[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Rules and Regulations]
[Pages 26960-26966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12908]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300489; FRL-5717-5]
RIN 2070-AB78


Propamocarb Hydrochloride; Pesticide Tolerance for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the fungicide propamocarb hydrochloride in or on the food 
commodities tomatoes, tomato puree, and tomato paste in connection with 
EPA's granting of emergency exemptions under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of 
propamocarb hydrochloride on

[[Page 26961]]

tomatoes in the states of California, Florida, Maryland, New Jersey, 
New York, Pennsylvania, and Virginia. The tolerances will expire and 
are revoked by EPA on May 15, 1999.
DATES: This regulation becomes effective May 16, 1997. Objections and 
requests for hearings must be received by EPA on or before July 15, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300489], 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-300489], 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-300489]. 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: Libby Pemberton, Registration 
Division (7505W), 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 Highway, 
Arlington, VA (703) 308-8326, 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 
residues of propamocarb hydrochloride on tomatoes at 0.5 parts per 
million (ppm), in tomato puree at 1.0 ppm, and in tomato paste at 3.0 
ppm. These tolerances will expire and be revoked by EPA on May 15, 
1999. After May 15, 1999, 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 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 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 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 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 tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemptions for Propamocarb hydrochloride on Tomatoes 
and FFDCA Tolerances

    Recent failures to control late blight in tomatoes and potatoes 
with the registered fungicides, have been caused almost exclusively by 
immigrant strains of late blight (Phytophthora infestans), which are 
resistant to the control of choice, metalaxyl. Before the immigrant 
strains of late blight arrived, all of the strains in the United States 
were previously controlled by treatment with metalaxyl. Presently, 
there are no fungicides registered in the United States that will 
provide adequate control of the immigrant strains of late blight. After 
having reviewed their submissions, EPA concurs that emergency 
conditions exist for the states previously listed.
    As part of its assessment of these specific exemptions, EPA 
assessed the potential risks presented by residues of propamocarb 
hydrochloride on tomatoes, in tomato puree, and in tomato paste. 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 clearly be consistent with the new safety 
standard and with FIFRA section 18. These tolerances will permit the 
marketing of tomatoes treated in accordance with the provisions of the 
section 18 emergency exemptions and the marketing of tomato puree and 
tomato paste containing residues resulting from the processing of 
treated tomatoes. Consistent with the need to move quickly on these 
emergency exemptions in order to address an urgent 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

[[Page 26962]]

these tolerances will expire and are revoked by EPA on May 15, 1999, 
under FFDCA section 408(l)(5), residues of propamocarb hydrochloride 
not in excess of the amount specified in these tolerances remaining in 
or on tomatoes, tomato puree and tomato paste after that date will not 
be unlawful, provided the pesticide is applied during the term of, and 
in accordance with all the conditions of, section 18 of 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.
    EPA has not made any decisions about whether propamocarb 
hydrochloride meets EPA's registration requirements for use on tomatoes 
or whether permanent tolerances for this use would be appropriate. 
These tolerances do not serve as a basis for registration of 
propamocarb hydrochloride by a State for special local needs under 
FIFRA section 24(c). Nor do these tolerances serve as the basis for any 
states other than California, Florida, Maryland, New Jersey, New York, 
Pennsylvania and Virginia 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 exemptions for propamocarb hydrochloride, 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 hundredfold 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 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.
    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. 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 propamocarb 
hydrochloride are discussed below.
    1. Acute toxicity. Agency toxicologists have recommended that the 
developmental NOEL of 150 milligrams per kilogram per day (mg/kg/day) 
from the rabbit developmental toxicity study be used for acute dietary 
risk calculations. The developmental lowest observable effect level 
(LOEL) of 300 mg/kg/day is based on increased post-implantation loss 
(developmental) and decreased body weight gain (maternal). The 
population of concern for this risk assessment is females 13+ years 
old.
    2. Short- and intermediate-term toxicity. OPP recommends use of the 
developmental toxicity study in rabbits for short- and intermediate 
term MOE calculations. The maternal NOEL was 150 mg/kg/day and the LOEL 
of 300 mg/kg/day was based on decreased body weight gain during 
gestation days 6 to 18. The developmental NOEL was 150 mg/kg/day. The 
developmental LOEL of 300 mg/kg/day was based on increased post-
implantation loss.

[[Page 26963]]

    3. Chronic risk. Based on the available chronic toxicity data, the 
Office of Pesticide Programs (OPP) has established the RfD for 
propamocarb hydrochloride at 0.11 milligrams(mg)/kilogram(kg)/day. The 
RfD was established based on a threshold LOEL of 33.31 mg/kg/day in 
males and 33.27 mg/kg/day in females in a 1-year dog feeding study. The 
LOEL was based on body weight gain depression, decreased food 
efficiency and gastritis. An uncertainty factor (UF) of 100 was used to 
account for both interspecies extrapolation and intraspecies 
variability. An additional UF of 3 was used to account for the lack of 
a NOEL.
    4. Cancer risk. Propamocarb hydrochloride is classified as a 
``Group D'', not classifiable as to human carcinogenicity due to 
inadequacy of the data. Dietary rodent studies conducted in 1983 in 
Germany showed no evidence of carcinogenicity. The registrant is 
currently conducting studies in accordance with U.S. protocols.

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. There are no established U.S. tolerances for propamocarb 
hydrochloride, and there are no registered uses for propamocarb 
hydrochloride on food or feed crops in the United States.
    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 1 day exposure is a reasonably probable event. It is 
highly unlikely that, in 1 day, an individual would have multiple high-
end exposures to the same pesticide by treating their house via crack 
and crevice application, swimming in a pool, and be maximally exposed 
in the food and water consumed. 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. In conjunction with this Section 18 use, the acute dietary 
(food only) risk assessment used tolerance level residue values and 
assumed 100% crop treated for all commodities requiring tolerances, as 
did the time-limited tolerance established for the Section 18 exemption 
for potatoes.
    2. Chronic exposure-- i. Dietary - food exposures. For the purpose 
of assessing chronic dietary exposure from propamocarb hydrochloride, 
EPA assumed tolerance level residues and 100% of crop treated for the 
proposed use of propamocarb hydrochloride on tomatoes. These 
conservative assumptions result in overestimation of human dietary 
exposures. Secondary residues of propamocarb hydrochloride are not 
expected to transfer to animal commodities as a result of the proposed 
use.
    ii. Drinking water exposure. 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 
consumption of contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause propamocarb 
hydrochloride 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 propamocarb hydrochloride 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.
    Based on the available studies used in EPA's assessment of 
environmental risk, propamocarb hydrochloride is relatively non-
persistent and mobility varies as a function of soil texture and soil 
reaction. There is no entry for propamocarb hydrochloride in the 
``Pesticides in Groundwater Data Base'' (EPA 734-12-92-001, September 
1992). There is no established Maximum Concentration Level (MCL) for 
residues of propamocarb hydrochloride in drinking water. No drinking 
water health advisory levels have been established for propamocarb 
hydrochloride.
    iii. Non-dietary, non-occupational exposure--short and intermediate 
term exposure. Short- and intermediate-term aggregate exposure takes 
into account chronic dietary food and water (considered to be 
background exposure level) plus indoor and outdoor residential 
exposure. Propamocarb hydrochloride is registered for uses, such as 
lawn and ornamentals, that could result in non-occupational exposure 
and EPA acknowledges that there may be short-, intermediate-, and long-
term non-occupational, non-dietary exposure scenarios. At this time, 
the Agency has insufficient information to assess the potential risks 
from such exposure.

C. Cumulative Exposure to Substances with Common Mechanisms 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

[[Page 26964]]

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 propamocarb hydrochloride 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, 
propamocarb hydrochloride 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 propamocarb hydrochloride 
has a common mechanism of toxicity with other substances.

D. Determination of Safety for U.S. Population

    1. Acute risk. The acute dietary MOE for females 13+ years old 
(accounts for both maternal and fetal exposure) is 8,333. This MOE 
calculation was based on the developmental NOEL of 150 mg/kg/day from 
the developmental toxicity study in rabbits. This risk assessment also 
assumed 100% crop treated with tolerance level residues on all treated 
crops consumed, resulting in a significant over-estimate of dietary 
exposure. The large acute dietary MOE calculated for females 13+ years 
old provides assurance that there is a reasonable certainty of no harm 
for both females 13+ and infants and children resulting from pre-natal 
exposure to propamocarb hydrochloride, even if an additional tenfold 
safety factor were applied.
    2. Short- and intermediate-term risk. Propamocarb hydrochloride is 
registered for use on turf and ornamentals and EPA acknowledges that 
there may be short-, intermediate-, and long-term non-occupational 
exposure scenarios. OPP has identified a toxicity endpoint for short- 
and intermediate-term residential risk assessment. However, no 
acceptable reliable exposure data to assess these potential risks are 
available at this time. Given the time-limited nature of these 
requests, the need to make emergency exemption decisions quickly, and 
the significant scientific uncertainty at this time about how to 
aggregate non-occupational exposure with dietary exposure, the Agency 
will make its safety determination for this tolerance based on those 
factors which it can reasonably integrate into a risk assessment.
    3. Chronic risk. Using the conservative TMRC exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
propamocarb hydrochloride from food will utilize 3 percent of the RfD 
for the U.S. 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 propamocarb hydrochloride in drinking water 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 propamocarb hydrochloride residues.

E. Determination of Safety for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of propamocarb hydrochloride, 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 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.
    Based on current toxicological data requirements, the data base for 
propamocarb hydrochloride relative to pre- and post-natal toxicity is 
not complete. Although two acceptable prenatal developmental toxicity 
studies (in rats and rabbits) have been submitted to the Agency, the 
available rat reproductive toxicity study is not adequate. The RfD 
Committee considered it to be supplementary and not upgradeable based 
on the lack of systemic toxicity at dose levels, which did not achieve 
the limit dose, indicating inadequacy of the high dose for reproductive 
toxicity. Thus conclusions concerning post-natal sensitivity cannot be 
made.
    In the developmental toxicity study in rabbits, the developmental 
and maternal NOELs were both 150 mg/kg/day. The developmental and 
maternal LOELs of 300 mg/kg/day were based on increased post-
implantation loss (developmental) and decreased body weight gain 
(maternal). The NOELs and LOELs occurred at the same doses for 
developmental and maternal findings; there was no indication of pre-
natal sensitivity for infants and children.
    In the developmental toxicity study in rats, the developmental NOEL 
was 221 mg/kg/day and was below the maternal NOEL (740 mg/kg/day). The

[[Page 26965]]

developmental LOEL of 740 mg/kg/day was based on increased fetal death, 
and an increased incidence of minor skeletal anomalies (incomplete 
ossification of some vertebrae and sternebrae). The maternal NOEL was 
740 mg/kg/day, based on increased maternal death, spastic gait and 
decreased body weight at the LOEL of 2,210 mg/kg/day. These findings 
indicate the possibility of increased prenatal sensitivity of fetuses 
to in utero exposure to propamocarb.
    An additional uncertainty factor of 10x for infants and children is 
appropriate for propamocarb hydrochloride, based upon the lack of data 
to evaluate postnatal exposure (due to the inadequate reproduction 
study) and based upon the increased sensitivity to prenatal exposure 
(indicated by the rat developmental study NOELs). EPA has concluded 
that the percent of the RfD that will be utilized by chronic dietary 
(food) exposure to residues of propamocarb hydrochloride ranges from 2% 
for nursing infants (<1 year old) up to 8% for non-nursing infants (<1 
year old). The uncertainty factor will not raise the percent of the RfD 
utilized above the level of concern (100%). Additionally, the RfD 
calculation assumes tolerance level residues for all commodities and is 
therefore an over-estimate of dietary risk. Refinement of the dietary 
risk assessment by using anticipated residue data would reduce dietary 
exposure. The addition of potential exposure from propamocarb 
hydrochloride residues in drinking water is not expected to result in 
an exposure which would exceed the RfD.

V. Other Considerations

    The metabolism of propamocarb hydrochloride in tomatoes is 
adequately understood for the purposes of this tolerance. A CODEX MRL 
of 1 mg/kg has been established for residues of propamocarb per se in/
on tomatoes. The use pattern used for determining the CODEX MRL differs 
from that in this section 18 exemption (maximum use rate overseas is 
3.2 lbs active ingredient(ai)/acre per application, the maximum use 
rate in the United States is 0.9 lbs ai/acre). No Canadian or Mexican 
residue limits have been established. The residue of concern for the 
purposes of these tolerances is propamocarb hydrochloride.
    The proposed enforcement method designated UPSR 22/91 (MRID No. 
439840-04) submitted with petition 6F4707 is adequate to support the 
proposed time-limited tolerances. The method has been adequately 
radiovalidated for recovery of parent compound. The method is available 
to anyone who is interested in pesticide residue enforcement from: By 
mail, Calvin Furlow, 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. Office location and telephone number: Crystal 
Mall #2, Rm 1128, 1921 Jefferson Davis Hwy., Arlington, VA 703-305-
5805.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of propamocarb 
hydrochloride in or on tomatoes at 0.5 parts per million (ppm), tomato 
puree at 1.0 ppm, and tomato paste at 3.0 ppm.

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 July 15, 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 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 control 
number [OPP-300489] (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 control number [OPP-300489]. Electronic 
comments on this proposed rule may be filed online at many Federal 
Depository Libraries.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not ``a significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition,

[[Page 26966]]

this action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993) or 
special consideration as required by Executive Order 12898 (59 FR 7629, 
February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950) (May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 
Stat. 847), EPA 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 the rule in today's Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

 List of Subjects in 40 CFR Part 180

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

    Dated: May 8, 1997.

Peter Caulkins,

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 180.499 is amended as follows:
    i. By redesignating the existing text as paragraph (b), revising 
the introductory text of newly designated paragraph (b), in the third 
column to the table by changing ``March 15, 1999'' to ``3/15/99'', and 
alphabetically adding entries for tomatoes; tomato paste and tomato 
puree.
    ii. By correctly alphabetizing the entry for ``milk'' in the table.
    iii. By adding and reserving paragraphs (a), (c), and (d).


Sec. 180.499 Propamocarb hydrochloride; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide propamocarb hydrochloride 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 
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Tomatoes........................  0.5                 May 15, 1999      
Tomato, puree...................  1.0                 May 15, 1999      
Tomato, paste...................  3.0                 May 15, 1999      
------------------------------------------------------------------------

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

[FR Doc. 97-12908 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F