[Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
[Rules and Regulations]
[Pages 15615-15620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8387]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300464; FRL-5597-2]
RIN 2070-AC78


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 raw 
agricultural commodities potatoes, milk; and meat, meat by-products, 
and fat of cattle, goat, horse, sheep, and hogs 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 potatoes in the states of California, and 
Texas. This regulation establishes maximum permissible levels for 
residues of propamocarb hydrochloride in these foods 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 tolerances will 
expire and be revoked by EPA on March 15, 1999.

DATES: This regulation becomes effective April 2, 1997. Objections and 
requests for hearings must be received by EPA on or before June 2, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300464], 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-300464], must also be submitted to: 
Public Response and Program Resources Branch, Field Operations 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: 
<a href="/cdn-cgi/l/email-protection#701f00005d141f131b1504301500111d11191c5e1500115e171f06"><span class="__cf_email__" data-cfemail="355a454518515a565e50417550455458545c591b5045541b525a43">[email protected]</span></a>. 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-
300464]. 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: 
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
Arlington, VA 22202. (703) 308-8326, e-mail: 
<a href="/cdn-cgi/l/email-protection#0171646c636473756e6f2f6d68636378416471606c60686d2f6471602f666e77"><span class="__cf_email__" data-cfemail="f8889d959a9d8a8c9796d694919a9a81b89d889995999194d69d8899d69f978e">[email protected]</span></a>.

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 potatoes at 0.5 parts per 
million (ppm) and in milk; and meat, meat by-products, and fat of 
cattle, goat, horse, sheep, and hogs at 0.1

[[Page 15616]]

ppm. These tolerances will expire on March 15, 1999.

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) 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, 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. Section 408(l)(6) 
also requires EPA to promulgate regulations by August 3, 1997, 
governing the establishment of tolerances and exemptions under section 
408(l)(6) and requires that the regulations be consistent with section 
408(b)(2) and (c)(2) and FIFRA section 18.
    Section 408(l)(6) allows EPA to establish tolerances or exemptions 
from the requirement for a tolerance, in connection with EPA's granting 
of FIFRA section 18 emergency exemptions, without providing notice or a 
period for public comment. Thus, consistent with the need to act 
expeditiously on requests for emergency exemptions under FIFRA, EPA can 
establish such tolerances or exemptions under the authority of section 
408(e) and (l)(6) without notice and comment rulemaking.
    In establishing section 18-related tolerances and exemptions during 
this interim period before EPA issues the section 408(l)(6) procedural 
regulation and before EPA makes its broad policy decisions concerning 
the interpretation and implementation of the new section 408, EPA does 
not intend to set precedents for the application of section 408 and the 
new safety standard to other tolerances and exemptions. Rather, these 
early section 18 tolerance and exemption decisions will be made on a 
case-by-case basis and will not bind EPA as it proceeds with further 
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new 
law.

II. Emergency Exemptions for Propamocarb Hydrochloride on Potatoes 
and FFDCA Tolerances

    EPA has authorized use under FIFRA section 18 of propamocarb 
hydrochloride on potatoes for control of late blight. Recent failures 
to control late blight in potatoes as well as tomatoes 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 U.S. were previously 
controlled by treatment with metalaxyl. Presently, there are no 
fungicides registered in the U.S. that will provide adequate control of 
the immigrant strains of late blight. After having reviewed their 
submission, EPA concurs that an emergency condition exists.
    As part of its assessment of these specific exemptions, EPA 
assessed the potential risks presented by residues of propamocarb 
hydrochloride on potatoes and milk; and meat, meat by-products, and fat 
of cattle, goat, horse, sheep, and hogs. 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 for residues of propamocarb hydrochloride 
will permit the marketing of potatoes treated in accordance with the 
provisions of the section 18 emergency exemptions and the marketing of 
milk; and meat, meat by-products, and fat of cattle, goat, horse, 
sheep, and hogs with secondary residues resulting from the feeding of 
the feedstuffs of treated potatoes. 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 these tolerances will expire and be revoked by EPA 
on March 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 potatoes and milk; and meat, meat 
by-products, and fat of cattle, goat, horse, sheep, and hogs after that 
date will not be unlawful, provided the pesticide is applied during the 
term of, and in accordance with all the conditions of, the emergency 
exemptions. EPA will take action to revoke these tolerances earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicates that the residues are not safe.
    EPA has not made any decisions about whether propamocarb 
hydrochloride meets the requirements for registration under FIFRA 
section 3 for use on potatoes or whether a permanent tolerance for 
propamocarb hydrochloride for potatoes and milk; and meat, meat by-
products, and fat of cattle, goat, horse, sheep, and hogs would be 
appropriate. This action by EPA does not serve as a basis for 
registration of propamocarb hydrochloride by a State for special local 
needs under FIFRA section 24(c). Nor does this action serve as the 
basis for any States other than California, Texas and States which are 
subsequently granted specific exemptions for this use to use this 
product 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

[[Page 15617]]

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% or less of the RfD) is 
generally considered acceptable by EPA.
    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, and other non-
occupational exposures, such as where residues leach into groundwater 
or surface water that is consumed as drinking water. 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% 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 
these actions. Propamocarb hydrochloride is registered by EPA for turf 
and ornamental use. EPA believes it has sufficient data to assess the 
hazards of propamocarb hydrochloride and to make a determination on 
aggregate exposure, consistent with section 408(b)(2), for the time-
limited tolerances for residues of propamocarb hydrochloride on 
potatoes at 0.5 parts per million (ppm) and in milk; and meat, meat by-
products, and fat of cattle, goat, horse, sheep, and hogs at 0.1 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing these tolerances follows.

A. Toxicological Profile

    1. Chronic toxicity. Based on the available chronic toxicity data, 
EPA's Office of Pesticide Programs (OPP) has established the RfD for 
propamocarb hydrochloride at 0.11 milligrams (mg)/kilograms (kg)/day. 
The RfD was established based on a threshold LOEL (lowest observable 
effect level) of 33.31 mg/kg/day in males and 33.27 mg/kg in females in 
a 11-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 inter-species 
extrapolation and intra-species variability. An additional UF of 3 was 
used to account for the lack of a NOEL.
    2. Acute toxicity. Agency toxicologists have recommended that the 
developmental NOEL of 150 mg/kg/day from the rabbit developmental 
toxicity study be used for acute dietary risk calculations. The 
developmental 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.
    3. Short-term non-dietary inhalation and dermal 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 6-18. The developmental NOEL was 150 
mg/kg/day. The developmental LOEL of 300 mg/kg/day was based on 
increased post-implantation loss.
    4. Carcinogenicity. 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

    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.
    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. 
These conservative assumptions result in overestimation of human 
dietary exposures.
    In examining aggregate exposure, FQPA directs EPA to consider 
available

[[Page 15618]]

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).
    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.
    Propamocarb hydrochloride is registered for uses, such as lawn and 
ornamental, 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. However, available data for propamocarb hydrochloride 
indicate no evidence of toxicity by the dermal or inhalation routes.
    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 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 subtances.

C. Safety Determinations For U.S. Population

    Taking into account the completeness and reliability of the 
toxicity data, EPA has concluded that dietary exposure to propamocarb 
hydrochloride in food from published tolerances will utilize 2% of the 
RfD for the U.S. population. A dietary (food only) MOE of greater than 
118 would not be of Agency concern. A MOE of 30,000 was calculated.
    EPA does not believe exposure to propamocarb hydrochloride in 
drinking water or from residential uses would raise the percent of RfD 
utilized or lower the MOE, to such extent that there was not an 
adequate margin of exposure. 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 
tolerance 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 tolerance is granted. An appropriate bounding figure for 
residential exposure is expected to be lower than for drinking water. 
Therefore, EPA concludes that there is a reasonable certainty that no 
harm will result from aggregate exposure to propamocarb hydrochloride 
residues.

D. Determination of Safety for Infants and Children.

    FFDCA section 408 provides that EPA shall apply an additional ten-
fold

[[Page 15619]]

margin of exposure (safety) for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the data base unless EPA determines that a different 
margin of exposure (safety) will be safe for infants and children. 
Margins of exposure (safety) are often referred to as uncertainty 
(safety) factors. EPA believes that reliable data support using the 
standard margin of exposure (usually 100x for combined inter- and 
intra-species variability)) and not the additional ten-fold margin of 
exposure 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. Based on 
current toxicological data requirements, the data base for propamocarb 
hydrochloride relative to pre- and post-natal toxicity is not complete.
    The pre- and post-natal toxicology data base for propamocarb is not 
complete with respect to current toxicological data requirements. 
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 
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 would be deemed appropriate for 
propamocarb, 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). However, considering the large dietary MOE calculated for 
females 13+ years (MOE = 30,000), even if an additional ten-fold 
uncertainty factor were applied, aggregate acute risk estimates would 
not exceed the margin of exposure. Therefore, EPA concludes that this 
tolerance will pose reasonable certainty of no harm to infants and 
children.
    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 7% 
for non-nursing infants (<1 year old). However, this 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 potatoes is 
adequately understood for the purposes of this tolerance. There are no 
Codex maximum residue levels established for residues of propamocarb 
hydrochloride. The residue of concern, for the purposes of this 
tolerance, 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; however, an independent laboratory validation has 
not been submitted. Further the method has not undergone Agency method 
validation. The method is available to anyone who is interested in 
pesticide residue enforcement from: By mail, Calvin Furlow, Public 
Response and Program Resources Branch, Field Operations 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 22202, 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 potatoes at 0.5 parts per million (ppm) and in 
milk; and meat, meat by-products, and fat of cattle, goat, horse, 
sheep, and hogs at 0.1 ppm. These tolerances will expire and be revoked 
by EPA on March 15, 1999.

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 June 2, 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

[[Page 15620]]

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

    A record has been established for this rulemaking under docket 
number [OPP-300464]. A public version of this record, 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 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, 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. The official rulemaking 
record is the paper record maintained at the address in ``ADDRESSES'' 
at the beginning of this document.

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.
    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), 
entitled Enhancing the Intergovernmental Partnership, 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 tolerances, 
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 Administrative Procedure Act 
(APA) as amended by 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 this 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

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

    Dated: March 17, 1997.

Stephen L. Johnson,
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. By adding Sec. 180.499 to read as follows:


Sec. 180.499   Propamocarb hydrochloride, tolerances for residues.

    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 are specified in the following table. The tolerances expire 
and will be revoked on the date specified in the table by EPA.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Potatoes                          0.5                 March 15, 1999    
Cattle, fat                       0.1                 March 15, 1999    
Cattle, meat                      0.1                 March 15, 1999    
Cattle, mbyp (except kidney and   0.1                 March 15, 1999    
 liver)                                                                 
Goats, fat                        0.1                 March 15, 1999    
Goats, meat                       0.1                 March 15, 1999    
Goats, mbyp (except kidney and    0.1                 March 15, 1999    
 liver)                                                                 
Hogs, fat                         0.1                 March 15, 1999    
Hogs, meat                        0.1                 March 15, 1999    
Hogs, mbyp (except kidney and     0.1                 March 15, 1999    
 liver)                                                                 
Horse, fat                        0.1                 March 15, 1999    
Horse, meat                       0.1                 March 15, 1999    
Horse, mbyp (except kidney and    0.1                 March 15, 1999    
 liver)                                                                 
Sheep, fat                        0.1                 March 15, 1999    
Sheep, meat                       0.1                 March 15, 1999    
Sheep, mbyp (except kidney and    0.1                 March 15, 1999    
 liver)                                                                 
Milk                              0.1                 March 15, 1999    
------------------------------------------------------------------------


[FR Doc. 97-8387 Filed 4-1-97; 8:45 am]
BILLING CODE 6560-50-F


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