[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Rules and Regulations]
[Pages 42921-42928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21144]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300521; FRL-5732-7]
RIN 2070-AB78


Glyphosate; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of glyphosate, per se in or on dry peas, pea vines, hay, and 
silage, lentils, and kidney (cattle, goats, horses and sheep). This 
action is in response to EPA's granting of emergency exemptions under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
authorizing use of the pesticide on dry peas, lentils and chickpeas. 
This regulation establishes a maximum permissible level for residues of 
glyphosate in this food commodity pursuant to section 408(l)(6) of the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996. The tolerance will expire and is revoked on 
August 30, 1998.

DATES: This regulation is effective August 11, 1997. Objections and 
requests for hearings must be received by EPA on or before October 10, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300521], 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-300521], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), 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. 1132, 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 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300521]. 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: Virginia Dietrich, 
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) 308-9359, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the herbicide N-(Phosphonomethyl)glycine, in or on dry 
peas, pea vines, hay, and silage, lentils, and kidney (cattle, goats, 
horses and sheep) at 5, 60, 200, 90, 5, and 4, respectively part per 
million (ppm). These tolerances will expire and are revoked on August 
30, 1998. After August 30, 1998, EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq . The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described below and

[[Page 42922]]

discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
    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***.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerance to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Glyphosate on (Dry Peas, Lentils, and 
Garbanzo Beans) and FFDCA Tolerances

    The Agency determined that an urgent, non-routine situation exists 
in areas where dense populations of Canada thistle develop in dry pea, 
chickpea and lentil crops in Idaho, Oregon and Washington. Crop loss of 
up to 100% may occur in areas heavily infested with Canada thistle. 
Both pre- and post-emergence herbicides are registered for these crops, 
but they are ineffective in controlling Canada thistle. Spot treatment 
with glyphosate to eliminate Canada thistle will not improve dry pea, 
chick pea and lentil crop yields this year since the application will 
also destroy the surrounding crop. However, the use of glyphosate will 
eliminate the Canada thistle pest and future crops are expected to 
improve. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this state. EPA has authorized under 
FIFRA section 18 the use of glyphosate on dry peas, garbanzo beans and 
lentils) for control of Canada thistle.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of glyphosate in or on dry 
peas, garbanzo beans and lentils. In doing so, EPA considered the new 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerance under FFDCA section 408(l)(6) would be consistent 
with the new safety standard and with FIFRA section 18. Consistent with 
the need to move quickly on the emergency exemption in order to address 
an urgent non-routine situation and to ensure that the resulting food 
is safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment under section 408(e), as provided in 
section 408(l)(6). Although these tolerances will expire and are 
revoked on August 30, 1998, under FFDCA section 408(l)(5), residues of 
the pesticide not in excess of the amounts specified in the tolerance 
remaining in or on dry peas, garbanzo beans, and lentils after that 
date will not be unlawful, provided the pesticide is applied in a 
manner that was lawful under FIFRA. EPA will take action to revoke this 
tolerance earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether glyphosate meets EPA's 
registration requirements for use on dry peas, garbanzo beans, and 
lentils or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
tolerance serves as a basis for registration of glyphosate by a State 
for special local needs under FIFRA section 24(c). Nor does this 
tolerance serve as the basis for any State other than Idaho, Oregon, 
and Washington to use this pesticide on this crop under section 18 of 
FIFRA without following all provisions of section 18 as identified in 
40 CFR part 166. For additional information regarding the emergency 
exemption for glyphosate, contact the Agency's Registration Division at 
the address provided above.

III. Risk Assessment and Statutory Findings

    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

[[Page 42923]]

the RfD to evaluate the chronic risks posed by pesticide exposure. For 
shorter term risks, EPA 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 hundredfold MOE is based on the same rationale as 
the hundredfold 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 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 3 
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 subgroup (non-nursing 
infants less than 1 year old ) was not regionally based.

IV. 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 
glyphosate and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of glyphosate on dry peas, pea vines, hay, and silage, 
lentils, and kidney (cattle, goats, horses and sheep) at 5, 60, 200, 
90, 5, and 4 ppm, respectively. 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

[[Page 42924]]

subgroups of consumers, including infants and children. The nature of 
the toxic effects caused by glyphosate are discussed below.
    1. Acute toxicity. No endpoint of concern was identified by the 
Office of Pesticide Programs .
     2. Short - and intermediate - term toxicity. No effects were 
observed in a 21-day dermal toxicity study at the limit dose. No 
adverse effects were observed in the developmental toxicity study in 
rats up to 1,000 mg/kg/day and in rabbits at up to 175 mg/kg/day.
    3. Chronic toxicity. EPA has established the RfD for glyphosate at 
2 milligrams/kilogram/day (mg/kg/day). This RfD is based on the 
maternal toxicity NOEL of 175 mg/kg/day from a rabbit developmental 
toxicity study using an uncertainty factor (UF) of 100. The lowest 
observed effect level (LOEL) of 350 mg/kg/day (highest dose tested) was 
based on treatment-related findings of diarrhea, nasal discharge, and 
death (62.5% of does died by gestation day 21). Developmental toxicity 
was not observed at any dose tested.
    4. Carcinogenicity. Glyphosate has been classified as a Group E 
chemical (evidence of non-carcinogenicity for humans) by the Office of 
Pesticide Programs. The classification was based on a lack of 
convincing evidence of carcinogenicity in adequate studies with two 
animal species, rat and mouse.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.364, 185.3500, 186.3500) for the combined residues of 
glyphosate and its metabolite aminomethylphosphonic acid in or on 
certain raw agricultural commodities ranging from 0.1 ppm in peanuts to 
200 ppm in alfalfa. This regulation also establishes a tolerance for 
secondary residues in kidney (cattle, goats, horses, and sheep). Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from glyphosate as follows:
    i.  Acute exposure and risk. No endpoint was identified for this 
duration of exposure, therefore no assessment was necessary. Acute 
dietary risk assessments are performed for a food-use pesticide only if 
a toxicological study has indicated the possibility of an effect of 
concern occurring as a result of a 1 day or single exposure.
    ii. Chronic exposure and risk. In conducting this exposure 
assessment, EPA has made very conservative assumptions--that 100% of 
dry peas, lentils, and chickpeas and all other commodities having 
glyphosate tolerances would contain glyphosate residues and that those 
residues would be at the level of the respective tolerances--which 
result in an overestimate of human dietary exposure. Thus, in making a 
safety determination for this tolerance, EPA is taking into account 
this conservative exposure assessment.
    All the glyphosate tolerances (published, pending, and including 
these Section 18 tolerances) result in a Theoretical Maximum Residue 
Contribution (TMRC) that is equivalent to the following percentages of 
the RfD:

                                                                        
------------------------------------------------------------------------
                Subgroups                          Percentage of RFD    
------------------------------------------------------------------------
U.S Population............................  1.2                         
Nursing Infants...........................  1.2                         
Non-Nursing Infants (<1 year old).........  3.3                         
Children (1-6 years old)..................  2.6                         
Children (7-12 years old).................  1.8                         
Western Region............................  1.3                         
------------------------------------------------------------------------

    The subgroups listed above are: (1) the U.S. population (48 
states); (2) those for infants and children; and, (3) the other 
subgroups for which the percentage of the RfD occupied is greater than 
that occupied by the subgroup U.S. population (48 states).
    iii. Cancer risk. Glyphosate has been classified as a Group E 
chemical (evidence of non-carcinogenicity for humans) by the Office of 
Pesticide Programs Cancer Peer Review Committee.
    2. From drinking water. Based on information in the EPA's files, 
glyphosate is not persistent and not mobile. A Maximum Contaminant 
Level has been established by the Agency's Office of Water (OW) for 
residues of glyphosate in drinking water at 0.7 ppm. OW has also 
established Health Advisory levels for glyphosate in drinking water at 
the following levels:

                                                                        
                                                                        
Child, 10 kg of body weight...............                              
  1-day...................................  20 mg/L                     
  10-day..................................  20 mg/L                     
  longer-term.............................  1 mg/L                      
Adult, 70 kg of body weight...............                              
  lifetime................................  0.7 mg/L                    
                                                                        

    i. Acute exposure and risk. No endpoint of concern was identified 
by the Agency so this risk assessment was not required.
    ii. Chronic exposure and risk. Because the Agency lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
risk assessment for many pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water-related exposure to the 
aggregate risk posed by a pesticide. In developing the bounding figure, 
EPA estimated residue levels in water for a number of specific 
pesticides using various data sources. The Agency then applied the 
estimated residue levels, in conjunction with appropriate toxicological 
endpoints (RfD's or acute dietary NOEL's) and assumptions about body 
weight and consumption, to calculate, for each pesticide, the increment 
of aggregate risk contributed by consumption of contaminated water. 
While EPA has not yet pinpointed the appropriate bounding figure for 
exposure from contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause glyphosate to 
exceed the RfD if the tolerance being considered in this document were 
granted. The Agency has therefore concluded that the potential 
exposures associated with glyphosate in water, even at the higher 
levels the Agency is considering as a conservative upper bound, would 
not prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerance is granted.
    3. From non-dietary exposure. Glyphosate is registered for uses on 
outdoor non-food sites such as turf and ornamentals. These uses may 
result in non-occupational exposures. However, since no toxicological 
endpoints for non-dietary exposures have been identified, the resulting 
risks cannot be assessed, therefore these exposures have not been 
estimated.
    4. Cumulative exposure to substances with 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.'' 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

[[Page 42925]]

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 glyphosate has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
glyphosate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that glyphosate has a common mechanism of toxicity 
with other substances.

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

    1. Acute risk. Since no toxicological endpoint of concern was 
identified, there is a reasonable certainty that no harm will result 
from aggregate acute exposures to glyphosate residues.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to glyphosate from 
food will utilize 1.2 percent of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is non-
nursing infants, which is further 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. Despite the 
potential for exposure to glyphosate in drinking water and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate 
exposure to exceed 100% of the RfD. EPA concludes that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to glyphosate residues.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure.
    An Ad Hoc Toxicology Endpoint Selection Committee concluded that 
this risk assessment is not required, based on the lack of any 
observable effects in a 21-day dermal toxicity study at the limit dose 
and the observation of no adverse effects in a developmental toxicity 
study in rats up to 1,000 mg/kg/day and rabbits up to  175 
mg/kg/day. Therefore, EPA concludes that there is a reasonable 
certainty that no harm will result from aggregate short- and 
inermediate-term exposure to glyphosate residues.

D. Aggregate Cancer Risk for U.S. Population

    As noted above, glyphosate has been classified as a Group E 
chemical (evidence of non-carcinogenicity for humans).

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

    1. Safety factor for infants and children--a. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of glyphosate, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from pesticide exposure during prenatal development 
to one or both parents. 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 MOE 
and 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.
    b. Developmental toxicity studies --i. Rat. In the rat 
developmental toxicity study, the maternal (systemic) NOEL is 1,000 mg/
kg/day. The maternal (systemic) LOEL of 3,500 mg/kg/day was based on 
the following treatment-related effects: diarrhea, decreased mean body 
weight gain, breathing rattles, inactivity, red matter around the nose 
and mouth, and on forelimbs and dorsal head, decreases in total 
implantations/dam and non-viable fetuses/dam, and death (24% of the 
group). The developmental (fetal) NOEL is 1,000 mg/kg/day. The 
developmental (fetal) LOEL of 3,500 mg/kg/day was based on treatment-
related developmental effects observed only in the high-dose group of: 
increased number of litters and fetuses with unossified sternebrae, and 
decreased mean fetal body weights.
    ii. Rabbit. In the rabbit developmental toxicity study, the 
maternal (systemic) NOEL is 175 mg/kg/day. The maternal (systemic) LOEL 
of 350 mg/kg/day was based on treatment-related effects that included: 
diarrhea, nasal discharge, and death (62.5% of does died by gestation 
day 21). The developmental (fetal) NOEL is  175 mg/kg/day 
(insufficient litters were available at 350 mg/kg/day to assess 
developmental toxicity). Developmental toxicity was not observed at any 
dose tested.
    c. Reproductive toxicity study--i. Rat. A three-generation 
reproductive toxicity study was conducted with Sprague-Dawley rats, the 
parental NOEL/LOEL is  30 mg/kg/day (highest dose tested). 
The only effect observed was an increased incidence of focal tubular 
dilation of the kidney (both unilateral and bilateral combined) in the 
high-dose male F3b pups.
    Since the focal tubular dilation of the kidneys was not observed at 
the 1,500 mg/kg/day level (HDT) in the 2-generation rat reproduction 
(see below),

[[Page 42926]]

but was observed at the 30 mg/kg/day level (HDT) in the 3-generation 
rat reproduction study, the OPP Developmental Peer Review Committee 
concluded that the latter was a spurious rather than glyphosate-related 
effect. Therefore, the parental and reproductive (pup) NOELs are 
 30 mg/kg/day.
    ii. Rat. A two-generation reproductive toxicity study was conducted 
with Sprague-Dawley rats. Treatment-related effects observed in the 
high dose group included: soft stools, very frequent, in the Fo and F1 
males and females, decreased food consumption and body weight gain of 
the Fo and F1 males and females during the growth (premating) period, 
and decreased body weight gain of the F1a, F2a and F2b male and female 
pups during the second and third weeks of lactation. Focal tubular 
dilation of the kidneys, observed in the 3-generation study, was not 
observed at any dose level in this study. Based on the above findings, 
the parental and developmental (pup) NOEL's are 500 mg/kg/day and the 
parental and developmental (pup) LOEL's are 1,500 mg/kg/day. The 
reproductive toxicity NOEL is  1,500 mg/kg/day.
    d. Pre- and post-natal sensitivity. Based on the developmental 
toxicity studies discussed above, for glyphosate there does not appear 
to be an extra sensitivity for pre-natal effects. The developmental rat 
study only had developmental findings above 1,000 mg/kg/day in the 
presence of severe maternal effects [death, etc.] at the highest dose 
tested of 3,500 mg/kg/day. In rabbits, developmental effects above the 
NOEL of 175 mg/kg/day were unable to be identified due to severe 
maternal effects [death, etc.] at 350 mg/kg/day [highest dose tested]. 
Based on the reproductive toxicity study discussed above, for 
glyphosate there does not appear to be an extra sensitivity for post-
natal effects. The pup and adult NOELs of 500 mg/kg/day and LOELs of 
1,500 mg/kg/day do not demonstrate any post-natal extra sensitivity for 
infants and children because the dose levels, respectively, are the 
same for pups and adults and the effects are similar as well.
    e. Conclusion. Therefore, the Agency concludes that no additional 
10X safety factor is necessary to protect infants and children.
    2. Acute risk. No endpoint was selected by the Agency so this risk 
assessment was not conducted.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
glyphosate from food will utilize no more than 3.3% of the RfD for non-
nursing infants, the most highly exposed sub-group. 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. 
Despite the potential for exposure to glyphosate in drinking water and 
from non-dietary, non-occupational exposure, EPA does not expect the 
aggregate exposure to exceed 100% of the RfD. EPA concludes that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to glyphosate residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants and animals is adequately 
understood. The current tolerances established under 40 CFR 180.364 
include glyphosate and its metabolite aminomethylphosphonic acid 
(AMPA). The Office of Pesticide Programs Metabolism Committee has 
concluded that AMPA need not be regulated and should be dropped from 
the tolerance regulation. The residue of concern is the parent 
compound, glyphosate, only.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (GLC and HPLC/fluorometric) are 
available (PAM, Vol. II, Method I) to enforce the tolerance expression.

C. Magnitude of Residues

    Residues of glyphosate, per se, are not expected to exceed the 
following levels as a result of this Section 18 use. Time-limited 
tolerances should be established at these levels: pea, dry at 5 ppm; 
lentil at 5 ppm; pea, field vines at 60 ppm; pea, field hay at 200 ppm; 
pea, field silage at 90 ppm; kidney, cattle, goats, horses, and sheep 
at 4 ppm.
    With the exception of the proposed increase in the kidney tolerance 
noted above, secondary residues in animal commodities are not expected 
to exceed existing tolerances as a result of this Section 18 use. The 
dietary burden for livestock will not exceed that from the use on 
grasses.

D. International Residue Limits

    A CODEX MRL has been established for residues of glyphosate, per 
se, on dry peas at 5 ppm. Canadian tolerances have been established for 
residues of glyphosate and AMPA on peas at 5 ppm and lentils at 4 ppm.

E. Rotational Crop Restrictions

    For this proposed Section 18 use, a 30-day plant-back interval for 
crops on which glyphosate is not registered is being required.

VI. Conclusion

    Therefore, the tolerance is established for residues of glyphosate 
in dry peas, pea vines, hay, and silage, lentils, and kidney (cattle, 
goats, horses and sheep) at 5, 60, 200, 90, 5, and 4, ppm, 
respectively.

VII. 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 October 11, 1997, 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 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

[[Page 42927]]

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.

VIII. Public Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300521] (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 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., 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.

IX. Regulatory Assessment Requirements

    This final rule establishes tolerances under FFDCA section 
408(l)(6). 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).
    In addition, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408 (l)(5), 
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 acations published on May 
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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, Animal feeds, Food additives, Pesticides and 
pests, Reporting and recordkeeping requirements.

    Dated: July 29, 1997.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

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

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

    b. Section 180.364 is amended by adding text to paragraph (b) to 
read as follows:


Sec. 180.364  Glyphosate; tolerances for residues.

    (a) General  . * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for combined residues of the herbicide glyphosate, per se 
in connection with use of the pesticide under section 18 emergency 
exemptions granted by EPA. The tolerances will expire and are revoked 
on the dates specified in the following table.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Cattle, kidney..................  4                   August 30, 1998   
Goats, kidney...................  4                   August 30, 1998   
Horses, kidney..................  4                   August 30, 1998   
Lentils.........................  5                   August 30, 1998   
Pea, hay........................  200                 August 30, 1998   
Pea, vines......................  60                  August 30, 1998   
Peas, dry.......................  5                   August 30, 1998   
Sheep, kidney...................  4                   August 30, 1998   
Silage, hay.....................  90                  August 30, 1998   
------------------------------------------------------------------------


[[Page 42928]]

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[FR Doc. 97-21144 Filed 8-8-97; 8:45 am]
BILLING CODE 6560-50-F