[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Rules and Regulations]
[Pages 17723-17730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9231]



[[Page 17723]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185, and 186

[OPP-300469; FRL-5598-6]


 Glyphosate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes permanent tolerances for residues of the 
herbicide glyphosate [N-(phosphonomethyl)glycine] in or on the raw 
agricultural commodities (RACs) corn, field, grain; corn, field, 
stover; corn, field, forage; aspirated grain fractions; sorghum, grain; 
sorghum, grain, stover; and oats. The residues from the treatment of 
field corn include residues in or on field corn varieties which have 
been genetically modified to be tolerant of glyphosate. Monsanto 
Company submitted petitions to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act of 
1996 (Pub L. 104-179) requesting the tolerances.
EFFECTIVE DATES: These regulations become effective April 11, 1997. 
Written objections must be submitted by June 10, 1997.

ADDRESSES: Written objection and hearing requests, identified by the 
docket control number, [OPP-300469; PP 8F3672, 8F3673, 5F4555, 6E4645], 
may be submitted to: Hearing Clerk (1900), Environmental Protection 
Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees 
accompanying objections 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 request filed with the Hearing Clerk should be 
identified by the docket control number and submitted to: Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), 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. 1132, CM#2, 1921 Jefferson 
Davis Highway., Arlington, VA 22202.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also 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 in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[OPP-300469; PP 8F3672, 8F3673, 5F4555, 6E4645]. 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. Additional 
information on electronic submission can be found in Unit XIII. of this 
document.

FOR FURTHER INFORMATION CONTACT: By mail, Philip V. Errico, Product 
Manager, Registration Division (H7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number and e-mail address: Rm. 241, CM #2, 
1921 Jefferson Davis Highway., Arlington, VA, (703)-305-6027; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of December 24, 1996 
(61 FR 67804)(FRL-5576-6), EPA issued a Notice of Filing amending 
petitions PP 8F3672, 8F3673, 5F4555, 6E4645 to bring the petitions into 
conformity with the Food Quality Protection Act (FQPA of 1996). The 
notice contained a summary of the petitions prepared by the petitioner 
and the summary contained conclusions and arguments to support its 
conclusion that the petitions complied with FPQA. In that notice 
Monsanto Company, 700 14th Street, NW., Suite 1100, Washington, DC 
20005 proposed amending 40 CFR 180.364 by establishing a regulation to 
permit residues of the herbicide glyphosate (N-
(phosphonomethyl)glycine) resulting from the application of the 
isopropylamine salt and/or the monoammonium salt of glyphosate in or on 
the raw agricultural commodities (RACs) field corn grain at 1.0 ppm; 
field corn forage at 1.0 ppm; field corn fodder at 100 ppm; aspirated 
grain fractions at 200 ppm; grain sorghum at 15 ppm; grain sorghum 
fodder at 40 ppm; and oats at 20 ppm. The notice stated that PP 5F4555 
specifically related to field corn which had been genetically modified 
to be tolerant to glyphosate.
    The Agency received one comment opposing the tolerances. The 
commentor`s objection was based on concerns of (1) Enhanced exposure of 
the public to glyphosate and other ingredients of the Roundup 
formulations, (2) greater use of Roundup/glyphosate which will result 
in adverse effects to the environment and human health, and (3) 
exposure of the public to Roundup from consumption of the corn or the 
animal product from animals fed corn. EPA`s response to this comment is 
provided below.
    The Agency determined that the terminology for field corn grain, 
field corn, forage; field corn, fodder; aspirated grain fractions; 
grain sorghum, and grain sorghum, fodder; should be corrected to read 
corn, field, grain; corn, field, stover; corn, field, forage; aspirated 
grain fractions; sorghum, grain; and sorghum, grain, stover; The 
subject regulation is therefore amended accordingly.
    The data submitted in the petitions and other relevant material 
have been evaluated. The glyphosate toxicological data listed below 
were considered in support of these tolerances.

I. Toxicological Profile

    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 1-year feeding study with dogs fed dosage levels of 0, 20, 
100, and 500 milligrams/kilogram/day (mg/kg/day) with a no-observable-
effect level (NOEL) of 500 mg/kg/day.
    3. 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.
    4. 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 NOEL 
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.
    5. 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 NOEL 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

[[Page 17724]]

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.
    6. A developmental toxicity study in rats given doses of 0, 300, 
1,000, and 3,500 mg/kg/day with a developmental NOEL 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 NOEL 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.
    7. A developmental toxicity study in rabbits given doses of 0, 75, 
175, and 350 mg/kg/day with a developmental NOEL of 175 mg/kg/day 
(insufficient litters were available at 350 mg/kg/day to assess 
developmental toxicity); a maternal NOEL of 175 mg/kg/day based on 
increased incidence of soft stool, diarrhea, nasal discharge, and 
deaths at 350 mg/kg/day HDT.
    8. A multigeneration reproduction study with rats fed dosage levels 
of 0, 3, 10, and 30 mg/kg/day with the parental no-observed-effect 
level/lowest observed effect level (NOEL/LOEL) 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 three-generation rat reproduction study the latter 
was a spurious rather than glyphosate-related effect. Therefore, the 
parental and reproductive (pup) NOELs are 30 mg/kg/day.
    9. A two 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 F0 and F1 males and females at 1,500 mg/kg/
day HDT and a reproductive NOEL 1,500 mg/kg/day HDT.
    10. 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).

II. Dose Assessment Response

    1. Reference Dose (RfD). The RfD represents the level at or below 
which daily aggregate dietary exposure over a lifetime will not pose 
appreciable risks to human health. The RfD is determined by using the 
toxicological end point or the NOEL for the most sensitive mammalian 
toxicological study. To assure the adequacy of the RfD, the Agency uses 
an uncertainly factor in deriving it. The factor is usually 100, based 
on the assumption that certain segments of the human population could 
be as much as 100 times more sensitive than the species represented by 
the toxicology. The Agency has determined a RfD of 2.0 mg/kg/day based 
on the maternal toxicity NOEL of 175 mg/kg/day from the developmental 
study with rabbits. The LOEL of 350 mg/kg/day HDT was based on 
treatment related findings of diarrhea, nasal, discharge, and death 
(62.5% of the does died by gestation day 21). Developmental toxicity 
was not observed at any dose tested.
    2. Carcinogenicity classification. The carcinogenic potential of 
glyphosate was first considered by a panel, then called the Toxicology 
Branch AD Hoc Committee, in 1985. The Committee, in a consensus review 
dated March 4, 1985, classified glyphosate as a Group C carcinogen 
based on an increased incidence of renal tumors in male mice. The 
Committee also concluded that dose levels tested in the 26-month rat 
study were not adequate for assessment of glyphosate's carcinogenic 
potential in this species. These findings, along with additional 
information, including a reexamination of the kidney slides from the 
long-term mouse study, were referred to the FIFRA Scientific Advisory 
Panel (SAP). In its report dated February 24, 1986, SAP classified 
glyphosate as a Group D Carcinogen (inadequate animal evidence of 
carcinogenic potential). SAP concluded that, after adjusting for the 
greater survival in the high-dose mice compared to concurrent controls, 
that no statistically significant pairwise differences existed, 
although the trend was significant.
    The SAP determined that the carcinogenic potential of glyphosate 
could not be determined from existing data and proposed that the rat 
and/or mouse studies be repeated in order to classify these equivocal 
findings. On reexamination of all information, the Agency classified 
glyphosate as a Group D Carcinogen and requested that the rat study be 
repeated and that a decision on the need for a repeat mouse study would 
be made upon completion of review of the rat study.
    Upon receipt and review of the second rat chronic feeding/
carcinogenicity study, all toxicological findings for glyphosate were 
referred to the Health Effects Division Carcinogenicity Peer Review 
Committee on June 26, 1991, for discussion and evaluation of the weight 
of evidence on glyphosate with particular emphasis on its carcinogenic 
potential. The Peer Review Committee classified glyphosate as a Group E 
(evidence of noncarcinogenicity for humans), based upon lack of 
convincing carcinogenicity evidence in adequate studies in two animal 
species. This classification is based on the following findings: (1) 
None of the types of tumors observed in the studies (pancreatic islet 
cell adenomas in male rat, thyroid c-cell adenomas and/or carcinomas in 
male and female rats, hepatocellular adenomas and carcinomas in male 
rats, and renal tubular neoplasms in male mice) were determined to be 
compound related; (2) glyphosate was tested up to the limit dose on the 
rat and up to levels higher than the limit dose in mice; and (3) there 
is no evidence of genotoxicity for glyphosate.

III. Non-Dietary (Residential and Other Non-Occupational) Exposure 
Assessment

    Glyphosate is registered for use on non-food sites such as around 
ornamental, shade trees, shrubs, walks, driveways, flowerbeds, home 
lawns, farmsteads including building foundations, along and in fences, 
in dry ditches and canals, along ditchbanks, farm roads, shelterbelts, 
forestry, Christmas trees, and industrial sites and other noncrop or 
industrial areas such as airports, lumber yards, manufacturing sites, 
utility substations, parking areas, petroleum tank farms, and pumping 
station.
    Margins of Exposure (MOE's) are determined for non-dietary exposure 
based on toxicological endpoints and measured or estimated exposures. 
Since glyphosate is a group E chemical (evidence of non-carcinogenicity 
for humans), the 21 day dermal study lacked any observable effects at 
the limit dose, and no adverse effects were observed in developmental 
toxicity studies in rats up to 1,000 mg/kg/day and rabbits up to 175 
mg/kg/day, no toxicological endpoints are applicable. Because available 
data indicated no evidence of significant toxicity via the dermal or 
inhalations routes, MOE`s were not calculated and risk assessments are 
not required for non-occupational (residential uses).

[[Page 17725]]

    Some glyphosate end-use products (non ``homeowner'' uses only) are 
in Toxicity Categories I and II for dermal and eye irritation and have 
been associated with illness or injuries related to skin or eye 
irritation. Under the protective clothing requirements of the Worker 
Protection Standards (WPS), handlers of these products are expected to 
be adequately protected.

IV. Dietary Exposure Assessment

    The use of a pesticide may result directly or indirectly, in 
residues in food. Primary residues or indirect/ inadvertent residues in 
the agricultural commodities harvested from the crop cultured with the 
aid of pesticide are determined by chemical analysis. To account for 
the diversity of growing conditions, culture practices, soil types, 
climatic conditions, crop varieties and method of use of the pesticide, 
data from studies that represent the resulting commodities are 
collected and evaluated to determine an appropriate level of the 
residue that would not be exceeded if the pesticide is used as 
represented in the studies. Available field trial data for glyphosate 
support these tolerances. However, because of the recent imposition of 
additional field trial data for specific geographical representation, 
additional field trial data are required for corn and grain sorghum. 
Because insufficient time has elapsed since imposition of these 
requirements the petitioner is being granted conditional registrations 
while obtaining the data. The conduct of the field trial and guidelines 
for determining the residues are given in EPA ``OPPTS Test Guidelines, 
Series 860, Residue Chemistry, August 28, 1996. See Federal Register, 
61 FR 44308-44311 for availability of document.
    The nature of the residue in plants and animals is adequately 
understood and consists of the parent, glyphosate. The Agency has 
decided that only glyphosate parent is to be regulated in plant and 
animal commodities and that the major metabolite, AMPA 
(aminomethylphosphonic acid) is not of toxicological concern regardless 
of its levels in food.
    Secondary residues in animal commodities are expected from these 
uses. However, the established livestock tolerances are adequate to 
cover secondary residues which may result from feeding field corn (both 
conventional and genetically modified), and sorghum commodities with 
residues of glyphosate to animals. Since no U.S. registration has been 
proposed for oats, it has been concluded that oat feed items are not 
likely to enter channels of trades in the United States.

V. International Harmonization

     Codex MRL`s for the residues of glyphosate exist in maize and the 
straw and fodder, dry cereal grains at 0.1 and 100 ppm respectively. 
Mexican limits on maize exist at 0.1 ppm. Canadian limits on all other 
food crops exist at 0.1 ppm. MRL`s of 20 ppm, 10 ppm, and 0.1 ppm on 
oats are established/pending for CODEX, Canada, and Mexico, 
respectively. Codex MRLS were established based on preplant/preemergent 
use of glyphosate and are identical to the existing tolerances for 
these crops under the same us conditions in the United States. The 
increased tolerances now being proposed on corn and sorghum are based 
on new preharvest uses of glyphosate in the United States. The import 
tolerance being proposed for oats is being proposed to harmonize with 
other international MRL's. The Agency suggests the petitioner consider 
providing all relevant studies to Codex once the U.S. tolerances are 
established in order that the Codex MRLs may be amended to accommodate 
the use needs of the United States.
    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 HPLC with fluormetric detection. Use of the 
GLC method is being discouraged due to lengthiness of the procedure. 
The HPLC method has undergone successful Agency validation and has been 
published in PAM II. A GC/MS method for glyphosate in crops has also 
been validated by the Agency. This method has not yet been submitted 
for publication in PAM II.

VI. Aggregate Exposure Assessment

    1. Acute dietary. There is no concern for acute effects due to 
dietary exposure to glyphosate.
    2. Chronic dietary. Using the Dietary Risk Evaluation System 
(DRES), a routine chronic exposure analysis was performed for 
glyphosate. The chronic analysis for glyphosate is a worst case 
estimate of dietary exposure with all residues at tolerance levels and 
100% of the commodities assumed to be treated with glyphosate.
    3. Drinking water. In examining aggregate exposure, FQPA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures. The 
primary non-food sources of exposure the Agency looks at include 
drinking water (whether from groundwater or surface water), and 
exposure through pesticide use in gardens. lawns, or buildings 
(residential and other indoor uses).
    The lifetime health advisory and maximum contaminant level (MCL), 
for glyphosate are the same and given as 700 parts per billion in the 
U.S. EPA Office of Drinking Water`s ``Drinking Water Health Advisory; 
Pesticides.'' Environmental Fate data for glyphosate indicate little 
potential for the7 chemical to migrate to ground water, but some 
potential for residues to migrate to surface waters. Glyphosate is not 
highly mobile and not persistent in a soil or water environment. 
Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water related exposures to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfD`s 
or acute dietary NOEL`s) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for 
consumption of contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause glyphosate to 
exceed the RfD if the tolerances being considered in this document were 
granted. The Agency has therefore concluded that the potential 
exposures associated with glyphosate in water, even the higher levels 
the Agency is considering as a conservative upper bound, would not 
prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerance is granted.
    4. Non occupational (residential) and non-dietary. Glyphosate is 
registered for residential uses. As part of the hazard assessment 
process, the Agency reviews the available toxicological database to 
determine the endpoints of concern. For glyphosate, the Agency does not 
have a concern for acute, short-term, or intermediate occupational or 
residential risk since the available data do not indicate any evidence 
of significant toxicity by the dermal or inhalation routes, or from a 1 
day or single event exposure by the oral route. Therefore, an

[[Page 17726]]

acute, a short-term, or intermediate-term occupational or residential 
risk assessment was not required.
    As part of the hazard assessment process it was determined that a 
chronic residential assessment was not necessary. The exposures which 
would result from the use of glyphosate were determined to be of an 
intermittent nature. The frequency and duration of these exposures do 
not exhibit a chronic exposure pattern. The exposures do not occur 
often enough to be considered a chronic exposure i.e., a continuous 
exposure that occurs for at least several months. Therefore, 
residential exposures were not aggregated with dietary exposures in 
estimating chronic risk.
    6. 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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through examination 
of particular classes of pesticides. The Agency hopes that the results 
of this pilot process will increase the Agency`s scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common 
mechanisms issues can be resolved. These pesticides include pesticides 
that are toxicologically and structurally dissimilar to existing 
chemical substances (in which the Agency can conclude that it is 
unlikely that a pesticide shares a common mechanism of activity with 
other substances) and pesticides that produce a common toxic metabolite 
(in which case common mechanism of activity will be assumed).
    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 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. A condition of the registrations associated with 
these tolerances will be that the registrant will provide common 
mechanism data in a timely manner when and if the Agency asks for it. 
After EPA develops methodologies for more fully applying common 
mechanism of toxicity issues to risk assessments, the Agency will 
develop a process (either as a part of the periodic review of 
pesticides or otherwise) to reexamine those tolerance decisions made 
earlier.

VII. Determination of Safety for the U.S. Population and Nonnursing 
Infants

    Using the Dietary Risks Evaluation System (DRES) a chronic analysis 
was based on 100% of the crop treated and all residues at tolerance 
levels. Based on the dietary risk assessment the proposed uses utilize 
0.115% of the RfD for U.S. population; 0.189% of the RfD for non-
nursing infants under 1 year old; 0.84 of the RfD for nursing infants 
under 1 year old; 0.866% of the RfD for children 1 to 6 years old; and 
0.443% of the RfD for children 7 to 12 years old. Total aggregate 
exposure from glyphosate residues in food, taking into account existing 
and proposed uses, uses 1% of the RfD for the overall U.S. population 
and nursing infants: 3% of the RfD for nonnursing infants under 1 year 
old and children 1 to 6 years old; 3%; and 2% of the RfD for children 7 
to 12 years old. An additional risk assessment for residential uses was 
not required because of no evidence of significant toxicology via 
dermal or inhalation routes. Even though the Agency has not pinpointed 
the appropriate bounding figure for consumption of contaminated water, 
the ranges the Agency is continuing to examine are all below the level 
that would cause glyphosate to exceed the RfD. EPA concluded that there 
is reasonable certainty that no harm will occur from aggregate exposure 
to glyphosate.

VIII. Determination of Safety for Infants and Children

    FFCDA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (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 exposure (safety) will be safe for infants and 
children. Margins or exposure (safety) are often referred to as 
uncertainty (safety) factors. EPA believes that reliable data support 
using the standard margin of exposure (usually 100x for combined inter- 
and intra-species variability) and not the additional tenfold margin of 
exposure when EPA has a complete data base under existing guidelines 
and when the severity of the effect in infants and children or the 
potency or unusual toxic properties of a compound do not raise concerns 
regarding the adequacy of the standard margin of exposure.
    Risk to infants and children was determined by the use of two 
developmental toxicity studies in rats and rabbits and the two-
generation reproduction study in rats discussed below. The 
developmental toxicity studies evaluates the potential for adverse 
effects on the developing organism resulting from exposure during 
prenatal development. The reproduction study provides information 
relating to effects from exposure to the chemical on the reproductive 
capability of both (mating) parents and on systemic toxicity.
    The toxicological database for evaluating pre- and post-natal 
toxicity for glyphosate is considered to be complete at this time. In 
the rabbits, no developmental toxicity was observed at doses where 
significant maternal toxicity was noted (death and clinical signs at 
350 mg/kg/day, highest dose tested HDT. In the rat developmental 
toxicity study, maternal (systemic) toxicity was noted at 3,500 mg/kg/
day, HDT as diarrhea, decreased mean body weight gain, breathing 
rattles, inactivity, red matter around the nose and mouth, and on 
forelimbs and dorsal head, decreases in total implantations/dam and 
inviable fetuses/dam and death (24% of the group). The developmental 
(pup) NOEL is 1,000 mg/kg/day. The

[[Page 17727]]

developmental (pup) toxicity was exhibited only in the high dose as 
increased numbers of litters and fetuses with unossified sternebrae, 
and decreased mean fetal body weights. However, these developmental 
effects were assumed to be due to the extreme maternal toxicity. No 
effects on reproductive parameters were observed.
    In the rat two-generation reproduction study, parental toxicity was 
observed at 1,500 mg/kg/day as soft stools, decreased food consumptions 
and body weight gain. The developmental (pup) toxicity was also only 
exhibited at 1,500 mg/kg/day as decreased body weight gain of the F1a, 
F2a, and F2b male and female pups during the second and third weeks of 
lactation.
    The RfD is based on the NOEL for maternal toxicity in the rabbit 
developmental study. No developmental effects were noted in the study. 
In the rat developmental study effects were noted only at 20x higher 
than the NOEL used for the RfD. No pre- or post-natal effects were seen 
in any study absent maternal toxicity. In the rat reproduction study 
developmental effects were noted at 5x the NOEL used for the RfD. The 
Agency does not believe the effects seen in these studies are of such 
concern to require an additional safety factor. Accordingly, the Agency 
believes the RfD has an adequate margin of protection for infants and 
children. The percent RfD utilized by glyphosate is from 1% for nursing 
infants (less than 1 year old) to 3% for non-nursing infants and 
children 1 to 6 years old. EPA concluded that there is reasonable 
certainty that no harm will occur to infants and children from 
aggregate exposure to glyphosate.

IX. Other Considerations

    Endocrine effects. No specific tests have been conducted with 
glyphosate to determine whether the chemical may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen or other endocrine effects. However, there are no significant 
findings in other relative toxicity studies, i.e., teratology and 
multi-generation reproductive studies which would suggest that 
glyphosate produces these kinds of effects.

X. Data Gaps

    Data desirable but lacking for these tolerances include specific 
geographic representative grain sorghum and corn field residue trials. 
Because of insufficient time since the imposition of additional data 
requirements the Agency is requiring that this data be submitted as a 
condition of registration.
    Based on the information cited above, the Agency has determined 
that the establishment of these tolerances by amending 40 CFR part 180 
will be safe, therefore the tolerances are established as set forth 
below.
    In addition to the time-limited tolerances being amended, since for 
purposes of establishing tolerances FQPA has eliminated all 
distinctions between raw and processed food, EPA is combining the 
tolerances that now appear in Secs. 185.3500 and 186.3500 with the 
tolerances in Sec. 180.364 and is eliminating Secs. 185.3500 and 
186.3500.

XI. Response to Comment

    The one commenter raised several concerns regarding these 
tolerances.
    1. Increased exposure. The commenter was concerned that approval of 
these tolerances would lead to increased exposure to glyphosate because 
it would enhance Monsanto`s ability to market glyphosate-tolerant corn 
and thus use glyphosate. The commentor argued that therefore approval 
of the tolerances would not protect the public health rather it would 
increase risk.
    EPA response. Approval of these tolerances may lead to higher 
exposure the glyphosate residues. That is the case when ever EPA 
approves a new tolerance. The question before EPA in ruling on a 
tolerance petition is whether the tolerance meets the FFDCA`s safety 
standard. As detailed above, EPA has concluded that these tolerances do 
meet the reasonable certainty of no harm standard. This standard 
requires consideration of exposure to glyphosate from existing uses as 
well as exposure from the uses covered by the tolerances in the 
petition before EPA.
    2. Glyphosate residues in foods derived from animals. The commenter 
asked EPA to confirm that the major route of exposure resulting from 
these tolerances would be from foods derived from animals. The 
commenter also asked how the tolerances would effect the level of 
glyphosate residues in animal feeds and what percentage of glyphosate 
treated corn would be consumed by humans.
    EPA response. The nature of glyphosate residue in plants and 
animals has been explored by various studies that have been reviewed by 
the Agency. A separate peer review committee ``Metabolism Committee'' 
evaluated glyphosate plant and animal commodities and decided that the 
major metabolite is not of toxicological concern regardless of its 
level in food. Due to the use pattern of glyphosate, secondary residues 
in animal commodities are expected. Corn grain, forage, fodder, and 
aspirated grain fractions are animal feed items. Based on the proposed 
tolerances on aspirated grain fractions, corn stover, forage, and 
grain, the dietary burden of at most 78 ppm glyphosate residue in/on 
corn commodities, (if all corn commodities (including corn genetically 
altered to be tolerant to glyphosate) are fed)) will be covered by the 
tolerances currently established on meat, milk, eggs, and livestock 
commodities including the recently (April 5, 1996, 61 FR 15192)(FRL-
5351-1), established tolerances on kidney of cattle, goats, hogs, 
horses, poultry, and sheep at 4 ppm. A chronic (long-term) dietary 
exposure analysis (DRES) was performed for the use of glyphosate in/on 
corn. The Agency used the following conservative (worst-case) 
assumptions: all corn (including genetically altered corn) would have 
the same tolerance level residues, and that 100 percent of the crop is 
treated. It is not believed that actual residues would reach tolerance 
levels, or that 100 percent of the total corn crop would be treated 
with glyphosate. The Agency feels that the risk to human health does 
not exceed a level of concern (100%) due to the percent of the RfD 
using the ``worst case'' assumptions. These dietary risk numbers 
include corn consumed directly by humans, plus meat, milk and eggs from 
which animals consumed corn raw agricultural commodities as feed. 
Published and proposed glyphosate tolerances result in the following 
percents of the RfD used: 1% for the overall U.S. population and 
nursing infants, 2% for children (7 to 12 years old), and 3% non-
nursing infants less than 1 year old and children (1 to 6 years old).
    3. Toxicology concerns. The commenter challenged Monsanto's 
assertions that glyphosate was of low toxicity. The commenter cited the 
fact that glyphosate ranked number 3 in California for acute illnesses 
in agriculture from 1984-1990. The commenter claimed that glyphosate is 
a skin and eye irritant, a possible carcinogen, a mutagen, and a 
reproductive toxicant. In support of glyphosate`s carcinogenicity, the 
commenter claimed that one of the metabolites or breakdown products of 
glyphosate is formaldehyde and the commenter asserted that formaldehyde 
is a carcinogen, mutagen, and reproductive toxicant.
    Additionally, the commenter claimed that a study showed that 
glyphosate decreased lung function and that studies showed that 
glyphosate inhibits enzymes involved in the detoxification of 
chemicals.

[[Page 17728]]

    4. Acute illnesses and skin and eye irritation--EPA response.  Data 
indicate that technical-grade glyphosate is in Toxicity Category III 
and Toxicity Category IV and that technical glyphosate is not a dermal 
sensitizer. Some formulations of glyphosate are in Category I and II 
where skin and eye irritation were associated with acute illnesses. 
Some of these formulations are being phased out of the U.S. market. 
Handlers and users of remaining formulations in Category I and II are 
expected to be adequately protected by the protective clothing 
requirements of the Worker Protection Standards (WPS). Data reviewed by 
the Agency on current formulations place these formulations in Toxicity 
Category III and IV.
    5. Carcinogen, mutagen and reproductive toxicity--EPA response. 
Data indicate that glyphosate is a group E carcinogen (evidence of 
noncarcinogenicity for studies in humans, causes no pre- or post-natal 
effects in any study absent maternal toxicity, and is not a mutagen 
(refer to toxicology discussion above for a detailed discussion of 
carcinogenicity, reproductive, developmental and mutagenicity testing).
    6. Formaldehyde--EPA response. Available rat metabolism data, 
residue data, and environmental data indicate that the major metabolite 
of glyphosate is AMPA which is further degraded by soil microbes to 
CO2. The Agency has determined that AMPA is not of 
toxicological concern. (Glyphosate Reregistration Eligibility Decision 
(RED) issued by EPA September 1993). Available data do not indicate 
that formaldehyde is a metabolite or a degradate of glyphosate.
    7. Decreased lung function--EPA response. Data reviewed by the 
Agency for glyphosate formulations for acute inhalation place most 
glyphosate formulations in Toxicity Category III and IV for acute 
inhalation. The Agency believes that handlers of these formulations and 
any formulations that may be Toxicity Category I or II are expected to 
be adequately protected by the protective clothing required by WPS.
    8. Interference with enzymes--EPA response. The mode of action for 
glyphosate does involve interference with enzymes that result in the 
death of plants by inhibiting the biosynthesis of aromatic amino acids 
which along with other biochemical changes results in the death of 
plants. This is a common mode of action for various pesticides, but the 
Agency has no information that indicates that the handling or ingestion 
of glyphosate in small amounts result in interference with enzymes in 
the human body.
    9. Inert Ingredients. The commentor also contended that EPA must 
examine the toxicity of the inert ingredients in glyphosate products in 
setting these tolerances.
    EPA response. These tolerances establish maximum legal levels of 
residues of the active ingredient glyphosate that can be present in 
certain foods. These tolerances do not legalize any inert ingredients 
in glyphosate products. If a pesticide product also contains inert 
ingredients, those inert ingredients must have tolerances or exemptions 
from the requirement or their presence in food will render the food 
adulterated. Before approving a pesticide registration under the 
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et 
seq., EPA checks to make sure that all needed tolerances or exemptions 
are in place. All inerts present in current glyphosate formulations for 
use on food crops either have tolerances or exemptions from tolerances. 
Additionally, under the FIFRA registration process, EPA evaluates the 
potential risks posed by inert ingredients. The Agency requires a full 
disclosure of inert ingredients for each Roundup formulation to 
determine acute toxicity such as acute eye, skin, inhalation, and 
dermal sensitization. Refer to previous discussions on skin, eye, and 
acute inhalation for discussion of formulations.
    10. Persistence in soil. The commenter claimed that glyphosate 
persists in soils from 3 to 141 days.
    EPA response. Data from background field dissipation trials from 
eight sites show that the median half-life (DT50) for glyphosate 
applied at maximum use rates was 13.9 days with a range of 2.6 (Texas) 
to 140.6 (Iowa) days. Acceptable aerobic soil, aerobic aquatic, and 
anaerobic aquatic metabolism studies demonstrate that under those 
conditions at 25  deg.C in the laboratory, glyphosate degrades rapidly 
with half-lives of approximately 2,7, and 8 days respectively. The 
reported half-lives from the field studies conducted in the coldest 
climates, i.e. Minnesota, New York, and Iowa, were the longest at 28.7 
days, 127.8 days, and 140.6 days respectively indicating that 
glyphosate residues in the field are somewhat more persistant in cooler 
climates as opposed to milder ones (Georgia, California, Arizona, Ohio, 
and Texas. AMPA was the major degradate in all studies. AMPA has been 
determined to not be of toxicological concern. (Glyphosate 
Reregistration Eligibility Decision (RED) issued by EPA September, 
1993).
    11. Environmental effects. The commenter also claimed that data was 
lacking regarding glyphosate`s toxicity to soil invertebrates, 
reptiles, and amphibians.
    EPA response. Environmental Effects are considered under FIFRA. In 
examining glyphosate under FIFRA the Agency required several tests with 
mammals; acute tests to birds, fish, aquatic invertebrates, and bees; 
subacute dietary testing on birds; avian reproduction; and chronic 
testing on freshwater fish and freshwater invertebrates. Data submitted 
to and reviewed by the Agency indicate that effects to birds, mammals, 
fish, and invertebrates are minimal. (Glyphosate Registration 
Eligibility Decision (RED) issued by EPA September, 1993).

XII. Objections and Hearing Requests

    The new FFDCA section 408 (g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
the new section 408 (e) and (1)(6) as was provided in the old section 
408 and section 409. However, the period for filing objections is 60 
days rather than 30 days. EPA currently has procedural regulations 
which governs 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 adversely affected by this regulation may, by June 10, 
1997, file written objections to any aspect of this regulation 
(including the automatic revocation provision) and may also request a 
hearing on those objections. Objections and hearing requests must be 
filed with the Hearing Clerk, at the address given below (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 
rulemaking. 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). If a hearing is requested, the objections must 
include a statement of the factual issue(s) on which the hearing is 
requested, the requestor`s contentions on each such issue, and a 
summary of any evidence relied upon by the objector (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 a genuine and

[[Page 17729]]

substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more issues in favor of the requestor, taking into 
account uncontested claims or facts to the contrary; and resolution of 
the factual issue(s) 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 or all of that information as 
``Confidential Business Information'' (CBI). Information marked as CBI 
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.

XIII. Public Docket

    EPA has established a record for this rulemaking under docket 
number [OPP-300469; PP 8F3672, 8F3673, 5F4555, 6E4645] (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 for 
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ADDRESSES at the beginning of this document.

XIV. Regulatory Assessments Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements subject 
to approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., 
it is not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, 1993), or special consideration as required by Executive 
Order 12898 (59 FR 7629, February 16, 1994).
    Because tolerances established on the basis of a petition under 
section 408(d) of FFDCA do not require issuance of a proposed rule, the 
regulatory flexibility analysis requirements of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the 
recent amendment of the FFDCA, EPA had treated such rulemakings as 
subject to the RFA; however, the amendments to the FFDCA clarify that 
no proposal is required for such rulemakings and hence that RFA is 
inapplicable. Nonetheless, the Agency has previously assessed whether 
establishing tolerances or exemptions from tolerance, raising tolerance 
levels, or expanding exemptions adversely impact small entities and 
concluded, as a generic matter, that there is no adverse impact. (46 FR 
24950, May 4, 1981).
    Pursuant to 5 U.S.C. 801 (a)(1)(A), EPA submitted 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 
General Accounting Office prior to publication of this rule in today`s 
Federal Register. This rule is not a major rule as defined by 5 U.S.C. 
804(2).

List of Subjects

40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agriculatural commodities, Pesticides and pest, Reporting and 
recordkeeping requirements.

40 CFR Part 185

    Environmental protection, Food additives, Pesticides and pests.

40 CFR Part 186

    Environmental protection, Animal feeds, Pesticides and pests.

    Dated: March 28, 1997.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, chapter I of title 40 of the Code of Federal Regulations 
is amended as follows:

PART 180--#[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    b. Section 180.364 is amended as follows:
    i. By adding a paragraph heading to paragraph (a), and in the table 
by revising the entry ``Grain crops (except wheat)'' and alphabetically 
adding the commodities: aspirated grain fractions; corn, field, forage; 
corn, field, grain; corn, field, stover; oats; sorghum, grain; and 
sorghum, grain, stover.
    ii. In paragraph (b) by transferring the entries in the table and 
alphabetically adding them to the table in paragraph (a), by removing 
the remaining text of paragraph (b), by adding a paragraph heading and 
reserving paragraph (b).
    iii. In paragraph (d) by transferring the entries in the table and 
alphabetically adding them to the table in paragraph (a), by removing 
the remaining text of paragraph (d).
    iv. In paragraph (c) is amended by adding a paragraph heading, 
``Indirect and inadvertent residues'', and redesignating the amended 
paragraph (c) as new paragraph (d), and by adding a heading and 
reserving new paragraph (c).

Sec. 180.364  Glyphosate, tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts Per 
                         Commodity                             Million  
                                                                (ppm)   
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Aspirated grain fractions..................................        200.0
                  *        *        *        *        *                 
Corn, field, forage........................................          1.0
Corn, field, grain.........................................          1.0
Corn, field, stover........................................        100.0
                  *        *        *        *        *                 
Grain crops (except wheat, corn, oats, and grain sorghum)..        0.010
                  *        *        *        *        *                 
Oats, grain................................................         20.0
                  *        *        *        *        *                 
Sorghum, grain.............................................         15.0
Sorghum, grain, stover.....................................         40.0

[[Page 17730]]

                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

    (b)  Section 18 emergency exemptions. [Reserved]
    (c)  Tolerances with regional registrations. [Reserved]
    (d)  Indirect or inadvertent residues. * * *

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read.
    Authority: 21 U.S.C. 346a and 348.

Sec. 185.3500 [Removed]

    b. In Sec. 185.3500 by transferring the entries in the tables to 
paragraphs (a)(1), (2), and (3), and alphabetically adding them to the 
table in paragraph (a) of Sec. 180.364, and by removing the remainder 
of Sec. 185.3500.

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 185 continues to read.
    Authority: 21 U.S.C. 342, 348 and 701.

Sec. 186.3500 [Removed]

    b. In Sec. 186.3500 by transferring the entries in the tables to 
paragraphs (a) and (b) and alphabetically adding them to the table in 
paragraph (a) of Sec. 180.364, and by removing the remainder of 
Sec. 186.3500.

[FR Doc. 97-9231 Filed 4-10-97; 8:45 am]
BILLING CODE 6560-50-F