[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60934-60950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24488]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0232; FRL-7200-2]


Glyphosate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
glyphosate in or on animal feed, nongrass group; grass, forage, fodder 
and hay, group and adds the potassium salt of glyphosate to the 
tolerance expression. 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 September 27, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0232, 
must be received on or before November 26, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0232 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins (PM 25), 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5697; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet homp page at http://www.epa.gov/. 
To access this document, on the home page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0232. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background

    In the Federal Register of April 17, 2002 (FR 67 18894) (FRL-6830-
5), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing 
the filing of pesticide petitions (PP 0F06130, 0F06195, and 0F06273) by 
Monsanto, 600 13th St., NW., Suite 660, Washington, DC 20005.

[[Page 60935]]

 The notice included a summary of the petition prepared by Monsanto, 
the registrant. Comments received in the public docket with respect to 
the Notice of Filing Pesticide Petitions to Establish a Tolerance for 
Glyphosate in or on Food (April 17, 2002, 67 FR 18894) are discussed in 
the section below.

III. Response to Comments

    The Northwest Coalition for Alternatives to Pesticides (NCAP) 
researches and cites studies that are not included in corporate 
evaluations of their products, and summarizes them in the Journal of 
Pesticide Reform. The following comments submitted to the Agency by 
Jill Davies/RiverCare, Martha T. Franks/Taylor Farms and Jeff 
Schahczenski/Executive Director/Western Sustainable Agriculture Working 
Group cite the opinions of the NCAP concerning the information 
contained within the April 17, 2002 Federal Register for glyphosate.

A. Residue Chemistry

    The Notice states:
    1. Plant metabolism. The nature of the residue in plants is 
adequately understood and consists of the parent, glyphosate and its 
metabolite aminomethyl-phosphonic acid (AMPA). Only the glyphosate 
parent is to be regulated in plant and animal commodities since the 
metabolite AMPA is not of toxicological concern in food.

    Comment: The metabolite AMPA is of toxicological concern. In 
subchronic (midterm) tests on rats, AMPA caused an increase in the 
activity of an enzyme, lactic dehydrogenase, in both sexes; a decrease 
in liver weights in males at all doses tested; and excessive cell 
division in the lining of the urinary bladder in both sexes.
    Agency response. The subchronic toxicity of AMPA has been 
investigated in rats and dogs. Treatment-related effects, such as 
urinary tract irritation, were observed in rats only at very high 
dosage levels. Gross and histopathologic examinations of these animals 
did not reveal effects in any other organ. No toxicities occurred in 
dogs at any dosage level tested. Based on these results, the Agency 
concluded that the metabolite of glyphosate, AMPA, is not of 
toxicological concern because the effects observed in subchronic 
toxicity studies cited above were: (1) Not dose-related, and/or (2) not 
considered biologically significant.
    Comment: The mode of action of the residue in plants is not 
adequately understood. It is known that glyphosate is a systemic and 
non-selective herbicide that kills grasses, sedges, and broad-leaved 
plants, but exactly how it works is not well understood.
    Agency response. Residue chemistry/plant metabolism studies for 
pesticidal active ingredients are not designed to determine the mode-
of-action in plants, but instead are designed to determine the 
metabolic fate, including the identification of plant metabolites of 
the active ingredient, when it is systemically present in plants.
    Although not relevant to nature of the residue studies, the primary 
mode of action for glyphosate is well understood and documented. 
Glyphosate is a member of the phosphono amino acid class of chemicals. 
These compounds are foliar-applied herbicides that interfere with 
normal plant amino acid synthesis, resulting in the inhibition of 
nucleic acid metabolism and protein synthesis. Specifically, glyphosate 
blocks the activity of 5-enolpyruvylshikimate 3-phosphate synthase 
(EPSP synthase), an enzyme that is involved in aromatic amino acid 
biosynthesis (essential for growth) and produced only by green plants. 
This pathway does not occur in animals, which must eat plants to obtain 
these essential amino acids. Consequently, glyphosate is toxic to all 
green plants and essentially nontoxic to other living organisms.

B. Toxicological Profile

    The Notice states:
    1. Acute toxicity. Several acute toxicology studies place 
technical-grade glyphosate in Toxicity Category III and Toxicity 
Category IV.
    Comment: This is correct, and Toxicity Category III means caution. 
But most toxicology studies are conducted using glyphosate alone, not 
the formulations that are in commercial products, which contain so-
called inert ingredients. Roundup, which contains glyphosate and the 
surfactant POEA, is three times as acutely toxic to rats as glyphosate 
alone. This deficiency in regulation needs to be corrected.
    Agency response. This action establishes a tolerance for 
glyphosate, not the inert polyethylated tallow amines (POEA). POEA is 
regulated separately under FFDCA and has been approved by the Agency. 
Additionally, under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), 7 U.S.C. 136 et seq., registration process, EPA evaluates 
the potential risks posed by inert ingredients such as the POEA. The 
Agency requires a full disclosure of inert ingredients for each Roundup 
formulation to determine acute toxicity such as acute oral, eye, skin, 
inhalation, and dermal sensitization. The combined effects of active 
and inert ingredients on a product's acute toxicity properties are 
reviewed by the Agency and used to define the appropriate personal 
protective equipment (PPE) and precautionary statements for each 
pesticide end-use product label that will provide adequate protection 
to users.
    2. Genotoxicity (mutagencicty)--Comment: The FR Notice describes 
assays showing that glyphosate does not cause genetic damage, but other 
studies have shown that both glyphosate and its commercial products are 
mutagenic, and the commercial products are more potent mutagens than 
glyphosate.
    Agency response. The mutagenicity studies referred to by the 
commenters is the Journal of Pesticide Reform (JPR), a magazine 
produced by the Northwest Coalition for Alternatives to Pesticides 
(NCAP) based in Eugene, OR. JPR has compiled and updated fact sheets on 
a number of pest-control products, including glyphosate (the active 
ingredient in Roundup agricultural herbicides).
    Based on the negative responses observed in well validated assays 
conducted according to the required test guidelines and in compliance 
with USEPA Good Laboratory Practice Standards, the Agency concluded 
that the active ingredient pesticide, glyphosate, is neither mutagenic 
or clastogenic.
    Several studies have tested herbicide formulations, including 
Roundup, for mutagenic/genotoxic potential. Although positive responses 
have been reported, the testing systems used in the cited studies may 
not be adequate for regulatory purposes for one or more of the 
following reasons: (1) Un-validated test systems that do not have 
established predictability based on broad experience using substances 
of known positive and negative genotoxicity/mutagenicity; (2) 
undocumented and uncharacterized test materials; (3) administered doses 
that cannot be correlated to expected exposures; (4) routes of exposure 
that vary from the required test protocols; (5) results that address 
endpoints which do not have a clear accepted relationship to human 
disease; and/or (6) deficient methodologies.
    3. Reproductive and developmental toxicity--Comment: A study in 
Ontario found that father's (mostly farmers) use of glyphosate was 
associated with an increase in miscarriages and premature births in 
farm families. Laboratory studies on rats and rabbits have also 
demonstrated a number of effects from glyphosate on reproduction.
    Agency response. Data from studies conducted according to accepted 
testing methods and reviewed by the Agency, demonstrate that glyphosate 
is not a

[[Page 60936]]

reproductive or developmental toxicant. Glyphosate was evaluated in two 
multigenerational rat reproduction studies and developmental toxicity 
studies in rats and rabbits. Results from these studies did not 
indicate any adverse effects on the animals' ability to mate, conceive, 
carry or deliver normal offspring. Based on the findings from 
developmental toxicity studies in rats and rabbits, it can be concluded 
that glyphosate does not produce birth defects and developmental 
toxicity is only seen at maternally toxic doses.
    The developmental toxicity of the surfactant POEA has been 
evaluated and found not to be a teratogen or a developmental toxicant 
in rats. Subchronic toxicity studies with the surfactant and/or Roundup 
herbicide have also been conducted in rats, rabbits, and dogs. In these 
studies, gross and microscopic pathology examinations were conducted on 
several reproductive tissues including ovaries, uterus, testes, and 
epididymis. No developmental effects or changes in reproductive tissues 
were found in any of these evaluations. There is no evidence that the 
surfactant or Roundup herbicide adversely impacts reproductive 
function.
    4. Subchronic (medium-term) and chronic (long-term) toxicity 
studies on rats and mice--Comment. Once again, studies (both subchronic 
and chronic) other than those cited by Monsanto reflect toxicity from 
glyphosate, and commercial products are more toxic than just 
glyphosate.
    Agency response. The Agency has determined that the existing data 
base for glyphosate is adequate according to testing guideline 
requirements for a food-use registration. There is high confidence in 
the quality of the existing studies and the reliability of the toxicity 
endpoints identified for use in risk assessments; there are no data 
gaps. Based on evaluation of the existing glyphosate data base, the 
Agency has concluded that the use of glyphosate and glyphosate products 
do not pose unreasonable risks or adverse effects to humans.
    The potential toxicity of POEA has been assessed in subchronic oral 
studies with rats and dogs. Roundup herbicide has also been evaluated 
for possible subchronic effects in an inhalation study with rats, a 
dermal study in rabbits, and an oral study with cattle. It was 
anticipated most observed effects would be related to the surface-
active properties and associated irritation potential of surfactants. 
These studies confirm that irritation at the site of contact was the 
primary finding with the test material. In the oral studies conducted 
with POEA and Roundup, effects secondary to gastrointestinal irritation 
(emesis and diarrhea) were noted; decreased food consumption and 
decreased body weight gain. However, these effects were not dose-
related in rats and dogs. In the study conducted with cattle in which 
slight decreases in body weight occurred, dosages of Roundup herbicide 
were 30 to 100 times greater than the dose typically applied to foliage 
for agricultural weed control purposes. There was no systemic toxicity 
in the inhalation and dermal studies conducted with Roundup. No 
indication of specific target organ toxicity was observed in any of the 
subchronic toxicity studies.
    5. Animal metabolism. The Notice states:

    The qualitative nature of the residue in animals is adequately 
understood.

    Comment: This is not true. There are a multitude of established 
effects on animals, including humans, and the mode of action is not 
understood at all. Roundup kills beneficial insects (parasitoid wasps, 
lacewings, ladybugs) and other arthropods that are important in humus 
production and soil aeration, and affect growth and survival of 
earthworms. Acute toxicities for fish LC50, the lethal 
concentration killing 50% of a population of test animals) range from 2 
ppm to 55 ppm and increase with increases in water temperature.
    Agency response. Animal metabolism studies for pesticide active 
ingredients do not evaluate toxicological effects, but instead are 
designed to determine the fate of the molecule within a mammalian 
metabolic system. The animal metabolism data reviewed by the Agency for 
glyphosate are adequate and the qualitative nature of the residue in 
animals is understood.
    Environmental consequences of pesticide use are considered in the 
FIFRA registration process. Based on the current toxicity data, 
application rates and observance of risk management measures for the 
active ingredient glyphosate, EPA has determined that the risks for 
birds, mammals, aquatic organisms, bees and invertebrates are minimal. 
Glyphosate is no more than slightly toxic to fish and wild birds, and 
practically non-toxic to aquatic invertebrate animals. There is a very 
low potential for the compound to build up in the tissues of aquatic 
invertebrates and other aquatic organisms such as fish. The Roundup 
formulation is moderately to slightly toxic to freshwater fish and 
aquatic invertebrate animals. Glyphosate is nontoxic to honeybees. This 
active ingredient pesticide as well as surfactants in the formulated 
products have no known effect on soil microorganisms. The reported 
contact lethal dose (LD50) for earthworms in soil are 
greater than 5,000 parts per million (ppm) for both the glyphosate 
trimethylsulfonium salt and Roundup.
    6. Cancer. Unit C.3.ii. of the Notice states:
    There is no evidence of carcinogenic potential.

    Comment: This is false. A recent Swedish Study of hairy cell 
leukemia (HCL), a form of non-Hodgkin's lymphoma cancer, found that 
people who were occupationally exposed to glyphosate herbicides had a 
threefold higher risk of HCL. A similar study of people with non-
Hodgkin's lymphoma found exposure to glyphosate was associated with an 
increase risk of about the same size.
    Agency response. The commenters are referring to two epidemiology 
studies published by Sweden. This type of epidemiologic evaluation does 
not establish a definitive link to cancer. Furthermore, this 
information has limitations because it is based solely on unverified 
recollection of exposure to glyphosate-based herbicides.
    The carcinogenic potential of glyphosate has been evaluated in 
acceptable studies conducted in rats and mice. In June of 1991, the 
Agency concluded, following a thorough review of all available toxicity 
data, that glyphosate should be classified in Category E--Evidence of 
Non-carcinogenicity in Humans. This cancer classification was based 
upon the observation of no treatment-related tumors at any dose level 
with glyphosate tested up to the limit in rats and up to dose levels 
higher than the limit dose in mice, and the lack of evidence of 
mutagenicity/genotoxicity for glyphosate.

C. Exposure and Risk Assessments

    1. Dietary exposure. Tolerances have been established (40 CFR 
180.364) for the residues of glyphosate in or on a variety of food and 
feed commodities. The petitioner proposes to add potassium salt to this 
list of acceptable salt forms to which the tolerances apply, and to 
amend or add a number of new animal feed tolerances and one food 
tolerance. Tolerances are also established for animal organs that may 
be consumed by humans (kidney at 4.0 ppm and liver at 0.5 ppm), and for 
poultry meat at 0.1 ppm, eggs at 0.05 ppm, and poultry meat by-products 
at 1.0 ppm, based on animal-feeding studies and reasonable worst-case 
livestock diets.
    The Notice states:

[[Page 60937]]

    This analysis showed that the existing livestock tolerances are 
sufficient for any additional dietary burden arising from the 
proposed feed tolerances.

    Comment: It is not clear what analysis this statement is referring 
to. In any case, raising the tolerances in feed should result in new 
meat tolerance studies being done.
    Agency response. EPA has conducted an analysis of the reasonable 
worst-case livestock diets, which include the additional dietary burden 
from the glyphosate feed tolerances proposed in the FR Notice. Adequate 
animal feeding studies are available for glyphosate in cattle, swine, 
and poultry. Based on the existing and proposed tolerances, the total 
estimated dietary burden derived from treated feed commodities 
(including those genetically altered to be tolerant to glyphosate) 
would not result in meat, milk, or egg residues that exceed currently 
established food tolerances on these commodities.
    2. Drinking water--Persistence in soil--Comment: Glyphosate is 
acknowledged to be extremely persistent in the soil under typical 
application conditions. AMPA (the primary metabolite) is even more 
persistent than glyphosate. Studies in eight states found that the 
half-life in soil (the time required for half of the original 
concentration of a compound to break down or dissipate) was between 119 
and 958 days. AMPA has been found in lettuce and barley planted a year 
after glyphosate treatment.
    Agency response. Based on studies conducted both in the laboratory 
and the field, the Agency has determined that glyphosate is readily 
degraded by soil microbes to AMPA which is subsequently degraded to 
CO2. Data from 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). The reported 
half-lives from the field studies conducted in the coldest climates, 
i.e., Minnesota, New York, and Iowa were longest at 28.7, 127.8, and 
140.6 days, respectively, indicating that the rate of glyphosate 
degradation is somewhat slower in cooler climates compared to milder 
ones. Further degradation of AMPA to CO2 occurs at a slower rate than 
the initial degradation of glyphosate. Because of the strong binding of 
both glyphosate and AMPA to soil particles, there is very little uptake 
into plants of either glyphosate or AMPA from soil, even right after 
application of glyphosate. AMPA was found in only trace levels in 
lettuce and barley planted a year after application of glyphosate to 
soil. AMPA has been determined to not be of toxicological concern.
    3. Found in water. The Notice states:
    Glyphosate adsorbs strongly to soil and would not be expected to 
move vertically below the 6 inch soil layer.

    Comment: This is a false assumption. Glyphosate can move into 
surface water when the soil particles to which it tends to bind are 
washed into streams or rivers. Glyphosate has been found in both ground 
and surface water, where it can be toxic to aquatic life for a time.
    Agency response. The FR notice statement refers to behavior of 
glyphosate in soil and its potential for movement to ground water, not 
its movement into surface water. Glyphosate adsorbs strongly to soil 
particles, which limits its vertical movement in soil and makes 
contamination of ground water unlikely to occur.
    Glyphosate can potentially occur in surface water from spray drift, 
runoff, soil particle movement, or by direct application, but at 
concentrations that are much lower than levels at which toxic effects 
to aquatic organisms may occur. The Agency has estimated glyphosate 
levels that could occur in surface water based on presently approved 
use patterns using computer-modeling methods. Based on toxicological 
data from acute and chronic tests on fish and other aquatic species, 
EPA has determined that the potential for environmental effects of 
glyphosate in surface water is minimal.
    The Notice states:

    The Agency lacks sufficient monitoring exposure data to complete 
a comprehensive dietary exposure analysis and risk assessment for 
glyphosate in drinking water. Because the Agency does not have 
comprehensive monitoring data, drinking water concentration 
estimates are made by reliance on simulation or modeling taking into 
account data on the physical characteristics of glyphosate.

    Comment: The Agency had better get monitoring exposure data for 
drinking water, for both glyphosate and for AMPA.
    Agency response. In November 1999, the EPA Office of Water issued a 
report titled ``A Review of Contaminant Occurrence in Public Drinking 
Water Systems.'' The data in the report is further discussed in the 
report ``Occurrence Summary and Use Support Document for the Six-Year 
Review of National Primary Drinking Water Regulations'' (draft report 
issued in March 2002). The study is an analysis to date of the 
occurrence of contaminants in public water systems (PWSs). State data 
bases of compliance-monitoring data from PWSs were the primary data 
sources for the analysis. Glyphosate monitoring data of both surface 
water and ground water sources for 7,800 PWSs were included in the 
analysis. Occurrences of detectable levels of glyphosate in ground 
water or surface water were very infrequent. All detections of 
glyphosate were below 10% of the Maximum Contaminant Level (MCL), which 
is the health-based maximum permissible level of a contaminant in water 
that is delivered to any user of a PWS. Only 0.1% of the PWSs reported 
any detection of glyphosate at a level above 1% of the MCL. These 
monitoring results are consistent with the modeling predictions 
discussed above, and reinforce the Agency's conclusion that aggregate 
exposure to glyphosate via all exposure routes, including drinking 
water, will not exceed the Agency's level of concern (100% of the 
cPAD).
    4. Non-dietary exposure. The Notice states:
    iii. Based on the low acute toxicity and the lack of other 
toxicological concerns, exposures from residential uses (e.g., for 
lawn and garden pest control, indoor pest control, termiticides, and 
flea and tick control on pets) of glyphosate are not expected to 
pose undue risks.

    Comment: There are many toxicological concerns and in California, 
glyphosate exposure illness among agricultural and landscape workers is 
common with serious effects reported including blurred vision, peeling 
of skin, nausea, headache, vomiting, diarrhea, chest pain, dizziness, 
numbness. How does EPA define undue risks?
    Agency response. Some glyphosate end-use products are assigned 
Toxicity Categories I and II for eye and dermal irritation because they 
contain POEA surfactants, which have been identified as eye and dermal 
irritants. For all such formulations, the Agency continues to recommend 
the addition of personal protective equipment (PPE) and precautionary 
statements appropriate for labeling of end-use products in Toxicity 
Categories I and II.

D. Cumulative Effects

    The Notice states:

    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. For the purposes of this tolerances action, therefore, 
EPA has not assumed that glyphosate has a common mechanism of 
toxicity with other substances.

    Comment: When the mode of action is not clearly understood, even 
more uncertainty exists regarding synergistic effects with other 
substances. Rather

[[Page 60938]]

than raising tolerances, EPA should be exercising the Precautionary 
Principle and lowering them.
    Agency response. The herbicidal mode-of-action of glyphosate in 
plants is well-understood (see Unit A. Residue Chemistry, Agency 
response of this document) but is not relevant to the determination of 
whether it shares a common mechanism of toxicity with other substances. 
Glyphosate does not appear to produce a toxic metabolite that is also 
produced by other substances that could be grouped together for a 
cumulative risk assessment, thus at this time, EPA will not include 
glyphosate in such an assessment.

E. Safety Determination

    U.S. population and infants and children--Comment: The mode of 
action of glyphosate is not understood, synergistic effects are not 
understood, and a multitude of studies indicate that glyphosate is 
toxic in all standard categories of toxicological testing. Again, 
rather than raising tolerances, EPA should be exercising the 
Precautionary Principle and lowering them.
    Agency response: The herbicidal mode-of-action of glyphosate in 
plants is well-understood (see the previous discussion above) but is 
not relevant to the determination of whether it shares a common 
mechanism of toxicity with other substances. Glyphosate does not appear 
to produce a toxic metabolite that is also produced by other substances 
that could be grouped together for a cumulative risk assessment, thus 
at this time, EPA will not include glyphosate in such an assessment. In 
evaluating these tolerance petitions, EPA has concluded that the 
proposed tolerances meet the FFDCA standard of reasonable certainty of 
no harm. This standard requires consideration of aggregate exposure to 
glyphosate from existing uses as well as exposure from the new uses 
proposed in the petitions before EPA. EPA requires that toxicological 
tests conducted with individual active ingredients using validated 
testing methods be submitted and reviewed in support of its 
registration decisions. Results from a complete data base of acceptable 
studies conducted with glyphosate have demonstrated that adverse 
effects will not occur at expected exposure levels. The Agency is not 
aware of scientific evidence that demonstrates enhanced potency of 
glyphosate's toxicological effects that arise through synergistic 
mechanisms.

F. International Tolerances

    Several maximum residue limits (MRLs) for glyphosate have been 
established by Codex in or on various commodities. The Codex MRL for 
rice grain is 0.1 ppm. The proposed rice grain tolerance of 15.0 ppm, 
is based on crop field trial data obtained using glyphosate-tolerant 
rice and therefore cannot be lowered to maintain harmonization with the 
Codex MRL of 0.1 ppm. (Unit F of the Notice). Also, the Codex MRL for 
grass hay is 50 ppm, and that proposed here is 300 ppm; the Codex MRL 
for field corn is 1 ppm, and that proposed here is 6 ppm and the same 
statement, that the tolerance cannot be lowered, applies.
    Comment: Here is a great example of one of the many detrimental 
ramifications from the widespread use of GMO's. They drive up the 
levels of pesticide residues in crops for food and feed, while the 
majority of society is trying to avoid consumption of pesticides. It is 
unclear here, who has written this part of the FR Notice, EPA or 
Monsanto. The phrase, cannot be lowered is an ominous statement. If 
followed, it means that if a corporation benefits from commercializing 
a product, all other values and considerations must be cast aside.
    Agency response. The rice grain tolerance of 15.0 ppm initially 
requested by Monsanto Company and cited in the notice of filing 
pesticide petition to establish a tolerance for glyphosate in or on 
food (April 17, 2002, 67 FR 18894) is not included in this tolerance 
petition. In addition, Monsanto Company has amended the tolerance 
petition by deleting the proposed tolerance increase to 6 ppm for 
wheat, grain and revising its Roundup UltraMax Herbicide label by 
removing all instructions related to a preharvest application of this 
product to Roundup Ready wheat. EPA has determined that the amended use 
instructions support the existing 5 ppm tolerance level for wheat, 
grain (40 CFR 180.364).
    The pesticide petition process exists so that petitioners can 
request that EPA establish new food or feed tolerances, or increase 
existing tolerances, to accommodate new pesticide uses. Petitions are 
only filed when residue studies have demonstrated that food residues 
requiring tolerances may occur. Although EPA's approval of such 
petitions does authorize the potential for increased exposure levels, 
the existence of food tolerances is not indicative of significant 
consumer risk. Using worst-case assumptions that: (1) 100% of crops 
will be treated and (2) that residues will occur at tolerance levels in 
all cases, EPA has concluded that exposure to glyphosate from food, 
including all present and proposed tolerances, will utilize only 1.8% 
of the cPAD for the U.S. population, 3.8% of the cPAD for all infants 
less than 1 year old, and 3.6% of the cPAD for children (1 to 6 years 
old). Thus, the risk to human health does not exceed the Agency's level 
of concern (100% of the cPAD).
    The phrase cannot be lowered indicates that glyphosate use patterns 
in the U.S. differ from those that have been considered by Codex, and 
therefore the new U.S. food and/or feed tolerances are not harmonized 
with established Codex MRLs. Codex procedures require that new 
pesticide uses and tolerances must first be approved by national 
governments before they can be considered by the Codex Committee on 
Pesticide Residues. As a result, differences between Codex MRLs and 
U.S. tolerances are anticipated as use patterns evolve. Codex uses the 
Periodic Review process to periodically update MRLs to reflect the 
modified use patterns.

G. Conclusions

    Comment: In many parts of this FR Notice, it is not possible to 
tell who has written it, EPA or Monsanto. As a member of an 
organization working hard to promote an environmentally sound, 
economically viable, socially just and humane agriculture and food 
system in this country, I was expecting to see evidence of an agency 
working to protect human health and our environment, this is very 
disappointing. Furthermore, there is no consideration given here to the 
effects the increased use of this pesticide may have on the soil. Lab 
studies have demonstrated that glyphosate reduces nitrogen fixation 
associated with legumes and increases the susceptibility of crop plants 
to a number of diseases. Roundup is toxic to mycorrhizal fungi, with 
effects on some species observed at concentrations of 1 ppm, lower than 
those found in soil following typical applications.
    Agency response. Publication of petitioner-generated summaries is 
dictated by the FFDCA, 21 U.S.C. 346a(d)(3). The Notice clearly 
indicates that the petitioner, Monsanto, has written the summary. 
However, much of this information can be found in the Agency's risk 
assessment document/supporting documentation for glyphosate. EPA has 
conducted a complete and thorough review of the available data for 
glyphosate. Based on the risk assessments conducted for glyphosate, the 
Agency determined that there is reasonable certainty that

[[Page 60939]]

exposure to glyphosate will not pose unreasonable risks or adverse 
effects to humans or the environment.
    The Agency has received no reports indicating that the use of 
glyphosate adversely effects nitrogen fixation in legumes or that it 
increases the disease susceptibility of crops. These type of 
environmental considerations are more appropriately raised in 
connection with the FIFRA registration process.

H. Biotechnology Related Issues

    Comment: Several comments were received in the public docket that 
expressed concern over the tolerance approvals for glyphosate that will 
directly support new uses in glyphosate-tolerant crops, namely wheat, 
rice and bentgrass. The list of commenters are as follows: Mark 
Trechock/Staff Director/Dakota Resource Council, Annie Ray/Oregon Rural 
Action, Helge Hellberg/Marketing Director/California Certified Organic 
Farmers, Lauran Dundee/Regional Outreach Coordinator/Partners for 
Global Justice and Sustainable Communities, Kevin L. Williams/Field 
Coordinator/Western Organization of Resource Councils, Suzin Kratina/
Chair of the Food Safety Task Force/Northern Plains Resource Council, 
Harriet Ritter and Renata Brillinger.
    Agency response. The rice grain tolerance of 15.0 ppm initially 
requested by Monsanto Company and cited in the Notice of Filing 
Pesticide Petition to establish a Tolerance for Glyphosate in or on 
Food (April 17, 2002, 67 FR 18894), is not included in this final rule.
    Tolerance actions for glyphosate are considered independently of 
the other regulatory assessments that a new crop trait must pass before 
it can be commercialized. Three U.S. Federal agencies regulate crops 
incorporating traits derived from biotechnology. The Food and Drug 
Administration (FDA) has responsibility for evaluating the safety of 
crops derived through biotechnology for use as food and feed. The U.S. 
Department of Agriculture, Animal Plant Health Inspection Service (USDA 
APHIS) is responsible for agronomic characteristics and environmental 
impact. EPA is responsible for the assessment of the human health and 
environmental risk of pesticide products, including plant-incorporated 
pesticides, and their registration under FIFRA, as amended. 
Commercialization by Monsanto of additional glyphosate-tolerant crops, 
i.e., wheat, rice and bentgrass, cannot occur until such time as the 
USDA APHIS and the FDA have received and evaluated necessary data from 
the registrant and granted necessary approvals. As of 2002, Monsanto 
has submitted a petition to USDA APHIS for GM bentgrass.
    Despite the separate nature of the evaluations and approvals, much 
closer communication has developed between the three agencies in recent 
years. In early 2001, EPA and USDA APHIS established an interagency 
work group for products derived from biotechnology. Through this joint 
working group, EPA consults on a stewardship plan for each new 
herbicide-tolerant crop that addresses the management of pest 
resistance and the potential for weedy volunteer crops in their 
herbicide-tolerant crops and in crop rotations. This stewardship plan 
is then incorporated into a full environmental impact assessment by 
USDA APHIS that addresses the potential for development of resistant 
weed populations through pollen flow, in addition to effects on non- 
target organisms and agricultural practices. EPA and USDA APHIS have 
established a strong working relationship through this joint review 
process that helps ensure that the concerns of both agencies are 
adequately addressed prior to final approval by either.
    Based on the incomplete status of the interagency approval process 
discussed above, EPA has decided not to register the use of glyphosate 
in or on herbicide-tolerant wheat or herbicide-tolerant bentgrass at 
this time.
    Some commenters express concern over the potential contamination of 
organic crops through pollen drift from herbicide-tolerance crop 
varieties that may be grown on near-by farms. The issue of organic 
operations in proximity to operations that employ methods that are 
prohibited under organic rules is discussed in the National Organic 
Program, Final Rule, available on the USDA Web site at: http://www.ams.usda.gov/nop/nop2000/Final%20Rule/nopfinal.pdf.

IV. Statutory Findings

    The petition requested that 40 CFR 180.364 be amended by 
establishing a tolerance for residues of the herbicide glyphosate, in 
or on animal feed, nongrass, group at 400 part per million (ppm), 
grass, forage, fodder and hay, group at 300 ppm, wheat, forage at 10 
ppm, wheat, hay at 10 ppm, and adding the potassium salt of glyphosate 
to the tolerance expression.
    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).

V. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of glyphosate on animal feed, 
nongrass, group at 400 ppm, grass, forage, fodder and hay, group at 300 
ppm, wheat, forage at 10 ppm, and wheat, hay at 10 ppm. EPA's 
assessment of 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 acute toxic effects caused by glyphosate 
are discussed in the following Table 1 as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies reviewed in the following Table 
2.

[[Page 60940]]



            Table 1.--Acute Toxicity of Glyphosate Technical
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.1100                          Acute oral          LD50 > 5,000 mg/kg
                                                      Toxicity Category
                                                       IV
------------------------------------------------------------------------
870.1200                          Acute dermal        LD50 > 5,000 mg/kg
                                                      Toxicity Category
                                                       IV
------------------------------------------------------------------------
870.1300                          Acute inhalation    The requirement
                                                       for an acute
                                                       inhalation LC50
                                                       study was waived
------------------------------------------------------------------------
870.2400                          Primary eye         Corneal opacity or
                                   irritation          irritation
                                                       clearing in 7
                                                       days or less
                                                      Toxicity Category
                                                       III
------------------------------------------------------------------------
870.2500                          Primary skin        Mild or slight
                                   irritation          irritant
                                                      Toxicity Category
                                                       IV
------------------------------------------------------------------------
870.2600                          Dermal              Not a dermal
                                   sensitization       sensitizer
------------------------------------------------------------------------


           Table 2.--Toxicity Profile of Glyphosate Technical
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 1,500 mg/
                                   toxicity rodents -  kg/day in males
                                    mouse              and females
                                                      LOAEL = 4,500 mg/
                                                       kg/day in males
                                                       and females based
                                                       on decreased body
                                                       weight gain
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = < 50 mg/kg/
                                   toxicity rodents -  day in males and
                                    rat (range-        females
                                   finding)           LOAEL = 50 mg/kg/
                                                       day in males and
                                                       females based on
                                                       increased
                                                       phosphorus and
                                                       potassium values
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 400 mg/kg/
                                   toxicity in         day in males and
                                   rodents - rat       females
                                   (aminomethyl       LOAEL = 1,200 mg/
                                   phosphoric acid -   kg/day in males
                                   plant metabolite    and females based
                                   of glyphosate)      on body weight
                                                       loss and
                                                       histopathological
                                                       lesions of the
                                                       urinary bladder.
------------------------------------------------------------------------
870.3485                          28-Day inhalation   NOAEL = 0.36 mg/L
                                   toxicity - rat     LOAEL = > 0.36
                                   (exposure; 6        (HDT) mg/L, not
                                   hours/day, 5 days/  established
                                   week for 4 weeks)
------------------------------------------------------------------------
870.3200                          21-Day dermal       NOAEL = 1,000 mg/
                                   toxicity - rabbit   kg/day in males
                                                       and females
                                                      LOAEL = 5,000 mg/
                                                       kg/day based on
                                                       slight erythema
                                                       and edema on
                                                       intact and
                                                       abraded skin of
                                                       both sexes, and
                                                       decreased food
                                                       consumption in
                                                       females
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 1,000 mg/
                                   rodents - rat       kg/day
                                                      LOAEL = 3,500 mg/
                                                       kg/day based on
                                                       inactivity,
                                                       mortality,
                                                       stomach
                                                       hemorrhages and
                                                       reduced body
                                                       weight gain
                                                      Developmental
                                                      NOAEL = 1,000 mg/
                                                       kg/day
                                                      LOAEL = 3,500 mg/
                                                       kg/day based on
                                                       increased
                                                       incidence in the
                                                       number of fetuses
                                                       and litters with
                                                       unossified
                                                       sternebrae and
                                                       decreased fetal
                                                       body weight.
------------------------------------------------------------------------

[[Page 60941]]

 
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 175 mg/kg/
                                   nonrodents -        day
                                   rabbit             LOAEL = 350 mg/kg/
                                                       day based on
                                                       mortality,
                                                       diarrhea, soft
                                                       stools, and nasal
                                                       discharge.
                                                      Developmental
                                                      NOAEL = 350 mg/kg/
                                                       day
                                                      LOAEL = > 350
                                                       (HDT) mg/kg/day,
                                                       not established
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects  NOAEL = 30 mg/kg/
                                   - rat (3-           day
                                   generation)        LOAEL = > 30 (HDT)
                                                       mg/kg/day, not
                                                       established
                                                      Reproductive
                                                      NOAEL = 30 mg/kg/
                                                       day
                                                      LOAEL = > 30 (HDT)
                                                       mg/kg/day, not
                                                       established
                                                      Offspring
                                                      NOAEL = 10 mg/kg/
                                                       day
                                                      LOAEL = 30 mg/kg/
                                                       day based on
                                                       focal dilation of
                                                       the kidney in
                                                       male F3b pups
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects  NOAEL = 500 mg/kg/
                                   - rat (2-           day in males and
                                   generation)         females
                                                      LOAEL = 1,500 mg/
                                                       kg/day in males
                                                       and females based
                                                       on soft stools,
                                                       decreased body
                                                       weight gain and
                                                       food consumption.
                                                       Focal dilation of
                                                       the kidney
                                                       observed at 30 mg/
                                                       kg/day in the 3-
                                                       generation study
                                                       was not observed
                                                       at any dose level
                                                       in this study.
                                                      Reproductive
                                                      NOAEL = > 1,500
                                                       (HDT) mg/kg/day
                                                       in males and
                                                       females
                                                      LOAEL = > 1,500
                                                       (HDT) mg/kg/day
                                                       in males and
                                                       females, not
                                                       established
                                                      Offspring
                                                      NOAEL = 500 mg/kg/
                                                       day in males and
                                                       females
                                                      LOAEL = 1,500 mg/
                                                       kg/day in males
                                                       and females based
                                                       on reduced pup
                                                       weights during
                                                       the second and
                                                       third weeks of
                                                       lactation
------------------------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL = 500 (HDT)
                                   dogs                mg/kg/day in
                                                       males and females
                                                      LOAEL =  500 mg/kg/day
                                                       in males and
                                                       females, not
                                                       established
------------------------------------------------------------------------
870.4300                          Chronic/            NOAEL = 362 mg/kg/
                                   carcinogenicity     day in males
                                   rats               LOAEL = 940 mg/kg/
                                                       day in males
                                                       based on
                                                       decreased urinary
                                                       pH, increased
                                                       incidence of
                                                       cataracts and
                                                       lens
                                                       abnormalities,
                                                       and increased
                                                       absolute and
                                                       relative (to
                                                       brain) liver
                                                       weights
                                                      NOAEL = 457 mg/kg/
                                                       day in females
                                                      LOAEL = 1,183 mg/
                                                       kg/day in females
                                                       based on
                                                       decreased body
                                                       weight gain
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------

[[Page 60942]]

 
870.4300                          Carcinogenicity     NOAEL = 750 mg/kg/
                                   mice                day in males
                                                      LOAEL = 4,500 mg/
                                                       kg/day in males
                                                       based on
                                                       significant
                                                       decreased body
                                                       weight gain,
                                                       hepatocyte
                                                       necrosis, and
                                                       interstitial
                                                       nephritis
                                                      NOAEL = 750 mg/kg/
                                                       day in females
                                                      LOAEL = 4,500 mg/
                                                       kg/day in females
                                                       based on
                                                       significant
                                                       decreased body
                                                       weight gain,
                                                       increased
                                                       incidence of
                                                       proximal tubule
                                                       epithelial
                                                       basophilia, and
                                                       hypertrophy in
                                                       the kidney of
                                                       females
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.5100                          Gene mutation       Negative. Non-
                                   assay in S.         mutagenic when
                                   typhimurium         tested up to
                                   strains             1,000 [mu]g/
                                                       plate, in
                                                       presence and
                                                       absence of
                                                       activation, in S.
                                                       typhimurium
                                                       strains TA98,
                                                       TA100, TA1535 and
                                                       TA1537.
------------------------------------------------------------------------
870.5100                          Gene mutation       Negative for
                                   assay in E. coli    reverse gene
                                   WP2hcrA and S.      mutation, both
                                   typhimurium         with and without
                                   strains             S-9, up to 5,000
                                                       [mu]g/plate (or
                                                       cytotoxicity)
                                                       with E. coli
                                                       WP2hcrA and S.
                                                       typhimurium TA98,
                                                       TA100, TA1535,
                                                       TA1537, and
                                                       TA1538
------------------------------------------------------------------------
870.5300                          Gene mutation       Negative. Non-
                                   assay in Chinese    mutagenic at the
                                   hamster ovary       HGPRT locus in
                                   (CHO) cells/HGPRT   Chinese hamster
                                                       ovary cells
                                                       tested up to
                                                       cytotoxic
                                                       concentrations or
                                                       limit of
                                                       solubility, in
                                                       presence and
                                                       absence of
                                                       activation.
------------------------------------------------------------------------
870.5385                          Cytogenetics - In   Negative. Non-
                                   vivo bone marrow    mutagenic in rat
                                   chromosomal         bone marrow
                                   aberration assay    chromosome assay
                                                       up to 1,000 mg/kg
                                                       in both sexes of
                                                       Sprague Dawley
                                                       rats
------------------------------------------------------------------------
870.5550                          Other mechanisms -  There was no
                                   In vitro Rec-       evidence of
                                   Assay with B.       recombination in
                                   subtilis H17        the rec-assay up
                                   (rec+) and M45      to 2,000 [mu]g/
                                   (rec-)              disk with B.
                                                       subtilis H17
                                                       (rec+) and M45
                                                       (rec-)
------------------------------------------------------------------------
870.6200                          Acute               N/A
                                   neurotoxicity
                                   screening battery
                                   in rats
------------------------------------------------------------------------
870.6200                          Subchronic          N/A
                                   neurotoxicity
                                   screening battery
                                   in rats
------------------------------------------------------------------------
870.6300                          Developmental       N/A
                                   neurotoxicity in
                                   rats
------------------------------------------------------------------------
870.7485                          Metabolism and      Absorption was 30-
                                   pharmacokinetics -  36% in males and
                                    rat                females.
                                                       Glyphosate was
                                                       excreted
                                                       unchanged in the
                                                       feces and urine
                                                       (97.5% minimum).
                                                       The only
                                                       metabolite
                                                       present in the
                                                       excreta was AMPA.
                                                       Less than 1% of
                                                       the absorbed dose
                                                       remained in the
                                                       carcass,
                                                       primarily bone.
                                                       Repeat dosing did
                                                       not alter
                                                       metabolism,
                                                       distribution, and
                                                       excretion.
------------------------------------------------------------------------
870.7600                          Dermal penetration  N/A
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is

[[Page 60943]]

routinely used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for glyphosate used for human risk assessment is shown in the 
following Table 3.

      Table 3.--Summary of Toxicological Dose and Endpoints for glyphosate for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF* and Level of     Assessment Study and
          Exposure Scenario                 Assessment, UF          Concern for Risk      Toxicological Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years     None                     None                     An acute dietary
 old and general population)                                                              endpoint was not
                                                                                          selected for the
                                                                                          general population or
                                                                                          females 13-50, since
                                                                                          an appropriate
                                                                                          endpoint attributable
                                                                                          to a single exposure
                                                                                          was not identified in
                                                                                          the toxicology data
                                                                                          base
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 175 mg/kg/day    FQPA SF = 1              Developmental toxicity
                                       UF = 100...............  cPAD = cRfD / FQPA SF..   study - rabbit
                                       Chronic RfD = 1.75 mg/   = 1.75 mg/kg/day.......  LOAEL = 350 mg/kg/day
                                        kg/day.                                           based on diarrhea,
                                                                                          nasal discharge and
                                                                                          death in maternal
                                                                                          animals
----------------------------------------------------------------------------------------------------------------
Short-, and intermediate-term          NOAEL = 175 mg/kg/day    LOC for MOE = 100        Developmental toxicity
 incidental, oral (Residential)                                                           study - rabbit
                                                                                         LOAEL = 350 mg/kg/day
                                                                                          based on diarrhea,
                                                                                          nasal discharge and
                                                                                          death in maternal
                                                                                          animals
----------------------------------------------------------------------------------------------------------------
Short-, intermediate- and long-term    None                     None                     Based on the systemic
 dermal (1-30 days, 1-6 months, 6                                                         NOAEL of 1,000 mg/kg/
 months-lifetime) (Occupational/                                                          day in the 21-day
 Residential)                                                                             dermal toxicity study
                                                                                          in rabbits, and the
                                                                                          lack of concern for
                                                                                          developmental and
                                                                                          reproductive effects,
                                                                                          the quantification of
                                                                                          dermal risks is not
                                                                                          required
----------------------------------------------------------------------------------------------------------------
Short-, intermediate- and long-term    None                     None                     Based on the systemic
 inhalation (1-30 days, 1-6 months, 6                                                     toxicity NOAEL of 0.36
 months-lifetime) (Occupational/                                                          mg/L (HDT) in the 28-
 Residential)                                                                             day inhalation
                                                                                          toxicity study in
                                                                                          rats, and the physical
                                                                                          characteristics of the
                                                                                          technical (wetcake),
                                                                                          the quantification of
                                                                                          inhalation risks is
                                                                                          not required
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Cancer classification    Risk Assessment not      No evidence of
                                        (Group E)                required                 carcinogenicity
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.364) for the residues of glyphosate, in or on a 
variety of raw agricultural commodities. The current proposal to 
establish glyphosate tolerances at 300 and 400 ppm for animal feed, 
nongrass, group (Crop Group 18) and grass, forage, fodder and hay, 
group (Crop Group 17), respectively, is not expected to result in an 
increase in the dietary burden for cattle, poultry, and hogs. 
Respective dietary burdens of 210 ppm and 220 ppm were recently 
estimated by the Agency for dairy and beef cattle, including a 
contribution from alfalfa hay as the roughage component of the diet 
with a tolerance of 400 ppm. Furthermore, no impact is expected on the 
dietary burden to poultry or hogs since grass forage and hay are not 
feed items for these livestock, and the contribution from alfalfa was 
already considered. Risk assessments were conducted by EPA to assess 
dietary exposures from glyphosate in food as follows:

[[Page 60944]]

    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. A review of the toxicity data base, including the 
developmental toxicity studies in rats and rabbits, did not provide an 
endpoint that could be used to quantitate risk to the general 
population and to females 13-50 years old from a single-dose 
administration of glyphosate. Therefore, no acute dietary analysis was 
conducted for glyphosate.
    ii. Chronic exposure. The glyphosate chronic dietary exposure 
analysis was conducted using the DEEMTM software Version 
7.73, which incorporates consumption data from USDA's CSFII, 1989-1992. 
The 1989-92 data are based on the reported consumption of more than 
10,000 individuals over 3 consecutive days, and therefore represent 
more than 30,000 unique person days of data. Foods as consumed (i.e., 
apple pie) are linked to raw agricultural commodities and their food 
forms (i.e., apples-cooked/canned or wheat-flour) by recipe translation 
files internal to the DEEMTM software. Consumption data are 
averaged for the entire U.S. population and within population subgroups 
for chronic exposure assessment, but are retained as individual 
consumption events for acute exposure assessment.
    For chronic dietary exposure and risk assessments, an estimate of 
the residue level in each food or food-form (i.e., orange or orange-
juice) on the commodity residue list is multiplied by the average daily 
consumption estimate for that food/food form. The resulting residue 
consumption estimate for each food/food form is summed with the residue 
consumption estimates for all other food/food forms on the commodity 
residue list to arrive at the total estimated exposure. Exposure 
estimates are expressed in mg/kg body weight/day and as a percent of 
the cPAD for chronic exposure. This procedure is performed for each 
population subgroup.
    The Tier 1 chronic dietary exposure analysis for glyphosate is an 
upper bound estimate of chronic dietary exposure. The chronic dietary 
exposure analysis was performed for the general U.S. population and all 
population subgroups using DEEMTM default processing factors 
for rice and corn commodities, tolerance levels, and 100% crop treated 
data for the proposed commodities and all registered uses. For chronic 
dietary risk, the Agency's LOC is less than 100% cPAD. Dietary exposure 
estimates for representative population subgroups are presented in 
Table 4. The results of the chronic analysis indicate that the 
estimated chronic dietary risk as represented by the percent cPAD is 
below the Agency's LOC (100% cPAD) for the U.S. population and all 
population subgroups.

                   Table 4.--Summary of Results from Chronic DEEM \TM\ Analysis of Glyphosate
----------------------------------------------------------------------------------------------------------------
                           Subgroup                               Exposure (mg/kg/day)            % cPAD
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                                                        0.031527                      1.8
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                                                     0.062218                      3.6
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                                       0.068016                      3.9
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                                      0.045529                      2.6
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                                      0.023477                      1.3
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                                        0.031938                      1.8
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                                          0.026745                      1.5
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                                        0.022733                      1.3
----------------------------------------------------------------------------------------------------------------

    iii. Cancer. The HED Cancer Peer Review Committee classified 
glyphosate as a Group E chemical, negative for carcinogenicity in 
humans, based on the absence of evidence of carcinogenicity in male and 
female rats as well as in male and female mice.
    iv. Anticipated residue and percent crop treated information. The 
Agency used tolerance levels and 100% percent crop treated (PCT) data 
for the proposed commodities and all registered uses.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for glyphosate in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of glyphosate.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a Tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental

[[Page 60945]]

concentrations (EECs) from these models to quantify drinking water 
exposure and risk as a %RfD or %PAD. Instead, drinking water levels of 
comparison (DWLOCs) are calculated and used as a point of comparison 
against the model estimates of a pesticide's concentration in water. 
DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food and from residential uses. Since DWLOCs address total aggregate 
exposure to glyphosate, they are further discussed in the aggregate 
risk section E. (Aggregate Risks and Determination of Safety) of this 
Unit.
    Based on the GENEEC and SCI-GROW models, the EECs of glyphosate for 
acute exposures are estimated to be 21 parts per billion (ppb) for 
surface water and 0.0038 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.83 ppb for surface water and 0.0038 ppb 
for ground water, based on glyphosate treatment crops. To estimate the 
possible concentration of glyphosate in surface water resulting from 
direct application to water, the Agency assumed application to a water 
body 6 feet deep. At an application rate of 3.75 lb acid equivalent 
(ae)/A, the estimated concentration is 230 ppb. Because the glyphosate 
water-application estimate is greater than the crop application 
estimate, 230 ppb is the appropriate value to use in the chronic risk 
estimate.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    i. Non-occupational (recreational) exposures. Glyphosate is 
currently registered for use on the following residential non-dietary 
sites: Recreational areas, including parks and golf courses for control 
of broadleaf weeds and grasses, and lakes and ponds, including 
reservoirs for control of nuisance aquatic weeds. Based on the 
registered uses, adult and child golfers are anticipated to have short-
term post-application dermal exposure at golf courses. Swimmers 
(adults, children and toddlers) are anticipated to have short-term 
post-application dermal and incidental ingestion exposures. However, 
since the Agency did not select dermal endpoints, no post-application 
dermal assessment is included; only a post-application incidental 
ingestion exposure assessment (swimmers) is included. Risk estimates 
for incidental ingestion by swimmers (adults, children, and toddlers) 
ranged from 7,600 to 36,000. It should be noted however, that 
glyphosate is used for non-selective weed control on emerged aquatic 
weeds. In this use pattern, it is unlikely that swimmers would be 
present in waterbodies with floating weeds present. Thus, the inclusion 
of the swimmer incidental ingestion exposure assessment is considered 
by the Agency to be conservative. Table 5 presents a summary of 
assumptions used to estimate the exposure to adult and toddler child 
swimmers and the corresponding risk estimates.

             Table 5.--Assumptions and Risk Estimates for Post-Application Swimmer Exposure Assessments for Glyphosate, Isopropylamine salt
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Potential Dose Rate
                  Exposure Scenario                       AR1 (lb a.e./A)       Maximum Concentration     (PDR; oral mg/kg bw/      Short-term MOE \4\
                                                                                 in water (mg/L) \2\            day) \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Incidental oral ingestion, adult-female                                  3.75                     1.38                  0.00493                   36,000
-----------------------------------------------------                                                  -------------------------------------------------
 Incidental oral, toddler                                                                                                 0.023                    7,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Application rate from registered labels for aquatic weed control using glyphosate IPA salt (ex. label = EPA Reg. No. 524-343; max rate = 7.5 pints/A
  containing 4 lb ae glyphosate/gal. x 1 gal./4 pints = 3.75 lb ae/A.
\2\ Maximum concentration in water (top 1 ft.) = 3.75 lb ae/A x 1A/43,560 ft \2\ x 454,000 mg/lb x 1/ft x ft \3\/28.32 L = 1.38 mg/L.
\3\ PDR, incidental oral exposure = concentration, Cw (mg/L) x ingestion rate, IgR (L/hr) x exposure time, ET (hrs/d) x 1/BW (adult-female = 60 kg;
  toddler = 15 kg).
\4\ MOE = NOAEL/PDR; short-term incidental oral NOAEL = 175 mg/kg bw/d; The LOC for adult females and toddlers for short-term, incidental oral exposures
  is MOEs < 100.

    The MOEs presented in Table 5 for post-application exposure by 
swimmers to glyphosate in aquatic weed control applications are greater 
than 100 and do not exceed the Agency's LOC for short-term non-
occupational (recreational) exposures (MOEs less than 100).
    ii. Residential exposures. Glyphosate, isopropylamine salt is also 
registered for broadcast and spot treatments on home lawns and gardens 
by homeowners and by lawn care operators (LCOs). Based on the 
registered residential use patterns, there is a potential for short-
term dermal and inhalation exposures to homeowners who apply products 
containing glyphosate (residential handlers). Additionally, based on 
the results of environmental fate studies, there is also a potential 
for short- and intermediate-term post-application dermal exposures by 
adults and toddlers and incidental ingestion exposures by toddlers. 
However, since the Agency did not select short- or intermediate-term 
dermal or inhalation endpoints, no residential handler or post-
application dermal assessment is included; only a post-application 
toddler assessment for incidental ingestion exposures is included. Risk 
estimates for toddler post-application incidental ingestion exposures 
ranged from 7,200 to greater than 106. All recreational and 
residential exposures assessed do not exceed the Agency's level of 
concern (MOEs less than 100). Table 6 provides a summary of the short- 
and intermediate-term risk estimates for post-application incidental 
ingestion exposures to toddlers.

[[Page 60946]]



        Table 6.--Summary of Toddler Incidental Ingestion Exposures and Risk Estimates for Residential Use of Glyphosate, Isopropylamine salt \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                   Short-/Intermediate-
                  Activity                      AR (lbs a.e./A) \2\          Residue Estimate \3\         PDR (mg/kg bw/d) \4\         term MOE \5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hand-to-mouth                                                    1.62  DFR: 0.908 [mu]g/cm \2\                           0.0242                    7,200
---------------------------------------------                         ----------------------------------------------------------------------------------
Object-to-mouth                                                        DFR: 3.63 [mu]g/cm \2\                           0.00605                   29,000
---------------------------------------------                         ----------------------------------------------------------------------------------
Soil ingestion                                                         Soil residue: 12.2 [mu]g/g soil              8.13 x 10-5                    > 106
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Sources: Standard Operating Procedures for Residential Exposure Assessments, Draft, December 17, 1997 and Exposure SAC Policy No. 11, February 22,
  2001: Recommended Revisions to the SOPs for Residential Exposure.
\2\ AR = maximum application rate on Roundup ProDry label (EPA Reg. No. 524-505) for residential lawn treatment.
\3\ Residue estimates based on the following protocol from the Residential SOPs:
a. Hand-to-mouth DFR = 1.62 lb ae/A x 0.05 x (4.54 x 10-8 [mu]g/lb ae) x (2.47 x 10-8 A/cm \2\) = 0.908 g/cm \2\.
b. Object-to-mouth DFR = 1.62 lb ae/A x 0.20 x (4.54 x 108 [mu]g/lb ae) x ( 2.47 x 10-8 A/cm \2\) = 3.63 [mu]g/cm \2\.
Soil Residue = 1.62 lb ae/A x fraction of residue in soil (100%)/cm x (4.54 x 10 \8\ [mu]g/lb ae) x ( 2.47 x 10-8A/cm2) x 0.67 cm \3\/g= 12.2 [mu]g/g
  soil.
\4\ Potential Dose Rate (PDR; already normalized to body weight of toddler).
a. Hand-to-mouth PDR = (0.908 g/cm \2\ x 0.50 x 20 cm \2\/event x 20 events/hr x 10-3 mg/[mu]g x 2 hrs/d)/15 kg = 0.0242 mg/kg bw/d.
Object-to-mouth PDR = (3.63 g/cm \2\ x 25 cm \2\/d x 10-3 mg/[mu]g)/15 kg = 0.00605 mg/kg bw/d.
Soil Ingestion PDR = (12.2 [mu]g/g soil x 100 mg soil/d x 10-6 g/[mu]g)/15 kg = 8.13 x 10-5 mg/kg bw/d.
\5\ MOE = NOAEL/PDR, where the short-term incidental oral NOAEL = 175 mg/kg/d the Agency's LOC is for MOEs < 100 (short-term residential).

    All MOEs calculated for post-application toddler exposures do not 
exceed the Agency's level of concern for residential exposures (MOEs 
less than 100).
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether glyphosate has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
glyphosate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that glyphosate has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1.In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
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.
    2. Prenatal and postnatal sensitivity. The toxicology data base for 
glyphosate is adequate according to the Subdivision F Guideline 
requirements for a food-use chemical. Acceptable developmental toxicity 
studies in the rat and rabbit are available, as is an acceptable 2-
generation reproduction study in the rat. Based on the available data, 
the Agency determined that there is no evidence of either a 
quantitative or qualitative increased susceptibility following in utero 
glyphosate exposure to rats and rabbits, or following prenatal/
postnatal exposure in the 2-generation reproduction study in rats.
    3. Conclusion. There is a complete toxicity data base for 
glyphosate and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The Agency 
determined that the FQPA Safety Factor to protect infants and children 
can be removed (reduced from 10X to 1X) for all population subgroups 
and exposure scenarios because:
    1. The toxicology data base is complete.
    2. A developmental neurotoxicity study is not required.
    3. The dietary (food and drinking water) exposure assessments will 
not underestimate the potential exposures for infants and children.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative

[[Page 60947]]

drinking water exposure assessments. Different populations will have 
different DWLOCs. Generally, a DWLOC is calculated for each type of 
risk assessment used: Acute, short-term, intermediate-term, chronic, 
and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute aggregate risk (food + drinking water). The Agency did not 
identify an appropriate acute dietary endpoint that is the result of a 
single-dose administration of glyphosate. Accordingly, glyphosate is 
not expected to pose an acute risk.
    2. Chronic aggregate risk (food + drinking water). Using the 
exposure assumptions described in this unit for chronic exposure 
(tolerance level residues, DEEM \TM\ default processing factors for 
rice and corn commodities, and 100% crop treated data for all proposed 
commodities and registered uses), EPA has concluded that exposure to 
glyphosate from food will utilize 1.8% of the cPAD for the U.S. 
population, 3.6% of the cPAD for [All Infants (less than 1 year old) 
and 3.9% of the cPAD for children 1-6 years old. The results of the 
chronic analysis (Table 4 in this unit) indicate that the chronic 
dietary risk estimates for the general U.S. population and all 
population subgroups associated with the existing and proposed uses of 
glyphosate do not exceed the Agency's LOC (less than 100% of the cPAD). 
Based on the use pattern, chronic residential exposure to residues of 
glyphosate is not expected. In addition, there is potential for chronic 
dietary exposure to glyphosate in drinking water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD, as 
shown in Table 7 below:

               Table 7.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to glyphosate
----------------------------------------------------------------------------------------------------------------
                                                                Maximum
                                                   Chronic      Chronic
                                    cPAD, mg/kg/     Food        Water        Ground      Surface      Chronic
   Scenario/Population Subgroup         day       Exposure,     Exposure    Water EEC,   Water EEC,   DWLOC \2\,
                                                  mg/kg/day   \1\, mg/kg/      ppb          ppb          ppb
                                                                  day
----------------------------------------------------------------------------------------------------------------
U.S. population                            1.75     0.031527     1.718473       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                 1.75     0.062218     1.687782       0.0038          230       17,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                   1.75     0.068016     1.681984       0.0038          230       17,000
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                  1.75     0.045529     1.704471       0.0038          230       17,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                  1.75     0.023473     1.726527       0.0038          230       52,000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                    1.75     0.031938     1.718062       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                      1.75     0.026745     1.723255       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                    1.75     0.022733     1.727267       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
\1\ Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from DEEM \TM\ (mg/kg/
  day).
\2\ The chronic DWLOCs were calculated as follows: DWLOC ([mu]g/L) = maximum water exposure (mg/kg/day) x body
  weight (kg) / consumption (L/day) x 0.001 mg/[mu]g.

    3. Short-/intermediate-term aggregate risk (food + residential + 
water). In aggregating short-/intermediate-term risk, HED considered 
background chronic dietary exposure (food + water) and short/
intermediate-term incidental oral exposures (see Tables 6 and 7). 
Because the incidental oral ingestion exposure estimates for toddlers 
from residential turf exposures (Table 7) exceeded the incidental oral 
exposure estimates from post-application swimmer exposures (Table 6), 
the Agency conducted this risk assessment using exposure estimates from 
just the worst-case situation. No attempt was made to combine exposures 
from the swimmer and residential turf scenarios due to the low 
probability of both occurring.
    The total short-/intermediate-term food and residential aggregate 
MOEs are 1,800-2,300. As these MOEs are greater than 100, the short-/
intermediate-term aggregate risk does not exceed the Agency's LOC. For 
surface water and ground water, the EECs of glyphosate are less than 
the DWLOCs for glyphosate in drinking water as a contribution to short-
/intermediate-term aggregate exposure. Therefore, the Agency concludes 
with reasonable certainty that residues of glyphosate in drinking water 
do not contribute significantly to the short-/intermediate-term 
aggregate human health risk at the present time. Table 8 summarizes the 
short-/intermediate-term aggregate exposure to glyphosate residues.

[[Page 60948]]



                       Table 8.--Short/Intermediate-Term Aggregate Risk and DWLOC Calculations for Exposure to Glyphosate Residues
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Short-/Intermediate-Term Exposure Scenario
                                    --------------------------------------------------------------------------------------------------------------------
             Population                                        Aggregate Level of
                                      Aggregate MOE (food +     Concern (LOC) or     Surface Water EEC \3\   Ground Water EEC \3\   Short/Intermediate-
                                        residential) \1\         Target MOE \2\              (ppb)                  (ppb)          Term DWLOC \4\, (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)            1,900                   100                     230                    0.0038                 17,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old)             1,800                   100                     230                    0.0038                 17,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (7-12 years old)            2,300                   100                     230                    0.0038                 17,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Aggregate MOE = NOAEL / (Average food exposure + Residential exposure).
\2\ Basis for the target MOE: interspecies and intraspecies uncertainty factors totaling 100.
\3\ The glyphosate use producing the highest level was used.
\4\ DWLOC([mu]g/L or ppb) = maximum water exposure (mg/kg/day) x body weight (kg) / water consumption (L) x 10-3 mg/[mu]g (10 kg body weight assumed).

    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to glyphosate residues.

VI. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for analysis of residues 
of glyphosate in or on plant and livestock commodities. These methods 
include GLC (Method I in Pesticides Analytical Manual (PAM) II; the 
limit of detection is 0.05 ppm) and 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). Thus, adequate analytical 
methods are available for residue data collection and enforcement of 
the proposed tolerances of glyphosate in/on the nongrass animal feed 
crop group; the grass forage, fodder, and hay crop group; wheat forage 
and hay; and livestock commodities.

B. International Residue Limits

    Codex and Mexican maximum residue limits (MRLs) are established for 
residues of glyphosate (glifosato) per se and Canadian MRLs are 
established for combined residues of glyphosate and AMPA in a variety 
of raw agricultural, processed, and animal commodities. Currently a 
relevant Codex MRL for hay or fodder (dry) of grasses is established at 
50 ppm. No Canadian MRLs are established for any grass commodity. A 
Mexican MRL is established for pasture at 0.2 ppm. Because of the 
higher residue levels resulting from the proposed use pattern, 
harmonization of U.S. grass tolerances with existing Codex or Mexican 
MRLs is not possible.
    For wheat-related commodities, relevant Codex MRLs exist for: wheat 
grain at 5 ppm; unprocessed wheat bran at 20 ppm; wheat flour at 0.5 
ppm; wheat wholemeal at 5 ppm; and straw and fodder (dry) of cereal 
grains at 100 ppm. Canadian MRLs are established for: wheat at 5 ppm 
and wheat milling fractions (excluding flour) at 15 ppm. A Mexican MRL 
is established for wheat at 5 ppm. By maintaining the wheat, milling 
fractions (excluding flour) tolerance at 20 ppm, harmony with 
international tolerances for wheat processed fractions can be 
maintained.
    There are currently no Codex or Canadian MRLs established for 
glyphosate for any nongrass animal feed items. A Mexican MRL is 
established for alfalfa at 200 ppm. Harmonization with this level is 
not possible due to the higher residue levels found in the submitted 
field trial studies.

C. Conditions

    None.

VII. Conclusion

    Therefore, the tolerance is established for residues of glyphosate, 
in or on animal feed, nongrass, group at 400 ppm and grass forage, 
fodder and hay, group at 300 ppm and the potassium salt of glyphosate 
is added to the tolerance expression. Based on the Agency's decision 
not to register tolerances for glyphosate use in or on herbicide-
tolerant wheat, the current tolerances on wheat are not modified.

VIII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0232 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
26, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing

[[Page 60949]]

is requested, the requestor's contentions on such issues, and a summary 
of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0232, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IX. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal

[[Page 60950]]

officials in the development of regulatory policies that have tribal 
implications.'' ``Policies that have tribal implications'' is defined 
in the Executive Order to include regulations that have ``substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal Government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

X. 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 to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 18, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.364 is amended by revising the introductory text of 
paragraph (a) and alphabetically adding commodities to the table in 
paragraph (a) to read as follows:


Sec.  180.364  Glyphosate; tolerances for residues.

    (a) General. Tolerances are established for residues of glyphosate 
(N-phosphomethyl)glycine) resulting from the application of glyphosate, 
the isopropylamine salt of glyphosate, the ethanolamine salt of 
glyphosate, the ammonium salt of glyphosate, and the potassium salt of 
glyphosate in or on the following food commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Animal feed, nongrass, group...................                      400
                                * * * * *
Grass, forage, fodder and hay, group...........                      300
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-24488 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S