[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Rules and Regulations]
[Pages 52660-52667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22168]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301034; FRL-6736-6]
RIN 2070-AB78


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 in or on certain raw 
agricultural commodities resulting from application of the ethanolamine 
salt and revises the headers for 40 CFR 180.364. 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 August 30, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301034, 
must be received by EPA on or before October 30, 2000.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301034 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: James A. Tompkins, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-5697; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:   

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                      Affected  Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 52661]]

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301034. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of January 10, 2000 (65 FR 1370) (FR-6394-
6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a as amended by the FQPA (Public Law 104-170) announcing the filing 
of a pesticide petition (PP) for tolerance by Monsanto Company, 600 
13th Street NW. Suite 660, Washington DC 20005. This notice included a 
summary of the petition prepared by Monsanto Company, the registrant. 
There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.364 be amended by 
establishing a tolerance for residues of the herbicide glyphosate, N-
(phosphonomethy) glycine from application of the ethanolamine salt of 
glyphosate. The petition (0F6071) notice requested that the 180.364(a) 
introductory text be revised.
    It also proposed that 40 CFR 180.364(a) be amended so that the 
introductory text for paragraphs (a)(2) and (a)(3) are removed and the 
commodity tolerances listed in paragraphs (a)(2) and (a)(3) are 
reorganized into section (a) in alphabetical order in the table. It is 
further that 40 CFR 180.364(d) be revised.
    Section 408(b)(2)(A)(i) of the 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) 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) 
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 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), 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), for a tolerance for residues of glyphosate by revising the 
existing regulation to include the ethanolamine salt of glyphosate and 
to revise the introductory text, remove the introductory text for 
paragraphs (a)(2) and (a)(3), and the commodity tolerances listed in 
paragraphs (a)(2) and (a)(3) are reorganized into paragraph (a) in 
alphabetical order in the table, and revising the text in paragraph 
(d).

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 are 
discussed in this unit as well as the no observed adverse effect level 
(NOAEL) and the lowest observed adverse effect level (LOAEL) from the 
toxicity studies reviewed.
    1. Several acute toxicology studies placing technical-grade 
glyphosate in Toxicity Category III and Toxicity Category IV. Technical 
glyphosate is not a dermal sensitizer.
    2. A 21-day dermal toxicity study in which rabbits were exposed to 
glyphosate at levels of 0, 10, 1,000, or 5,000 milligrams/kilogram/day 
(mg/kg/day). The systemic no observed adverse effect level (NOAEL) was 
1,000 mg/kg/day and the lowest observed adverse effect level (LOAEL) 
was 5,000 mg/kg/day based on decreased food consumption in males. 
Although serum lactate dehydrogenase was decreased in both sexes at the 
high dose, this finding was not considered to be toxicologically 
significant.
    3. A 1-year feeding study with dogs fed dosage levels of 0, 20, 
100, and 500 mg/kg/day with a NOAEL of 500 mg/kg/day.
    4. A 2-year carcinogenicity study in mice fed dosage levels of 0, 
150, 750, and 4,500 mg/kg/day with no carcinogenic effect at the 
highest dose tested (HDT) of 4,500 mg/kg/day.
    5. A chronic feeding/carcinogenicity study in male and female rats 
fed dosage levels of 0, 3, 10, and 31 mg/kg/day (males) and 0, 3, 11, 
or 34 mg/kg/day (females) with no carcinogenic effects observed under 
the conditions of the study at dose levels up to and including 31 mg/
kg/day HDT (males) and 34 mg/kg/day HDT (females) and a systemic NOAEL 
of 31 mg/kg/day HDT (males) and 34 mg/kg/day HDT (females). Because a 
maximum tolerated dose (MTD) was not reached, this study was classified 
as supplemental for carcinogenicity.
    6. A chronic feeding/carcinogenicity study in male and female rats 
fed dosage levels of 0, 89, 362, and 940 mg/kg/day (males) and 1, 113, 
457, and 1,183 mg/kg/day (females) with no carcinogenic effects noted 
under the conditions of the study at dose levels up to and including 
940/1,183 mg/kg/day (males/females)

[[Page 52662]]

HDT and a systemic NOAEL of 362 mg/kg/day (males) based on an increased 
incidence of cataracts and lens abnormalities, decreased urinary pH, 
increased liver weight and increased liver weight/brain ratio (relative 
liver weight) at 940 mg/kg/day (males) HDT and 457 mg/kg/day (females) 
based on decreased body weight gain 1,183 mg/kg/day (females) HDT.
    7. A developmental toxicity study in rats given doses of 0, 300, 
1,000, and 3,500 mg/kg/day with a developmental (fetal) NOAEL of 1,000 
mg/kg/day based on an increase in number of litters and fetuses with 
unossified sternebrae, and decrease in fetal body weight at 3,500 mg/
kg/day, and a maternal NOAEL of 1,000 mg/kg/day based on decrease in 
body weight gain, diarrhea, soft stools, breathing rattles, inactivity, 
red matter in the region of nose, mouth, forelimbs, or dorsal head, and 
deaths at 3,500 mg/kg/day HDT.
    8. A developmental toxicity study in rabbits given doses of 0, 75, 
175, and 350 mg/kg/day with a developmental NOAEL of 175 mg/kg/day 
(insufficient litters were available at 350 mg/kg/day to assess 
developmental toxicity); a maternal NOAEL of 175 mg/kg/day based on 
increased incidence of soft stool, diarrhea, nasal discharge, and 
deaths at 350 mg/kg/day HDT.
    9. A multi-generation reproduction study with rats fed dosage 
levels of 0, 3, 10, and 30 mg/kg/day with the parental NOAEL/LOAEL 30 
mg/kg/day (HDT). The only effect observed was an increased incidence of 
focal tubular dilation of the kidney (both unilateral and bilateral 
combined) in the high-dose male F3b pups. Since the focal 
tubular dilation of the kidneys was not observed at the 1,500 mg/kg/day 
level HDT in the rat reproduction study discussed below, but was 
observed at the 30 mg/kg/day level HDT in the 3-generation rat 
reproduction study, the latter was a spurious rather than glyphosate-
related effect. Therefore, the parental and reproductive (pup) NOAELs 
are 30 mg/kg/day.
    10. A 2-generation reproduction study with rats fed dosage levels 
of 0, 100, 500, and 1,500 mg/kg/day with a systemic NOAEL of 500 mg/kg/
day based on soft stools in F0 and F1 males and 
females at 1,500 mg/kg/day HDT and a reproductive NOAEL 1,500 mg/kg/day 
HDT.
    11. Mutagenicity data included chromosomal aberration in vitro (no 
aberrations in Chinese hamster ovary cells were caused with and without 
S9 activation); DNA repair in rat hepatocyte; in vivo bone marrow 
cytogenic test in rats; rec-assay with B. subtilis; reverse mutation 
test with S. typhimurium; Ames test with S. typhimurium; and dominant-
lethal mutagenicity test in mice (all negative).

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.
    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 the 
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA 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 is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOE cancer = point of 
departure/exposures) is calculated.
    1. Acute toxicity. No toxicological endpoint attributable to a 
single dose was identified in oral studies including the rat and rabbit 
developmental studies. There are no data requirements for acute or 
subacute neurotoxicity studies since there was no evidence of 
neurotoxicity in any of the toxicology studies at very high doses.
    2. Short- and intermediate-term toxicity. No short- or 
intermediate-term dermal or inhalation endpoints were identified. In a 
21-day dermal toxicity study with rabbits, no systemic or dermal 
toxicity was seen following repeated applications of glyphosate at 0, 
100, 1,000, or 5,000 mg/kg/day. The NOAEL was 1,000 mg/kg/day and the 
LOAEL was 5,000 mg/kg/day based on decreased food consumption in males. 
In addition, the use of 3% dermal absorption rate (estimated) in 
conjunction with the oral NOAEL of 175 mg/kg/day established in the 
rabbit development study yields a dermal equivalent dose of greater 
than 5,000 mg/kg/day.
    Based on the low toxicity of the formulation product (Toxicity 
Category III and IV) and the physical characteristics of the technical 
product, there is minimal concern for potential inhalation exposure or 
risk. The acute inhalation study was waived for technical glyphosate. 
Some glyphosate end-use products are in Toxicity Category I or II for 
eye or dermal irritation. The Reregistration Eligibility Decision 
document for Glyphosate (September 1993) indicates that the Agency is 
not adding any additional personal protective equipment (PPE) 
requirements to labels of end-use products, but that it continues to 
recommend the PPE and precautionary statements required for end-use 
products in Toxicity Categories I and II.
    3. Chronic toxicity. EPA has established the Reference Dose (RfD) 
for glyphosate at 2.0 mg/kg/day. This RfD is based on the maternal 
NOAEL of 175 mg/kg/day from a rabbit developmental study and a 100-fold 
UF.
    4. Carcinogenicity. Glyphosate has been classified as a Group E 
chemical - no evidence of carcinogenicity in two acceptable animal 
species.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.364 or the residues of glyphosate, in or on a 
variety

[[Page 52663]]

of raw agricultural commodities. Tolerances are established on kidney 
of cattle, goats, hogs, horses, and sheep at 4.0 ppm; liver of cattle, 
goats, hogs, horses, and sheep at 0.5 ppm; and liver and kidney of 
poultry at 0.5 ppm. 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 one day 
or single exposure. An acute dietary risk assessment was not performed 
because no endpoints attributable to single dose were identified in the 
oral studies including rat and rabbit developmental studies. There are 
no data requirements for acute and subchronic neurotoxicity studies and 
no evidence of neurotoxicity in any of the toxicity studies at very 
high doses. The Agency concludes with reasonable certainty that 
glyphosate dose not elicit an acute toxicological response. An acute 
dietary risk assessment is not needed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA [1989-1992] 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: The chronic dietary exposure analysis 
was conduced using the (RfD) of 2.0 mg/kg/day based on the maternal 
NOAEL of 175 mg/kg/day from a developmental study and an uncertainty 
factor of 100 (applicable to all population groups). The Dietary 
Exposure Evaluation Model (DEEM) analysis assumed tolerance 
levels residues and 100% of the crop treated. These assumptions 
resulted in the following theoretical maximum residue contributions 
(TMRCs) and percent of the RfDs for certain population subgroups. The 
TMRC for the US population (48 states) was 0.029960 or 1.5% of the RfD, 
0.026051 or 1.3% of the RfD for nursing infants (less than 1 year old), 
0.065430 or 3.3% of the RfD for non-nursing infants less than 1 year 
old; 0.064388 or 3.2% of the RfD for children (1-6 years old); 0.043017 
or 2.2% of the RfD for children (7-12 years old); 0.030928 or 1.5% of 
the RfD for females (13+/nursing); 0.030241 or 1.5% of the RfD for non-
Hispanic whites; and 0.030206 or 1.5% of the RfD for non-Hispanic 
blacks. Neither percent crop treated nor anticipated residues were used 
for this risk assessment.
    iii. Cancer. A cancer risk assessment was not performed because 
glyphosate has been classified as a Group E chemical no evidence of 
carcinogenicity in two acceptable aninal species. The Agency concludes 
with reasonable certaintly that glyphosate does not elict a 
toxicological cancer response. A cancer risk assessment is not needed.
    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/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, 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 coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever 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) from these models 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 below.
    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of glyphosate in surface water and ground water 
for acute exposures are estimated to be 1.64 parts per billion (ppb) 
for surface water and 0.000852 ppb for ground water. The EECs for 
chronic exposures are estimated to be 0.19 ppb for surface water and 
0.00111 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Glyphosate is currently registered for use on the following 
residential non-dietary sites: around ornamentals, shade trees, shrubs, 
walks driveways, flower beds, and home lawns. Based on the registered 
uses for glyphosate, the potential for residential exposure exists. 
However based on the low acute toxicity and lack of other toxicological 
concerns, glyphosate does not meet the Agency`s criteria for 
residential data requirements. This risk assesment was not conducted. 
Exposures from residenitial uses are not expected to pose undue risks 
or harm to the public health.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether glyphosate has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
glyphosate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not

[[Page 52664]]

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 final rule for Bifenthrin 
Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines 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 margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The oral perinatal and 
prenatal data demonstrated no indication of increased sensitivity of 
rats or rabbits to in utero and postnatal exposure to glyphosate.
    3. Conclusion. There is a complete toxicity data base for 
glyphosate and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
removed. The FQPA factor is removed because there was no indication of 
increased susceptablilty of rats or rabbits to in utero and/or 
postnatal exposure to glyphosate. In the prenatal developmental 
toxicity studies in rats and rabbits and the 2-generation reproductions 
study in rats, effects in the offspring were observed only at or above 
treatment levels whichresulted in evidence of appreciable parental 
toxicity. The use of generally high quality data, conservative models 
and/or assumptions in the exposure assessment provide adequate 
protection of infants and childern.

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 the model estimates of 
a pesticide's concentration in water (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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute risk assessment is not applicable because 
an acute dietary endpoint and dose was not identified in the toxicology 
data base. Adequate rat and rabbit developmental studies did not 
provide a dose or endpoint that could be used for acute dietary risk 
purposes. Additionally, there were no data requirements for acute or 
subchronic rat neurotoxicity studies since there was no evidence of 
neurotoxicity in any of the toxicology studies at very high doses.
    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 1.5 % of the cPAD for the U.S. 
population, 3.3 % of the cPAD for non-nursing infants (less than one-
year old) and 3.2 % of the cPAD for childern (1-6 years old). Based the 
use pattern, chronic residential exposure to residues of the glyphosate 
is not expected to pose undue risks to the general population, 
including infants and childern. In addition, there is potential for 
chronic dietary exposure to glyphosate in drinking water. After 
calculating the 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.

                    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                                     0.029960          1.5         0.19       0.0011        69000
 
Non-nursing infants  1                              0.065430          3.3         0.19       0.0011        19000
 
Childern (1-6)                                      0.064388          3.2         0.19       0.0011        19000
----------------------------------------------------------------------------------------------------------------

    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). Though residential 
exposure could occur with the use of glyphosate, no toxicological 
effects have been identified for short-term toxicity. Therefore, the 
aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure

[[Page 52665]]

takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Though 
residential exposure could occur with the use of glyphosate, no 
toxicological effects have been identified for intermediate-term 
toxicity. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Glyphosate has been 
classified as a Group E chemical no evidence of carcinogenicity for 
humans in two animal species. EPA concludes that there is a reasonable 
certainty that no harm will result from aggregate exposure to 
glyphosate residues.
    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 enforcement methods are available for analysis of 
residues of glyphosate in or on plant commodities. These methods 
include GLC (Method I in Pesticides Analytical Manual (PAM) II; the 
limit of detection is 0.05 ppm) and High Performance Liquid 
Chromatography (HPLC) with fluorometric detection. Use of the GLC 
method is discouraged due to the lengthiness of the experimental 
procedure. The HPLC procedure has undergone successful Agency 
validation and was recommended for inclusion in PAM II. A GC/MS method 
for glyphosate in crops has also been validated by EPA's Analytical 
Chemistry Laboratory (ACL).

B. International Residue Limits

     Codex Maximum Residue Levels (MRLs) exist for barley, dry peas, 
dry beans, and canola seed at 20, 5, 2, and 10 pp, respectively for 
glyphosate. Canadian glyphosate MRLs exist for barley, barley milling 
fractions, peas, beans, and lentils at 10, 15, 5, 2, and 4 ppm, 
respectively. Mexican glyphosate MRLs exist for barley, peas, and beans 
at 0.1, 0.2, and 0.2 ppm, respectively. Application of glyphosate as 
the acid in the United Sates will not cause any new conflicts with 
existing MRLs.

C. Conditions

    There are no conditons of registration associated with this action.

V. Conclusion

    Therefore, the tolerance is established for residues of glyphosate, 
N-(phosphonomethyl)glycine by revising the existing regulation to 
include the ethanolamine salt of glyphosate and to revise the 
introductory text, remove the introductory text for paragraphs (a)(2) 
and (a)(3), and the commodity tolerances listed in paragraphs (a)(2) 
and (a)(3) are reorganized into paragraph (a) in alphabetical order in 
the table, and revising the text in paragraph (d).

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301034 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 October 
30, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301034, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental

[[Page 52666]]

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    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: August 15, 2000.

  Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.


    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority:  21 U.S.C. 321(q), (346a) and 371.

    2. Section 180.364 is amended by revising paragraphs (a) and (d) to 
read as follows:


Sec. 180.364   Glyphosate; tolerances for residues.

    (a) General. Tolerances are established for residues of glyphosate, 
(N-(phosphonomethyl)glycine) resulting from the application of 
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine 
salt of glyphosate and the ammonium salt of glyphosate in or on the 
following food commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Acerola.................................................        0.2
Alfalfa.................................................      200.0
Alfalfa, forage.........................................       75.0
Alfalfa, fresh and hay..................................        0.2
Alfalfa, hay............................................      200.0
Almonds, hulls..........................................        1
Almond hulls............................................       25
Artichokes, Jerusalem...................................        0.2
Asparagus...............................................        0.5
Aspirated grain fractions...............................      200.0
Atemoya.................................................        0.2
Avocados................................................        0.2
Bahiagrass..............................................      200.0
Bananas.................................................        0.2
Barley, bran............................................       30
Barley, grain...........................................       20
Beets...................................................        0.2
Beets, sugar, dried pulp................................       25
Beets, sugar, roots.....................................       10
Beets, sugar, tops......................................       10
Bermudagrass............................................      200.0
Bluegrass...............................................      200.0
Breadfruit..............................................        0.2
Bromegrass..............................................      200.0
Canistel................................................        0.2
Canola, meal............................................       15
Canola, seed............................................       10
Carambola...............................................        0.2
Carrots.................................................        0.2
Cattle, kidney..........................................        4.0
Cattle, liver...........................................        0.5
Celeriac................................................        0.2
Cherimoya...............................................        0.2

[[Page 52667]]

 
Chickory................................................        0.2
Citrus, fruits..........................................        0.5
Citrus pulp, dried......................................        1.5
Clover..................................................      200.0
Cocoa beans.............................................        0.2
Coconut.................................................        0.1
Coffee beans............................................        1
Corn, field, forage.....................................        1.0
Corn, field, grain......................................        1.0
Corn, field, stover.....................................      100.0
Cotton gin byproducts...................................      100.0
Cottonseed..............................................       15
Cranberries.............................................        0.2
Dates...................................................        0.2
Durian..................................................        0.2
Fescue..................................................      200.0
Figs....................................................        0.2
Fish....................................................        0.25
Forage grasses..........................................        0.2
Forage legumes (except soybeans and peanuts)............        0.4
Fruits, small, and berries..............................        0.2
Genip...................................................        0.2
Goats, kidney...........................................        4.0
Goats, liver............................................        0.5
Grain crops (except wheat, oats, grain sorghum and              0.1
 barley)................................................
Grapes..................................................        0.2
Grasses, forage.........................................        0.2(N)
Guavas..................................................        0.2
Hogs, kidney............................................        4.0
Hogs, liver.............................................        0.5
Horseradish.............................................        0.2
Horses, kidney..........................................        4.0
Horses, liver...........................................        0.5
Jaboticaba..............................................        0.2
Jackfruit...............................................        0.2
Kiwifruit...............................................        0.2
Leafy vegetables........................................        0.2(N)
Legume vegetables (succculent and dried) group (except          5
 soybeans)..............................................
Longan..................................................        0.2
Lychee..................................................        0.2
Mamy sapote.............................................        0.2
Mangoes.................................................        0.2
Mangosteen..............................................        0.2
Molasses, sugarcane.....................................       30.0
Nuts....................................................        0.2
Oats, grain.............................................       20.0
Oil, palm...............................................        0.1
Olives..................................................        0.2
Olives, imported........................................        0.1
Orchardgrass............................................      200.0
Papayas.................................................        0.2
Parsnips................................................        0.2
Passion fruit...........................................        0.2
Peanut, forage..........................................        0.5
Peanut, hay.............................................        0.5
Peanuts.................................................        0.1
Peppermint..............................................      200
Persimmons..............................................        0.2
Pineapple...............................................        0.1
Pistachio nuts..........................................        0.2
Pome fruits.............................................        0.2
Pomegranates............................................        0.2
Potatoes................................................        0.2
Poultry, kidney.........................................        0.5
Poultry, liver..........................................        0.5
Radishes................................................        0.2
Rambutan................................................        0.2
Rutabagas...............................................        0.2
Ryegrass................................................      200.0
Salsify.................................................        0.2
Sapodilla...............................................        0.2
Sapote, black...........................................        0.2
Sapote, white...........................................        0.2
Seed and pod vegetables.................................        0.2(N)
Seed and pod vegetables, forage.........................        0.2(N)
Seed and pod vegetable, hay.............................        0.2(N)
Sheep, kidney...........................................        4.0
Sheep, liver............................................        0.5
Shellfish...............................................        3.0
Sorghum, grain..........................................       15.0
Sorghum, grain, stover..................................       40.0
Soursop.................................................        0.2
Soybean, hulls..........................................      100.0
Soybeans................................................       20.0
Soybeans, aspirated grain fractions.....................       50.0
Soybeans, forage........................................      100.0
Soybeans, grain.........................................       20.0
Soybeans, hay...........................................      200.0
Spearmint...............................................      200
Stone fruit.............................................        0.2
Sugar apple.............................................        0.2
Sugarcane...............................................        2.0
Sunflower seed..........................................        0.1
Sweet potatoes..........................................        0.2
Tamarind................................................        0.2
Tea, dried..............................................        1.0
Tea, instant............................................        7.0
Timothy.................................................      200.0
Tree nut crop group.....................................        1.0
Turnips.................................................        0.2
Vegetables, bulb........................................        0.2
Vegetables, cucurbit....................................        0.5
Vegetables, fruiting (except cucurbits) group...........        0.1
Vegetables, leafy, Brassica (cole)......................        0.2
Wheat, grain............................................        5.0
Wheat, straw............................................       85.0
Wheat milling fractions (excluding flour)...............       20.0
Wheatgrass..............................................      200.0
Yams....................................................        0.2
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of glyphosate N-(phosphonomethyl glycine) per se resulting 
from the use of irrigation water containing residues of 0.5 ppm 
following applications on or around aquatic sites, at 0.1 ppm on the 
crop groupings citrus, cucurbits, forage grasses, forages legumes, 
fruiting vegetables, grain crops, leafy vegetables, nuts, pome fruits, 
root crop vegetables, seed and pod vegetables, stone fruits, and the 
individual commodities cottonseed, hops, and avocados. Where tolerances 
are established at higher levels from other uses of glyphosate in or on 
the subject crops, the higher tolerances should also apply to residues 
from the aquatic uses cited in this paragraph.

[FR Doc. 00-22168 Filed 8-29-00; 8:45 am]
BILLING CODE 6560-50-S