Rule: Air Pollution Control New Motor Vehicles and Engines: Spinosad

68534 Federal Register / Vol. 72, No.
233 / Wednesday, December 5, 2007 / Rules and Regulations
on the relationship between the national adding the following commodities to the Certain other material, such as
government and the States or tribal table in paragraph (a) to read as follows: copyrighted material, is not placed on
governments, or on the distribution of the Internet and will be publicly
power and responsibilities among the §180.416 Ethalfluralin; tolerances for available only in hard copy form.
residues.
various levels of government or between Publicly available docket materials are
the Federal Government and Indian (a) * * * available in the electronic docket at
tribes. Thus, the Agency has determined http://www.regulations.gov, or, if only
Commodity Parts per million
that Executive Order 13132, entitled available in hard copy, at the OPP
Federalism (64 FR 43255, August 10, * * * * * Regulatory Public Docket in Rm. S–
1999) and Executive Order 13175, Dill, dried leaves ............. 0.05 4400, One Potomac Yard (South Bldg.),
entitled Consultation and Coordination Dill, fresh leaves ............. 0.05 2777 S. Crystal Dr., Arlington, VA. The
with Indian Tribal Governments (65 FR Mustard, seed ................. 0.05 Docket Facility is open from 8:30 a.m.
67249, November 6, 2000) do not apply * * * * * to 4 p.m., Monday through Friday,
to this rule. In addition, This rule does Potato ............................. 0.05 excluding legal holidays. The Docket
not impose any enforceable duty or Rapeseed, seed ............. 0.05 Facility telephone number is (703) 305–
* * * * *
contain any unfunded mandate as 5805.
described under Title II of the Unfunded FOR FURTHER INFORMATION CONTACT:
* * * * *
Mandates Reform Act of 1995 (UMRA) Susan Stanton, Registration Division
(Public Law 104–4). [FR Doc. E7–23578 Filed 12–4–07; 8:45 am]
BILLING CODE 6560–50–S
(7505P), Office of Pesticide Programs,
This action does not involve any Environmental Protection Agency, 1200
technical standards that would require Pennsylvania Ave., NW., Washington,
Agency consideration of voluntary ENVIRONMENTAL PROTECTION DC 20460–0001; telephone number:
consensus standards pursuant to section AGENCY (703) 305–5218; e-mail address:
12(d) of the National Technology stanton.susan@epa.gov.
Transfer and Advancement Act of 1995 40 CFR Part 180
(NTTAA), Public Law 104–113, section SUPPLEMENTARY INFORMATION:
12(d) (15 U.S.C. 272 note). [EPA–HQ–OPP–2007–0310; FRL–8339–8]
I. General Information
VII. Congressional Review Act Spinosad; Pesticide Tolerance A. Does this Action Apply to Me?
The Congressional Review Act, 5 AGENCY: Environmental Protection You may be potentially affected by
U.S.C. 801 et seq., generally provides Agency (EPA). this action if you are an agricultural
that before a rule may take effect, the ACTION: Final rule. producer, food manufacturer, or
agency promulgating the rule must pesticide manufacturer. Potentially
submit a rule report to each House of SUMMARY: This regulation establishes
affected entities may include, but are
the Congress and to the Comptroller tolerances for residues of spinosad in or
on spice, subgroup 19B, except black not limited to those engaged in the
General of the United States. EPA will following activities:
submit a report containing this rule and pepper; pineapple; and pineapple,
process residue. Interregional Research • Crop production (NAICS code
other required information to the U.S. 111), e.g., agricultural workers;
Senate, the U.S. House of Project Number 4 (IR-4) requested these
tolerances under the Federal Food, greenhouse, nursery, and floriculture
Representatives, and the Comptroller workers; farmers.
General of the United States prior to Drug, and Cosmetic Act (FFDCA).
publication of this final rule in the DATES: This regulation is effective • Animal production (NAICS code
Federal Register. This final rule is not December 5, 2007. Objections and 112), e.g., cattle ranchers and farmers,
a ‘‘major rule’’ as defined by 5 U.S.C. requests for hearings must be received dairy cattle farmers, livestock farmers.
804(2). on or before February 4, 2008, and must • Food manufacturing (NAICS code
be filed in accordance with the 311), e.g., agricultural workers; farmers;
List of Subjects in 40 CFR Part 180 instructions provided in 40 CFR part greenhouse, nursery, and floriculture
Environmental protection, 178 (see also Unit I.C. of the workers; ranchers; pesticide applicators.
Administrative practice and procedure, SUPPLEMENTARY INFORMATION). • Pesticide manufacturing (NAICS
Agricultural commodities, Pesticides ADDRESSES: EPA has established a code 32532), e.g., agricultural workers;
and pests, Reporting and recordkeeping docket for this action under docket commercial applicators; farmers;
requirements. identification (ID) number EPA–HQ– greenhouse, nursery, and floriculture
OPP–2007–0310. To access the workers; residential users.
Dated: November 26, 2007.
electronic docket, go to http:// This listing is not intended to be
Donald R. Stubbs,
www.regulations.gov, select ‘‘Advanced exhaustive, but rather to provide a guide
Acting Director, Registration Division, Office
Search,’’ then ‘‘Docket Search.’’ Insert for readers regarding entities likely to be
of Pesticide Programs.
the docket ID number where indicated affected by this action. Other types of
■Therefore, 40 CFR chapter I is and select the ‘‘Submit’’ button. Follow entities not listed in this unit could also
amended as follows: the instructions on the regulations.gov be affected. The North American
website to view the docket index or Industrial Classification System
PART 180—[AMENDED] access available documents. All (NAICS) codes have been provided to
■ 1. The authority citation for part 180 documents in the docket are listed in assist you and others in determining
continues to read as follows: the docket index available in whether this action might apply to
sroberts on PROD1PC70 with RULES
regulations.gov. Although listed in the certain entities. If you have any

Authority: 21 U.S.C. 321(q), 346a and 371. index, some information is not publicly questions regarding the applicability of
■ 2. Section 180.416 is amended by available, e.g., Confidential Business this action to a particular entity, consult
removing the current tolerance on Information (CBI) or other information the person listed under FOR FURTHER
‘‘Canola, seed’’ and alphabetically whose disclosure is restricted by statute. INFORMATION CONTACT.
VerDate Aug<31>2005 17:07 Dec 04, 2007 Jkt 214001 PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 E:\FR\FM\05DER1.SGM 05DER1
Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations 68535
B. How Can I Access Electronic Copies Docket Facility telephone number is of infants and children to the pesticide
of this Document? (703) 305–5805. chemical residue in establishing a
In addition to accessing an electronic tolerance and to ‘‘ensure that there is a
II. Petition for Tolerance
copy of this Federal Register document reasonable certainty that no harm will
In the Federal Register of May 9, 2007 result to infants and children from
through the electronic docket at http:// (72 FR 26375) (FRL–8128–1), EPA
www.regulations.gov, you may access aggregate exposure to the pesticide
issued a notice pursuant to section chemical residue....’’ These provisions
this Federal Register document 408(d)(3) of FFDCA, 21 U.S.C. were added to FFDCA by the Food
electronically through the EPA Internet 346a(d)(3), announcing the filing of a Quality Protection Act (FQPA) of 1996.
under the ‘‘Federal Register’’ listings at pesticide petition (PP 6E7148) by Consistent with section 408(b)(2)(D)
http://www.epa.gov/fedrgstr. You may Interregional Research Project Number 4 of FFDCA, and the factors specified in
also access a frequently updated (IR–4), 500 College Road East, Suite 201 section 408(b)(2)(D) of FFDCA, EPA has
electronic version of EPA’s tolerance W, Princeton, NJ 08540–6635. The reviewed the available scientific data
regulations at 40 CFR part 180 through petition requested that 40 CFR 180.495 and other relevant information in
the Government Printing Office’s pilot be amended by establishing a tolerance support of this action. EPA has
e-CFR site at http://www.gpoaccess.gov/ for residues of the insecticide spinosad, sufficient data to assess the hazards of
ecfr. in or on Spice crop subgroup 19B, and to make a determination on
C. Can I File an Objection or Hearing except black pepper at 1.7 parts per aggregate exposure for the petitioned-for
Request? million (ppm); pineapple at 0.02 ppm; tolerances for residues of spinosad on
and pineapple, process residue at 0.08 spice, subgroup 19B, except black
Under section 408(g) of FFDCA, any ppm. Spinosad is a fermentation pepper at 1.7 ppm; pineapple at 0.02
person may file an objection to any product of Saccharopolyspora spinosa, ppm; and Pineapple, process residue at
aspect of this regulation and may also consisting of two related active 0.08 ppm. EPA’s assessment of
request a hearing on those objections. ingredients: Spinosyn A (Factor A; CAS exposures and risks associated with
You must file your objection or request # 131929–60–7) or 2-[(6-deoxy-2,3,4-tri- establishing the tolerance follows.
a hearing on this regulation in O-methyl-a-L-manno-pyranosyl)oxy]-
accordance with the instructions 13-[[5-(dimethylamino)-tetrahydro-6- A. Toxicological Profile
provided in 40 CFR part 178. To ensure methyl-2H-pyran-2-yl]oxy]-9-ethyl- EPA has evaluated the available
proper receipt by EPA, you must 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- toxicity data and considered its validity,
identify docket ID number EPA–HQ– tetradecahydro-14-methyl-1H-as- completeness, and reliability as well as
OPP–2007–0310 in the subject line on Indaceno[3,2-d]oxacyclododecin-7,15- the relationship of the results of the
the first page of your submission. All dione; and Spinosyn D (Factor D; CAS studies to human risk. EPA has also
requests must be in writing, and must be # 131929–63–0) or 2-[(6-deoxy-2,3,4-tri- considered available information
mailed or delivered to the Hearing Clerk O-methyl-a-L-manno-pyranosyl)oxy]- concerning the variability of the
as required by 40 CFR part 178 on or 13-[[5-(dimethyl-amino)-tetrahydro-6- sensitivities of major identifiable
before January 4, 2008. methyl-2H-pyran-2-yl]oxy]-9-ethyl- subgroups of consumers, including
In addition to filing an objection or 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- infants and children. Specific
hearing request with the Hearing Clerk tetradecahydro-4,14-methyl-1H-as- information on the studies received and
as described in 40 CFR part 178, please Indaceno[3,2-d]oxacyclododecin-7,15- the nature of the adverse effects caused
submit a copy of the filing that does not dione. That notice referenced a by spinosad as well as the no-observed-
contain any CBI for inclusion in the summary of the petition prepared by adverse-effect-level (NOAEL) and the
public docket that is described in Dow AgroSciences LLC, the registrant, lowest-observed-adverse-effect-level
ADDRESSES. Information not marked which is available to the public in the (LOAEL) from the toxicity studies are
confidential pursuant to 40 CFR part 2 docket, http://www.regulations.gov. discussed in the final rule published in
may be disclosed publicly by EPA Comments were received on the notice the Federal Register of September 27,
without prior notice. Submit this copy, of filing from a private citizen. EPA’s 2002 (67 FR 60923) (FRL–7199–5),
identified by docket ID number EPA– response to these comments is available on-line at http://www.epa.gov/
HQ–OPP–2007–0310, by one of the discussed in Unit IV.C. below. fedrgstr/EPA-PEST/2002/September/
following methods: Day-27/p24484.htm.
• Federal eRulemaking Portal: III. Aggregate Risk Assessment and
http://www.regulations.gov. Follow the Determination of Safety B. Toxicological Endpoints
on-line instructions for submitting Section 408(b)(2)(A)(i) of FFDCA For hazards that have a threshold
comments. allows EPA to establish a tolerance (the below which there is no appreciable
• Mail: Office of Pesticide Programs legal limit for a pesticide chemical risk, the toxicological level of concern
(OPP) Regulatory Public Docket (7502P), residue in or on a food) only if EPA (LOC) is derived from the highest dose
Environmental Protection Agency, 1200 determines that the tolerance is ‘‘safe.’’ at which no adverse effects are observed
Pennsylvania Ave., NW., Washington, Section 408(b)(2)(A)(ii) of FFDCA (the NOAEL) in the toxicology study
DC 20460–0001. defines ‘‘safe’’ to mean that ‘‘there is a identified as appropriate for use in risk
• Delivery: OPP Regulatory Public reasonable certainty that no harm will assessment. However, if a NOAEL
Docket (7502P), Environmental result from aggregate exposure to the cannot be determined, the lowest dose
Protection Agency, Rm. S–4400, One pesticide chemical residue, including at which adverse effects of concern are
Potomac Yard (South Bldg.), 2777 S. all anticipated dietary exposures and all identified (the LOAEL) is sometimes
Crystal Dr., Arlington, VA. Deliveries other exposures for which there is used for risk assessment. Uncertainty/
are only accepted during the Docket’s reliable information.’’ This includes safety factors (UFs) are used in
normal hours of operation (8:30 a.m. to exposure through drinking water and in conjunction with the LOC to take into
4 p.m., Monday through Friday, residential settings, but does not include account uncertainties inherent in the
excluding legal holidays). Special occupational exposure. Section extrapolation from laboratory animal
arrangements should be made for 408(b)(2)(C) of FFDCA requires EPA to data to humans and in the variations in
deliveries of boxed information. The give special consideration to exposure sensitivity among members of the
68536 Federal Register / Vol. 72, No. 233 / Wednesday, December 5, 2007 / Rules and Regulations
human population as well as other C. Exposure Assessment tolerance level residues for the
unknowns. Safety is assessed for acute 1. Dietary exposure from food and remaining food crop commodities;
and chronic risks by comparing feed uses. In evaluating dietary average feed crop residues for feed
aggregate exposure to the pesticide to exposure to spinosad, EPA considered commodities from the following crops:
the acute population adjusted dose exposure under the petitioned-for Sweet corn forage, leaves of root and
(aPAD) and chronic population adjusted tolerances as well as all existing tuber vegetables and aspirated grain
dose (cPAD). The aPAD and cPAD are spinosad tolerances in 40 CFR 180.495. fractions; average residues from animal
calculated by dividing the LOC by all Since spinosad and spinetoram are feeding and dermal magnitude of
applicable UFs. Short-term, toxicologically identical, EPA residue studies; and DEEMTM (Version
intermediate-term, and long-term risks considered exposure to both in 7.81) default processing factors for all
are evaluated by comparing aggregate assessing aggregate risk. EPA assessed commodities, excluding field corn
exposure to the LOC to ensure that the (meal, starch, flour and oil), grape juice
dietary exposures from spinosad and
margin of exposure (MOE) called for by and wheat (flour and germ), where
spinetoram in food as follows:
the product of all applicable UFs is not i. Acute exposure. Quantitative acute processing factors based on the results
exceeded. dietary exposure and risk assessments of processing studies were assumed.
iii. Cancer. Based on the results of
For non-threshold risks, the Agency are performed for a food-use pesticide,
carcinogenicity studies in rats and mice,
assumes that any amount of exposure if a toxicological study has indicated the
spinosad has been classified as ‘‘Not
will lead to some degree of risk and possibility of an effect of concern
likely to be carcinogenic to humans.’’
estimates risk in terms of the probability occurring as a result of a 1–day or single Preliminary results of a carcinogenicity
of occurrence of additional adverse exposure. No such effects were study in mice indicate that spinetoram
cases. Generally, cancer risks are identified in the toxicological studies is not carcinogenic to mice at doses up
considered non-threshold. For more for spinosad and spinetoram; therefore, to 37.5 milligram/kilogram/day (mg/kg/
information on the general principles a quantitative acute dietary exposure day). Based on these preliminary results
assessment is unnecessary. and spinetoram’s structural and
EPA uses in risk characterization and a
ii. Chronic exposure. Spinosad and toxicological similarity to spinosad,
complete description of the risk
spinetoram are registered for use on the spinetoram is also considered to be ‘‘Not
assessment process, see http:// same crops; however, EPA has
www.epa.gov/pesticides/factsheets/ likely to be carcinogenic to humans.’’
concluded it would overstate exposure Consequently, a quantitative cancer
riskassess.htm. to assume that residues of both spinosad exposure and risk assessment is not
The Agency has concluded that and spinetoram would appear on the appropriate for spinosad or spinetoram.
spinosad should be considered same crop. It is unlikely that both will iv. Anticipated residue and PCT
toxicologically identical to another be applied to the same crop, since information. Section 408(b)(2)(E) of
pesticide, spinetoram. This conclusion spinosad and spinetoram control the FFDCA authorizes EPA to use available
is based on the following: (1) same pest species. Rather, EPA data and information on the anticipated
Spinetoram and spinosad are large aggregated exposure from residues of residue levels of pesticide residues in
molecules with nearly identical spinosad and spinetoram by assuming food and the actual levels of pesticide
structures; and (2) the toxicological that spinosad residues would be present residues that have been measured in
profiles for each are similar (generalized in all commodities, because side-by-side food. If EPA relies on such information,
systemic toxicity) with similar doses spinosad and spinetoram residue data EPA must pursuant to FFDCA section
and endpoints chosen for human-health indicated that spinetoram residues were 408(f)(1) require that data be provided 5
risk assessment. Spinosad and less than or equal to spinosad residues. years after the tolerance is established,
spinetoram should be considered EPA assumed that 100 percent of each modified, or left in effect, demonstrating
toxicologically identical in the same food crop commodity would be treated that the levels in food are not above the
manner that metabolites are generally with spinosad. For feed crop levels anticipated. For the present
considered toxicologically identical to commodities, EPA summed the action, EPA will issue such data call-ins
the parent. percentage of the crop that would be as are required by FFDCA section
treated with spinosad and the 408(b)(2)(E) and authorized under
Although, as stated above, the doses percentage expected to be treated with
and endpoints for spinosad and FFDCA section 408(f)(1). Data will be
spinetoram and used this estimate in required to be submitted no later than
spinetoram are similar, they are not conjunction with spinosad residue data
identical due to variations in dosing 5 years from the date of issuance of this
to develop anticipated residues for tolerance.
levels used in the spinetoram and livestock commodities. Section 408(b)(2)(F) of FFDCA states
spinosad toxicological studies. EPA The chronic dietary exposure that the Agency may use data on the
compared the spinosad and spinetoram assessment was conducted using the actual percent of food treated for
doses and endpoints for each exposure Dietary Exposure Evaluation Model - assessing chronic dietary risk only if:
scenario and selected the lower of the Food Consumption Intake Database a. The data used are reliable and
two doses for use in human risk (DEEMTM-FCID), Version 2.03, which provide a valid basis to show what
assessment. A summary of the incorporates food consumption data percentage of the food derived from
toxicological endpoints for spinosad from the United States Department of such crop is likely to contain such
and spinetoram used for human risk Agriculture (USDA) 1994–1996 and pesticide residue.
assessment can be found at http:// 1998 Continuing Surveys of Food b. The exposure estimate does not
www.regulations.gov in the document Intakes by Individuals (CSFII). In underestimate exposure for any
Spinosad and Spinetoram. Human- addition to the Percent Crop Treated significant subpopulation group.
Health Risk Assessment for Application (PCT) assumptions described above, c. Data are available on pesticide use
of Spinosad to Pineapple and the Spice EPA, in estimating chronic exposure, and food consumption in a particular
Subgroup (19B, except black pepper) at relied upon average field trial residues area, the exposure estimate does not
page 11 in docket ID number EPA–HQ– for apple, leafy vegetables (except understate exposure for the population
OPP–2007–0310. Brassica), citrus and fruiting vegetables; in such area. In addition, the Agency
must provide for periodic evaluation of An estimated PPCT, based on the monitoring data to complete a
any estimates used. To provide for the average PCT of the market leaders, is comprehensive dietary exposure
periodic evaluation of the estimate of appropriate for use in chronic dietary analysis and risk assessment for
PCT as required by FFDCA section risk assessment. This method of spinosad in drinking water. Because the
408(b)(2)(F), EPA may require estimating PPCT for a new use of a Agency does not have comprehensive
registrants to submit data on PCT. registered pesticide or a new pesticide monitoring data, drinking water
The Agency used PCT information as produces a high-end estimate that is concentration estimates are made by
follows: unlikely, in most cases, to be exceeded reliance on simulation or modeling
One-hundred percent crop treated during the initial 5 years of actual use. taking into account data on the
was assumed for all food crop Predominant factors that bear on environmental fate characteristics of
commodities and some feed crop whether the PPCT could be exceeded spinosad. Further information regarding
commodities (aspirated grain fractions, may include PCTs of similar EPA drinking water models used in
sugarbeet molasses and cottonseed). For chemistries, pests controlled by pesticide exposure assessment can be
certain feed crop commodities, the alternatives, pest prevalence in the found at http://www.epa.gov/oppefed1/
Agency summed the projected PCT for market and other factors. All relevant models/water/index.htm.
spinosad and spinetoram and used the information currently available for Based on the First Index Reservoir
combined estimates in conjunction with predominant factors has been Screening Tool (FIRST) and Screening
average field trial residues to calculate considered for the combined use of Concentration in Ground Water (SCI-
cattle dietary burdens and anticipated spinetoram and spinosad on each of GROW) models, the estimated
residues of spinosad in meat and milk. these several crops. It is the Agency’s environmental concentrations (EECs) of
The following combined projected PCT opinion that it is unlikely that actual spinosad for acute exposures are
estimates were used: sweet corn forage combined PCTs for spinetoram and estimated to be 34.5 parts per billion
(39%), sorghum grain (5%), soybean spinosad will exceed the corresponding (ppb) for surface water and 1.1 ppb for
seed meal (5%) and leaves of root and estimated PPCTs during the next 5 ground water. The EECs for chronic
tuber vegetables (50%). years. exposures are estimated to be 10.5 ppb
Spinetoram is a new, recently The PPCTs for the combined use of for surface water and 1.1 ppb for ground
registered pesticide. EPA estimates an spinosad and spinetoram for chronic water.
upper bound of projected percent crop risk assessment were determined using Modeled estimates of drinking water
treated (PPCT) for a new pesticide use the market leader approach for the feed concentrations were directly entered
by assuming that its actual PCT during commodities of sweet corn, grain into the dietary exposure model. As
the initial 5 years of use on a specific sorghum, soybeans and turnip greens. explained above, an acute dietary risk
use site will not exceed the recent PCT For turnip greens, the PCTs of market assessment was not conducted for
of the market leader (i.e., the one with leaders were averaged over states rather spinosad and spinetoram. For chronic
the greatest PCT) on that site. EPA calls than years because only 1–year of data dietary risk assessment, the water
this the market leader PPCT estimate. In was available. concentration of value 10.5 ppb was
this specific case, the new use to be The Agency believes that the three used to access the contribution to
estimated is the combined use of conditions listed in this Unit have been drinking water.
spinosad together with that of met. With respect to Condition 1, PCT 3. From non-dietary exposure. The
spinetoram since the most new use of estimates are derived from Federal and term ‘‘residential exposure’’ is used in
spinetoram will likely replace previous private market survey data, which are this document to refer to non-
use of spinosad. An average market reliable and have a valid basis. The occupational, non-dietary exposure
leader PCT, based on three recent Agency is reasonably certain that the (e.g., for lawn and garden pest control,
surveys of pesticide usage, if available, percentage of the food treated is not indoor pest control, termiticides, and
is used for chronic risk assessment. The likely to be an underestimation. As to flea and tick control on pets).
average market leader PCT may be based Conditions 2 and 3, regional The Agency has concluded that
on one or two survey years if three are consumption information and spinosad and spinetoram are
not available. Also, with limited consumption information for significant toxicologically equivalent; therefore,
availability of data, the average market subpopulations is taken into account residential exposure to both spinosad
leader PCT may be based on a cross- through EPA’s computer-based model and spinetoram was evaluated.
section of state PCTs. Comparisons are for evaluating the exposure of Spinosad is currently registered for the
only made among pesticides of the same significant subpopulations including following residential non-dietary sites:
pesticide type (i.e., the leading several regional groups. Use of this Homeowner application to turf grass
insecticide on the use site is selected for consumption information in EPA’s risk and ornamentals to control a variety of
comparison with the new insecticide), assessment process ensures that EPA’s worms, moths, flies, beetles, midges,
or, for refined estimates, among exposure estimate does not understate thrips, leafminers and fire ants (granular
pesticides targeting the same pests. The exposure for any significant formulation). Spinetoram is registered
market leader PCTs used to determine subpopulation group and allows the for homeowner applications to gardens,
the average may be each for the same Agency to be reasonably certain that no lawns/ornamentals and turf grass for
pesticide or for different pesticides for regional population is exposed to control of lepidopterous larvae (worms
any year since the same or different residue levels higher than those or caterpillars), dipterous leafminers,
pesticides may dominate for each year. estimated by the Agency. Other than the thrips, sawfly larvae, certain psyllids
Typically, EPA uses U.S. Department of data available through national food and leaf-feeding beetles and red
Agriculture/National Agricultural consumption surveys, EPA does not imported fire ants.
Statistics Service (USDA/NASS) as the have available information on the There is potential for residential
source for raw PCT data because it is regional consumption of food to which handler and post-application exposures
publicly available. When a specific use spinosad may be applied in a particular to both spinosad and spinetoram. Since
site is not surveyed by USDA/NASS, area. spinosad and spinetoram control the
EPA uses other sources including 2. Dietary exposure from drinking same pests, EPA concludes that these
proprietary data. water. The Agency lacks sufficient products will not be used in
combination with each other and available for both spinosad and commodities are conservative, high-end
combining the residential exposures is spinoteram: developmental toxicity estimates developed using the market
unnecessary. Short-term residential studies in rats and rabbits and a two– leader approach that are unlikely to be
inhalation risks were estimated for adult generation reproduction study in rats. exceeded. Conservative ground and
residential handlers, as well as short- There is no evidence of increased surface water modeling estimates were
term post-application incidental oral susceptibility of rat or rabbit fetuses to used. Similarly, conservative
risks for toddlers, based on applications in utero exposure to spinosad or Residential SOPs were used to assess
to home lawns, home gardens and spinetoram. In the spinosad and incidental oral exposure of toddlers.
ornamentals. Dermal exposures were spinetoram rat and rabbit These assessments will not
not assessed, since no dermal endpoints developmental toxicity studies, no underestimate the exposure and risks
of concern were identified in the developmental toxicity was observed at posed by spinosad and spinetoram.
toxicology studies for spinosad and dose levels that induced maternal
E. Aggregate Risks and Determination of
spinetoram. toxicity. In the spinosad two–generation
4. Cumulative effects from substances Safety
reproduction study, maternal and
with a common mechanism of toxicity. offspring toxicity were equally severe, Safety is assessed for acute and
Section 408(b)(2)(D)(v) of FFDCA indicating no evidence of increased chronic risks by comparing aggregate
requires that, when considering whether susceptibility. In the spinetoram 2– exposure to the pesticide to the aPAD
to establish, modify, or revoke a generation reproduction study, no and cPAD. The aPAD and cPAD are
tolerance, the Agency consider adverse effects were observed in the calculated by dividing the LOC by all
‘‘available information’’ concerning the offspring at dose levels that produced applicable UFs. For linear cancer risks,
cumulative effects of a particular parental toxicity. Therefore, there is no EPA calculates the probability of
pesticide’s residues and ‘‘other evidence of increased susceptibility and additional cancer cases given aggregate
substances that have a common there are no concerns or residual exposure. Short-term, intermediate-
mechanism of toxicity.’’ uncertainties for pre and/or post-natal term, and long-term risks are evaluated
Unlike other pesticides for which EPA toxicity. by comparing aggregate exposure to the
has followed a cumulative risk approach 3. Conclusion. EPA has determined LOC to ensure that the MOE called for
based on a common mechanism of that reliable data show that it would be by the product of all applicable UFs is
toxicity, EPA has not made a common safe for infants and children to reduce not exceeded.
mechanism of toxicity finding as to the FQPA safety factor to 1X. That 1. Acute risk. None of the toxicology
spinosad and any other substances and decision is based on the following studies available for spinosad or
spinosad does not appear to produce a findings: spinetoram has indicated the possibility
toxic metabolite produced by other i. The toxicity database for spinosad of an effect of concern occurring as a
substances. For the purposes of this is complete. The toxicity database for result of a 1–day or single exposure;
tolerance action, therefore, EPA has not spinetoram is adequate for this risk therefore, spinosad and spinetoram are
assumed that spinosad has a common assessment despite the lack of a chronic not expected to pose an acute risk.
mechanism of toxicity with other toxicity study in rats. The preliminary 2. Chronic risk. Using the exposure
substances. For information regarding review of a mouse carcinogenicity study assumptions described in this unit for
EPA’s efforts to determine which for spinetoram provides evidence that chronic exposure, EPA has concluded
chemicals have a common mechanism the chronic toxicity of spinosad and that exposure to spinosad and
of toxicity and to evaluate the spinetoram are comparable, since spinetoram from food and water will
cumulative effects of such chemicals, spinetoram produced similar toxicity at utilize 81% of the cPAD for children, 1
see EPA’s website at http:// doses similar to those seen previously to 2 years old, the population group
www.epa.gov/pesticides/cumulative. with spinosad. Therefore, it is expected with the greatest estimated exposure.
that the ongoing spinetoram chronic Based on the use patterns, chronic
D. Safety Factor for Infants and residential exposure to residues of
carcinogenicity study in rats would
Children spinosad or spinetoram is not expected.
produce similar chronic toxicity at a
1. In general. Section 408 of FFDCA similar dose as was seen in the chronic 3. Short-term risk. Short-term
provides that EPA shall apply an toxicity study in rats with spinosad. aggregate exposure takes into account
additional (‘‘10X’’) tenfold margin of ii. There is no indication that residential exposure plus chronic
safety for infants and children in the spinosad or spinetoram are neurotoxic exposure to food and water (considered
case of threshold effects to account for chemicals and there is no need for a to be a background exposure level).
prenatal and postnatal toxicity and the developmental neurotoxicity study or Spinosad and spinetoram are
completeness of the database on toxicity additional UFs to account for currently registered for uses that could
and exposure unless EPA determines neurotoxicity. result in short-term residential
based on reliable data that a different iii. There is no evidence that spinosad exposure, and the Agency has
margin of safety will be safe for infants or spinetoram results in increased determined that it is appropriate to
and children. This additional margin of susceptibility in in utero rats or rabbits aggregate chronic food and water and
safety is commonly referred to as the in the prenatal developmental studies or short-term exposures for spinosad and
FQPA safety factor. In applying this in young rats in the 2–generation spinetoram. Using the exposure
provision, EPA either retains the default reproduction studies. assumptions described in this unit for
value of 10X when reliable data do not iv. There are no residual uncertainties short-term exposures, EPA has
support the choice of a different factor, identified in the exposure databases. concluded that food, water, and
or, if reliable data are available, EPA The dietary food exposure assessments residential exposures aggregated result
uses a different additional FQPA safety were performed based on tolerance-level in aggregate MOEs of 650 to 710 for
factor value based on the use of residues or anticipated residues derived adults and 180 to 300 for infants and
traditional UFs and/or special FQPA from reliable field trial data. 100 PCT children. The aggregate MOEs for adults
safety factors, as appropriate. was assumed for all commodities except are based on the residential turf scenario
2. Prenatal and postnatal sensitivity. certain feed crop commodities. The and include combined food, drinking
The following acceptable studies are projected PCT estimates used for these water and handler inhalation exposures
to spinetoram. Inhalation exposures are C. Response to Comments spice and pineapple commodities, there
not expected for residential handlers of Several comments were received from is no need for this column. Therefore,
spinosad, based on its granular a private citizen, B. Sachau, objecting to the third column of the table is being
formulation and low vapor pressure. establishing these tolerances for a deleted.
The aggregate MOEs for infants and variety of generalized and Time-limited tolerances were
children include food, drinking water unsubstantiated reasons, including the established at 40 CFR 180.495(b) for
and incidental oral exposures on turf lack of ‘‘combinant’’ testing and long- residues of spinosad in or on livestock
areas previously treated with spinosad term testing, pesticide residues and commodities in connection with FIFRA
or spinetoram. Dermal exposures were unacceptable risk to Americans. The section 18 emergency exemptions
not assessed for adults or children, since Agency has received these same or granted by EPA. All of these time-
a dermal endpoint of concern was not similar comments from this commenter limited tolerances have expired and are
identified in the toxicology studies for on numerous previous occasions. Refer no longer necessary, because permanent
spinosad or spinetoram. to Federal Registers of June 30, 2005 (70 tolerances have been established on
4. Intermediate-term risk. FR 37683) (FRL–7718–3), January 7, these commodities at higher levels.
Intermediate-term aggregate exposure 2005 (70 FR 1349) (FRL–7691–4), and Therefore, these expired, time-limited
takes into account residential exposure October 29, 2004 (69 FR 63083) (FRL– tolerances for residues of spinosad
plus chronic exposure to food and water 7681–9) for the Agency’s response to (Factor A and Factor D) are revoked.
(considered to be a background these objections. The commenter also Finally, EPA is correcting the
exposure level). Spinosad is not objected to issuance of ‘‘exemptions’’ for commodity terminology for ‘‘Vegetable,
registered for use on any sites that this pesticide, an irrelevant comment in brassica, leafy, group 5’’ in 40 CFR
would result in intermediate-term (1–6 the context of this tolerance-setting 180.495(a) to read ‘‘Brassica, leafy
months) residential exposure. Therefore, action. Finally, this same commenter greens, subgroup 5B’’ at 10.0 ppm, to
the aggregate risk is the sum of the risk raised concerns about risk to insects and undo a transcription error. In 1998, EPA
from food and water, which does not other animals from spinosad. EPA established spinosad tolerances for the
exceed the Agency’s level of concern. considers such environmental risks in two subgroups in Crop Group 5 -
5. Aggregate cancer risk for U.S. deciding whether to register pesticide Brassica (Cole) Leafy Vegetables (40 CFR
population. Based on the results of products under the Federal Insecticide, 180.41(c)(5). (63 FR 18329, April 15,
carcinogenicity studies with spinosad in Fungicide and Rodenticide Act (FIFRA); 1998). The two subgroups in Group 5
rats and mice and the preliminary however, the safety standard for are Crop Subgroup 5A - Head and Stem
results of a carcinogenicity study with approving tolerances under section 408 Brassica and Crop Subgroup 5B - Leafy
spinetoram in mice, spinosad and of the FFDCA focuses on potential Brassica Greens. Tolerances were
spinetoram are considered ‘‘Not likely harms to human health and does not established for the subgroups at levels of
to be carcinogenic to humans.’’ permit consideration of effects on the 2 ppm and 10 ppm respectively. No
Spinosad and spinetoram are not environment. Therefore, the comment tolerance applying across the whole
expected to pose a cancer risk. regarding risk to insects and other brassica crop group was established.
6. Determination of safety. Based on animals is not relevant to this tolerance Subsequently, in a rulemaking
these risk assessments, EPA concludes action. establishing spinosad tolerances for
that there is a reasonable certainty that various non-brassica commodities the
no harm will result to the general V. Conclusion tolerance for the ‘‘greens’’ subgroup was
population, or to infants and children Therefore, tolerances are established incorrectly transcribed as a tolerance for
from aggregate exposure to spinosad and for residues of spinosad, consisting of the entire brassica group (70 FR 1349,
spinetoram residues. two related active ingredients: Spinosyn January 7, 2005). This transcription
IV. Other Considerations A (Factor A; CAS # 131929–60–7) or 2- error occurred when the tolerance table,
[(6-deoxy-2,3,4-tri-O -methyl-a-L- as revised by the addition of the new
A. Analytical Enforcement Methodology manno-pyranosyl)oxy]-13-[[5- non-brassica tolerances, was printed in
DowElanco Method 97.05, an (dimethylamino)-tetrahydro-6-methyl- the Federal Register. The changing of
immunoassay particle-based method, 2H-pyran-2-yl]oxy]-9-ethyl- the subgroup tolerance to a group
and Dow AgroSciences Method GRM 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- tolerance was clearly nothing more than
03.15, a high performance liquid tetradecahydro-14-methyl-1H-as- a transcription error, because it was not
chromatography method with Indaceno[3,2-d]oxacyclododecin-7,15- mentioned in the notice of filing for the
ultraviolet absorption detection (HPLC/ dione; and Spinosyn D (Factor D; CAS rulemaking or the preamble to the final
UV), have been adequately validated # 131929–63–0) or 2-[(6-deoxy-2,3,4-tri- rule. Moreover, it is inconsistent with
and determined to be acceptable to O-methyl-a-L-manno-pyranosyl)oxy]- the generic crop group regulation to
enforce the tolerance expression in 13-[[5-(dimethyl-amino)-tetrahydro-6- establish both a crop group and
spices and pineapple, respectively. The methyl-2H-pyran-2-yl]oxy]-9-ethyl- subgroup of that crop group for the same
methods may be requested from: Chief, 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- pesticide because the former would
Analytical Chemistry Branch, tetradecahydro-4,14-methyl-1H-as- displace the latter. This change merely
Environmental Science Center, 701 Indaceno[3,2-d]oxacyclododecin-7,15- corrects the tolerance regulation to
Mapes Rd., Ft. Meade, MD 20755–5350; dione, in or on Spice, subgroup 19B, specify the crop subgroup tolerance that
telephone number: (410) 305–2905; e- except black pepper at 1.7 ppm; was actually promulgated, since this
mail address: residuemethods@epa.gov. Pineapple at 0.02 ppm; and Pineapple, tolerance is intended to cover only those
process residue at 0.08 ppm. commodities in the ‘‘greens’’ subgroup.
B. International Residue Limits The table of spinosad tolerances at 40 A separate, lower tolerance of 2.0 ppm
There are currently no established CFR 180.495(a) currently includes a has been established to cover head and
Codex, Canadian, or Mexican maximum third column for expiration/revocation stem Brassica in subgroup 5A. The
residue levels (MRLs) for spinosad (i.e., dates. Since none of the existing tolerance for the ‘‘greens’’ subgroup was
the combined residues of spinosyn A tolerances are time-limited and EPA is incorrectly modified in connection with
and D). not time-limiting the new tolerances for the establishment of new spinosad
tolerances in the Federal Register of tribes. Thus, the Agency has determined The product consists of two related
January 7, 2005 (70 FR 1349). that Executive Order 13132, entitled active ingredients: Spinosyn A (Factor
EPA finds there is good cause to make Federalism (64 FR 43255, August 10, A: CAS # 131929–60–7) or 2-[(6-deoxy-
these latter three changes without prior 1999) and Executive Order 13175, 2,3,4-tri-O -methyl-a-L-manno-
notice and comment because they are entitled Consultation and Coordination pyranosyl)oxy]-13-[[5-(dimethylamino)-
technical corrections which either with Indian Tribal Governments (65 FR tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-
eliminate obsolete or unused portions of 67249, November 6, 2000) do not apply 9-ethyl-
the regulation or correct a transcription to this rule. In addition, This rule does 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
error. EPA concludes notice and not impose any enforceable duty or tetradecahydro-14-methyl-1H-as-
comment are unnecessary on such contain any unfunded mandate as Indaceno[3,2-d]oxacyclododecin-7,15-
changes. described under Title II of the Unfunded dione; and Spinosyn D (Factor D; CAS
VI. Statutory and Executive Order Mandates Reform Act of 1995 (UMRA) # 131929–63–0) or 2-[(6-deoxy-2,3,4-tri-
Reviews (Public Law 104–4). O-methyl-a-L-manno-pyranosyl)oxy]-
This action does not involve any 13-[[5-(dimethyl-amino)-tetrahydro-6-
This final rule establishes a tolerance technical standards that would require methyl-2H-pyran-2-yl]oxy]-9-ethyl-
under section 408(d) of FFDCA in Agency consideration of voluntary 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
response to a petition submitted to the consensus standards pursuant to section tetradecahydro-4,14-methyl-1H-as-
Agency. The Office of Management and 12(d) of the National Technology Indaceno[3,2-d]oxacyclododecin-7,15-
Budget (OMB) has exempted these types Transfer and Advancement Act of 1995 dione.
of actions from review under Executive (NTTAA), Public Law 104–113, section
Order 12866, entitled Regulatory 12(d) (15 U.S.C. 272 note). Commodity Parts per million
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has VII. Congressional Review Act Acerola ............................ 1.5
been exempted from review under The Congressional Review Act, 5 Alfalfa, seed .................... 0.15
Executive Order 12866, this rule is not U.S.C. 801 et seq., generally provides Alfalfa, seed screenings 2.0
subject to Executive Order 13211, that before a rule may take effect, the Almond, hulls .................. 2.0
Actions Concerning Regulations That agency promulgating the rule must Amaranth, grain, grain .... 1.0
Amaranth, grain, stover .. 10
Significantly Affect Energy Supply, submit a rule report to each House of Animal feed, nongrass,
Distribution, or Use (66 FR 28355, May the Congress and to the Comptroller group, 18 ..................... 0.02
22, 2001) or Executive Order 13045, General of the United States. EPA will Animal feed, nongrass,
entitled Protection of Children from submit a report containing this rule and group, 18, forage ........ 35.0
Environmental Health Risks and Safety other required information to the U.S. Animal feed, nongrass,
Risks (62 FR 19885, April 23, 1997). Senate, the U.S. House of group, 18, hay ............. 30.0
This final rule does not contain any Representatives, and the Comptroller Apple pomace ................. 0.5
information collections subject to OMB General of the United States prior to Artichoke, globe .............. 0.3
approval under the Paperwork Asparagus ....................... 0.2
publication of this final rule in the Atemoya .......................... 0.3
Reduction Act (PRA), 44 U.S.C. 3501 et Federal Register. This final rule is not Avocado .......................... 0.3
seq., nor does it require any special a ‘‘major rule’’ as defined by 5 U.S.C. Banana ........................... 0.25
considerations under Executive Order 804(2). Beet, sugar, molasses .... 0.75
12898, entitled Federal Actions to Biriba ............................... 0.3
Address Environmental Justice in List of Subjects in 40 CFR Part 180 Brassica, head and stem,
Minority Populations and Low-Income Environmental protection, subgroup 5A ................ 2.0
Populations (59 FR 7629, February 16, Administrative practice and procedure, Brassica, leafy greens,
1994). Agricultural commodities, Pesticides subgroup 5B ................ 10.0
Since tolerances and exemptions that and pests, Reporting and recordkeeping Bushberry subgroup 13B 0.250
are established on the basis of a petition Caneberry subgroup 13A 0.7
requirements.
Canistel ........................... 0.3
under section 408(d) of FFDCA, such as Dated: November 27, 2007. Cattle, fat ........................ 50
the tolerance in this final rule, do not Donald R. Stubbs, Cattle, liver ...................... 10
require the issuance of a proposed rule, Cattle, meat .................... 2.0
Acting Director, Registration Division, Office
the requirements of the Regulatory of Pesticide Programs. Cattle, meat byproducts,
Flexibility Act (RFA) (5 U.S.C. 601 et except liver .................. 5.0
seq.) do not apply. ■Therefore, 40 CFR chapter I is Cherimoya ...................... 0.3
This final rule directly regulates amended as follows: Citrus, oil ......................... 3.0
growers, food processors, food handlers, Citrus, dried pulp ............ 0.5
PART 180—[AMENDED] Coriander, leaves ........... 8.0
and food retailers, not States or tribes,
Corn, sweet, kernel plus
nor does this action alter the ■ 1. The authority citation for part 180 cob with husks re-
relationships or distribution of power continues to read as follows: moved ......................... 0.02
and responsibilities established by Authority: 21 U.S.C. 321(q), 346a and 371. Cotton, gin byproducts ... 1.5
Congress in the preemption provisions ■ 2. Section 180.495 is revised to read Cotton, undelinted seed 0.02
of section 408(n)(4) of FFDCA. As such, as follows: Cranberry ........................ 0.01
the Agency has determined that this Custard apple ................. 0.3
action will not have a substantial direct § 180.495 Spinosad; tolerances for Egg ................................. 0.30
effect on States or tribal governments, residues. Feijoa .............................. .05
Fig ................................... 0.10
on the relationship between the national (a) General. Tolerances are
Fish ................................. 4.0
government and the States or tribal established for residues of the Fish-shellfish, crustacean 4.0
governments, or on the distribution of insecticide spinosad in or on the food Fish-shellfish, mollusc .... 4.0
power and responsibilities among the commodities in the table to this Food commodities .......... 0.02
various levels of government or between paragraph. Spinosad is a fermentation Fruit, citrus, group 10 ..... 0.3
the Federal Government and Indian product of Saccharopolyspora spinosa. Fruit, pome, group 11 ..... 0.20
Commodity Parts per million Commodity Parts per million Commodity Parts per million
Fruit, stone, group 12 ..... 0.20 Lingonberry ..................... 0.250 Soybean .......................... 0.02
Goat, fat .......................... 50 Longan ............................ 0.3 Spanish lime ................... 0.3
Goat, liver ....................... 10 Lychee ............................ 0.3 Spearmint, tops .............. 3.5
Goat, meat ...................... 2.0 Mango ............................. 0.3 Spice, subgroup 19B, ex-
Goat, meat byproducts, Milk ................................. 7.0 cept black pepper ....... 1.7
except liver .................. 5.0 Milk, fat ........................... 85 Star apple ....................... 0.3
Grain, aspirated fractions 200 Nut, tree, group 14 ......... 0.02 Starfruit ........................... 0.3
Grain, cereal, group 15 .. 1.5 Okra ................................ 0.40 Strawberry ...................... 1.0
Grain, cereal, group 16, Onion, green ................... 2.0 Sugar apple .................... 0.3
forage, except rice ...... 2.5 Papaya ............................ 0.3 Ti, leaves ........................ 10.0
Grain, cereal, group 16, Passionfruit ..................... 0.3 Vegetable, bulb, group 3,
hay, except rice ........... 10.0 Pea and bean, dried except green onion ..... 0.10
Grain, cereal, group, 16, shelled, except soy- Vegetable, cucurbit,
stover, except rice ....... 10.0 bean, subgroup 6C ..... 0.02 group 9 ........................ 0.3
Grain, cereal, group, 16, Pea and bean, succulent Vegetable, foliage of leg-
straw, except rice ........ 1.0 shelled, subgroup 6B .. 0.02 ume, group 7 ............... 8.0
Grape .............................. 0.50 Peanut ............................ 0.02 Vegetable, fruiting, group
Grape, raisin ................... 0.70 Peanut, hay .................... 11.0 8 .................................. 0.4
Grass, forage, fodder Peppermint, tops ............ 3.5 Vegetable, leafy, except
and hay, group 17, for- Pineapple ........................ 0.02 brassica, group 4 ........ 8.0
age .............................. 10.0 Pineapple, process res- Vegetable, leaves of root
Grass, forage, fodder idue ............................. 0.08 and tuber, group 2 ...... 10.0
and hay, group 17, hay 5.0 Pistachio ......................... 0.020 Vegetable, legume, edi-
Guava ............................. 0.3 Poultry, fat ...................... 1.3 ble podded, subgroup
Herb subgroup 19A, Poultry, meat .................. 0.10 6A ................................ 0.30
dried ............................ 22 Poultry, meat byproducts 0.10 Vegetable, root and
Herb subgroup 19A, Pulasan ........................... 0.3 tuber, group 1 ............. 0.10
fresh ............................ 3.0 Rambutan ....................... 0.3 Watercress ...................... 8.0
Hog, fat ........................... 33 Rice, hulls ....................... 4.0 Wax jambu ...................... 0.3
Hog, meat byproducts .... 8.0 Salal ................................ 0.250
Hog, meat ....................... 1.5 Sapodilla ......................... 0.3
Hop, dried cones ............ 22 Sapote, black .................. 0.3 (b) Section 18 emergency exemptions.
Horse, fat ........................ 50 Sapote, mamey .............. 0.3 [Reserved]
Horse, liver ..................... 10 Sapote, white .................. 0.3 (c) Tolerances with regional
Horse, meat .................... 2.0 Sheep, fat ....................... 50 registrations. [Reserved]
Horse, meat byproducts, Sheep, liver ..................... 10 (d) Indirect or inadvertant residues.
except liver .................. 5.0 Sheep, meat ................... 2.0
Ilama ............................... 0.3 Sheep, meat byproducts,
[Reserved]
Jaboticaba ...................... 0.3 except liver .................. 5.0 [FR Doc. E7–23579 Filed 12–4–07; 8:45 am]
Juneberry ........................ 0.25 Soursop .......................... 0.3 BILLING CODE 6560–50–S

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68534 Federal Register / Vol. 72, No.

233 / Wednesday, December 5, 2007 / Rules and Regulations

regulations.gov. Although listed in the certain entities. If you have any

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