[Federal Register Volume 64, Number 188 (Wednesday, September 29, 1999)]
[Rules and Regulations]
[Pages 52450-52457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25312]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300921; FRL-6382-1]
RIN 2070-AB78
Diflubenzuron; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of diflubenzuron (N-[[4-
[[Page 52451]]
chlorophenyl)amino]-carbonyl]-2,6-difluorobenzamide) and its
metabolites PCA (4-chloroaniline) and CPU (4-chlorophenylurea),
expressed as parent compound in or on pears. This action is in response
to EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on pears. This regulation establishes a maximum
permissible level for residues of diflubenzuron in this food commodity.
The tolerance will expire and is revoked on March 31, 2001.
DATES: This regulation is effective September 29, 1999. Objections and
requests for hearings, identified by docket control number OPP-300921,
must be received by EPA on or before November 29, 1999.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300921 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail:Andrea Beard, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703)308-9356; and e-mail address: beard.andrea@epa.gov.
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 categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300921. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408 (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing a tolerance for residues of the insecticide diflubenzuron
and its metabolites PCA and CPU, expressed as parent compound, in or on
pears at 0.5 part per million (ppm). This tolerance will expire and is
revoked on March 31, 2001. EPA will publish a document in the Federal
Register to remove the revoked tolerance from the Code of Federal
Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
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. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Diflubenzuron on Pears and FFDCA
Tolerances
The Oregon and Washington Departments of Agriculture requested use
of diflubenzuron on pears, for control of pear psylla, which had
developed resistance to currently available pesticides, and was
expected to cause significant economic loss if not adequately
controlled. EPA has authorized under FIFRA section 18 the use of
diflubenzuron on pears for
[[Page 52452]]
control of pear psylla in Oregon and Washington. After having reviewed
the submission, EPA concurs that emergency conditions exist for these
states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of diflubenzuron in or on
pears. In doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerance under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address an urgent non-routine situation
and to ensure that the resulting food is safe and lawful, EPA is
issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on March 31, 2001, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on pears after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this tolerance at the time of that application. EPA will take action
to revoke this tolerance earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether diflubenzuron meets EPA's
registration requirements for use on pears or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of diflubenzuron by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than Oregon and Washington to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
diflubenzuron, contact the Agency's Registration Division at the
address provided under the ``ADDRESSES'' section.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
diflubenzuron and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of diflubenzuron and its metabolites PCA and CPU, expressed as
parent compound on pears at 0.5 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 diflubenzuron are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. A risk assessment for acute (1-day) dietary
exposure is not necessary. One day single dose oral studies in rats and
mice indicated only marginal effects on methemoglobin levels at a dose
level of 10,000 milligrams/kilogram/day (mg/kg/day).
2. Short- and intermediate-term toxicity. The toxicological
endpoint for short-term occupational or residential exposure (1-7 days)
is sulfhemoglobinemia observed in the 14-day subchronic oral study in
mice dosed with technical grade diflubenzuron. The no observed adverse
effect level (NOAEL) in this study was 40 mg/kg/day, and the lowest
observed adverse effect level (LOAEL) was 200 mg/kg/day.
The toxicological endpoint for intermediate-term occupational or
residential exposure (1 week to several months) is methemoglobinemia
observed in the 13-week subchronic feeding study in dogs. For the
purpose of risk assessments, the NOAEL of 1.64 mg/kg/day in this study
should be rounded up to 2 mg/kg/day, so as to be consistent with the
NOAEL of 2 mg/kg/day in the chronic study used to calculate the
Reference Dose (RfD). The LOAEL in this study was 6.24 mg/kg/day. Since
an oral NOAEL was selected for a dermal endpoint, a dermal absorption
factor of 0.5% should be used for this risk assessment when converting
dermal exposure to oral equivalents. Therefore, the dermal equivalent
dose producing a NOAEL by the oral route is calculated to be 400 mg/kg/
day (2.0 mg/kg/day divided by 0.005 = 400 mg/kg/day).
3. Chronic toxicity. EPA has established the RfD for diflubenzuron
at 0.02 mg/kg/day, based on the NOAEL of 2.0 mg/kg/day from the 52-
week chronic oral study in dogs. Increases in methemoglobin and
sulfhemoglobin were observed at the next higher dose level (LOAEL) of
10.0 mg/kg/day. An uncertainty factor of 100 was applied to account for
the interspecies extrapolation and intraspecies variability.
Diflubenzuron has been reviewed by the FAO/WHO joint committee on
pesticide residues and an Acceptable Daily Intake (ADI) of 0.02 mg/kg/
day was established in 1985. The ADI was based upon the 1- year oral
toxicity study in dogs with a NOAEL of 2.0 mg/kg/day, with a safety
factor of 100 applied to account for inter- and intra- species
variability.
4. Carcinogenicity. Based on the available evidence, which included
adequate carcinogenicity studies in rats and mice, and a battery of
negative mutagenicity studies, diflubenzuron per se has been classified
as Group E (evidence of non- carcinogenicity for humans). However, p-
chloroaniline (PCA), a metabolite of diflubenzuron, was classified as a
Group B2 carcinogen (probable human carcinogen). The classification for
PCA was based on the results of a National Toxicology Program (N.T.P.)
study reported in July 1989, in which PCA-HCL was administered by
gavage to rats and mice for 2 years. In rats, clearly increased
incidences of uncommon sarcomas (fibrosarcomas, hemangiosarcomas, and/
or osteosarcomas) of the spleen were observed in males. In females, two
additional sarcomas of the spleen were also found. Pheochromocytomas of
the adrenal gland may also have been associated with the test material
in male and female rats. In mice, increased incidences of
hepatocellular neoplasms in the liver and of hemangiosarcomas in the
spleen and/or liver were observed in males. In females, no evidence of
carcinogenic activity was observed. The results of several mutagenicity
studies on PCA were also included in the same N.T.P. Report. PCA was
mutagenic in Salmonella strains TA98 and TA100 with metabolic
activation. Gene
[[Page 52453]]
mutations were induced by PCA in cultured mouse lymphoma cells with and
without metabolic activation. In cultured Chinese Hamster Ovary (CHO)
cells, treatment with PCA produced significant increases in sister
chromatic exchanges (SCEs) with and without metabolic activation.
Chromosomal aberrations were also significantly increased in CHO cells
in the presence of metabolic activation.
For the purpose of calculating dietary risk assessments, the
following procedure was used:
i. P-chlorophenylurea (CPU) and p-chloroacetanilide (PCAA),
additional metabolites of diflubenzuron that are closely related to PCA
and for which there are no adequate carcinogenicity data available,
should be considered to be potentially carcinogenic and to have the
same carcinogenic potency (Q1*) as PCA.
ii. The sum of PCA, CPU, and PCAA residues in ingested food should
be used to estimate the dietary exposure of humans to the carcinogenic
metabolites of diflubenzuron.
iii. In addition to ingested residues of these three metabolites,
amounts of PCA, CPU, and/or PCAA formed in vivo following ingestion of
diflubenzuron should also be included when estimating the total
exposure of humans to the carcinogenic metabolites of diflubenzuron.
The in vivo conversion of ingested diflubenzuron to PCA and/or CPU was
estimated to be 2.0%, based on data in the rat metabolism study.
The Q1* (estimated unit risk) for PCA, based upon spleen
sarcoma rates in male rats, was calculated to be 6.38 x 10-2
(mg/kg/day)-1 in human equivalents. It has been determined
that PCAA does not occur in animal or plant tissues in significant
amounts.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.377) for the residues of diflubenzuron per se, in or on citrus,
artichokes, walnuts, mushrooms, cottonseed, soybean, rice, and
associated livestock commodities. Existing tolerances range from 0.05
ppm in/on soybeans, to 6.0 ppm in/on artichokes. Tolerances of 0.05 ppm
have also been established for residues of diflubenzuron in animal
commodities. Risk assessments were conducted by EPA to assess dietary
exposures and risks from diflubenzuron as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. One day single dose oral studies in rats
and mice indicated only marginal effects on methemoglobin levels at a
dose level of 10,000 mg/kg/day. Therefore, this risk assessment is not
needed, as there are no significant acute effects observed.
ii. Chronic exposure and risk. For conducting the chronic dietary
risk assessment, refined residue estimates were used for all
commodities except for pears. Percent of crop treated figures were also
used for certain commodities. The percent of RfD utilized for Non-
Nursing Infants <1 yr.="" old="" (the="" most="" highly="" exposed="" subgroup)="" was="" 6.1%.="" for="" nursing="" infants,="" this="" figure="" was="" 2.2%,="" and="" for="" all="" other="" population="" subgroups,="" including="" the="" overall="" u.s.="" population,="" the="" arc="" utilized="" less="" than="" 1%="" of="" the="" rfd.="" section="" 408(b)(2)(e)="" authorizes="" epa="" to="" use="" available="" data="" and="" information="" on="" 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.="" section="" 408(b)(2)(f)="" states="" that="" the="" agency="" may="" use="" data="" on="" the="" actual="" percent="" of="" crop="" treated="" (pct)="" for="" assessing="" chronic="" dietary="" risk="" only="" if="" the="" agency="" can="" make="" the="" following="" findings:="" that="" the="" data="" used="" are="" reliable="" and="" provide="" a="" valid="" basis="" to="" show="" what="" percentage="" of="" the="" food="" derived="" from="" such="" crop="" is="" likely="" to="" contain="" such="" pesticide="" residue;="" that="" the="" exposure="" estimate="" does="" not="" underestimate="" exposure="" for="" any="" significant="" subpopulation="" group;="" and="" if="" data="" are="" available="" on="" pesticide="" use="" and="" food="" consumption="" in="" a="" particular="" area,="" the="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" the="" population="" in="" such="" area.="" in="" addition,="" the="" agency="" must="" provide="" for="" periodic="" evaluation="" of="" any="" estimates="" used.="" to="" provide="" for="" the="" periodic="" evaluation="" of="" the="" estimate="" of="" pct="" as="" required="" by="" section="" 408(b)(2)(f),="" epa="" may="" require="" registrants="" to="" submit="" data="" on="" pct.="" the="" agency="" used="" pct="" information="" as="" follows:="" 1%="" for="" grass/rangeland;="" 3%="" for="" cottonseed;="" 8%="" for="" grapefruit;="" 3.1%="" for="" mushrooms;="" 2%="" for="" oranges;="" 4%="" for="" tangerines;="" 1%="" for="" soybean;="" and="" 5%="" for="" cattle="" bolus.="" other="" commodities="" were="" assumed="" to="" be="" 100%="" treated.="" the="" agency="" believes="" that="" the="" three="" conditions,="" discussed="" in="" section="" 408="" (b)(2)(f)="" in="" this="" unit="" concerning="" the="" agency's="" responsibilities="" in="" assessing="" chronic="" dietary="" risk="" findings,="" have="" been="" met.="" the="" pct="" estimates="" are="" derived="" from="" federal="" and="" private="" market="" survey="" data,="" which="" are="" reliable="" and="" have="" a="" valid="" basis.="" typically,="" a="" range="" of="" estimates="" are="" supplied="" and="" the="" upper="" end="" of="" this="" range="" is="" assumed="" for="" the="" exposure="" assessment.="" by="" using="" this="" upper="" end="" estimate="" of="" the="" pct,="" the="" agency="" is="" reasonably="" certain="" that="" the="" percentage="" of="" the="" food="" treated="" is="" not="" likely="" to="" be="" underestimated.="" the="" regional="" consumption="" information="" and="" consumption="" information="" for="" significant="" subpopulations="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluating="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" use="" of="" this="" consumption="" information="" in="" epa's="" risk="" assessment="" process="" ensures="" that="" epa's="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" significant="" subpopulation="" group="" and="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" other="" than="" the="" data="" available="" through="" national="" food="" consumption="" surveys,="" epa="" does="" not="" have="" available="" information="" on="" the="" regional="" consumption="" of="" food="" to="" which="" diflubenzuron="" may="" be="" applied="" in="" a="" particular="" area.="" 2.="" from="" drinking="" water.="" the="" agency="" currently="" lacks="" sufficient="" water-="" related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" exposure="" analysis="" and="" risk="" assessment="" for="" diflubenzuron.="" because="" the="" agency="" does="" not="" have="" comprehensive="" and="" reliable="" monitoring="" data,="" drinking="" water="" concentration="" estimates="" must="" be="" made="" by="" reliance="" on="" some="" sort="" of="" simulation="" or="" modeling.="" to="" date,="" there="" are="" no="" validated="" modeling="" approaches="" for="" reliably="" predicting="" pesticide="" levels="" in="" drinking="" water.="" the="" agency="" is="" currently="" relying="" on="" the="" models="" geneec="" and="" przm/exams="" for="" surface="" water,="" which="" are="" used="" to="" produce="" estimates="" of="" pesticide="" concentrations="" in="" a="" farm="" pond;="" and="" sci-grow,="" which="" predicts="" pesticide="" concentrations="" in="" groundwater.="" none="" of="" these="" models="" include="" consideration="" of="" the="" impact="" that="" processing="" of="" raw="" water,="" for="" distribution="" as="" drinking="" water,="" would="" likely="" have="" on="" the="" removal="" of="" pesticides="" from="" the="" source="" water.="" the="" primary="" use="" of="" these="" models="" by="" the="" agency="" at="" this="" stage="" is="" to="" provide="" a="" coarse="" screen="" for="" sorting="" out="" pesticides="" for="" which="" it="" is="" highly="" unlikely="" [[page="" 52454]]="" that="" drinking="" water="" concentrations="" would="" ever="" exceed="" human="" health="" levels="" of="" concern.="" in="" the="" absence="" of="" monitoring="" data="" for="" pesticides,="" drinking="" water="" levels="" of="" comparison="" (dwlocs)="" are="" calculated="" and="" used="" as="" a="" point="" of="" comparison="" against="" the="" model="" estimates="" of="" a="" pesticide's="" concentration="" in="" water.="" dwlocs="" are="" theoretical="" upper="" limits="" for="" a="" pesticide's="" concentration="" in="" drinking="" water="" in="" light="" of="" total="" aggregate="" exposure="" to="" a="" pesticide="" in="" food,="" drinking="" water,="" and="" residential="" uses.="" a="" dwloc="" will="" vary="" depending="" on="" the="" toxic="" endpoint,="" with="" drinking="" water="" consumption,="" and="" body="" weights.="" different="" populations="" will="" have="" different="" dwlocs.="" dwlocs="" are="" used="" in="" the="" risk="" assessment="" process="" as="" a="" surrogate="" measure="" of="" potential="" exposure="" associated="" with="" pesticide="" exposure="" through="" drinking="" water.="" dwloc="" values="" are="" not="" regulatory="" standards="" for="" drinking="" water.="" since="" dwlocs="" address="" total="" aggregate="" exposure="" to="" diflubenzuron="" they="" are="" further="" discussed="" in="" the="" aggregate="" risk="" sections="" below.="" 3.="" from="" non-dietary="" exposure.="" diflubenzuron="" is="" a="" restricted="" use="" pesticide="" and="" therefore="" not="" available="" for="" use="" by="" homeowners,="" although="" it="" is="" possible="" that="" non-="" agricultural="" uses="" of="" diflubenzuron="" may="" expose="" people="" in="" residential="" locations.="" however,="" based="" on="" the="" low="" dermal="" absorption="" rate="" (0.5%),="" and="" the="" extremely="" low="" dermal="" and="" inhalation="" toxicity,="" these="" uses="" are="" expected="" to="" result="" in="" insignificant="" risks.="" 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.''="" diflubenzuron="" is="" structurally="" similar="" to="" other="" substituted="" benzoylurea="" insecticides="" including="" triflumuron="" and="" flucycloxuron.="" however,="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" diflubenzuron="" 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,="" diflubenzuron="" 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="" diflubenzuron="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" for="" more="" information="" regarding="" epa's="" efforts="" to="" determine="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" to="" evaluate="" the="" cumulative="" effects="" of="" such="" chemicals,="" see="" the="" final="" rule="" for="" bifenthrin="" pesticide="" tolerances="" (62="" fr="" 62961,="" november="" 26,="" 1997).="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" since="" one="" day="" single="" dose="" oral="" studies="" in="" rats="" and="" mice="" indicated="" only="" marginal="" effects,="" this="" risk="" assessment="" is="" not="" needed,="" as="" there="" were="" no="" significant="" acute="" effects="" observed.="" 2.="" chronic="" risk.="" using="" the="" arc="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" diflubenzuron="" from="" food="" will="" utilize=""><1 of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-="" nursing="" infants,=""><1 year="" old,="" for="" which="" 6.1%="" of="" the="" rfd="" was="" utilized.="" 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.="" the="" agency="" does="" not="" have="" monitoring="" data="" available="" to="" perform="" a="" quantitative="" drinking="" water="" risk="" assessment="" for="" diflubenzuron="" at="" this="" time.="" based="" on="" przm/exams="" modeling,="" the="" average="" annual="" mean="" concentration="" of="" diflubenzuron="" in="" surface="" water="" sources="" is="" not="" expected="" to="" exceed="" 0.05="" ppb.="" estimated="" concentrations="" of="" cpu="" in="" surface="" water="" sources="" is="" not="" expected="" to="" exceed="" 0.73="" ppb.="" these="" values="" reflect="" the="" maximum="" concentrations="" for="" any="" of="" the="" crops="" treated="" with="" diflubenzuron="" (including="" pears).="" the="" dwlocs="" for="" chronic="" (non-cancer)="" exposure="" to="" diflubenzuron="" in="" drinking="" water="" for="" the="" u.s.="" population="" and="" non="" nursing="" infants="">< 1="" yr.="" old),="" and="" females="" (13+="" yrs.="" old/nursing)="" are="" 700,="" 190,="" and="" 600="" ppb,="" respectively.="" the="" estimated="" maximum="" concentration="" of="" diflubenzuron="" in="" surface="" and="" ground="" water="" (0.05="" ppb)="" is="" lower="" than="" the="" dwlocs="" as="" a="" contribution="" to="" chronic="" aggregate="" exposure.="" therefore,="" epa="" concludes="" that="" residues="" of="" diflubenzuron="" and="" its="" metabolites="" in="" drinking="" water="" would="" not="" result="" in="" an="" unacceptable="" estimate="" of="" chronic,="" non-="" cancer="" risk.="" despite="" the="" potential="" for="" exposure="" to="" diflubenzuron="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" as="" stated="" earlier,="" although="" residential="" exposure="" has="" been="" considered="" possible="" from,="" for="" example,="" area-wide="" gypsy="" moth="" or="" mosquito="" control,="" this="" contribution="" is="" anticipated="" to="" be="" negligible.="" thus,="" it="" was="" determined="" that="" this="" risk="" assessment="" is="" not="" necessary.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" a="" cancer="" risk="" assessment="" was="" conducted="" for="" the="" metabolites="" of="" diflubenzuron,="" pca="" and="" cpu.="" as="" a="" conservative="" measure,="" epa="" assumes="" that="" pca/cpu="" occupied="" 2%="" of="" diflubenzuron="" tolerance="" levels,="" based="" upon="" metabolism="" studies.="" based="" upon="" the="" arc="" estimates="" described="" above,="" the="" cancer="" risk="" for="" the="" overall="" u.s.="" population="" from="" dietary="" (food="" only)="" was="" calculated="" to="" be="" 5="" x="">-7, which does not exceed EPA's levels of concern. The
DWLOC for cancer risk for the U.S. population is 0.26 ppb. Estimated
drinking water concentrations from PCA/CPU (0.73 ppb) are greater than
the DWLOC of 0.26, for cancer risk. However, EPA believes these
estimates are significantly overstated for several reasons. The PRZM/
EXAMS model used to derive these estimates was designed for ecological
risk assessments, and uses a scenario of a body of water approximating
the size of a 2.5 acre pond. This tends to overstate chronic drinking
water exposure levels for the following reasons. First, surface water
source drinking water generally comes from bodies of water that are
substantially larger. Second, the scenario assumes that the whole basin
receives an application of the pesticide, but in virtually all cases,
basins used for drinking water will contain a substantial portion of
the area that does not receive pesticide application. Third, there is
often at least some flow or turnover of the water, so the persistence
of the pesticide near the drinking water facility is usually
overestimated. Fourth, even assuming that the reservoir is directly
adjacent to an agricultural field, the field may not be used to grow a
crop on which the pesticide in question is registered for use. Fifth,
the PRZM/EXAMS scenario does not take into account reductions in
residue-loading due to applications less than the maximum application
rate or no treatment of the crop at all. Considering these
uncertainties associated with the modeled water estimates noted above,
and the fact that the estimated concentrations are within close range
of the DWLOCs, EPA concludes with reasonable certainty that residues of
diflubenzuron in drinking water will
[[Page 52455]]
not contribute significantly to the aggregate cancer human health risk.
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 diflubenzuron 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 diflubenzuron, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre- and post-natal toxicity and the
completeness of the 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 MOE and uncertainty factor (usually 100 for combined
inter- and intra-species variability) and not the additional tenfold
MOE/uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal (systemic) and the developmental (fetal) NOAEL were
both 1,000 mg/kg/day. No LOAELs were achieved, as no maternal or
developmental toxicity was observed.
In the developmental toxicity study in rabbits, both the maternal
(systemic) and the developmental (fetal) NOAELs were both 1,000 mg/kg/
day. As with the rat study, mentioned above, no LOAELs were achieved,
as no maternal or developmental toxicity was observed.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the parental (systemic) NOAEL was considered to
be less than 36 mg/kg/day for males, and less than 42 mg/kg/day for
females based on hematological effects at all dose levels tested. For
offspring effects, the NOAEL was equal to 427 mg/kg/day, and the LOAEL
was equal to 4,254 mg/kg/day, based on statistically significant
decreases in F-1 pup weight on days 4, 8, and 21 of lactation.
iv. Pre- and post-natal sensitivity. The toxicological database for
evaluating pre- and post-natal toxicity for diflubenzuron is completed
with respect to current data requirements. There are no pre- or post-
natal toxicity concerns for infants and children, based upon the result
of the developmental and reproductive studies mentioned above.
v. Conclusion. The OPP FQPA Safety Factor Committee recommended
that the 10X factor for increased susceptibility of infants and
children be reduced to 1X, for diflubenzuron. This decision was based
on the determination that there was no indication of increased
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to diflubenzuron, and because exposure assessments do not indicate a
concern for potential risk to infants and children. There is a complete
toxicity database for diflubenzuron and exposure data is complete or is
estimated based on data that reasonably accounts for potential
exposures.
2. Acute risk. Since one day single dose oral studies in rats and
mice indicated only marginal effects, this risk assessment is not
needed, as there are no significant acute effects observed.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to diflubenzuron from
food will utilize 6.1% of the RfD for Non-Nursing Infants < 1="" year="" old,="" the="" most="" highly="" exposed="" infant/children="" population="" subgroup.="" 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.="" despite="" the="" potential="" for="" exposure="" to="" diflubenzuron="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" intermediate-term="" risk.="" as="" stated="" earlier,="" although="" residential="" exposure="" has="" been="" considered="" possible="" from,="" for="" example,="" area-wide="" gypsy="" moth="" or="" mosquito="" control,="" this="" contribution="" is="" anticipated="" to="" be="" negligible.="" thus,="" it="" was="" determined="" that="" this="" risk="" assessment="" is="" not="" necessary.="" 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="" diflubenzuron="" residues.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" and="" animals="" is="" adequately="" understood.="" the="" residue="" of="" concern="" is="" diflubenzuron="" and="" its="" metabolites="" p-chloroaniline="" (pca)="" and="" p-="" chlorophenylurea="" (cpu),="" expressed="" as="" the="" parent="" compound.="" b.="" analytical="" enforcement="" methodology="" adequate="" methodology="" for="" the="" analysis="" of="" diflubenzuron="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" three="" analytical="" methods="" for="" diflubenzuron="" are="" published="" in="" pam,="" vol.="" ii="" as="" methods="" i,="" ii,="" and="" iii.="" all="" three="" methods="" have="" undergone="" successful="" agency="" validations="" and="" are="" acceptable="" for="" enforcement="" purposes.="" c.="" magnitude="" of="" residues="" residues="" of="" diflubenzuron="" and="" its="" metabolites="" are="" not="" expected="" to="" exceed="" 0.5="" ppm="" in/on="" pears="" as="" a="" result="" of="" this="" use.="" d.="" international="" residue="" limits="" there="" is="" a="" codex="" maximum="" residue="" limit="" (mrl)="" for="" pears="" at="" 1="" mg/kg,="" a="" mrl="" for="" mexico="" at="" 1.0="" mg/kg,="" and="" no="" limits="" set="" for="" canada="" for="" pears.="" this="" tolerance="" is="" to="" be="" set="" at="" a="" lower="" level="" than="" the="" mrls.="" this="" is="" a="" time-limited="" tolerance,="" established="" solely="" in="" support="" of="" this="" section="" 18="" use.="" in="" considering="" permanent="" tolerances="" for="" pears="" in="" the="" future,="" the="" agency="" will="" take="" these="" circumstances="" into="" account.="" e.="" rotational="" crop="" restrictions="" available="" data="" for="" diflubenzuron="" indicate="" that="" tolerances="" for="" residues="" in="" rotational="" crops="" will="" not="" be="" required,="" provided="" the="" label="" specifies="" a="" restriction="" for="" the="" planting="" of="" rotational="" crops="" of="" at="" least="" 30="" days.="" vi.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" combined="" residues="" of="" diflubenzuron="" and="" its="" metabolites="" pca="" and="" cpu,="" expressed="" as="" parent="" compound="" in="" pears="" at="" 0.5="" ppm.="" vii.="" objections="" and="" hearing="" requests="" under="" section="" 408(g)="" of="" the="" ffdca,="" as="" amended="" by="" the="" fqpa,="" any="" person="" may="" file="" an="" objection="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" [[page="" 52456]]="" hearing="" on="" those="" objections.="" the="" epa="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" requests="" for="" hearings="" appear="" in="" 40="" cfr="" part="" 178.="" although="" the="" procedures="" in="" those="" regulations="" require="" some="" modification="" to="" reflect="" the="" amendments="" made="" to="" the="" ffdca="" by="" the="" fqpa="" of="" 1996,="" epa="" will="" continue="" to="" use="" those="" procedures,="" with="" appropriate="" adjustments,="" until="" the="" necessary="" modifications="" can="" be="" made.="" the="" new="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" regulation="" for="" an="" exemption="" from="" the="" requirement="" of="" a="" tolerance="" issued="" by="" epa="" under="" new="" section="" 408(d),="" as="" was="" provided="" in="" the="" old="" ffdca="" sections="" 408="" and="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" now="" 60="" days,="" rather="" than="" 30="" days.="" a.="" what="" do="" i="" need="" to="" do="" to="" file="" an="" objection="" or="" request="" a="" hearing?="" you="" must="" file="" your="" objection="" or="" request="" a="" hearing="" on="" this="" regulation="" in="" accordance="" with="" the="" instructions="" provided="" in="" this="" unit="" and="" in="" 40="" cfr="" part="" 178.="" to="" ensure="" proper="" receipt="" by="" epa,="" you="" must="" identify="" docket="" control="" number="" opp-300921="" in="" the="" subject="" line="" on="" the="" first="" page="" of="" your="" submission.="" all="" requests="" must="" be="" in="" writing,="" and="" must="" be="" mailed="" or="" delivered="" to="" the="" hearing="" clerk="" on="" or="" before="" november="" 29,="" 1999.="" 1.="" filing="" the="" request.="" your="" objection="" must="" specify="" the="" specific="" provisions="" in="" the="" regulation="" that="" you="" object="" to,="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues(s)="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" objector="" (40="" cfr="" 178.27).="" 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.="" mail="" your="" written="" request="" to:="" office="" of="" the="" hearing="" clerk="" (1900),="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" you="" may="" also="" deliver="" your="" request="" to="" the="" office="" of="" the="" hearing="" clerk="" in="" room="" m3708,="" waterside="" mall,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" the="" office="" of="" the="" hearing="" clerk="" is="" open="" from="" 8="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" telephone="" number="" for="" the="" office="" of="" the="" hearing="" clerk="" is="" (202)="" 260-4865.="" 2.="" tolerance="" fee="" payment.="" if="" you="" file="" an="" objection="" or="" request="" a="" hearing,="" you="" must="" also="" pay="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i)="" or="" request="" a="" waiver="" of="" that="" fee="" pursuant="" to="" 40="" cfr="" 180.33(m).="" you="" must="" mail="" the="" fee="" to:="" epa="" headquarters="" accounting="" operations="" branch,="" office="" of="" pesticide="" programs,="" p.o.="" box="" 360277m,="" pittsburgh,="" pa="" 15251.="" please="" identify="" the="" fee="" submission="" be="" labeling="" it="" ``tolerance="" petition="" fees.''="" 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.''="" (cite).="" for="" additional="" information="" regarding="" the="" waiver="" of="" these="" fees,="" you="" may="" contact="" james="" tompkins="" by="" phone="" at="" (703)="" 305-5697,="" by="" e-mail="" at="">tompkins.jim@epa.gov, or by mailing a request for information to Mr.
Tompkins at Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A. of
this preamble, you should also send a copy of your request to the PIRIB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by the docket
number OPP-300921, 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 or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. of this preamble. You
may also send an electronic copy of your request via e-mail to: docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 5.1/6.1 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
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(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes a tolerance under section 408 of the
FFDCA. 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 prior consultation with
State, local, and tribal government officials as specified by Executive
Order 12875, entitled Enhancing the Intergovernmental Partnership (58
FR 58093, October 28, 1993) and Executive Order 13084, entitled
Consultation and Coordination with Indian Tribal Governments (63 FR
27655, May 19,1998), or special consideration of environmental justice
related issues 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 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). 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 12612, entitled Federalism (52 FR 41685, October 30,
1987). This action directly regulates growers, food processors, food
handlers and food retailers, not States. This
[[Page 52457]]
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of the FFDCA, 21 U.S.C. 346a(n)(4). 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). In addition, since
tolerances and exemptions that are established under FFDCA section
408(l)(6), 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.
IX. 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 to 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 this 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: September 14, 1999 .
Peter Caulkins,
Acting 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), 346(a), and 371.
2. In Sec. 180.377, by adding text to paragraph (b) to read as
follows:
Sec. 180.377 Diflubenzuron; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of diflubenzuron and its metabolites, PCA (4-
chloroaniline) and CPU (4-chlorophenylurea), expressed as the parent
diflubenzuron, in connection with use of this pesticide under a section
18 emergency exemption granted by EPA. The tolerances will expire on
the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Pears........................... 0.5 3/31/00
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-25312 Filed 9-28-99; 8:45 am]
BILLING CODE 6560-50-F
