[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Notices]
[Pages 59789-59790]
[FR Doc No: 2022-21411]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10226-01-OA]

Public Meeting of the Chartered Science Advisory Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office announces a public meeting of the chartered
Science Advisory Board. The chartered SAB will meet to: (1) receive
briefings from two EPA offices on activities and research priorities
for environmental justice considerations; (2) conduct a consultation
with EPA's Office of Water on environmental justice impacts of lead
service line removal in drinking water systems; (3) deliberate on the
adequacy of the scientific and technical basis of the proposed rule
titled Control of Air Pollution From New Motor Vehicles: Heavy-Duty
Engine and Vehicle Standards; and (4) discuss recommendations received
from the SAB Work Group for Review of Science Supporting EPA Decisions
concerning SAB review of EPA planned regulatory actions.

DATES: The public meeting for the chartered Science Advisory Board will
be held on Thursday, November 3, 2022, from 12:00 p.m. to 6:00 p.m. and
Friday, November 4, 2022, from 12:00 p.m. to 6:00 p.m. All times listed
are in Eastern Standard Time.

ADDRESSES: The meeting will be conducted virtually. Please refer to the
SAB website at https://sab.epa.gov for information on how to attend the
meeting.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning this notice may contact Dr. Thomas
Armitage, Designated Federal Officer (DFO), via telephone (202) 564-
2155, or email at [email protected]. General information about
the SAB, as well as any updates concerning the meetings announced in
this notice can be found on the SAB website at https://sab.epa.gov.

SUPPLEMENTARY INFORMATION:
    Background: The SAB was established pursuant to the Environmental
Research, Development, and Demonstration Authorization Act (ERDDAA),
codified at 42 U.S.C. 4365, to provide independent scientific and
technical advice to the EPA Administrator on the scientific and
technical basis for agency positions and regulations. The SAB is a
Federal Advisory Committee chartered under the Federal Advisory
Committee Act (FACA), 5 U.S.C. app. 2. The SAB will comply with the
provisions of FACA and all appropriate SAB Staff Office procedural
policies. Pursuant to FACA and EPA policy, notice is hereby given that
the chartered Science Advisory will hold a public meeting to discuss
and deliberate on the following topics.
    The SAB will receive briefings from EPA's Office of Policy and
Office of Research and Development on activities and research
priorities for consideration of environmental justice. The chartered
SAB will also conduct a consultation with the EPA's Office of Water on
environmental justice impacts of lead service line removal in drinking
water systems.
    Under the SAB's authorizing statute, the SAB ``may make available
to the Administrator, within the time specified by the Administrator,
its advice and comments on the adequacy of the scientific and technical
basis'' of proposed rules. The SAB Work Group for Review of Science
Supporting EPA Decisions is charged with identifying EPA planned
actions that may warrant SAB review. The SAB will discuss the
scientific and technical basis of the proposed rule titled Control of
Air Pollution From New Motor Vehicles: Heavy-Duty Engine and Vehicle
Standards (FR 87 17414) and also discuss recommendations received from
the SAB Work Group for Review of Science Supporting EPA Decisions with
regard to SAB review of other EPA planned actions.
    Availability of Meeting Materials: All meeting materials, including
the agenda will be available on the SAB web page at https://sab.epa.gov.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process

for submitting comments to a federal advisory committee is different
from the process used to submit comments to an EPA program office.
Federal advisory committees and panels, including scientific advisory
committees, provide independent advice to the EPA. Members of the
public can submit relevant comments pertaining to the committee's
charge or meeting materials. Input from the public to the SAB will have
the most impact if it provides specific scientific or technical
information or analysis for the SAB to consider or if it relates to the
clarity or accuracy of the technical information. Members of the public
wishing to provide comment should follow the instruction below to
submit comments.
    Oral Statements: Individuals or groups requesting an oral
presentation during the public meeting will be limited to three
minutes. Each person making an oral statement should consider providing
written comments as well as their oral statement so that the points
presented orally can be expanded upon in writing. Persons interested in
providing oral statements should contact the DFO, in writing
(preferably via email) at the contact information noted above by
October 25, 2022, to be placed on the list of registered speakers.
    Written Statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by SAB members,
statements should be submitted to the DFO by October 25, 2022, for
consideration at the public meeting on November 3, 2022, and November
4, 2022. Written statements should be supplied to the DFO at the
contact information above via email. Submitters are requested to
provide a signed and unsigned version of each document because the SAB
Staff Office does not publish documents with signatures on its
websites. Members of the public should be aware that their personal
contact information if included in any written comments, may be posted
to the SAB website. Copyrighted material will not be posted without the
explicit permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact the DFO, at the contact
information noted above, preferably at least ten days prior to the
meeting, to give the EPA as much time as possible to process your
request.

V Khanna Johnston,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2022-21411 Filed 9-30-22; 8:45 am]
BILLING CODE P


June 20, 2003 Memorandum Subject: Review of Administrative Materials in support of an Application for an Experimental Use Permit for Genetically Modified Corn ( Vector ZMIR39) Producing a Cry3Bb1 Protein that Provides Control of Corn Rootworm ( Diabrotica sp.). EPA Reg. No. 524 EUP OA; DP Barcode D287619; Case No. 071318; Submission No. S625460; Chemical No. 6498.

To: Mike Mendelsohn, Regulatory Action Leader Biopesticides and Pollution Prevention Division, 7511C From: Robyn Rose, Entomologist Biopesticides and Pollution Prevention Division, 7511C Peer Review: Chris Wozniak, Ph. D., Biologist Biopesticides and Pollution Prevention Division, 7511C Classification: It is acceptable to plant corn containing ZMIR39 Background:

On November 11, 2002 Monsanto submitted a request for a FIFRA Section G Experimental Use Permit ( EUP) for Cry3Bb1 corn rootworm ( CRW, Diabrotica spp.) protected corn events produced from vector ZMIR39. Under this EUP, Monsanto intends to plant ZMIR39 corn during the 2003 and 2004 growing seasons in diverse agronomic zones of 25 states and Puerto Rico. These studies are proposed to be conducted at various research stations, seed production sites, privately owned and University farms from the present through February 28, 2005. Monsanto intends to plant a total of 829 acres during the 2003 growing season and 2299 acres during the 2004 growing season ( Table 1).

No more than 450 acres of ZMIR39 corn will be planted in a state during a growing season. A supplemental submission dated May 19, 2003 details the acreage of ZMIR39 corn that will be planted per state for each research trial. In addition to conducting studies with CRW protected corn ( vector ZMIR39), hybrids of ZMIR39 corn cross bred with event MON 810 corn borerprotected corn ( YieldGard ® ) will be tested under this EUP. The ZMIR39 corn expresses the Cry3Bb1 protein and whereas, event MON 810 corn expresses the Cry1Ab protein. 2 Monsanto currently has a registration for Cry3Bb1 corn rootworm protected corn event MON 863 ( vector ZMIR13L). There is already a tolerance exemption granted for the Cry3Bb1 protein ( 40 CFR § 180.1214); therefore, residue data is not required. According to Monsanto, event MON 863 and vector ZMIR39 corn share an amino acid sequence identity of 99.8%; there is only one difference of the 653 amino acids. Differences between MON 863 and ZMIR39 corn are the selectable marker proteins which are considered inert ingredients. MON 863 corn contains the nptII protein ( neomycin phosphotransferase II) and ZMIR39 events contain 5 enolpyruvylshikimate 3 phosphate synthase protein from Agrobacterium sp. strain CP4 ( CP4 EPSPS). The marker protein CP4 EPSPS in ZMIR39 corn provides tolerance to glyphosate herbicide and has been granted a tolerance ( 40 CFR § 180.1174).

Studies submitted in support of the MON 863 registration indicate a lack of toxicity of the Cry3Bb1 protein to humans as well as a lack of risk to the environment. A summary of these studies can be found in MRID 454240 09 and the Cry3Bb1 Biopesticides Registration Action Document ( BRAD). Based on results of these previously submitted studies, Monsanto expects minimal risk from field testing ZMIR39 corn and similar efficacy between MON 863 and ZMIR39 corn. None of the ZMIR39 corn grown will be used for commercial food or feed until FDA has completed their safety and nutritional assessment. ZMIR39 corn may be fed to animals as part of experimental trials, otherwise, the crop will be destroyed at the end of the trial or after harvest due to USDA APHIS requirements. Administrative materials and data were submitted in support of this EUP. The information submitted as part of the administrative materials are summarized and reviewed below.

Table 1. Proposed Acreage and Active Ingredient Quantities for Each State and Territory State Acres Planting Seed ( lb) A. I. in Planting Seed ( g)

2003 2004 Total 2003 2004 Total 2003 2004 Total AL 2.5 2.5 5 50 50 100 1.36 1.36 2.72 CA 50 450 500 1000 9000 10000 27.24 245.16 272.40 CO 10 20 30 200 400 600 5.45 10.9 16.34 HI 266 616 882 5320 121320 17640 144.92 335.60 480.51 IA 101.2 330.2 431.4 2024 6604 8628 55.13 179.89 235.03 IL 116.5 236 352.5 2330 4720 7050 63.47 128.57 192.04 IN 38.3 85.8 124.1 766 1716 2482 20.87 46.74 67.61 KS 19 36.5 54.5 360 730 1090 9.81 19.89 29.69 KY 0.5 0.5 1 10 10 20 0.27 0.27 0.54 MD 1.3 1.8 3.1 26 36 62 0.71 0.98 1.69 MI 2.5 13 15.5 50 260 310 1.36 7.08 8.44 MN 31.6 42.1 73.7 632 842 1474 17.22 22.94 40.15 3 Table 1. Continued State Acres Planting Seed ( lb) A. I. in Planting Seed ( g)

2003 2004 Total 2003 2004 Total 2003 2004 Total MO 20.3 30.8 51.1 406 616 1022 11.06 16.78 27.84 MS 2.5 4.5 7 50 90 140 1.36 2.45 3.81 NC 0.5 0.5 1 10 10 20 0.27 0.27 0.54 NE 50.3 101.3 151.6 1006 2026 3032 27.40 55.19 82.59 NM 0.5 0.5 1 10 10 20 0.27 0.27 0.54 NY 0.5 1 1.5 10 20 30 0.27 0.54 0.82 OH 29.6 40.6 70.2 592 812 1404 16.13 22.12 38.24 PA 3.3 16.3 19.6 66 326 392 1.80 8.88 10.68 PR 29 182 211 580 3640 4220 15.80 99.15 114.95 SD 20 30 50 400 600 1000 10.90 16.34 27.24 TN 12.5 12.5 25 250 250 500 6.81 6.81 13.62 TX 5.5 15.5 21 110 310 420 3.00 8.44 11.44 VA 0.5 0.5 1 10 10 20 0.27 0.27 0.54 WI 15.3 28.3 43.6 306 566 872 8.34 15.42 23.75 Total 829 2299 3128 16574 45974 62548 451.48 1252.33 1703.81 ( 0.99 lb) ( 2.76 lb) ( 3.75 lb)

EUP Label Statements Proposed by Monsanto:

° " FOR EXPERIMENTAL USE ONLY" ° " Not for sale to any person other than a participant or cooperator of the EPA approved Experimental Use Program." ° " For use only at a site of a participant or cooperator and in accordance with the terms and conditions of the Experimental Use Permit." ° " This package contains corn rootworm protected corn seed producing Cry3Bb1, and insecticidal protein from Bacillus thuringiensis. This protein is effective in controlling feeding damage caused by corn rootworm larvae ( Diabrotica spp.)." ° " Active Ingredient: Corn produced Bacillus thuringiensis Cry3Bb1 protein and the genetic material necessary ( vector ZMIR39) for its production in corn........... 0.006%" ° " Inert Ingredients: Substance produced by marker gene and the genetic material necessary for its production in corn...........< 0.007%." ° " The contents may only be used according to the approved EUP program. Cooperators must have at least one copy of each applicable protocol prior to initiating any research 4 with the contents." ° " Any seed not used in these experiments must be returned to Monsanto Company or seed company partners / affiliates, or disposed of as specified in the field protocols."

BPPD Conclusions:

Insect Resistance Management An insect resistance management ( IRM) plan is not necessary for the small acreage of ZMIR39 corn that will be planted under this EUP. However, an IRM plan will be required for a Section 3 commercial registration for all corn events containing the ZMIR39 vector.

Ecological Effects ( Nontarget Organisms and Fate in the Soil) Adverse effects to populations of nontarget organisms from planting ZMIR39 corn are not expected during the short duration and on the limited acreage that will be planted under this EUP. Based on previously submitted studies for registered Bt proteins including Cry3Bb1, detectable amounts are not expected to accumulate and persist in soil during this EUP. The following studies will need to be submitted for a Section 3 commercial registration for all corn events containing the ZMIR39 vector.

Avian A six week chicken broiler study with the chickens fed starter diets to day 17, grower diets to day 31 and finisher diets to day 42 ( 50 60 % transgenic corn) should be conducted and submitted for EPA to review. A control study with non transgenic corn in the standard diets should be run concurrently.

Mammalian Wildlife Acute oral toxicity including but not limited to in vitro digestibility, in vitro simulated gastric fluid digestibility and a SDS PAGE sensitivity analysis in support of the simulated gastric fluid digestion study will be considered as part of the risk assessment for mammalian wildlife toxicity.

Non target Plants Since the active ingredient in this product is an insect toxin that has never shown any toxicity to plants, these studies have been waived for this product. In addition, there is no evidence of transfer of any gene, including introduced genes, to organisms other than those with which corn is sexually compatible. In addition, there are no weedy relatives of corn in the continental U. S or Puerto Rico.

Non target invertebrates ° Honey bee larval acute toxicity studies should be conducted and submitted to the Agency 5 for review prior to a full commercial registration. This study should be conducted through adult emergence. ° Tier 1 acute toxicity tests should also be conducted on three non target beneficial invertebrates. Testing lady beetles ( Coleomegilla maculata), the minute pirate bug ( Orius insidiosus), and a Carabid ( e. g., Pterostichus sp.) is recommended. Since ZMIR39 is active against coleopterans, lady beetle testing with pollen and purified protein is recommended. ° In addition, an appropriate non target coleopteran ( e. g., Tetraopes, milkweed beetle) that may be unintentionally exposed to ZMIR39 should be evaluated. ° Field studies should also be conducted that evaluate potential effects of growing ZMIR39 corn on varying trophic levels ( e. g., plant feeders, predators, parasitoids, decomposers). ° Although an earthworm study is not required for full commercial registration, the Agency recognizes their importance as decomposers living in the soil. Therefore, conducting an earthworm dietary toxicity study is recommended prior to commercialization. ° A collembola study should also be submitted.

Fish The requirement for a static renewal toxicity study for freshwater fish is normally waived based on a lack of exposure of fish to Bt proteins produced in corn. Exposure from corn pollen, if it does take place, will be of a very short duration and quantity and is not expected to have any detectable effect on freshwater fish. A waiver request should be submitted if nontarget fish studies are not conducted.

Aquatic Invertebrates Published and in house data for Bt crystal protein containing corn show that Bt crystal proteins have no measurable deleterious effects on Daphnia magna, a sensitive aquatic invertebrate species. Therefore, no adverse effects are expected to occur to nontarget aquatic invertebrate during the two seasons ZMIR39 will be grown under this EUP. However, acceptable Tier 1 toxicity tests are required for a Section 3 commercial registration.

Estuarine and Marine Animals The estuarine fish and shrimp studies are not required for this product because of very low potential for exposure.

Endangered Species Based on the previously submitted Cry protein toxicity and exposure data there will not be a " may effect" situation for endangered mammals, birds, plants and aquatic species. All endangered/ threatened insect species that are susceptible to Cry3Bb1 ( e. g., coleopterans) may be adversely affected if exposed. In the case of Cry3Bb1 protein, the test plots for the proposed 6 EUP program must not be near the habitats of endangered beetle ( coleopteran) species since these may be adversely affected if exposed to the Bt protein in the soil or through pollen consumption. An assessment of potential impacts on endangered species should be conducted and submitted to the Agency for review prior to full commercial registration.

Soil Fate The potential accumulation and/ or persistence of Cry3Bb1 expressed in ZMIR39 corn in soil should be evaluated prior to full commercial registration. This should be done by determining the DT 50 or time to 50% degradation of protein in varying soil types. In particular the DT 50 in a " worst case scenario" should be determined. Since Cry proteins have been shown to readily bind to clay soils and persist longer at low pH, the DT 50 of Cry3Bb1 should be determined in soils with a high clay content. Studies should include insect bioassays with a sensitive species such as the Colorado potato beetle as well as an ELISA for comparative purposes.

Additional field studies should be conducted after full commercial registration. Field studies should be conducted in a variety of soil types and should utilize fields that have had ZMIR39 corn grown for three consecutive years. Persistence of Cry3Bb1 in the soil should be monitored close to the soil surface ( e. g., 12  18 inches deep) as well as deep in the soil ( e. g., several feet below surface level) where microbial activity is reduced. Sampling should occur immediately after anthesis as well as post harvest and should continue until no Bt protein is detected.

Experimental Program Summary:

Sampling Samples including whole corn plants, tissue and/ or seed may be sent to Monsanto or other laboratories for analysis.

Isolation Research plots will be isolated from other corn plots by planting Bt corn

660 ft from openpollination non transgenic corn, bagging tassels from pre anthesis until after pollen shed and/ or detasseling prior to anthesis.

Schedule There will be continuos plantings in Hawaii and Puerto Rico with at least 60 days after harvest that fields will remain fallow and be irrigated. There will be at least two plantings per site in the continental U. S. Plantings in the continental U. S. will occur from February until June and fields will be harvested from August to November.

Harvest Procedures Corn ears harvested by hand will be put into cloth or mesh bags that prevent seed loss. Handharvested ears may be dried before shelling to remove moisture. Seed from machine harvested ears will be shelled during harvest and weighed prior to disposal. Before leaving research plots, 7 all equipment will be thoroughly cleaned.

Final Disposition Seed that is not planted under this EUP may be used for other research purposes, as food or feed if approved by the FDA, returned to Monsanto or seed companies based on USDA requirements or destroyed ( e. g., incineration, autoclaving or buried at test sites). Harvested corn may be used in additional research, for future plantings or as food or feed in experimental studies or if approved by the FDA. Corn plants will be destroyed after test termination.

Volunteer Plants Plots and border rows will only be monitored for volunteer plants in areas allowed to flower. Fields not allowed to flower will not be monitored for volunteer plants. All volunteer plants will be removed and destroyed prior to seed set or flowering. Monsanto expects the occurrence of volunteer plants to be minimal because Bt plants will be located in a defined area and all seed and plant material will be appropriately disposed of ( see Final Disposition section above). Research plots will be monitored for volunteer plants for at least 12 months after harvest and will continue until no volunteers are detected. If volunteer plants persist, Cooperators should contact Monsanto. Plots in Hawaii and Puerto Rico will be monitored for volunteer plants during the 60 day fallow period after harvest.

Breeding and Observation Nursery Trials According to Monsanto, these studies will be conducted to "[ o] bserve the phenotype of corn expressing the cry3Bb1 gene in various elite corn lines derived from CRW protected corn ( vector ZMIR39) and/ or maintain these transgenic lines through seed production." Corn plants containing vector ZMIR39 in various genetic backgrounds will be used in these trials ( Table 2). Hybrids containing vector XMIR39 and event MON 810 will also be planted ( Table 2). Plants containing the cry3Bb1 gene will be hand pollinated with non Bt corn or other Bt corn hybrids. Hand pollinations will include selfing, backcrossing or crossing plants to a tester line. Plants may also be sampled to determine phenotype or genotype.

Table 2. Acreage planted per state in 2003 and 2004 for the Breeding and Observation Nursery Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 CA 37.5 12.5 CO 1.5 0.5 3.0 1.0 HI 112.5 37.5 150.0 50.0 IA 15.0 5.0 37.5 12.5 IL 25.5 8.5 22.5 7.5 IN 3.8 1.3 3.8 1.3 KS 2.3 0.8 2.3 0.8 8 MI 0.4 0.1 0.8 0.3 MN 2.3 0.8 3.0 1.0 Table 2. Continued State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 MO 2.3 0.8 2.3 0.8 NE 2.3 0.8 7.5 2.5 OH 2.3 0.8 3.8 1.3 PA 0.8 0.3 1.5 0.5 PR 11.3 3.8 80.3 26.8 SD 1.5 0.5 2.3 0.8 TN 1.5 0.5 1.5 0.5 TX 0.8 0.3 1.5 0.5 WI 1.5 0.5 3.0 1.0 Total 187.1 62.4 363.8 121.3 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Inbred Seed Increase Production Trials According to Monsanto, these studies will be conducted to "[ p] roduce seed and plant material for further testing and product development." These trials will utilize a variety of inbred corn lines containing the cry3Bb1 gene ( Table 3). Corn plants will be allowed to open pollinate to generate seed in plots that are isolated according to the Isolation section above. Only corn containing vector ZMIR39 in various genetic backgrounds will be planted.

Table 3. Acreage planted per state in 2003 and 2004 for the Inbred Seed Production Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 CA 18.8 6.3 175.0 175.0 HI 37.5 12.5 125.0 125.0 IA 3.8 1.3 15.0 15.0 IL 2.3 0.8 10.0 10.0 IN 1.5 0.5 1.0 1.0 KS 1.5 0.5 1.0 1.0 MN 1.5 0.5 1.0 1.0 9 MO 1.5 0.5 1.0 1.0 NE 1.5 0.5 4.0 4.0 OH 0.8 0.3 1.0 1.0 Table 3. Continued State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 PR 4.5 1.5 25.0 25.0 SD 0.8 0.3 0.5 0.5 TN 0.8 0.3 0.5 0.5 WI 0.8 0.3 0.5 0.5 Total 77.3 25.8 360.5 360.5 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Line Per Se and Hybrid Yield Trials According to Monsanto, these studies will be conducted to "[ a] ssess any agronomic effects of the genetic insertion in CRW protected corn ( vector ZMIR39) in various corn genetic backgrounds." Only corn containing vector ZMIR39 in various genetic backgrounds will be planted ( Table 4). Inbred and hybrid corn lines represented by a segregant with and without the cry3Bb1 gene will be planted in a randomized design or as single large blocks. Up to 100 different lines may be planted at each location. Agronomic characteristics such as early plant vigor, color, height, days to flowering and maturity, yield and weight will be evaluated. More than one trial conducted at a location will be analyzed as unique locations.

Table 4. Acreage planted per state in 2003 and 2004 for the Line Per Se and Hybrid Yield Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 CA 18.8 6.3 25.0 25.0 CO 1.5 0.5 3.5 3.5 HI 30.0 10.0 50.0 50.0 IA 28.5 9.5 95.0 95.0 IL 33.8 11.3 64.0 64.0 IN 7.5 2.5 5.0 5.0 KS 4.5 1.5 8.5 8.5 MI 0.8 0.3 4.0 4.0 MN 7.5 2.5 7.5 7.5 MO 4.5 1.5 6.0 6.0 10 MS 0.8 0.3 1.0 1.0 NE 22.5 7.5 17.5 17.5 OH 9.0 3.0 9.0 9.0 PA 0.8 0.3 4.0 4.0 Table 4. Continued State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 PR 6.0 2.0 12.5 12.5 SD 2.3 0.8 3.5 3.5 TN 3.0 1.0 2.0 2.0 TX 0.8 0.3 2.5 2.5 WI 3.0 1.0 7.0 7.0 Total 185.3 61.8 327.5 327.5 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Insect Efficacy Trials According to Monsanto, these studies will be conducted to "[ a] ssess the efficacy of corn expressing the cry3Bb1 gene in various corn genetic backgrounds against corn rootworm and other potential soil pests of corn." Only corn containing vector ZMIR39 in various genetic backgrounds will be planted ( Table 5). These trials will utilize corn lines containing the cry3Bb1 gene planted in a randomized design or as single large blocks. Control plots will include nontransgenic corn plants untreated or treated with insecticides. More than one trial conducted at a location will be analyzed as unique locations.

Table 5. Acreage planted per state in 2003 and 2004 for the Insect Efficacy Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 AL 1.5 1.0 1.3 1.3 CO 2.4 1.6 3.0 3.0 IA 7.9 5.3 10.1 10.1 IL 7.5 5.0 10.5 10.5 IN 3.2 2.1 7.9 7.9 KS 1.8 1.2 5.3 5.3 KY 0.3 0.2 0.3 0.3 MD 0.8 0.5 0.9 0.9 11 MI 0.6 0.4 2.0 2.0 MN 1.6 1.0 2.6 2.6 MO 2.0 1.3 3.9 3.9 MS 0.9 0.6 1.3 1.3 NC 0.3 0.2 0.3 0.3 Table 5. Continued State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 NE 3.2 2.1 4.2 4.2 NM 0.3 0.2 0.3 0.3 NY 0.3 0.2 0.5 0.5 OH 3.4 2.2 3.8 3.8 PA 0.8 0.5 3.2 3.2 SD 2.4 1.6 4.5 4.5 TN 1.5 1.0 1.3 1.3 TX 0.9 0.6 2.8 2.8 VA 0.3 0.2 0.3 0.3 WI 2.0 1.3 2.2 2.2 Total 45.7 30.5 71.9 71.9 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Product Characterization and Performance Trials According to Monsanto, these studies will be conducted "[ t] o produce grain and plant material for product characterization, further regulatory testing, and benefits studies." Only corn containing vector ZMIR39 in various genetic backgrounds will be planted ( Table 6). These trials will include plants that are hand or open pollinated to generate seed or plant tissue to be analyzed for composition, equivalency, phenotype and molecular characterization. Only corn containing vector ZMIR39 in various genetic backgrounds will be planted.

Table 6. Acreage planted per state in 2003 and 2004 for the Product Characterization and Performance Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 CO 1.0 1.0 1.0 1.0 HI 13.0 13.0 33.0 33.0 IA 5.0 5.0 2.0 2.0 12 IL 5.0 5.0 2.5 2.5 IN 1.5 1.5 1.5 1.5 KS 0.5 0.5 0.5 0.5 MN 0.5 0.5 0.5 0.5 MO 0.5 0.5 0.5 0.5 NE 0.5 0.5 1.5 1.5 Table 6. Continued State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 OH 0.5 0.5 0.5 0.5 SD 0.5 0.5 0.5 0.5 TN 0.5 0.5 0.5 0.5 WI 0.5 0.5 0.5 0.5 Total 29.5 29.5 45.0 45.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Insect Resistance Management Trials According to Monsanto, these studies will be conducted "[ t] o develop additional data for use in further refining a corn rootworm insect resistance management ( IRM) plan. Studies include characterizing dose, larval movement, adult movement and mating behavior, and effects of the Cry3Bb1 protein on adult CRW fitness." Only corn containing vector ZMIR39 in various genetic backgrounds will be planted ( Table 7). These trials will utilize corn lines containing the cry3Bb1 gene planted in a randomized design or as single large blocks. Control plots will include nontransgenic corn plants untreated or treated with insecticides. Efficacy trials as well as CRW adult emergence and fitness studies will be conducted. Across and between row larval movement will also be evaluated in Bt and non Bt plots. In addition, various ratios of Bt and non Bt corn seed mixtures will be evaluated. Yields for each treatment will also be determined.

Table 7. Acreage planted per state in 2003 and 2004 for the Insect Resistance Management Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 CO 0.5 0.5 IA 4.0 4.0 4.0 4.0 IL 2.5 2.5 2.5 2.5 IN 5.0 5.0 12.5 12.5 KS 1.0 1.0 1.0 1.0 13 MN 5.0 5.0 5.0 5.0 MO 2.0 2.0 2.0 2.0 NE 2.0 2.0 5.0 5.0 OH 2.0 2.0 2.0 2.0 SD 2.0 2.0 2.0 2.0 TN 0.5 0.5 0.5 0.5 TX 0.5 0.5 1.0 1.0 Table 7. Continued State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 WI 1.0 1.0 1.0 1.0 Total 27.5 27.5 39.0 39.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Nontarget Organisms and Benefits Trials According to Monsanto, these studies will be conducted to "[ d] evelop additional data to assess the impact of the Cry3Bb1 protein on nontarget organisms, including a wide variety of soil and surface dwelling organisms." Only corn containing vector ZMIR39 in various genetic backgrounds will be planted. These trials will utilize corn lines containing the cry3Bb1 gene planted in a randomized design or as single large blocks in a variety of environments. Control plots will include non transgenic corn plants untreated or treated with insecticides. The amount of Cry3Bb1 protein in Bt and non Bt plots will be evaluated as well as microbial community structure, earthworm populations and terrestrial invertebrates at and below the soil surface.

Table 8. Acreage planted per state in 2003 and 2004 for the Nontarget Organisms and Benefits Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 IA 2.5 2.5 3.0 3.0 IL 2.5 2.5 2.5 2.5 IN 1.5 1.5 2.5 2.5 KS 0.5 0.5 0.5 0.5 MN 1.5 1.5 2.5 2.5 MO 0.5 0.5 0.5 0.5 NE 1.5 1.5 2.5 2.5 OH 1.0 1.0 1.0 1.0 14 SD 2.0 2.0 2.0 2.0 TN 0.5 0.5 0.5 0.5 WI 0.5 0.5 0.5 0.5 Total 14.5 14.5 18.0 18.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Seed Treatment Trials According to Monsanto, these studies will be conducted "[ t] o evaluate effects of diverse chemical seed treatments, in combination with transgenic corn, on corn rootworm and additional insect pests." Only corn containing vector ZMIR39 in various genetic backgrounds will be planted ( Table 9). Bt and non transgenic corn seed will be treated with soil insecticides and/ or insect deterrents. Experimental plots will be planted in a randomized design or as single large blocks in a variety of environments. Control plots will include non transgenic corn plants untreated or treated with insecticides. Efficacy of the various treatments against CRW and other invertebrate pests will be evaluated. Agronomic characteristics ( e. g., germination, seedling vigor) will also be evaluated.

Table 9. Acreage planted per state in 2003 and 2004 for the Seed Treatment Trials State ZMIR39 Acreage 2003 Stacked1 Acreage 2003 ZMIR39 Acreage 2004 Stacked1 Acreage 2004 IA 1.0 1.0 1.0 1.0 IL 1.0 1.0 1.0 1.0 NE 1.0 1.0 1.0 1.0 OH 0.5 0.5 0.5 0.5 SD 0.5 0.5 0.5 0.5 TX 0.5 0.5 0.5 0.5 WI 0.5 0.5 0.5 0.5 Total 5.0 5.0 5.0 5.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Swine Growth and Feed Efficiency Trials According to Monsanto, these studies will be conducted "[ t] o evaluate feeding performance in growing finishing pigs fed diets containing grain from CRW protected corn ( vector ZMIR39)." These trials will use half gilt and half barrow pigs which will be put in pens according to body weight and allowed ad libitum access to food and water. Pigs will be fed CRW protected corn ( vector ZMIR39) or a control with similar genetic background or one of two other commercial hybrids until they reach market weight ( Table 10). Feeding will occur from harvest to approximately 120 days post harvest in 2004 only. Weight and food intake will be determined periodically. Pigs will be returned to their owner or sent to a commercial slaughterhouse for meat 15 production.

Isolation will be accomplished in the study by using confined pens, grinding grain prior to feeding to devitalize it and monitoring for volunteer plants. Volunteer plants will be monitored as described in the Volunteer Plants section above. Corn not fed to pigs will be destroyed according to USDA guidelines, stored on site, used in other research trials, used as food or feed upon FDA approval or returned to Monsanto.

Table 10. Acreage planted per state in 2004 for the Swine Growth and Feed Efficiency Trials State ZMIR39 Acreage 2004 Stacked1 Acreage 2004 IA 2.5 2.5 IL 2.5 2.5 Table 10. Continued State ZMIR39 Acreage 2004 Stacked1 Acreage 2004 IN 2.5 2.5 NE 2.5 2.5 Total 10.0 10.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Dairy Cattle Feed Efficiency Trials According to Monsanto, these studies will be conducted "[ t] o evaluate milk yield and feeding performance in lactating dairy cows fed diets containing grain and silage from CRW protected corn ( vector XMIR39)." Lactating dairy cattle will be fed fermented silage and ground grain ad libitum from harvest to approximately 110 days post harvest in 2004 only. Cattle will be fed CRW protected corn ( vector ZMIR39) or a control with similar genetic background or one of two other commercial hybrids ( Table 11).. Treatments will be applied in a latin square design and feed intake and lactation performance will be evaluated.

Isolation will be accomplished by performing studies in confined pens and fermenting silage which results in devitalization. Volunteer plants will be monitored and removed prior to seed set or flowering in feed bunkers and feed milling sites for at least 12 months and continue until no volunteers are found. Corn not fed to cattle will be destroyed according to USDA guidelines, stored on site, used in other research trials, used as food or feed upon FDA approval or returned to Monsanto. Cattle will be returned to owners after completion of the studies.

Table 11. Acreage planted per state in 2004 for the Dairy Cattle Feed Efficiency Trials State ZMIR39 Acreage 2004 Stacked1 Acreage 2004 IA 2.5 2.5 IL 2.5 2.5 16 IN 2.5 2.5 NE 2.5 2.5 Total 10.0 10.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Beef Cattle Growth and Feed Efficiency According to Monsanto, these studies will be conducted "[ t] o evaluate growth and feeding performance in feedlot cattle fed diets containing grain from CRW protected corn ( vector ZMIR39)." Steers assigned to pens according to weight will be fed CRW protected corn ( vector ZMIR39) or a control with similar genetic background or one of two other commercial hybrids ad libitum ( Table 12). Testing will take place until steers reach market weight which will occur from harvest until approximately 100 to 150 days post harvest in 2004 only. Feed will include ground corn grain and intake and weight will be recorded periodically during testing.

Isolation will be accomplished by performing studies in confined areas and grinding corn which results in devitalization. Volunteer plants will be monitored and removed prior to seed set or flowering in feed bunkers and feed milling sites for at least 12 months and continue until no volunteers are found. Corn not fed to steers will be destroyed according to USDA guidelines, stored on site, used in other research trials, used as food or feed upon FDA approval or returned to Monsanto. Cattle will be returned to their owner or sent to a commercial slaughterhouse for meat production.

Table 12. Acreage planted per state in 2004 for the Dairy Cattle Feed Efficiency Trials State ZMIR39 Acreage 2004 Stacked1 Acreage 2004 IA 2.5 2.5 IL 2.5 2.5 IN 2.5 2.5 NE 2.5 2.5 Total 10.0 10.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn Cattle Grazing Feed Efficiency Trials According to Monsanto, these studies will be conducted "[ t] o evaluate feeding performance of cattle as a result of grazing on corn stover and stubble from CRW protected corn ( vector ZMIR39)." Calves or mature cattle will be assigned to pens according to weight will be fed CRW protected corn ( vector ZMIR39) or a control with similar genetic background or one of two other commercial hybrids ad libitum. Test animals will be allowed to freely graze on corn stover and stubble in test plots after harvest for up to approximately 90 days in 2004 only ( Table 13). Body weight of cattle will be monitored and recorded. Fields used for grazing will be monitored for volunteer plants for at least 12 months and continue until no volunteers are found. 17 Grain is expected to be devitalized after digestion by test animals. Corn not fed to cattle will be destroyed according to USDA guidelines, stored on site, used in other research trials, used as food or feed upon FDA approval or returned to Monsanto. Cattle will be returned to their owner at test termination.

Table 13. Acreage planted per state in 2004 for the Dairy Cattle Feed Efficiency Trials State ZMIR39 Acreage 2004 Stacked1 Acreage 2004 IA 2.5 2.5 IL 2.5 2.5 IN 2.5 2.5 NE 2.5 2.5 Total 10.0 10.0 1Stacked products contain CRW protected vector ZMIR39 corn and YieldGard event MON 810 corn


[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42198-42199]
[FR Doc No: 2018-17938]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Availability of Noise Compatibility Program for Chicago Executive
Airport, Wheeling and Prospect Heights, Illinois

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the updated noise exposure maps submitted by the
Chicago Executive Airport under the provisions of the (Aviation Safety
and Noise Abatement Act) and Title 14 Code of Federal Regulations (CFR)
Part 150

are in compliance with applicable requirements.

DATES: This notice is effective August 20, 2018, and applicable August
9, 2018. The public comment period ends September 10, 2018.

FOR FURTHER INFORMATION CONTACT: Ms. Amy Hanson, Environmental
Protection Specialist, CHI-603, Federal Aviation Administration,
Chicago Airport District Office, 2300 East Devon Avenue, Des Plaines,
IL 60018. Telephone number:<PHONE_NUMBER>. Email: [email protected].

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the updated noise exposure maps submitted for Chicago Executive
Airport are in compliance with applicable requirements of14 CFR part
150, effective (Note 1). Under 49 U.S.C. 47503 of the Aviation Safety
and Noise Abatement Act (hereinafter referred to as ``the Act''), an
airport operator may submit to the FAA noise exposure maps which meet
applicable regulations and which depict non-compatible land uses as of
the date of submission of such maps, a description of projected
aircraft operations, and the ways in which such operations will affect
such maps. The Act requires such maps to be developed in consultation
with interested and affected parties in the local community, government
agencies, and persons using the airport. An airport operator who has
submitted noise exposure maps that are found by FAA to be in compliance
with the requirements of 14 CFR part 150, promulgated pursuant to the
Act, may submit a noise compatibility program for FAA approval which
sets forth the measures the operator has taken or proposes to take to
reduce existing non-compatible uses and prevent the introduction of
additional non-compatible uses.
    The FAA has completed its review of the updated noise exposure maps
and accompanying documentation submitted by Chicago Executive Airport.
The documentation that constitutes the ``noise exposure maps'' as
defined in section 150.7 of Part 150 includes: Figure D3, Existing
(2016) Noise Exposure Map; Figure D4, Future (2022) Noise Exposure Map;
Table B2, Summary Annual and Aircraft Operations Forecast; Figure D1,
Arrival Flight Tracks; Figure D2, Departure Flight Tracks; Table E1,
Existing Land Use Within Existing Noise Contours, 2016; and Table E2,
Existing Land Use Within Existing Noise Future Noise Contours.
    The FAA has determined that these updated noise exposure maps and
accompanying documentation are in compliance with applicable
requirements. This determination is effective on August 9, 2018. FAA's
determination on an airport operator's noise exposure maps is limited
to a finding that the maps were developed in accordance with the
procedures contained in Appendix A of FAR Part 150. Such determination
does not constitute approval of the applicant's data, information or
plans, or a commitment to approve a noise compatibility program or to
fund the implementation of that program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a noise exposure map
submitted under section 47503 of the Act, it should be noted that the
FAA is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise contours, or in
interpreting the noise exposure maps to resolve questions concerning,
for example, which properties should be covered by the provisions of
section 47506 of the Act. These functions are inseparable from the
ultimate land use control and planning responsibilities of local
government. These local responsibilities are not changed in any way
under Part 150 or through FAA's review of noise exposure maps.
Therefore, the responsibility for the detailed overlaying of noise
exposure contours onto the map depicting properties on the surface
rests exclusively with the airport operator that submitted those maps,
or with those public agencies and planning agencies with which
consultation is required under section 47503 of the Act. The FAA has
relied on the certification by the airport operator, under section
150.21 of FAR Part 150, that the statutorily required consultation has
been accomplished.
    Copies of the full updated noise exposure map documentation and of
the FAA's evaluation of the maps are available for examination, upon
prior appointment during normal business hours, at the following
locations:
    Chicago Executive Airport, 1020 South Plant Road, Wheeling,
Illinois 60090.
    Federal Aviation Administration, Chicago Airports District Office,
2300 E Devon, Suite 320, Des Plaines, IL 60018.
    Questions may be directed to the individual named above under the
heading FOR FURTHER INFORMATION CONTACT.

    Issued in Des Plaines, IL, August 9, 2018.
Deb Bartell,
Manager, Chicago Airports District Office, FAA Great Lakes Region.
[FR Doc. 2018-17938 Filed 8-17-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Page 40749]
[FR Doc No: 2014-16344]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14215-001]

Commission of Public Works of the City of Spartanburg, South
Carolina; Notice of Intent To File License Application, Filing of Pre-
Application Document, and Approving Use of the Traditional Licensing
Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14215-001.
    c. Date Filed: May 27, 2014.
    d. Submitted By: Commission of Public Works of the City of
Spartanburg, South Carolina (Spartanburg Water System).
    e. Name of Project: Fingerville Hydroelectric Project.
    f. Location: At the existing Fingerville Dam on the North Pacolet
River, in Spartanburg County, South Carolina. No federal lands are
occupied by the project works or located within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Ken Tuck, Spartanburg Water System,
200 Commerce Street, P.O. Box 251, Spartanburg, South Carolina 29304;
(864) 580-5642<EMAIL_ADDRESS>    i. FERC Contact: Rachel McNamara at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Spartanburg Water System filed its request to use the
Traditional Licensing Process on May 27, 2013. Spartanburg Water System
provided public notice of its request on May 25, 2013. In a letter
dated July 7, 2014, the Director of the Division of Hydropower
Licensing approved Spartanburg Water System's request to use the
Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the South Carolina State Historic Preservation
Officer, as required by section 106, National Historical Preservation
Act, and the implementing regulations of the Advisory Council on
Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Spartanburg Water System as
the Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act; and consultation pursuant to section 106 of the
National Historic Preservation Act.
    m. Spartanburg Water System filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: July 7, 2014.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-16344 Filed 7-11-14; 8:45 am]
BILLING CODE 6717-01-P