[Federal Register Volume 69, Number 159 (Wednesday, August 18, 2004)]
[Notices]
[Pages 51301-51312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18770]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0160; FRL-7364-6]


Glyphosate; Notice of Filing a Pesticide Petition to Establish a 
Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2004-0160, must be received on or before September 17, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: James A. Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; 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 potentially affected by this action if you an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0160. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this FederalRegister document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public

[[Page 51302]]

docket that are available electronically. Although not all docket 
materials may be available electronically, you may still access any of 
the publicly available docket materials through the docket facility 
identified in Unit I.B.1. Once in the system, select ``search,'' then 
key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' andthen key in docket ID number 
OPP-2004-0160. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0160. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information andRecords 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0160.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2004-0160. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is (CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior

[[Page 51303]]

notice. If you have any questions about CBI or the procedures for 
claiming CBI, please consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: August 9, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

Monsanto Company

PP 0F6195, 1F6273, 1F6274, and 3F6570

    EPA has received pesticide petitions (0F6195, 1F6273, 1F6274, and 
3F6570) from Monsanto Company, 600 13th St., NW., Suite 660, 
Washington, DC 20005, proposing pursuant to section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 
amend 40 CFR 180.364 by establishing a regulation to permit residues of 
the herbicide glyphosate (N-phosphonomethyl) glycine in or on the 
following raw agricultural commodities:Alfalfa, seed at 0.5 parts per 
million (ppm); rice, grain at 15.0 ppm; and cotton, gin by-products at 
150 ppm; wheat, forage at 10.0 ppm, wheat, hay at 10.0 ppm; and the 
following processed commodities: Rice, bran at 30.0 ppm; andrice, hulls 
at 25.0 ppm. Monsanto further proposes to delete the entire entries for 
alfalfa, forage at 175 ppm and alfalfa, hay at 400 ppm as these 
tolerances are no longer needed, and to revise the entry for grain, 
cereal group to read: Grain, cereal, group 15 except barley, field 
corn, grain sorghum, oats, rice and wheat at 0.1 ppm. EPA has 
determined that the petitions contain data or information regarding the 
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petitions. Additional data 
may be needed before EPA rules on these petitions.
    The petitions request that 40 CFR 180.364 be amended by 
establishing tolerances for residues of the herbicide glyphosate in or 
on alfalfa, seed at 0.5 ppm; rice, grain at 15. 0 ppm; rice, bran at 
25.0 ppm; rice, hulls at 30.0 ppm; wheat, forage at 10.0 ppm; and 
wheat, hay at 10.0 ppm, increasing the established tolerance for 
cotton, gin by-products from 100 ppm to 150 ppm; by deleting the 
tolerances for alfalfa, forage at 175 ppm and alfalfa, hay at 400ppm, 
and by revising the grain, cereal group tolerance to ``except rice'' 
and read as follows: Grain, cereal group 15 except barley, field corn, 
grain sorghum, oats, rice and wheat at 0.1 ppm. PP 0F6195 has been 
amended to delete the proposal for wheat, grain at 6 ppm that was 
announced earlier (May 17, 2002, 67 FR 18894) (FRL-6830-5). ``The 
tolerances for alfalfa, rice, wheat, and cotton, gin by-products 
include both conventional and genetically altered crops.'' It is also 
proposed the 40 CFR 180.364 be amended by replacing the current listing 
``Vegetable, legume group (except soybean) at 5.0 ppm with the current 
crop group'' pea and bean, dried shelled, except soybean, subgroup 6C 
at 5.0 ppm.
    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).

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 51304]]



            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-         female
                                   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        high dose tested
                                   hours/day, 5 days/  (HDT) mg/L, not
                                   week for 4 weeks)   established
------------------------------------------------------------------------
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
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 175 mg/kg/
                                   nonrodents-rabbit   day
                                                      LOAEL = 350 mg/kg/
                                                       day based on
                                                       mortality,
                                                       diarrhea, soft
                                                       stools, and nasal
                                                       discharge
                                                      Developmental
                                                      NOAEL = 350 mg/kg/
                                                       day
                                                      LOAEL = > mg/kg/
                                                       day, not
                                                       established
------------------------------------------------------------------------

[[Page 51305]]

 
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 = > 30 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 mg/
                                   dogs                kg/day in males
                                                       and females
                                                      LOAEL = > 500 mg/
                                                       kg/day in males
                                                       and females, not
                                                       established
------------------------------------------------------------------------
870.4300                          Chronic/            NOAEL = 362 mg/kg/
                                   carcinogenic city   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
------------------------------------------------------------------------
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
                                   strain              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
------------------------------------------------------------------------

[[Page 51306]]

 
870.5550                          Other mechanisms -  There was no
                                   in vitro rec-       evidence of
                                   assay with B.       recombination in
                                   subtilis            the rec-assay up
                                                       to 2,000 [mu]g/
                                                       disk with B.
                                                       subtilis H17
                                                       (rec+) and M45
                                                       H17 (rec+) and
                                                       M45 (rec-) (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/         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 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 (aRfD or cRfD) 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 is100. 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 106 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 (MOE (cancer) = 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
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                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 used in the
                                                                                          toxicology data base
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 175 mg/kg/day    FQPA SF = 1              Developmental toxicity
                                       UF = 100...............  cPAD = cRfD............   study rabbit
                                       Chronic RfD = 1.75 mg/    FQPA SF = 1.75 mg/kg/   LOAEL = 350 mg/kg/day
                                        kg/day.                  day.                     based on diarrhea,
                                                                                          nasal discharge and
                                                                                          death in maternal
                                                                                          animals
----------------------------------------------------------------------------------------------------------------

[[Page 51307]]

 
Short-term, 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-term, and long-term dermal (1-   None                     None                     Based on the
 30 days, 1-6 months, 6 months -                                                          intermediate systemic
 lifetime)                                                                                NOAEL of 1,000 mg/kg/
(Occupational/Residential)...........                                                     day inthe 21-day
                                                                                          dermal toxicity study
                                                                                          in rabbits, and the
                                                                                          lack of concern for
                                                                                          developmental and
                                                                                          reproductive effects,
                                                                                          the quantification of
                                                                                          dermal risks is not
                                                                                          required
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term and      None                     None                     Based on the systemic
 long-term inhalation (1-30 days, 1-6                                                     toxicity
 months, 6 month-lifetime)                                                               NOAEL of 0.36 mg/L HDT
(Occupational/Residential)...........                                                     in the 28-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 tolerances for rice, bran at 30 parts per million (ppm); 
rice, grain at 15 ppm; rice, hulls at 25 ppm; wheat, forage at 10 ppm; 
wheat, hay at 10 ppm; and alfalfa, seed at 0.5 ppm, and to increase the 
established glyphosate tolerance for cotton, gin by-products to 150 
ppm, 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. 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. 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 dietary exposure evaluation model 
(DEEM) software Version 7.87, which incorporates consumption data from 
the United States Department of Agriculture (USDA) Continuing Survey of 
Food Intake by Individuals (CSFII), 1989-1992. The 1989-1992 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 DEEM 
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 milligrams/kilogram body weight day (mg/kg 
bwt/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 DEEM assuming tolerance levels residues 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.

[[Page 51308]]



                      Table 4.--Summary of Results from Chronic DEEM Analysis of Glyphosate
----------------------------------------------------------------------------------------------------------------
                Subgroup                         Exposure (mg/kg/day)                        %cPAD
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                                             0.033880                                 1.9
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                                          0.075573                                 4.3
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                            0.072077                                 4.1
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                           0.047851                                 2.7
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                           0.025983                                 1.5
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                             0.032773                                 1.9
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                               0.028664                                 1.6
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                             0.023927                                 1.4
----------------------------------------------------------------------------------------------------------------

    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 (PCT) information. 
The Agency used tolerance levels and 100% 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 
Screening Concentration in Groundwater (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 PC area 
factor as an adjustment to account for the maximum PC 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 percent (%) %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 section E below.
    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

[[Page 51309]]

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 MOE4
                                                                                   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
--------------------------------------------------------------------------------------------------------------------------------------------------------
1Application 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.
2Maximum concentration in water (top 1 ft.) = 3.75 lb ae/A x 1A/43,560 ft2 x 454,000 mg/lb x 1/ft x ft3 /28.32 L = 1.38 mg/L.
3PDR, 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).
4MOE = 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 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-term 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-term and intermediate-
term risk estimates for post-application incidental ingestion exposures 
to toddlers.

         Table 6.--Summary of Toddler Incidental Ingestion Exposures and Risk Estimates for Residential Use of Glyphosate, Isopropylamine salt1
--------------------------------------------------------------------------------------------------------------------------------------------------------
             Activity                  AR (lbs a.e./A)2      Residue Estimate3             PDR (mg/kg bw/d)4           Short-term/Intermediate-term MOE5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hand-to-mouth                       1.62                   DFR: 0.908 [mu]g/cm2                               0.0242                               7,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Object-to-mouth                                            DFR: 3.63 [mu]g/cm2                               0.00605                              29,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Soil ingestion                                             Soil residue: 12.2                            8.13 x 10-5                                10-6
                                                            [mu]g/g soil
--------------------------------------------------------------------------------------------------------------------------------------------------------
1Sources: 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.
2AR = maximum application rate on Roundup ProDry label (EPA Reg. No. 524-505) for residential lawn treatment.
3Residue estimates based on the following protocol from the Residential SOPs:
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/cm2) = 0.908 g/cm2.
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/cm2 = 3.63 [mu]g/cm2.
Soil Residue = 1.62 lb ae/A x fraction of residue in soil (100%)/cm x (4.54 x 108 [mu]g/lb ae) x (2.47 x 10-8 A/cm2) x 0.67 cm3/g = 12.2 [mu]g/g soil.
4Potential Dose Rate (PDR; already normalized to body weight of toddler).
Hand-to-mouth PDR = (0.908 g/cm2 x 0.50 x 20 cm2/event x 20 events/hr x 10-3 mg/[mu]g x 2 hrs/d)/15 kg = 0.0242 mg/kg bwt/day.
Object-to-mouth PDR = (3.63 g/cm2 x 25 cm2 /d x 10-3 mg/[mu]g)/15 kg = 0.00605 mg/kg bwt/day.
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 bwt/day.
5MOE = NOAEL/PDR, where the short-term incidental oral NOAEL = 175 mg/kg/day 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

[[Page 51310]]

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 MOE analysis or 
through using UFs (safety) 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 EPA 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 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 and 100% crop treated data for all proposed 
commodities and registered uses), EPA has concluded that exposure to 
glyphosate from food will utilize 1.9% of the cPAD for the U.S. 
population, 4.3% of the cPAD for all infants (less than 1-year old) and 
4.1% 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 water 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       Ground      Surface
   Scenario/Population Subgroup     cPAD,mg/kg/    Food Ex-      Water      Water EEC,   Water EEC,    Chronic
                                        day       posure mg/   Exposure1,      ppb          ppb      DWLOC2, ppb
                                                    kg/day     mg/kg/day
----------------------------------------------------------------------------------------------------------------
U.S. population                            1.75     0.033880     1.716120       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
All infants (< 1-year old)                 1.75     0.075573     1.674427       0.0038          230       17,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                   1.75     0.072077     1.677923       0.0038          230       17,000
----------------------------------------------------------------------------------------------------------------

[[Page 51311]]

 
Children (7-12 years old)                  1.75     0.047851     1.702149       0.0038          230       17,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                  1.75     0.025983     1.724017       0.0038          230       52,000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                    1.75     0.032773     1.717227       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                      1.75     0.028664     1.721336       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                    1.75     0.023927     1.726073       0.0038          230       60,000
----------------------------------------------------------------------------------------------------------------
1Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from DEEMTM (mg/kg/day).
2The 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-term/intermediate-term aggregate risk (food + residential 
+ water). In aggregating short-term-/intermediate-term risk, HED 
considered background chronic dietary exposure (food + water) and 
short-term/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-term/intermediate-term food and residential 
aggregate MOEs are 1,800-2,300. As these MOEs are greater than 100, the 
short-term/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-term/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-term/intermediate-term aggregate human health risk at the present 
time. Table 8 summarizes the short-term/intermediate-term aggregate 
exposure to glyphosate residues.

Table 8.--Short-Term/Intermediate-Term Aggregate Risk and DWLOC Calculations for Exposure to Glyphosate Residues
                                 Short-Term/Intermediate-Term Exposure Scenario
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                              Level of     Surface       Ground     Short-Term/
            Population               Aggregate MOE (food+     Concern     Water EEC3   Water EEC3  Intermediate-
                                        residential)1         (LOC) or      (ppb)        (ppb)      Term DWLOC4,
                                                            Target MOE2                                (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
----------------------------------------------------------------------------------------------------------------
1Aggregate MOE = NOAEL/(Average food exposure + Residential exposure).
2Basis for the target MOE: interspecies and intraspecies uncertainty factors totaling 100.
3The glyphosate use producing the highest level was used.
4DWLOC ([mu]g/L or ppb) = maximum water exposure (mg/kg/day) x bwt (kg) / water consumption (L) x 10-3 mg/[mu]g
  (10 kg bwt 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.

F. 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 Manual (PAM) II; the limit of detection is 0.05 ppm) and 
High Performance 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 Spectrometry (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 
tolerance changes for glyphosate.

G. 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 no 
relevant Codex MRL for cotton gin by-products is established. The 
proposed ``rice, grain'' tolerance of

[[Page 51312]]

15.0 ppm is based on crop field trial data obtained when using 
glyphosate-tolerant rice and thus cannot be lowered to maintain 
harmonization with the CODEX MRL of 0.1 ppm for residues of glyphosate 
in or on this commodity. This petition proposes no additional numerical 
changes that would effect agreement between United States tolerances 
and Codex MRLs.
[FR Doc. 04-18770 Filed 8-17-04; 8:45 am]
BILLING CODE 6560-50-S