[Federal Register Volume 61, Number 181 (Tuesday, September 17, 1996)]
[Rules and Regulations]
[Pages 48843-48848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23905]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300436; FRL-5395-8]
RIN 2070-AB78


Pyridaben; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of the insecticide/miticide pyridaben in or on the 
raw agricultural commodity apples and the processed feed commodity wet 
apple pomace in connection with EPA's granting of emergency exemptions 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act authorizing use of pyridaben on apples in Delaware, New Jersey, and 
Virginia. This regulation establishes maximum permissible levels for 
residues of pyridaben 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 (Pub. L. 104-170). The tolerances will expire 
and be revoked automatically without further action by EPA on August 
23, 1997.
DATES: This regulation becomes effective September 17, 1996. This 
regulation expires and is revoked automatically without further action 
by EPA on August 23, 1997. Objections and requests for hearings must be 
received by EPA on November 18, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [OPP-300436], 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 number, [OPP-300436], should 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 22202. A copy of 
objections and hearing requests filed with the Hearing Clerk may also 
be submitted electronically by sending electronic mail (e-mail) to: 
[email protected]. Copies of objections and hearing requests 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Copies of objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1 file format 
or ASCII file format. All copies of objections and hearing requests in 
electronic form must be identified by the docket number [OPP-300436]. 
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 (7505W), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Sixth 
Floor, Crystal Station #1, 2800 Jefferson Davis Highway, Arlington, VA 
22202. (703) 308-8328, 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 the insecticide/miticide pyridaben [2-tert-butyl-5-(4-tert-
butylbenzylthio)-4-chloropyridazin-3(2H)-one] in or on apples at 0.5 
part per million (ppm) and in or on wet apple pomace at 1.0 ppm. These 
tolerances will expire and be revoked automatically without further 
action by EPA on August 23, 1997.

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.

[[Page 48844]]

    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 408(b)(2)(D) specifies factors EPA is to consider 
in establishing a tolerance. Section 408(b)(3) requires EPA to 
determine that there is a practical method for detecting and measuring 
levels of the pesticide chemical residue in or on food and that the 
tolerance be set at a level at or above the limit of detection of the 
designated method. Section 408(b)(4) requires EPA to determine whether 
a maximum residue level has been established for the pesticide chemical 
by the Codex Alimentarius Commission. If so, and EPA does not propose 
to adopt that level, EPA must publish for public comment a notice 
explaining the reasons for departing from the Codex level. Section 
408(c) governs EPA's establishment of exemptions from the requirement 
for a tolerance using the same safety standard as section 408(B)(2)(A) 
and incorporating the provisions of section 408(b)(2)(C) and (D).
    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. Generally, these regulations 
allow a State or Federal agency to apply for an exemption to allow use 
of a pesticide for which that pesticide is not registered to alleviate 
an emergency condition. The regulations set forth information 
requirements, procedures, and standards for EPA's approval or denial of 
such exemptions.
    Prior to FQPA, when EPA granted an emergency exemption under 
section 18 in connection with use of a pesticide that could result in 
residues of the pesticide chemical in or on food, EPA did not establish 
a tolerance or exemption from the requirement for a tolerance under 
FFDCA. Rather, EPA advised the Food and Drug Administration (FDA) of 
the emergency exemption and of the level of residues that EPA concluded 
would be present in or on affected foods as a result of the emergency 
use. However, new section 408(l)(6) requires EPA to establish a 
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(e) gives EPA general authority to establish tolerances 
and exemptions from the requirement for a tolerance through notice and 
comment rulemaking procedures upon EPA's initiative. 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 authority of section 408(e) and (l)(6) 
without notice and comment rulemaking. The other procedures set out in 
section 408(e) and (g) are applicable to these tolerances and 
exemptions. Tolerances and exemptions issued under section 408(l)(6) 
must be consistent with the safety standards in section 408(b)(2) and 
(c)(2), respectively, that are applicable to all tolerances and 
exemptions under section 408, and with FIFRA section 18. Section 
408(l)(6) specifies that such tolerances and exemptions must have an 
expiration date but does not specify how EPA is to set such an 
expiration date.
    In light of FQPA, EPA is engaged in an intensive process, including 
consultation with registrants, States, and other interested 
stakeholders, to make decisions on the new policies and procedures that 
will be appropriate as a result of enactment of FQPA. This process will 
generally delay the review of food use applications, particularly those 
involving exposure to children. However, recognizing the importance of 
FIFRA section 18 emergency exemptions and their time sensitive nature, 
EPA will continue to process section 18 applications for food uses 
which clearly are emergencies and which clearly are consistent with the 
new FFDCA section 408 safety standard and with FIFRA section 18. EPA 
will publish a notice in the Federal Register soon summarizing the 
requirements of FQPA, indicating how EPA intends to meet those 
requirements, and describing actions necessary to assure that EPA 
complies with the law. EPA intends to promulgate the procedural rule 
required under section 408(l)(6) by August 3, 1997, but EPA also 
intends to continue to grant appropriate section 18 emergency 
exemptions and issue the associated tolerances and exemptions in the 
interim pending promulgation of that rule. EPA also intends to issue 
interim guidance to States and others on how EPA will implement section 
18 of FIFRA and section 408(l)(6) in the near future.
    EPA intends to address how it will provide an expiration date for 
section 408(l)(6) tolerances and exemptions in the general procedural 
rule to be promulgated by August 3, 1997. In the interim, EPA has 
decided to proceed as follows. Section 408(l)(5) specifies that, if a 
tolerance or exemption from the requirement for a tolerance for a 
pesticide chemical residue in or on a food has been revoked under 
section 408, food containing the residue is not unsafe (and thus 
subject to action by FDA as ``adulterated'') if ``the residue is 
present as the result of an application or use of a pesticide at a time 
and in a manner that was lawful'' under FIFRA and ``the residue does 
not exceed a level that was authorized at the time of that application 
or use to be present on the food under a tolerance....'' Taking section 
408(l)(5) and (6) together, EPA has concluded that the best way to 
effect an ``expiration date'' during this interim period for a 
tolerance or exemption established in connection with EPA's grant of a 
FIFRA section 18 emergency exemption is to specify that the tolerance 
or exemption will expire and be revoked automatically, without further 
action by EPA, as of a specified date. That date will generally be 
approximately 1 year from the date of issuance of the emergency 
exemption. Under section 408(l)(5), food that contains residues of the 
pesticide chemical as a result of lawful use under the terms of the 
section 18 emergency exemption, and at levels that are within those set 
by the tolerance or exemption that was established under section 
408(l)(6) in connection with the section

[[Page 48845]]

18 action, would remain lawful after the tolerance or exemption is 
automatically revoked. EPA believes that handling the section 18-
related tolerances and exemptions in this manner will allow EPA to 
respond promptly to emergency conditions during this interim period and 
will ensure that food containing pesticide residues as a result of use 
under an emergency exemption will not be considered ``adulterated.''
    In deciding to continue to act on section 18 emergency exemptions 
and to issue the associated tolerances and exemptions early in the 
process of FQPA implementation, EPA recognizes that it will be 
necessary to make decisions about the new FFDCA section 408, including 
the new safety standard. 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 Pyridaben on Apples and FFDCA 
Tolerances

    On August 23, 1996, EPA approved emergency exemptions under FIFRA 
section 18 for the states of Delaware, New Jersey and Virginia for use 
of pyridaben on apples in those states to control European red mite and 
two-spotted spider mite. Emergency conditions are determined to exist 
since there are no effective pesticides available for late-season use 
in Integrated Pest Management (IPM) programs for control of mites in 
Delaware, New Jersey and Virginia. The available data indicate that 
pyridaben is effective for mite control and is compatible with mid-
Atlantic apple IPM programs.
    As part of its assessment of these applications for emergency 
exemptions, EPA assessed the potential risks presented by residues of 
pyridaben in or on apples and all foods derived from such apples. In 
doing so, EPA considered the new safety standard in FFDCA section 
408(b)(2), and EPA decided to grant the section 18 exemptions only 
after concluding 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 pyridaben will permit the 
marketing of apples treated in accordance with the provisions of the 
section 18 emergency exemptions. Consistent with the need to move 
quickly on the emergency exemptions 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 
automatically without further action by EPA on August 23, 1997, under 
FFDCA section 408(l)(5), residues of pyridaben not in excess of the 
amounts specified in the tolerances remaining in or on apples and wet 
apple pomace (and foods derived from such apples) 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 indicate that the residues are not safe.
    EPA has not made any decisions about whether pyridaben meets the 
requirements for registration under FIFRA section 3 for use on apples 
or whether permanent tolerances for pyridaben for apples and wet apple 
pomace would be appropriate. This action by EPA does not serve as a 
basis for registration of pyridaben by a State for special local needs 
under FIFRA section 24(c). For additional information regarding the 
emergency exemptions for pyridaben, 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 effects 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.
    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

[[Page 48846]]

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 1 in 1 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.
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. Pyridaben is already registered by EPA for greenhouse use 
on non-food ornamental plants. EPA has also assessed the toxicology 
data base for pyridaben in its evaluation of applications for 
registration on apples and citrus. Thus, while EPA has made no decision 
on the pending registration application for apples and citrus, EPA has 
sufficient data to assess the hazards of pyridaben and to make a 
determination on aggregate exposure, consistent with section 408(b)(2), 
for the time-limited tolerances for residues of pyridaben on apples at 
0.5 ppm and apple pomace at 1.0 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing these tolerances 
follows.

A. Toxicological Profile

    1. Chronic effects. Based on the available chronic toxicity data, 
EPA has established the RfD for pyridaben at 0.005 milligrams(mg)/
kilogram(kg)/day. The RfD for pyridaben is based on a 1-year feeding 
study in dogs with a No-Observed Adverse Effect Level (NOAEL) of 0.5 
mg/kg/day and an uncertainty factor of 100. For this chemical, EPA has 
used the NOAEL instead of a NOEL because effects that were judged by 
EPA to be minor were observed at the lowest dose tested (0.5 mg/kg/
day). The effects observed at the NOAEL were vomiting, excessive 
salivation, and soft stool/diarrhea (all clinical signs unassociated 
with changes in biochemical parameters and histopathology). EPA 
questioned the biological significance of the small increase in these 
effects as compared to effects noted in the control group. Futher, 
after consideration of the frequency, severity, and transient nature of 
effects observed, EPA concluded that any effects noted at the 0.5 mg/
kg/day feeding level (the NOAEL) were sufficiently negligible as to not 
require the application of an additional uncertainty factor above the 
100-fold factor already applied to the NOAEL.
    2. Acute toxicity. Based on the available acute toxicity data, EPA 
has determined that pyridaben does not pose any acute dietary risks.
    3. Carcinogenicity. Using its Guidelines for Carcinogen Risk 
Assessment published September 24, 1986 (51 FR 33992), EPA has 
classified pyridaben as Group ``E'' for carcinogenicity (no evidence of 
carcinogenicity) based on the results of carcinogenicity studies in two 
species. There was no evidence of carcinogenicity in an 18-month 
feeding study in mice and a 2-year feeding study in rats at the dosage 
levels tested. The doses tested are adequate for identifying a cancer 
risk. Thus, a cancer risk assessment would not be appropriate.

B. Aggregate Exposure

     For purposes of assessing the potential dietary exposure under 
these tolerances, EPA has estimated aggregate exposure based on the 
TMRC from the tolerance for pyridaben on apples at 0.5 ppm and apple 
pomace at 1.0 ppm. The TMRC is obtained by multiplying the tolerance 
level residue for apples (0.5 ppm) by the consumption data which 
estimates the amount of apples and apple products eaten by various 
population subgroups. Apple pomace is fed to animals; thus exposure of 
humans to residues in apple pomace might result if such residues are 
transferred to meat, milk, poultry, or eggs. However, based on the 
results of animal metabolism studies and the amount of pyridaben 
residues expected in animal feeds, EPA has concluded that there is no 
reasonable expectation that measurable residues of pyridaben will occur 
in meat and milk under the terms of this emergency exemption. Apple 
pomace is not a poultry feed item, thus no residues are expected in 
poultry or eggs. There are no other established U.S. tolerances for 
pyridaben, and there are no registered uses for pyridaben on food or 
feed crops in the United States. In conducting this exposure 
assessment, EPA has made very conservative assumptions--100% of apples 
will contain pyridaben residues and those residues would be at the 
level of the tolerance--which result in an overestimate of human 
exposure. Thus, in making a safety determination for these tolerances, 
EPA is taking into account this conservative exposure assessment.
    Other potential sources of exposure of the general population to 
residues of pesticides are residues in drinking water and exposure from 
non-occupational sources. Based on the available studies used in EPA's 
assessment of environmental risk, EPA does not anticipate exposure to 
residues of pyridaben in drinking water. There is no established 
Maximum Concentration Level for residues of pyridaben in drinking 
water. EPA has not estimated non-occupational exposure for pyridaben 
since the current registration for pyridaben is limited to commercial 
greenhouse use for non-food ornamental plants and the only other use 
will be for commercial apple production under the conditions of the 
section 18 emergency exemptions EPA just granted. The potential for 
non-occupational exposure to the general population is, thus, not 
expected to be significant.
    EPA also considered the potential for cumulative effects of 
pyridaben and other substances that have a common mechanism of 
toxicity. EPA concluded that consideration of a common mechanism of 
toxicity is not appropriate at this time. EPA does not have reliable 
information to indicate that toxic effects produced by pyridaben would 
be cumulative with those of any other chemical compounds; thus EPA is 
considering only the potential risks of pyridaben in its aggregate 
exposure assessment.

C. Safety Determinations

    1. U.S. population in general. Using the conservative exposure 
assumptions described above, based on the completeness and reliability 
of the toxicity data, EPA has concluded that aggregate exposure to 
pyridaben will utilize 6.8 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. EPA concludes that there is a reasonable certainty that 
no harm will result from aggregate exposure to pyridaben residues.
    2.  Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of pyridaben, 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

[[Page 48847]]

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.
    Developmental toxicity (delayed ossification) was observed in 
studies using rats and rabbits. The (NOEL's) for developmental effects 
were established at 13 mg/kg/day in the rat study and 15 mg/kg/day in 
the rabbit study. The developmental effect observed in these studies is 
believed to be a secondary effect resulting from maternal stress 
(decreased body weight gain and food consumption).
    In a 2-generation reproduction study in rats, pups from the high 
dose group, which were fed diets containing 80 ppm pyridaben, gained 
less weight beginning on lactation day 14. The only effects seen in 
pups were decreased body weight gain, indicating that they were 
receiving the test compound from the diet. Parental systemic toxicity 
including decreased body weights, body weight gains and food efficiency 
in males, and slightly decreased body weights and body weight gains in 
females during lactation was also observed in the high dose group. The 
LOEL for parental systemic toxicity is 80 ppm (equivalent to 6.31 and 
7.82 mg/kg/day in male and females, respectively). The NOEL for 
parental systemic toxicity is 28 ppm (equivalent to 2.20 and 2.41 mg/
kg/day in male and females, respectively). There was no effect on 
reproductive parameters at all dose levels tested in this study.
    FFDCA section 408 provides that EPA may apply an additional safety 
factor for infants and children in the case of threshold effects to 
account for pre- and post-natal toxicity and the completeness of the 
database. Based on the current toxicological data requirements, the 
database relative to pre- and post-natal effects for children is 
complete. Further, for the chemical pyridaben, the NOAEL at 0.5 mg/kg/
day from the dog study, which was used to calculate the RfD (discussed 
above), is already lower than the NOEL's from the developmental studies 
in rats and rabbits by a factor of more than 10-fold. As to the 
reproduction study, the lack of severity of the pup effects observed 
(decreased body weight) in the reproduction study at the systemic LOEL 
and the fact that the effects began at day 14 and continued through 
adulthood suggests that there is no additional sensitivity for infants 
and children. Therefore; EPA concludes that an additional uncertainty 
factor is not warranted and that the RfD at 0.005 mg/kg/day is 
appropriate for assessing aggregate risk to infants and children.
    Using the conservative exposure assumptions described above, EPA 
has concluded that the percent of the RfD that will be utilized by 
aggregate exposure to residues of pyridaben ranges from 9.6 percent for 
children 7 to 12 years old, up to 63 percent for non-nursing infants. 
Therefore, based on the completeness and reliability of the toxicity 
data and the conservative exposure assessment, EPA concludes that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to pyridaben residues.

D. Other Considerations

    The metabolism of pyridaben in plants and animals is adequately 
understood for the purposes of these tolerances. There are no Codex 
maximum residue levels established for residues of pyridaben on apples 
or wet apple pomace. There is a practical analytical method for 
detecting and measuring levels of pyridaben in or on food with a limit 
of detection that allows monitoring of food with residues at or above 
the levels set in these tolerances. EPA has provided information on 
this method to FDA. 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.

E. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of pyridaben in 
apples at 0.5 ppm and wet apple pomace at 1.0 ppm. These tolerances 
will expire and be automatically revoked without further action by EPA 
on August 23, 1997.

IV. 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 November 18, 1996, file written objections to 
any aspect of this regulation (including the automatic revocation 
provision) and may also request a hearing on those objections. 
Objections and hearing requests must be filed with the Hearing Clerk, 
at the address given above (40 CFR 178.20). A copy of the objections 
and/or hearing requests filed with the Hearing Clerk should be 
submitted to the OPP docket for this rulemaking. The objections 
submitted must specify the provisions of the regulation deemed 
objectionable and the grounds for the objections (40 CFR 178.25). Each 
objection must be accompanied by the fee prescribed by 40 CFR 
180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as 
Confidential Business Information (CBI). Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

V. Public Docket

     A record has been established for this rulemaking under docket 
number [OPP-300436] (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,

[[Page 48848]]

is available for inspection from 8 a.m. to 4:30 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.
    Electronic comments can be sent directly to EPA at:
    opp-D[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 all comments 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 address in ``ADDRESSES'' at the 
beginning of this document.

VI. 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, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), or special considerations 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, analysis under the 
Regulatory Flexibility Act, 5 U.S.C. 604(a), is not required.
    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 the 
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: September 6, 1996.

Daniel M. Barolo,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I is amended as follows:

PART 180-- [AMENDED]

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

    Authority: 21 U.S.C. 346a and 371.
    b. By adding a new Sec. 180.494 to read as follows:


Sec. 180.494  Pyridaben; tolerances for residues.

    (a) [Reserved].
    (b) Time-limited tolerances. Time-limited tolerances are 
established for residues of the insecticide/miticide pyridaben [2-tert-
butyl-5-(4-tert- butylbenzylthio)-4-chloropyridazin-3(2H)-one] in 
connection with use of the pesticide under section 18 emergency 
exemptions granted by EPA. The tolerances are specified in the 
following table. Each tolerance expires and is automatically revoked on 
the date specified in the table without further action by EPA.

------------------------------------------------------------------------
                                Parts per                               
          Commodity              million     Expiration/Revocation Date 
------------------------------------------------------------------------
Apples.......................          0.5               August 23, 1997
Apples, pomace, wet..........          1.0               August 23, 1997
------------------------------------------------------------------------

[FR Doc. 96-23905 Filed 9-16-96; 8:45 am]
BILLING CODE 6560-50-F