[Federal Register Volume 63, Number 92 (Wednesday, May 13, 1998)]
[Rules and Regulations]
[Pages 26466-26472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12426]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300651; FRL-5788-2]
RIN 2070-AB78
Pyriproxyfen; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of pyriproxyfen in or on citrus fruit, juice, dried pulp, and
oil; pears; and tomatoes. This action is in response to EPA's granting
of emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on citrus, pears, and tomatoes. This regulation establishes maximum
permissible levels for residues of pyriproxyfen in these food and feed
commodities pursuant to section 408(l)(6) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
of 1996 (FQPA). The tolerances will expire and are revoked on July 31,
1999.
DATES: This regulation is effective May 13, 1998. Objections and
requests for hearings must be received by EPA on or before July 13,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300651], 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-300651], 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, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300651]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: Telephone numbers and e-mail
addresses: For pyriproxyfen on citrus: Andrea Beard (703) 308-9356, e-
mail: beard.andrea@epamail.epa.gov; For pyriproxyfen on pears or
tomatoes: Virginia Dietrich (703) 308-9359, e-mail:
dietrich.virginia@epamail.epa.gov. Office location (both): Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA. By mail (both):
Registration Division 7505C, Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the FFDCA, 21 U.S.C. 346a(e) and (l)(6),
is establishing tolerances for residues of the pesticide pyriproxyfen,
in or on citrus fruit at 0.3 parts per million (ppm), citrus juice and
dried citrus pulp at 1.0 ppm, and citrus oil at 300 ppm; pears at 0.2
ppm; and tomatoes at 0.1 ppm. These tolerances will expire and are
revoked on July 31, 1999. EPA will publish a document in the Federal
Register to remove the revoked tolerances from the Code of Federal
Regulations.
I. Background and Statutory Authority
The FQPA (Pub. L. 104-170) was signed into law August 3, 1996. FQPA
amends both the FFDCA, 21 U.S.C. 301 et seq., and the FIFRA, 7 U.S.C.
136 et seq . The FQPA amendments went into effect immediately. Among
other things, FQPA amends FFDCA to bring all EPA pesticide tolerance-
setting activities under a new section 408 with a new safety standard
and new procedures. These activities are described below and discussed
in greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
[[Page 26467]]
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 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 FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Pyriproxyfen on Citrus and FFDCA
Tolerances
Pyriproxyfen on Citrus: A request was received from California for
use of pyriproxyfen on citrus to control red scale, which has developed
resistance to available controls, in some localized citrus-producing
areas of California, causing significant losses to the affected citrus
producers.
Pyriproxyfen on Pears: A request was received from Oregon for the
use of pyriproxyfen on pears for control of pear psylla, which has
developed resistance to currently available controls, and is expected
to cause significant economic loss if not adequately controlled.
Pyriproxyfen on Tomatoes: A request was received from Florida for
the use of pyriproxyfen on tomatoes for control of whiteflies. A
recently introduced strain or species of whitefly has caused extensive
damage over the past several years to various vegetable crops in
southern areas of the U.S., including tomatoes. This pest has
demonstrated resistance to available materials and is expected to cause
significant economic losses if not adequately controlled.
EPA has authorized under FIFRA section 18 the use of pyriproxyfen
on citrus for control of red scale in California; on pears for control
of pear psylla in Oregon; and, on tomatoes for control of whiteflies in
Florida. After having reviewed the submissions, 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 pyriproxyfen in or on
citrus, pears, and tomatoes. In doing so, EPA considered the new safety
standard in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerances under FFDCA section 408(l)(6) would be consistent with the
new 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 these tolerances without notice and
opportunity for public comment under section 408(e), as provided in
section 408(l)(6). Although these tolerances will expire and are
revoked on July 31, 1999, under FFDCA section 408(l)(5), residues of
the pesticide not in excess of the amounts specified in the tolerances
remaining in or on citrus commodities, pears and tomatoes 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 these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether pyriproxyfen
meets EPA's registration requirements for use on citrus, pears, or
tomatoes, or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of pyriproxyfen by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than California,
Oregon, and Florida to use this pesticide on these crops under section
18 of FIFRA without following all provisions of section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for pyriproxyfen, contact the Agency's Registration
Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor
[[Page 26468]]
is warranted. Thus, an aggregate daily exposure to a pesticide residue
at or below the RfD (expressed as 100% or less of the RfD) is generally
considered acceptable by EPA. EPA generally uses the RfD to evaluate
the chronic risks posed by pesticide exposure. For shorter term risks,
EPA calculates a margin of exposure (MOE) by dividing the estimated
human exposure into the NOEL from the appropriate animal study.
Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 100-
fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. 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 percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (Children 1 - 6
Years Old) was not regionally based.
IV. 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
pyriproxyfen and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of pyriproxyfen on citrus fruit at 0.3 ppm, citrus juice and
dried citrus pulp at 1.0 ppm, and citrus oil at 300 ppm; pears at 0.2
ppm; and tomatoes at 0.1 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as
[[Page 26469]]
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
pyriproxyfen are discussed below.
1. Acute toxicity. There are no acute dietary endpoints of concern
for pyriproxyfen. No concern exists for acute dietary exposure to
pyriproxyfen residues.
2. Short - and intermediate - term toxicity. There are no
endpoints and no concern exists for short- or intermediate-term
toxicity from pyriproxyfen.
3. Chronic toxicity. EPA has established the RfD for pyriproxyfen
at 0.35 milligrams/kilogram/day (mg/kg/day). This RfD is based on 2-
year and 90-day feeding studies in rats with a NOEL of 35.1 mg/kg/day
and an uncertainty factor of 100, based on intra-and interspecies
differences. At the LOEL of 141.28 mg/kg/day, there was a decrease in
body weight gain in females.
4. Carcinogenicity. Pyriproxyfen has been classified in Group E of
EPA's cancer classification system, indicating there is evidence of
non-carcinogenicity for humans. Therefore, there is no concern for
cancer risk from exposure to pyriproxyfen.
B. Exposures and Risks
1. From food and feed uses. Time-limited tolerances have been
established (40 CFR 180.510) for the residues of pyriproxyfen, in or on
cotton commodities, in association with the use under emergency
exemptions. There are currently no registered food uses for
pyriproxyfen, and thus no permanent tolerances established. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from pyriproxyfen as follows:
Chronic exposure and risk. As stated above, there are time-limited
tolerances for cotton commodities established in connection with use
under emergency exemptions. This risk assessment took these into
account, as well as these tolerances being established for citrus
commodities, pears, and tomatoes. The chronic dietary (food only) risk
assessment used tolerance level residues and assumed 100% crop treated.
Therefore, the resulting exposure estimates should be viewed as
conservative; further refinement using anticipated residues and/or
percent of crop treated would result in lower dietary exposure
estimates. For chronic dietary (food only) risk estimates, the two most
highly exposed subgroups, Non-Nursing Infants (<1 year="" old)="" and="" children="" (1-6="" years="" old)="" had="" 1.54="" and="" 1.84%="" of="" the="" rfd="" utilized,="" respectively.="" all="" other="" population="" subgroups="" had="" less="" than="" 1%="" of="" the="" rfd="" utilized.="" 2.="" from="" drinking="" water.="" a="" tier="" ii="" drinking="" water="" assessment="" of="" pyriproxyfen="" was="" conducted,="" using="" computer="" models="" which="" simulate="" the="" fate="" in="" a="" surface="" water="" body.="" the="" estimated="" environmental="" concentrations="" (eecs)="" are="" generated="" for="" high="" exposure="" agricultural="" scenarios="" and="" represent="" one="" in="" ten="" years="" eecs="" in="" a="" stagnant="" pond="" with="" no="" outlet="" that="" receives="" pesticide="" loading="" from="" an="" adjacent="" 100%="" cropped,="" 100%="" treated="" field.="" as="" such,="" these="" computer="" generated="" eecs="" represent="" conservative="" screening="" levels="" for="" ponds="" and="" lakes="" and="" are="" used="" only="" for="" screening.="" the="" eecs="" for="" surface="" water="" ranged="" from="" a="" peak="" of="" 0.677="" ppb,="" to="" a="" 60-days="" average="" of="" 0.142="" ppb,="" to="" a="" 1-year="" average="" of="" 0.103="" ppb.="" these="" estimates="" are="" based="" on="" 2="" applications="" at="" a="" rate="" of="" 0.11="" lb.="" active="" ingredient="" per="" acre.="" for="" ground="" water,="" a="" computer="" model="" was="" used="" which="" resulted="" in="" estimated="" 60-day="" average="" concentrations="" of="" pyriproxyfen="" of="" 0.006="" ppb.="" chronic="" exposure="" and="" risk.="" a="" human="" health="" drinking="" water="" level="" of="" concern="" (dwloc)="" is="" the="" concentration="" in="" drinking="" water="" that="" would="" be="" acceptable="" as="" an="" upper="" limit="" in="" light="" of="" total="" aggregate="" exposure="" to="" that="" chemical="" from="" food,="" water="" and="" non-occupational="" (residential)="" sources.="" the="" dwloc="" for="" chronic="" risk="" is="" the="" concentration="" in="" drinking="" water="" as="" a="" part="" of="" the="" aggregate="" chronic="" exposure,="" that="" occupies="" no="" more="" than="" 100%="" of="" the="" rfd.="" in="" conducting="" these="" calculations,="" default="" body="" weights="" are="" used="" of="" 70="" kg="" (adult="" male),="" 60="" kg="" (adult="" female)="" and="" 10="" kg="" (child);="" default="" consumption="" values="" of="" water="" are="" used="" of="" 2="" liters="" per="" day="" for="" adults="" and="" 1="" liter="" per="" day="" for="" children.="" using="" these="" assumptions="" and="" the="" levels="" provided="" by="" the="" computer="" models,="" given="" above,="" the="" resultant="" percentage="" of="" the="" rfd="" utilized="" for="" both="" children="" and="" adults="" was="" calculated="" to="" be="" 0.35%.="" therefore,="" taking="" into="" account="" present="" uses,="" including="" this="" use="" on="" citrus="" under="" section="" 18,="" epa="" concludes="" that="" there="" is="" reasonable="" certainty="" of="" no="" harm="" if="" these="" tolerances="" are="" established.="" 3.="" from="" non-dietary="" exposure.="" pyriproxyfen="" is="" currently="" registered="" for="" use="" on="" the="" following="" residential="" non-food="" sites:="" products="" for="" flea="" and="" tick="" control,="" including="" foggers,="" aerosol="" sprays,="" emulsifiable="" concentrates,="" and="" impregnated="" material="" (pet="" collars).="" chronic="" exposure="" and="" risk.="" long-term="" exposure="" to="" pyriproxyfen="" in="" residential="" use="" products="" is="" not="" expected.="" consumer="" use="" of="" these="" products="" typically="" results="" in="" short-term="" intermittent="" exposures.="" hence,="" a="" chronic="" residential="" exposure="" assessment="" is="" not="" required.="" 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.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" pyriproxyfen="" has="" a="" common="" mechanism="" [[page="" 26470]]="" 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,="" pyriproxyfen="" 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="" pyriproxyfen="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" there="" are="" no="" acute="" dietary="" endpoints="" of="" concern="" for="" pyriproxyfen.="" no="" concern="" exists="" for="" acute="" dietary="" exposure="" to="" pyriproxyfen="" residues.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" pyriproxyfen="" from="" food="" and="" drinking="" water="" will="" utilize="" 0.67="" and="" 0.35%="" of="" the="" rfd,="" respectively,="" for="" the="" u.s.="" population="" (total="" of="" 1.02%="" rfd="" utilized).="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" children="" (1-6="" years="" old),="" with="" 1.84="" and="" 0.35%="" of="" the="" rfd="" utilized="" by="" food="" and="" drinking="" water,="" respectively,="" for="" a="" total="" of="" 2.19%="" of="" the="" rfd="" utilized.="" this="" is="" discussed="" further="" 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.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" pyriproxyfen="" residues.="" 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.="" there="" are="" no="" endpoints="" and="" no="" concern="" exists="" for="" short-="" or="" intermediate-term="" toxicity="" from="" pyriproxyfen.="" d.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" pyriproxyfen="" has="" been="" classified="" in="" group="" e="" of="" epa's="" cancer="" classification="" system,="" indicating="" there="" is="" evidence="" of="" non-="" carcinogenicity="" for="" humans.="" therefore,="" there="" is="" no="" concern="" for="" cancer="" risk="" from="" exposure="" to="" pyriproxyfen.="" 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="" pyriproxyfen,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" during="" gestation.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" 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)="" noel="" was="" 100="" mg/kg/day,="" based="" on="" decreased="" bodyweight,="" body="" weight="" gain,="" food="" consumption,="" and="" increased="" water="" consumption="" at="" the="" loel="" of="" 300="" mg/kg/day.="" the="" developmental="" (fetal)="" noel="" was="" 300="" mg/kg/day,="" based="" on="" increased="" skeletal="" variations="" and="" unspecified="" visceral="" variations="" at="" the="" loel="" of="" 1,000="" mg/kg/day="" in="" the="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" (systemic)="" noel="" was="" 100="" mg/kg/day,="" based="" on="" abortions,="" soft="" stools,="" emaciation,="" decreased="" activity,="" and="" bradypnea="" at="" the="" loel="" of="" 300="" mg/kg/="" day.="" the="" developmental="" (pup)="" noel="" was="" 300="" mg/kg/day,="" based="" on="" decreased="" viable="" litters="" available="" for="" examination="" at="" the="" loel="" of="" 1,000="" mg/kg/="" day.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" 2-generation="" reproductive="" toxicity="" study="" in="" rats,="" the="" maternal="" (systemic)="" noel="" was="" 87/96="" mg/kg/="" day="" for="" males/females,="" based="" on="" decreased="" body="" weights,="" body="" weight="" gains,="" and="" increased="" liver="" weight="" associated="" with="" histopathological="" findings="" in="" the="" liver="" at="" the="" loel="" of="" 453/498="" mg/kg/day="" for="" m/f.="" the="" developmental="" (pup)="" noel="" was="" 87/96="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" on="" lactation="" days="" 14="" and="" 21="" at="" the="" loel="" of="" 453/498="" mg/kg/day.="" the="" reproductive="" noel="" was="" 453/498="" mg/kg/day="" for="" m/f="" (the="" highest="" dose="" tested).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" in="" both="" rats="" and="" rabbits,="" developmental="" studies="" demonstrated="" that="" the="" developmental="" findings="" occurred="" at="" dose="" levels="" at="" which="" maternal="" toxicity="" was="" also="" present,="" demonstrating="" no="" special="" pre-natal="" sensitivity="" for="" developing="" fetuses.="" in="" the="" post-natal="" evaluation="" to="" infants="" and="" children,="" as="" shown="" in="" the="" results="" of="" the="" rat="" reproduction="" study,="" the="" noel="" and="" loel="" for="" both="" parental="" systemic="" toxicity="" and="" pup="" toxicity="" occurred="" at="" the="" same="" dose="" levels,="" demonstrating="" no="" special="" post-natal="" sensitivity="" for="" infants="" and="" children.="" v.="" conclusion.="" given="" the="" fact="" that="" there="" is="" a="" complete="" toxicity="" data="" base="" for="" pyriproxyfen,="" and="" no="" special="" pre-="" or="" post-="" natal="" sensitivities="" are="" indicated="" for="" infants="" and="" children,="" an="" additional="" 10-="" fold="" safety="" factor="" is="" not="" warranted.="" epa="" concludes="" that="" there="" is="" reasonable="" certainty="" of="" safety="" for="" infants="" and="" children="" exposed="" to="" dietary="" residues="" of="" pyriproxyfen.="" 2.="" acute="" risk.="" there="" are="" no="" acute="" dietary="" endpoints="" of="" concern="" for="" pyriproxyfen.="" no="" concern="" exists="" for="" acute="" dietary="" exposure="" to="" pyriproxyfen="" residues.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" pyriproxyfen="" from="" food="" will="" utilize="" 1.84%="" of="" the="" rfd="" for="" children="" 1-6="" years="" old,="" the="" most="" highly="" exposed="" subgroup="" of="" 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.="" the="" risk="" from="" drinking="" water="" is="" conservatively="" estimated="" to="" utilize="" 0.35%="" of="" the="" rfd="" for="" infants="" and="" children,="" as="" discussed="" above.="" despite="" the="" potential="" for="" exposure="" to="" pyriproxyfen="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" pyriproxyfen="" residues.="" [[page="" 26471]]="" 4.="" short-="" or="" intermediate-term="" risk.="" there="" are="" no="" endpoints="" and="" no="" concern="" exists="" for="" short-="" or="" intermediate-term="" toxicity="" from="" pyriproxyfen.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" for="" the="" purposes="" of="" these="" uses="" under="" section="" 18,="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood,="" and="" the="" residue="" to="" be="" regulated="" is="" parent="" pyriproxyfen="" per="" se="" [4-phenoxyphenyl="" (rs)-2-(2-="" pyridyloxy)propyl="" ether].="" there="" are="" no="" detectable="" residues="" expected="" in="" animal="" commodities="" as="" a="" result="" of="" these="" uses.="" b.="" analytical="" enforcement="" methodology="" adequate="" analytical="" methodology="" is="" available="" to="" enforce="" the="" tolerance="" expression,="" in="" residue="" analytical="" method="" rm-33p-2="" using="" gas="" chromatography="" with="" a="" nitrogen-phosphorus="" detector.="" this="" has="" been="" validated="" by="" epa="" and="" is="" available="" from="" the="" registrant="" of="" pyriproxyfen,="" valent="" u.s.a.="" corporation,="" dublin,="" california.="" c.="" magnitude="" of="" residues="" residues="" of="" pyriproxyfen="" are="" not="" expected="" to="" exceed="" 0.3="" ppm="" in/on="" citrus="" fruit,="" 1.0="" ppm="" in="" citrus="" juice="" and="" dried="" citrus="" pulp,="" and="" 300="" ppm="" in="" citrus="" oil;="" 0.2="" ppm="" in/on="" pears;="" and="" 0.1="" ppm="" in/on="" tomatoes;="" no="" detectable="" residues="" are="" expected="" to="" occur="" in="" animal="" commodities,="" as="" a="" result="" of="" these="" emergency="" exemption="" uses.="" d.="" international="" residue="" limits="" there="" are="" no="" canadian,="" mexican,="" or="" codex="" maximum="" residue="" limits="" (mrls)="" for="" residues="" of="" pyriproxyfen="" in/on="" citrus,="" pears,="" or="" tomatoes.="" e.="" rotational="" crop="" restrictions="" there="" are="" no="" applicable="" rotational="" crop="" restrictions="" for="" these="" emergency="" exemption="" uses.="" vi.="" conclusion="" therefore,="" the="" tolerances="" are="" established="" for="" residues="" of="" pyriproxyfen="" in/on="" citrus="" fruit="" at="" 0.3="" ppm,="" citrus="" juice="" and="" dried="" citrus="" pulp="" at="" 1.0="" ppm,="" and="" citrus="" oil="" at="" 300="" ppm;="" 0.2="" ppm="" in/on="" pears;="" and="" 0.1="" ppm="" in/on="" tomatoes.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" july="" 13,="" 1998,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" cbi.="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" viii.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300651]="" (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.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes time-limited tolerances under FFDCA
section 408(d) in response to petitions 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) (Pub. L. 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).
[[Page 26472]]
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the time-limited
tolerances 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 has
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.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's Federal Register. This 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 27, 1998.
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. 346a and 371.
2. In Sec. 180.510, in paragraph (b) by alphabetically adding the
following commodities to the table to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Citrus fruit.................... 0.3 7/31/99
Citrus juice.................... 1.0 7/31/99
Citrus oil...................... 300 7/31/99
Citrus pulp, dried.............. 1.0 7/31/99
* * * * *
* *
Pears........................... 0.2 7/31/99
Tomatoes........................ 0.1 7/31/99
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-12426 Filed 5-12-98; 8:45 am]
BILLING CODE 6560-50-F
