[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Notices]
[Page 19700]
[FR Doc No: 2016-07781]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: General
Operating and Flight Rules

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to revise a previously approved
information collection. Part A of Subtitle VII of the Revised Title 49
U.S.C. authorizes the issuance of regulations governing the use of
navigable airspace. Information is collected to determine compliance
with Federal regulations. This revision addresses requirements from the
Enhanced Flight Vision Systems (EFVS) Rule, RIN 2120-AJ94.

DATES: Written comments should be submitted by May 5, 2016.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0005.
    Title: General Operating and Flight Rules.
    Form Numbers: None.
    Type of Review: Revision of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on January 4, 2016 (81 FR 139). There were no comments.
The reporting and recordkeeping requirements of Federal Aviation
Regulation (FAR) Part 91, General Operating and Flight Rules, are
authorized by Part A of Subtitle VII of the Revised Title 49 United
States Code. FAR Part 91 prescribes rules governing the operation of
aircraft (other than moored balloons, kites, rockets and unmanned free
balloons) within the United States. The reporting and recordkeeping
requirements prescribed by various sections of FAR Part 91 are
necessary for FAA to assure compliance with these provisions.
    Respondents: Approximately 21,200 airmen, state or local
governments, and businesses.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: .5 hour.
    Estimated Total Annual Burden: 235,183 hours.

    Issued in Washington, DC, on March 30, 2016.
Ronda Thompson,
FAA Information Collection Clearance Officer, Performance, Policy &
Records Management Branch, ASP-110.
[FR Doc. 2016-07781 Filed 4-4-16; 8:45 am]
BILLING CODE 4910-13-P


 Mixing and loading wettable powders for groundboom application to field crops. The MOE at the maximum application rate of 0.5 lb ai/ acre is 160. MOEs greater than the target MOE of 300 MOEs result at an application rate of 0.25 lb ai/ acre for this scenario.

 Mixing, loading and applying liquids for high pressure handwand application to greenhouse crops. The MOE at the maximum application rate of 1.5 lb ai/ acre is 160. MOEs greater than the target MOE of 300 result at an application rate of 0.7 lb ai/ acre for this scenario. Page 48 of 61  Mixing, loading and applying wettable powders for low pressure handwand application to greenhouse crops. The MOE at the maximum application rate of 1.5 lb ai/ acre is 85. MOEs greater than the target MOE of 300 result at an application rate of 0.4 lb ai/ acre for this scenario.

The results of the worker exposure assessment indicate that the following pest control operator application exposure scenarios result in MOEs less than the target MOE of 1000 for long term exposure.

 Mixing, loading and applying liquids for low pressure handwand application for crack and crevice treatment. The MOE at the maximum application rate of 2.2 lb ai/ 1000 ft2 and 7 buildings treated per day is 380. MOEs greater than the target MOE of 1000 result at the maximum application rate of 2.2 lb ai/ 1000 ft2 if the number of buildings treated per day is reduced to one, or if the application rate is reduced to 0.3 ai/ 1000 ft2 for 7 buildings treated per day.

 Mixing, loading and applying wettable powders for low pressure handwand application for indoor surface spray treatment. The MOE at the maximum application rate of 0.56 lb ai/ 1000 ft2 and 7 buildings treated per day is 40. MOEs greater than the target MOE of 1000 result if the application rate is reduced to of 0.16 lb ai/ 1000 ft2 and only 1 building is treated per day.

 Mixing, loading and applying wettable powders for low pressure handwand application for crack and crevice treatment. The MOE at the maximum application rate of 2.2 lb ai/ 1000 ft2 and 7 buildings treated per day is 10. MOEs greater than the target MOE of 1000 result if the application rate is reduced to of 0.16 lb ai/ 1000 ft2 and only 1 building is treated per day.

 Applying aerosols for indoor space spray application. The MOE at the likely maximum application rate of 0.025 lb ai per 16 oz. can with two cans applied per building and 7 buildings treated per day is 615. MOEs greater than the target MOE of 1000 result if the application rate is reduced to 0.012 lb ai per 16 oz can.

The results of the worker exposure assessment indicate that the following mosquito abatement application exposure scenario results in an MOE less than the target MOE of 1000 for long term exposure.

 Mixing and loading liquids for aerial spray application. The MOE at the maximum application rate of 0.08 lb ai/ acre is 390 if an open cab is assumed. MOEs greater than the target MOE of 1000 result if the maximum application rate is reduced to 0.03 0.08 lb ai/ acre.

 Mixing, loading and applying liquids for ULV truck mounted spray application. The MOE at the maximum application rate of 0.08 lb ai/ acre is 260 if an open cab is assumed. MOEs greater than the target MOE of 1000 result at the maximum application rate if a closed cab is assumed. Page 49 of 61 All other occupational exposure scenarios assessed based on master label specified uses result in MOEs greater than the applicable target MOEs.

9.0 INCIDENT REPORT Based on data from Poison Control Centers, there appears to be a greater risk of moderate or major symptoms among those exposed to products containing pyrethrins and piperonyl butoxide than those exposed to pyrethrins alone. A detailed review of symptoms found that respiratory symptoms ( bronchospasm, cough/ choke, and dyspnea) and selected dermal symptoms ( dermal irritation/ pain, itching, and rash) were more likely if the exposure included piperonyl butoxide. These symptoms are likely the reason for increased risk of moderate effects which typically would require medical attention. Other literature suggests that pyrethrin based products may pose a hazard to asthmatics. The findings from analysis of symptoms from Poison Control Centers suggests that piperonyl butoxide adds to that risk.

Based on these findings, it is recommended that labeling advise handlers using products containing piperonyl butoxide as follows: Avoid contact with skin or eyes. Susceptible individuals may experience irritant or allergic type reactions. Persons with respiratory illness may experience difficulty breathing and should avoid use in enclosed spaces and consult their physician prior to use. ( Review of Pyrethrins Incident Reports  Second Revision, J. Blondell, D320300, 8/ 16/ 04)

10.0 UNCERTAINTIES AND RISK CHARACTERIZATION The dietary exposure analyses conservatively assume use of maximum application rates. The highly refined acute and chronic dietary exposure assessment for piperonyl butoxide could be refined further by additional residue data on the level of metabolites and parent in cereal grains and beans/ peas where the ratio of 2 as recommended by the HED MARC was used. In addition, monitoring data or field trial residues for field corn, sweet corn, and cottonseed could further refine the assessment.

The drinking water assessment focuses on the terrestrial agricultural uses of piperonyl butoxide since they are considered more likely to contaminate drinking water sources. The cranberry, mosquito adulticide and carp bait uses are not considered, although each has the potential to contaminate water, because EFED does not have standard methods for estimating drinking water contamination from these use patterns.

Inhalation risk estimates are conservatively based on a local or portal of entry effect ( i. e., laryngeal hyperplasia and metaplasia). The NOAEL for systemic inhalation effects is 30 times higher than the endpoint selected based on local effects.

Initial exposure estimates for the occupational and residential assessment are conservatively based use of maximum application rates provided in the master label. It was also assumed, based on the master label, that products for all applications are supported/ available in multiple forms i. e., Page 50 of 61 liquids, dust, wettable powders. However, given that the majority of piperonyl butoxide products are available as liquid formulations, scenarios involving handling and application of liquid formulations are likely to be more representative of actual exposure.

The SOP default occupational and residential unit exposures selected for each scenario were based on central tendency values from PHED. The mean exposure data from the NDETF study used to estimate exposures from indoor fogger release is comprehensive and should accurately represent likely exposures from total release foggers.

Uncertainties identified by BEAD regarding the NPMA survey data used to determine potential exposures to PCOs should also be noted. Regarding the robustness and validity of the NPMA survey data BEAD drew the following conclusions. Given that there are approximately 19,000 PCO firms in the U. S., it is highly unlikely that a sample size of 67 represents a statistically valid sample. The use of a retrospective survey methodology may have introduced errors in the data. Pesticide survey firms like Doane use a prospective survey instrument sent to growers in advance thus allowing them to keep detailed accounts of their pesticide usage in real time throughout the year. Despite its small size and retrospective methodology, however, the information collected is more robust than BEAD typically gets when asking questions of this nature. BEAD typically contacts 1 5 PCO's and asks chemical specific questions which may bias the responses if PCO's value the chemical under review. ( D. Brassard, D305276, 7/ 04) HED believes the NPMA survey provides reasonable estimates of average number of buildings treated per day by PCOs.

For pest control operator and mosquito abatement scenarios, assuming full day, long term application for each application method may significantly overestimate total exposure. Based on data on usage of likely piperonyl butoxide containing pesticides presented in the NPMA survey, this assumption would result in significant overestimate of exposure for PCOs. Similarly, assuming continuous usage of piperonyl butoxide containing pesticides for mosquito abatement applications would also significantly overestimate total exposure based on personal communication with mosquito control district officials regarding current usage of these products. However, piperonyl butoxide is used to control a large number and a wide variety of pests and labels do not restrict or preclude repeated applications or long term use. Given the potential for multiple applications and long term use for occupational handlers, inclusion of a repeated use/ long term exposure scenario for pest control operators and mosquito abatement is considered reasonable.

Application of dust with shaker can, bulb duster and power duster, a relevant and potentially significant exposure scenario for both residential and occupational exposures, was not assessed due to lack of dust specific or adequate surrogate data on inhalation exposure associated with this activity. Use of existing applicator data for surrogate exposure assumptions for this exposure scenario would likely underestimate potential risk HED did not conduct a quantitative assessment of potential exposure from indoor misters due to data limitations. However, HED recommends that the use restrictions, both general and Page 51 of 61 specific, prescribed by the master label be required for all labels for indoor misters that contain PBO. These restrictions include the following: general use restrictions  do not apply when other persons are present, do not apply when pets ( except fish) are present, remove or cover exposed food and water before application, remove or cover dishes, utensils, food processing equipment, and food preparation surfaces or wash them thoroughly before use, do not breathe dust, vapors, or spray mist; specific metered release application use restrictions  do not use in nurseries or rooms where infants, ill or aged persons are confined, do not place metering device directly over or within 8 feet of exposed foods, dishes, utensils, food processing equipment, and food handling or prepartion areas. It should be noted that a screening assessment of indoor misters was conducted for the pyrethrin risk assessment. HED believes the pyrethrin assessment provides support for the label restrictions listed above for indoor misters.

For outdoor automatic misters, the exposure durations used in the short term inhalation exposure ( 5 hours/ day for adults, 3 hours/ day for toddlers) represent the 95th percentile values for time spent outdoors at a restaurant/ picnic area ( USEPA, 1997). During this exposure period the individual is assumed to be exposed to the average air concentration following 2 spray events each lasting a period of either 1 minute or 30 seconds. Inhalation risks of concern are seen when exposure results from air concentrations after 2, 1 minute spray durations. Although this spray duration is considered reasonable, lower spray durations ( i. e., 20 or 30 second durations) may be more representative of actual system rates. Standard label language for use rates could provide a more refined risk assessment. Label language requiring systems to activate at times when people are not present ( i. e., EPA Reg. No. 1021 1785) or systems with motion detectors would also significantly reduce inhalation exposure. Risks were calculated based on automatic dispersions ( i. e., 2 6 pre set spray events per day) throughout the day. It was noted in the CSPA discussion paper that the systems can be manually activated by the homeowner. Although costs of re filling and service maintenance costs would likely deter homeowners from frequent or over use, label language indicating appropriate daily spray cycles should be considered.

11.0 DATA NEEDS 11.1 Product Chemistry Data Requirements Outstanding product chemistry data requirements for piperonyl butoxide Technical Grade Active Ingredients are listed for each individual registrant in Table 1 of the Product and Residue Chemistry Document ( T. Morton, D288366, 6/ 30/ 04). In addition, the Agency requires that the registrants of all products listed in Table 1 submit updated Confidential Statements of Formulation for all basic and alternate formulations on which the name of the producer or producers and the site( s) where the piperonyl butoxide TGAIs are produced are clearly identified. Page 52 of 61 11.2 Residue Chemistry Data Requirements C Label revisions and clarifications are required for some crops in order to reflect the use pattern parameters for which adequate residue data are available.

C Further analytical work to upgrade the previously submitted oral metabolism studies with ruminant and poultry. Representative egg, milk, and tissue samples from the dermal or oral ruminant/ poultry metabolism studies must be analyzed using the enforcement method or any preferred data collection method to determine whether the method( s) adequately recover Piperonyl butoxide residues of concern. Data are under review.

C Additional storage stability data for plant ( and processed) and livestock commodities to upgrade previously submitted studies or to support new studies.

C Data to support uses of piperonyl butoxide on foods stored in multi walled paper or cloth bags.

C A magnitude of the residue study with ruminants reflecting premise treatment. In addition, the registrants need to perform further analysis on milk samples from the dermal and oral studies.

C A magnitude of the residue study with poultry reflecting direct applications to laying hens using a 10% dust formulation.

C Magnitude of the residue studies reflecting preharvest uses on representative commodities of all crop groups ( and a few miscellaneous commodities) which are being supported for reregistration.

C Magnitude of the residue studies reflecting postharvest uses for all crops ( except potato and sweet potato) which are being supported for reregistration C Processing studies on apple, barley, coconut, corn ( field), fig, flax, oat, peanut, pineapple, plum, potato, rice, rye, sorghum, and wheat.

C A confined rotational crop study. A field accumulation study in rotational crops ( OPPTS 860.1900) is required if the level of the total radioactive residue in the confined rotational crops is equal to or exceeds 0.01 ppm at the desired rotational interval or at 12 months, and once the nature of the residue in the rotational crops is understood. Page 53 of 61 Tables 13 21  Residential Exposure and Risk Estimates Table 13. Piperonyl Butoxide Inhalation Exposure & MOEs for Residential Handler Activities Target Short and Intermediate Term MOE = 300 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Crop2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 1) 30 Indoor Residential Surface Spray 0.56 lb ai per 1000 ft2 1 home of avg area of 1600 sf 0.0004 10400 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 2) 30 Indoor Residential Crack & Crevice 2.2 lb ai per 1000 ft2 1 home of avg area of 1600 sf 0.0015 2700 Mixing/ Loading/ Applying Liquids for Garden hose end sprayer application ( 3) 11 Lawn 1 lb ai per acre 0.5 Acres per day 0.000079 51000 1Baseline inhalation unit exposures represent no respirator. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2Crops and use patterns are from the master label 3Application rates are based on maximum values provided in the master label Most application rates upon which the analysis is based are presented as lb ai/ A. In some cases, the application rate is based on applying a solution at concentrations specified by the label ( i. e., presented as lb ai/ gallon). 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ g unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = short term and intermediate term endpoint for inhalation; 4 mg/ kg/ day ( inhalation LOAEL)/ Daily Inhalation Dose. Target Short and Intermediate Term Inhalation MOE is 300. Target Long Term Inhalation MOE is 1000.

Table 14. Piperonyl Butoxide Inhalation Exposure & MOEs for Residential Handler Activities for Outdoor Automatic Mister ( 4) Application Rate ( lb PBO/ gal) Reservoir size ( gallons) System Maintenance ( tanks filled/ day) Daily Dose ( mg/ kg/ day) Acute ( Target MOE = 100) ST/ IT ( Target MOE = 300)

0.0384 55 1 0.0000362 17000000 110000 250 1 0.0001645 3800000 24000 1 Daily Dose ( mg/ kg/ day) = [ Application Rate ( lb PBO/ gal soln) * Unit Exposure ( 1.2 ug/ lb PBO handled) * Holding Tank Size ( gallons/ tank) * System Maint. ( tanks/ day) * Inhalation Abs. Factor ( 100%)] / [ CF ( 1000 ug/ mg) * Body Weight ( 70 kg)] 2 MOE = Acute NOAEL ( 630 mg/ kg/ day) / Daily Dose ( mg/ kg/ day) or ST/ IT LOAEL ( 3.91 mg/ kg/ day) / Daily Dose ( mg/ kg/ day)

Table 15. Piperonyl Butoxide Post application Inhalation Risks To Adults and Children Following Mosquito Adulticide Application  Acute Target MOE = 100 Exposed Individual Breathing Zone Concentration ( mg/ m3) Breathing Rate ( m3/ hr) Inhalation Dose ( mg/ kg/ day) 1 MOE Aerial Spray ( Fixed Wing and Rotary Aircraft) ( 1)

Adult 0.03 1.0 0.0009 740000 Child 0.03 0.8 0.004 160000 Truck Mounted ULV Sprayer ( 2)

Adult 0.3 1.0 0.005 75000 Table 15. Piperonyl Butoxide Post application Inhalation Risks To Adults and Children Following Mosquito Adulticide Application  Acute Target MOE = 100 Exposed Individual Breathing Zone Concentration ( mg/ m3) Breathing Rate ( m3/ hr) Inhalation Dose ( mg/ kg/ day) 1 MOE Page 54 of 61 Child 0.3 0.8 0014 20000 ID ( mg/ kg/ day) = Inhalation Dose = PDR/ BW PDR ( t) ( mg/ day) = (( AR t) ( lb ai/ A) BZC * BR * ED where: PDR = Potential Dose Rate  inhalation dose in breathing zone after spray application ( mg/ m3) AR = application rate lb/ ai per acre converted to mg/ m3 BZC = Breathing Zone Concentration ( mg/ m3)  from Ag Drift Model for aerial spray application; 1% of application rate for truck mounted ULV sprayer application BR = Breathing rate for adult or child ( m3/ hr) ( 1.0 m3/ hr adult, 0.8 m3/ hr child) BW = 70 kg for adult; 15 kg for toddler ED = Exposure Duration ( 2 hr/ day) MOE = Acute Inhalation NOAEL ( 630 mg/ kg/ day)/ Inhalation Dose ( mg/ kg/ day) MOEs are reported to two significant figures.

Table 16. Piperonyl Butoxide Post application Incidental Ingestion Risks to Toddlers Reentering Treated Lawns Hand to Mouth ( HTM), Object to Mouth ( OTM), Incidental Soil Ingestion ( SI), Aggregate  Short Term Target MOE = 100 Inputs Hand to Mouth ( 3) Object to Mouth ( 4) Soil Ingestion ( 5) Aggregate Max App Rate ( lb ai/ A) Hand Transfer ( ug/ cm2) Daily Oral Dose ( mg/ kg/ day) MOE Dislogeable Foliar Residue ( ug/ cm2) Daily Oral Dose ( m/ k/ d) MOE3 Soil Residue ( ug/ g) Daily Oral Dose ( m/ k/ d) MOE Aggregate MOE 1.0 0.56 0.015 6000 2.2 0.004 24000 0.00075 0.00005 > 1E+ 06 4800 1 DOD( mg/ kg/ day) = Daily Oral Dose ( PDR/ BW) BW = 15 kg for toddler Hand To Mouth Calculation PDR ( t) ( mg/ day) = ( HTF ( t) ( µ g/ cm2) * SEF * SA * Freq * ED/ 1000 ( µ g/ mg) where: PDR = Potential Dose Rate at time ( t) attributable for activity in a previously treated area ( mg/ day) HTE ( t) = Hand Transfer Efficiency at time t = 5% of Application Rate ( µ g/ cm2) SEF = Saliva Extraction Factor ( 50%) SA = Surface Area of Two Fingers ( 20 cm2) Freq = Frequency of Hand to Mouth Events ( 20) ED = Exposure Duration in hours ( 2 hr/ day) t = Postapplication Day on which exposure is being assessed ( day 0) MOE = Short Term Oral NOAEL ( 89 mg/ kg/ day)/ Daily Oral Dose ( mg/ kg/ day) Object to Mouth Calculation PDR ( t) ( mg/ day) = ( DFR ( t) ( µ g/ cm2) * SA/ 1000 ( µ g/ mg) where: PDR = Potential Dose Rate at time ( t) attributable for activity in a previously treated area ( mg/ day) DFR ( t)= Dislogeable Foliar Residue at time t = 20% of Application Rate ( µ g/ cm2) SA = Surface Area of grass or toy mouthed by toddler ( 25 cm2 day) t = Postapplication day on which exposure is being assessed ( day 0) MOE = Short Term Oral NOAEL ( 25 mg/ kg/ day)/[ Daily Oral Dose ( mg/ kg/ day) MOEs are reported to two significant figures Soil Ingestion Calculation PDR ( t) ( mg/ day) = ( SR t * IgR * CF1) where: PDR = Potential Dose Rate  nondietary ingestion rate from contact with treated surface ( mg/ day) SR t = Soil Residue on day " t" ( µ g/ g)

IgR = Ingestion Rate of soil ( mg/ day); ( 100 mg/ day) CF1 = Weight unit conversion factor ( 1E 6 g/ µ g) where: SR t = Application Rate ( µ g/ cm2) * 1/ cm * 0.67 cm3/ g soil [ 1/ cm is fraction of ai available in uppermost cm of soil] t = Postapplication Day on which exposure is being assessed, assumed to be day zero MOE = Short Term Oral NOAEL ( 25 mg/ kg/ day)/[ Daily Oral Dose ( mg/ kg/ day) MOEs are reported to two significant figures AggMOE= 1/( 1/ MOE HTM + 1/ MOE OTM + 1/ MOE SI) Page 55 of 61 Table 17. Piperonyl Butoxide Post application Incidental Ingestion Risks To Toddlers Playing on Vinyl Floor and Carpet after Treatment with Fogger Formulation  Short Term Target MOE = 100 Indoor Surface Indoor Surface Residue ( ug/ cm2) Hand Transfer Efficiency (%) Daily Oral Dose ( mg/ kg/ day) 1 MOE carpet ( 6) 10 13 0.021 4200 vinyl ( 7) 10 8 0.035 2600 1 DOD( mg/ kg/ day) = Daily Oral Dose = PDR/ BW PDR ( t) ( mg/ day) = ( ISR t) ( µ g/ cm2) * TE * SEF * SA * Freq * ED/ 1000 ( µ g/ mg) where: PDR = Potential Dose Rate on day of application ( mg/ day) ISR = Indoor Surface Residue ( µ g/ cm2) at maximum AR of 0.033 lbs ai/ 1000 ft2 HTE = Hand Transfer Efficiency  transfer of ( 13% for carpet; 8% for vinyl) SEF = Saliva Extraction Factor ( 50%) SA = Surface Area of Two Fingers ( 20 cm2) Freq = Frequency of Hand to Mouth Events ( 20) ED = Exposure Duration in hours = 2 hr/ day t = Postapplication Day on which exposure is being assessed ( day 0) BW = 15 kg for toddler MOE = Short Term Oral NOAEL ( 89 mg/ kg/ day)/ Daily Oral Dose ( mg/ kg/ day) MOEs are reported to two significant figures.

Table 18. Piperonyl Butoxide Post application Incidental Ingestion Risks To Toddlers Playing with Pets after Treatment with Spray Formulation  Short Term Target MOE = 100 Application Method AR ( mg ai/ cm2) Transferable Residue (%) Daily Oral Dose ( mg/ kg/ day) 1 MOE Aerosol Spray ( 8) 1.14 20 0.15 600 1 DOD( mg/ kg/ day) = Daily Oral Dose = PDR/ BW PDR ( t) ( mg/ day) = (( AR t) ( mg ai/ animal) * F)/ SA pet ) * SEF * SA hands * Freq where: PDR = Potential Dose Rate  nondietary ingestion dose from contact with treated pets ( mg/ day) AR = Application Rate or amount applied to animal in a single treatment ( mg ai/ animal) = ½ of 16 oz spray container with maximum of 3% ai per 6000 cm2/ animal F AR = Fraction of Application Rate available for dermal contact as transferable residue ( 20%) SA pet = Surface Area of a treated dog ( 6000 cm2/ animal) t = Time After Application ( 0 days) SEF = Saliva Extraction Factor ( 50%) SA hands = Surface Area of the hands ( 20 cm2) Freq = Hand to Mouth Events ( 1 event/ day) BW = 15 kg for toddler MOE = Short Term Oral NOAEL ( 89 mg/ kg/ day)/ Daily Oral Dose ( mg/ kg/ day) MOEs are reported to two significant figures.

Table 19. Piperonyl Butoxide Inhalation Risks To Adults and Children During and After Indoor Space Spray Application  Acute Target MOE = 100 Application Method Exposed Individual Breathing Zone Concentration ( mg/ m3) Breathing Rate ( m3/ hr) Inhalation Dose ( mg/ kg/ day) 1 MOE Aerosol Spray ( 9) Adult 5.8 1.0 0.09 3800 Child 5.8 0.8 0.28 1000 Inhalation Dose ( mg/ kg/ day) = PDR/ BW PDR ( t) ( mg/ day) = (( AR t) ( lb ai/ A) BZC * BR * ED where: PDR = Potential Dose Rate  inhalation dose in breathing zone after spray application ( mg/ m3) AR = application rate  1 16 oz can containing 2.5% ai applied to a 16 x 16 x 8 ft room BZC = Breathing Zone Concentration ( mg/ m3)  measured air concentration from NDETF study adjusted to reflect a likely maximum application rate BR = Breathing rate for adult or child ( m3/ hr) ( 1.0 m3/ hr adult, 0.8 m3/ hr child) BW = 70 kg for adult; 15 kg for toddler ED = Exposure Duration ( 2 hr/ day) 34 Page 56 of 61 MOE = Acute Inhalation NOAEL ( 630 mg/ kg/ day)/ Inhalation Dose ( mg/ kg/ day) MOEs are reported to two significant figures.

Table 20. Outdoor Automatic Mister Residential Outdoor Bystander   Acute Inhalation Exposure and Risk Estimates ( 10)

Population Sub Group Application Rate ( lb PBO/ ft3 min) Air Concentration1 ( mg PBO/ m3) Inhalation Rate ( m3/ hour) Daily Dose2 ( mg/ kg/ day) MOE3 ( Target MOE = 100)

Adult 0.000000469 7.50974 1 0.00179 350000 Toddler 0.000000469 7.50974 0.7 0.00585 110000 1 Air Concentration ( mg PBO/ m3) = Application Rate ( lb PBO/ ft3 min) * CF ( 454000 mg/ lb) * CF ( 35 ft3/ m3) * # Spray Events ( 1) * Spray Duration ( 1 minute) 2 Daily Dose ( mg/ kg/ day) = [ Air Concentration ( mg PBO/ m3) * Inhalation Rate ( m3/ hr) * Inhalation Abs. Factor ( 100%) * Exposure Duration ( 0.0167 hrs/ day)] / Body Weight ( kg) 3 MOE = Acute NOAEL ( 630 mg/ kg/ day) / Daily Dose ( mg/ kg/ day)

Table 21. Outdoor Automatic Mister Residential Outdoor Bystander   Short Term Inhalation Exposure and Risk Estimates ( 11)

Population Sub Group Application Rate ( lb PBO/ ft3 min) Inhalation Rate ( m3/ hour) Spray Duration ( minutes) Air Concentration1 ( mg PBO/ m3) Daily Dose2 ( mg/ kg/ day) MOE3 ( Target MOE = 300)

Adult 0.000000469 1 1 0.150195 0.010728 360 0.5 0.0750974 0.005364 730 Toddler 0.000000469 0.7 1 0.150195 0.0210273 190 0.5 0.0750974 0.0105136 370 1 Air Concentration ( mg PBO/ m3) = [ Application Rate ( lb PBO/ ft3 min) * CF ( 454000 mg/ lb) * CF ( 35 ft3/ m3) * # Spray Events ( 2) * Spray Duration ( min)]/ Dilution Factor ( 100) 2 Daily Dose ( mg/ kg/ day) = [ Air Concentration ( mg PBO/ m3) * Exposure Duration ( hrs/ day) * Inhalation Rate ( m3/ hr) * Inhalation Abs. Factor ( 100%)]/ Body Weight ( kg) 3 MOE = ST/ IT NOAEL ( 3.91 mg/ kg/ day) / Daily Dose ( mg/ kg/ day)

Tables 19 23   Occupational Exposure and Risk Estimates Table 22. Piperonyl Butoxide Inhalation Exposure & MOEs for Agricultural Handler Activities Target Short and Intermediate Term MOE = 300 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Crop2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalatio n MOE6 Mixer/ Loader Mixing/ Loading Liquids for Aerial and/ or Chemigation application ( 1) 1.2 Field Crops 0.50 lb ai/ acre 350 Acres/ day 0.003 1300 High Acre Crops 1200 A/ day 0.01 380 Mixing/ Loading Liquids for Groundboom application ( 2) 1.2 Field Crops 0.5 lb ai/ acre 80 Acres/ day 0.00069 5800 Mixing/ Loading Liquids for Airblast application ( 3) 1.2 Field Crops 0.5 lb ai per acre 40 Acres/ day 0.00021 19000 Mixing/ Loading Wettable Powders for Aerial application and/ or Chemigation application ( 4) 43 Field Crops 0.50 lb ai/ acre 350 Acres/ day 0.11 40 0.06 lb ai/ acre 0.013 310 High Acre Crops 0.50 lb ai/ acre 1200 Acres/ day 0.37 11 0.018 lb ai/ acre 0.013 300 Table 22. Piperonyl Butoxide Inhalation Exposure & MOEs for Agricultural Handler Activities Target Short and Intermediate Term MOE = 300 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Crop2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalatio n MOE6 Page 57 of 61 Mixing/ Loading Wettable Powders for Groundboom application ( 5) 43 Field Crops 0.50 lb ai/ acre 80 Acres/ day 0.025 160 0.25 lb ai/ acre 0.012 325 Mixing/ Loading Wettable Powders for Airblast application ( 6) 43 Field Crops 0.50 lb ai/ acre 40 Acres/ day 0.012 330 Applicator Sprays for Aerial application ( 7) 0.07 Field Crops 0.50 lb ai/ acre 350 Acres/ day 0.00018 23000 Sprays for Groundboom applic ( 8) 0.74 Field Crops 0.50 lb ai/ acre 80 Acres/ day 0.00042 9500 Sprays for Airblast application ( 9) 4.5 Field Crops 0.50 lb ai/ acre 40 Acres/ day 0.0013 3100 Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquids for High Pressure Handwand application ( 10) 120 Greenhouse 1.5 lb ai/ acre 10 Acres/ day 0.026 160 0.07 lb ai/ acre 0.012 330 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand or Backpack Sprayer application ( 11) 30 Greenhouse 1.5 lb ai/ acre 2 Acres/ day 0.0013 3100 Mixing/ Loading/ Applying Wettable Powders for Low Pressure Handwand or Backpack Sprayer application ( 12) 1100 Greenhouse 1.5 lb ai/ acre 2 Acres/ day 0.05 85 0.4 lb ai/ acre 0.013 320 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand or Backpack Sprayer application ( 13) 30 Outdoor Premise & Equipment 1 lb lb ai/ acre 2 Acres/ day 0.0009 4700 Flagger Flagging for Spray application ( 14) 0.35 Field Crops 0.5 lb ai per acre 350 Acres per day 0.00088 4600 1Baseline inhalation unit exposures represent no respirator. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2Crops and use patterns are from the master label 3Application rates are based on maximum values provided in the master label Most application rates upon which the analysis is based are presented as lb ai/ A. In some cases, the application rate is based on applying a solution at concentrations specified by the label ( i. e., presented as lb ai/ gallon). 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ g unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = short term and intermediate term endpoint for inhalation; 4 mg/ kg/ day ( inhalation LOAEL)/ Daily Inhalation Dose. Target Short and Intermediate Term Inhalation MOE is 300. Target Long Term Inhalation MOE is 1000.

Table 23 Piperonyl Butoxide Inhalation Exposure & MOEs for Residential Handler Activities for Outdoor Automatic Mister ( 4)

Application Rate ( lb PBO/ gal) Reservoir size ( gallons) System Maintenance ( tanks filled/ day) Daily Dose1 ( mg/ kg/ day) Acute ( Target MOE = 100) ST/ IT ( Target MOE = 300) Page 58 of 61 0.0384 55 5 0.0002534 3500000 22000 250 5 0.0011516 770000 4800 1 Daily Dose ( mg/ kg/ day) = [ Application Rate ( lb PBO/ gal soln) * Unit Exposure ( 1.2 ug/ lb PBO handled) * Holding Tank Size ( gallons/ tank) * System Maint. ( tanks/ day) * Inhalation Abs. Factor ( 100%)] / [ CF ( 1000 ug/ mg) * Body Weight ( 70 kg)] 2 MOE = Acute NOAEL ( 630 mg/ kg/ day) / Daily Dose ( mg/ kg/ day) or ST/ IT LOAEL ( 3.91 mg/ kg/ day) / Daily Dose ( mg/ kg/ day)

Table 24. Piperonyl Butoxide Inhalation Exposure & MOEs for Pesticide Control Operator Activities Target Short and Intermediate Term MOE = 300 Target Long Term MOE = 1000 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Use2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application  Surface Spray ( 1) 30 Indoor Surface Spray 0.56 lb ai per 1000 sf 7 buildings avg area treated  1600 sf 0.0034 1500 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application  Crack & Crevice Treatment ( 2) 30 Indoor Crack & Crevice 2.2 lb ai per 1000 sf 7 buildings avg area treated  1600 sf 0.12 380 1 building avg area treated  1600 sf 0.0004 2700 Mixing/ Loading/ Applying Wet Powders for Low Pressure Handwand application  Surface Spray ( 3) 1100 Indoor Surface Spray 0.56 lb ai per 1000 sf 7 buildings avg area treated  1600 sf 0.113 40 1 building avg area treated  1600 sf 0.0015 280 0.16 lb ai per 1000 sf 1 building avg area treated  1600 sf 0.004 1020 Mixing/ Loading/ Applying Wettable Powders for Low Pressure Handwand application  Crack & Crevice Treatment ( 4) 1100 Indoor Crack & Crevice 2.2 lb ai per 1000 ft2 7 buildings avg area treated  1600 sf 0.385 10 1 building avg area treated  1600 sf 0.055 70 0.16 lb ai per 1000 ft2 1 building avg area treated  1600 sf 0.004 1020 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand and Backpack Sprayer application ( 5) 30 Outdoor Premise 3.5 lb ai per acre 2 acres per day 0.003 1300 Mixing/ Loading/ Applying Liquids for Handgun ( lawn) Sprayer application ( 6) 1.8 Lawn Care 1 lb ai per acre 5 Acres per day 0.00013 31000 Mixing/ Loading Liquids for Groundboom application ( 7) 1.2 Golf course 1 lb ai per acre 40 Acres per day 0.0007 5800 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand and Backpack Sprayer application ( 8) 30 Stored Grain 0.5 lb ai per 1000 ft2 5 bins per day 1000 ft2 per bin 0.0011 3700 Table 24. Piperonyl Butoxide Inhalation Exposure & MOEs for Pesticide Control Operator Activities Target Short and Intermediate Term MOE = 300 Target Long Term MOE = 1000 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Use2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Page 59 of 61 Mixing/ Loading/ Applying Liquids for High Pressure Handwand application ( 9) 120 Stored Grain 0.5 lb ai per 1000 ft2 5 bins per day 1000 ft2 per bin 0.0043 930 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 10) 30 Stored Produce 0.1 lb ai per 1000 ft2 5 storage facilities per day 10000 ft2 per facility 0.0021 1900 Applicator Sprays for Groundboom application ( 11) 0.74 Golf course 1 lb ai per acre 40 Acres per day 0.0004 9500 Sprays for Aerosol Application ( 12) 1300 Indoor Space Spray 0.025 lb ai per 16 oz can 7 homes per day 2 cans per home 0.0065 615 0.012 lb ai per 16 oz can 0.0033 1200 1Baseline inhalation unit exposures represent no respirator. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2 Use patterns are from the master label 3Application rates are based on maximum values provided in the master label Most application rates upon which the analysis is based are presented as lb ai/ A. In some cases, the application rate is based on applying a solution at concentrations specified by the label ( i. e., presented as lb ai/ gallon). 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ g unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = short term and intermediate term endpoint for inhalation; 4 mg/ kg/ day ( inhalation LOAEL)/ Daily Inhalation Dose. Target Short and Intermediate Term Inhalation MOE is 300. Target Long Term Inhalation MOE is 1000.

Table 25. Piperonyl Butoxide Inhalation Exposure & MOEs for Mosquito Abatement Activities Target Short and Intermediate Term MOE = 300 Target Long Term MOE = 1000 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Use2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Mixer/ Loader Mixing/ Loading Liquids for Aerial application ( 1) 1.2 Mosquito Control 0.08 lb ai per acre 7500 Acres per day 0.0100 390 0.03 lb ai per acre 0.0040 1000 Mixing/ Loading Liquids for ULV truck mounted spray application ( 2) 1.2 Mosquito Control 0.08 lb ai per acre 3000 Acres per day 0.0041 970 Mixer/ Loader/ Applicator Sprays for ULV truck mounted spray ( Airblast Surrogate Unit Exposure) ( 3) 4.5 ( Open Cab) Mosquito control 0.08 lb ai per acre 3000 Acres per day 0.0150 260 0.45 ( Closed Cab) 0.0004 2600 Table 25. Piperonyl Butoxide Inhalation Exposure & MOEs for Mosquito Abatement Activities Target Short and Intermediate Term MOE = 300 Target Long Term MOE = 1000 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Use2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Page 60 of 61 Mixing/ Loading/ Applying Liquids for Backpack sprayer application ( 4) 30 Mosquito Control 0.08 lb ai per acre 2 acres per day 0.00007 58000 1Baseline inhalation unit exposures represent no respirator. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2Use patterns are from the master label 3Application rates are based on maximum values provided in the master label. Most application rates upon which the analysis is based are presented as lb ai/ A. In some cases, the application rate is based on applying a solution at concentrations specified by the label ( i. e., presented as lb ai/ gallon). 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ g unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = short term and intermediate term endpoint for inhalation; 4 mg/ kg/ day ( inhalation LOAEL)/ Daily Inhalation Dose. Target Short and Intermediate Term Inhalation MOE is 300. Target Long Term Inhalation MOE is 1000.

Table 26. Piperonyl Butoxide Inhalation Exposure & MOEs for Pet Groomer and Veterinarian Activities Target Short and Intermediate Term MOE = 300 Long Term MOE = 1000 Exposure Scenario Inhalation Unit Exposure ( µ g/ lb ai) 1 Use2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Aerosol Application 1300 Pet Spray 0.03 lb ai per 16 oz can 8 pets treated per day ½ can of spray per pet 0.002 1800 1Baseline inhalation unit exposures represent no respirator. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2 Use pattern is from the master label 3Application rates are based on maximum values provided in the master label 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ g unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = short term and intermediate term endpoint for inhalation; 4 mg/ kg/ day ( inhalation LOAEL)/ Daily Inhalation Dose. Target Short and Intermediate Term Inhalation MOE is 300. Target Long Term Inhalation MOE is 1000. Page 61 of 61 O O O O O O PBO prop 1 one " M16"

O O O O PBO prop 1 one benzaldehyde " M11"

O O OH O O O O OH 5[ 2( 2 butoxyethoxy) hydroxymethyl] 6 carboxy 1,3 benzodioxole " M8"

O O O O O PBO alcohol dimer PBO PBO Degradation: Aerobic Soil Pathway 2 PBO acid PBO alcohol ( Soil Photodeg. only) Attachment 1


[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Notices]
[Page 964]
[FR Doc No: 2022-00082]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9060-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed December 23, 2021 10 a.m. EST Through January 3, 2022 10 a.m. EST
Pursuant to 40 CFR 1506.9

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20220000, Final, NMFS, FL, Final Amendment 53 to the Fishery
Management Plan for the Reef Fish Fishery in the Gulf of Mexico, Review
Period Ends: 02/07/2022, Contact: Peter Hood<PHONE_NUMBER>.
EIS No. 20220001, Final, USPS, DC, Next Generation Delivery Vehicle
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202-268-4570.
EIS No. 20220002, Final, USN, CA, Point Mugu Sea Range, Review Period
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Amended Notice

EIS No. 20210172, Draft Supplement, BR, CA, Sites Reservoir Project
Revised Draft Environmental Impact Report/Supplemental Draft
Environmental Impact Statement, Comment Period Ends: 01/28/2022,
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    Revision to FR Notice Published 11/12/2021; Extending the Comment
Period from 01/11/2022 to 01/28/2022.

    Dated: January 3, 2022.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2022-00082 Filed 1-6-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Rules and Regulations]
[Pages 76736-76738]
[FR Doc No: 2013-30230]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-1054; Notice No. 25-513-SC]

Special Conditions: Bombardier Inc., Models BD-500-1A10 and BD-
500-1A11 Series Airplanes; Side Stick Controllers: Pilot Strength,
Pilot Control Authority, and Pilot Control

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Bombardier Inc.
Models BD-500-1A10 and BD-500-1A11 series airplanes. These airplanes
will have a novel or unusual design feature associated with side stick
controllers for pitch and roll control instead of conventional wheels
and columns. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: The effective date of these special conditions is December 19,

2013. We must receive your comments by February 3, 2014.

ADDRESSES: Send comments identified by docket number FAA-2013-1054
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/ gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: Joe Jacobsen, FAA, Airplane and
Flightcrew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The substance of these special conditions
has been subject to the public comment process in several prior
instances with no substantive comments received. The FAA therefore
finds that good cause exists for making these special conditions
effective upon publication in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive on or before the closing
date for comments. We may change these special conditions based on the
comments we receive.

Background

    On December 10, 2009, Bombardier Inc. applied for a type
certificate for their new Models BD-500-1A10 and BD-500-1A11 series
airplanes (hereafter collectively referred to as ``C-series.'' The C-
series airplanes are swept-wing monoplanes with a pressurized cabin.
They share an identical supplier base and significant common design
elements. The fuselage is aluminum alloy material, blended double-
bubble fuselage, sized for nominal 5-abreast seating. Each airplane's
powerplant consists of two under wing Pratt and Whitney PW1524G ultra-
high bypass, geared turbofan engines. Flight controls are fly-by-wire
flight with two passive/uncoupled side sticks. Avionics includes five
landscape primary cockpit displays. The dimension of the airplanes
encompass a wingspan of 115 feet; a height of 37.75 feet; and a length
of 114.75 feet for the Model BD-500-1A10 and a length of 127 feet for
the Model BD-500-1A11. Passenger capacity is designated as 110 for the
Model BD-500-1A10 and 125 for the Model BD-500-1A11. Maximum takeoff
weight is 131,000 pounds for the Model BD-500-1A10 and 144,000 pounds
for the Model BD-500-1A11. Maximum takeoff thrust is 21,000 pounds for
the Model BD-500-1A10 and 23,300 pounds for the Model BD-500-1A11.
Range is 3,394 miles (5,463 kilometers) for both models of airplanes.
Maximum operating altitude is 41,000 feet for both model airplanes.
    The Bombardier C-series airplanes will use side stick controllers
for pitch and roll control. Regulatory requirements pertaining to
conventional wheel and column, such as pilot strength and
controllability, are not directly applicable for the side stick. In
addition, pilot control authority may be uncertain because the side
sticks are not mechanically interconnected as with conventional wheel
and column controls.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.17, Bombardier Inc. must show that the C-series airplanes meet
the applicable provisions of 14 CFR part 25 as amended by Amendments
25-1 through 25-129 thereto.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the C-series airplanes because of a
novel or unusual design feature, special conditions are prescribed
under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the C-series airplanes must comply with the fuel vent and
exhaust emission requirements of 14 CFR part 34 and the noise
certification requirements of 14 CFR part 36, and the FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The C-series airplanes will incorporate the following novel or
unusual design features: Side stick controllers for pitch and roll
control, which are not mechanically interconnected as with conventional
wheel and column controls. These airplanes also have a fly-by-wire
electronic flight control system. This system provides an electronic
interface between the pilot's flight controls and the flight control
surfaces for both normal and failure states, and it generates the
actual surface commands that provide for stability augmentation and
control about all three airplane axes. In addition, pilot control
authority may be uncertain, because the side sticks are not
mechanically interconnected as with conventional wheel and column
controls.

Discussion

    Current FAA regulations do not specifically address the use of side
stick controllers for pitch and roll control.

The unique features of the side stick must therefore be demonstrated
through flight and simulator tests to have suitable handling and
control characteristics when considering the following:
    1. The handling qualities tasks/requirements of the C-series
airplanes special conditions and other part 25 stability, control, and
maneuverability requirements, including the effects of turbulence.
    2. General ergonomics: Arm rest comfort and support, local freedom
of movement, displacement angle suitability, and axis harmony.
    3. Inadvertent input in turbulence.
    4. Inadvertent pitch-roll cross talk.
    These requirements are elaborated upon in these special conditions,
which contain the additional safety standards that the Administrator
considers necessary to establish a level of safety equivalent to that
established by the existing airworthiness standards.
    The FAA Handling Qualities Rating Method (HQRM) in Appendix 5 of
Advisory Circular 25-7C, Flight Test Guide for Certification of
Transport Category Airplanes, may be used to show compliance.

Applicability

    As discussed above, these special conditions are applicable to the
Bombardier Models BD-500-1A10 and BD-500-1A11 series airplanes. Should
Bombardier Inc. apply at a later date for a change to the type
certificate to include another model incorporating the same novel or
unusual design feature, the special conditions would apply to that
model as well.

Conclusion

    This action affects only certain novel or unusual design features
on two model series of airplanes. It is not a rule of general
applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, the FAA has determined
that prior public notice and comment are unnecessary, and good cause
exists for adopting these special conditions upon publication in the
Federal Register. The FAA is requesting comments to allow interested
persons to submit views that may not have been submitted in response to
the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Bombardier Inc. Models BD-500-1A10
and BD-500-1A11 series airplanes.
    In the absence of specific requirements for side stick controllers,
the following apply:
    1. Pilot strength: In lieu of the ``strength of pilots'' limits
shown in Sec.  25.143(c) for pitch and roll, and in lieu of specific
pitch force requirement of Sec. Sec.  25.145(b) and 25.175(d), it must
be shown that the temporary and maximum prolonged force levels for the
side stick controllers are suitable for all expected operating
conditions and configurations, whether normal or non-normal.
    2. Pilot control authority: The electronic side stick controller
coupling design must provide for corrective and/or overriding control
inputs by either pilot with no unsafe characteristics. Annunciation of
the controller status must be provided and must not be confusing to the
flightcrew.
    3. Pilot control: It must be shown by flight tests that the use of
side stick controllers does not produce unsuitable pilot-in-the-loop
control characteristics when considering precision path control/tasks
and turbulence. In addition, pitch and roll control force and
displacement sensitivity must be compatible, so that normal inputs on
one control axis will not cause significant unintentional inputs on the
other.

    Issued in Renton, Washington, on December 12, 2013.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-30230 Filed 12-18-13; 8:45 am]
BILLING CODE 4910-13-P


367 Environmental Protection Agency § 799.9380 Pharmakologie und Experimentelle Pathologie. 247: 367 ( 1964). ( 20) Spark, C. and Dawson, A. B. The order and time of appearance of centers of ossification in the fore and hind limbs of the albino rat, with special reference to the possible influence of the sex factor. American Journal of Anatomy. 41: 411   445 ( 1928). ( 21) Staples, R. E. Detection of visceral alterations in mammalian fetuses. Teratology. 9( 3): A37   A38 ( 1974). ( 22) Staples, R. E. and Schnell, V. L. Refinements in rapid clearing technique in the KOH   alizarin red S method for fetal bone. Stain Technology. 39: 61   63 ( 1964). ( 23) Strong, R. M. The order time and rate of ossification of the albino rat ( mus norvegicus albinus) skeleton. American Journal of Anatomy. 36: 313   355 ( 1928). ( 24) Stuckhardt, J. L. and Poppe, S. M. Fresh visceral examination of rat and rabbit fetuses used in teratogenicity testing. Teratogenesis, Carcinogenesis, and Mutagenesis. 4: 181   188 ( 1984). ( 25) Van Julsingha, E. B. and Bennett, C. G. Eds. Neubert, D., Merker, H. J., and Kwasigroch, T. E. A dissecting procedure for the detection of anomalies in the rabbit foetal head. Methods in Prenatal Toxicology ( University of Chicago, Chicago, IL, 1977) pp. 126   144. ( 26) Whitaker, J. and Dix, D. M. Doublestaining for rat foetus skeletons in teratological studies. Laboratory Animals. 13: 309   310 ( 1979). ( 27) Wilson, J. G. Eds. Wilson, J. G. and Warkany, J. Embryological considerations in teratology. Teratology: Principles and Techniques ( University of Chicago, Chicago, IL, 1965) pp. 251   277.

§ 799.9380 TSCA reproduction and fertility effects.

( a) Scope. This section is intended to meet the testing requirements under section 4 of the TSCA. This section is for two generation reproduction testing and is designed to provide general information concerning the effects of a test substance on the integrity and performance of the male and female reproductive systems, including gonadal function, the estrous cycle, mating behavior conception, gestation, parturition lactation, and weaning, and on the growth and development of the offspring The study may also provide information about the effects of the test substance on neonatal morbidity, mortality target organs in the offspring, and preliminary data on prenatal and postnatal developmental toxicity and serve as a guide for subsequent tests. Additionally, since the study design includes in utero as well as postnatal exposure this study provides the opportunity to examine the susceptibility of the immature/ neonatal animal. ( b) Source. The source material used in developing this TSCA test guideline is the OPPTS harmonized test guideline 870.3800 ( February 1996 Public Draft). This source is available at the address in paragraph ( g) of this section. ( c) Good laboratory practice standards. The study shall be conducted in compliance with 40 CFR part 792   Good Laboratory Practice Standards. ( d) Principle of the test method. The test substance is administered to parental ( P) animals prior to and during their mating, during the resultant pregnancies, and through the weaning of their F1 offspring. The substance is then administered to selected F1 offspring during their growth into adulthood mating, and production of an F2 generation, until the F2 generation is weaned. ( e) Test procedures   ( 1) Animal selection   ( i) Species and strain. The rat is the most commonly used species for testing. If another mammalian species is used, the tester shall provide justification reasoning for its selection, and appropriate modifications will be necessary. Healthy parental animals, which have been acclimated to laboratory conditions for at least 5 days and have not been subjected to previous experimental procedures, should be used. Strains of low fecundity shall not be used. ( ii) Age. Parental ( P) animals shall be 5 to 9 weeks old at the start of dosing. The animals of all test groups should be of uniform weight, age, and parity as nearly as practicable, and should be representative of the species and strain under study. ( iii) Sex. ( A) For an adequate assessment of fertility, both males and females shall be studied. ( B) The females shall be nulliparous and nonpregnant. ( iv) Number of animals. Each control group shall contain a sufficient number of mating pairs to yield approximately 20 pregnant females. Each test group shall contain a similar number of mating pairs.

VerDate Aug< 1,> 2002 13: 31 Aug 02, 2002 Jkt 197164 PO 00000 Frm 00367 Fmt 8010 Sfmt 8010 Y:\ SGML\ 197164T. XXX pfrm15 PsN: 197164T OPPT 2003 0010 0008 RECEIVED OPPT NCIC 2003 MAR11 5: 03PM 368 40 CFR Ch. I ( 7   1   02 Edition) § 799.9380 ( v) Identification of animals. Each animal shall be assigned a unique identification number. For the P generation, this should be done before dosing starts. For the F1 generation, this should be done for animals selected for mating; in addition, records indicating the litter of origin shall be maintained for all selected F1 animals. ( 2) Administration of test and control substances   ( i) Dose levels and dose selection ( A) At least three dose levels and a concurrent control shall be used. Healthy animals should be randomly assigned to the control and treatment groups, in a manner which results in comparable mean body weight values among all groups. The dose levels should be spaced to produce a gradation of toxic effects. Unless limited by the physical/ chemical nature or biological properties of the test substance, the highest dose should be chosen with the aim to induce some reproductive and/ or systemic toxicity but not death or severe suffering. In the case of parental mortality, this should not be more than approximately 10%. The intermediate dose levels should produce minimal observable toxic effects. The lowest dose level should not produce any evidence of either systemic or reproductive toxicity ( i. e., the no observed adverse effect level, NOAEL) or should be at or near the limit of detection for the most sensitive endpoint. Two or four fold intervals are frequently optimal for spacing the dose levels, and the addition of a fourth test group is often preferable to using very large intervals ( e. g., more than a factor of 10) between dosages. ( B) It is desirable that additional information on metabolism and pharmacokinetics of the test substance be available to demonstrate the adequacy of the dosing regimen. This information should be available prior to testing ( C) The highest dose tested should not exceed 1,000 mg/ kg/ day ( or 20,000 ppm in the diet), unless potential human exposure data indicate the need for higher doses. If a test performed at the limit dose level, using the procedures described for this study, produces no observable toxicity and if an effect would not be expected based upon data from structurally related compounds, then a full study using three dose levels may not be considered necessary. ( ii) Control group. ( A) A concurrent control group shall be used. This group shall be an untreated or sham treated group or a vehicle control group if a vehicle is used in administering the test substance. ( B) If a vehicle is used in administering the test substance, the control group shall receive the vehicle in the highest volume used. ( C) If a vehicle or other additive is used to facilitate dosing, consideration should be given to the following characteristics Effects on the absorption, distribution, metabolism, or retention of the test substance; effects on the chemical properties of the test substance which may alter its toxic characteristics and effects on the food or water consumption or the nutritional status of the animals. ( D) If a test substance is administered in the diet and causes reduced dietary intake or utilization, the use of a pair fed control group may be considered necessary. ( iii) Route of administration. ( A) The test substance is usually administered by the oral route ( diet, drinking water, or gavage). ( B) If administered by gavage or dermal application, the dosage administered to each animal prior to mating and during gestation and lactation shall be based on the individual animal body weight and adjusted weekly at a minimum. ( C) If another route of administration is used, for example, when the route of administration is based upon the principal route of potential human exposure the tester should provide justification and reasoning for its selection and appropriate modifications may be necessary. Care should be taken to minimize stress on the maternal animals and their litters during gestation and lactation. ( D) All animals should be dosed by the same method during the appropriate experimental period. ( iv) Dosing schedule. ( A) The animals should be dosed with the test substance on a 7 days a week basis. ( B) Daily dosing of the parental ( P) males and females shall begin when they are 5 to 9 weeks old. Daily dosing VerDate Aug< 1,> 2002 13: 31 Aug 02, 2002 Jkt 197164 PO 00000 Frm 00368 Fmt 8010 Sfmt 8010 Y:\ SGML\ 197164T. XXX pfrm15 PsN: 197164T 369 Environmental Protection Agency § 799.9380 of the F1 males and females shall begin at weaning. For both sexes ( P and F1), dosing shall be continued for at least 10 weeks before the mating period. ( C) Daily dosing of the P and F1 males and females shall continue until termination. ( 3) Mating procedure   ( i) Parental. ( A) For each mating, each female shall be placed with a single randomly selected male from the same dose level ( 1: 1 mating until evidence of copulation is observed or either 3 estrous periods or 2 weeks has elapsed. Animals should be separated as soon as possible after evidence of copulation is observed. If mating has not occurred after 2 weeks or 3 estrous periods, the animals should be separated without further opportunity for mating. Mating pairs should be clearly identified in the data. ( B) Vaginal smears shall be collected daily and examined for all females during mating, until evidence of copulation is observed. ( C) Each day, the females shall be examined for presence of sperm or vaginal plugs. Day 0 of pregnancy is defined as the day a vaginal plug or sperm are found. ( ii) F1 mating. For mating the F1 offspring at least one male and one female should be randomly selected from each litter for mating with another pup of the same dose level but different litter to produce the F2 generation. ( iii) Second mating. In certain instances such as poor reproductive performance in the controls, or in the event of treatment related alterations in litter size, the adults may be remated to produce an F1b or F2b litter If production of a second litter is deemed necessary in either generation, the dams should be remated approximately 1   2 weeks following weaning of the last F1a or F2a litter. ( iv) Special housing. After evidence of copulation, animals that are presumed to be pregnant shall be caged separately in delivery or maternity cages. Pregnant animals shall be provided with nesting materials when parturition is near. ( v) Standardization of litter sizes. ( A) Animals should be allowed to litter normally and rear their offspring to weaning. Standardization of litter sizes is optional. ( B) If standardization is performed, the following procedure should be used. On day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, four males and four females per litter or five males and five females per litter. Selective elimination of pups, i. e. based upon body weight, is not appropriate. Whenever the number of male or female pups prevents having four ( or five) of each sex per litter, partial adjustment ( for example, five males and three females, or four males and six females is acceptable. Adjustments are not appropriate for litters of eight pups or less. ( 4) Observation of animals   ( i) Parental ( A) Throughout the test period, each animal shall be observed at least once daily, considering the peak period of anticipated effects after dosing. Mortality, moribundity, pertinent behavioral changes, signs of difficult or prolonged parturition, and all signs of overt toxicity shall be recorded at this cageside examination. In addition, thorough physical examinations should be conducted weekly on each animal. ( B) Parental animals ( P and F1) shall be weighed on the first day of dosing and weekly thereafter. Parental females ( P and F1) should be weighed at a minimum on approximately gestation days 0, 7, 14, and 21, and during lactation on the same days as the weighing of litters. ( C) During the premating and gestation periods, food consumption shall be measured weekly at a minimum. Water consumption should be measured weekly at a minimum if the test substance is administered in the water. ( D) Estrous cycle length and pattern should be evaluated by vaginal smears for all P and F1 females during a minimum of 3 weeks prior to mating and throughout cohabitation; care should be taken to prevent the induction of pseudopregnancy. ( E) For all P and F1 males at termination sperm from one testis and one epididymis shall be collected for enumeration of homogenization resistant spermatids and cauda epididymal sperm reserves, respectively. In addition sperm from the cauda epididymis ( or vas deferens) should be collected for VerDate Aug< 1,> 2002 13: 31 Aug 02, 2002 Jkt 197164 PO 00000 Frm 00369 Fmt 8010 Sfmt 8010 Y:\ SGML\ 197164T. XXX pfrm15 PsN: 197164T 370 40 CFR Ch. I ( 7   1   02 Edition) § 799.9380 evaluation of sperm motility and sperm morphology. ( 1) The total number of homogenization resistant testicular sperm and cauda epididymal sperm should be enumerated The method described in the reference under paragraph ( g)( 8) of this section may be used. Cauda sperm reserves can be derived from the concentration and volume of sperm in the suspension used to complete the qualitative evaluations, and the number of sperm recovered by subsequent mincing and/ or homogenizing of the remaining cauda tissue. Enumeration in only control and high dose P and F1 males may be performed unless treatment related effects are observed; in that case, the lower dose groups should also be evaluated. ( 2) An evaluation of epididymal ( or vas deferens) sperm motility should be performed. Sperm should be recovered while minimizing damage ( the evaluation techniques as described in the reference under paragraph ( g)( 8) of this section may be used), and the percentage of progressively motile sperm should be determined either subjectively or objectively. For objective evaluations, an acceptable counting chamber of sufficient depth can be used to effectively combine the assessment of motility with sperm count and sperm morphology. When computer assisted motion analysis is performed, the derivation of progressive motility relies on user defined thresholds for average path velocity and straightness or linear index. If samples are videotaped, or images otherwise recorded, at the time of necropsy, subsequent analysis of only control and high dose P and F1 males may be performed unless treatment related effects are observed; in that case, the lower dose groups should also be evaluated. In the absence of a video or digital image, all samples in all treatment groups should be analyzed at necropsy. ( 3) A morphological evaluation of an epididymal ( or vas deferens) sperm sample shall be performed. Sperm ( at least 200 per sample) should be examined as fixed, wet preparations ( the techniques for such examinations is described in the references under paragraphs ( g)( 4) and ( g)( 8) of this section may be used) and classified as either normal ( both head and midpiece/ tail appear normal) or abnormal. Examples of morphologic sperm abnormalities would include fusion, isolated heads, and misshapen heads and/ or tails. Evaluation of only control and high dose P and F1 males may be performed unless treatment related effects are observed; in that case, the lower dose groups should also be evaluated. ( ii) Offspring. ( A) Each litter should be examined as soon as possible after delivery ( lactation day 0) to establish the number and sex of pups, stillbirths, live births, and the presence of gross anomalies. Pups found dead on day 0 should be examined for possible defects and cause of death. ( B) Live pups should be counted, sexed, and weighed individually at birth, or soon thereafter, at least on days 4, 7, 14, and 21 of lactation, at the time of vaginal patency or balanopreputial separation, and at termination ( C) The age of vaginal opening and preputial separation should be determined for F1 weanlings selected for mating. If there is a treatment related effect in F1 sex ratio or sexual maturation anogenital distance should be measured on day 0 for all F2 pups. ( 5) Termination schedule. ( i) All P and F1 adult males and females should be terminated when they are no longer needed for assessment of reproductive effects. ( ii) F1 offspring not selected for mating and all F2 offspring should be terminated at comparable ages after weaning. ( 6) Gross necropsy. ( i) At the time of termination or death during the study, all parental animals ( P and F1) and when litter size permits at least three pups per sex per litter from the unselected F1 weanlings and the F2 weanlings shall be examined macroscopically for any structural abnormalities or pathological changes. Special attention shall be paid to the organs of the reproductive system. ( ii) Dead pups or pups that are terminated in a moribund condition should be examined for possible defects and/ or cause of death. ( iii) At the time of necropsy, a vaginal smear should be examined to determine the stage of the estrous cycle.

VerDate Aug< 1,> 2002 13: 31 Aug 02, 2002 Jkt 197164 PO 00000 Frm 00370 Fmt 8010 Sfmt 8010 Y:\ SGML\ 197164T. XXX pfrm15 PsN: 197164T 371 Environmental Protection Agency § 799.9380 The uteri of all cohabited females should be examined, in a manner which does not compromise histopathological evaluation, for the presence and number of implantation sites. ( 7) Organ weights. ( i) At the time of termination, the following organs of all P and F1 parental animals shall be weighed: ( A) Uterus ( with oviducts and cervix), ovaries. ( B) Testes, epididymides ( total weights for both and cauda weight for either one or both), seminal vesicles ( with coagulating glands and their fluids), and prostate. ( C) Brain, pituitary, liver, kidneys, adrenal glands, spleen, and known target organs. ( ii) For F1 and F2 weanlings that are examined macroscopically, the following organs shall be weighed for one randomly selected pup per sex per litter ( A) Brain. ( B) Spleen and thymus. ( 8) Tissue preservation. The following organs and tissues, or representative samples thereof, shall be fixed and stored in a suitable medium for histopathological examination. ( i) For the parental ( P and F1) animals ( A) Vagina, uterus with oviducts, cervix and ovaries. ( B) One testis ( preserved in Bouins fixative or comparable preservative), one epididymis, seminal vesicles, prostate and coagulating gland. ( C) Pituitary and adrenal glands. ( D) Target organs, when previously identified, from all P and F1 animals selected for mating. ( E) Grossly abnormal tissue. ( ii) For F1 and F2 weanlings selected for macroscopic examination: Grossly abnormal tissue and target organs, when known. ( 9) Histopathology   ( i) Parental animals Full histopathology of the organs listed in paragraph ( e)( 8)( i) of this section shall be performed for ten randomly chosen high dose and control P and F1 animals per sex, for those animals that were selected for mating. Organs demonstrating treatment related changes shall also be examined for the remainder of the high dose and control animals and for all parental animals in the low and mid dose groups. Additionally reproductive organs of the low and mid dose animals suspected of reduced fertility, e. g., those that failed to mate, conceive, sire, or deliver healthy offspring, or for which estrous cyclicity or sperm number, motility, or morphology were affected, shall be subjected to histopathological evaluation. Besides gross lesions such as atrophy or tumors, testicular histopathological examination should be conducted in order to to identify treatment related effects such as retained spermatids, missing germ cell layers or types, multinucleated giant cells, or sloughing of spermatogenic cells into the lumen. Examination of the intact epididymis should include the caput, corpus and cauda, which can be accomplished by evaluation of a longitudinal section, and should be conducted in order to identify such lesions as sperm granulomas, leukocytic infiltration ( inflammation), aberrant cell types within the lumen, or the absence of clear cells in the cauda epididymal epithelium The postlactational ovary should contain primordial and growing follicles as well as the large corpora lutea of lactation. Histopathological examination should detect qualitative depletion of the primordial follicle population A quantitative evaluation of primordial follicles should be conducted for all F1 females; the number of animals, ovarian section selection, and section sample size should be statistically appropriate for the evaluation procedure used. Examination should include enumeration of the number of primordial follicles, which can be combined with small growing follicles ( see paragraphs ( g)( 1) and ( g)( 2) of this section), for comparison of treated and control ovaries. ( ii) Weanling. For F1 and F2 weanlings, histopathological examination of treatment related abnormalities noted in macroscopic examination should be considered, if such evaluation were deemed appropriate and would contribute to the interpretation of the study data. ( f) Data and reporting   ( 1) Treatment of results. Data shall be reported individually and summarized in tabular form, showing for each test group the VerDate Aug< 1,> 2002 13: 31 Aug 02, 2002 Jkt 197164 PO 00000 Frm 00371 Fmt 8010 Sfmt 8010 Y:\ SGML\ 197164T. XXX pfrm15 PsN: 197164T 372 40 CFR Ch. I ( 7   1   02 Edition) § 799.9380 types of change and the number of animals displaying each type of change. ( 2) Evaluation of study results. ( i) An evaluation of test results, including the statistical analysis, shall be provided This should include an evaluation of the relationship, or lack thereof between the exposure of the animals to the test substance and the incidence and severity of all abnormalities. ( ii) When appropriate, historical control data should be used to enhance interpretation of study results. Historical data, when used, should be compiled presented, and analyzed in an appropriate and relevant manner. In order to justify its use as an analytical tool, information such as the dates of study conduct, the strain and source of the animals, and the vehicle and route of administration should be included. ( iii) Statistical analysis of the study findings should include sufficient information on the method of analysis, so that an independent reviewer/ statistician can reevaluate and reconstruct the analysis. ( iv) In any study which demonstrates an absence of toxic effects, further investigation to establish absorption and bioavailability of the test substance should be considered. ( 3) Test report. In addition to the reporting requirements as specified under 40 CFR part 792, subpart J, the following specific information shall be reported Both individual and summary data should be presented. ( i) Species and strain. ( ii) Toxic response data by sex and dose, including indices of mating, fertility gestation, birth, viability, and lactation; offspring sex ratio; precoital interval, including the number of days until mating and the number of estrous periods until mating; and duration of gestation calculated from day 0 of pregnancy. The report should provide the numbers used in calculating all indices ( iii) Day ( week) of death during the study or whether animals survived to termination; date ( age) of litter termination ( iv) Toxic or other effects on reproduction offspring, or postnatal growth. ( v) Developmental milestone data ( mean age of vaginal opening and preputial separation, and mean anogenital distance, when measured). ( vi) Number of P and F1 females cycling pattern and mean estrous cycle length. ( vii) Day ( week) of observation of each abnormal sign and its subsequent course. ( viii) Body weight and body weight change data by sex for P, F1, and F2 animals. ( ix) Food ( and water, if applicable) consumption, food efficiency ( body weight gain per gram of food consumed and test material consumption for P and F1 animals, except for the period of cohabitation. ( x) Total cauda epididymal sperm number, homogenization resistant testis spermatid number, number and percent of progressively motile sperm, number and percent of morphologically normal sperm, and number and percent of sperm with each identified anomaly. ( xi) Stage of the estrous cycle at the time of termination for P and F1 parental females. ( xii) Necropsy findings. ( xiii) Implantation data and postimplantation loss calculations for P and F1 parental females. ( xiv) Absolute and adjusted organ weight data. ( xv) Detailed description of all histopathological findings. ( xvi) Adequate statistical treatment of results. ( xvii) A copy of the study protocol and any amendments should be included ( g) References. For additional backgound information on this test guideline, the following references should be consulted. These references are available for inspection at the TSCA Nonconfidential Information Center, Rm. NE   B607, Environmental Protection Agency, 401 M St., SW., Washington, DC, 12 noon to 4 p. m., Monday through Friday, except legal holidays. ( 1) Gray, L. E. et al. A dose response analysis of methoxychlor induced alterations of reproductive development and function in the rat. Fundamental and Applied Toxicology. 12: 92   108 ( 1989). ( 2) Heindel, J. J. et al. Ed. Hirshfield, A. N. Histological assessment of ovarian follicle VerDate Aug< 1,> 2002 13: 31 Aug 02, 2002 Jkt 197164 PO 00000 Frm 00372 Fmt 8010 Sfmt 8010 Y:\ SGML\ 197164T. XXX pfrm15 PsN: 197164T 373 Environmental Protection Agency § 799.9410 number in mice as a screen of ovarian toxicity Growth Factors and the Ovary ( Plenum, NY, 1989) pp. 421   426. ( 3) Korenbrot, C. C. et al. Preputial separation as an external sign of pubertal development in the male rat. Biology of Reproduction 17: 298   303 ( 1977). ( 4) Linder, R. E. et al. Endpoints of spermatoxicity in the rat after short duration exposures to fourteen reproductive toxicants Reproductive Toxicology. 6: 491   505 ( 1992). ( 5) Manson, J. M. and Kang, Y. J. Ed. Hayes, A. W. Test methods for assessing female reproductive and developmental toxicology. Principles and Methods of Toxicology ( Raven, NY, 1989). ( 6) Organisation for Economic Co operation and Development, No. 416: Two Generation Reproduction Toxicity Study, Guidelines for Testing of Chemicals. [ C( 83) 44 ( Final)] ( 1983). ( 7) Pederson, T. and Peters, H. Proposal for classification of oocytes and follicles in the mouse ovary. Journal of Reproduction and Fertility. 17: 555   557 ( 1988). ( 8) Seed, J., Chapin, R. E. E. D. Clegg, L. A. Dostal, R. H. Foote, M. E. Hurtt, G. R. Klinefelter, S. L. Makris, S. D. Perreault, S. Schrader, D. Seyler, R. Sprando, K. A. Treinen, D. N. R. Veeramachaneni, and Wise, L. D. Methods for assessing sperm motility, morphology, and counts in the rat, rabbit, and dog: a consensus report. Reproductive Toxicology. 10( 3): 237   244 ( 1996). ( 9) Smith, B. J. et al. Comparison of random and serial sections in assessment of ovarian toxicity. Reproductive Toxicology. 5: 379   383 ( 1991). ( 10) Thomas, J. A. Eds. M. O. Amdur, J. Doull, and C. D. Klaassen. Toxic responses of the reproductive system. Casarett and Doull's Toxicology ( Pergamon, NY, 1991). ( 11) Working, P. K. and Hurtt, M. Computerized videomicrographic analysis of rat sperm motility. Journal of Andrology. 8: 330   337 ( 1987). ( 12) Zenick, H. et al. Ed. Hayes, A. W. Assessment of male reproductive toxicity: a risk assessment approach. Principles and Methods of Toxicology ( Raven, NY, 1994).

[ 62 FR 43824, Aug. 15, 1997, as amended at 64 FR 35078, June 30, 1999]

§ 799.9410 TSCA chronic toxicity.

( a) Scope   ( 1) Applicability. This section is intended to meet the testing requirement of the Toxic Substances Control Act ( TSCA) ( 15 U. S. C. 2601). ( 2) Source. The source material used in developing this TSCA test guideline is the Office of Prevention, Pesticides and Toxic Substances ( OPPTS) harmonized test guideline 870.4100 ( August 1998, final guidelines). This source is available at the address in paragraph ( h) of this section ( b) Purpose. The objective of a chronic toxicity study is to determine the effects of a substance in a mammalian species following prolonged and repeated exposure. A chronic toxicity study should generate data from which to identify the majority of chronic effects and to define long term dose response relationships. The design and conduct of chronic toxicity tests should allow for the detection of general toxic effects, including neurological physiological, biochemical, and hematological effects and exposure related morphological ( pathological) effects ( c) Definitions. The definitions in section 3 of TSCA and in 40 CFR Part 792   Good Laboratory Practice Standards apply to this section. The following definitions also apply to this section. Chronic toxicity is the adverse effects occurring as a result of the repeated daily exposure of experimental animals to a chemical by the oral, dermal, or inhalation routes of exposure. Cumulative toxicity is the adverse effects of repeated doses occurring as a result of prolonged action on, or increased concentration of, the administered test substance or its metabolites in susceptible tissue. Dose in a chronic toxicity study is the amount of test substance administered daily via the oral, dermal or inhalation routes for a period of at least 12 months. Dose is expressed as weight of the test substance ( grams, milligrams) per unit body weight of test animal ( milligram per kilogram), or as weight of the test substance in parts per million ( ppm) in food or drinking water per day. For inhalation exposure, dose is expressed as weight of the test substance per unit volume of air ( milligrams per liter) or as parts per million per day. For dermal exposure, dose is expressed as weight of the test substance ( grams, milligrams) per unit body weight of the test animal ( milligrams per kilogram) or as weight of the substance per unit of surface area ( milligrams per square centimeter) per day. No observed effects level ( NOEL) is the maximum dose used in a study which produces no adverse effects. The NOEL VerDate Aug< 1,> 2002 13: 31 Aug 02, 2002 Jkt 197164 PO 00000 Frm 00373 Fmt 8010 Sfmt 8010 Y:\ SGML\ 197164T. XXX pfrm15 PsN: 197164T


[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Proposed Rules]
[Pages 26518-26519]
[FR Doc No: 2015-11215]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 704

[EPA-HQ-OPPT-2010-0572; FRL-9926-86]

Chemical Substances When Manufactured or Processed as Nanoscale
Materials; TSCA Reporting and Recordkeeping Requirements; Notice of
Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: EPA is holding a public meeting during the comment period of
the proposed rule that published in the Federal Register of April 6,
2015, which involved proposed reporting and recordkeeping requirements
for certain chemical substances when they are manufactured or processed
at the nanoscale. Specifically, that proposal involves one-time
reporting for existing nanoscale materials and one-time reporting for
new discrete nanoscale materials before they are manufactured or
processed. As stated in that proposed rule, the public meeting will
provide an opportunity for further discussion of the proposed
requirements and is intended to facilitate comments on all aspects of
that proposed rule, especially comments on specific issues as
identified in the proposed rule.

DATES: The meeting will be held on June 11, 2015, from 9:00 a.m. to
4:00 p.m. Requests to participate in the meeting must be received on or
before June 1, 2015.
    To request accommodation of a disability, please contact the
technical person listed under FOR FURTHER INFORMATON CONTACT,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

ADDRESSES: The meeting will be held at the East William Jefferson
Clinton Building, Room 1153, 1201 Constitution Avenue NW., Washington,
DC.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Alwood, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8974; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What is the topic of this public meeting?

    In the Federal Register issue of April 6, 2015 (80 FR 18330; FRL-
9920-90), EPA proposed reporting and recordkeeping requirements for
certain chemical substances when they are manufactured or processed at
the nanoscale. EPA is seeking public comment on all aspects of the
proposed rule. In addition, EPA is especially interested in comments
pertaining to the following specific issues identified in Unit V. of
the proposed rule:

1. Identifying the chemical substances that would be subject to
reporting.
2. Distinguishing between nanoscale forms of a reportable chemical
substance.
3. Reporting discrete forms at least 135 days before commencement of
manufacture or processing.
4. Considerations for the Agency's economic analysis.
5. Electronic reporting.
6. Consideration of potential future rulemaking regarding periodic
reporting.

II. How can I request to participate in this meeting?

    Requests to participate in this meeting, as well as any requests
for accommodation of a disability, should be submitted directly to the
technical person listed under FOR FURTHER INFORMATION CONTACT. Do not
submit any information in your request that is considered Confidential
Business Information (CBI), and do not submit any comments. Such
requests must be received on or before June 1, 2015.
    Please remember that your comments must be submitted in accordance
with the instructions in the proposed rule; must be identified by
docket ID number EPA-HQ-OPPT-2010-0572; and must be received on or
before July 6, 2015.

III. How can I access the docket for the Proposed Rule?

    The docket for the proposed rule, identified by docket
identification (ID) number EPA-HQ-OPPT-2010-0572, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional

information about the docket available at http://www.epa.gov/dockets.

    Authority: 15 U.S.C. 2607(a).

    Dated: May 4, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2015-11215 Filed 5-7-15; 8:45 am]
 BILLING CODE 6560-50-P