Glyphosate; Pesticide Tolerance
[Federal Register: November 24, 1999 (Volume 64, Number 226)]
[Rules and Regulations]
[Page 66108-66114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no99-11]
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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:
tompkins.james@epa.gov.
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
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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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. Please use an ASCII file format and avoid the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 6.1/8.0 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
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