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diphenylamine (coraza) Pesticide Tolerances 2/99


  


[Federal Register: February 19, 1999 (Volume 64, Number 33)]
[Proposed Rules]               
[Page 8273-8278]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe99-20]


[[Page 8273]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300773; FRL-6052-2]
RIN 2070-AB78

 
Diphenylamine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This is a proposed regulation to establish a time-limited 
tolerance for residues of diphenylamine in or on pears. This regulation 
proposes to establish a maximum permissible level for residues of 
diphenylamine in this food commodity pursuant to section 408(e) of the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996. The tolerance will expire and is revoked on 
December 1, 2001.

DATES: Comments must be received by EPA on or before March 8, 1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300773], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300773], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), 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. 119, Crystal 
Mall #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: opp-docket@epamail.epa.gov. 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 5.1/6.1 
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-300773]. 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, Office of the 
Director (7501C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 308-9357, e-mail: 
Cimino.pat@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
sections 408(e) and (l) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l), is proposing to establish a 
tolerance for residues of the plant growth regulator diphenylamine, in 
or on pears at 10 parts per million (ppm). This proposed regulation is 
for a time-limited tolerance which will expire December 1, 2001.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq . The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described below and discussed in 
greater detail in the final rule establishing the time-limited 
tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''

II. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the Final Rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997)(FRL-5754-7) .
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
diphenylamine and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of diphenylamine on pears at 10 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing the tolerance 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by diphenylamine are 
discussed below.
    1. Acute toxicity. For acute dietary exposure (1 day) a risk 
assessment is not required since no appropriate toxicity endpoint or 
NOEL could be identified from the available data. No developmental 
toxicity was observed at any dose level in the test animals. The 
highest doses tested were 100 milligrams/kilogram/day (mg/kg/day) in 
rats and 300 mg/kg/day in rabbits.
     2. Short - and intermediate - term toxicity. Short- and 
intermediate-term risk assessments take into account exposure from 
indoor and outdoor residential exposure plus chronic dietary food and 
water (considered to be a background exposure level). This risk 
assessment is not required because there are no indoor or residential 
uses for this pesticide. Risk from chronic dietary food and water 
toxicity endpoints and

[[Page 8274]]

exposure is taken into account under the chronic exposure and risk 
section in Unit II.B.2.ii. in the preamble of this document.
    3. Chronic toxicity. EPA has established the RfD for diphenylamine 
at 0.03 mg/kg/day. This RfD is based on a chronic dog study with a LOEL 
of 10 mg/kg/day. An Uncertainty Factor (UF) of 100 was used to account 
for both the interspecies extrapolation and the intraspecies 
variability. An additional UF of 3 was recommended to account for the 
lack of a NOEL and the Committee's concern with respect to potential 
methemoglobinemia which was not tested in this study.
    It should be noted that although the LOEL was established at 10 mg/
kg/day, in both males and females (based on hematological and clinical 
chemistry changes, and clinical signs of toxicity), because of the lack 
of information on methemoglobinemia the LOEL could not be verified and 
was considered tentative until this issue is addressed. The Agency has 
required that a subchronic study of sufficient duration be conducted in 
dogs to investigate this possible methemoglobinemic effect to 
accurately define the NOEL in the critical study. This study has been 
initiated by the registrant.
    This chemical has been reviewed by the FAO/WHO joint committee 
meeting on pesticide residue (JMPR) and an acceptable daily intake 
(ADI) of 0.02 mg/kg/day has been established by that Committee.
    4. Carcinogenicity. The Agency classified diphenylamine as ``not 
likely'' in reference to carcinogenicity in April, 1997. This 
classification was based on the lack of evidence for carcinogenicity in 
the two acceptable carcinogenicity studies in either male or female CD-
1 mice or Sprague-Dawley rats.
    A nitrosamine impurity, diphenylnitrosamine, occurs in 
diphenylamine technical product. Diphenylnitrosamine is a quantified 
carcinogen. The technical product producer, Elf Atochem, has submitted 
nitrosamine data which confirms that the maximum total nitrosamine 
contamination expected for the diphenylamine technical would be 10 ppm. 
The Agency concluded that residue data depicting nitrosamine levels in 
pome fruits (apples and pears) would not be required, but that a 
nitrosamine level of 0.0001 ppm in apples and pears should be used in 
dietary risk assessments for diphenylamine.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.190) for the residues of diphenylamine, in or on apples, meat 
and milk. Risk assessments were conducted by EPA to assess dietary 
exposures and risks from diphenylamine as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. An acute risk assessment is not 
required since no appropriate endpoint or NOEL could be identified from 
the available data. No developmental toxicity was seen at any dose 
level in the test animals. The highest doses tested were 100 mg/kg/day 
in rats and 300 mg/kg/day in rabbits.
    ii. Chronic exposure and risk. A Dietary Exposure Evaluation Model 
(DEEM) chronic exposure analysis was performed by the Agency using 
Anticipated Residue Concentration (ARC) for apples and Theorhetical 
Maximum Residue Concentration (TMRC) for pears, meat and milk. 
Tolerances are currently established for apples at 10 ppm and for meat 
and milk at 0 ppm. The Agency has recommended that the following 
tolerances be established in the 1998 Registration Eligibility Document 
(RED) for diphenylamine: wet apple pomace (an animal feed item) at 30.0 
ppm, milk at 0.01 ppm, meat except liver at 0.01 ppm, and meat liver at 
0.10 ppm. The recommended tolerances are supported by data and the 
Agency, on its own initiative, is in the process of establishing these 
tolerances.
    The Agency determined that 10 ppm is appropriate for diphenlyamine 
residues in pears for a time-limited tolerance based on bridging data 
from the apple residue studies to pears. The use patterns are identical 
for apples and pears and the fruit are substantially similar. The TMRC 
level for apples, 10 ppm, was determined from field testing at maximum 
label rates and sampling immediately after treatment. The wet apple 
pomace residue value, 30 ppm, was derived from apple processing data 
using the highest average field trial residue value, 5.86 ppm, 
multiplied by the average concentration factor, 4.7x, observed in wet 
apple pomace. The meat and milk TMRC values recommended in the 1998 RED 
for diphenylamine were obtained from a ruminant feeding study which 
indicates that at 1x, 3x and 10x feeding rates (30 ppm, 90 ppm and 300 
ppm diphenylamine) diphenylamine was detected in one or more meat, meat 
by-product or milk fractions.
    The ARC for apples used in the DEEM chronic exposure analysis is 
0.562 ppm and was obtained from USDA's Pesticide Data Program (PDP). 
The PDP program was designed by EPA and USDA to provide EPA with market 
basket type residue values for refined risk assessments. The PDP 
samples crop commodities from grocery store distribution centers for 
pesticide residue analysis in order to better determine the residues 
which occur in foods at the time consumers purchase them. The 18 fold 
drop in tolerance values between the TMRC derived apple tolerance of 10 
ppm compared to the ARC/PDP derived tolerance of 0.562 ppm represents 
the difference in tolerance levels at the ``farm gate'' (worst case 
tolerance levels measured immediately after harvest or in the case of 
diphenylamine, immediately after treatment) versus the tolerance level 
which occurs close to actual purchase time.
    The proposed pear tolerance at the TMRC of 10 ppm, was used in the 
DEEM chronic exposure analysis to calculate the dietary contribution 
from pears. The addition of pears to the apple ARC and RED recommended 
tolerances for meat, mild and wet apple pomace represents 3.9% of the 
RfD for the general U.S. population, and 31.3% of the RfD for the most 
sensitive sub-population, non-nursing infants (<1 year old).
    Diphenylamine is classified as ``not likely'' to be carcinogenic to 
humans via the relevant routes of exposure.
    A dietary risk assessment for diphenylnitrosamine, an impurity in 
technical product diphenylamine, was calculated using the nitrosamine 
residue level of 0.0002 ppm (0.0001 ppm each for apples and pears). The 
Q* for diphenylnitrosamine is 4.9 x 10<SUP>-3</SUP> as reported on 
IRIS. The DEEM chronic exposure analysis calculated an anticipated 
residue contribution (ARC) for the total U.S. population of 0.001155 
mg/kg/day.
    To calculate the cancer risk for the diphenylnitrosamine, multiply 
the ARC (0.001155 mg/kg/day) by 2.0 x 10<SUP>-5</SUP> (because 
diphenylnitrosamine dietary contribution from apples and pears is 20 
ppm or 20/1,000,000). Divide this result by 70 years to correct the 
average daily dose to a lifetime average daily dose. Finally, multiply 
this result by the Q* of 0.0049 mg/kg/day and the cancer risk is 
calculated to be 1.6 x 10<SUP>-12</SUP>.
    0.001155 mg/kg/day x 2.0 x 10<SUP>-5</SUP> = 2.3 x 10<SUP>-8</SUP>
    2.3 x 10<SUP>-8</SUP>/70 years = 3.3 x 10<SUP>-10</SUP>
    3.3 x 10<SUP>-10</SUP> x 4.9 x 10<SUP>-3</SUP> = 1.6 x 
10<SUP>-12</SUP> mg/kg/day

[[Page 8275]]

    This value is well below the Agency's level of concern for 
nitrosamine in the diet.
    2. From drinking water. Dietary risk from drinking water is assumed 
to be negligable because negligable exposure results from the 
pesticidal uses. The use pattern is limited to pome fruit drenches in 
fruit packing houses and there are no detections in the Agency's 
Pesticides in Ground water Database or the U.S. EPA's ``STORET'' 
database.
    3. From non-dietary exposure. Diphenylamine is not currently 
registered for use in residential non-food sites.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether diphenylamine 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, 
diphenylamine 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 diphenylamine has a common mechanism of 
toxicity with other substances. For more information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the Final Rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

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

    1. Acute risk. An acute dietary risk assessment was not conducted 
since no appropriate endpoint or NOEL could be identified from the 
available data. No developmental toxicity was observed at any dose 
level in the test animals. The highest doses tested were 100 mg/kg/day 
in rats and 300 mg/kg/day in rabbits.
    2. Chronic risk. Using the combination of ARC and TMRC exposure 
assumptions described in Unit II.B.1.ii. in the preamble of this 
document, EPA has concluded that aggregate exposure to diphenylamine 
from food will utilize 3.9% of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is non- 
nursing infants and is discussed below. EPA generally has no concern 
for exposures below 100% of the RfD because the RfD represents the 
level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Exposure is 
from food only as drinking water exposure is considered negligable and 
there are no residential uses and consequently no exposure from non-
dietary, non-occupational uses of this pesticide.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account indoor and outdoor residential 
exposure plus chronic dietary food and water (considered to be a 
background exposure level). A short- and intermediate-term risk 
assessment is not required as there are no indoor or outdoor 
residential uses for this pesticide and chronic exposure is accounted 
for above.
    4. Aggregate cancer risk for U.S. population. Diphenylamine is 
classified as ``not likely'' to be carcinogenic to humans via the 
relevant routes of exposure.
     A dietary risk assessment for diphenylnitrosamine, the impurity in 
diphenylamine, was calculated using the nitrosamine residue level of 
0.0001 ppm each for apples and pears. The Q* for diphenylnitrosamine is 
4.9 x 10<SUP>-3</SUP> as reported on IRIS. The chronic DRES analysis 
calculated an anticipated residue contribution (ARC) for the total U.S. 
population of 0.001155 mg/kg/day. Using these values, the cancer risk 
is calculated to be 1.6 x 10<SUP>-12</SUP>. This value is well below 
the Agency's level of concern for nitrosamine in the diet.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to diphenylamine residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of diphenylamine, 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 maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (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.
     ii. Developmental toxicity studies. In a developmental toxicity 
study, pregnant female Sprague-Dawley rats (25/group) received 
diphenylamine (99.9%) in corn oil by oral gavage at dose levels of 0, 
10, 50, or 100 mg/kg/day from gestation day six through gestation day 
15 inclusive; dams were sacrificed on gestation day 20. None of the 
rats died during the study. Maternal toxicity was evidenced by 
increased splenic weights, enlarged spleens and blackish-purple colored 
spleen in the dams at 100 mg/kg/day. The maternal toxicity NOEL was 50 
mg/kg/day and the LOEL was 100 mg/kg/day. No developmental toxicity was 
seen at any dose level. The developmental toxicity NOEL was equal to or 
greater than 100 mg/kg/day the highest dose tested (HDT); a LOEL was 
not established.
    In a developmental toxicity study, pregnant New Zealand White 
rabbits received either 0, 33, 100, or 300 mg/kg/day diphenylamine 
(99.9%) suspended in 1% methylcellulose by oral gavage from gestation 
day 7 through 19, inclusive. Animals came from 3 sources (vendors). 
Maternal toxicity was noted at 300 mg/kg as decreases in food 
consumption and associated initial reductions in body weight gain. The 
maternal toxicity NOEL was 100 mg/kg/day and the LOEL was 300 mg/kg/day 
based on decreased body weight gains and food consumption early during 
the treatment period. No developmental toxicity was noted at any dose 
level. The developmental toxicity NOEL was

[[Page 8276]]

equal to or greater than 300 mg/kg/day (HDT); a LOEL was not 
established.
    iii. Reproductive toxicity study. In a two-generation reproductive 
toxicity study, Sprague-Dawley rats (28 per sex/group) received 
diphenylamine (99.8%) in the diet at dose levels of 0, 500, 1,500, or 
5,000 ppm (0, 40, 115, or 399 mg/kg/day for F<INF>0</INF> males and 0, 
46, 131, or 448 mg/kg/day for F<INF>0</INF> females, respectively, 
during premating). Compound-related systemic toxicity was observed in a 
dose related manner among both sexes and generations at all dose 
levels. The systemic toxicity NOEL was less than 500 ppm (40 mg/kg/day 
in males and 46 mg/kg/day in females) and the LOEL was less than or 
equal to 500 ppm based on gross pathological findings in the kidney, 
liver, and spleen. Developmental toxicity was observed at 1,500 and 
5,000 ppm, as evidenced by significantly decreased body weight for 
F<INF>1</INF> pups at 5,000 ppm throughout lactation (11-25 % less than 
control), for F<INF>2</INF> pups at 5,000 ppm from lactation day (LD) 4 
through LD 21 (10%-29% less than control), and for F<INF>2</INF> pups 
at 1,500 ppm on LD 14 (10%) and LD 21 (12%). The developmental toxicity 
NOEL was 500 ppm (46 mg/kg/day for maternal animals) and the LOEL was 
1,500 ppm (131 mg/kg/day for maternal animals) based on decreased 
F<INF>2</INF> pup body weight in late lactation. Reproductive toxicity 
was noted as smaller litter sizes at birth (significant for the 
F<INF>2</INF> litters) in both generations at 5,000 ppm. The 
reproductive toxicity NOEL was 1,500 ppm (131 mg/kg/day for maternal 
animals) and the LOEL was 5,000 ppm (448 mg/kg/day for maternal 
animals), based upon decreased litter size in both generations.
    iv. Pre- and post-natal sensitivity. For purposes of assessing the 
pre- and post-natal toxicity of diphenylamine, EPA has evaluated two 
developmental and one reproduction study. Based on current 
toxicological data requirements, the data base for diphenylamine, 
relative to pre- and post-natal toxicity is complete. However, as EPA 
fully implements the requirements of FQPA, additional data related to 
the special sensitivity of infants and children may be required.
    The data provided no indication of increased sensitivity of rats or 
rabbits to in utero and/or postnatal exposure to diphenylamine. The 
reproduction study demonstrated that the offspring were less sensitive 
than the adults and there was no developmental toxicity observed in 
either the rat or rabbit developmental studies at any dose tested.
    v. Conclusion. There is a complete toxicity database for 
diphenylamine and exposure data is complete or is estimated based on 
data that reasonably accounts for potential exposures.
    2. Acute risk. An acute dietary risk assessment was not conducted 
since no appropriate endpoint or NOEL could be identified from the 
available data. No developmental toxicity was observed at any dose 
level in the test animals. The highest doses tested were 100 mg/kg/day 
in rats and 300 mg/kg/day in rabbits.
    3. Chronic risk. Using the exposure assumptions described above, 
EPA has concluded that aggregate exposure to diphenylamine from food 
will utilize 31.3% of the RfD for infants and children. EPA generally 
has no concern for exposures below 100% of the RfD because the RfD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. 
Exposure is from food only as drinking water exposure is considered 
negligable and there are no residential uses and consequently no 
exposure from non-dietary, non-occupational uses of this pesticide
    4. Short- or intermediate-term risk. Short- or intermediate-term 
non-dietary, non-occupational exposure scenarios do not exist for 
diphenlyamine and a short- or intermediate-term aggregate risk 
assessment is not required.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to diphenylamine 
residues.

IV. Other Considerations

A. Metabolism In Plants and Animals

    The qualitative nature of the residue in plants and livestock is 
adequately understood based on acceptable apple, ruminant and poultry 
metabolism studies. The Agency has concluded that the residue of 
concern in plants and livestock is diphenylamine per se.

B. Analytical Enforcement Methodology

     The FDA PESTDATA database dated 1/94 (Pam Vol. I, Appendix I) 
indicates that diphenylamine is completely recovered using FDA 
Multiresidue Protocol D (PAM I Section 232.4). In addition, a GC/mass 
selective detection (MSD) method is available for the quantitation of 
diphenylamine residues in apples which should be bridgeable to pears.

C. Magnitude of Residues

    For the purposes of this time-limited tolerance, apple data have 
been used to estimate the magnitude of residues on pears. The use 
patterns for apples and pears are identical and the fruit types are 
substantially similar. Adequate magnitude of the residue data are 
available to support the use on apples. Acceptable residue data 
depicting diphenylamine residues in apples following a single 
posttreatment application at the maximum use rate have been submitted, 
and indicate that the existing 10 ppm tolerance for diphenylamine 
residues in apples is also appropriate for pears.

D. International Residue Limit

    There are no international residues limits established for 
diphenylamine on pears.

E. Rotational Crop Restrictions

    Rotational crop restrictions do not apply for two reasons: (1) 
diphenylamine is used indoors only in fruit packing houses as a 
postharvest drench treatment to control scald; and (2) pears are a 
perennial crop and are not subject to rotational crop restrictions.

V. Conclusion

    Numerous residues of diphenylamine have been detected on pears, a 
use which is not registered and does not have an established tolerance, 
by the United States Department of Agriculture's (USDA) Pesticide Data 
Program (PDP) in both domestic and foreign pears due to inadvertant 
transfer of diphenylamine residues from apples to pears during packing. 
Public reporting of PDP food residue monitoring is expected in late 
December, 1999 and in order to prevent public concern regarding 
residues of diphenylamine in pears the Agency assessed the aggregate 
risk from exposure on pears, found it acceptable, and is proposing to 
establish a time-limited tolerance for this use before the USDA report 
is released. A 15-day comment period is being allowed for this proposed 
rule in order to establish a tolerance before the USDA report is 
released. The U.S. pear industry has asked the IR-4 program and 
pesticide registrants to generate the reports and data required to 
support the establishment of a tolerance and registration of 
diphenylamine on pears. The data generation have been initiated and the 
Agency expects these data to be submitted in two years. In the 
meantime, the Agency has assessed the risk from this use on pears based 
on bridging data from apples to pears and found that a reasonable 
certainty of no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other

[[Page 8277]]

exposures for which there is reliable information. Therefore, the 
Agency is proposing that a time-limited tolerance for residues of 
diphenylamine which will expire on December 1, 2001 be established for 
pears at the same level as apples, 10 ppm.

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation 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 March 8, 1999, 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 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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this proposed rulemaking under 
docket control number [OPP-300773] (including any comments and data 
submitted electronically). A public version of this record, including 
printed, paper versions of electronic comments, which does not include 
any information claimed as CBI, is available for inspection from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
public record is located in Room 119 of the Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C) Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    opp-docket@epamail.epa.gov.


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This action proposes exemptions from the tolerance requirement 
under FFDCA section 408(d). The Office of Management and Budget (OMB) 
has exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). In addition, this proposed action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any special considerations as required by Executive Order 
12898, entitled Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994), or require OMB review in accordance with Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997).
    In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 
601 et seq.), the Agency previously assessed whether establishing 
tolerances, exemptions from tolerances, raising tolerance levels or 
expanding exemptions might adversely impact small entities and 
concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental 
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a 
regulation that is not required by statute and that creates a mandate 
upon a State, local or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments. If the mandate is unfunded, EPA must 
provide to OMB a description of the extent of EPA's prior consultation 
with representatives of affected State, local and tribal governments, 
the nature of their concerns, copies of any written communications from 
the governments, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 12875 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of State, local and tribal governments ``to provide 
meaningful and timely input in the development of regulatory proposals 
containing significant unfunded mandates.''
    Today's proposed rule does not create an unfunded Federal mandate 
on State, local or tribal governments. The rule does not impose any 
enforceable duties on these entities. Accordingly, the requirements of 
section 1(a) of Executive Order 12875 do not apply to this rule.

[[Page 8278]]

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's proposed rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

List of Subjects in 40 CFR Part 180

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

    Dated: February 10, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

    2. Section 180.190 is revised to read as follows:


Sec. 180.190   Diphenylamine; tolerances for residues.

    (a) General. Tolerances for the residues of the plant regulator 
diphenylamine are established as follows:


------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Apples from preharvest or postharvest use   10
 (including use of impregnated wraps)..
Cattle, meat..............................  0
Goat, meat................................  0
Horse, meat...............................  0
Sheep, meat...............................  0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. A time-limited tolerance is 
established for the indirect or inadvertent residues of diphenylamine 
in or on the following commodity:


------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Pears...........................  10                  12/1/01
------------------------------------------------------------------------


[FR Doc. 99-4159 Filed 2-18-99; 8:45 am]
BILLING CODE 6560-50-F