[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]


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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.

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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