[Federal Register Volume 62, Number 168 (Friday, August 29, 1997)]
[Rules and Regulations]
[Pages 45741-45747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23096]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300532; FRL-5738-5]
RIN 2070-AB78


Desmedipham; 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 the 
herbicide desmedipham in or on garden beet roots

[[Page 45742]]

and tops. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of the pesticide on garden beet roots 
and tops. This regulation establishes a maximum permissible level for 
residues of desmedipham 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 29, 1997. Objections and 
requests for hearings must be received by EPA on or before October 28, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300532], 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-300532], 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-300532]. 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: Pat Cimino, 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) 308-9357, 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 tolerances for 
the herbicide desmedipham, in or on garden beet roots and tops at 0.2 
and 15.0 part per million (ppm) respectively. These tolerances will 
expire and are revoked on August 30, 1998. EPA will publish a document 
in the Federal Register to remove the revoked tolerances 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 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 Desmedipham on Garden Beet Roots and 
Tops and FFDCA Tolerances

    The New York State Department of Environmental Conservation 
requested the use of the herbicide desmedipham (Betanex 1.3 EC) for 
postemergence control of hairy galinsoga, redroot pigweed, common 
ragweed, common lambsquarters, wild mustard, eastern black nightshade, 
hairy nightshade and velvetleaf weeds in red garden beets in New York. 
These weeds were controlled by diethatyl-ethyl (Antor); however, this 
product was voluntarily canceled in 1993 and existing stocks have been 
exhausted. Alternatives do not provide effective control and growers 
will experience significant economic losses without the use of 
desmedipham. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of desmedipham in or on 
garden beet roots and tops. In doing so, EPA considered the new safety 
standard in FFDCA section 408(b)(2), and EPA decided that the necessary 
tolerances 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

[[Page 45743]]

non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances 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 tolerances 
remaining in or on garden beet roots and tops 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 these tolerances 
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 desmedipham meets EPA's 
registration requirements for use on garden beet roots and tops or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for registration of desmedipham by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances serve as the 
basis for any State other than New York 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 desmedipham, 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 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 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based 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

[[Page 45744]]

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 children (1-6 
years 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 
desmedipham and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
desmedipham on garden beet roots and tops at 0.2 and 15.0 ppm 
respectively. EPA's assessment of the dietary exposures and risks 
associated with establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by desmedipham are 
discussed below.
    1. Acute toxicity. For acute dietary risk assessment, the Agency 
recommended use of the NOEL of 150 mg/kg/day, based on slight increase 
in skeletal variations in developing pups at the lowest effect level 
(LEL) of 450 mg/kg/day, from the developmental study in rabbits. This 
NOEL is used to evaluate the Margin of Exposure (MOE) from the acute 
dietary risk to pregnant women (females 13+ years or older).
     2. Short - and intermediate - term toxicity. No short- or 
intermediate-term non-dietary, non-occupational exposure scenario 
exists for desmedipham.
    3. Chronic toxicity. EPA has established the RfD for desmedipham at 
0.04 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 
reproduction study in rats with a NOEL of 4 mg/kg/day and an 
uncertainty factor of 100. The effects observed at the LEL of 20 mg/kg/
day were significant increases in splenic weights and compensatory 
functioning of the thyroid.
    4. Carcinogenicity. Cancer risks have not been identified by the 
Agency. Desmedipham has been classified as a Group ``E'' chemical, no 
evidence of carcinogenicity, based on the results from two acceptable 
studies with two species.

B. Exposures and Risks

    1. From food and feed uses. A permanent tolerance of 0.2 ppm has 
been previously established (40 CFR 180.353) for negligible residues of 
the herbicide desmedipham, in or on sugar beet roots and tops. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from desmedipham as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. The acute dietary exposure endpoint of 
concern for desmedipham is a slight increase in skeletal variations in 
developing pups which was observed in the rabbit developmental study. 
The population subgroup of concern is females 13+ years old (women of 
childbearing age). Acute dietary exposure (food only) was calculated 
using the high end exposure value and TMRC (worst case) assumptions. 
Therefore, this risk assessment is considered conservative. Despite the 
potential for acute exposure to desmedipham in drinking water, EPA does 
not expect the aggregate acute exposure to exceed the Agency's level of 
concern.
    ii. Chronic exposure and risk. In conducting exposure assessments 
for this section 18 request, EPA used tolerance level residues and 
assumed that 100% of the crop would be treated with the pesticide (TMRC 
worst-case analysis assumptions, as described above).
    2. From drinking water. Based on information from the Weed Science 
Society Handbook (7th ed., 1994), desmedipham has the following 
environmental fate characteristics: 1) soluble in water to the extent 
of 7 mg/L at 20 C and pH 7; 2) half-life of 1 month in silty 
loam, sandy loam, and silty clay loam soils; and 3) exhibits no 
appreciable leaching with residues remaining in the top 2 inches of 
soil.
    No Maximum Concentration Level or Health Advisory Level has been 
established for residues of desmedipham in drinking water. There is no 
entry for desmedipham in the ``Pesticides in Groundwater Database'' 
(EPA 34-12-92-001, Sept. 1992).
    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

[[Page 45745]]

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 desmedipham to exceed the RfD if 
the tolerances being considered in this document were granted. The 
Agency has therefore concluded that the potential exposures associated 
with desmedipham 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 
tolerances are granted.
    3. From non-dietary exposure. Non-dietary, non-occupational 
exposure is not expected because desmedipham is not registered for 
indoor or outdoor residential uses.
    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 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 desmedipham 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, 
desmedipham 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 desmedipham has a common mechanism of toxicity 
with other substances.

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

    1. Acute risk. For the US population subgroup of concern, pregnant 
females (13+ years of age), an MOE value of 375,000 was calculated 
using the high end human exposure value of 0.0004 mg/kg/day. The Agency 
generally considers MOEs over 100 (food only) acceptable. This acute 
dietary (food only) risk assessment used tolerance level residues and 
assumed 100% crop-treated (TMRC worst-case analysis, described above).
    Despite the potential for risk from acute exposure to desmedipham 
in drinking water, the Agency does not expect acute aggregate exposure 
to exceed its level of concern. EPA concludes that there is a 
reasonable certainty that no harm will result from acute aggregate 
exposure to desmedipham.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to desmedipham from 
food will utilize less than 1.0% of the RfD for the U.S. population. 
Aggregate exposure to desmedipham from food utilizes less than 1% of 
the RfD for all major identifiable subgroups, including infants and 
children. 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 desmedipham 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 desmedipham 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. Because no short- or intermediate-term non-
dietary, non-occupational exposure scenario exists for desmedipham, a 
short- or intermediate-term aggregate risk assessment is not required.

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 desmedipham, 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

[[Page 45746]]

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 developmental toxicity. 
The maternal (systemic) NOEL was 100 mg/kg/day, based on decreased 
weight gain at the lowest observed effect level (LOEL) of 1,000 mg/kg/
day. The developmental (pup) NOEL was 100 mg/kg/day, based on decreased 
fetal body weight and increased incidence of skeletal anomalies at the 
LOEL of 1,000 mg/kg/day.
    ii. Rabbit developmental toxicity. The maternal (systemic) NOEL was 
150 mg/kg/day, based on decreased weight gain at the LOEL of 450 mg/kg/
day. The developmental (pup) NOEL was 150 mg/kg/day, based on a slight 
increase in skeletal variations at the LEL of 450 mg/kg/day.
    c. Reproductive toxicity study-- Rat reproduction toxicity. The 
maternal (systemic) NOEL was 4 mg/kg/day, based on decreased body 
weight and hemolytic anemia at the LOEL of 20 mg/kg/day. The 
reproductive/developmental (pup) NOEL was 4 mg/kg/day, based on 
decreased pup body weight and reduced litter size at the LEL of 20 mg/
kg/day.
    d. Pre- and post-natal sensitivity. In the rat and rabbit 
developmental studies, both the developmental and maternal NOELs and 
LOELs (100 and 1,000 mg/kg/day for rats and 150 and 450 mg/kg/day for 
rabbits), respectively, occurred at the same dose levels which 
demonstrates that there is no special pre-natal sensitivity in infants 
and children exposed to desmedipham.
    In the rat reproductive study, both the pup and parental NOEL and 
LOEL of 4 and 20 mg/kg/day, respectively, occurred at the same dose 
level which demonstrates that there is no special post-natal 
sensitivity in infants and children exposed to desmedipham.
    e. Conclusion. The Agency concluded that the developmental and 
reproductive findings in rats did not demonstrate any pre-natal or 
post-natal acute risk concerns for infants and children.
    The Agency concluded that the observed developmental effects in the 
rabbit study, a slight increase in skeletal variations in developing 
pups, presents a pre-natal acute risk concern for infants and children. 
An acute dietary risk assessment evaluating margin of exposure (MOE) 
for pregnant women 13+ years or older is required when the Agency 
determines that there is a pre- or post- natal acute risk effect of 
concern.
    2. Acute risk. As described above, the acute dietary MOE for 
pregnant women 13+ years old is 375,000 based on the rabbit 
developmental NOEL of 150 mg/kg/day and the high end human exposure 
value of 0.0004 mg/kg/day. This MOE is much higher than the minimal 
acceptable MOE of 100 for acute exposure to food. Despite the potential 
for acute exposure to desmedipham in drinking water, the Agency does 
not expect acute aggregate exposure to exceed its level of concern. EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from acute aggregate exposure to desmedipham.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate chronic exposure to 
desmedipham from food will utilize less than 1% of the RfD for infants 
and children. 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 chronic exposure to 
desmedipham in drinking water, 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 chronic aggregate exposure to desmedipham residues.
    4. Short- or intermediate-term risk. Because no short- or 
intermediate-term non-dietary, non-occupational scenario exists for 
desmedipham, a short- or intermediate-term aggregate risk assessment is 
not required.

V. Other Considerations

A. Metabolism In Plants and Animals

    The qualitative nature of the desmedipham residue in plants is 
adequately understood. The residue of concern is desmedipham per se.

B. Analytical Enforcement Methodology

    A desmedipham-specific analytical method (HPLC UV/VIS) is available 
for enforcement.

C. Magnitude of Residues

     Residues of desmedipham are not expected to exceed 0.2 ppm in 
garden beet roots and 15.0 ppm in garden beet tops (leaves) as a result 
of this Section 18 use. Secondary residues of desmedipham are not 
expected in animal commodities as no livestock feed items are 
associated with this Section 18 use.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican international residue 
limits established for use of desmedipham on red (garden) beets.

VI. Conclusion

    Therefore, the tolerances are established for desmedipham in garden 
beet roots and tops at 0.2 and 15.0 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 28, 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

[[Page 45747]]

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

    EPA has established a record for this rulemaking under docket 
control number [OPP-300532] (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(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408 (d), 
such as the tolerances in this final rule, do not require the issuance 
of a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance 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, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 13, 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 180.353 is amended to read as follows:
    a. By designating the existing text as paragraph (a) and adding a 
heading.
    b. By adding paragraph (b).
    c. By adding the headings and reserving paragraphs (c) and (d).
    The added text reads as follows:


Sec. 180.353  Desmedipham; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date   
------------------------------------------------------------------------
Garden beet roots.............................          0.2      8/30/98
Garden beet tops..............................         15.0      8/30/98
------------------------------------------------------------------------

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

[FR Doc. 97-23096 Filed 8-28-97; 8:45 am]
BILLING CODE 6560-50-F