[Federal Register Volume 65, Number 143 (Tuesday, July 25, 2000)]
[Notices]
[Pages 45769-45773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18794]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-957; FRL-6596-4]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-957, must be 
received on or before August 24, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-957 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Jim Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
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 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.''

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 PF-957. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, 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 Highway, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-957 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs

[[Page 45770]]

(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3.Electronically. You may submit your comments electronically by e-
mail to: ``[email protected],'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-957. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under ``FOR FURTHER INFORMATION 
CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: July 20, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Monsanto Company

0F6130

    EPA has received a pesticide petition 0F6130 from Monsanto Company, 
600 13th St., NW., Suite 660, Washington, DC 20005 proposing, pursuant 
to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 
180 by establishing a tolerance for residues of glyphosate (N-
phosphonomethyl)glycine from the application of glyphosate, the 
isopropylamine salt of glyphoste, the ethanolamine salt of glyphosate, 
and the ammonium salt of glyphosate in or on the raw agricultural 
commodity grass forage, fodder, and hay group at 300 parts per million 
(ppm). These tolerances would replace the existing tolerances for Bahia 
grass, Bermuda grass, bluegrass, bromegrass, fescue, orchard grass, rye 
grass, timothy, and wheat grass at 200 ppm, and forage, grasses at 0.2 
ppm, grasses forage, at 0.2 ppm, and grasses forage, at 0.1 ppm. The 
Agency has determined that the petition contains data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of the residue in 
plants is adequately understood. Studies with a variety of plants 
including corn, cotton, soybeans, and wheat indicate that the uptake of 
glyphosate or its metabolite, aminomethylphosphonic acid (AMPA), from 
soil is limited. The material which is taken up is readily 
translocated. Foliarly applied glyphosate is readily absorbed and 
translocated throughout the trees or vines to the fruit of apples, 
coffee, dwarf citrus (calamondin), pears, and grapes. Metabolism via N-
methylation yields N-methylated glycines and phosphonic acids. For the 
most part, the ratio of glyphosate to AMPA is 9 to 1 but can approach 1 
to 1 in a few cases (e.g., soybeans and carrots). Much of the residue 
data for crops reflects a detectable residue of parent (0.05-0.15 ppm) 
along with residues below the level of detection (0.05 ppm) of AMPA. 
The terminal residue to be regulated in plants is glyphosate per se.
    2. Analytical method. Adequate enforcement methods are available 
for analysis of residues of glyphosate in or on plant commodities. 
These methods include GLC (Method I in Pesticides

[[Page 45771]]

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 gas chromatography mass spectrometry (GC/MS) method for 
glyphosate in crops has also been validated by EPA's analytical 
chemistry laboratory (ACL).
    Adequate analytical methods are available for residue data 
collection and enforcement of the proposed tolerances of glyphosate in 
or on grass forage, fodder, and hay group.
    3. Magnitude of residues. The available crop field trial residue 
data support the establishment of tolerances in grass forage, fodder, 
and hay at 300 ppm. This new tolerance will be sufficient to replace 
the existing tolerances for specific grass species at 200 ppm. Any 
secondary residues occurring in the liver or kidney of cattle, goats, 
horses, sheep, liver, and kidney of poultry will be covered by existing 
tolerances, and the available data indicate that residues of glyphosate 
are not anticipated to occur in any other livestock commodities as a 
result of this action.

B. Toxicological Profile

    1. Acute toxicity. Several acute toxicology studies placing 
technical-grade glyphosate in toxicity category III and toxicity 
category IV. Technical glyphosate is not a dermal sensitizer.
    2. Genotoxicty. Mutagenicity data included chromosomal aberration 
in vitro (no aberrations in chinese hamster ovary (CHO) cells were 
caused with and without S9 activation); DNA repair in rat hepatocyte; 
in vivo bone marrow cytogenetic 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).
    3. Reproductive and developmental toxicity. A developmental 
toxicity study in rabbits given doses of 0, 75, 175, and 350 
milligrams/kilograms/day (mg/kg/day) with a developmental no observed 
adverse effect level (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 clinical signs of toxicity and 
mortality at 350 mg/kg/day highest dose tested (HDT).
    A multi-generation reproduction study with rats fed dosage levels 
of 0, 3, 10, and 30 mg/kg/day with the parental and reproductive (pup) 
NOAELs at 30 mg/kg/day HDT based on no adverse effects related to 
dosing at any level tested.
    In a 2-generation reproduction study, rats were 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 Fo and F1 males and females at 1,500 mg/kg/
day HDT and a reproductive NOAEL 1,500 mg/kg/day HDT.
    4. Subchronic toxicity. In a 2-day dermal toxicity study, rabbits 
were exposed to glyphosate at levels of 0, 10, 1,000, or 5,000 mg/kg/
day. The systemic 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.
    5. Chronic toxicity. 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. 
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.
    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.
    A second 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) 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 
(bwt) body weight gain 1,183 mg/kg/day (females) HDT. There was no 
carcinogenic response at any dose level.
    6. Animal metabolism. The qualitative nature of the residue in 
animals is adequately understood. Studies with lactating goats and 
laying hens fed a mixture of glyphosate and AMPA indicate that the 
primary route of elimination was by excretion (urine and feces). These 
results are consistent with metabolism studies in rats, rabbits, and 
cows. The terminal residues in eggs, milk, and animal tissues are 
glyphosate and its metabolite AMPA; there was no evidence of further 
metabolism. The terminal residue to be regulated in livestock is 
glyphosate per se.
    7. Metabolite toxicology. The metabolite AMPA has been determined 
to not be of toxicological significance.
    8. Endocrine disruption. The toxicity studies required by EPA for 
the registration of pesticides measure numerous endpoints with 
sufficient sensitivity to detect potential endocrine-modulating 
activity. No effects have been identified in subchronic, chronic or 
developmental toxicity studies to indicate any endocrine-modulating 
activity by glyphosate. In addition, negative results were obtained 
when glyphosate was tested in a dominant-lethal mutation assay. While 
this assay was designed as a genetic toxicity test, agents that can 
affect male reproduction function will also cause effects in this 
assay. More importantly, the multi-generation reproduction study in 
rodents is a complex study design which measures a broad range of 
endpoints in the reproductive system and in developing offspring that 
are sensitive to alterations by chemical agents. Glyphosate has been 
tested in two separate multi-generation studies and each time the 
results demonstrated that glyphosate is not a reproductive toxin.

C. Aggregate Exposure

    1. Dietary exposure--From food and feed uses. Tolerances have been 
established (40 CFR 180.364) for the residues of (N-
(phosphonomethyl)glycine resulting from the application of the 
isopropylamine salt of glyphosate, and/or the ammonium salt of 
glyphosate, in or on a variety of raw agricultural commodities. 
Tolerances are established on the 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 based on 
animal feeding studies and worst-case livestock diets. Risk assessments 
were conducted by EPA to assess dietary exposures from glyphosate as 
follows.
    i. Food--a. Acute exposure and risk. Acute dietary risk assessments 
are

[[Page 45772]]

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. 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 has concluded with 
reasonable certainty that glyphosate dose not elicit an acute 
toxicological response, and that an acute dietary risk assessment is 
not needed.
    b. Chronic exposure and risk. The chronic dietary exposure analysis 
was conduced using the reference dose (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 and 
percent RfDs for certain population subgroups. The theoretical maximum 
residue contribution (TMRC) for the U.S. population (48 contiguous 
states) was 0.029960 or 1.5% of the RfD; 0.026051 or 1.3% of the RfD 
for nursing infants (less than on 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. These exposure 
levels are unaffected by the proposed tolerances on grass forage, 
fodder, and hay group. These commodities are only consumed by 
livestock, and the existing tolerances in liver and kidney fractions of 
cattle, goats, horses, sheep, and poultry are considered sufficient to 
account for any additional dietary burden these animals may encounter.
    c. Chronic risk-carcinogenic. Glyphosate has been classified as a 
group E chemical no evidence of carcinogenicity in two acceptable 
animal species.
    ii. Drinking water. Generic Expected Environmental Concentration 
(GENEEC) and Screening Concentration and Groundwater (SCI-GROW) models 
were run by EPA to produce maximum estimates of glyphosate 
concentrations in surface and ground water, respectively. The drinking 
water exposure for glyphosate from the ground water screening model, 
SCI-GROW, yields a peak and chronic estimated environmental 
concentration (EEC) of 0.0011 parts per billion (ppb) in ground water. 
The GENEEC values represent upper-bound estimates of the concentrations 
that might be found in surface water due to glyphosate use. Thus, the 
GENEEC model predicts that glyphosate surface water concentrations 
range from a peak of 1.64 ppb to a 56-day average of 0.19 ppb. The 
model estimates are compared directly to drinking water levels of 
comparison (DWLOC) (chronic). The DWLOC (chronic) is the theoretical 
concentration of glyphosate in drinking water so that the aggregate 
chronic exposure (food + water + residential) will occupy no more than 
100% of the RfD. This assessment does not take into account expected 
reductions in any glyphosate concentrations in water arising from water 
treatment of surface water prior to releasing it for drinking purposes. 
The Agency's default body weights (bwts) and consumption values used to 
calculate DWLOCs are as follows: 70 kg/2 liter (L) (adult male), 60 kg/
2L (adult female), and 10 kg/1L (child).
    a. Acute exposure and risk. 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.
    b. Chronic exposure and risk. The DWLOC (chronic, non-cancer) risk 
is calculated by multiplying the allowed chronic water exposure (mg/kg/
day) x bwt/kg divided by the consumption (L) x 103 
g/mg. The DWLOCs are 69,000 g/L for the U.S. 
population in 48 contiguous states, males (13+), non-hispanic whites, 
and non-hispanic blacks; and 19,000 for non-nursing infants (less than 
1-year old) and children (1-6 years). Although the GENEEC and SCI-GROW 
models are known to produce worst-case estimates, the resulting average 
concentrations of glyphosate in the surface and ground water are more 
than 10,000-fold less than the DWLOC (chronic). Therefore, taking into 
account present uses and uses proposed in this action, Monsanto 
concludes with reasonable certainty that no harm will result from 
chronic aggregate exposure to glyphosate.
    2. Non-dietary exposure. Glyphosate is currently registered for use 
on the following residential non-food sites: Around ornamentals, shade 
trees, shrubs, walks, driveways, flower beds, and home lawns. Based on 
the registered uses of glyphosate, the potential for residential 
exposures 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 and a residential exposure 
assessment is not required since there are no toxicological endpoints 
selected for either dermal or inhalation exposure. Exposures from 
residential uses are not expected to pose undue risks or harm to public 
health.
    i. Acute exposure and risk. There are no acute toxicological 
concerns for glyphosate. Glyphosate has been the subject of numerous 
incident reports, primarily for eye and skin irritation injuries, in 
California. Some glyphosate end-use products are in toxicity categories 
I and II for eye and dermal irritation. The reregistration eligibility 
decision document for glyphosate (SEP-1993) indicated that the Agency 
is not adding 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.
    ii. Chronic exposure and risk. Although there are registered 
residential uses for glyphosate, glyphosate does not meet the Agency's 
criteria for residential data requirements, due to the lack of 
toxicological concerns. Incidental acute and/or chronic dietary 
exposures from residential uses of glyphosate are not expected to pose 
undue risks to the general population, including infants and children.
    iii. Short- and intermediate-term exposure and risk. EPA identified 
no toxicological concerns for short-, intermediate-, and long-term 
dermal or inhalation routes of exposures for glyphosate. The Agency has 
concluded that exposures from residential uses of glyphosate are not 
expected to pose undue risks.

D. Cumulative Effects

    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 residue and ``other substances that have a 
common mechanism of toxicity.''

[[Page 45773]]

    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 produce a toxic metabolite that is also produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA should assumed that glyphosate does not have 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) 
(FRL-5754-7).

E. Safety Determination

    1. U.S. population--i. Acute risk. There was no acute dietary 
endpoint identified, therefore there are no acute toxicological 
concerns for glyphosate.
    ii. Chronic risk. Using the TMRC exposure assumptions described in 
this unit, EPA has concluded that aggregate exposure to glyphosate from 
food will utilize 1.5% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is non-
nursing infants (less than 1-year) and children (1-6) as discussed 
below. EPA generally has no concern for exposures below 100% of the RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. Despite the potential for exposure to glyphosate in 
drinking water and from non-dietary, non-occupational exposure, the 
aggregate exposure will not exceed 100% of the RfD. EPA has previously 
concluded that there is a reasonable certainty that no harm will result 
from aggregate exposure to glyphosate residues at this level.
    iii. Short- and intermediate-term risk. Short- and intermediate-
term dermal and inhalation risk is not a concern due to the lack of 
significant toxicological effects observed with glyphosate under these 
exposure scenarios. Short- and intermediate-term aggregate exposure 
takes into account chronic dietary food and water (considered to be a 
background exposure level) plus indoor and outdoor residential 
exposure.
    iv. Aggregate cancer risk for U.S. population. Glyphosate has been 
classified as a group E chemical, with no evidence of carcinogenicity 
for humans in two acceptable animal studies.
    v. Determination of safety. Based on these risk assessments, 
Monsanto concludes that there is a reasonable certainty that no harm 
will result from aggregate exposure to glyphosate residues.
    2. Infants and children--i. Safety factor for infants and children. 
In general, when assessing the potential for additional sensitivity of 
infants and children to residues of glyphosate, EPA considers data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional ten-
fold 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 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. EPA believes that reliable data support 
using the standard uncertainty factor (usually 100 for combined 
interspecies and intraspecies variability) and not the additional ten-
fold MOE/uncertainty factor when EPA has a complete data base under 
existing guidelines and when the severity of the effect in infants or 
children or the potency or unusual toxic properties of a compound do 
not raise concerns regarding the adequacy of the standard MOE/safety 
factor.
    ii. 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.
    iii. 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. Based on these 
data, there is no indication that the developing fetus or neonate is 
more sensitive than adult animals. No developmental neurotoxicity 
studies have been required at this time. A developmental neurotoxicity 
data requirement is an upper tier study and is required only if effects 
observed in the acute and 90-day neurotoxicity studies indicate 
concerns for frank neuropathy or alterations seen in fetal nervous 
system in the developmental or reproductive toxicology studies. The 
Agency has concluded that reliable data support the use of the standard 
100-fold uncertainty factor for glyphosate, and that a ten-fold (10x) 
uncertainty factor is not needed to protect the safety of infants and 
children.
    iv. Acute risk. There are no acute toxicological endpoints for 
glyphosate. The Agency has concluded that establishment of the proposed 
tolerances would not pose an unacceptable aggregate risk.
    v. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to glyphosate from food 
utilizing present tolerances will utilize 3.0.% of the RfD for infants 
and children. EPA generally has no concern for exposures below 100% of 
the RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. These dietary exposure levels are unaffected by 
the proposed tolerances on grass forage, fodder, and hay group, because 
these commodities are only consumed by livestock, and the existing 
tolerances in liver and kidney fractions of cattle, goats, horses, 
sheep, and poultry are considered sufficient to account for any 
additional dietary burden these animals may encounter. Although there 
is a low likelihood, potential exposure to glyphosate in drinking water 
and from non-dietary, non-occupational exposure, EPA has previously 
concluded that the aggregate exposure is not expected to exceed 100% of 
the RfD.
    vi. Short- or intermediate-term risk. Short-term and intermediate-
term dermal and inhalation risk is not a concern due to the lack of 
significant toxicological effects observed with glyphosate under these 
exposure scenarios.
    vii. Determination of safety. Based on these risk assessments, EPA 
has previously concluded that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
glyphosate residues at these levels.

F. International Tolerances

    A Codex Maximum Residue Level exists for ``hay or fodder (dry) of 
grasses'' at 50 ppm.

[FR Doc. 00-18794 Filed 7-24-00; 8:45 am]
BILLING CODE 6560-50-F