[Federal Register Volume 64, Number 226 (Wednesday, November 24, 1999)]
[Rules and Regulations]
[Pages 66108-66114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30408]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300946; FRL-6390-5]
RIN 2070-AB78


Glyphosate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for glyphosate (N-
(phosphonomethyl)glycine) in or on certain raw agricultural commodities 
from application of glyphosate in its acid form. Entek Corporation 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective November 24, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300946, 
must be received by EPA on or before January 24, 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-300946 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, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Crystal Mall #2, 
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697, e-mail: 
[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 OPP-300946. 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 August 25, 1999 (64 FR 46382) (FRL-6093-
7), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing 
the filing of a pesticide petition (PP 9F5095) for a tolerance by Entek 
Corporation, 6835 Deerpath Road, Suite E, Elkridge, MD 21075. This 
notice included a summary of the petition prepared by Entek, 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 revising 
the existing tolerance regulation for glyphosate to allow application 
of glyphosate (in its acid form) on raw agricultural commodities 
(RACs).

[[Page 66109]]

    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 tolerances for glyphosate by revising the existing 
tolerance regulation for glyphosate to allow application of glyphosate 
(in its acid form) on raw agricultural commodities (RACs). EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerances 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 are 
discussed in this unit.
    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) (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

    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

[[Page 66110]]

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 
uncertainty factor.
    4. Carcinogenicity. Glyphosate has been classified as a Group E 
chemical - no evidence of carcinogenicity in two acceptable animal 
species.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.364) for the residues of glyphosate (N-(phosphonomethyl)glycine 
and its metabolite aminomethylphosphonic acid resulting from the 
application of the isopropylamine salt of glyphosate and/or the 
monoammonium salt of glyphosate, in or on a variety 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 as follows:
    i. Acute exposure and risk. 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. 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 and risk. 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.
    2. From drinking water. Generic expected environmental 
concentration (GENEEC) and Screening concentration and ground water 
(SCI-GROW) models were run to produce 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 to chronic 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. Glyphosate is registered for residential products, 
however, a residential exposure assessment is not required, since there 
are no endpoints selected for either dermal or inhalation exposure. The 
Agency`s default body weights and consumption values used to calculate 
DWLOCs are as follows: 70 kilograms/liter (kg/2L) (adult male), 60 kg/
2L (adult female), and 10 kg/1L (child).
    i. 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.
    ii. Chronic exposure and risk. The DWLOC (chronic) (non-cancer) 
risk is calculated by multiplying the chronic water exposure (mg/kg/
day) x (body weight) divided by the consumption (L) x 10-3 
mg/g. The DWLOCS are 69,000 g/L for the U.S. 
population in 48 states, males (13+), non-Hispanic whites, and non-
Hispanic blacks; and 19,000 g/L for non-nursing infants (less 
than 1 year old) and children (1-6 years). The GENEEC and SCI-GROW 
estimated that average concentrations of glyphosate in the surface and 
ground water are less than the DWLOC (chronic). Therefore, taking into 
account present uses and uses proposed in this action, the Agency 
concludes with reasonable certainty that no harm will result from 
chronic aggregate exposure to glyphosate.
    3. From non-dietary exposure. Glyphosate is currently registered 
for use on the following residential non-food sites: Around 
ornamentals, shade trees, shrubs, walk, 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. 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

[[Page 66111]]

Categories I and II for eye and dermal irritation. The Reregistration 
Eligibility Decision Document for Glyphosate (September 1993) indicates 
the Agency is not adding additional 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. The Agency concludes that exposures 
from residential uses of glyphosate are not expected to pose undue 
risks.
    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 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. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. There was no acute dietary endpoint identified, 
therefore there are no acute toxicological concerns for glyphosate.
    2. 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 old) and children (1-6 years) 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, EPA 
does not expect the aggregate exposure to exceed 100% of the RfD. EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to glyphosate residues.
    3. Short- and intermediate-term risk. 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. 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.
    4. 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.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of glyphosate, EPA considered 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 during 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 
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 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 
tenfold 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 are being required at this time. A developmental neurotoxicity 
data requirement is an upper tier study and 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 believes that reliable data support the use of the standard 100-
fold uncertainty factor, and that a tenfold (10x) uncertainty factor is 
not needed to protect the safety of infants and children.
    2. Acute risk. There are no acute toxicological endpoints for 
glyphosate. The Agency concludes that establishment of the proposed 
tolerances would not pose an unacceptable aggregate risk.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to glyphosate from food 
will utilize 3.3% 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

[[Page 66112]]

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, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD.
    4. 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.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to glyphosate residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    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 
reflect 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.
    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.

B. 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).

C. Magnitude of Residues

    The available crop field trial residue data support established 
tolerances for glyphosate. Application of glyphosate as the acid will 
not result in residues which exceed currently established tolerances.

D. 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.

E. Rotational Crop Restrictions

    Glyphosate labels currently bear a 30-day minimum plant back 
interval for crops on which the use of glyphosate is not registered.

V. Conclusion

    Therefore, the tolerances are established for residues of 
glyphosate (N-(phosphonomethyl)glycine) resulting from the application 
of glyphosate, the isopropylamine salt of glyphosate and/or the 
monoammonium salt of glyphosate in or on the raw agricultural 
commodities.

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-300946 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 
24, 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, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, 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

[[Page 66113]]

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, 401 M St., SW., 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, 401 M St., SW., 
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-300946, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., 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. 
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 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 General Accounting Office

    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: November 9, 1999.

James Jones,
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. In Sec. 180.364, by revising paragraph (a)(1) introductory text, 
paragraph (a)(2) introductory text, and paragraph (a)(3) introductory 
text to read as follows:


Sec. 180.364  Glyphosate; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of glyphosate, (N-

[[Page 66114]]

(phosphonomethyl)glycine) resulting from the application of glyphosate, 
the isopropylamine salt of glyphosate, and/or the monoammonium salt of 
glyphosate in or on the following food commodities:
    *       *       *       *       *
    (2) Tolerances are established for the residues of glyphosate, (N- 
(phosphonomethyl)glycine) resulting from the application of glyphosate, 
the isopropylamine salt of glyphosate, and/or the monoammonium salt of 
glyphosate in or on the following food commodities:
    *       *       *       *       *
    (3) Tolerances are established for the residues of glyphosate, (N- 
(phosphonomethyl)glycine) resulting from the application of glyphosate, 
the isopropylamine salt of glyphosate, and/or the monoammonium salt of 
glyphosate in or on the following food commodities:
    *       *       *       *       *

[FR Doc. 99-30408 Filed 11-23-99; 8:45 am]
BILLING CODE 6560-50-F