[Federal Register Volume 64, Number 71 (Wednesday, April 14, 1999)]
[Rules and Regulations]
[Pages 18360-18367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9317]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300835; FRL-6073-5]
RIN 2070-AB78
Glyphosate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of (N-
(phosphonomethyl)glycine) resulting from the use of the isopropylamine
salt of glyphosate or the monoammonium salt of glyphosate in or on
barley, grain; barley, bran; beets, sugar, dried pulp; beets, sugar,
roots; beets, sugar, tops; canola, meal; canola, seed; grain crops
(except wheat, corn, oats, grain sorghum, and barley); and legume
vegetables (succulent and dried) crop group (except soybeans). The
residues from treatment of sugar beets and canola include residues in
or on sugarbeet and canola varieties which have been genetically
altered to be tolerant of glyphosate. Entries for grain crops and sugar
beets will replace current entries. Monsanto Company 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 April 14, 1999. Objections and
requests for hearings must be received by EPA on or before June 14,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300835], must be submitted to: Hearing
Clerk (1900), Environmental Protection
[[Page 18361]]
Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees
accompanying objections and hearing requests shall be labeled
``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251. A copy of any objections and hearing requests
filed with the Hearing Clerk identified by the docket control number,
[OPP-300835], must also be submitted 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, bring a copy of objections
and hearing requests to Rm. 119, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII
file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300835]. No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Jim 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: Rm. 237, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-5697;
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of February 20, 1998
(63 FR 8635) (FR-5768-9), 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) (Pub. L. 104-
170) announcing the filing of pesticide petitions (PP) 2E4118 and
7F4886 for tolerance by Monsanto Company, 700 14th Street, Suite 1100,
Washington, DC 20005 address. This notice included a summary of the
petition prepared by Monsanto Company, the registrant. There were no
comments received in response to the notice of filing.
The petition requested that 40 CFR 180.364 be amended by
establishing tolerances for residues of the herbicide (N-
(phosphonomethyl)glycine), in or on the imported raw agricultural
commodities barley, grain at 20 parts per million (ppm); barley bran
and pearled barley at 60 ppm; cereal grains group (except wheat, corn,
oats, grain sorghum, and barley) at 0.1 ppm; canola, seed at 10 ppm;
canola, meal at 25 ppm; legume vegetables (succulent or dried) group
(except soybeans) at 5 ppm (PP 2E4118) and in or on the commodies
beets, sugar, tops (leaves) at 10 ppm; beets, sugar, roots at 10 ppm;
and beets, sugar, pulp, dried at 25 ppm (PP 7F4886).
The correct tolerance expression for glyphosate is (N-
(phosphonomethyl)glycine) resulting from the application of the
isopropylamine salt of glyphosate and/or the monoammonium salt of
glyphosate. The correct terminology for cereal grains; beets, sugar,
tops (leaves); and beets, sugar, pulp, dried ; is grain crops; beet,
sugar, tops; and beets, sugar, dried pulp, respectively. The Agency is
correcting the terminology with this rule. During the course of the
review the Agency determined that available data support tolerances of
20 ppm for barley bran, 15 ppm for canola, meal and that a tolerance
for barley, pearled is not necessary. Concentration in barley, pearled
is not expected.
The Agency is amending the proposal to read that 40 CFR 180.364 be
amended by establishing tolerances for residues of the herbicide
glyphosate (N-(phosphonomethyl)glycine) resulting from the application
of the isopropylamine salt of glyphosate and/or the monoammonium salt
of glyphosate in or the raw agricultural commodities barley, grain at
20 ppm; barley, bran at 30 ppm; grain crops (except wheat, corn, oats,
grain sorghum, and barley) at 0.1 ppm; canola, seed at 10 ppm; canola,
meal at 15 ppm; beets, sugar, tops at 10 ppm; beets, sugar, roots at 10
ppm; and beets, sugar, dried pulp at 25 ppm; and legume vegetables
(succulent and dried) group (except soybeans) at 5.0 ppm.
I. Background and Statutory Findings
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).
II. 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
glyphosate and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for residues of (N-
(phosphonomethyl)glycine) resulting from the application of the
isopropylamine salt of glyphosate and/or the monoammonium salt of
glyphosate on barley, bran at 20 ppm; barley, grain at 30 ppm; beets
sugar, dried pulp at 25 ppm; beets, sugar, roots at 10 ppm; beets,
sugar, tops at 10 ppm; canola, meal at 15 ppm; canola, seed at 10 ppm;
grain crops (except wheat, corn, oats, grain sorghum, and barley) at
0.1 ppm; and legume vegetables (succulent and dried) group (except
soybeans) at 5 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by glyphosate are
discussed in this unit.
[[Page 18362]]
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 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 milligrams/kilogram/day (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 NOEL 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 NOEL 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 and
glyglyphosate lacks a leaving group.
2. Short- and intermediate-term toxicity. No short or intermediate
dermal or inhalation endpoints were identified. In a 21-day dermal
toxicity study with rabbits, no systemic or dermal toxicity was seen
following repeated applications of glyphosate at 0, 100, 1,000, or
5,000 mg/kg/day. The NOAEL was 1,000 mg/kg/day and the LOAEL was 5,000
mg/kg/day based 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 Reregistation Eligibility Decision
Document for Glyphosate (Sept, 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
safety 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 (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
[[Page 18363]]
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 and
% 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 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.
iii. Chronic risk-carcinogenic. Glyphosate has been classified as a
group E chemical no evidence of carcinogenicity in two acceptable
animal species.
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 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 drinking water level 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 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/ug. 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 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 Categories
I and II for eye and dermal irritation. The Reregistation Eligibility
Decision Document for Glyphosate (SEP-1993) indicates 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. The Agency concludes that exposures
from residential uses of glyphosate are not expected to pose undue
risks.
4. Cumulative exposure to substances with 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).
[[Page 18364]]
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) 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, 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
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.
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 glyphosate 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 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 pre-and post-natal toxicity and the
completeness of the database 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 inter-
and intra-species 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. Pre- and post-natal 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 database for
glyphosate and exposure data is complete or is 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 3.0.% 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.
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.
III. 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
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.
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
[[Page 18365]]
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
chromotography (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).
Adequate analytical methods are available for residue data
collection and enforcement of the proposed tolerances of glyphosate in
or on barley, bran, barley, grain; cereal grains (except wheat, corn,
oats, grain sorghum, and barley); canola seed, canola meal, and legume
vegetables group.
C. Magnitude of Residues
The available crop field trial residue data support the
establishment of tolerances in barley, bran at 30 ppm; barley, grain at
20 ppm; beets, sugar, dried pulp at 25 ppm; beets, sugar, roots at 10
ppm; beets, sugar, tops at 10 ppm; canola, meal at 15 ppm; canola, seed
at 10 ppm; and legume vegetable (succulent and dried) group (except
soybeans) at 5 ppm. These entries for sugar beets will replace the
current entry for beets, sugar at 0.2 ppm.
The available data support deleting the current entry for grain
crops (except wheat, corn, oats, and grain sorghum) at 0.01 ppm and
replacing it with grain crops (except wheat, corn, oats, grain sorghum
and barley) at 0.1 ppm.
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 ppm respectively.
Canadian MRLs exist for barley, barley milling fractions, pes, beans,
and lentils at 10, 15, 5, 2 and 4 ppm respectively. Mexican MRLs exist
for barley, peas, and beans at 0.1, 0.2, and 0.2 ppm, respectively. The
Mexican and Canadian MRLs are lower than needed to cover residues form
the proposed use pattens in the U.S. The tolerances to be established
for group (excluding soybeans), barley, grain, and canola seed agree
with Codex MRLs in place. The legume vegetable group tolerance includes
tolerances for peas, beans, and lentils. The crop group tolerance on
legume vegetables is necessary to cover use patterns in the Unitied
States.
No Codex, Canadian or Mexican MRLs exist for sugar beets or canola
meal, therefore harmonization is not an issue.
E. Rotational Crop Restrictions
Glyphosate labels currently bear is a 30-day minimum plant back
interval for crops on which the use of glyphosate is not registered.
IV. Conclusion
Therefore, the tolerance is established for residues of (N-
(phosphonomethyl)glycine) resulting from the application of the
isopropylamine salt of glyphosate and/or the monoammonium salt of
glyphosate in or on the raw agricultural commodities barley, grain to
20 ppm; barley bran at 30 ppm; beets, sugar, dried pulp at 25 ppm;
beets, sugar, roots at 10 ppm; beet, sugar, tops at 10 ppm; canola,
meal at 15 ppm; canola, seed at 10 ppm; grain crops (except wheat,
corn, oats, grain sorghum, and barley) at 0.1 ppm; and legume
vegetables (succulent and dried) group (except soybeans) at 5 ppm. The
entries for grain crops and beets, sugar replace current entries for
these commodities.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by June 14, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
regulation. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). 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 tolerance objection fee waivers,
contact James 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: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697; [email protected]. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is 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 in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). 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.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300835] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available
[[Page 18366]]
for inspection from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The public record is located in Room 119 of
the Public Information and Records Integrity Branch, Information
Resources and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
[email protected].
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or 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 in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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 the rule in the Federal Register. This 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: March 30, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 18367]]
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a, and 371.
2. Section 180.364 is amended, by removing from the table in
paragraph (a)(1), the commodities ``beets, sugar'' and ``grain crops
(except wheat, corn, oats, and grain sorghum)'' and by alphabetically
adding new paragraph (a)(3) to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) * * *
(3) Tolerances are established for residues of glyphosate, (N-
(phosphonomethyl)glycine) resulting from the applicaiton of the
isopropylamine salt of glyphosate and/or the monoammium salt of
glyphosate in or on the following food commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Barley, bran.............................. 30
Barley, grain............................. 20
Beets, sugar, dried pulp.................. 25
Beets, sugar, roots....................... 10
Beets, sugar, tops........................ 10
Canola, meal.............................. 15
Canola, seed.............................. 10
Grain crops (except wheat, oats, grain 0.1
sorghum and barley).
Legume vegetables (succculent and dried) 5
group (except soybeans).
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-9317 Filed 4-13-99; 8:45 am]
BILLING CODE 6560-50-F