[Federal Register: November 10, 2004 (Volume 69, Number 217)]
[Rules and Regulations]
[Page 65081-65088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no04-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0323; FRL-7683-9]
Glyphosate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
glyphosate, N-(phosphonomethyl)glycine, resulting from the application
of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine
salt of glyphosate, the ammonium salt of glyphosate, and the potassium
salt of glyphosate in or on cotton, gin byproducts and cotton,
undelinted seed. Monsanto Company 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 November 10, 2004. Objections and
requests for hearings must be received on or before January 10, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0323. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket/.
Although listed in the index, some information is not publicly
available, i.e., 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 electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 South Bell St., 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.
FOR FURTHER INFORMATION CONTACT: James A.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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of August 18, 2004 (69 FR 51301) (FRL-7364-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
0F6195, 1F6274, 2F6487, and 3F6570) by Monsanto Company, 600 13\th\
St., NW., Suite 660, Washington, DC 20005. The petition requested that
40 CFR 180.364 be amended by establishing a tolerance for residues of
the herbicide glyphosate, N-(phosphonomethyl)glycine, in or on alfalfa
seed at 0.5 parts per million (ppm) (PP 2F6487); increasing the current
tolerance for cotton, gin byproducts from 100 ppm to 150 ppm (PP
3F6570); rice, bran at 30 ppm; rice, grain at 15 ppm; and rice, hulls
at 25 ppm (PP 1F6274); wheat, forage at 10.0 ppm; wheat, hay at 10.0
ppm (PP 0F6195). Monsanto Company also proposed to revise the entry for
grain, cereal group tolerance ``except rice'' to read as grain, cereal
group 15 except barley, field corn, grain sorghum, oats, rice, and
wheat at 0.1 ppm (PP 1F6274). Monsanto Company also amended PP 0F6195
to delete the proposal for wheat grain at 6 ppm that was announced in
the Federal Register of April 17, 2002 (67 FR 18894) (FRL-6830-5). The
notice stated that tolerances for alfalfa, rice, wheat, and cotton gin
byproducts include both conventional and genetically altered crops.
The notice also proposed that the tolerances for alfalfa, forage at
175 ppm and alfalfa, hay at 400 ppm be deleted from Sec. 180.364. Also
proposed was to amend Sec. 180.364 by replacing the current listing
vegetable, legume, group 6 except soybean at 5.0 ppm with the current
crop group pea and bean, dried and shelled, subgroup 6C at 5.0 ppm.
That notice included a summary of the petition prepared by Monsanto
Company, the registrant. One comment was received in response to the
notice of filing from B. Sachau, 15 Elm St., Florham Park, NJ 07932.
The commenter objected to allowing any tolerance, wavier, or exemption
for glyphosate. The commenter also objected to animal testing and
stated that a more reliable method of testing should be developed. This
comment is discussed further in Unit V.
During the course of the review the Agency decided to correct the
company address to read Monsanto Company, 1300 I St., NW., Suite 450
East, Washington, DC 20005. The Agency also determined the tolerance
proposed for cotton, gin byproducts should be raised to 175 ppm and
that the current tolerance for cotton, undelinted seed be increased to
35 ppm.
The Agency has determined that based on available data, the current
tolerances for alfalfa, forage and alfalfa, hay are to be maintained
and that the current listing for vegetable, legume,
[[Page 65082]]
group 6 except soybean at 5 ppm is correct; therefore, these proposed
changes are not made at this time. Also, even though the proposed
tolerances for alfalfa, seed; rice, bran; rice, grain; rice, hulls;
wheat, forage; and wheat, hay are included in the risk assessment
discussed in Units III.C., D., and E., these tolerances are not being
issued at this time.
The Agency is also correcting the proposed tolerance expression to
agree with the current tolerance expression by including references to
the salts. Therefore, the tolerance expression is corrected to read:
Tolerances are established for residues of glyphosate, N-
(phosophonomethyl)glycine, resulting from the application of
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine
salt of glyphosate, the ammonium salt of glyphosate, and the potassium
salt of glyphosate in or on cotton, gin byproducts at 175 ppm and
cotton, undelinted seed at 35 ppm.
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 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 glyphosate, N-
(phosophonomethyl)glycine, resulting from the application of
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine
salt of glyphosate, the ammonium salt of glyphosate, and the potassium
salt of glyphosate on cotton, gin byproducts at 175 ppm and cotton,
undelinted seed at 35 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 glyphosate as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies
reviewed are discussed in the Federal Register of September 27, 2002
(67 FR 60934) (FRL-7200-2).
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 UFs 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 UFs 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 glyphosate used for
human risk assessment is discussed in
[[Page 65083]]
Unit V.B. of the final rule published in the Federal Register of
September 27, 2002 (67 FR 60934) (FRL-7200-2).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.364) for the residues of glyphosate, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from glyphosate 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.
A review of the toxicity database, including developmental toxicity
studies in rats and rabbits, did not provide an endpoint that could be
used to quantitate risk to the general population and to females 13-50
years old from a single-dose administration of glyphosate. Therefore,
no acute dietary analysis was conducted for glyphosate.
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\TM\), 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, DEEM default factors and 100%
crop treated. PCT and/or anticipated residues were not used.
iii. Cancer. Glyphosate is classified as a Group E chemical,
negative for carcinogenicity in humans, based on the absence of
carcinogenicity in male and female rats as well as male and female
mice.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for glyphosate 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 glyphosate.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and Screening Concentration and Ground Water (SCI-GROW) model,
which predicts pesticide concentrations in ground water. In general,
EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2
model) for a screening-level assessment for surface water. The GENEEC
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. GENEEC incorporates a farm pond
scenario, while PRZM/EXAMS incorporate an index reservoir environment
in place of the previous pond scenario. The PRZM/EXAMS model includes 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 in quantitative risk assessments.
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 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 glyphosate they are further discussed in the aggregate risk
sections, Unit III.E.
Based on the GENEEC, and SCI-GROW models, the EECs of glyphosate
for acute exposures are estimated to be 21.0 parts per billion (ppb)
for surface water and 0.0038 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.83 ppb for surface water. The EEC
resulting from the registered use of direct glyphosate application to
surface water is 230 ppb. Because the glyphosate water-application
estimate is greater than the crop-application estimate, 230 ppb is the
appropriate value to use in the chronic risk assessment. The EEC for
chronic exposure in ground water is 0.0038 ppb.
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).
i. Non-occupational (recreational) exposures. Glyphosate is
currently registered for use on the following residential non-dietary
sites: Recreational areas, including parks and golf courses for control
of broadleaf weeds and grasses, and lakes and pond, including
reservoirs for control of nuisance aquatic weeds. Based on the
registered uses, adult and child golfers are anticipated to have short-
term post-application dermal exposure at golf courses. Swimmers
(adults, children, and toddlers) are anticipated to have short-term
post-application dermal and incidental ingestion exposures. However,
since the Agency did not select dermal endpoints, no post-application
dermal assessment was performed.
A post-application incidental ingestion exposure assessment for
swimmers was performed. This assessment assumed 100% of applied
concentration available at maximum application rate in the top one foot
of water column; an ingestion rate of 0.05 Liter/hour (L/hr), and an
exposure duration of 5 hrs/day (although a toddler is unlikely to be
exposed for 5 hrs/day). Adult and toddler swimmers were included in
this assessment as they are anticipated to represent the upper and
lower bound of swimmer exposures. The respective body weights are 60
kilogram (kg) for adult-females (since NOAEL is based on developmental
study) and 15 kg for toddlers. This exposure assessment is fully
discussed in Unit V.C. of the final rule published in the Federal
Register of September 27, 2002 (67 FR 60934) (FRL-7200-2). MOEs for
incidental exposure for incidental ingestion by swimmers were 7,600 for
toddler and to 36,000 for adult females and therefore, do not exceed
the Agency`s level of concern (LOC) for short-term non-occupational
(recreational ) exposures (MOEs of less than 100).
ii. Residential exposures. Glyphosate is also registered for
broadcast and spot treatments on home lawns and gardens by homeowners
and by lawn care operators (LCOs). Based on the registered residential
use pattern, there is a potential for short-term dermal and inhalation
exposures to homeowners who apply products containing
[[Page 65084]]
glyphosate (residential handlers). Additionally, based on the results
of the environmental fate studies, there is a potential for incidental
ingestion by toddlers. However, since the Agency did not select short-
or intermediate-term dermal or inhalation endpoints, no residential
handler or post-application dermal assessment was performed.
A post-application toddler assessment for incidental ingestion
exposure assessment was performed. The SOPs For Residential Exposure
Assessments, Draft, 17-DEC-1997 and Exposure Science Advisory Committee
(ExpoSAC) Policy No. 11, 22-FEB-2001: Recommended Revisions to the SOPs
for Residential Exposure were used to estimate post-application
incidental ingestion exposures and risk estimates for toddlers. The
following assumptions were used to assess exposures to toddlers after
contact with treated lawns: Toddler body weight of 15 kg; toddler hand-
surface area is 20 centimeter squared (cm)\2\, and a toddler performs
20 hand-to-mouth events per hr for short-term exposures; exposure
duration of 2 hrs per day; 5% of application rate represents fraction
of glyphosate available for transfer to hands and a 50% saliva
extraction factor for hand-to-mouth exposures; surface area of a object
(for toddler object-to-mouth exposures; surface area of an object (for
toddler object-to-mouth exposures) is approximately 25 cm\2\; 20% of
application rate available as dislodgeable residues for object-to-mouth
exposures; 100% of application rate is avaible in the top 1 cm of soil
for soil ingestion exposures; and that a toddler can ingest 100
milligram (mg) soil/day. This risk assessment is fully discussed in
Unit V.C. of the final rule published in the Federal Register of
September 27, 2002 (67 FR 60934) (FRL-7200-2). MOEs for toddler post-
application incidental ingestion exposures were 7,200 for hand-to-
mouth, 29,000 for object-to-mouth and greater than 10\6\ for soil
ingestion, and therefore, do not exceed the Agency`s level of concern
for residential exposures (MOEs) less than 100.
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 glyphosate and any other
substances and glyphosate 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 glyphosate 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 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. 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 10X
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. Based on the acceptable
developmental studies, the Agency has determined that there is no
evidence of either a quantitative or qualitative increased
susceptibility following in utero glyphosate exposure to rats or
rabbits, or following prenatal/postnatal exposure in the 2-generation
reproduction study in rats.
3. Conclusion. There is a complete toxicity database for glyphosate
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. The impact of glyphosate
on the nervous system has not been specifically evaluated in
neurotoxicity studies. However, there was no evidence of neurotoxicity
seen in either acute, subchronic, chronic, or reproductive studies. and
there are no concerns for potential developmental neurotoxicity.
Therefore, neurotoxicity studies are not required for glyphosate. EPA
determined that the 10X SF to protect infants and children should be
removed. The FQPA factor is removed because the toxicology database is
complete; a developmental neurotoxicity study is not required; there is
no evidence of quantitative or qualitative increased susceptibility of
the young demonstrated in the prenatal developmental studies in rats or
rabbits and pre-/postnatal reproduction study in rats; and the dietary
(food and drinking water) exposure assessments will not underestimate
the potential exposure for infants and children.
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 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
[[Page 65085]]
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.
1. Acute risk. Glyphosate is not expected to pose an acute risk
because no toxicological endpoints attributable to a single exposure
(dose), including maternal toxicity in developmental toxicity studies,
were identified in the available data.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
glyphosate from food will utilize 2.2% of the cPAD for the U.S.
population, 3.9% of the cPAD for all infants < 1 year old, and 5.4% of
the cPAD for children 1-2 years old. Based the use pattern, chronic
residential exposure to residues of glyphosate is not expected. In
addition, there is potential for chronic dietary exposure to glyphosate
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 1 of this unit:
Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Glyphosate
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 1.75 2.2 230 0.0038 60,000
------------------------------------------------ < 1 year
------------------------------------------------
--------------------------------------------------------------
--------------------------------------------------------------
--------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
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).
Glyphosate is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for glyphosate.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 1,800 for all infants < 1 year
old, 1,500 for children 1-6 years old, and 2000 for children 7-12 years
old. Because the incidental oral ingestion exposure estimates for
toddlers from residential turf exposures exceeded the incidental oral
exposure from post-application swimmer exposures, the Agency conducted
this risk assessment using exposure estimates from the worst case
situation. No attempt was made to combine exposures from swimmer and
residential turf scenarios due to the low probability of both
occurring. See Tables 5 and 6 from the final rule published in the
Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2) for
detailed discussion. These aggregate MOEs do not exceed the Agency's
level of concern for aggregate exposure to food and residential uses.
In addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of glyphosate in ground and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in Table 2 of this unit:
Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Glyphosate
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old 1,800 100 230 0.0038 16,500
-----------------------------------------------
-----------------------------------------------
----------------------------------------------------------------------------------------------------------------
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).
Glyphosate is currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for glyphosate.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 1,800 for
all infants < 1 year old, 1,500 for children 1-6 years old, and 2,000
for
[[Page 65086]]
children 7-12 years old. Because the incidental oral ingestion exposure
estimates for toddlers from residential turf exposures exceeded the
incidental oral exposure from post-application swimmer exposures, the
Agency conducted this risk assessment using exposure estimates from the
worst case situation. No attempt was made to combine exposures from
swimmer and residential turf scenarios due to the low probability of
both occurring. See Tables 5 and 6 from the final rule published in the
Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2) for
detailed discussion. These aggregate MOEs do not exceed the Agency's
level of concern for aggregate exposure to food and residential uses.
In addition, intermediate-term DWLOCs were calculated and compared to
the EECs for chronic exposure of glyphosate in ground and surface
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect intermediate-term
aggregate exposure to exceed the Agency's level of concern, as shown in
Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Intermediate-Term Exposure to Glyphosate
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old 1,800 100 230 0.0038 16,500
---------------------------------------------
---------------------------------------------
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. Glyphosate has no
carcinogenic potential.
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 glyphosate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate analytical methods are available for the enforcement of
tolerances for glyphosate in plant and livestock commodities. These
methods include gas liquid chromatography (GLC) (Method I in Pesticides
Analytical Manual (PAM II)) and High Performance Liquid Chromatography
(HPLC) with fluorometric detection. Use of GLC is discouraged due to
the lengthiness of the experimental procedure. The HPLC procedure has
undergone successful Agency validation and was recommended for
inclusion into PAM II. A Gas Chromatography Spectrometry (GC/MS) method
for glyphosate in crops has also been validated by EPA.
These 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
Codex and Mexican maximum residue levels (MRLS) are established for
residues of glyphosate per se and Canadian MRLs are established for
combined residues of glyphosate and aminomethylphosphonic acid (AMPA)
in a variety of raw agricultural commodities. Codex MRLs exist for dry
peas and dry beans at 5 ppm and 2 ppm, respectively. Canadian MRLs
exist for peas, beans, and lentils at 5 ppm, 2 ppm, and 4 ppm,
respectively. Mexican MRLs of 0.2 ppm exist for both peas and beans.
Codex and Canadian MRLs for beans and lentils, and Mexican MRLs for
peas and beans are lower then necessary to cover residues from the use
patterns in the United States. The proposed U. S. tolerance for the
crop group peas and beans, dried and shelled, except soybeans, is in
agreement with the Codex and Canadian MRLs for dry peas and peas,
respectively, and are necessary to cover use patterns in the United
States.
Currently no Codex MRL for cotton, gin byproducts or cotton,
undelinted seed are established.
C. Conditions
There are no conditions of registration for the establishment of
tolerances on cotton, gin byproducts or cotton, undelinted seed.
V. Comments
One comment was received in response to the notice of filing from
B. Sachau, 15 Elm St., Florham Park, NJ 07932. The commenter objected
to the allowance of any tolerances, waiver, or exemption from tolerance
for glyphosate because there are bad effects from glyphosate. The
commenter also objected to animal testing, because testing on rabbit or
dog constitutes animal abuse, and stated that a more reliable method of
testing should be developed.
The comment contained no scientific data or evidence to rebut the
Agency`s conclusion that there is a reasonable certainty that no harm
will result from aggregate expose to glyphosate, including all
anticipated dietary exposure and all other exposures for which the is
reliable information.
Health Effects Guidelines (Series 870) recommends that dog or
rabbit be used for various acute, subchronic, and longer term chronic,
carcinogenic, developmental, and reproductive studies. Information
derived from these tests serve to indicate the presence of possible
hazards likely to arise from exposure to the test substance. Currently,
there are not in vitro studies that can address the questions these
studies answer. The EPA is currently working with the Interagency
Coordinating Committee on the Validation or Alternative Methods
(ICCVAM) to investigate alternative in vitro methods.
VI. Conclusion
Therefore, the tolerance is established for residues of glyphosate,
N-(phosophonomethyl)glycine, resulting from the application of
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine
salt of glyphosate, the ammonium salt of glyphosate, and the potassium
salt of glyphosate in or on cotton, gin byproducts at 175 ppm and
cotton, undelinted seed at 35 ppm.
VII. 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
[[Page 65087]]
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-2004-0323 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 January
10, 2005.
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 issue(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 (1900L),
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 Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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 (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0323, 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 ADDRESSES. 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 issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. 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
[[Page 65088]]
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.
IX. 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: October 25, 2004.
Betty Shackleford,
Acting 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 180.364, paragraph (a) is amended by:
0
i. Revising the chemical name ``(N-phosphomethyl)glycine)'' in the
introductory text to read ``N-(phosphonomethyl)glycine.''
0
ii. Revising in the table the entries ``cotton, gin byproducts'' and
``cotton, undelinted seed'' to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cotton, gin byproducts..................................... 175
Cotton, undelinted seed.................................... 35
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-25098 Filed 11-9-04; 8:45 am]
BILLING CODE 6560-50-S