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diphenylamine Pesticide Tolerance 4/99

  


[Federal Register: May 13, 1999 (Volume 64, Number 92)]
[Rules and Regulations]               
[Page 25842-25848]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my99-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300773A; FRL-6077-3]
RIN 2070-AB78

 
Diphenylamine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
diphenylamine in or on pears. IR-4 requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective May 13, 1999. Objections and 
requests for hearings must be received by EPA on or before July 12, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300773A], 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-300773A], 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 be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@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-300773A]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of

[[Page 25843]]

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: Rm. 1119, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-9357, 
cimino.pat@epa.gov.

 SUPPLEMENTARY INFORMATION: In the Federal Register of February 19, 
1999 (64 FR 8273) (FRL-6052-2), EPA issued a notice pursuant to section 
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a 
as amended by the Food Quality Protection Act of 1996 (FQPA) (Public 
Law 104-170) announcing a proposed regulation to establish a time-
limited tolerance for residues of diphenylamine on pears. This notice 
was initiated by the Agency and included a summary of the toxicological 
profile and safety findings of the Agency. There were no comments 
received in response to the notice of filing.
    The proposed rule requested that 40 CFR 180.190 be amended by 
establishing a tolerance for residues of the plant growth regulator 
diphenylamine, in or on pears at 10 part per million (ppm).

I. Background and Statutory Findings

    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....''
    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).

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
diphenylamine and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a 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 in this unit.

B. Toxicological Endpoints

    1. Acute toxicity. For acute dietary exposure (1 day) a risk 
assessment is not required since no appropriate toxicity endpoint or 
no-observed adverse effect level (NOAEL) 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 exposure is taken into account under the chronic exposure and risk 
section below.
    3. Chronic toxicity. EPA has established the RfD for diphenylamine 
at 0.03 (mg/kg/day). This Reference Dose (RfD) is based on a chronic 
dog study with a lowest observed adverse effect level (LOAEL) 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 three was recommended to account for the lack of a 
NOAEL and the Committee's concern with respect to potential 
methemoglobinemia which was not tested in this study.
    It should be noted that although the LOAEL 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 LOAEL 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 NOAEL 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.

C. 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 a variety of 
raw agricultural commodities. These include apples, and cattle, goat, 
horse and sheep meat. Risk assessments were conducted by EPA to assess 
dietary exposures from diphenylamine as follows:
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on

[[Page 25844]]

the anticipated residue levels of pesticide residues in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must require that data be 
provided 5 years after the tolerance is established, modified, or left 
in effect, demonstrating that the levels in food are not above the 
levels anticipated. Following the initial data submission, EPA is 
authorized to require similar data on a time frame it deems 
appropriate. As required by section 408(b)(2)(E), EPA will issue a data 
call-in for information relating to anticipated residues to be 
submitted no later than 5 years from the date of issuance of this 
tolerance
    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 1-day or single exposure. An acute risk assessment is not required 
since no appropriate endpoint or NOAEL 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 Theoretical 
Maximum Residue Concentration (TMRC) for pears, meat and milk. Percent 
crop treated estimates were not used for the chronic risk assessment. 
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 diphenylamine 
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 
eighteenfold 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, milk 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 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

    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 negligible because negligible 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 on 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 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).

 D. 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 NOAEL could be identified from the 
available data. No developmental toxicity was observed at

[[Page 25845]]

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 ARC exposure assumptions described in 
this unit, 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.
    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 DEEM analysis 
calculated an 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 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 data base 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 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 6 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 NOAEL was 50 mg/kg/day 
and the LOAEL was 100 mg/kg/day. No developmental toxicity was seen at 
any dose level. The developmental toxicity NOAEL was equal to or 
greater than 100 mg/kg/day the highest dose tested (HDT); a LOAEL 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% methyl cellulose 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 NOAEL was 100 mg/kg/day and the LOAEL 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 NOAEL was equal to or greater 
than 300 mg/kg/day (HDT); a LOAEL was not established.
    iii. Reproductive toxicity study. In a 2-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 NOAEL was less than 500 ppm (40 mg/kg/day 
in males and 46 mg/kg/day in females) and the LOAEL 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% to 25 % less 
than control), for F<INF>2</INF> pups at 5,000 ppm from lactation day 
(LD) 4 through LD 21 (10% to 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 NOAEL was 500 ppm (46 mg/kg/day for maternal 
animals) and the LOAEL was 1,500 ppm (131 mg/kg/day for maternal 
animals) based on decreased F<INF>2</INF> pup body weight in late 
lactation. 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 
NOAEL was less than 500 ppm (40 mg/kg/day in males and 46 mg/kg/day in 
females) and the LOAEL 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% to 25 % less than control), for F<INF>2</INF> 
pups at 5,000 ppm from lactation day (LD) 4 through LD 21 (10% to 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 NOAEL was 500 ppm (46 
mg/kg/day for maternal animals) and the LOAEL was 1,500 ppm (131 mg/kg/
day

[[Page 25846]]

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 NOAEL was 1,500 ppm 
(131 mg/kg/day for maternal animals) and the LOAEL 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 data base 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 NOAEL 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 in this 
unit, EPA has concluded that aggregate exposure to diphenylamine from 
food will utilize 31.3 percent 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 negligible 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 
diphenylamine 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.

III. 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 Food and Drug Administration (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 gas chromatography (GC)/mass selective detection (MSD) 
method is available for the quantitation of diphenylamine residues in 
apples which should be bridgeable to pears.
    Adequate enforcement methodology (example - gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.

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 Limits

    There are no international residue 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.

IV. 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 inadvertent 
transfer of diphenylamine residues from apples to pears during packing. 
Public reporting of PDP food residue monitoring occurred earlier this 
year 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 proposed to establish a 
time-limited tolerance for this use on February 19, 1999. No comments 
were received during the 15-day comment period.
    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 2 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 exposures for 
which there is reliable information. Therefore, a time-limited 
tolerance is established for residues of diphenylamine in pears at 10 
ppm, the same level as currently established on apples, which will 
expire on December 1, 2001.

V. 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

[[Page 25847]]

modification to reflect the new law. However, until those modifications 
can be made, EPA will continue to use those procedural regulations with 
appropriate adjustments to reflect the new law.
    Any person may, by July 12, 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 under the ``ADDRESSES'' section (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 
regulation. 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). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW, 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    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.

VI. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300773A] (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 Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:

     opp-docket@epa.gov.

    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit 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 record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency 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 the 
Intergovernmental Partnership (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

[[Page 25848]]

governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's 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.

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 officials 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 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.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: April 30, 1999.
James Jones,
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. 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 growth 
regulator diphenylamine are established as follows:


------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Apple, preharvest or postharvest, including wraps.......              10
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    Revocation
                                                  million        Date
------------------------------------------------------------------------
Pears.........................................           10      12/1/01
------------------------------------------------------------------------


[FR Doc. 99-12135 Filed 5-12-99; 8:45 am]
BILLING CODE 6560-50-F