[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Rules and Regulations]
[Pages 33563-33569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16215]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 186

[OPP-300496; FRL-5720-4]
RIN 2070-AB78


Bentazon; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of the herbicide bentazon and its metabolite(s) in or on the 
raw agricultural commodity succulent peas in connection with EPA's 
granting an emergency exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of the 
pesticide on succulent peas in Minnesota and Wisconsin. The tolerance 
will expire and is revoked on June 30, 1998.
DATES: This regulation becomes effective June 20, 1997. Objections and 
requests for hearings must be received by EPA on or before August 19, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300496], 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 
document control number, [OPP-300496], must 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 number 
[OPP-300496]. 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 (7505W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Sixth Floor, 
Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA (703) 308-
8347, 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 bentazon and its 6- and 8-hydroxy metabolites 
in or on succulent peas at 3 part per million (ppm). This tolerance 
will expire and is revoked on June 30, 1998. After June 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 FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA 
amends FFDCA to bring all EPA pesticide tolerance-setting activities 
under section 408 with a new safety standard and new procedures. These 
activities are described below and 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 CFR 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

[[Page 33564]]

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 Bentazon on Succulent Peas and FFDCA 
Tolerances

    In February and March of 1997, the Departments of Agriculture from 
Minnesota and Wisconsin each applied for emergency exemptions for the 
use of bentazon on succulent peas. Bentazon is currently registered for 
use on succulent peas for the control of Canada thistle. However, to 
effectively control Canada thistle with bentazon, two applications are 
needed. The current 30-day preharvest interval (PHI) does not allow for 
a second application of bentazon. If Canada thistle is not adequately 
controlled, its buds can be harvested along with the peas because they 
are similar in size and shape. Growers face docking or rejection of 
their crop if contaminated with Canada thistle buds. This could result 
in significant economic loss. Minnesota and Wisconsin therefore have 
requested an exemption from the 30-day PHI currently required for the 
use of bentazon in succulent peas to control Canada thistle; requesting 
a 10-day PHI instead. This exemption was granted on May 9, 1997. They 
also requested that a time-limited tolerance be established that would 
accommodate residues greater than those allowed under the current 
tolerance for succulent peas.
    EPA has authorized the use of bentazon on succulent peas for 
control of Canada thistle under FIFRA section 18. After having reviewed 
the submission, EPA concurs that emergency conditions exist for these 
states.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of bentazon in or on 
succulent peas. 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. This tolerance will permit the 
marketing of succulent peas treated in accordance with the provisions 
of the section 18 emergency exemption. 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 this tolerance will expire and is revoked on June 
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 
succulent peas after that date will not be unlawful, provided the 
pesticide is applied in a manner that is 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 bentazon meets 
EPA's registration requirements for use on succulent peas 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 bentazon 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 Minnesota and Wisconsin 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 bentazon, 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. For many 
of these 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 percent 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 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 hundreddfold margin of exposure 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 margin of exposure 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.
    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

[[Page 33565]]

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. 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 
percent 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.

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.

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 bentazon are 
discussed below.
    1. Acute toxicity. For acute dietary risk assessment, the Agency 
selected the NOEL of 100 milligrams per kilogram per day (mg/kg/day), 
based on developmental effects of increased post-implantation loss and 
decreased fetal body weight at the lowest effect level (LEL) of 250 mg/
kg/day, from the developmental toxicity study in rats. Since there were 
no maternal findings, but there were developmental findings, at the 
highest dose tested of 250 mg/kg/day, an MOE of at least 300 is 
considered appropriate for females 13+ years of age exposed to dietary 
residues of bentazon.
    2. Chronic toxicity. An RfD of 0.03 mg/kg/day was established based 
on the 1-year dog feeding study with a NOEL of 3.2 mg/kg/day and an 
uncertainty factor of 100 based on body weight loss and anemia at the 
LEL of 13.1 mg/kg/day. Due to the extra sensitivity of pups in the rat 
reproductive toxicity study, an additional modifying factor of 3 should 
be added to the usual uncertainty factor of 100. The RfD should be, 
therefore, changed from 0.03 mg/kg/day to 0.01 mg/kg/day for purposes 
of these section 18's only, resulting in a total uncertainty factor of 
300.
    3. Carcinogenicity. Bentazon has been classified as a Group ``E'' 
chemical (evidence of non-carcinogenicity in two acceptable animal 
studies) by the Office of Pesticide Program's Cancer Peer Review 
Committee.

B. Aggregate Exposure

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses). In 
evaluating food exposures, EPA takes into account varying consumption 
patterns of major identifiable subgroups of consumers, including 
infants and children.
    Bentazon is currently registered for use on food and feed crops and 
for outdoor residential uses on ornamentals and ornamental turf. 
Permanent tolerances (see 40 CFR 180.355) for combined residues of 
bentazon and its 6- and 8- hydroxy metabolites, have been established 
for over 2 dozen food or feed commodities. Permanent tolerances are 
also established in animal raw agricultural commodities for bentazon 
and its metabolite, 2-amino-N-isopropyl benzamide.
    1. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. Drinking water is also considered a component of the 
acute dietary exposure, however, EPA generally will not include 
residential or other non-dietary exposure as a component of the acute 
exposure assessment. Theoretically, it is also possible that a 
residential, or other non-dietary, exposure could be combined with the 
acute total dietary exposure from food and water. However, the Agency 
does not believe that aggregating multiple exposure to large amounts of 
pesticide residues in the residential environment via multiple products 
and routes for a one day exposure is a reasonably probable event. 
Additionally, the concept of an acute exposure as a single exposure 
does not allow for including post-application exposures, in which 
residues decline over a period of days after application. Therefore, 
the Agency believes that residential exposures are more appropriately 
included in the short-term exposure scenario.
    The acute dietary (food only) risk assessment used tolerance level 
residues and assumed 100% crop-treated. The resulting high-end exposure 
estimate of 0.01125 mg/kg/day, results in a dietary (food only) MOE of 
8,888 for females 13+ years old which is considered acceptable.
    Using the available monitoring data for groundwater, an exposure 
estimate of 3  x  10-3 mg/kg/day for adults was calculated. 
Adding this water exposure to the food exposure resulted in a MOE of 
7,000 for females 13+ years.
    It should be noted that the acute drinking water component of the 
risk calculations presented in this document are relevant to sub-
populations with high-end exposure within the United States (FL and 
CA). Because the calculated risk, based on high-end exposure is 
acceptable, we believe that the overall risk assessment is protective 
of the whole U.S. population.
    In the best scientific judgment of the Office of Pesticide 
Programs, the aggregate acute risk (food and water) from the currently 
registered uses and this section 18 use of bentazon does not exceed our 
level of concern.
    2. Chronic exposure-- i. Dietary-food exposure. The chronic dietary 
(food only) risk assessment used tolerance level residues and assumed 
100% crop treated. Therefore, the resulting exposure estimates should 
be viewed as conservative; further refinement using anticipated 
residues and percent of crop-treated would result in lower dietary 
exposure estimates. The existing bentazon tolerances plus the proposed 
Section 18 use resulted in a Theoretical Maximum Residue Contribution 
(TMRC) that is equivalent to the following percentages of the RfD:

------------------------------------------------------------------------
                                                 TMRC(mg/kg/            
                 Subpopulation                      day)     Percent RfD
------------------------------------------------------------------------
U.S. Population................................  0.001079             12
Nursing Infants................................  0.001755             18
Non-Nursing Infants (< 1 year old).............  0.003755             39
Children (1-6 years old).......................  0.002411             24
Children (7-12 years old)......................  0.001633             15
Hispanics......................................  0.001074             12
------------------------------------------------------------------------


[[Page 33566]]

    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).
    ii. Dietary and drinking water exposure. To account for the 
exposure from drinking water, the Agency decided to use the Health 
Advisory level of 20 ppb. This level is a conservative estimate of 
exposure since it is unlikely that a person would be exposed to this 
level daily for a life-time. The following assumptions were made during 
the calculations: an adult weighs 70 kg and consumes 2 liters of water 
a day, a child weighs 10 kg and consumes 1 liter of water a day. Using 
the Health Advisory level of 20 ppb for bentazon in groundwater, and 
adding the calculated percentage of the RfD based on consumption by 
adults and children, to the existing percent of the RfD for food 
consumption, the total percentage of the RfD taken up by food and water 
consumption is:

------------------------------------------------------------------------
                                      Percent RfD                       
         Subpopulation          ---------------------- Total Percent RfD
                                    Food      Water                     
------------------------------------------------------------------------
U.S. Population................         12          6  18               
Nursing Infants................         18         21  39               
Non-Nursing Infants (<1 year            39         21  60               
 old).                                                                  
Children (1-6 years old).......         24         21  45               
Children (7-12 years old)......         15         21  36               
Hispanics......................         12          6  18               
------------------------------------------------------------------------

    Using these conservative estimates, the sum total of the aggregate 
chronic risk estimates (food + water) for bentazon for the population 
subgroup with the largest percentage of the RfD occupied (non-nursing 
infants less than 1 year old) is 60%. In the best scientific judgement 
of HED, the bentazon aggregate chronic risk does not exceed our level 
of concern.
    3. Short- and intermediate-term exposure. 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. Although residential exposure data are 
not available for ornamentals and ornamental turf uses of bentazon, the 
Agency notes that large MOEs were calculated for acute aggregate risk 
( 7,000) and occupational exposure (> 6,000 for the most 
highly exposed group, aerial mixer loader). Therefore the Agency 
believes short- and intermediate-term aggregate risk is likely to be 
below the Agency's level of concern.

C. 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 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 bentazon 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, 
bentazon 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 bentazon has a common mechanism of toxicity 
with other substances.

D. Determination of Safety for U.S. Population

    1. Acute risk. The acute dietary (food only) risk assessment used 
tolerance level residues and assumed 100% crop-treated. The resulting 
high-end exposure estimate of 0.01125 mg/kg/day, results in a dietary 
(food only) MOE of 8,888 for females 13+ years old, which is considered 
acceptable.
    Using the available monitoring data for groundwater, an exposure 
estimate of 3  x  10-3 mg/kg/day for adults was calculated. 
Adding this water exposure to the food exposure resulted in a MOE of 
7,000 for females 13+ years.
    It should be noted that the acute drinking water component of the 
risk calculations presented in this document are relevant to sub-
populations with high-end exposure within the United States (FL and 
CA). Because the calculated risk, based on high-end exposure is 
acceptable, we believe that the overall risk assessment is protective 
of the whole U.S. population.
    The Agency believes that the aggregate acute risk (food and water) 
from the currently registered uses and this Section 18 use of bentazon 
does not exceed our level of concern.
    2. Short- and intermediate-term risk. Although residential exposure 
data are not available for ornamental lawn uses of bentazon, the Agency 
notes that large MOEs were calculated for acute aggregate risk 
( 7,000) and occupational exposure (> 6,000 for the most 
highly exposed group, aerial mixer loader). In the best scientific 
judgement of the Agency, short- and intermediate-term aggregate risk 
will be below the Agncy's level of concern.
    3. Chronic risk. Using the conservative TMRC exposure assumptions 
described above, EPA has concluded that aggregate exposure to bentazon 
from food will utilize 18% of the RfD for the U.S. population. The 
major identifiable subgroup with the

[[Page 33567]]

highest aggregate exposure is non-nursing infants which is discussed 
below. EPA generally has no concern for exposures below 100 percent of 
the RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose 0appreciable 
risks to human health. Despite the potential for exposure to bentazon 
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 bentazon residues.

E. Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of bentazon, 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 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 margin of exposure 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 margin of exposure and uncertainty factor (usually 
100 for combined inter- and intra-species variability) and not the 
additional tenfold margin of exposure/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 margin of exposure/safety factor.
    1. Developmental toxicity studies--a. Rat study. From the rat 
developmental toxicity study, the maternal (systemic) NOEL was 250 mg/
kg/day, the highest dose tested (HDT). The developmental (fetal) NOEL 
was 100 mg/kg/day, based on increased post-implantation loss and 
decreased fetal body weight at the lowest observed effect level (LOEL) 
of 250 mg/kg/day.
    b. Rabbit study. From the rabbit developmental toxicity study, the 
maternal (systemic) NOEL was 150 mg/kg/day, based on abortion and 
embryonic resorptions at the LOEL of 375 mg/kg/day. The developmental 
(fetal) NOEL was 375 mg/kg/day, the HDT.
    The presence of developmental effects in the absence of maternal 
effects in the rat developmental toxicity study indicates that there is 
extra pre-natal sensitivity for infants and children. The significant 
developmental findings in the rat required an acute dietary risk 
assessment for females 13+ years of age.
    2. Reproductive toxicity study.--a. Rat study. From the rat 
reproductive study, the parental (systemic) NOEL was 62 mg/kg/day, 
based on increased incidences of kidney mineralization and liver 
microgranules at the LOEL of 249 mg/kg/day. The reproductive (pup) NOEL 
was 15 mg/kg/day, based on decreased pup body weight and weight gain at 
the LEL of 62 mg/kg/day.
    3. Pre- and post-natal sensitivity. Based on the results of the 
reproductive toxicity study in rats, there were developmental (pup) 
effects in the absence of parental effects. These results indicate 
extra post-natal sensitivity for infants and children. This finding 
requires a modifying factor of 3 to be added to the RfD. The RfD should 
be, therefore, changed from 0.03 mg/kg/day to 0.01 mg/kg/day for 
purposes of these section 18's only.
    4. Acute risk. The acute dietary (food only) risk assessment used 
tolerance level residues and assumed 100% crop-treated. The resulting 
high-end exposure estimate of 0.01125 mg/kg/day, results in a dietary 
(food only) MOE of 8,888 for females 13+ years old. If water is 
considered in the acute exposure, the MOE is 7,000. Exposure estimates 
(MOEs) for both scenarios are considered acceptable.
    5. Short- or 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. Although residential exposure data are not 
available for ornamental lawn uses of bentazon, the Agency notes that 
large MOEs were calculated for acute aggregate risk ( 7,000) 
and occupational exposure (> 6,000 for the most highly exposed group, 
aerial mixer loader). Therefore the Agency believes short- and 
intermediate-term aggregate risk is likely to be below the Agency's 
level of concern.
    6. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to bentazon 
from food and water will utilize no more than 60% of the RfD for non-
nursing infants and children, the most highly exposed sub-population. 
EPA generally has no concern for exposures below 100 percent 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 bentazon 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 bentazon residues.

V. Other Considerations

    1. Metabolism in plants and animals. The qualitative nature of the 
residue in plants is considered to be adequately understood. 
Radiolabelled studies conducted at rates of up to 2.5 lb active 
ingredient/acre on beans, corn, soybeans, rice and wheat indicate that 
bentazon is readily absorbed from foliage, roots and seeds, and 
translocates in some plant types. Bentazon is rapidly metabolized, 
conjugated and incorporated into natural plant constituents. Metabolism 
involves the hydroxylation of bentazon at the 6- and 8-position. The 
terminal residues of regulatory concern are bentazon, 6-hydroxy 
bentazon, and 8-hydroxy bentazon (as specified in 40 CFR 180.355 (a)).
    2. Analytical enforcement methodology. Adequate enforcement methods 
are available for the determination of residues of bentazon and its 6- 
and 8-hydroxy metabolites in/on plant commodities. The Pesticide 
Analytical Manual (PAM) Vol. II lists Method II, a GLC method with 
flame photometric detection for the determination of bentazon and its 
hydroxy metabolites in/on corn, rice, and soybeans; the limit of 
detection for each compound is 0.05 ppm. Method III, modified from 
Method II, is available for the determination of bentazon and its 
hydroxy metabolites in/on peanuts and seed and pod vegetables with a 
limit of detection of 0.05 ppm for each compound.
    3. Magnitude of residues. Regulable residues of bentazon and its 
metabolites are not expected to exceed 3 ppm in/on succulent peas as a 
result of this Section 18 use only.

[[Page 33568]]

    4. Rotational crop restrictions. Confined rotational crop data 
indicate that bentazon residues may be taken up by rotational crops (39 
to 102 day plantback intervals), and that field rotational crop studies 
are needed for the purposes of reregistration in order to determine if 
plantback restrictions for bentazon end-use products are needed. The 
petitioner will need to modify the proposed Basagran label once the 
field rotational crop studies are submitted by the petitioner and 
review by the Agency.
    5. International residue limits. There is a Codex MRL of 0.2 ppm 
for bentazon and its metabolites established in/on garden peas (young 
pods), a Canadian MRL for parent only of 0.1 ppm (negligible) 
established in/on peas, and a Mexican limit for parent (presumed) of 
0.05 ppm established in/on green peas. Therefore, a compatibility issue 
is relevant to the proposed tolerance. Harmonization of the U.S. 
tolerance will not be possible as the use pattern proposed in this 
petition will result in residues which greatly exceed the Codex MRL.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of bentazon in 
succulent peas at 3 ppm. In addition to the tolerance being established 
for residues of bentazon in succulent peas, EPA is also, removing 
Sec. 186.375 which contains a tolerance for residues of bentazon on 
spent mint hay. That tolerance is being transferred to the table in 
paragraph (a) of Sec. 180.355.

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 August 19, 1997, file written objections to any 
aspect of this regulation (including the revocation provision) 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 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

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket number 
[OPP-300499] (including comments and data submitted electronically as 
described below). 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 
official rulemaking record is located at the address in ADDRESSES at 
the beginning of this document.
    Electronic comments can 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. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number [OPP-300499]. Electronic comments on 
this proposed rule may be filed online at many Federal Depository 
Libraries.

IX. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA and is related to EPA's granting emergency exemptions 
under section 18 of the FIFRA. 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). In addition, this final rule does not contain any 
information collections subject to additional 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, because these tolerances are established without 
notice and comment rulemaking, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. Nonetheless, 
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 significant adverse economic impact 
associated with these actions (46 FR 24950, May 4, 1981). In accordance 
with Small Business Administration (SBA) policy, this determination 
will be provided to the Chief Counsel for Advocacy of the SBA upon 
request.

[[Page 33569]]

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 Parts 180 and 186

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

    Dated: June 2, 1997.

James Jones,

Acting 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 180.355 is amended as follows:
    i. By adding a paragraph heading to paragraph (a), and revising the 
phrase ``raw agricultural commodities'' to read ``food commodities''.
    ii. By adding alphabetically an entry for ``Mint, spent hay'' to 
the table in paragraph (a).
    iii. In paragraph (b), by transferring and alphabetically adding 
all of the entries currently in the table to the table in paragraph (a)
    iv. By revising the remainder of paragraph (b).
    v. By adding and reserving paragraphs (c) and (d).


Sec. 180.355   Bentazon; tolerances for residues.

    (a) General. *  *  *

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Mint, spent hay............................................            4
                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for combined residues of the herbicide bentazon and its 
metabolites 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    Revocation
                                                  million        Date   
------------------------------------------------------------------------
Peas, succulent...............................            3      6/30/98
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues.  [Reserved]
*     *     *     *      *

PART 186--[AMENDED]

    2. In part 186:
    a.The authority citation for part 186 continues to read as follows:

    Authority: 21 U.S.C. 342, 348, and 701.

Sec. 186.375 [Removed]

    b. Section 186.375 is removed.

[FR Doc. 97-16215 Filed 6-19-97; 8:45 am]
BILLING CODE 6560-50-F