[Federal Register Volume 64, Number 92 (Thursday, May 13, 1999)]
[Rules and Regulations]
[Pages 25842-25848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12135]
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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="">-3 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 10-5 (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 10-12.
0.001155 mg/kg/day x 2.0 x 10-5 = 2.3 x
10-8
2.3 x 10-8/70 years = 3.3 x 10-10
3.3 x 10-10 x 4.9 x 10-3 = 1.6 x
10-12 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 10-3 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
10-12. 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 F0 males and 0,
46, 131, or 448 mg/kg/day for F0 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
F1 pups at 5,000 ppm throughout lactation (11% to 25 % less
than control), for F2 pups at 5,000 ppm from lactation day
(LD) 4 through LD 21 (10% to 29% less than control), and for
F2 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 F2 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 F0 males and 0, 46, 131, or 448 mg/kg/day for
F0 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 F1 pups at 5,000 ppm
throughout lactation (11% to 25 % less than control), for F2
pups at 5,000 ppm from lactation day (LD) 4 through LD 21 (10% to 29%
less than control), and for F2 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 F2 pup body weight
in late lactation. Reproductive toxicity was noted as smaller litter
sizes at birth (significant for the F2 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
