[Federal Register: December 6, 2006 (Volume 71, Number 234)]
[Proposed Rules]
[Page 70703-70709]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de06-19]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0731; FRL-8104-1]
Diphenylamine; Proposed Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes to establish a tolerance for residues
of diphenylamine in or on pear under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).
DATES: Comments must be received on or before February 5, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0731, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0731. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
[[Page 70704]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background and Statutory Findings
EPA on its own initiative, under section 408(e) of the FFDCA, 21
U.S.C. 346a(e), is proposing to establish a tolerance for residues of
the fungicide, diphenylamine in or on pear at 5.0 parts per million
(ppm). The Interregional Research Project Number 4 (IR-4) submitted a
petition (PP 0E6107) for this use. However, neither IR-4 nor Atomchem
North American Incorporated, the registrant, submitted all required
elements of a petition in support of establishing a tolerance. Because
the petition was incomplete, EPA did not publish a Notice of Filing for
the petition.
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) of the FFDCA 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) of the FFDCA 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 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, 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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for residues of diphenylamine
on pear at 5.0 ppm. EPA's assessment of 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 is
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
[[Page 70705]]
Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL = 75 mg/kg/day
rodents LOAEL = 375 mg/kg/day based on decreased
body weight and body weight gain, dark
urine, increased absolute spleen and liver
weights, congestion in spleen, kidney, and
liver, discoloration and alterations in
hematological and clinical chemistry
parameters.
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL = 2 mg/kg/day
rodents M/F LOAEL = 94/107 mg/kg/day based on liver/
spleen alterations (extramedullary
hematopoiesis in the liver, discoloration
and hemosiderosis of the liver, congestion
and extramedullary hematopoiesis in the
spleen).
----------------------------------------------------------------------------------------------------------------
870.3150 90-Day oral toxicity non- M/F NOAEL = 50 mg/kg/day
rodents LOAEL (mg/kg/day) not determined
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity NOAEL = 500 mg/kg/day
LOAEL = 1,000 mg/kg/day based on effects in
the stomach (dark foci-red foci in both
sexes-6/10).
Dermal: NOAEL = 1,000 mg/kg/day;
LOAEL (mg/kg/day): Not determined.
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL = 50 mg/kg/day
rodents Maternal LOAEL = 100 mg/kg/daybased on
decreased spleen weights and discoloration
of the spleen
Developmental NOAEL = 100 mg/kg/day
Developmental LOAEL (mg/kg/day): Not
determined
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL = 100 mg/kg/day
nonrodents Maternal LOAEL = 300 mg/kg/daybased on
deceased body weight gains andfood
consumption
Developmental NOAEL = 300 mg/kg/day
Developmental LOAEL (mg/kg/day): Not
determined
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL (mg/kg/day): Not
effects determined.
Parental/Systemic M/F LOAEL = 40/46 mg/kg/
day based on gross pathological findings
in the spleen and microscopic findings in
the kidney, liver, and spleen.
Reproductive M/F NOAEL = 115/131 mg/kg/day.
Reproductive M/F LOAEL = 399/448 mg/kg/day
based on decreased litter size in both
generations.
Offspring M/F NOAEL = 40/46 mg/kg/day.
Offspring M/F LOAEL = 115/131 mg/kg/day
based on decreased body weight of F2 pups
in late lactation.
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity dogs NOAEL = 10 mg/kg/day
LOAEL = 50 mg/kg/day based on alterations
in clinical chemistry parameters
(increased BUN, cholesterol, total
bilirubin) and increased absolute/relative
kidney, liver and spleen weights.
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity rats NOAEL (mg/kg/day): Not determined.
M/F LOAEL = 73/91 mg/kg/day based on
histopathological lesions in the spleen.
No evidence of carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4300 Carcinogenicity mice M/F NOAEL = 29/25 mg/kg/day.
M/F LOAEL = 147/138 mg/kg/day based on
reduced body weight and body weight gains,
changes in hematological parameters,
spleen and kidney lesions and increased
clinical signs of toxicity. No evidence of
carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100 Gene mutation Negative
----------------------------------------------------------------------------------------------------------------
870.5300 Cytogenetics Weakly mutagenic in the presence of
metabolic activation
----------------------------------------------------------------------------------------------------------------
870.5395 Other effects Negative
----------------------------------------------------------------------------------------------------------------
[[Page 70706]]
870.7485 Metabolism and Terminal distribution data showed no
pharmacokinetics significant residual activity in tissues
168 hours post-dose for both the low and
high oral dose groups: Urine was the major
route for excretion.
Recovery after 168 hours: Single/repeated
low dose = urine 68-81% (both sexes)
single high dose = 73-74%
Male rats excreted a greater percentage of
diphenylamine derived activity at the low
dose, while female rats showed greater
excretion in feces at this dose. At the
high dose, the percentage eliminated in
urine was equivalent in both males and
females.
Metabolites-urine: Dihydroxylated
conjugates of diphenylamine, mono-
hydroxylated sulfate conjugates of
diphenylamine, monohydroxylated
glucuronide conjugates of diphenylamine.
Metabolites-feces: Parent chemical and 4-
hydroxydiphenylamine, which comprised 0.5-
3% administered dose in both sexes.
----------------------------------------------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor
(SF).
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for diphenylamine used for human risk assessment is shown in
Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Diphenylamine for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of N/A N/A An acute reference dose
age) for females aged 13-50
has not been
established.
Developmental toxicity
studies in rats and
rabbits and a 2-
generation
reproduction study in
rats did not
demonstrate evidence
of toxicity
attributable to a
single dose.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population N/A N/A An endpoint
including infants and children) attributable to a
single dose was not
identified from the
available database.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 10 mg/kg/day FQPA SF = 1X Chronic Toxicity - Dog
UF = 100 Chronic RfD = cPAD = chronic RfD/FQPA LOAEL = 50 mg/kg/day
0.1 mg/kg/day. SF = 0.1 mg/kg/day. based on alterations
in clinical chemistry
parameters (increased
BUN, cholesterol,
total bilirubin) and
increased absolute/
relative kidney,
liver, and spleen
weights.
----------------------------------------------------------------------------------------------------------------
[[Page 70707]]
Short-Term Dermal (1 to 30 days) Dermal (or oral) study LOC for MOE = 100 21-Day Dermal - Rabbit
(Residential)........................ NOAEL= 500 mg/kg/day... (Residential).......... LOAEL = 1,000 mg/kg/day
based on effects in
the stomach (dark red
foci in both sexes).
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to Dermal (or oral) study LOC for MOE = 100 21-Day Dermal- Rabbit
several months) NOAEL = 500 mg/kg/day (Residential).......... LOAEL = 1,000 mg/kg/day
(Residential)........................ based on effects in
the stomach (dark red
foci in both sexes).
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days) Inhalation (or oral) LOC for MOE = 100 Developmental Toxicity
(Residential)........................ study (Residential).......... Rat
NOAEL = 50 mg/kg/day LOAEL = 100 mg/kg/day
(inhalation absorption based on increased
rate = 100%). spleen weights and
discoloration of the
spleen.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week Inhalation (or oral) LOC for MOE = 100 Developmental Toxicity
to several months) study (Residential).......... Rat
(Residential)........................ NOAEL = 50 mg/kg/day LOAEL = 100 mg/kg/day
(inhalation absorption based on increased
rate = 100%). spleen weights and
discoloration of the
spleen.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) N/A N/A Classification: This
chemical is ``not
likely'' to be a human
carcinogen.
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. The residue of concern
in plants and livestock for the tolerance enforcement and risk
assessment is parent diphenylamine. Tolerances are established in 40
CFR 180.190(a) for diphenylamine residues in/on apple at 10 ppm and
apple, wet pomace at 30 ppm. Diphenylamine (EC or SC/L) is applied to
apples (pre- or post-harvest) as a spray, dip or drench application.
Additionally, tolerances are established at 0.01 ppm in milk, meat,
fat, and meat byproducts (except liver) of cattle, goat, horse, and
sheep, and at 0.1 ppm in liver of these animals. Risk assessments were
conducted by EPA to assess dietary exposures from diphenylamine in food
as follows:
i. Acute exposure. There were no toxic effects attributable to a
single dose. An endpoint of concern was not identified to quantitate an
acute-dietary risk to the U.S. general population or to the
subpopulation females 13-50 years old. Therefore, an acute aggregate
exposure assessment was not performed.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments: The chronic dietary exposure analysis was based
on tolerance level residues, DEEM (Version 7.81) default processing
factors, an empirical processing factor for apple juice, and 100% crop
treated assumptions.
iii. Cancer. Diphenylamine was classified as ``not likely to be a
human carcinogen;'' therefore, a cancer dietary exposure analysis was
not performed.
2. Dietary exposure from drinking water. Diphenylamine uses are
post-harvest; therefore, residues in drinking water are not relevant to
this risk assessment.
3. Dietary exposure from non-dietary exposure. Diphenylamine is not
registered for use on any sites that would result in residential
exposure. Therefore a residential exposure risk assessment was not
performed.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to diphenylamine and any
other substances and 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 policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
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 MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no indication of
increased sensitivity of rats or rabbits to in utero and postnatal
exposure to diphenylamine. In prenatal
[[Page 70708]]
developmental toxicity studies in rats and rabbits, no evidence of
developmental toxicity was observed. In a 2-generation reproduction
study, offspring toxicity (decreased body weight) was seen only in the
presence of maternal toxicity.
3. Conclusion. EPA recommended the FQPA safety factor be reduced to
1X for the following reasons:
i. There is a complete toxicity data base for diphenylamine;
ii. The toxicity database showed no increase in susceptibility in
fetuses and pups with in utero and postnatal exposure, and
iii. The dietary food exposure assessment is based on recommended
tolerance-level residues (except those processed commodities for which
processing factors were used) and assumes 100% crop treated for all
commodities, which resulted in very high-end estimates of dietary
exposure.
E. Aggregate Risks and Determination of Safety
1. Acute risk. There were no toxic effects attributable to a single
dose. An endpoint of concern was not identified to quantitate an acute-
dietary risk to the U.S. general population or to the subpopulation
females 13-50 years old. Therefore, diphenylamine is not expected to
pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
diphenylamine from food will utilize 12% of the cPAD for the U.S.
population, 69% of the cPAD for all infants < 1 year old, and 90% of the
cPAD for children 1-2 years old. There are no residential uses for
diphenylamine that result in chronic residential exposure. In addition,
there is no potential for chronic dietary exposure in drinking water as
diphenylamine is applied only as a post-harvest use. Therefore, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD.
3. Short and intermediate-term risk. There are no residential uses
for diphenylamine, and residues are not expected to occur in drinking
water. Therefore, short and intermediate-term aggregate risk
assessments were not performed.
4. Aggregate cancer risk for U.S. population. Diphenylamine is not
likely to be carcinogenic to humans. Therefore, a cancer aggregate risk
assessment was not performed.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to diphenylamine residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography/mass-selective detector (GC/MSD)
method is available for enforcing tolerances on apple commodities, and
this method was used for data collection in the current post-harvest
study. The method was adequately validated in conjunction with the
sample analyses. A modification of this method was used in the pear
analyses. Therefore, the Agency requires the registrant to submit an
analytical reference standard of diphenylamine to the EPA National
Pesticide Standards Repository. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
Codex MRLs have been established for the post harvest use of
diphenylamine on pears. The MRL for pear is 5 ppm, and is the same as
the recommended pear tolerance.
V. Conclusion
A tolerance is proposed for residues of diphenylamine in pear at
5.0 ppm.
VI. Statutory and Executive Order Reviews
This proposed 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). Because this proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
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 special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed
action will not have significant negative economic impact on a
substantial number of small entities. Establishment of a tolerance
legalizes the presence of a pesticide residue in a food. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 3175, requires EPA to develop
an accountable process to ensure ``meaningful and timely input by
tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the
[[Page 70709]]
Executive order to include regulations that have ``substantial direct
effects on one or more Indian tribes, on the relationship between the
Federal Government and the Indian tribes, or on the distribution of
power and responsibilities between the Federal Government and Indian
tribes.'' This proposed rule will not have substantial direct effects
on tribal governments, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes, as
specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this proposed 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: November 22, 2006.
Donald R. Stubbs,
Acting 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 amended by alphabetically adding a commodity
to the table in paragraph (a) to read as follows:
Sec. 180.190 Diphenylamine; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pear (post harvest)........................................ 5.0
* * * * *
------------------------------------------------------------------------
[FR Doc. E6-20648 Filed 12-5-06; 8:45 am]
BILLING CODE 6560-50-S