[Federal Register Volume 65, Number 188 (Wednesday, September 27, 2000)]
[Rules and Regulations]
[Pages 57957-57966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24318]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301053; FRL-6746-6]
RIN 2070-AB78


Glyphosate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
glyphosate in or on various food commodities.

[[Page 57958]]

Monsanto Company and the Interregional Research Project Number 4 (IR-4) 
requested these tolerances 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, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301053, 
must be received by EPA on or before November 27, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301053 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT By mail: Hoyt Jamerson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: 703-308-9368; and 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 Potentially
             Categories                 NAICS       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 Home 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/. 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 control number OPP-301053. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of January 10, 2000 and July 25, 2000 (65 
FR 1370) (FRL-6394-6) and (65 FR 45769) (FRL-6596-4),respectively, EPA 
issued notices 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) for tolerance by Monsanto Company, 
600 13th Street NW., Suite 660, Washington DC 20005. In addition, in 
the Federal Register of August 14, 2000 (65 FR 49563) (FRL-6739-2), 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 petition (PP) for tolerance by IR-4, Technology 
Center of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 
08902-3390. These notices included a summary of the petitions prepared 
by Monsanto Company. Comments were received from Monsanto in response 
to the notice of filing. Monsanto noted that the tolerance proposal for 
the leafy vegetable group is for residues of glyphosate at 0.2 ppm, not 
2.0 ppm, and that there is no proposal for residues of glyphosate in or 
on poultry meat. The Agency agrees that the appropriate tolerance level 
for the leafy vegetable group is 0.2 ppm. Monsanto has agreed that a 
tolerance for poultry meat at 0.1 ppm is needed to harmonize with 
CODEX. There were no other comments received in response to the notices 
of filing.
    The petitions requested that 40 CFR 180.364 be amended by 
establishing tolerances for residues of glyphosate, (N-
(phosphonomethyl)glycine) resulting from the application of glyphosate, 
the isopropylamine salt of glyphosate, the ethanolamine salt of 
glyphosate, and the ammonium salt of glyphosate in or on alfalfa hay at 
400 ppm; grass, forage, fodder and hay group; nongrass animal feed 
group, kenaf forage, and leucaena forage at 200 ppm; alfalfa forage at 
175 ppm; cereal grain group (except barley, field corn, grain sorghum, 
oats and wheat) at 100 ppm; rapeseed meal at 15, rapeseed seed at 10 
ppm, flax meal at 8.0 ppm; dried hops cones, and spices subgroup at 7.0 
ppm; teff grain at 5.0 ppm, flax seed at 4.0 ppm; field corn forage at 
3.0 ppm; dokudami at 2.0 ppm, and Mexican oregano leaves at 2.0; 
perilla tops at 1.8 ppm; epazote at 1.3 ppm; betelnut. chaya, pine nut, 
and stevia dried leaves at 1.0 ppm; aloe vera, cactus fruit, cactus 
pads, okra, ugli fruit, and quinoa grain at 0.5 ppm; ambarella, globe 
artichoke, bambo shoots, berry group, biriba, blimbe, custard apple, 
feijoa, galangal roots, ginger white flower, governor's plum, gow kee 
leaves, herbs subgroup, ilama, imbe, imbu, juneberry, kava roots, 
lingonberry, mamey apple, mioga flower, palm heart, palm heart leaves, 
mountain papaya, pawpaw, pepper leaf (fresh leaves), pulasan, rose 
apple, salal, Spanish lime, star apple, strawberry, surinam cherry, ti 
leaves, ti roots, Brassica leafy vegetable, foliage of legume vegetable 
group (except soybean forage and hay), leafy vegetable group, leaves of 
root and tuber vegetable group (except sugar beet

[[Page 57959]]

tops), root and tuber vegetable group (except sugar beet), wasabi root, 
water spinach tops, upland watercress, and wax jambu at 0.2; borage 
seed, crambe seed, buffalo gourd seed, egg, jojoba seed, lesquerella 
seed, meadowfoam seed, mustard seed, poultry meat, safflower seed, and 
sesame seed at 0.1 ppm.
    In addition to the commodity tolerances proposed by IR-4 and 
Monsanto, Monsanto proposed to amend 40 CFR part 180 by revising the 
tolerance expression under Sec. 180.364(a)(1) to read as follows:
    Sec. 180.364 Glyphosate; tolerances for residues. (a)(1)General. 
Tolerances are established for residues of glyphosate (N-
(phosphonomethyl)glycine) from the application of glyphosate, the 
ethanolamine salt of glyphosate, and the ammonium salt of glyphosate 
.... ''
    Monsanto also proposed that the existing text in Sec. 180.364(a)(1) 
by redesignated as Sec. 180.364(a), that the tolerances in 
Secs. 180.364(a)(2) and (a)(3) be transferred to the table in newly 
designated Sec. 180.364(a), and that the introductory text of 
Sec. 180.364(a)(2) and (a)(3) be deleted. Additional revisions to the 
table in Sec. 180.364(a) are the deletion of duplicate commodity 
tolerance entries and the deletion of commodity tolerances that are 
superceded by the proposed crop group tolerances and the conversion of 
commodity terms to comply with EPA's Food and Feed Vocabulary Data Base 
(http://www.epa.gov/pesticides/foodfeed/). The Agency is also deleting 
all commodity entries under Sec. 180.364(d)--indirect or inadvertent 
residues since these commodities will have tolerance established at the 
same or higher levels in the newly established Sec. 180.364(a).
    IR-4 proposed a tolerance for residues of glyphosate in or on the 
grass, forage, fodder and hay group at 200 ppm. IR-4's proposal is 
based on data previously reviewed by EPA in support of established 
tolerances for bahiagrass, bluegrass, bermudagrass, fescue, 
orchardgrass, ryegrass, timothy, and wheatgrass at 200 ppm. Monsanto 
has also proposed a grass, forage, fodder and hay tolerance; however, 
Monsanto has requested a tolerance level of 300 ppm. Monsanto's 
tolerance proposal for the grass group is based on new residue data 
which reflect changed use patterns and pre-grazing intervals for the 
grasses. In the notice filings cited above, reference was made to the 
300 ppm tolerance level but not the 200 ppm level. Because the Agency 
has determined that the available data are adequate to support IR-4's 
tolerance proposal for residues of glyphosate in or on the grass, 
forage, fodder and hay group at 200 ppm and EPA has not completed 
review of Monsanto's new data supporting the 300 ppm level, EPA is 
establishing the tolerance for grass, forage, fodder and hay at 200 
ppm. The Agency will reevaluate the grass group tolerance based on the 
residue data submitted by Monsanto and will make a decision on the 
proposed grass group tolerance at 300 ppm at a later date.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for these tolerances for residues of glyphosate. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by glyphosate are 
discussed in 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.

            Table 1.--Subchronic, Chronic and Other Toxicity
------------------------------------------------------------------------
         Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL less than 50
                                  toxicity in rats    milligrams (mg)/
                                                      kilogram (kg)/day
                                                      for both sexes
                                                     LOAEL = 50 mg/kg/
                                                      day based on
                                                      increased
                                                      phosphorus and
                                                      potassium in both
                                                      sexes
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = 1,500 mg/kg/
                                  toxicity in mice    day in both sexes
                                                     LOAEL = 7,500 mg/kg/
                                                      day in both sexes
                                                      based on decreased
                                                      body weight gain
                                                      in both sexes.
------------------------------------------------------------------------
870.3200                         21/28-Day dermal    NOAEL = 1,000 mg/kg/
                                  toxicity in         day for males and
                                  rabbits             5,000 mg/kg/day
                                                      for females
                                                     LOAEL = 5,000 mg/kg/
                                                      day in males based
                                                      on decreased food
                                                      consumption
------------------------------------------------------------------------
870.3700a                        Prenatal            Maternal NOAEL =
                                  developmental       1,000 mg/kg/day
                                  toxicity in rats
                                                     LOAEL = 3,500 mg/kg/
                                                      day based on
                                                      mortality,
                                                      increased clinical
                                                      signs, and reduced
                                                      body weight gain

[[Page 57960]]

 
                                                     Developmental NOAEL
                                                      = 1,000 mg/kg/day
                                                     LOAEL = 3,500 mg/kg/
                                                      day based on
                                                      decreases in total
                                                      implantations/dam
                                                      and nonviable
                                                      fetuses/dam,
                                                      increased number
                                                      of litters and
                                                      fetuses with
                                                      unossified
                                                      sternebrae, and
                                                      decreased fetal
                                                      body weight
------------------------------------------------------------------------
870.3700b                        Prenatal            Maternal NOAEL =
                                  developmental       175 mg/kg/day
                                  toxicity in
                                  rabbits
                                                     LOAEL = 350 mg /kg/
                                                      day based on
                                                      mortality, and
                                                      clinical signs
                                                     Developmental NOAEL
                                                      = 175 mg/kg/day
                                                     LOAEL = 350 mg/kg/
                                                      day (insufficient
                                                      litters available
                                                      to assess
                                                      developmental
                                                      toxicity)
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Systemic
                                  fertility effects   NOAEL = 500 mg/kg/
                                  in rats             day for males and
                                                      females
                                                     LOAEL = 1,500 mg/kg/
                                                      day for males and
                                                      females based on
                                                      clinical signs,
                                                      decreased body
                                                      weights, decreased
                                                      weight gain, and
                                                      decreased food
                                                      consumption in
                                                      both sexes
                                                     Reproductive/
                                                      Offspring NOAEL =
                                                      500 mg/kg/day for
                                                      males and females
                                                     LOAEL = 1500 mg/kg/
                                                      day for males and
                                                      females based on
                                                      reduced pup
                                                      weights in both
                                                      sexes during
                                                      second and third
                                                      weeks of lactation
------------------------------------------------------------------------
870.4100b                        Chronic toxicity    NOAEL = 500 mg/kg/
                                  in dogs             day (highest dose
                                                      tested)
                                                     LOAEL greater than
                                                      500 mg/kg/day
------------------------------------------------------------------------
870.4300                         Combined Chronic    NOAEL = 362 mg/kg/
                                  Toxicity/           day in males and
                                  Carcinogenicity     457 mg/kg/day in
                                  in rats             females
                                                     LOAEL = 940 mg/kg/
                                                      day in males and
                                                      1,183 mg/kg/day in
                                                      females based on
                                                      decreased weight
                                                      gain in females,
                                                      and increased
                                                      incidence of
                                                      cataracts and lens
                                                      abnormalities,
                                                      decreased urinary
                                                      pH, increased
                                                      absolute liver
                                                      weight, and
                                                      increased relative
                                                      liver weight/brain
                                                      weight in males.
                                                      There was no
                                                      evidence of
                                                      carcinogenicity.
------------------------------------------------------------------------
870.4200b                        Carcinogenicity in  NOAEL = 750 mg/kg/
                                  mice                day in males and
                                                      females
                                                     LOAEL = 4,500 mg/kg/
                                                      day in both sexes
                                                      based on decreased
                                                      body weight gains
                                                      in both sexes,
                                                      increased
                                                      incidence of renal
                                                      proximal tubule
                                                      epithelial
                                                      basophilia and
                                                      hypertrophy in
                                                      females and
                                                      increased
                                                      incidence of
                                                      interstitial
                                                      nephritis,
                                                      hepatocellular
                                                      hypertrophy and
                                                      hepatocellular
                                                      necrosis in males
                                                      There was no
                                                      evidence of
                                                      carcinogenicity.
------------------------------------------------------------------------
870.5100                         In vitro rec-assay  There was no
                                  with B. subtilis    evidence of
                                  H17 (rec+) and      genotoxicity up to
                                  M45 (rec-) and      the limit dose or
                                  reverse mutation    cytotoxicity in
                                  assay using E.      the presence or
                                  coli WP2 hcr and    absence of
                                  S. typhimurium      metabolic
                                  strains             activation.
------------------------------------------------------------------------
870.5265                          In vitro reverse   There was no
                                  gene mutation       evidence of
                                  assay in S.         induced mutant
                                  typhimurium         colonies over
                                  bacteria            background in
                                                      Salmonella strains
                                                      TA 98, TA 100, TA
                                                      1535, and TA 1537
                                                      both in the
                                                      presence and
                                                      absence of
                                                      metabolic
                                                      activation at
                                                      doses up to
                                                      cytoxic levels or
                                                      the limit dose.
------------------------------------------------------------------------
870.5300                          In vitro gene      There was no
                                  mutation assay in   evidence of
                                  Chinese hamster     genotoxicity up to
                                  ovary cells/HGPRT   cytotoxic levels
                                                      in the presence
                                                      and absence of
                                                      metabolic
                                                      activation.
------------------------------------------------------------------------
870.5385                         Bone marrow         There was no
                                  chromosome          significant
                                  aberrations assay   increase in the
                                                      frequency of
                                                      chromosome
                                                      aberrations in
                                                      bone marrow at the
                                                      limit dose of
                                                      1,000 mg/kg in
                                                      both sexes of
                                                      Sprague-Dawley
                                                      rats.
------------------------------------------------------------------------
870.7485                         Metabolism in rats  Following a single
                                                      oral dose, 30-36%
                                                      was absorbed and
                                                      less than 0.27%
                                                      was eliminated as
                                                      CO2. Urine and
                                                      feces contained
                                                      97.5% as parent.
                                                      Aminomethylphospho
                                                      nic acid (AMPA)
                                                      was only
                                                      metabolite found
                                                      at 0.2-0.3% of
                                                      administered dose.
                                                      Less than 1.0% of
                                                      the absorbed dose
                                                      remained in
                                                      tissues and
                                                      organs, primarily
                                                      in the bone.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which 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 routinely 
used, 10X to account for

[[Page 57961]]

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 2:

      Table 2.--Summary of Toxicological Dose and Endpoints for Glyphosate for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          None                     Not applicable           There were no effects
                                                                                          that could be
                                                                                          attributed to a single
                                                                                          exposure (dose) in
                                                                                          oral toxicity studies
                                                                                          including the
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 175 mg/kg/day;   FQPA SF = 1X; cPAD =     Developmental toxicity
                                        UF = 100; Chronic RfD    chronic RfD      in rabbits Maternal
                                        = 2.0 mg/kg/day          FQPA SF = 2.0 mg/kg/     LOAEL = 350 mg/kg/day
                                                                 day                      based on diarrhea,
                                                                                          nasal discharge and
                                                                                          mortality
                                                                                          Developmental toxicity
                                                                                          was not observed at
                                                                                          any dose tested.
Short-, Intermediate-, and Long-Term   None                     Not applicable.          No systemic toxic
 Dermal (Residential)                                                                     effects were seen at
                                                                                          doses up to 1,000 mg/
                                                                                          kg/day in the 21-day
                                                                                          dermal toxicity study.
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period)           None                     Not applicable.          Based on low toxicity
 (Residential)                                                                            of formulations and
                                                                                          technical material wet
                                                                                          cake inhalation study
                                                                                          was waived.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Group E                  Not applicable           There is no evidence of
                                                                                          carcinogenic
                                                                                          potential.
----------------------------------------------------------------------------------------------------------------
\*\ 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 food commodities. Tolerances are established for cattle, 
hog, horse and sheep kidney at 4.0 ppm and liver at 0.5 ppm. Tolerance 
levels for residues of glyphosate at 0.1 ppm for egg and poultry meat 
and 1.0 ppm for poultry meat byproducts were proposed by IR-4. Risk 
assessments were conducted by EPA to assess dietary exposures from 
glyphosate in food as follows:
    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. An acute dietary endpoint and dose was not identified 
for glyphosate. A review of the rat and rabbit developmental studies 
did not provide a dose or endpoint that could be used for acute dietary 
risk purposes. Additionally, there were no data requirements for acute 
or subchronic rat neurotoxicity studies since there was no evidence of 
neurotoxicity in any of the toxicology studies at very high doses and 
glyphosate lacks a leaving group.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: The chronic dietary exposure analysis from food 
sources was conducted using the reference dose (RfD) of 2.0 mg/kg/day. 
The RfD is based on the maternal NOAEL of 175 mg/kg/day from a rabbit 
developmental study and an uncertainty factor of 100 (applicable to all 
population subgroups). The DEEM analysis assumed tolerance 
level residues and 100% crop treated in/on all commodities with an 
existing or proposed glyphosate tolerance.
    iii. Cancer. There is no evidence of carcinogenic potential.
    2. Dietary exposure from drinking water. The available field and 
laboratory data indicate that glyphosate adsorbs strongly to soil and 
would not be expected to move vertically below the 6 inch soil layer. 
Based on unaged batch equilibrium studies glyphosate and glyphosate 
residues are expected to be immobile with Kd(ads) values ranging from 
62 to 175. The mechanism of adsorption is unclear; however, it is

[[Page 57962]]

speculated that it may be associated with vacant phosphate sorption 
sites or high levels of metallic soil cations. The data indicate that 
chemical and photochemical decomposition is not a significant pathway 
of degradation of glyphosate in soil and water. However, glyphosate is 
readily degraded by soil microbes to AMPA, which is degraded to 
CO2, although at a slower rate than parent glyphosate.
    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 
the Screening Concentration in Ground Water model (SCI-GROW), which 
predicts pesticide concentrations in groundwater. 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 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 sections below.
    Using available environmental fate parameters and assuming two 
applications with a retreatment interval of 90 days at a rate of 5 lbs 
ai/A (3.75 lbs ai/A), the ground water EEC from glyphosate using SCI-
GROW was 0.0038 parts per billion (ppb). The current label allows 
multiple applications of 0.37 - 5 lbs ai/A up to a maximum of 10.6 lbs 
ai/A/year. The ground water EECs generated by SCI-GROW are based on the 
largest 90-day average recorded during the sampling period. Since there 
is relatively little temporal variation in ground water concentrations 
compared to surface water, the concentrations can be considered as 
acute and chronic values.
    The GENEEC model was used to estimate surface water concentrations 
for glyphosate resulting from its maximum use rate on crops. GENEEC is 
a single event model (one runoff event), but can account for spray 
drift from multiple applications. GENEEC represents a 10 hectare field 
immediately adjacent to a 1 hectare pond that is 2 meters deep with no 
outlet. The pond receives a spray drift event from each application 
plus one runoff event. The runoff event moves a maximum of 10% of the 
applied pesticide into the pond. This amount can be reduced due to 
degradation on the field and by soil sorption. Spray drift is estimated 
at 5% of the application rate. The GENEEC values represent upper- bound 
estimates of the concentrations that might be found in surface water 
due to glyphosate use. Thus, the GENEEC model predicts that glyphosate 
surface water EECs range from a peak of 21 ppb to a 56-day average of 
2.5 ppb. For comparison purposes, EPA guidance suggests dividing the 
56-day GENEEC EEC value by 3 before comparison to the calculated 
DWLOCchronic value ``Interim Guidance for Incorporating 
Drinking Water Exposure into Aggregate Risk Assessments,'' 01-AUG-1999 
(SOP 99.5). Thus, 2.5 divided by 3 or 0.83 ppb is the predicted surface 
water EEC value resulting from glyphosate treatment of crops.
    To estimate the possible concentration of glyphosate in surface 
water resulting from direct application to water, EPA assumed 
application to a water body 6 feet deep. At an application rate of 3.75 
lb ai/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 compare to the calculated 
DWLOCchronic value for aggregate risk considerations.
    Based on the GENEEC and SCI-GROW models the EECs of glyphosate for 
chronic exposures are estimated to be 230 ppb for surface water and 
0.004 ppb for ground water.
    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).
    Glyphosate is currently registered for use on the following 
residential non-dietary sites: ornamentals, greenhouses, residential 
areas, lawns, and industrial rights of way. Glyphosate is formulated in 
liquid and solid forms and it is applied using ground or aerial 
equipment. Based on the low acute toxicity and the lack of other 
toxicological concerns, exposures from residential uses of glyphosate 
are not expected to pose undue risks.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether glyphosate has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
glyphosate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that glyphosate has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

[[Page 57963]]

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. 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.
    ii. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility in rats and rabbits to in utero and/or 
postnatal exposure to glyphosate.
    iii. Conclusion. There is a complete toxicity data base for 
glyphosate and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
removed. The FQPA factor is removed because:
     The toxicology data base is complete
     There is no indication of increased susceptibility of rats 
or rabbits to in utero and/or postnatal exposure to glyphosate (in the 
prenatal developmental toxicity study in rats, effects in the offspring 
were observed only at or above treatment levels which resulted in 
evidence of appreciable parental toxicity)
     The use of generally high quality data, conservative 
models and/or assumptions in the exposure assessment provide adequate 
protection of 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 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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. No appropriate toxicological endpoint for a single 
dose exposure was identified in oral toxicity studies with glyphosate. 
Therefore, an acute RfD was not established, and there is no 
expectation of acute dietary risk from food and water.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
glyphosate from food will utilize 1.5% of the cPAD for the U.S. 
population, 3.1% of the cPAD for all infants less than 1 year old and 
3.2% of the cPAD for children (1 to 6 years old). 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 the 
following Table 3:

              Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Glyphosate
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                          2.0          1.5          230        0.004       69,000
All infants, less than 1 year old                        2.0          3.1          230        0.004       19,000
Children, 1-6 years old                                  2.0          3.2          230        0.004       19,000
----------------------------------------------------------------------------------------------------------------

    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Though residential exposure could occur with the use of 
glyphosate, no toxicological effects have been identified for short- or 
intermediate-term toxicity. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    4. Aggregate cancer risk for U.S. population. Glyphosate is not 
expected to pose a cancer risk to humans.
    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.

IV. 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 gas-liquid chromatography (GLC) (Method I in Pesticides 
Analytical

[[Page 57964]]

Manual (PAM) II; the limit of detection is 0.05 ppm) and high-pressure 
liquid chromatography (HPLC) with fluorometric detection. Use of the 
GLC method is discouraged due to the lengthiness of the experimental 
procedure. The HPLC procedure has undergone successful Agency 
validation and was recommended for inclusion in PAM II. A gas 
chromatography/mass spectometry method for glyphosate in crops has also 
been validated by EPA's Analytical Chemistry Laboratory.
    The unpublished methods may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; 
telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    Several maximum residue limits (MRLs) for glyphosate (including 
AMPA) have been established by CODEX in or on various commodities. 
Based on toxicological considerations, EPA has determined that AMPA no 
longer needs to be regulated and with this regulation has deleted AMPA 
from the tolerance expression. Thus, harmonization with the MRLs for 
AMPA is not possible. The existing and recommended ``rape, seed'' 
tolerance of 10 ppm is already in harmony with the CODEX MRL. The 
recommended ``corn, forage'' tolerance of 3.0 ppm is based on crop 
field trial data obtained when using a new strain of Roundup Ready corn 
and thus cannot be lowered to achieve harmonization with the CODEX MRL 
of 1.0 ppm for ``maize, forage.'' There is no conflict between the 
CODEX MRL of 0.1 ppm for ``poultry, meat'' and the recommended U.S. 
tolerance of 1.0 ppm for ``poultry, meat byproducts'' as these 
commodities are not the same. Finally, although the available data 
support a tolerance of 0.05 ppm for egg, for harmonization purposes and 
because no risk issues are involved, a tolerance level of 0.1 ppm for 
``egg'' is being established.

V. Conclusion

    Therefore, tolerances are established for residues of glyphosate, 
(N-(phosphonomethyl)glycine) resulting from the application of 
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine 
salt of glyphosate, and the ammonium salt of glyphosate, in or on the 
food commodities listed in this document.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301053 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 
27, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 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 control number OPP-301053, 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 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

[[Page 57965]]

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(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). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require OMB review or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(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).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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 12, 2000.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

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

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


    2. Section 180.364 is amended by revising paragraph (a) and by 
removing and reserving paragraph (d), to read as follows:


Sec. 180.364  Glyphosate; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 Acerola...................................................          0.2
Alfalfa, forage............................................          175
Alfalfa, hay...............................................          400
Almond, hulls..............................................           25
Animal feed, nongrass group (except alfalfa)...............          200
Aloe vera..................................................          0.5
Ambarella..................................................          0.2
Artichoke, globe...........................................          0.2
Aspirated grain fractions..................................          200
Asparagus..................................................          0.5
Atemoya....................................................          0.2
Avocado....................................................          0.2
Bamboo shoots..............................................          0.2
Banana.....................................................          0.2
Barley, bran...............................................           30
Barley, grain..............................................           20
Beet, sugar, dried pulp....................................           25
Beet, sugar, roots.........................................           10
Beet, sugar, tops..........................................           10
Berry group................................................          0.2
Betelnut...................................................          1.0
Biriba.....................................................          0.2
Blimbe.....................................................          0.2
Borage, seed...............................................          0.1
Breadfruit.................................................          0.2
Cactus, fruit..............................................          0.5
Cactus, pads...............................................          0.5
Canistel...................................................          0.2
Canola, meal...............................................           15
Canola, seed...............................................           10
Cattle, kidney.............................................          4.0
Cattle, liver..............................................          0.5
Chaya......................................................          1.0
Cherimoya..................................................          0.2
Citrus, dried pulp.........................................          1.5
Cacao bean.................................................          0.2
Coconut....................................................          0.1
Coffee, bean...............................................          1.0
Corn, field, forage........................................          3.0
Corn, field, grain.........................................          1.0
Cotton, gin byproducts.....................................          100
Cotton, undelinted seed....................................           15
Cranberry..................................................          0.2
Crambe, seed...............................................          0.1
Custard apple..............................................          0.2
Date.......................................................          0.2
Dokudami...................................................          2.0

[[Page 57966]]

 
Durian.....................................................          0.2
Egg........................................................         0.05
Epazote....................................................          1.3
Feijoa.....................................................          0.2
Fig........................................................          0.2
Fish.......................................................         0.25
Flax, meal.................................................          8.0
Flax, seed.................................................          4.0
Fruit, citrus, group.......................................          0.5
Fruit, pome, group.........................................          0.2
Fruit, stone, group........................................          0.2
Galangal root..............................................          0.2
Ginger, white, flower......................................          0.2
Goat, kidney...............................................          4.0
Goat, liver................................................          0.5
Gourd, buffalo, seed.......................................          0.1
Governor's plum............................................          0.2
Gow kee, leaves............................................          0.2
Grain, cereal, group (except barley, field corn, grain               0.1
 sorghum, oats and wheat)..................................
Grain, cereal, stover and straw, group.....................          100
Grape......................................................          0.2
Grass, forage, fodder and hay, group.......................          200
Guava......................................................          0.2
Herbs subgroup.............................................          0.2
Hog, kidney................................................          4.0
Hog, liver.................................................          0.5
Hop, dried cones...........................................          7.0
Horse, kidney..............................................          4.0
Horse, liver...............................................          0.5
Ilama......................................................          0.2
Imbe.......................................................          0.2
Imbu.......................................................          0.2
Jaboticaba.................................................          0.2
Jackfruit..................................................          0.2
Jojoba, seed...............................................          0.1
Juneberry..................................................          0.2
Kava, roots................................................          0.2
Kenaf, forage..............................................          200
Kiwifruit..................................................          0.2
Lesquerella, seed..........................................          0.1
Leucaena, forage...........................................          200
Lingonberry................................................          0.2
Longan.....................................................          0.2
Lychee.....................................................          0.2
Mamey apple................................................          0.2
Mamey sapote...............................................          0.2
Mango......................................................          0.2
Mangosteen.................................................          0.2
Marmaladebox...............................................          0.2
Meadowfoam, seed...........................................          0.1
Mioga, flower..............................................          0.2
Mustard, seed..............................................          0.1
Nut, pine..................................................          1.0
Nut, tree, group...........................................          1.0
Oat, grain.................................................           20
Okra.......................................................          0.5
Olive......................................................          0.2
Oregano, Mexican, leaves...................................          2.0
Palm heart.................................................          0.2
Palm heart, leaves.........................................          0.2
Palm, oil..................................................          0.1
Papaya.....................................................          0.2
Papaya, mountain...........................................          0.2
Passionfruit...............................................          0.2
Pawpaw.....................................................          0.2
Peanut.....................................................          0.1
Peanut, forage.............................................          0.5
Peanut, hay................................................          0.5
Pepper leaf, fresh leaves..................................          0.2
Peppermint, tops...........................................          200
Perilla, tops..............................................          1.8
Persimmon..................................................          0.2
Pineapple..................................................          0.1
Pistachio..................................................          1.0
Pomegranate................................................          0.2
Poultry, meat..............................................          0.1
Poultry, meat byproduct....................................          1.0
Pulasan....................................................          0.2
Quinoa, grain..............................................          5.0
Rambutan...................................................          0.2
Rapeseed, meal.............................................           15
Rapeseed, seed.............................................           10
Rose apple.................................................          0.2
Safflower, seed............................................          0.1
Salal......................................................          0.2
Sapodilla..................................................          0.2
Sapote, black..............................................          0.2
Sapote, white..............................................          0.2
Sesame, seed...............................................          0.1
Sheep, kidney..............................................          4.0
Sheep, liver...............................................          0.5
Shellfish..................................................          3.0
Sorghum, grain, grain......................................           15
Soursop....................................................          0.2
Soybean, seed..............................................           20
Soybean, aspirated grain fractions.........................           50
Soybean, forage............................................          100
Soybean, hay...............................................          200
Soybean, hulls.............................................          100
Spanish lime...............................................          0.2
Spearmint, tops............................................          200
Spices subgroup............................................          7.0
Star apple.................................................          0.2
Starfruit..................................................          0.2
Stevia, dried leaves.......................................          1.0
Strawberry.................................................          0.2
Sugar apple................................................          0.2
Sugarcane..................................................          2.0
Sugarcane, molasses........................................           30
Sunflower, seed............................................          0.1
Surinam cherry.............................................          0.2
Tamarind...................................................          0.2
Tea, dried.................................................          1.0
Tea, instant...............................................          7.0
Teff, grain................................................          5.0
Ti, leaves.................................................          0.2
Ti, roots..................................................          0.2
Ugli fruit.................................................          0.5
Vegetable, Brassica leafy, group...........................          0.2
Vegetable, bulb, group.....................................          0.2
Vegetable, cucurbit, group.................................          0.5
Vegetable, foliage of legume, group (except soybean forage           0.2
 and hay)..................................................
Vegetable, fruiting, group.................................          0.1
Vegetable, leafy, group....................................          0.2
Vegetable, leaves of root and tuber, group(except sugar              0.2
 beet tops)................................................
Vegetable, legume, group (except soybean)..................          5.0
Vegetable, root and tuber, group (except sugar beet).......          0.2
Wasabi, roots..............................................          0.2
Water spinach, tops........................................          0.2
Watercress, upland.........................................          0.2
Wax jambu..................................................          0.2
Wheat, grain...............................................          5.0
Wheat, milling fractions (except flour)....................           20
Yacon, tuber...............................................          0.2
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. [Reserved]

FR Doc. 00-24318 Filed 9-26-00; 8:45 am
BILLING CODE 6560-50-S