[Federal Register Volume 66, Number 184 (Friday, September 21, 2001)]
[Rules and Regulations]
[Pages 48601-48614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23605]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301173; FRL-6801-8]
RIN 2070-AB78


Sulfosate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
sulfosate (the trimethylsulfonium salt of glyphosate, also known as 
glyphosate-trimesium) in or on cotton, gin by-products, cotton 
undelinted seed, dried shelled pea and bean (except soybean) subgroup, 
edible podded legume vegetable subgroup, fruiting vegetable group, 
grain sorghum forage, grain sorghum grain, grain sorghum stover, leaves 
of root and tuber vegetable (except radish) subgroup, pistachio, radish 
roots, radish tops, succulent shelled pea and bean subgroup, sweet corn 
forage, sweet corn kernals plus cob with husks removed, sweet corn 
stover, tuberous vegetable and corm subgroup, and vegetable root 
(except radish) subgroup. This regulation increases tolerances in wheat 
bran, wheat grain, wheat hay, wheat shorts, wheat straw, and poultry 
meat by-products. Zeneca Ag. Products, now Syngenta Crop Protection, 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective September 21, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301173 
must be received by EPA on or before November 20, 2001.

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-301173 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; 
telephone number: 703-305-5697; 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
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet 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. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301173. The official record 
consists of the documents specifically referenced in this action, and 
other

[[Page 48602]]

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 April 8, 1999 (64 FR 17171) (FRL-60712-
), September 16, 1999 (64 FR 50280) (FRL-6089 -3), and July 13, 2000 
(65 FR 43326) (FRL-6592-9), EPA issued a 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 ``a'' pesticide petition (PP) for 
a tolerance by Zeneca Ag. Products, now Syngenta Crop Protection, P.O. 
Box 18300, Greensboro, NC 27419. This notice included a summary of the 
petition prepared by Zeneca Ag. Products, the registrant. There were no 
comments received in response to these notices of filing.
    The petition announced in the April 8, 1999 notice requested that 
40 CFR 180.489 be amended by establishing a tolerance for residues of 
the herbicide sulfosate, sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1), in or on fruiting vegetables (except 
cucurbits) group at 0.05 parts per million (ppm); the edible-podded 
legume vegetables subgroup at 0.5 ppm (of which no more than 0.3 ppm is 
trimethylsulfonium (TMS)), the succulent shelled pea and bean subgroup 
at 0.2 ppm (of which no more than 0.1 ppm is TMS); the dried shelled 
pea and bean (except soybean) subgroup at 6 ppm (of which no more than 
1.5 ppm is TMS); in cattle, goat, hog, sheep, and horse kidney at 3.5 
ppm; in cattle, goat, hog, sheep, and horse meat by-products, except 
liver and kidney, at 2.5 ppm; and to increase the tolerance in cattle, 
goat, hog, sheep, and horse fat to 0.2 ppm; in cattle, goat, hog, 
sheep, and horse meat to 0.6 ppm; in cattle, goat, hog, sheep, and 
horse liver to 0.75 ppm; in milk to 1.1 ppm; in poultry liver to 0.1 
ppm; in poultry meat by-products to 0.25 ppm; in or on soybean seed to 
21 ppm (of which no more than 13 ppm is TMS); in soybean hulls to 45 
ppm (of which no more than 25 ppm is TMS); and in aspirated grain 
fractions to 1,300 ppm (of which no more than 720 ppm is TMS). The 
above proposed crop group and crop subgroup were changed to reflect 
regulations under 40 CFR 180.41(c).
    The petition announced in the September 16, 1999 notice requested 
that 40 CFR 180.489 be amended by establishing a tolerance for residues 
of the herbicide sulfosate in or on wheat grain at 10 ppm) (of which no 
more than 2.5 ppm is TMS); wheat hay at 1 ppm (of which no more than 
0.5 ppm is TMS); wheat straw at 90 ppm (of which no more than 40 ppm is 
TMS); wheat bran at 30 ppm (of which no more than 6 ppm is TMS); and 
wheat shorts at 20 ppm (of which no more than 5 ppm is TMS); and to 
increase the tolerance in poultry meat by-products to 0.5 ppm and in 
milk to 2 ppm.
    The petition announced in the July 13, 2000 notice requested that 
40 CFR 180.489 be amended by establishing a tolerance for residues of 
the herbicide sulfosate in or on cotton gin by-products at 120 ppm of 
which no more than 35 ppm is TMS; cotton, undelinted seed at 40 ppm (of 
which no more than 10 ppm is TMS); leaves of root and tuber vegetables 
group (except radish) at 0.25 ppm (of which no more than 0.2 ppm is 
TMS); pistachio at 0.05 ppm; potato flakes at 2 ppm (of which no more 
than 1.5 ppm is TMS); radish roots at 16 ppm (of which no more than 15 
ppm is TMS); radish tops at 10 ppm (of which no more than 8 ppm is 
TMS); root vegetables subgroup (except radish) at 0.15 ppm (of which no 
more than 0.1 ppm is TMS); sorghum grain at 35 ppm (of which no more 
than 15 ppm is TMS); sorghum forage at 0.2 ppm (of which no more than 
0.1 ppm is TMS); sorghum stover at 140 ppm (of which no more than 60 
ppm is TMS); sweet corn forage at 20 ppm (of which no more than 5 ppm 
is TMS); sweet corn, kernels + cob with husks removed at 0.15 ppm (of 
which no more than 0.1 ppm is TMS); sweet corn stover at 165 ppm (of 
which no more than 65 ppm is TMS); tuberous and corm vegetables 
subgroup at 1 ppm (of which no more than 0.5 ppm is TMS); and to 
increase the tolerance in poultry meat by-products to 0.5 ppm and in 
milk to 2 ppm.
    EPA has determined that existing tolerances for cattle, goat, hog, 
sheep, horse, and milk are adequate to account for existing raw 
agricultural commodities (RACs) and the other proposed RACs listed 
above based on calculation of the maximum theoretical dietary burden 
(MTDB); therefore, new tolerances are not being established for cattle, 
goat, hog, sheep, horse, and milk. The proposed separate tolerance for 
poultry liver at 0.1 ppm is not needed because it is covered by the 
tolerance for poultry meat by-products that is being established at 0.5 
ppm; therefore, a tolerance is not being established for poultry liver. 
EPA has determined that a tolerance is not needed for potato flakes 
because sulfosate does not concentrate in potato flakes; therefore, a 
tolerance is not being established for potato flakes. EPA has 
determined that the appropriate tolerance for leaves of root and tuber 
vegetables group (except radish) is 0.30 ppm instead of the proposed 
tolerance of 0.25 ppm, and that the appropriate tolerance for sweet 
corn stover is 170 ppm instead of the proposed tolerance of 165 ppm. 
Tolerances were previously established for the soybean commodities and 
aspirated grain fractions in the Federal Register notice dated June 11, 
1999 (64 FR 31505) (FRL-6086-6).
    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.

[[Page 48603]]

EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure, consistent with section 408(b)(2), 
for a tolerance for residues of sulfosate on cotton, gin by-products at 
120 ppm (of which no more than 35 ppm is TMS), cotton, undelinted seed 
at 40 ppm (of which no more than 10 ppm is TMS), pea and bean, dried 
shelled (except soybean), subgroup (6C) at 6.00 ppm (of which no more 
than 1.5 ppm is TMS), vegetable, legume, edible podded subgroup (6A) at 
0.50 ppm (of which no more than 0.3 ppm is TMS), vegetable, fruiting 
group (8) at 0.05 ppm, sorghum, grain, forage at 0.20 ppm (of which no 
more than 0.10 ppm is TMS), sorghum, grain, grain at 35 ppm (of which 
no more than 15 ppm is TMS), sorghum, grain, stover at 140 ppm (of 
which no more than 60 ppm is TMS), vegetable, leaves of root and tuber 
(except radish) group (2) at 0.30 ppm (of which no more than 0.20 ppm 
is TMS), pistachio at 0.05 ppm, radish, roots at 16 ppm (of which no 
more than 15 ppm is TMS), radish, tops at 10 ppm (of which no more than 
8.0 ppm is TMS), pea and bean, succulent shelled subgroup (6B) at 0.20 
ppm (of which no more than 0.10 ppm is TMS), corn, sweet, forage at 20 
ppm (of which no more than 5.0 ppm is TMS), corn, sweet, kernals plus 
cob with husks removed at 0.15 ppm (of which no more than 0.10 ppm is 
TMS), corn, sweet, stover at 170 ppm (of which no more than 65 ppm is 
TMS), vegetable, tuberous and corm subgroup (1C) at 1.0 ppm (of which 
no more than 0.50 ppm is TMS), and vegetable, root (except radish) 
subgroup (1A) at 0.15 ppm (of which no more than 0.10 ppm is TMS). This 
regulation increases tolerances in wheat, bran at 30 ppm (of which no 
more than 6.0 ppm is TMS), wheat, grain at 10 ppm (of which no more 
than 2.5 ppm is TMS), wheat, hay at 1.0 ppm (of which no more than 0.50 
ppm is TMS), wheat, shorts at 20 ppm (of which no more than 5.0 ppm is 
TMS), wheat, straw at 90 ppm (of which no more than 40 ppm is TMS), and 
poultry meat by-products at 0.05 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by sulfosate is 
discussed in Unit II.A. of the Federal Register document published on 
September 11, 1998 (63 FR 48597) (FRL-6026-6). Please note that this 
unit included a typographical error. In the discussion of the feeding 
carcinogenicity study in mice, ``79'' should have been ``7.9'' in the 
following phrase: ``In addition, there was increased incidence of white 
matter degeneration in the lumbar region of the spinal cord (males 
only) (2, 3, 4, 4, 79% response, controls to high dose).'' The nature 
of these toxic effects is also 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 toxicity - rat      NOAEL =
                                                                 36 mg/
                                                                 kg/day
                                                                 (males)
                                                                 LOAEL =
                                                                 88 mg/
                                                                 kg/day
                                                                 (males)
                                                                 , based
                                                                   on
                                                                 signifi
                                                                 cant
                                                                 overall
                                                                 decreas
                                                                 e in
                                                                 body
                                                                 weight
                                                                 gain of
                                                                  22%
------------------------------------------------------------------------
870.3150                         90-Day oral toxicity - dog      NOAEL =
                                  (gavage)                       10 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 50 mg/
                                                                 kg/day,
                                                                 based
                                                                   on
                                                                 signifi
                                                                 cant
                                                                 earlier
                                                                 onsets
                                                                  and
                                                                 increas
                                                                   ed
                                                                 inciden
                                                                 ce of
                                                                 salivat
                                                                 ion and
                                                                 emesis
                                                                  and
                                                                 hydroce
                                                                 phalus
                                                                 and/or
                                                                 dilated
                                                                 lateral
                                                                 ventric
                                                                  les
                                                                 (brain)
------------------------------------------------------------------------
870.3150                         90-Day oral toxicity - dog      NOAEL =
                                  (capsule)                      25 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 50 mg/
                                                                 kg/day,
                                                                 based
                                                                   on
                                                                 salivat
                                                                 ion in
                                                                 both
                                                                 sexes,
                                                                 clinica
                                                                 l signs
                                                                   of
                                                                 neuroto
                                                                 xicity
                                                                 in the
                                                                 females
                                                                  and
                                                                 possibl
                                                                    e
                                                                 treatme
                                                                   nt
                                                                 related
                                                                 signs
                                                                 (hydroc
                                                                 ephalus
                                                                 ) in
                                                                  one
                                                                 male
------------------------------------------------------------------------
870.3200                         21-Day dermal toxicity -        Systemi
                                  rabbit (technical)                c
                                                                 NOAEL =
                                                                 1,000
                                                                 mg/kg/
                                                                  day
                                                                 (highes
                                                                 t dose
                                                                 tested
                                                                 (HDT))
                                                                 LOAEL
                                                                  not
                                                                 establi
                                                                 shed
------------------------------------------------------------------------
870.3200                         21-Day dermal toxicity - rat    NOAEL =
                                  (formulation)                  250 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 1,000
                                                                 mg/kg/
                                                                 day,
                                                                 based
                                                                   on
                                                                 sciatic
                                                                 nerve
                                                                 finding
                                                                    s
------------------------------------------------------------------------

[[Page 48604]]

 
870.3700                         Prenatal developmental          Materna
                                  toxicity - rat                    l
                                                                 NOAEL =
                                                                 100 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 333 mg/
                                                                 kg/day,
                                                                 based
                                                                   on
                                                                 decreas
                                                                 ed body
                                                                 weight,
                                                                 feed
                                                                 consump
                                                                 tion
                                                                  and
                                                                 body
                                                                 weight
                                                                 gain
                                                                 along
                                                                 with
                                                                 increas
                                                                   ed
                                                                 inciden
                                                                 ces of
                                                                 salivat
                                                                 ion,
                                                                 chromor
                                                                 hinorrh
                                                                 ea, and
                                                                 letharg
                                                                 y after
                                                                 dosing
                                                                 Develop
                                                                 mental
                                                                 NOAEL =
                                                                 100 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 333 mg/
                                                                 kg/day,
                                                                 based
                                                                   on
                                                                 decreas
                                                                   ed
                                                                 fetal
                                                                 body
                                                                 weight
------------------------------------------------------------------------
870.3700                         Prenatal developmental          Materna
                                  toxicity - rabbit                 l
                                                                 NOAEL =
                                                                 40 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 100 mg/
                                                                 kg/day,
                                                                 based
                                                                 on 6
                                                                 deaths
                                                                 in 17
                                                                 pregnan
                                                                 t does,
                                                                    4
                                                                 abortio
                                                                 ns in
                                                                 the 11
                                                                 survivo
                                                                   rs
                                                                 along
                                                                 with
                                                                 decreas
                                                                 ed body
                                                                 weight,
                                                                 feed
                                                                 consump
                                                                 tion
                                                                  and
                                                                 body
                                                                 weight
                                                                 gain
                                                                 Develop
                                                                 mental
                                                                 NOAEL =
                                                                 40 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 100 mg/
                                                                 kg/day,
                                                                 based
                                                                   on
                                                                 decreas
                                                                   ed
                                                                 number
                                                                 of live
                                                                 fetuses/
                                                                 doe for
                                                                    7
                                                                 survivi
                                                                   ng
                                                                 rabbits
                                                                 (5.4
                                                                 versus
                                                                 7.4 in
                                                                 control
                                                                 s), 4
                                                                 rabbits
                                                                 aborted
                                                                 their
                                                                 litters
                                                                    .
                                                                 Having
                                                                 only 7
                                                                 litters
                                                                 does
                                                                  not
                                                                 give a
                                                                 suffici
                                                                 ently
                                                                 higher
                                                                 number
                                                                   of
                                                                 animals
                                                                   to
                                                                 absolut
                                                                  ely
                                                                 conclud
                                                                 e that
                                                                   no
                                                                 develop
                                                                 mental
                                                                 toxicit
                                                                 y is
                                                                 occurri
                                                                  ng,
                                                                 particu
                                                                 larly
                                                                   in
                                                                 light
                                                                 of the
                                                                 massive
                                                                 losses
                                                                   to
                                                                 death
                                                                  and
                                                                 abortio
                                                                   ns
------------------------------------------------------------------------
870.3800                         2-Generation reproduction and   Systemi
                                  fertility effects - rat           c
                                                                 NOAEL =
                                                                 150 ppm
                                                                 (6/8 mg/
                                                                 kg/day
                                                                  for
                                                                 males/
                                                                 females
                                                                    )
                                                                 LOAEL =
                                                                 800 ppm
                                                                 (35/41
                                                                 mg/kg/
                                                                 day for
                                                                 males/
                                                                 females
                                                                   ),
                                                                 based
                                                                 on a
                                                                 decreas
                                                                 e in
                                                                 absolut
                                                                 e and
                                                                 sometim
                                                                   es
                                                                 relativ
                                                                 e organ
                                                                 weights
                                                                 in both
                                                                 generat
                                                                 ions
                                                                 (thymus
                                                                    ,
                                                                 heart,
                                                                 kidney
                                                                  and
                                                                 liver)
                                                                 at 800
                                                                  and
                                                                 2,000
                                                                 ppm and
                                                                    a
                                                                 decreas
                                                                 e in
                                                                 body
                                                                 weights
                                                                  and
                                                                 body
                                                                 weight
                                                                 gains
                                                                 during
                                                                  the
                                                                 premati
                                                                   ng
                                                                 period
                                                                   at
                                                                 2,000
                                                                  ppm
                                                                 Reprodu
                                                                 ctive/
                                                                 develop
                                                                 mental
                                                                 NOAEL =
                                                                 150 ppm
                                                                 (6/8 mg/
                                                                 kg/day
                                                                  for
                                                                 males/
                                                                 females
                                                                    )
                                                                 LOAEL =
                                                                 800 ppm
                                                                 (35/41
                                                                 mg/kg/
                                                                 day for
                                                                 males/
                                                                 females
                                                                   ),
                                                                 based
                                                                   on
                                                                 decreas
                                                                   ed
                                                                 litter
                                                                 size in
                                                                 F1a and
                                                                  F2b
                                                                 litters
                                                                   at
                                                                 2,000
                                                                 ppm and
                                                                   on
                                                                 decreas
                                                                 e in
                                                                 mean
                                                                  pup
                                                                 weights
                                                                 during
                                                                 lactati
                                                                 on in
                                                                 second
                                                                 litters
                                                                 at 800
                                                                 ppm and
                                                                 in all
                                                                 litters
                                                                   at
                                                                 2,000
                                                                  ppm
------------------------------------------------------------------------
870.4100                         Chronic toxicity - dog          NOAEL =
                                                                 10 mg/
                                                                 kg/day
                                                                 LOAEL =
                                                                 50 mg/
                                                                 kg/day,
                                                                 based
                                                                   on
                                                                 salivat
                                                                 ion and
                                                                 emesis,
                                                                  and
                                                                 hydroce
                                                                 phalus
                                                                  and
                                                                 support
                                                                 from
                                                                 shorter
                                                                 term
                                                                 studies
                                                                 also
                                                                 with
                                                                 these
                                                                 finding
                                                                    s
------------------------------------------------------------------------

[[Page 48605]]

 
870.4200                         Carcinogenicity - mouse         NOAEL =
                                                                 1,000
                                                                  ppm
                                                                 (118/
                                                                 159 mg/
                                                                 kg/day
                                                                  for
                                                                 males/
                                                                 females
                                                                    )
                                                                 LOAEL
                                                                   is
                                                                 8,000
                                                                  ppm
                                                                 (991/
                                                                 1,341
                                                                 mg/kg/
                                                                 day for
                                                                 males/
                                                                 females
                                                                   ),
                                                                 based
                                                                   on
                                                                 decreas
                                                                 ed body
                                                                 weight
                                                                  and
                                                                 food
                                                                 consump
                                                                 tion
                                                                 (both
                                                                 sexes);
                                                                 increas
                                                                   ed
                                                                 inciden
                                                                 ce of
                                                                 white
                                                                 matter
                                                                 degener
                                                                 ation
                                                                   in
                                                                 lumbar
                                                                  bar
                                                                 region
                                                                   of
                                                                 spinal
                                                                 cord
                                                                 (males
                                                                 only);
                                                                 increas
                                                                   ed
                                                                 inciden
                                                                 ce of
                                                                 epithel
                                                                  ial
                                                                 hyperpl
                                                                 asia of
                                                                 duodenu
                                                                    m
                                                                 (female
                                                                 s only)
                                                                 There
                                                                 was no
                                                                 evidenc
                                                                 e of
                                                                 carcino
                                                                 genicit
                                                                 y in
                                                                 this
                                                                 study
                                                                   at
                                                                 doses
                                                                 tested
------------------------------------------------------------------------
870.4300                         Chronic toxicity/               NOAEL =
                                  carcinogenicity - rat          > 1,000
                                                                  ppm
                                                                 (41.8/
                                                                 55.7 mg/
                                                                 kg/day,
                                                                 males/
                                                                 females
                                                                 ) HDT
                                                                 LOAEL =
                                                                 > 1,000
                                                                  ppm
                                                                 (41.8/
                                                                 55.7 mg/
                                                                 kg/day,
                                                                 males/
                                                                 females
                                                                    )
                                                                   No
                                                                 evidenc
                                                                 e of
                                                                 carcino
                                                                 genicit
                                                                    y
------------------------------------------------------------------------
870.5100                         Gene mutation/bacteria Ames      Not
                                  Salmonella typhimurium         mutagen
                                                                 ic in
                                                                 TA1535,
                                                                 TA1537,
                                                                 TA1538,
                                                                 TA98,
                                                                  and
                                                                 TA100
                                                                 tested
                                                                 with
                                                                  and
                                                                 without
                                                                 metabol
                                                                   ic
                                                                 activat
                                                                  ion
------------------------------------------------------------------------
870.5100                         Gene mutation/bacteria Ames     Not a
                                  Salmonella typhimurium         mutagen
                                                                 up to
                                                                   40
                                                                 14
                                                                 sulfosa
                                                                 te was
                                                                 rapidly
                                                                 excrete
                                                                 d: IV
                                                                 treated
                                                                 male
                                                                  and
                                                                 females
                                                                 elimina
                                                                 ted 90%
                                                                 of the
                                                                 adminis
                                                                 tered
                                                                 dose in
                                                                 urine.
                                                                 Absorpt
                                                                 ion of
                                                                 C14-
                                                                 sulfosa
                                                                 te was
                                                                 incompl
                                                                 ete by
                                                                  the
                                                                 oral
                                                                 route:
                                                                 Most
                                                                 groups
                                                                 elimina
                                                                 te 47-
                                                                 57% of
                                                                  the
                                                                 adminis
                                                                 tered
                                                                 dose in
                                                                  the
                                                                 urine
                                                                 and 36-
                                                                 42% in
                                                                  the
                                                                 feces.
                                                                 Females
                                                                 treated
                                                                 with a
                                                                 high
                                                                 dose
                                                                 elimina
                                                                  ted
                                                                 less in
                                                                  the
                                                                 urine
                                                                 (36% of
                                                                 dose)
                                                                  and
                                                                 more in
                                                                  the
                                                                 feces
                                                                 (54% of
                                                                 dose).
                                                                 Negligi
                                                                  ble
                                                                 14CO2
                                                                 elimina
                                                                 tion.
                                                                 Tissue
                                                                  C14
                                                                 residue
                                                                 s were
                                                                 < 0.32%
                                                                   of
                                                                 adminis
                                                                 tered
                                                                 dose.
                                                                 Carcass
                                                                  C14
                                                                 residue
                                                                 s were
                                                                 < 2.2%
                                                                   of
                                                                 adminis
                                                                 tered
                                                                 dose
                                                                 (mostly
                                                                   in
                                                                 bones,
                                                                 3-7 ppm
                                                                 in low
                                                                 dose
                                                                 rats
                                                                 and 19-
                                                                 32 ppm
                                                                 in high
                                                                 dose
                                                                 rats).
                                                                 Most
                                                                 excrete
                                                                    d
                                                                 radioac
                                                                 tivity
                                                                  was
                                                                 unchang
                                                                   ed
                                                                 anion
                                                                 (carbox
                                                                 ymethyl
                                                                 amino-
                                                                 methylp
                                                                 hosphon
                                                                 ate).
                                                                  One
                                                                 fecal
                                                                 metabol
                                                                 ite was
                                                                 aminome
                                                                 thyl
                                                                 phospho
                                                                  nic
                                                                 acid.
                                                                 Several
                                                                 minor
                                                                 unident
                                                                 ified
                                                                 metabol
                                                                 ites
                                                                 were
                                                                 recover
                                                                  ed.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The toxicological endpoints for sulfosate are discussed in Unit II. 
B. of the Federal Register document published on September 11, 1998 (63 
FR 48597).
    A summary of the toxicological endpoints for sulfosate used for 
human risk assessment is shown in the following Table 2:

     Table 2.--Summary of Toxicological Dose and Endpoints for Sulfosate for Use in Human Risk Assessment1.
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF* and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = 100 mg/kg/day    FQPA SF = 3X             Acute neurotoxicity -
 including infants and children)       UF = 100...............  aPAD = aRfD       rat
                                       Acute RfD = 1 mg/kg/day   FQPA SF.                LOAEL = 300 mg/kg/day
                                                                = 0.33 mg/kg/day.......   based on mortality,
                                                                                          decreased body weight
                                                                                          and food consumption,
                                                                                          and neurotoxicity.
----------------------------------------------------------------------------------------------------------------

[[Page 48608]]

 
Chronic dietary (all populations)      NOAEL= 25 mg/kg/day      FQPA SF = 3X             Subchronic toxicity
                                       UF = 100...............  cPAD = cRfD       (capsule) - dog
                                       Chronic RfD = 0.25 mg/    FQPA SF.                Subchronic toxicity
                                        kg/day.                 = 0.083 mg/kg/day......   (gavage) - dog
                                                                                         Chronic toxicity - dog
                                                                                         LOAEL = 50 mg/kg/day
                                                                                          based on salivation
                                                                                          and emesis, clinical
                                                                                          signs of
                                                                                          neurotoxicity, and
                                                                                          hydrocephalus
----------------------------------------------------------------------------------------------------------------
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.
**UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, LOC = level of concern, MOE = margin of exposure

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.489) for the residues of sulfosate, in or on a 
variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from sulfosate 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. The Dietary Exposure Evaluation Model 
(DEEMTM) 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 acute exposure assessments: Tolerance level residues, DEEM 
default processing factors, and 100% crop treated (CT) information for 
all commodities. For acute dietary risk estimates, EPA's level of 
concern is for exposure at greater than 100% of the acute population 
adjusted dose (aPAD). The acute exposure estimates at the 
95th percentile were < 100% of the aPAD for the general U.S. 
population and all subgroups, with children 1-6 years old as the 
highest exposure estimate at 55% of the aPAD. The results of the 
analysis indicate that the acute dietary risk estimates associated with 
the existing and proposed uses of sulfosate do not exceed EPA's level 
of concern for the general U.S. population and all population 
subgroups.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEMTM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
Tolerance level residues for all commodities, DEEM default processing 
factors, and %CT information for some commodities (oranges, grapefruit, 
soybeans, corn, peaches, and wheat). This procedure represents an over-
estimation of dietary exposure, since tolerance level residue values 
were used for all commodities. For chronic dietary risk estimates, 
EPA's level of concern is for exposure at greater than 100% chronic 
population adjusted dose (cPAD). The chronic exposure estimates were < 
100% of the cPAD for the general U.S. population and all subgroups, 
with children 1-6 years old as the most highly exposed population 
subgroup at 60% of the cPAD. The results of the analysis indicate that 
the chronic dietary risk estimates associated with the existing and 
proposed uses of sulfosate do not exceed EPA's level of concern for the 
U.S. population and all population subgroups.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of percent crop 
treated (PCT) as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows.
    For the acute analysis, tolerance level residues and 100% CT were 
used. For the chronic analysis, PCT information was used for oranges 
(1% CT), grapefruit (10% CT), soybeans (1% CT), corn (10% CT), peaches 
(1% CT), and wheat (1% CT). For corn, peaches, and wheat, which have 
PCT estimates of zero, a value of 1% CT was used in the analysis. For 
all crops other than oranges, grapefruit, soybeans, corn, peaches, and 
wheat, 100% CT was used, and tolerance level residues were used for all 
crops.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. The Agency is reasonably certain that the percentage of the 
food treated is not likely to be an underestimation. As to Conditions 2 
and 3, regional consumption information and consumption information for 
significant subpopulations is taken into

[[Page 48609]]

account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which sulfosate may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for sulfosate 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 sulfosate.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum 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 %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 sulfosate they are further 
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW model, EECs of total sulfosate for 
acute exposures are estimated to be 125.5 ppb for surface water and 
0.328 ppb for ground water. The EECs for chronic exposures are 
estimated to be 27.8 ppb for surface water and 0.328 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).
    Sufosate is not registered for use on any sites that would result 
in residential exposure.
    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 sulfosate 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, 
sulfosate 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 sulfosate 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. Safety factor for infants and children--In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. Prenatal and postnatal 
sensitivity is discussed in Unit II.E.1.iv. of the Federal Register 
document published on September 11, 1998 (63 FR 48597).
    3. Conclusion. With the exception of the requested developmental 
neurotoxicity study, there is a complete toxicity data base for 
sulfosate and exposure data are complete or are estimated based on data 
that reasonably accounts for potential exposures. The determination of 
the 3x safety factor for infants and children is discussed in Unit 
II.E.1.i. of the Federal Register document published on September 11, 
1998 (63 FR 48597).

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

[[Page 48610]]

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 risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
sulfosate will occupy 33% of the aPAD for the U.S. population, up to 
18% of the aPAD for females 13 years and older, 50% of the aPAD for all 
infants (< 1 year old) and 55% of the aPAD for children 1-6 years old. 
In addition, there is potential for acute dietary exposure to sulfosate 
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 aPAD, as shown in the following Table 3:

                                           Table 3.--Aggregate Risk Assessment for Acute Exposure to Sulfosate
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Surface Water EEC   Ground Water EEC
           Population Subgroup               aPAD (mg/kg)       %aPAD (Food)          (ppb)              (ppb)                 Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                        0.33                  3              125.5              0.328                               7,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (< 1-year old)                             0.33                 50              125.5              0.328                               1,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               0.33                 55              125.5              0.328                               1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                              0.33                 36              125.5              0.328                               2,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                              0.33                 18              125.5              0.328                               8,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                0.33                 28              125.5              0.328                               8,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males (20 + years old)                                 0.33                 18              125.5              0.328                               9,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seniors (55 + years old)                               0.33                 15              125.5              0.328                               9,900
--------------------------------------------------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to sulfosate 
from food will utilize 19% of the cPAD for the U.S. population, 47% of 
the cPAD for all infants (< 1 year old) and 60% of the cPAD for 
children 1-6 years old. There are no residential uses for sulfosate 
that result in chronic residential exposure to sulfosate. In addition, 
there is potential for chronic dietary exposure to sulfosate 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 4:

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Sulfosate
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.083           19         27.8        0.328        2,400
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                             0.083           47         27.8        0.328          440
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               0.083           60         27.8        0.328          340
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                              0.083           34         27.8        0.328          560
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                              0.083           12         27.8        0.328        2,300
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                0.083           21         27.8        0.328        2,300
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                  0.083           12         27.8        0.328        2,600
----------------------------------------------------------------------------------------------------------------

[[Page 48611]]

 
Seniors (55+ years old)                                0.083           11         27.8        0.328        2,600
----------------------------------------------------------------------------------------------------------------

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

IV. Other Considerations

A. Analytical Enforcement Methodology

    Analytical enforcement methodology for sulfosate is discussed in 
Unit III.B. of the Federal Register document published on September 11, 
1998 (63 FR 48597).
    Adequate enforcement methodology (e.g; gas chromotography) is 
available to enforce the tolerance expression. The method 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

    There are no Codex, Canadian or Mexican tolerances or maximum 
residue limits for residues of sulfosate in the subject commodities. 
Therefore, a compatibility issue is not relevant to the proposed 
tolerances.

C. Conditions

    EPA is imposing requirements of the following studies as conditions 
of registration: A developmental neurotoxicity study (DNT) in the rat 
(OPPTS Guideline No. 870.6300) (previously imposed and in progress) and 
a 28-day inhalation toxicity study. The DNT study in the rat is 
required based on the weight-of-the-evidence concerns for neurotoxicity 
in the mouse oncogenicity study, the subchronic and chronic dog 
studies, the 21-day dermal toxicity study in rats, and acute and 
subchronic neurotoxicity studies in the rat. Signs of neurotoxicity due 
to sulfosate included function observational battery (FOB) effects in 
the rat neurotoxicity studies, and treatment-related chemical signs of 
salivation and emesis in the dog. There were also concerns for 
hydrocephalus in all dog studies (at least one dog/study at the high 
dose, none in controls) and possible treatment related histopathology 
in the mouse carcinogenicity and 21-day dermal rat studies. The 28-day 
inhalation toxicity study is required to provide further 
characterization of inhalation risk. Due to the potential for 
inhalation exposure, there is concern for toxicity by the inhalation 
route. The 28-day inhalation toxicity study would give a dose and 
endpoint examined via the route of exposure of concern (i.e., route 
specific study) and thus would avoid using an oral study and route-to-
route extrapolation. The protocol for the existing 90-day inhalation 
toxicity study (OPPTS 870.3465) should be followed with the exposure 
(treatment) ending after 28 days, instead of 90 days.

V. Conclusion

    Therefore, the tolerance is established for residues of sulfosate, 
sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine (1:1), in or 
on cotton, gin by-products at 120 ppm (of which no more than 35 ppm is 
TMS), cotton, undelinted seed at 40 ppm (of which no more than 10 ppm 
is TMS), pea and bean, dried shelled except soybean), subgroup (6C) at 
6.00 ppm (of which no more than 1.5 ppm is TMS), vegetable, legume, 
edible podded subgroup (6A) at 0.50 ppm (of which no more than 0.3 ppm 
is TMS), vegetable, fruiting group (8) at 0.05 ppm, sorghum, grain, 
forage at 0.20 ppm (of which no more than 0.10 ppm is TMS), sorghum, 
grain, grain at 35 ppm (of which no more than 15 ppm is TMS), sorghum, 
grain, stover at 140 ppm (of which no more than 60 ppm is TMS), 
vegetable, leaves of root and tuber (except radish) group (2) at 0.30 
ppm (of which no more than 0.20 ppm is TMS), pistachio at 0.05 ppm, 
radish, roots at 16 ppm (of which no more than 15 ppm is TMS), radish, 
tops at 10 ppm (of which no more than 8.0 ppm is TMS), pea and bean, 
succulent shelled subgroup (6B) at 0.20 ppm (of which no more than 0.10 
ppm is TMS), corn, sweet, forage at 20 ppm (of which no more than 5.0 
ppm is TMS), corn, sweet, kernals plus cob with husks removed at 0.15 
ppm (of which no more than 0.10 ppm is TMS), corn, sweet, stover at 170 
ppm (of which no more than 65 ppm is TMS), vegetable, tuberous and corm 
subgroup (1C) at 1.0 ppm (of which no more than 0.50 ppm is TMS), and 
vegetable, root (except radish) subgroup (1A) at 0.15 ppm (of which no 
more than 0.10 ppm is TMS). This regulation increases tolerances in 
wheat, bran at 30 ppm (of which no more than 6.0 ppm is TMS), wheat, 
grain at 10 ppm (of which no more than 2.5 ppm is TMS), wheat, hay at 
1.0 ppm (of which no more than 0.50 ppm is TMS), wheat, shorts at 20 
ppm (of which no more than 5.0 ppm is TMS), wheat, straw at 90 ppm (of 
which no more than 40 ppm is TMS), and poultry meat by-products at 0.05 
ppm.

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-301173 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 
20, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing

[[Page 48612]]

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-301173, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

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). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any 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). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with

[[Page 48613]]

Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive 
Order 13175, requires EPA to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' ``policies that 
have tribal implications'' is defined in the Executive Order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes.'' This rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

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, 2001.
Peter Caulkins,
Director, Registration Division, Office of Pesticide Programs.


    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.489 is amended by revising the introductory text of 
paragraph (a); revising the entries for poultry, mbyp, wheat bran, 
wheat grain, and wheat hay; and alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec. 180.489  Sulfosate (Sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1)); tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide sulfosate (sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1)) as the sum of the residues of the 
trimethylsulfonium cation (TSM) and the N-(phosphonomethyl glycine 
anion measured separately in or on the following raw and processed 
agricultural commodities.

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                  *        *        *        *        *
Corn, sweet, forage (of which no more than 5.0 ppm is                                                         20
 TMS).................................................
Corn, sweet, kernels plus cob with husks removed (of                                                        0.15
 which no more than 0.10 ppm is TMS)..................
Corn, sweet, stover (of which no more than 65 ppm is                                                         170
 TMS).................................................
Cotton, gin by-products (of which no more than 35 ppm                                                        120
 is TMS)..............................................
Cotton, undelinted seed (of which no more than 10 ppm                                                         40
 is TMS)..............................................
                                  *        *        *        *        *
Crop group 2: Leaves of root and tuber vegetables                                                           0.30
 (human food or animal feed (except radish) group (of
 which no more than 0.20 ppm is TSM)..................
Crop group 8: Fruiting vegetables (except cucurbits)                                                        0.05
 group................................................
Crop subgroup 1-A: Root vegetables (except radish)                                                          0.15
 subgroup (of which no more than 0.10 ppm is TSM).....
Crop subgroup 1-C: Tuberous and corm vegetables                                                                1
 subgroup (of which no more than 0.50 ppm is TSM).....
Crop subgroup 6-A: Edible-podded legume vegetables                                                           0.5
 subgroup (of which no more than 0.3 ppm is TSM)......
Crop subgroup 6-B: Succulent shelled pea and bean                                                           0.20
 subgroup (of which no more than 0.1 ppm is TSM)......
Crop subgroup 6-C: Dried shelled pea and bean (except                                                        6.0
 soybean and animal feeds) subgroup (of which no more
 than 1.5 ppm is TSM).................................
Pistachio.............................................                                                      0.05
                                  *        *        *        *        *
Poultry, meat byproduct...............................                                                      0.50
                                 *        *        *        *         *
Radish, roots (of which no more than 15 ppm is TMS)...                                                        16
Radish, tops (of which no more than 8.0 ppm is TMS)...                                                        10
                                  *        *        *        *        *
Sorghum, grain, forage (of which no more than 0.10 ppm                                                      0.20
 is TMS)..............................................
Sorghum, grain, grain (of which no more than 15 ppm is                                                        35
 TMS).................................................
Sorghum, grain, stover (of which no more than 60 ppm                                                         140
 is TMS)..............................................
                                  *        *        *        *        *
Wheat, bran (of which no more than 6.0 ppm is TMS)....                                                        30
Wheat, grain (of which no more than 2.5 ppm is TMS)...                                                        10
                                  *        *        *        *        *
Wheat, hay (of which no more than 0.50 ppm is TMS)....                                                       1.0
Wheat, shorts (of which no more than 5.0 ppm is TMS)..                                                        20

[[Page 48614]]

 
Wheat, straw (of which no more than 40 ppm is TMS)....                                                        90
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 01-23605 Filed 9-20-01; 8:45 am]
BILLING CODE 6560-50-S