[Federal Register Volume 69, Number 217 (Wednesday, November 10, 2004)]
[Rules and Regulations]
[Pages 65081-65088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25098]


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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: 
[email protected].

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: 
[email protected].

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: [email protected]. 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