[Federal Register Volume 63, Number 176 (Friday, September 11, 1998)]
[Rules and Regulations]
[Pages 48597-48607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24468]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 185

[OPP-300709; FRL 6026-6]
RIN 2070-AB78


Sulfosate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes new tolerances to replace 
recently-expired time-limited tolerances for residues of the herbicide 
sulfosate (the trimethylsulfonium salt of glyphosate, also known as 
glyphosate-trimesium) in or on cattle, goats, horses, hogs and sheep, 
in fat, meat by-products, and meat; in poultry fat, meat-by-products 
(except liver), meat and liver; in eggs; in milk; in corn stover (field 
and pop), grain (field and pop), and forage (field); in soybean forage, 
hay, and seed; and in aspirated grain fractions. Zeneca Ag Products 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(Pub. L. 104-170). In addition, this regulation moves existing 
tolerances for prunes at 0.20 ppm, raisins at 0.20 ppm, and soybean 
hulls at 7.0 ppm from 40 CFR 185.5375 to 40 CFR 180.489.

DATES: This regulation is effective September 11, 1998. Objections and 
requests for hearings must be received by EPA on or before November 10, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, OPP-300709, must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
requests filed with the Hearing Clerk identified by the docket control 
number, OPP-300709, must also be submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to Rm. 119, CM #2, 1921 Jefferson Davis 
Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of objections and hearing requests in 
electronic form must be identified by the docket control number OPP-
300709. No Confidential Business Information (CBI) should be submitted 
through e-mail. Electronic copies of objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA, 703-305-5697; e-mail: 
[email protected].


[[Page 48598]]


SUPPLEMENTARY INFORMATION: In the Federal Register of March 8, 1996 (61 
FR 9355) (FRL 5353-4), time-limited tolerances were established for 
sulfosate on corn and animal commodities (listed below). In the Federal 
Register of April 10, 1996 (61 FR 15899) (FRL 5782-9), time-limited 
tolerances were established for unprocessed soybean commodities and 
aspirated grain fractions (listed below).
    In the Federal Register of March 4, 1998 (63 FR 10614) (FRL 5772-
6), EPA, issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) announcing the filing 
of a pesticide petition for tolerance by Zeneca Ag Products, 1800 
Concord Pike, P. O. Box 15458, Wilmington, DE 19850-5458. This notice 
included a summary of the petition prepared by Zeneca Ag Products, the 
registrant. There were no comments received in response to the notice 
of filing.
    The petition 0F3860 requested that 40 CFR 180.489 be amended by 
removing the expiration date of April 10, 1998, for residues of the 
herbicide sulfosate (glyphosate-trimesium; sulfonium, trimethyl salt 
with N- (phosphonomethyl)glycine (1:1)), in or on soybean forage (2.00 
ppm, of which no more than 1 ppm is trimethylsulfonium (TMS)), soybean 
aspirated grain fractions (210.00 ppm, of which no more than 60 ppm is 
TMS), soybean hay (5.00 ppm, of which no more than 2 ppm is TMS), and 
soybean seed (3.00 ppm of which no more than 1 ppm is TMS). The 
petition 9F3796 requested that 40 CFR 180.489 be amended by removing 
the expiration date of March 9, 1998 for residues of sulfosate in or on 
cattle, goat, hog, horse, sheep and poultry fat (0.10 ppm), meat by 
products (1.00 ppm), and meat (0.20 ppm); poultry liver (0.05 ppm), 
poultry meat by-products (0.10 ppm), and poultry meat (0.05 ppm); corn 
fodder (0.30, of which no more than 0.20 is trimethylsulfonium TMS)), 
corn forage (0.10 ppm), and corn grain (0.20 ppm, of which no more than 
0.10 ppm is TMS); milk (0.20 ppm); and eggs (0.02 ppm).
    In the corn tolerances for this action, the commodity term 
``stover'' replaces the older term ``fodder'' in keeping with current 
EPA policy for naming this commodity. In this action, the previous 
tolerance for ``soybean aspirated grain fractions'' is replaced with 
the tolerance for ``aspirated grain fractions''. The term ``soybean 
aspirated grain fractions'' was printed in error in the April 10, 1996 
FR notice (61 FR 15899); aspirated grain fractions typically contain 
more than one type of grain and typically contain both soybeans and 
corn.
    This action also moves tolerances for prunes, raisins, and soybean 
hulls from 40 CFR 185.5375 to 40 CFR 180.489. The Food Quality 
Protection Act (FQPA) amended the Federal Food, Drug and Cosmetic Act 
(FFDCA) to consolidate pesticide tolerances for raw and processed 
agricultural commodities under FFDCA section 408(j)(2). Prior to this 
change, raw agricultural commodity tolerances were established 
according to FFDCA section 408 and processed commodities were 
established according to FFDCA section 409. As a result of the change 
in the regulations governing FFDCA, all new tolerances for both raw and 
agricultural commodities are established according to FFDCA section 
408(j)(2) in 40 CFR part 180. When 40 CFR part 180 is amended as to a 
specific pesticide, it is EPA's policy to move existing related 
regulations governing residues of that pesticide on processed 
agricultural commodities from 40 CFR parts 185 and 186 and place them 
in part 180. Ultimately, EPA will amend all tolerance regulations so 
that all tolerances are listed in 40 CFR part 180.

I. Risk Assessment and Statutory Findings

    New 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. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA uses a RfD approach or calculates a margin of exposure 
(MOE) by dividing the estimated human exposure into the NOEL from the 
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be 
unacceptable. This 100-fold MOE is based on the same rationale as the 
100-fold uncertainty factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based

[[Page 48599]]

on the appropriate NOEL) will be carried out based on the nature of the 
carcinogenic response and the Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 
three sources are not typically added because of the very low 
probability of this occurring in most cases, and because the other 
conservative assumptions built into the assessment assure adequate 
protection of public health. However, for cases in which high-end 
exposure can reasonably be expected from multiple sources (e.g. 
frequent and widespread homeowner use in a specific geographical area), 
multiple high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
The TMRC is a ``worst case'' estimate since it is based on the 
assumptions that food contains pesticide residues at the tolerance 
level and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroups (females, 
infants, and children) were not regionally based.

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action, EPA has sufficient data to assess the hazards of sulfosate 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for tolerance for residues of sulfosate on cattle, 
goats, horses, hogs and sheep at 0.10 ppm in fat, at 1.00 ppm in meat 
by-products, and at 0.20 ppm in meat; in poultry at 0.05 ppm in fat, 
meat-by-products (except liver), and meat, and at 0.10 ppm in liver; in 
eggs at 0.02 ppm; in milk at 0.20 ppm; in corn at 0.30 ppm (of which no 
more than 0.20 ppm is TMS) in stover (field and pop), at 0.20 ppm (of 
which no more than 0.10 ppm is TMS) in grain (field and pop), at 0.10 
ppm in forage (field); in soybeans at 2.00 ppm (of which no more than 
1.0 ppm is TMS) in forage, at 5.00 ppm (of which no more than 2.0 ppm 
is TMS) in hay, and at 3.00 (of which no more than 1.0 ppm is TMS) ppm 
in seed; and in aspirated grain fractions at 210 ppm (of which no more 
than 60 ppm is TMS). EPA's assessment of the dietary 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 are 
discussed below.
    Several acute toxicity studies were performed, placing technical-
grade sulfosate in Toxicity Category III. The acute toxicity data for 
sulfosate show that this chemical is not acutely toxic by the oral, 
inhalation, and dermal routes

[[Page 48600]]

of exposure. Sulfosate technical is, however, a slight dermal 
sensitizer.
    In a subchronic feeding study, 6 week old CrL: CD(SD)BR Sprague-
Dawley rats were treated with Sulfosate technical at doses of 0, 150, 
350, 800 or 2,000 ppm sulfosate in their diet (males for 90 days & 
females for 96 days). At 2,000 ppm in males (88 mg/kg/day) there was a 
significant overall decrease in body weight gain of 22%. At 2,000 ppm, 
the females exhibited some sporadic and minimal decreases in body 
weight (6% at week 2, 8% at week 11, 21% at week 13) which were due to 
a decrease in food consumption and is not used to set a lowest effect 
level (LOEL). No significant changes were observed in clinical 
chemistry, hematology, clinical observations, organ weight, and 
macroscopic/microscopic histopathology. The systemic no effect level 
(NOEL) is 800 ppm in males (36 mg/kg/day) and 2,000 ppm (108 mg/kg/day) 
in females. The systemic LOEL is 2,000 ppm in males (88 mg/kg/day), 
based on significant overall decrease in body weight gain of 22%. The 
maximum tolerated dose (MTD) was achieved only in male rats.
    Two subchronic toxicity studies on dogs were conducted. In one 
subchronic oral study, beagle dogs were treated with Sulfosate 
technical at doses of 0, 2, 10 or 50 mg/kg/day. The dose volume was 0.5 
milliliter per kilogram body weight (ml/kg b.w.) by oral gavage (5 
days/week) for 45-50 days. The NOEL is 10 mg/kg/day for both males and 
females. The LOEL is 50 mg/kg/day for both males and females, based on 
significant earlier onsets and increased incidence of salivation and 
emesis. No significant change was observed in body weight, food 
consumption, urinalysis, organ weights, macroscopic/microscopic 
histopathology, hematology, and clinical chemistry including 
cholinesterase activity. In another subchronic toxicity study, 
Sulfosate was administered to 4 male and 4 female beagle dogs by 
gelatin capsule at doses of 0, 10, 25, or 50 mg/kg/day for at least 90 
days. Evaluations included clinical observations, body weight, food 
consumption, clinical pathology, organ weights and gross and 
microscopic histopathology. There were no effects on food consumption, 
body weight, clinical pathology, organ weights or histopathology. 
Observed at 50 mg/kg/day in both sexes was salivation at dosing (weeks 
2-14) and/or salivation (weeks 1-13) either consistently or 
intermittently, and resisting dosing (weeks 6-13) occasionally. A 
female in the 50 mg/kg/day group was sacrificed on day 2 after being 
found cold and recumbent and replaced with another female dog. The dose 
was lowered to 40 mg/kg/day in another female dog (50 mg/kg/day group) 
for most of the remainder of the study following two incidents of 
tremors, recumbency, and voluntary paddling of the limbs. One high dose 
male had a unilateral cataract. The LOEL is 50 mg/kg/day, based on 
clinical signs of neurotoxicity in the females. The NOEL is 25 mg/kg/
day.
    Two 21-day dermal studies were conducted. In one 21-day dermal 
study, Rabbits (New Zealand White) were treated with sulfosate soluble 
concentrate (51.2% a.i.), Sulfosate at doses of 0, 10, 100, 1,000 mg/
kg/day, 6 hrs/day, 5 days/wk for 3 weeks. There was no systemic 
toxicity at any dose. There was mild erythema at application sites in 
all sulfosate-treated groups. The systemic NOEL is 1,000 mg/kg/day, the 
highest dose tested (HDT). In another 21-day dermal study, sulfosate 
emulsifiable concentrate (39.8% a.i.) was applied to the skin of rats 
(Alpk: AP (Wistar derived), 5/sex/group) at doses of 25, 250, 1,000 mg/
kg in 0.0021, 0.027, and 0.0826 ml/100 g body wt. At 25 and 1,000 mg/
kg/day (not 250 mg/kg/day) there was a slight increase in testes weight 
with normal histology (toxicological significance is unclear). There 
was occasional sciatic nerve fiber degeneration (1 male and 2 females 
out of a total of 10) at 1,000 mg/kg/day. There was occasional sciatic 
nerve fiber degeneration (1/5 males, 2/5 females) at 1,000 mg/kg/day 
with none in controls. Dermal irritation occurred in male rats at 1,000 
mg/kg/day including scabbing, erythema, edema and desquamation. There 
were no histological changes. The systemic LOEL was 1,000 mg/kg/day 
based on sciatic nerve findings. The NOEL was 250 mg/kg/day.
    In a feeding/carcinogenicity study, 60/sex/group Sprague-Dawley 
(Crl: CD SD BR) rats were tested with sulfosate soluble concentrate 
(56.2% a.i.) at dose levels of 0 (basal diet, no vehicle), 0 (basal 
diet plus 1% propylene glycol), 100, 500 or 1,000 ppm a.i. (male - 0, 
4.2, 21.2, or 41.8; female - 0, 5.4, 27.0, or 55.7) for 2 years. Rats 
may have tolerated higher dose levels. At 1,000 ppm there were 
decreases in bodyweight in both males and females and an increase in 
incidences of chronic laryngeal and nasopharyngeal inflammation in 
males. Bodyweight decrease was secondary to the decrease in food 
consumption. The LOEL and NOEL were at or above 1,000 ppm (41.8 and 
55.7 mg/kg/day for males and females, respectively). There was no 
evidence of carcinogenicity in this study at the doses tested. The 
study is considered acceptable based on the results of a subchronic and 
reproduction study. The high dose for a feeding/carcinogenicity study 
should be near, but not necessarily at, a dose that would produce well 
defined toxicity. The subchronic rat study indicated well defined 
toxicity at 2,000 ppm (only twice the high dose in the feeding/
carcinogenicity study), a dose that is adequate for estimating a 
maximum tolerated dose (MTD). Therefore, 1,000 ppm in the feeding/
carcinogenicity study is considered a reasonable extrapolation from the 
subchronic toxicity study results. In addition, at 2,000 ppm in the 
reproduction study there is well defined toxicity with some evidence of 
toxicity, although less severe, at 800 ppm. Therefore, it is believed 
that sulfosate was adequately tested for carcinogenicity in the rat.
    In a chronic oral gavage study, beagle dogs (5/sex/dose) were 
treated with sulfosate soluble concentrate (56.2% a.i.) for 1 year at 
doses of 0, 2, 10, or 50 mg kg/day. Signs of toxicity were limited to 
the 50 mg/kg/day group females and included transient salivation (1/5 
at 10 mg/kg/day and 5/5 at 50 mg/kg/day) and emesis (single episodes in 
3/5 dogs). The decreased lactic acid dehydrogenase (LDH) in females at 
12 months is of questionable biological significance. The high dose was 
however, supported by subchronic studies where transient salivation and 
emesis again occurred at 50 mg/kg/day in a 90 day study and at 75 mg/
kg/day in a 28 day study; with death occurring within 3 days at 150 mg/
kg/day in the 28 day study. The LOEL is 50 mg/kg/day based on 
salivation and emesis and support from shorter term studies also with 
emesis and salivation. The NOEL is 10 mg/kg/day.
    In a feeding carcinogenicity study, mice (60/sex/dose) were given 
sulfosate technical ( 56.17% a.i.) in the diet at concentrations of 0a 
(dietary control), 0b (vehicle control), 100, 1,000 and 8,000 ppm 
(males at 0, 0, 11.7, 118, or 991 mg/kg/day; and females at 0, 0, 16.0, 
159, or 1,341 mg/kg/day) for 2 years. The only signs of toxicity 
occurred at 8,000 ppm and included (in both sexes) decreased body 
weight (about 10% lower than controls) and weight gain (about 50% lower 
than controls). Decreased food consumption (0 to 15% lower than 
controls in both sexes) was responsible only in part for the decreased 
weight gain. 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), and increased incidence 
of epithelial hyperplasia of duodenum (females only) (10, 13, 16, 15, 
24%

[[Page 48601]]

response, controls to high dose). The systemic LEL is 8,000 ppm (991, 
1,340 mg/kg/day for males and females) based on decreased body weight & 
food consumption (both sexes), increased incidence of white matter 
degeneration in lumbar bar region of spinal cord (males only), and 
increased incidence of epithelial hyperplasia of duodenum (females 
only). The systemic NOEL is 1000 ppm (118, 159 mg/kg/day for males and 
females). This study was tested to adequate doses based on decreased 
body weight and weight gain. There was no evidence of carcinogenicity 
in this study at the doses tested.
    In a developmental toxicity study, rats (25/dose) were treated with 
sulfosate soluble concentrate (19.2% a.i.) by gavage on gestation days 
6 through 20 at dose levels of 0, 30, 100, or 333 mg/kg/day. The test 
material was dissolved in water and administered in a volume of 5 ml/
kg. Treatment related effects were limited to the high dose dams and 
included decreased body weight (17% less than the control), body weight 
gain and feed consumption. There was also salivation, chromorhinorrhea 
and lethargy after dosing in this group (p < 0.05). The Maternal LOEL 
is 333 mg/kg/day based on decreased body weight, feed consumption and 
body weight gain along with increased incidences of salivation, 
chromorhinorrhea, and lethargy after dosing. The Maternal NOEL is 100 
mg/kg/day. Developmental signs of toxicity were limited to the high 
dose and included decreased fetal body weight (5.0, 4.9, 4.9, 4.2 gm, 
controls to high dose). The Developmental toxicity LOEL is 333 mg/kg/
day based on decreased fetal body weight. The Developmental toxicity 
NOEL is 100 mg/kg/day.
    In a developmental toxicity study, New Zealand white rabbits (15/
group except 21 at the high dose) were treated by gavage with sulfosate 
soluble concentrate (56.2% ai) from gestation days 7-19. The test 
material was dissolved in water and administered in a volume of 2 ml/kg 
at dose levels of 0, 10, 40 or 100 mg/kg/day. The Maternal LOEL is 100 
mg/kg/day (6 deaths in 17 pregnant does, 4 abortions in the 11 
survivors along with decreased body weight, feed consumption and body 
weight gain). The Maternal NOEL is 40 mg/kg/day. The developmental LOEL 
is 100 mg/kg/day based on decreased number of live fetuses/doe for 7 
surviving rabbits (5.4 versus 7.4 in controls), 4 rabbits aborted their 
litters. Having only 7 litters does not give a sufficiently high number 
of animals to absolutely conclude that no developmental toxicity is 
occurring, particularly in light of the massive losses to death and 
abortions. The developmental NOEL is 40 mg/kg/day.
    In a 2-generation reproduction study, 20 male and 30 female/group 
Sprague-Dawley rats received sulfosate soluble concentrate (19.2% a.i.) 
at dose levels of 0, 150, 800, or 2,000 ppm in the diet (average for 
P0 and P1 - males - 0, 6.0, 35, 88.5 mg/kg/day; 
females - 0, 8, 41, 98 mg/kg/day). The systemic LEL is 800 ppm (35 and 
41 mg/kg/day for males and females) based on a decrease in absolute and 
sometimes relative organ weights in both generations (thymus, heart, 
kidney and liver) at 800 and 2,000 ppm and a decrease in body weights 
and body weight gains during the premating period at 2,000 ppm. The 
Systemic NOEL is 150 ppm (6 and 8 mg/kg/day for males and females). The 
reproductive/developmental LOEL is 800 ppm (35 and 41 mg/kg/day for 
males and females) is based on decreased litter size in F0a 
and F1b litters at 2,000 ppm and on decrease in mean pup 
weights during lactation in second litters at 800 ppm & in all litters 
at 2,000 ppm. The reproductive/developmental NOEL is 150 ppm (6 and 8 
mg/kg/day for males and females).
    In an acute neurotoxicity study, white leghorn chickens (6 hens/
group in control groups, 8 hens/group in treated groups) were treated 
with technical sulfosate (56.9% a.i.) by gavage at doses of 0, 500 or 
5,000 mg/kg in 5 ml/kg water. Tri-ortho-cresylphosphate (TOCP, 500 mg/
kg) was the positive control. Each animal was dosed twice during study; 
day 1 and day 22. Each animal was evaluated up to day 41 (or 42). At 
500 mg/kg there was diarrhea starting a few days after each dosing, 
lasting for 2-3 days. At 5,000 mg/kg there was diarrhea, changes in 
comb appearance, early decreased food consumption and decrease in egg 
production. No indications of neurotoxicity were observed. The positive 
control indicated the appropriate clinical sings of toxicity, increased 
ataxia and microscopic observations for an organophosphate. The NOEL 
for systemic toxicity was 500 mg/kg. The LEL for systemic toxicity was 
5,000 mg/kg.
    In an acute neurotoxicity study, sulfosate technical (59.4% a.i.) 
was used to treat Alpk: APfsD rats, 10/sex/dose by gavage at 1 ml/100 g 
bw with doses of 0, 30, 100 or 300 mg/kg. Adequate positive control 
data were provided. At 300 mg/kg there was death, ptosis, decreased 
activity, decreased splay reflex, upward curvature of spine, 
chromodacryorrhea, staining around the nose, decreased bodyweight and 
food consumption (males), shaking, sides pinched in, signs of urinary 
incontinence, irregular breathing, hunched posture, abnormal or 
staggering gait, increased time to tail flick, decreased landing foot 
splay, decreased forelimb grip strength, decreased hindlimb grip 
strength, decreased motor activity. There was no microscopic evidence 
of neurotoxicity. There were no indications of neurotoxicity below a 
lethal dose. The LEL was 300 mg/kg based on mortality, neurologic signs 
described above and decreased body weight and food consumption. The 
NOEL was 100 mg/kg.
    Technical sulfosate (59.4% a.i.) was tested in a 90 day 
neurotoxicity feeding study in Alpk: APfSD rats. Rats (12/sex/group) 
received either 0, 200, 600, or 2,000 ppm (0, 15.6, 47.6 or 153.2 mg/
kg/day for males; 0, 18.2, 54.4 or 171.0 mg/kg/day for females) in the 
diet. Six/sex/dose group received complete necropsy and 
neurohistopathology. Positive control data were provided. The other 6/
sex/dose were perfused and the neurohistopathology carried out. 
Clinical signs of toxicity, body weights, food consumption, functional 
battery, motor activity and neuropathology parameters were measured and 
recorded regularly. Positive control data were provided. At 2,000 ppm, 
decreased body weights (16% for males and 9% for females), food 
consumption and utilization were observed. In addition, mean forelimb 
grip strength values for high dose females were statistically 
significantly decreased over the values for the controls during weeks 
5-14 (75 - 82% of controls). There was no microscopic evidence of 
neurotoxicity. The significance of the decreased grip strength as a 
neurotoxicological effect is less certain since there were no effects 
in mean hindlimb grip strength for high dose females, in either of the 
mean grip strength values at any time period for males, in any of the 
other functional battery parameters, in motor activity values or in 
neuropathology microscopic examinations for either sex. However, it 
occurred at all time points, was statistically significant, and signs 
of neurotoxicity occur in other studies. The LEL is 2,000 ppm (153.2 
mg/kg/day) based on decreases in mean body weight, food consumption, 
food utilization and mean forelimb grip strength values. The NOEL is 
600 ppm (47.6 mg/kg/day).
    Several mutagenicity tests were conducted. In some of the in vitro 
mutagenicity tests (forward mutation/mouse lymphoma cells, structural 
chromosomal aberrations/CHO cells), sulfosate induced a false positive 
mutagenic effect. A common feature of

[[Page 48602]]

these tests was that the pHs of the test incubation media were acidic 
(pH 5.67-7.07) due to the addition of sulfosate. These positive results 
were no longer observed when the pH was readjusted to a more 
physiological level (pH 7.4) before the mutagenicity tests were 
conducted. Based on the available mutagenicity studies, there are no 
concerns for mutagenicity at this time.
    In a metabolism study, rats were treated with sulfosate soluble 
concentrate (14C labeled). Radiolabelled trimethylsulfonium 
ion (TMS) was rapidly excreted unmetabolized in urine and feces; the 
principal sites of localization of TMS are adrenals, kidneys, bladder, 
liver, thyroid and stomach.
    In a metabolism study, rats were treated with sulfosate 
(14C-labeled on the anionic part of the molecule, 56.1% ai). 
Intravenous (IV) or oral 14C- sulfosate was rapidly 
excreted; over a 5 day period most (86-95%) of the administered dose 
was excreted in the urine & feces. IV treated male & females eliminated 
90% of the administered dose in urine. Absorption of 14C-
sulfosate was incomplete by the oral route; most groups eliminated 47-
57% of the administered dose in the urine and 36-42% in the feces. 
Females treated with a high dose eliminated less in the urine (36% of 
dose) and more in the feces (54% of dose). There was negligible 
14C-carbon dioxide (14CO2) elimination. Tissue 
14C residues were < 0.32% of administered dose. Carcass 
14C residues were < 2.2% of administered dose (mostly in 
bones, 3-7 ppm in low dose rats & 19-32 ppm in high dose rats). Most 
excreted radioactivity (77-96% of fecal; 80-95% of urinary) was 
unchanged anion (carboxymethylamino-methylphosphonate). One fecal 
metabolite (repeated dose females; 8.5% of fecal radioactivity) was 
aminomethyl phosphonic acid. Several minor unidentified (: 
3% of total urinary/fecal radioactivity) metabolites were recovered. 
The low dose was 25 mg/kg. At the high dose of 250 mg/kg, toxic signs 
were lethargy, moderate to severe depression, tremors, dehydration, and 
decreased food consumption in 2 - 5 rats (total of 10 rats tested). 
Recovery was within 72 hours.

B. Toxicological Endpoints

    1. Acute toxicity. An acute NOEL of 100 mg/kg was determined based 
on mortality, decreased body weight and food consumption, and 
neurotoxicity at 300 mg/kg (LOEL) from an acute rat neurotoxicity 
study. An acute RFD of 1.0 mg/kg was calculated by dividing the 100 mg/
kg NOEL by the uncertainty factor of 100 (10x for inter-species 
extrapolation and 10x for intra-species variations). Based on FQPA, EPA 
has determined that an additional safety factor of 3x must be retained 
for the acute dietary assessment to protect infants and children. 
Without the 3x safety factor, the level of concern is dietary 
consumption above the level of 100% of the RfD. With the 3x safety 
factor, the level of concern is consumption above the level of 33% of 
the acute RfD.
    2. Short - and intermediate - term toxicity. There are currently no 
residential uses for suslfosate; therefore, assessment of short- and 
intermediate-term toxicity is not necessary for the purpose of 
establishing sulfosate tolerances.
    3. Chronic toxicity. EPA has established the RfD for sulfosate at 
0.10 milligrams/kilogram/day (mg/kg/day). This RfD is based on an oral 
NOEL of 10 mg/kg/day (LOEL of 50 mg/kg/day) from a chronic oral gavage 
study in dogs and an uncertainty factor of 100. Based on FQPA, EPA has 
determined that an additional safety factor of 3x must be retained for 
the chronic dietary assessment to protect infants and children. Without 
the 3x safety factor, the level of concern is dietary consumption above 
the level of 100% of the RfD. With the 3x safety factor, the level of 
concern is consumption above the level of 33% of the chronic RfD.
    4. Carcinogenicity. Sulfosate was classified as a ``Group E'' 
carcinogen (no evidence for carcinogenicity in humans) based on the 
lack of evidence of carcinogenicity in mice and rats at doses that were 
judged to be adequate to assess the carcinogenic potential and the 
``Guidelines for Carcinogen Risk Assessment'' [51 FR 33992] for 
classifying the weight-of-evidence for carcinogenicity.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been previously 
established (40 CFR 180.489) for the residues of sulfosate, in or on a 
variety of raw agricultural commodities. Time-limited tolerances for 
soybeans expired on April 10, 1998, and time limited tolerances for 
corn, ruminants, poultry, milk, and eggs expired on March 9, 1998. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from sulfosate as follows:
    i.  Acute exposure and risk. 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 one day or single exposure. An acute dietary (food only) risk 
assessment was conducted for sulfosate. The exposure to the most 
sensitive population subgroup, in this instance non-nursing infants, 
was 9.7% of the acute RfD (1.0 mg/kg bwt/day). Based on FQPA, EPA has 
determined that an additional safety factor of 3x must be retained for 
the acute dietary assessment to protect infants and children. Without 
the 3x safety factor, the level of concern is dietary consumption above 
the level of 100% of the RfD. With the 3x safety factor, the level of 
concern is consumption above the level of 33% of the acute RfD. 
Therefore, the acute dietary risk due to food does not exceed the level 
of concern.
    ii. Chronic exposure and risk. An chronic dietary (food only) risk 
assessment was conducted for sulfosate. This risk assessment assumed 
100% of the crops with existing tolerances plus those established in 
this notice were treated and that residues were consumed at the 
theoretical Maximum Residue Contribution (TMRC, the level of residues 
consumed daily if each food item contained pesticide residues equal to 
the tolerance). The exposure to the most sensitive population subgroup, 
in this instance children 1 to 6 years old, was 20.3% of the chronic 
RfD (0.1 mg/kg bwt/day). Based on FQPA, EPA has determined that an 
additional safety factor of 3x must be retained for the acute dietary 
assessment to protect infants and children. Without the 3x safety 
factor, the level of concern is dietary consumption above the level of 
100% of the RfD. With the 3x safety factor, the level of concern is 
consumption above the level of 33% of the acute RfD. Therefore, the 
chronic dietary risk due to food does not exceed the level of concern.
    2. From drinking water. Results from computer modeling indicate 
that sulfosate in groundwater will not contribute significant residues 
in drinking water as a result of sulfosate use at the recommended 
maximum annual application rate (1 application at 4.75 lbs., a.i., 
acre-1). The computer model uses conservative numbers, 
therefore it is unlikely that groundwater concentrations would exceed 
the estimated concentration of 0.00224 ppb, and sulfosate should not 
pose a threat to ground water.
    The surface water estimates are based on an exposure modeling 
procedure called GENEEC (Generic Expected Environmental Concentration). 
The assumptions of 1 application of 4.75 lbs., a.i., acre-1 
resulted in calculated estimated maximum concentrations of 125 ppb 
(acute, based on the highest 56 day value) and 35 ppb (chronic, 
average). GENEEC modeling procedures assumed that sulfosate was applied 
to a

[[Page 48603]]

10-hectare field that drained into a 1-hectare pond, 2-meters deep with 
no outlet for all crops.
    As a conservative assumption, because sulfosate residues in ground 
water are expected to be insignificant compared to surface water, EPA 
assumed that 100% of drinking water consumed was derived from surface 
water in all drinking water exposure and risk calculations.
    To calculate the maximum acceptable acute and chronic exposures to 
sulfosate in drinking water, the dietary food exposure (acute or 
chronic) was subtracted from 33% of the appropriate (acute or chronic) 
RfD. DWLOCs were then calculated using the maximum acceptable acute or 
chronic exposure, default body weights (70 kg - adult, 10 kg - child) 
and drinking water consumption figures (2 litres - adult, 1 litre - 
child).
    i. Acute exposure and risk. OPP has calculated drinking water 
levels of concern (DWLOCs) for acute exposure to be 9,740 ug/l parts 
per billion (ppb) for U.S. population, 2,360 ug/l (ppb) for non-nursing 
infants (<1 year old), and 2600 ug/l (ppb) for children (1-6 years 
old). These levels include the FQPA additional safety factor of 3x to 
protect infants and childern. The estimated maximum concentration of 
sulfosate in surface water of 125 ppb (highest 56 day value) is less 
than all of the calculated acute DWLOCs. Therefore, taking into account 
the present uses plus uses on corn and soybeans, EPA concludes with 
reasonable certainty that acute exposure to residues of sulfosate 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.
    ii. Chronic exposure and risk. OPP has calculated DWLOCs for 
chronic (non-cancer) exposure to be 925 ug/l (ppb) for U.S. population 
and 130 ug/l (ppb) for the most sensitve population group, in this 
instance children 1 to 6 years old. These levels include the FQPA 
additional safety factor of 3x to protect infants and childern. The 
estimated concentration 35 ppb (chronic, average) of sulfosate in 
surface water of is less than all of the calculated chronic DWLOCs. 
Therefore, taking into account the present uses plus uses on corn and 
soybeans, EPA concludes with reasonable certainty that chronic exposure 
to residues of sulfosate 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.
    3. From non-dietary exposure. Sulfosate is currently not registered 
for use on any residential non-food sites: Therefore, residential 
exposure to sulfosate residues will be through dietary exposure only.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Sulfosate is structurally similar to glyphosate. Further, 
other pesticides may have common toxicity endpoints with sulfosate. 
Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether 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.

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. Since there are no residential uses for sulfosate, 
the acute aggregate exposure only includes food and water. For the U.S. 
population, 5.8% of the acute RfD is occupied by dietary (food) 
exposure. The estimated average concentrations of sulfosate in surface 
and ground water are less than EPA's levels of concern for sulfosate in 
drinking water as a contribution to acute aggregate exposure. The above 
calculations include the FQPA safety factor of 3x. Therefore, EPA 
concludes with reasonable certainty that residues of sulfosate in 
drinking water do not contribute significantly to the aggregate acute 
human health risk at the present time considering the present uses and 
uses proposed in this action.
    2. Chronic risk. Using the exposure assumptions TMRCs described 
above, EPA has concluded that aggregate exposure to sulfosate from food 
will utilize 7.6% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is children 1 
to 6 years old (discussed below). EPA generally has no concern for 
exposures below 100% of the RfD because the RfD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health. For infants, children, and 
women, EPA determined that the 10x factor for increased susceptibility 
of infants and children (as required by FQPA) should be reduced to 3x. 
Therefore, for infants, children, and women, there is no concern for 
exposures below 33% of the RfD. Despite the potential for exposure to 
sulfosate in drinking water, EPA does not expect the aggregate exposure 
to exceed 33% of the RfD.
    3. Aggregate cancer risk for U.S. population. Sulfosate was 
classified as a

[[Page 48604]]

``Group E'' carcinogen (no evidence for carcinogenicity in humans, see 
section B.4 of this document).
    4. Conclusions. EPA concludes that there is a reasonable certainty 
that no harm will result from aggregate exposure to sulfosate residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of sulfosate, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    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 pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard 
uncertainty factor (usually 100 for combined inter- and intra-species 
variability) and not the additional tenfold MOE/uncertainty factor when 
EPA has a complete data base under existing guidelines and when the 
severity of the effect in infants or children or the potency or unusual 
toxic properties of a compound do not raise concerns regarding the 
adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. In a prenatal developmental 
toxicity study, sulfosate was administered by gavage to groups of 
pregnant Sprague-Dawley rats on gestation days 6-20 at dose levels of 
0, 30, 100, or 333 mg/kg/day. The maternal NOEL was 100 mg/kg/day and 
LOEL was 333 mg/kg/day based on decreased body weight, food 
consumption, and increased clinical signs. The developmental NOEL was 
100 mg/kg/day and LOEL was 333 mg/kg/day based on decreased fetal body 
weight.
    In another prenatal developmental toxicity study, Sulfosate was 
administered by gavage to groups of New Zealand White rabbits on 
gestation days 6-18 at doses of 0, 10, 40, or 100 mg/kg/day. The 
maternal NOEL was 40 mg/kg/day and LOEL was 100 mg/kg/day based on 
abortions, deaths, decreased body weight and food consumption. The 
developmental NOEL was 40 mg/kg/day and LOEL was 100 mg/kg/day based on 
decreased number (7) of surviving does, and decrease in number of live 
fetuses/doe (5.4 vs 7.4 in controls).
    iii. Reproductive toxicity study. Sulfosate was administered by 
diet to Sprague-Dawley rats at dose levels of 0, 150, 800, or 2,000 ppm 
for 2-generations. The parental systemic NOEL was 140 ppm (7.5 mg/kg/
day) and the LOEL was 800 ppm (40 mg/kg/day) based on decreased body 
weight, decreased organ weights and decreased food consumption. The 
reproductive/offspring NOEL was 7.5 mg/kg/day (140 ppm) and LOEL was 40 
mg/kg/day (800 ppm) based on decreased pup body weight during 
lactation.
    iv. Pre- and post-natal sensitivity. The data provided no 
indication of increased susceptibility in rats or rabbits from in utero 
and/or post natal exposure to sulfosate. In the prenatal developmental 
toxicity study in rats, evidence of developmental toxicity was seen 
only in the presence of maternal toxicity. In the developmental 
toxicity study in rabbits, developmental toxicity was seen in the 
presence of maternal toxicity at the highest dose level. In the 2-
generation reproduction study in rats, effects in the offspring were 
observed only at or above treatment levels which results in evidence of 
parental toxicity. It should be noted that a developmental 
neurotoxicity study is required.
    v. Developmental neurotoxicity. A developmental neurotoxicity study 
is not available. One is required due to neurotoxicity observed in the 
rat, dog and mouse. Sulfosate is a neurotoxic chemical, which produces 
clinical findings such as salivation, tremors, emesis, and decreased 
activity in dogs and/or rats. Salivation was the most consistent sign, 
and in dogs may have served as a precursor to more severe symptoms. In 
one study, salivation stopped upon withdrawal of sulfosate and recurred 
upon reintroduction of treatment. Dogs appear to be the most sensitive 
species for these effects, with high intra-individual variability in 
sensitivity. Acute neurotoxicity effects observed after a single dose 
of 300 mg/kg in the rat included ptosis, decreased activity, decreased 
splay reflex, upward curvature of spine, shaking, sides pinched in, 
signs of urinary incontinence, irregular breathing, hunched posture, 
abnormal or staggering gait, increased time to tail flick, decreased 
landing foot splay, decreased forelimb grip strength, decreased 
hindlimb grip strength, decreased motor activity. There was also death 
at this dose. In the subchronic rat neurotoxicity study, the decreased 
forelimb grip strength observed at 153 mg/kg/day, in females only, may 
also have been due to treatment. Hydrocephalus or dilated ventricles 
were observed in at least one animal at the HDT (50 mg/kg/day) in adult 
dogs in all the dog studies, following both 90-days (gavage or capsule) 
and one year of dosing. This finding was never seen in controls or low 
dose groups. Hydrocephaly and/or dilated ventricles in dogs of this age 
may have been due to inherent asymptomatic incidences in the beagle 
(Vullo et al., 1997), but it was noted that these animals were not 
supplied by the same breeding colony, and the incidences were only 
observed at the high dose levels across several studies. Therefore, 
these findings can not be dismissed. Neuropathology was observed in the 
21-day rat dermal study (sciatic nerve degeneration) at 1000 mg/kg, and 
the 2-year chronic mouse study (degeneration of the sciatic nerve, 
lumbar spinal root, and lumbar spinal white matter in males) at 991 mg/
kg. Although these findings were previously discounted due to lack of 
supporting neuropathology data in the acute and subchronic 
neurotoxicity studies in rats, the overall neurotoxicity profile of the 
chemical indicated that the neuropathology could be a treatment-related 
effect of concern.
    v. Conclusion. EPA concludes that the 10x factor for increased 
susceptibility of infants and children (as required by FQPA) should be 
reduced to 3x. The Agency determined that the data indicate that there 
is no increased susceptibility to young rats or rabbits following in 
utero exposure in prenatal studies or in the postnatal study in rats, 
and the guideline requirements for the toxicology data base are 
completed. Additionally, the exposure assessments for sulfosate do not 
indicate a concern for potential risk to infants and children since: 
(1) The dietary exposure assessments are unrefined (assuming that all 
commodities contain tolerance level residues) resulting in an over 
estimate of dietary exposure; (2) data from modeling are used for the 
ground and surface source drinking water exposure assessments, 
resulting in estimates considered to be reasonable upper-bound 
concentrations; and (3) there are currently no registered residential 
uses for sulfosate.

[[Page 48605]]

    However, the FQPA safety factor was reduced to 3x instead of being 
removed because of the concern for the overall neurotoxicity exhibited 
in long-term studies in adult animals (mice, rats, and dogs) and the 
Agency's determination based on these findings that additional data are 
needed. In mice, sulfosate induced degeneration of the sciatic nerve, 
lumbar spinal root and lumbar spinal white matter was reported. In 
rats, degeneration of the sciatic nerve was seen following dermal 
applications. In dogs, hydrocephalus and/or dilated ventricles were 
observed following subchronic and chronic exposures. In addition, 
clinical signs indicative of neurotoxicity such as salivation, tremors, 
emesis, decreased activity was seen in rats and dogs. Based on these 
factors, the Agency determined that a developmental neurotoxicity study 
in rats is required to characterize the observed neuropathology in the 
subchronic and chronic studies.
    2. Acute risk. Since there are no residential uses for sulfosate, 
the acute aggregate exposure only includes food and water. For infants 
and children, 7.3-9.4% of the acute RfD is occupied by dietary (food) 
exposure. The estimated average concentrations of sulfosate in surface 
and ground water are less than EPA's levels of concern for sulfosate in 
drinking water as a contribution to acute aggregate dietary exposure. 
The above calculations include the FQPA safety factor of 3x. Therefore, 
EPA concludes with reasonable certainty that residues of sulfosate in 
drinking water do not contribute significantly to the aggregate acute 
human health risk at the present time considering the present uses and 
uses proposed in this action. EPA concludes that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate acute exposure to sulfosate residues.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to sulfosate 
from food will utilize 11.9-20.3% of the RfD for infants and children. 
EPA has no concern for exposures below 33% of the RfD because the RfD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to health of infants 
and children. Despite the potential for exposure to sulfosate in 
drinking water, EPA does not expect the aggregate dietary exposure to 
exceed 33% of the RfD. EPA concludes that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to sulfosate residues.

III. Other Considerations

A. Metabolism In Plants and Animals

     The nature of the residues in plants and animals is understood. 
EPA has determined that the tolerance expression for sulfosate must 
include both of the parent ions.

B. Analytical Enforcement Methodology

    1. Plants. Analytical methods are available for enforcement. There 
is currently a PAM II enforcement method for the N-
(phosphonomethyl)glycine anion (PMG) in crops. For TMS, the registrant 
has proposed gas chromatography (GC) Method RR 93-105B as the 
analytical enforcement method. A successful petition method validation 
(PMV) of this analytical enforcement method for the TMS moiety in 
plants has been completed by the EPA laboratory. EPA concludes that 
Method RR 93-105B is adequate for enforcement of the permanent 
tolerances.
    2. Animals. Analytical methods are available for enforcement. For 
PMG, the registrant has proposed GC Method RR 93-104B as the analytical 
enforcement method. For TMS, the registrant has proposed GC Method RR 
93-100B as the analytical enforcement method. Successful PMV of these 
analytical enforcement methods for the PMG and TMS moieties in meat, 
milk and eggs have been completed by the EPA laboratory. EPA concludes 
that Method RR 93-104B and Method RR 93-100B are adequate for 
enforcement of the permanent tolerances.

C. Magnitude of Residues

    The crop field trial data are adequate to support these tolerances.

D. International Residue Limits

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

E. Rotational Crop Restrictions.

     EPA has previously reviewed two confined rotational crop studies 
for sulfosate and concluded that rotational crop restrictions were not 
required .

IV. Conclusion

    Therefore, the tolerance is established for residues of sulfosate 
in cattle, goats, horses, hogs and sheep at 0.10 ppm in fat, at 1.00 
ppm in meat by-products, and at 0.20 ppm in meat; in poultry at 0.05 
ppm in fat, meat-by-products (except liver), and meat, and at 0.10 ppm 
in liver; in eggs at 0.02 ppm; in milk at 0.20 ppm; in corn at 0.30 ppm 
(of which no more than 0.20 ppm is TMS) in stover (field and pop), at 
0.20 ppm (of which no more than 0.10 ppm is TMS) in grain (field and 
pop), at 0.10 ppm in forage (field); in soybeans at 2.00 ppm (of which 
no more than 1.0 ppm is TMS) in forage, at 5.00 ppm (of which no more 
than 2.0 ppm is TMS) in hay, and at 3.00 (of which no more than 1.0 ppm 
is TMS) ppm in seed; and in aspirated grain fractions at 210 ppm (of 
which no more than 60 ppm is TMS). In addition, the existing tolerances 
for prunes at 0.20 ppm, raisins at 0.20 ppm, and soybean hulls at 7.0 
ppm are moved from 40 CFR 185.5375 to 40 CFR 180.489.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by November 10, 1998, file written objections to 
any aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is 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

[[Page 48606]]

the requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues in the manner sought by 
the requestor would be adequate to justify the action requested (40 CFR 
178.32). Information submitted in connection with an objection or 
hearing request may be claimed confidential by marking any part or all 
of that information as Confidential Business Information (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.

VI. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number OPP-300709 (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Other Executive Orders

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or 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 in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental 
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a 
regulation that is not required by statute and that creates a mandate 
upon a State, local or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments. If the mandate is unfunded, EPA must 
provide to the Office of Management and Budget (OMB) a description of 
the extent of EPA's prior consultation with representatives of affected 
State, local and tribal governments, the nature of their concerns, 
copies of any written communications from the governments, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 12875 requires EPA to develop an effective process 
permitting elected officials and other representatives of State, local 
and tribal governments ``to provide meaningful and timely input in the 
development of regulatory proposals containing significant unfunded 
mandates.''
    Today's rule does not create an unfunded federal mandate on State, 
local or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerances 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. Nevertheless, the Agency has 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

[[Page 48607]]

VIII. Submission to Congress and the General Accounting Office

    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 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 the rule in the Federal Register. This is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 180

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

40 CFR Part 185

    Environmental protection, Food additives, Pesticides and pests.

    Dated: August 31, 1998.

James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180 -- [AMENDED]

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

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


    2. Section 180.489 is revised 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)) in or on the following raw and 
processed agricultural commodities:

                                                                        
------------------------------------------------------------------------
                 Commodity                        Parts per million     
------------------------------------------------------------------------
Almond, hulls (of which no more than 0.30     1.00                      
 ppm is trimethylsulfonium (TMS)).                                      
                                                                        
Aspirated grain fractions (of which no      210.00                      
 more than 60 ppm is TMS).                                              
                                                                        
Bananas (imported only)a..................    0.05                      
                                                                        
Cattle, fat...............................    0.10                      
                                                                        
Cattle, mbyp..............................    1.00                      
                                                                        
Cattle, meat..............................    0.20                      
                                                                        
Citrus fruit group........................    0.05                      
                                                                        
Corn, field, forage.......................    0.10                      
                                                                        
Corn, field and pop, grain (of which no       0.20                      
 more than 0.10 ppm is TMS).                                            
                                                                        
Corn, field and pop, stover (of which no      0.30                      
 more than 0.20 ppm is TMS).                                            
                                                                        
Eggs......................................    0.02                      
                                                                        
Goats, fat................................    0.10                      
                                                                        
Goats, mbyp...............................    1.00                      
                                                                        
Goats, meat...............................    0.20                      
                                                                        
Grape.....................................    0.10                      
                                                                        
Hogs, fat.................................    0.10                      
                                                                        
Hogs, mbyp................................    1.00                      
                                                                        
Hogs, meat................................    0.20                      
                                                                        
Horses, fat...............................    0.10                      
                                                                        
Horses, mbyp..............................    1.00                      
                                                                        
Horses, meat..............................    0.20                      
                                                                        
Milk......................................    0.20                      
                                                                        
Poultry, fat..............................    0.05                      
                                                                        
Poultry, liver............................    0.05                      
                                                                        
Poultry, mbyp (except liver)..............    0.10                      
                                                                        
Poultry, meat.............................    0.05                      
                                                                        
Prune (of which no more than 0.05 ppm is      0.20                      
 TMS).                                                                  
                                                                        
Raisin (of which no more than 0.05 ppm is     0.20                      
 TMS).                                                                  
                                                                        
Sheep, fat................................    0.10                      
                                                                        
Sheep, mbyp...............................    1.0                       
                                                                        
Sheep, meat...............................    0.20                      
                                                                        
Soybean, forage (of which no more than 1      2.0                       
 ppm is TMS).                                                           
                                                                        
Soybean, hay (of which no more than 2 ppm     5.0                       
 is TMS).                                                               
                                                                        
Soybean, hulls (of which no more than 2       7.0                       
 ppm is TMS).                                                           
                                                                        
Soybean, seed (of which no more than 1 ppm    3.0                       
 is TMS).                                                               
                                                                        
Stone fruit group.........................    0.05                      
                                                                        
Tree nut group............................    0.05                      
------------------------------------------------------------------------
aThere are no U.S. registrations as of the date of publication of the   
  tolerance in the Federal Register.                                    

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

PART 185 -- [AMENDED]

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


Sec. 185.5375 [Removed]

    2. By removing Sec.  185.5375 Sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1).

[FR Doc. 98-24468 Filed 9-10-98; 8:45 am]
BILLING CODE 6560-50-F