuron-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Method EM F08/99-0 (liquid chromatography/mass spectroscopy/mass
spectroscopy ) is adequate for tolerance enforcement for mesosulfuron-
methyl in plant commodities. The method has been subjected to
successful independent laboratory validations (ILVs), satisfactory
radiovalidation data have been submitted, and the method has been
reviewed by an EPA chemist.
Method EM F07/00-0 (liquid chromatography/mass spectroscopy/mass
spectroscopy) is adequate for tolerance enforcement for mesosulfuron-
methyl in livestock commodities. The method has been reviewed by an EPA
chemist. Although there has been no independent lab validation of this
method in animal commodities, EPA determined that independent lab
validation is not necessary because:
1. This method (F07/00-0) is essentially identical to the plant
method (EM F08/99-0), which was succesfully validated in an independent
laboratory, and
2. EPA has previously validated single-analyte methods for members
of this class of chemicals which use similar extraction and cleanup
procedures.
Both methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no Codex, Canadian, or Mexican MRL's or
tolerances for mesosulfuron-methyl on wheat.
C. Conditions
The following are being imposed as conditions of registration of
mesosulfuron-methyl:
A one year storage stability (guideline
830.6317) and corrosion characteristics (guideline 830.6320) must be
submitted to EPA by October 1, 2005.
Storage stability data must be submitted to
demonstrate the stability of mesosulfuron-methyl residues in/on wheat
forage stored frozen for up to 26 months and in/on wheat grain and
straw stored frozen for up to 25 months by October 1, 2005.
D. Response to Comments
The one comment received on the tolerance petition stated: ``I
oppose any tolerance allowance granted for mesosulfuron-methyl on any
food product. I am totally against any chemicals in the food I eat. I
do not think we should allow these chemical polluters in our food. I
know industry waves lots of money to get these
[[Page 18262]]
approvals. The American public disapproves of EPA granting these. EPA
is even being sued for these approvals. I am totally against granting
approval of this pesticide on any food in any amount at all. I prefer
zero tolerance.''
Response: This commenter has a disagreement not with how EPA is
implementing FFDCA section 408 as it applies to the tolerance petition
on mesosulfuron-methyl but with FFDCA section 408 itself. The
commenter--and in the commenter's view the general American public as
well--would prefer that FFDCA section 408 bar the establishment of any
tolerance permitting any pesticide residues to remain on food. That,
however, is not the law. Rather, FFDCA section 408 as it is currently
written establishes a safety standard under which EPA must evaluate
petitions to establish tolerances. EPA has applied that safety standard
in ruling on the mesosulfuron-methyl tolerance petition. EPA cannot
take a commenter's policy preference on what the FFDCA should say into
account in ruling on application of the FFDCA to a particular
situation.
V. Conclusion
Therefore, the tolerance is established for residues of methyl 2-
[[[[(4,6-dimethoxy-2-pyrimidinyl) amino]carbonyl]amino] sulfonyl]-4-
[[(methylsulfonyl)amino] methyl]benzoate]], mesosulfuron-methyl, in or
on the raw agricultural commodities aspirated grain fractions at 0.60
ppm; meat byproducts of cattle, goat, horse, and sheep at 0.01 ppm;
wheat forage at 0.60 ppm; wheat germ at 0.10 ppm; wheat grain at 0.03
ppm; wheat hay at 0.06 ppm; and wheat straw at 0.30 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0257 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 June 7,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0257, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
[[Page 18263]]
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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: March 26, 2004.
James Jones,
Director, 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 180.597 is added to read as follows:
Sec. 180.597 Mesosulfuron-methyl; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide mesosulfuron-methyl, (methyl 2-[[[[ (4,6-dimethoxy-2-
pyrimidinyl) amino]carbonyl]amino]sulfonyl] -4-[[(methylsulfonyl)amino]
methyl]benzoate]) in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, meat byproducts.................................... 0.01
Goat, meat byproducts...................................... 0.01
Grain, aspirated fractions 0.60
Horse, meat byproducts..................................... 0.01
Sheep, meat byproducts..................................... 0.01
Wheat, forage.............................................. 0.60
Wheat, germ................................................ 0.10
Wheat, grain............................................... 0.03
Wheat, hay................................................. 0.06
Wheat, straw............................................... 0.30
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 04-7781 Filed 4-6-04; 8:45 am]
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